System and methods for supporting a TAVI procedure

Abstract

A computer implemented method of generating angulation information for a fluoroscopic imager based on a 3D image, comprising: (a) identifying one or more features in a fluoroscopic image acquired with known angulation information; (b) identifying an angulation of projection of the 3D image which would produce a similar feature arrangement; and (c) generating an instruction or an alert to an operator based on a difference between said identified angulation and an angulation used to acquire the fluoroscopic image.

Description

[0001] SYSTEM AND METHODS FOR SUPPORTING A TA VI PROCEDURE

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 530,724 filed on August 4, 2023, U.S. Provisional Patent Application No. 63 / 531,063 filed on August 7, 2023 and U.S. Provisional Patent Application No. 63 / 532,995 filed on August 16, 2023, the contents of which are incorporated herein by reference in their entirety.

[0004] BACKGROUND

[0005] The present invention, in some embodiments thereof, relates to a transcatheter aortic valve implantation (TAVI) procedure and, more specifically, but not exclusively, to systems and methods for supporting a TAVI procedure.

[0006] TAVI, also known as Transcatheter Aortic Valve Replacement (TAVR), is a minimally invasive procedure used to treat medical conditions impacting the aortic valve, for example, aortic valve stenosis, a condition in which the aortic valve becomes narrowed and restricts blood flow from the heart to the rest of the body. TAVI provides an alternative to traditional open-heart surgery for patients who are considered high risk or inoperable for conventional valve replacement. TAVI may be considered in some patients that a medium and / or low risk.

[0007] During a TAVI procedure, a specially designed artificial valve is implanted within the existing diseased aortic valve, without the need for open-heart surgery. The procedure is typically performed in a cardiac catheterization laboratory rather than an operating room.

[0008] TAVI is one example of structural heart catheter-based procedures; other procedure include:

[0009] • Mitral Valve Repair / Replacement:

[0010] • A device delivered via catheter to clip together parts of the mitral valve, treating mitral regurgitation.

[0011] • Transcatheter Mitral Valve Replacement (TMVR): A catheter-based procedure to replace the mitral valve.

[0012] • Percutaneous Left Atrial Appendage Closure (LAAC):

[0013] • Used to reduce the risk of stroke in patients with atrial fibrillation.

[0014] • Devices may be implanted to close off the left atrial appendage.

[0015] • Transcatheter Pulmonary Valve Replacement (TPVR):

[0016] • A procedure to replace a dysfunctional pulmonary valve, often used in congenital heart disease patients. • Patent Foramen Ovale (PFO) Closure:

[0017] • A catheter-based procedure to close a small hole in the heart present at birth that didn’t close naturally.

[0018] • Atrial Septal Defect (ASD) Closure:

[0019] • Closing an abnormal hole between the upper chambers of the heart using a closure device delivered via catheter.

[0020] • Balloon Valvuloplasty:

[0021] • A procedure to widen a narrowed heart valve using a balloon-tipped catheter.

[0022] • Paravalvular Leak Closure:

[0023] • Repairing leaks that occur around the edges of prosthetic valves using occluders delivered via catheter

[0024] The article “Double S-Curve Versus Cusp-Overlap Technique: Defining the Optimal Fluoroscopic Projection for TAVR With a Self-Expanding Device”, doi: 10.1016 / j.jcin.2020.10.033, discusses various ways of selecting a view for fluoroscopy during TAVR procedures and determining s-curves and concludes: “The double S-curve and cusp-overlap methods provide comparable TAVR projections, mostly RAO and CAU. TAVR using the double S-curve model is associated with a high rate of device success and low rate of procedural complications.”

[0025] SUMMARY

[0026] According to some embodiments of the present invention, there is provided a computer implemented method for guiding a performance of an ongoing transcatheter aortic valve implantation (TAVI) procedure, comprising: monitoring 2D images captured during an ongoing TA VI procedure for implantation of a transcatheter heart valve (THV) to detect a start of a step of the TAVI procedure associated with increased likelihood of risk to the subject, triggering a watchdog application configured for monitoring the step of the TAVI procedure for actions associated with likelihood of risk to the subject, monitoring subsequent 2D images to detect an end of the step, and in response to the end of the step, terminating the watchdog application.

[0027] Optionally, the step of the TAVI indicates inflation of a balloon within a native aortic valve and the watchdog is configured for analyzing the 2D images to detect presence of an accessory catheter in an anatomical location linked to higher risk of damage to a conduction system of a heart of the subject.

[0028] Optionally, the step of the TAVI indicates insertion of a guidewire into the left ventricle, and the watchdog is configured for at least one of: analyzing the 2D images to detect a curvature of the guidewire above a threshold, monitoring a balloon on a distal end of the guidewire for protecting, and checking whether a stiff guidewire is present instead of a soft guidewire.

[0029] Optionally, the step of the TAVI indicates presence of a guidewire in the left ventricle, and the watchdog is configured for analyzing the 2D images to detect additional displacement motion of the guidewire greater than a baseline motion of the guidewire due to respiratory and / or cardiac cycles.

[0030] Optionally, the step of the TAVI indicates start of expansion of the THV for deployment, and the watchdog is configured for analyzing the 2D images to detect displacement of the THV in a partially expanded state.

[0031] Optionally, the step of the TAVI indicates displacement of the THV from the descending aorta, across the aortic arch, to the ascending aorta, and the watchdog is configured for monitoring for a mismatch in alignment between the THV and coronary ostia.

[0032] Optionally, the step of the TAVI indicates the THV located in the ascending aorta, and the watchdog is configured for analyzing the 2D images for detecting a mismatch between a pose of the THV and a pose of an annulus line of the native aortic valve.

[0033] Optionally, the step of the TAVI indicates the THV located in the ascending aorta, and the watchdog is configured for analyzing the 2D images for computing a device depth of the THV relative to an annulus line, and monitoring for deviation of the device depth from a target range.

[0034] According to some embodiments of the present invention, there is provided a computer implemented method of guiding a transcatheter aortic valve replacement, comprising: obtaining a 2D image depicting THV in an aorta of a subject, computing a current pose of the THV in the aorta by analyzing at least one marker disposed on the aortic valve prosthesis device depicted in at least one 2D image and according to a pose of an image sensor that captured the 2D image, computing a pose of an annular plane of a 3D image of the subject, and providing the current pose of the THV relative to the pose of the annulus plane.

[0035] Optionally, further comprising generating a presentation of the current pose of the THV relative to the pose of the annulus plane.

[0036] Optionally, the presentation comprises a first visual indication of alignment between the current pose of the THV relative to the pose of the annulus, and a second visual indication of non- alignment between the current pose of the THV relative to the pose of the annulus.

[0037] Optionally, the second visual indication comprises at least two sub-visual indications each indicating a respective direction for changing the current pose of the THV to obtain alignment relative to the pose of the annulus, and / or an amount of the change of the current pose to obtain alignment Optionally, the first visual indication comprises a first color, and the at least two sub-visual indication each comprise a different second color, wherein an intensity of each different second color indicates the amount of the change.

[0038] Optionally, a pose of an image sensor capturing the 2D target image remains constant as the THV is maneuvered in the aorta, and dynamically iteratively performing the obtaining, the computing the current pose of the THV, the computing the pose of the annular plane, and for dynamically and iteratively providing the current pose of the THV relative to the pose of the annulus plane as the THV is maneuvered in the aorta.

[0039] Optionally, the current pose of the THV and the pose of the annulus plane each have 6 degrees of freedom.

[0040] Optionally, the pose of the THV is within a 3D space of the 3D image.

[0041] According to some embodiments of the present invention, there is provided a computer implemented method for updating one or more applications running during a TAVI procedure, comprising: monitoring outputs of one or more applications running during an ongoing TAVI procedure for implantation of a transcatheter heart valve (THV), obtaining at least one indication of at least one outcome of the TAVI procedure, and updating the one or more applications using the at least one indication of the at least one outcome of the TAVI procedure.

[0042] Optionally, the application is implemented as a machine learning (ML) model that is fed a 2D image and generates the output as an outcome of the ML model, and further comprising: creating a new record including the 2D image, and the outcome of the TAVI procedure as a ground truth, updating the ML model using the new record for generating the output for meeting a target outcome.

[0043] Optionally, the indication of the outcome of the TAVI procedure includes at least one of: ECG indicating new conduction disturbance, no significant change in ECG between pre and post procedure, duration of TAVI procedure, complications post TAVI procedure, and indication of successful implant of the THV.

[0044] Optionally, each application is configured for being activated in response to detecting a specific step of the TAVI procedure and terminated in response to end of the specific step, and the indication of the outcome of the TAVI procedure comprises an indication of the outcome of the specific step.

[0045] Optionally, at least one of the one or more applications process 2D fluoroscopic images captured during the TAVI procedure.

[0046] Optionally, the output of at least one of the one or more applications comprises an enhanced visual presentation of the 2D fluoroscopic images. Optionally, the one or more applications are configured for one or more of: (i) detecting presence of an accessory catheter in an anatomical location linked to higher risk of damage to a conduction system of a heart of the subject, (ii) analyzing at least one 2D image to detect a curvature of the guidewire above a threshold, (iii) monitoring a balloon on a distal end of the guidewire for protecting, (iv) checking whether a stiff guidewire is present instead of a soft guidewire, (v) detecting additional displacement motion of the guidewire greater than a baseline motion of the guidewire due to respiratory and / or cardiac cycles, (vii) analyzing at least one 2D image to detect displacement of the THV in a partially expanded state, (viii) analyzing the 2D images for detecting a mismatch between a pose of the THV and a pose of an annulus line of the native aortic valve, and (ix) analyzing the 2D images for computing a device depth of the THV relative to an annulus line, and monitoring for deviation of the device depth from a target range.

[0047] Optionally, the one or more applications are configured for one or more of: (i) planning a path for guiding a THV from a descending aorta for arriving in alignment with coronary ostia of the native aortic valve, (ii) computing a pose for setting of an image sensor for viewing an annulus, (iii) selecting the THV, (iv) pre-procedure recommendation for pacemaker, (v) tracking the annulus, (vi) tracking the accessory catheter, (vii) tracking coronary ostia, (viii) generating a presentation of a pose of the THV relative to a plane of the annulus, (ix) monitoring device depth, (x) motoring alignment of the THV relative to the coronary ostia.

[0048] According to some embodiments of the present invention, there is provided a computer implemented method of guiding a transcatheter aortic valve replacement, comprising: obtaining a 2D image depicting a native valve of a subject, wherein the 2D image excludes an accessory catheter, detecting a calcification signature in the 2D image, selecting a calcification template from a plurality of calcification templates of a 3D image of the subject according to a pose of the image sensor that captured the 2D target image, wherein an anatomical feature is indicated on the 3D image, registering the 2D image to the calcification template, wherein the anatomical features of the 3D image is mapped to a corresponding location of the anatomical feature on the calcification template, and mapping the anatomical feature on the calcification template to the registered 2D image, without using the accessory catheter.

[0049] Optionally, the accessory catheter excluded from the 2D image comprises a pigtail catheter.

[0050] Optionally, the 2D image excludes contrast injection from the accessory catheter.

[0051] Optionally, the anatomical features is selected from: an annulus line, and coronary arteries.

[0052] Optionally, no external marker is depicted in the 2D image, wherein the accessory catheter excluded from the 2D image comprises the external marker. According to some embodiments of the present invention, there is provided a computer implemented method for guiding a performance of an ongoing transcatheter aortic valve implantation (TAVI) procedure, comprising: monitoring 2D images captured during an ongoing TA VI procedure for implantation of a transcatheter heart valve (THV) to detect start of expansion of the THV for deployment, analyzing the 2D images to detect displacement of the THV in a partially expanded state, and indicating such displacement.

[0053] According to some embodiments of the present invention, there is provided a computer implemented method for guiding a performance of an ongoing transcatheter aortic valve implantation (TAVI) procedure, comprising: monitoring 2D images captured during an ongoing TAVI procedure for implantation of a transcatheter heart valve (THV) to detect inflation of a balloon within a native aortic valve, and analyzing the 2D images to detect presence of an accessory catheter in an anatomical location linked to higher risk of damage to a conduction system of a heart of the subject, and indicating such presence.

[0054] According to some embodiments of the present invention, there is provided a computer implemented method for guiding a performance of an ongoing transcatheter aortic valve implantation (TAVI) procedure, comprising: monitoring 2D images captured during an ongoing TAVI procedure for implantation of a transcatheter heart valve (THV) to detect insertion of a guidewire into the left ventricle, and at least one of: analyzing the 2D images to detect a curvature of the guidewire above a threshold, monitoring a balloon on a distal end of the guidewire for protecting, and checking whether a stiff guidewire is present instead of a soft guidewire, and indicating such detection, monitoring, and / or presence.

[0055] According to some embodiments of the present invention, there is provided a computer implemented method for guiding a performance of an ongoing transcatheter aortic valve implantation (TAVI) procedure, comprising: monitoring 2D images captured during an ongoing TAVI procedure for implantation of a transcatheter heart valve (THV) to detect presence of a guidewire in the left ventricle, and analyzing the 2D images to detect additional displacement motion of the guidewire greater than a baseline motion of the guidewire due to respiratory and / or cardiac cycles, and indicating such additional displacement.

[0056] According to some embodiments of the present invention, there is provided a computer implemented method for guiding a performance of an ongoing transcatheter aortic valve implantation (TAVI) procedure, comprising: monitoring 2D images captured during an ongoing TAVI procedure for implantation of a transcatheter heart valve (THV) to detect displacement of the THV from the descending aorta, across the aortic arch, to the ascending aorta, and analyzing the 2D images to detect monitoring for a mismatch in alignment between the THV and coronary ostia, and indicating such mismatch.

[0057] According to some embodiments of the present invention, there is provided a computer implemented method for guiding a performance of an ongoing transcatheter aortic valve implantation (TAVI) procedure, comprising: monitoring 2D images captured during an ongoing TA VI procedure for implantation of a transcatheter heart valve (THV) to detect the THV located in the ascending aorta, and analyzing the 2D images for detecting a mismatch between a pose of the THV and a pose of an annulus line of the native aortic valve, and indicating such mismatch.

[0058] According to some embodiments of the present invention, there is provided a computer implemented method for guiding a performance of an ongoing transcatheter aortic valve implantation (TAVI) procedure, comprising: monitoring 2D images captured during an ongoing TAVI procedure for implantation of a transcatheter heart valve (THV) to detect the THV located in the ascending aorta, and analyzing the 2D images for computing a device depth of the THV relative to an annulus line, and monitoring for deviation of the device depth from a target range, and indicating such deviation.

[0059] Optionally, the indicating is presented on a display.

[0060] Optionally, the analyzing the 2D image is performed by a machine learning model.

[0061] According to some embodiments of the present invention, there is provided a computer implemented method of computing an area of a conduction system at risk during a transcatheter procedure on a subject, comprising: analyzing a combination of at least one personal parameter of the subject and at least one procedure parameter of the transcatheter procedure for computing an area of a conduction system at risk for being damaged during the transcatheter procedure, and providing the area of the conduction system at risk.

[0062] Optionally, the area of the conduction system at risk is presented as an overlay on 2D images captured during the transcatheter procedure.

[0063] Optionally, the area of the conduction system at risk is determined on a 3D image obtained pre-procedure, and further comprising projecting the area of the conduction system to a 2D plane registered with a 2D image obtained during the procedure.

[0064] Optionally, the analyzing is performed by feeding the combination of at least one personal parameter of the subject and at least one procedure parameter of the transcatheter procedure into a machine learning model, and obtaining the area of the conduction system at risk as an outcome of the machine learning model, wherein the machine learning model is trained on a training dataset of records, each record including the combination of at least one personal parameter of a sample individual, and at least one procedure parameter of the transcatheter procedure performed on the sample individual, and a ground truth indication of the conduction system at risk.

[0065] Optionally, the at least one personal parameter includes one or more of: subject demographics, mapping data including a location of the conduction system computed using a 3D image obtained pre-procedure, patient history, and ECG conduction analysis.

[0066] Optionally, the at least one procedure parameter includes one or more of: procedure related incidence of conduction disturbances, procedure specific tools related incidence of conduction disturbances, type and size of the tools used in the procedure, indication of stress-strain of the tools being used (e.g., extracted from imaging during procedure), indication of the stress-strain of the tools being used extracted from a strain stress sensor on the tool itself during procedure, and ECG conduction analysis during the procedure.

[0067] Optionally, the area of the conduction system at risk includes one or more of: sinoatrial (SA) node, atrioventricular (AV) node, the non bifurcating bundle (including the HIS bundle), the penetrating bundle, the bifurcating bundle, the right bundle, the left bundle, and / or the branches of the left bundle (e.g., approximated location).

[0068] Optionally, 2D images captured during the transcatheter procedure are dynamically fed into the machine learning model for monitoring the area of the conduction system at risk.

[0069] Optionally, further comprising determining a risk level for at least one region of the area of the conduction system, and visually coding the at least one region according to the risk level.

[0070] Optionally, further comprising monitoring that a pressure applied by a transcatheter device to the area of the conduction system at risk remains below a threshold.

[0071] Optionally, further comprising monitoring that a distance between a transcatheter device and the area of the conduction system remains above below a distance threshold.

[0072] Optionally, further comprising monitoring that an accessory catheter is not present during certain parts of the procedure that may damage the area of the conduction system at risk and / or that the accessory catheter is not placed in proximity to the area of the conduction system at risk where the accessory catheter can cause damage.

[0073] Optionally, further comprising generating a recommendation for a safe location for placement of the accessory catheter for not damaging or reducing risk of damage to the area of the conduction system at risk, below a risk threshold.

[0074] Optionally, further comprising generating, in response to the monitoring of the accessory location, a first indication of safe expansion of a THV, or a second indication of unsafe expansion of the THV. Optionally, further comprising in response to detecting a location of a transcatheter device likely to damage the area of the conduction system at risk, generating instructions for a mini-robot that is attached to the transcatheter device, for blocking further movement of the transcatheter device.

[0075] Optionally, further comprising computing a target range for a device depth for deployment of a THV according to the area of the conduction system at risk.

[0076] Optionally, the transcatheter procedure is selected from a group including: TAV repair, Mitral Valve repair, Tricuspid valve repair, TAV replacement, Mitral Valve replacement, and Tricuspid valve replacement.

[0077] According to some embodiments of the present invention, there is provided a computer implemented method of displaying an area of a conduction system at risk during a transcatheter procedure on a subject, comprising: analyzing a 3D image obtained pre-procedure for computing an area of a conduction system at risk for being damaged during the transcatheter procedure, and presenting the conduction system at risk as an overlay on 2D images captured during the transcatheter procedure.

[0078] Optionally, the area of the conduction system at risk includes one or more of: sinoatrial (SA) node, atrioventricular (AV) node, the non bifurcating bundle (including the HIS bundle), the penetrating bundle, the bifurcating bundle, the right bundle, the left bundle, and / or the branches of the left bundle.

[0079] According to some embodiments of the present invention, there is provided a computer implemented method of reducing risk of conductance disturbance during a transcatheter procedure on a subject, comprising: computing an area of a conduction system at risk during the transcatheter procedure, and monitoring that a pressure applied by a transcatheter device to the area of the conduction system at risk remains below a threshold.

[0080] Optionally, the threshold is 10 gram (gr).

[0081] According to some embodiments of the present invention, there is provided a computer implemented method of reducing risk of conductance disturbance during a transcatheter procedure on a subject, comprising: computing an area of a conduction system at risk during the transcatheter procedure and avoiding applying a pressure by a transcatheter device to the area of the conduction system at risk above a threshold.

[0082] Optionally, the threshold is lOgr.

[0083] According to some embodiments of the present invention, there is provided a computer implemented method of guiding a transcatheter procedure on a subject, comprising: analyzing a 3D image obtained pre-procedure for computing an area of a conduction system at risk for being damaged during the transcatheter procedure, and presenting the conduction system at risk as an overlay on 2D images captured during the transcatheter procedure.

[0084] According to some embodiments of the present invention, there is provided a computer implemented method of guiding a transcatheter procedure on a subject, comprising: computing an area of a conduction system at risk during the transcatheter procedure and computing a target range for a device depth for deployment of a THV according to the area of the conduction system at risk.

[0085] Optionally, an area of a conduction system at risk comprises analyzing a 3D image obtained pre-procedure.

[0086] According to some embodiments of the present invention, there is provided a computer implemented method of guiding a transcatheter procedure on a subject, comprising: computing an area of a conduction system at risk during the transcatheter procedure, and monitoring that an accessory catheter is not present during certain parts of the procedure that may damage the area of the conduction system at risk and / or that the accessory catheter is not placed in proximity to the area of the conduction system at risk where the accessory catheter can cause damage.

[0087] Optionally, computing an area of a conduction system at risk comprises analyzing a 3D image obtained pre-procedure.

[0088] According to some embodiments of the present invention, there is provided a computer implemented method of guiding a transcatheter procedure on a subject, comprising: computing an area of a conduction system at risk during the transcatheter procedure, and monitoring that a distance between a transcatheter device and the area of the conduction system remains below a distance threshold.

[0089] Optionally, computing an area of a conduction system at risk comprises analyzing a 3D image obtained pre-procedure.

[0090] According to some embodiments of the present invention, there is provided an apparatus comprising at least one processor configured to execute a method according to any one of the aforementioned embodiments of methods.

[0091] Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below.

[0092] Example 1. A computer implemented method of generating angulation information for a fluoroscopic imager based on a 3D image, comprising:

[0093] (a) identifying one or more features in a fluoroscopic image acquired with known angulation information; (b) identifying an angulation of projection of the 3D image which would produce a similar feature arrangement; and

[0094] (c) generating an instruction or an alert to an operator based on a difference between said identified angulation and an angulation used to acquire the fluoroscopic image.

[0095] Example 2. A method according to example 1, wherein identifying one or more features comprises identifying an annulus line.

[0096] Example 3. A method according to any of the preceding examples, wherein identifying one or more features comprises identifying one or more of a cusp nadir, a calcification signature, a coronary feature and an aortic outline.

[0097] Example 4. A method according to any of the preceding examples, comprising receiving a confirmation by user of said identified one or more feature.

[0098] Example 5. A method according to any of the preceding examples, wherein said generating comprises generating a corrected fluoroscopic s-curve for imaging using said fluoroscopic imager.

[0099] Example 6. A method according to any of the preceding examples, comprising generating a device s-curve based on identifying a device deformation in said fluoroscopic image as compared to an expected device geometry.

[0100] Example 7. A method according to any of examples 1-5, comprising generating both a fluoroscopic s-curve of a valve annulus and a device s-curve and determining an intersection between the s-curves.

[0101] Example 8. A method according to any of examples 5-7, wherein said alert comprises an alert regarding the imager angulation matching or not matching an s-curve.

[0102] Example 9. A method according to any of examples 1-8, wherein said instruction comprises an instruction to said imager for repositioning thereof.

[0103] Example 10. A method according to any of examples 1-9, wherein said identifying comprises identifying with only one contrast material injection to an aortic region for said identifying.

[0104] Example 11. A method according to any of examples 1-10, wherein said identifying comprises identifying after a user correction for a pose mismatch between a patient pose during said fluoroscopic imaging and while acquiring said 3D image.

[0105] Example 12. A method according to any of the preceding examples, wherein said 3D images comprises a preoperative CT image used for calculating an s-curve. Example 13. A method according to any of the preceding examples, comprising verifying by a user of said instruction or alert by performing another fluoroscopic imaging using said instruction.

[0106] Example 14. A method according to any of the preceding examples, comprising using said instruction to correct data to be projected onto fluoroscopic images acquired by said imager.

[0107] Example 15. A method according to any of the preceding examples, wherein (a)-(c) are performed during a structural heart catheter-based procedure.

[0108] Example 16. A method according to any of the preceding examples, wherein said identifying an angulation comprises comparing said fluoroscopic image or a feature thereon to a set of projections of said 3D image, each with an associated angulation of projection.

[0109] Example 17. A method according to any of the preceding examples, comprising triggering a recalculation of said angulation information in response to contrast injection or suspected or indicated movement of said fluoroscopic imager.

[0110] Example 18. A method according to Example 17, further comprising iterating (b) and (c).

[0111] Example 19. A computer implemented method of generating angulation information for a fluoroscopic imager based on a 3D image, comprising:

[0112] (a) identifying a device in a fluoroscopic image acquired with known angulation information;

[0113] (b) identifying an angulation of the device based on an expected device geometry;

[0114] (c) generating at least one angulation value or an s-curve of such values for imaging the device in a parallel view.

[0115] Example 20. A method according to example 19, wherein said expected device geometry is retrieved from a data store based on an identification of the device and / or based on user input.

[0116] Example 21. A method according to example 19 or example 20, comprising generating an intersection between said angulation value or s-curve and a fluoroscopic s-curve of a feature of interest in a cardiac procedure.

[0117] Example 22. The method according to any one of examples 19-21, wherein the feature of interest is selected from: annulus line, coronary arteries, calcification signature, cusp or portion thereof, and aortic outline.

[0118] Example 23. A system for generating angulation information for a fluoroscopic imager based on a 3D image, comprising: at least one processor executing a code for:

[0119] (a) identifying one or more features in a fluoroscopic image acquired with known angulation information; (b) identifying an angulation of projection of the 3D image which would produce a similar feature arrangement; and

[0120] (c) generating an instruction or an alert to an operator based on a difference between said identified angulation and an angulation used to acquire the fluoroscopic image.

[0121] Example 24. A system according to example 23, wherein identifying one or more features comprises identifying an annulus line.

[0122] Example 25. A system according to example 23 or 24, wherein identifying one or more features comprises identifying one or more of a cusp nadir, a calcification signature, a coronary feature and an aortic outline.

[0123] Example 26. A system according to any one of examples 23-25, comprising receiving a confirmation by user of said identified one or more feature.

[0124] Example 27. A system according to any one of examples 23-26, wherein said generating comprises generating a corrected fluoroscopic s-curve for imaging using said fluoroscopic imager.

[0125] Example 28. A system according to any one of examples 23-27, comprising generating a device s-curve based on identifying a device deformation in said fluoroscopic image as compared to an expected device geometry.

[0126] Example 29. A system according to any one of examples 23-28, comprising generating both a fluoroscopic s-curve of a valve annulus and a device s-curve and determining an intersection between the s-curves.

[0127] Example 30. A system according to any one of examples 23-29, wherein said alert comprises an alert regarding the imager angulation matching or not matching an s-curve.

[0128] Example 31. A system according to any one of examples 23-30, wherein said instruction comprises an instruction to said imager for repositioning thereof.

[0129] Example 32. A system according to any one of examples 23-31, wherein said identifying comprises identifying with only one contrast material injection to an aortic region for said identifying.

[0130] Example 33. A system according to any one of examples 23-32, wherein said identifying comprises identifying after a user correction for a pose mismatch between a patient pose during said fluoroscopic imaging and while acquiring said 3D image.

[0131] Example 34. A system according to any one of examples 22-33, wherein said 3D images comprises a preoperative CT image used for calculating an s-curve.

[0132] Example 35. A system according to any one of examples 23-34, comprising code for verifying by a user of said instruction or alert by performing another fluoroscopic imaging using said instruction. Example 36. A system according to any one of examples 23-35, comprising code for using said instruction to correct data to be projected onto fluoroscopic images acquired by said imager.

[0133] Example 37. A system according to any one of examples 23-36, wherein (a)-(c) are performed during a structural heart catheter-based procedure.

[0134] Example 38. A system according to any one of examples 23-37, wherein said identifying an angulation comprises comparing said fluoroscopic image or a feature thereon to a set of projections of said 3D image, each with an associated angulation of projection.

[0135] Example 39. A system according to any one of examples 23-38, comprising code for triggering a recalculation of said angulation information in response to contrast injection or suspected or indicated movement of said fluoroscopic imager.

[0136] Example 40. A system according to example, 39, further comprising code for iterating (b) and (c).

[0137] Example 41. A system for generating angulation information for a fluoroscopic imager based on a 3D image, comprising: at least one processor executing a code for:

[0138] (a) identifying a device in a fluoroscopic image acquired with known angulation information;

[0139] (b) identifying an angulation of the device based on an expected device geometry;

[0140] (c) generating at least one angulation value or an s-curve of such values for imaging the device in a parallel view.

[0141] Example 42. A system according to example 41, wherein said expected device information is retrieved from a data store based on an identification of the device and / or based on user input.

[0142] Example 43. A system according to example 41 or example 42, comprising code for generating an intersection between said angulation value or s-curve and a fluoroscopic s-curve of a feature of interest in a cardiac procedure.

[0143] Example 44. The system according to any one of examples 41-43, wherein the feature of interest is selected from: annulus line, coronary arteries, calcification signature, cusp or portion thereof, and aortic outline.

[0144] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0145] BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

[0146] Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

[0147] In the drawings:

[0148] FIG. 1 is a pictorial illustration of an operating room equipped with a system for implanting and / or guiding an aortic valve prosthesis device, in accordance with some embodiments of the present invention;

[0149] FIG. 2 is a block diagram of components of a system for guiding a TAVI procedure, in accordance with some embodiments of the present invention;

[0150] FIG. 3 is a flowchart of a process for guiding a TAVI procedure, in accordance with some embodiments of the present invention;

[0151] FIG. 4 is a flowchart of a process for triggering a watchdog application during the TAVI procedure, in accordance with some embodiments of the present invention;

[0152] FIG. 5 is a flowchart of a method for computing pose of the THV relative to pose of the annulus, in accordance with some embodiments of the present invention;

[0153] FIG. 6 is a flowchart of a method of updating applications used during the TAVI procedure, in accordance with some embodiments of the present invention;

[0154] FIGs. 7A-7C are schematics of features that may be identified on a 3D image as part of the pre-procedure planning step, in accordance with some embodiments of the present invention;

[0155] FIG. 8 is an image of a GUI for monitoring a conduction system of a heart of a patient, in accordance with some embodiments of the present invention;

[0156] FIG. 9 is a schematic of a protective balloon, in accordance with some embodiments of the present invention;

[0157] FIG. 10 is a schematic of a sensing component of a mini-robot that includes a displacement sensor, that is connected to a guidewire and / or sheath for monitoring movement of the guidewire and / or sheath and / or for maintaining the position of the guidewire and / or sheath, in accordance with some embodiments of the present invention; FIG. 11 is a schematic of an exemplary GUI indicating device depth and / or tilt, in accordance with some embodiments of the present invention;

[0158] FIG. 12 is a schematic of an annulus line and / or a conduction system displayed (e.g., as an overlay) over a fluoroscopic image during the procedure, optionally within a GUI, in accordance with some embodiments of the present invention;

[0159] FIG. 13 is a schematic indicating a computed conduction system, and a table of empirical data obtained from subjects for computing the conduction system, in accordance with some embodiments of the present invention;

[0160] FIG. 14 is a schematic of a LAAO transcatheter procedure, in accordance with some embodiments of the present invention;

[0161] FIG. 15 is a flowchart of a method of annulus line generation, in accordance with some embodiments of the invention; and

[0162] FIG. 16 is a flowchart of a method of generating fluoroscopy and / or device s-curves, in accordance with some embodiments of the invention.

[0163] DETAILED DESCRIPTION

[0164] The present invention, in some embodiments thereof, relates to a transcatheter aortic valve implantation (TAVI) procedure and, more specifically, but not exclusively, to systems and methods for supporting a TAVI procedure.

[0165] As used herein, the term valve prosthesis refers to the aortic valve prosthesis which is being used in the TAVI procedure.

[0166] As used herein, the term transcatheter heart valve (THV), valve prosthesis, prosthetic valve, and aortic valve prosthesis device, are used interchangeable.

[0167] As used herein, the phrase indication of correctness may refer to presenting, optionally with a graphical user interface (GUI), one or more of: a binary indication of whether a current state (e.g., orientation of the valve prosthesis) is correct or not (e.g., green means correct, red means not correct), and / or multiple categories indicating correctness and / or how to fix to obtain correctness (e.g., green means correct, varying intensity of red means rotate clockwise optionally indicating the amount of rotation, varying shades of blue means rotate counterclockwise optionally indicating the amount of rotation).

[0168] As used herein, the term aortic outline may refer to, and / or may be interchanged with, one or more of: outline of a portion of an aorta, contour of a portion of the aorta (e.g., lower boundary of a contrast filled region), aortic valve outline, aortic annulus outline, annulus contour, and contour of the annulus. In some cases, two or more of the aforementioned terms may be interchanged and / or are used interchangeably herein.

[0169] As used herein, a feature of interest in a cardiac procedure includes, for example, one or more of: annulus line, coronary arteries, calcification signature, cusp or portion thereof, and aortic outline. The cardiac procedure may be TAVI, or other structural heart catheter-based procedures described herein.

[0170] It is to be understood that the TAVI procedure is an exemplary, not necessarily limiting procedure. Embodiments described herein with reference to TAVI may be adapted for other transcatheter procedures for treatment of other structural heat diseases and / or other procedures (e.g., ablation, implantation of pacemaker), which may be on other valves and / or on other tissues of the body. For example, for treatment of left atrial appendage (e.g., left atrial appendage occlusion procedure (LAAO)), mitral, pulmonary and / or tricuspid valve, such as by valvuloplasty, clipping and / or valve replacements. Examples of other procedure include: TAV repair, Mitral Valve repair, Tricuspid valve repair, TAV replacement, Mitral Valve replacement, and Tricuspid valve replacement. For example, for the case of LAAO, the pre-planning step described herein may include the feature(s) that information from the 3D image (e.g., CT) may be used for trans septal alignment - corresponding to the coronary alignment step described herein with reference to the TAVI procedure. Information from the 3D image (.g., CT) may be used for tracking the Left Atrial Appendage (LAA) opening (OS) on fluoroscopic images - corresponding to the annulus line tracking step described herein with reference to the TAVI procedure. Monitoring of LAAO depth and / or width on fluoroscopic image - corresponding to the device depth and / or tilt (e.g., pose, orientation) described herein with reference to the TAVI procedure.

[0171] An aspect of some embodiments of the present invention relates to systems, methods, computing devices, and / or code instructions for providing tools for assisting and / or guiding the performance of a TAVI procedure. At least some tools described herein are designed to reduce manual evaluation by the operator, increase patient safety, and / or enable an operator to visualize data that cannot be visualized using standard approaches. At least some tools described herein are designed to free up the cognitive resources of the operator, to focus on performing the specific tasks related to implanting the THV in the correct location, rather than on other secondary tasks which have been automated using tools described herein. At least some tools described herein enable using a “single view” of the THV, depicted in a 2D image such as a fluoroscopic image, to guide the THV, rather than requiring the operator to iteratively adjust the image sensor to different poses for capturing 2D images of the THV. At least some tools described herein include monitoring for safety risks. At least some tools described herein generate a presentation (e.g., within a graphical user interface (GUI)) for improving alignment of the THV with the coronary ostia.

[0172] The automated features described herein improve upon the existing TAVI process, and / or change the existing TAVI process, as detailed below. A brief review of the existing TAVI procedure is now provided, to aid the reader in understanding and appreciating the automated tools described herein, and / or how the automated tools relate to the existing TAVI procedure.

[0173] The TAVI procedure, also known as Transcatheter Aortic Valve Replacement (TAVR), is a minimally invasive surgical technique used to treat aortic valve stenosis, a condition where the aortic valve narrows, restricting blood flow from the heart to the rest of the body. The TAVI procedure involves replacing the damaged aortic valve with a new prosthetic valve.

[0174] An exemplary TAVI procedure typically includes the following steps:

[0175] 1. Patient Preparation: The patient is prepared for the procedure by undergoing various tests, including echocardiography, computed tomography (CT) scans, and angiography, to assess the severity of the aortic valve stenosis and determine the most appropriate approach for the TAVI procedure.

[0176] 2. Catheter Insertion: Once the access site is chosen, a sheath is inserted into the artery or the apex of the heart, and a catheter is advanced through the blood vessels until it reaches the aortic valve.

[0177] 3. Balloon Valvuloplasty (Optional): Before inserting the new valve, a balloon may be used to stretch open the narrowed aortic valve. This step is known as balloon valvuloplasty, and it helps to create space for the new valve.

[0178] 4. Deployment of the New Valve: The collapsible THV is mounted on a catheter. Typically, the THV is self-expandable, but other designs of the THV are based on a balloon for expansion. The catheter carrying the valve is carefully guided to the location of the diseased aortic valve under 2D fluoroscopic image guidance, by periodically injecting contrast into the aorta. Once in place, THV is released (or the balloon is inflated), expanding the new valve and pressing it into position, effectively pushing the old valve leaflets aside.

[0179] 5. Valve Placement Validation: After deployment, the medical team ensures that the new valve is functioning correctly and that there are no significant leaks or complications.

[0180] 6. Catheter Removal: Once the valve is securely in place and functioning well, the catheter and other instruments are carefully removed.

[0181] It's important to note that the steps may vary slightly depending on, for example, the model of THV used, the specific approach, and / or the medical center performing the TAVI procedure. An aspect of some embodiments of the present invention relates to systems, methods, computing devices, and / or code instructions for guiding the performance of a TA VI procedure by activating and terminating watchdog applications. The watchdog applications are designed to enhance patient safety and procedural efficiency during the implantation of a THV by closely monitoring specific steps associated with an increased likelihood of risk to the subject, for example, damage to a conduction system of the heart and / or damage to other tissues of the heart. 2D images captured during the ongoing TAVI procedure are automatically analyzed to detect the initiation of a step in the TAVI procedure that is correlated with an elevated risk to the subject. Upon identifying such a step, a watchdog application is triggered, specifically designed to monitor the actions taken during this high-risk phase of the TAVI procedure. The watchdog application remains actively engaged, scrutinizing subsequent 2D images to recognize the conclusion of the previously detected high-risk step. Once the end of the step is confirmed, the watchdog application responds promptly by terminating its monitoring activity. Medical professionals conducting TAVI procedures may gain real-time insights into potentially hazardous phases of the operation. This timely intervention allows them to take necessary precautions and implement appropriate safety measures during the critical steps, reducing the likelihood of complications and improving patient outcomes. Activating and terminating specific watchdog applications according to current steps of the TAVI procedure improves computational performance of a computing device executing the watchdogs. Watchdogs, each optionally designed for a single specific monitoring task (or a small number of monitored tasks) are activated when needed, and terminated when not needed, thereby optimizing use of the processing resources and / or memory resources of the executing computing device.

[0182] An aspect of some embodiments of the present invention relates to systems, methods, computing devices, and / or code instructions for providing a “single view” feature for the operator during the TAVI procedures. The “single view” features allows the operator to maintain the same pose of the image sensor for capturing the 2D image as the THV is maneuvered in the aorta, for example, from the descending aorta to the ascending aorta. The “single view” feature is in contrast to existing approaches where the operator is required to change the pose of the image sensor multiple times to evaluate the pose of the THV, which is prone to error, inaccurate, and / or time consuming. The “single view” features is enabled by using a 2D image depicting THV in an aorta of a subject. A current pose of the THV in the aorta is computed by analyzing marker(s) disposed on the aortic valve prosthesis device depicted in the 2D image and according to a pose of an image sensor that captured the 2D image. A pose of an annular plane of a 3D image of the subject (e.g., CT scan obtained pre-procedure) is computed. The current pose of the THV relative to the pose of the annulus plane is provided, for example, as a presentation presented on a display. The operator may use the presentation to dynamically adjust the pose of the THV to substantially match the pose of the annulus plane without having to change the pose of the image sensor.

[0183] An aspect of some embodiments of the present invention relates to systems, methods, computing devices, and / or code instructions for avoiding or reducing the use of an accessory catheter, such as a pigtail catheter. The accessory catheter, typically used in standard TAVI procedures for injecting contrast or as a marker, is not introduced into (or used for less time in) the patient's aorta, native aortic valve, or left ventricle during the TAVI procedure. Instead, some embodiments utilize non-contrast 2D fluoroscopic images, identifying calcification deposits to track anatomical structures (e.g., annulus, commissures, coronary ostia) projected from 3D images obtained pre-procedure using a CT scan. By avoiding or reducing the use of the accessory catheter during the TAVI procedure, potential risks associated with tissue damage, such as to the heart's conduction system, are minimized. This may prevent complications like conduction block, which could necessitate the need for a pacemaker implantation.

[0184] An aspect of some embodiments of the present invention relates to systems, methods, computing devices, and / or code instructions for dynamically updating one or more applications being utilized during the TAVI procedure for improvement of the TAVI procedure. These applications may be medical software and / or automated tools used to aid the medical team during the procedure, as described herein. One or more indications of the outcome of the TAVI procedure are obtained. These indications may be related to various parameters, such as the successful positioning of the THV, procedural complications, or other relevant metrics that influence the procedure's success. Based on the obtained outcome indications, the one or more applications may be dynamically updated, in real-time or near real-time. These updates may improve the performance of the applications, optimize decision-making, and / or enhance overall procedural efficiency and safety. Such updates might involve algorithm adjustments, parameter modifications, and / or integration of new information into the applications. By continuously monitoring and updating applications during the TAVI procedure, improved patient outcomes and / or reduced procedural risks may be obtained. The real-time adaptability may ensure that the latest information and / or insights are promptly incorporated into the applications, making the TAVI procedure safer and more effective. The updated applications may help improve outcomes of the TAVI procedure. For example, the application for monitoring device depth may learn that certain device depths are associated with higher risk of post implantation dislodgement while other device depths have lower risk of post implantation dislodgement, and may shift the recommended target device depth to obtain better outcomes. In another example, the application that computes a path for obtaining an alignment between the THV and coronary ostia may learn a better path to obtain a better alignment. In yet another example, the application that tracks the location of the guidewire and / or accessory catheter may learn that certain actions by the operator for moving and / or placing the guidewire and / or accessory catheter lead to higher risk of conduction disturbance and may warn the operator when such actions are detected.

[0185] At least some embodiments described herein address the medical problem of increasing patient safety during a TAVI, and / or improving patient outcome during the TAVI, for example, reduced risk of conduction system problems, improved placement of the TAVI (e.g., to reduce or prevent paravalvular leaks), and the like. At least some embodiments described herein address the technical problem of providing automated computer-based tools and / or medical devices to assist an operator (e.g., interventional cardiologist) in performing the TAVI procedure. The problem may relate to analyzing 2D images of the valve prosthesis to obtain information which the operator cannot visually see by manual inspection of the image, and / or information which is difficult to see by manual inspection of the image. The majority of the procedure is done without automated assisting tools, using limited viewing capabilities, and based on the operator’s experience. Currently, much of the procedure is performed manually, using a 2D fluoroscopic imaging device, which is repeatedly moved and placed at different locations and / or different poses. The catheter with the valve prosthesis is moved by controlling wires from outside the body. Contrast dye is injected to improve visualization.

[0186] At least some embodiments described herein improve upon existing approaches for performing the TAVI procedure, by providing automated tools and / or medical devices for reducing risk of damage to the patient, and / or improvement navigation of the valve prosthesis, and / or improved visualization.

[0187] While Transcatheter Aortic Valve Implantation (TAVI) is generally considered a safe and effective procedure, there can be certain challenges or complications associated with its performance. Here are some of the potential problems that can arise during or after a TAVI procedure, which at least some embodiments described herein may reduce or prevent:

[0188] • Valve-related complications: Complications related to the artificial valve itself. These may include valve malpositioning, valve migration, valve embolization (detachment of the valve), valve leakages, or valve dysfunction. At least some embodiments described herein may improve image based navigation of the valve, which may reducing these complications.

[0189] • Conduction disturbances: During TAVI, the electrical conduction system of the heart may be damaged, leading to conduction abnormalities such as heart block or arrhythmias. This can require further intervention, such as implantation of a pacemaker or other devices, to maintain normal heart rhythm.

[0190] • Paravalvular leak: In some cases, a small amount of blood may leak around the artificial valve, which is known as paravalvular leak. While mild leakage may not cause significant symptoms or require intervention, moderate to severe leakage can affect the overall effectiveness of the procedure and may necessitate further treatment or valve replacement.

[0191] • Kidney injury: The use of contrast dye and hemodynamic changes during the procedure can potentially impact kidney function, particularly in patients with pre-existing kidney disease. Close monitoring and appropriate management of hydration and contrast dye usage can help minimize the risk of kidney injury.

[0192] • Access site complications: The puncture or incision site where the catheter is inserted can sometimes lead to bleeding, hematoma (accumulation of blood), infection, or damage to blood vessels or nerves.

[0193] • Sizing and correct 3D positioning: Proper sizing and accurate positioning of the artificial valve are critical for the success of TAVI. If the valve is undersized or oversized, it can result in inadequate sealing, paravalvular leaks, or impaired valve function.

[0194] • Paravalvular leaks: Paravalvular leaks occur when there is a small gap or insufficient sealing between the artificial valve and the native valve annulus, allowing blood to leak around the prosthesis. Although efforts are made to minimize leaks, they can occur in a small percentage of cases. Severe paravalvular leaks may require additional interventions or valve replacement to improve the overall function and prevent complications such as heart failure or hemolysis (red blood cell breakdown).

[0195] • Pressure gradients and turbulent flow: The aim of TAVI is to restore normal blood flow across the aortic valve and reduce pressure gradients. However, in some cases, residual pressure gradients may persist, limiting the effectiveness of the procedure. Additionally, the implantation of an artificial valve can disrupt the normal flow patterns within the aorta, leading to turbulent flow. While mild turbulence is generally well-tolerated, significant turbulence can increase the risk of complications such as blood clots or hemolysis.

[0196] • Thrombosis: Thrombosis refers to the formation of blood clots on or around the artificial valve. This can occur due to factors such as inadequate anticoagulation therapy, improper valve sizing or positioning, or underlying patient conditions. Clots can obstruct the valve, impede blood flow, and increase the risk of stroke or other cardiovascular events.

[0197] • Valve mechanical failures: These failures may include structural valve deterioration, valve leaflet dysfunction, or fracture of the valve frame. Such failures can lead to valve dysfunction, impaired blood flow, or other complications. Close monitoring and regular follow-up appointments are important to detect any signs of valve mechanical failures early on.

[0198] • Fluoroscopy is a real-time X-ray imaging technique that allows the medical team to visualize the catheters, wires, and devices used during the procedure. While fluoroscopy is crucial for guiding the TAVI procedure, it can expose both patients and healthcare professionals to ionizing radiation. Excessive exposure to ionizing radiation can have harmful effects, including an increased risk of radiation-induced tissue damage and the potential development of long-term complications such as cancer. It is essential to minimize radiation exposure during TAVI while still ensuring adequate visualization and guidance for the medical team.

[0199] • Pre-planning complications in Transcatheter Aortic Valve Implantation (TAVI) refer to challenges or issues that may arise during the pre-procedural assessment and planning phase. These complications can impact the overall success of the procedure and patient outcomes.

[0200] • Human resources: Since TAVI is complicated and risky, highly trained and specialized operators perform TAVI. Such highly trained and specialized operators are in very limited supply, which limits the availability of the TAVI procedure.

[0201] At least some embodiments described herein address the aforementioned medical and / or technical problem(s), and / or improve upon the aforementioned prior approaches, by providing automated tools and / or medical devices, that, for example, reduce risk to the patient (e.g., reduce damage to the conduction system), improve navigation of the valve prosthesis, improve visualization, reducing injection of contrast (e.g., by automatically tracking the annulus of the aortic valve), reduce amount of radiation exposure by reducing number of x-rays, enabling less skilled staff to perform procedures, enabling a single view during the procedure (in contrast to existing approaches where different views are required to evaluate the position of the valve prosthesis) and / or other features as described herein.

[0202] An aspect of some embodiments of the present invention relates to methods, systems, computing devices, and / or code instructions for computing an area of a conduction system at risk during a transcatheter procedure on a subject. A combination of one or more personal parameters of the subject and one or more procedure parameters of the transcatheter procedure are analyzed, for computing an area of a conduction system at risk for being damaged during the transcatheter procedure. The area of the conduction system at risk may be presented on a display, for example, as an overlay of images (e.g., 2D fluoroscopic images) captured during the procedure (e.g., in real time or near real time).

[0203] At least some embodiments described herein address the technical problem of reducing risk of damage to a conduction system of a heart of a subject, by computing the area of the conduction system at risk, and presenting the area as an overlay on fluoroscopic images, which may enable an operator to avoid the area and / or be more careful when moving devices near the area.

[0204] The conduction system of the heart is responsible for generating and coordinating the electrical impulses that regulate the heart's rhythm and ensure its proper functioning. During a transcatheter procedure, which is a minimally invasive heart procedure, there is a potential risk of damage to the heart's conduction system.

[0205] Transcatheter procedures involve inserting a catheter (a thin, flexible tube) through a blood vessel and guiding it to the heart to perform various interventions, such as repairing heart valves, closing defects, or treating other cardiovascular conditions.

[0206] One specific transcatheter procedure that poses a risk to the conduction system is the transcatheter aortic valve replacement (TAVR) or transcatheter aortic valve implantation (TAVI). During this procedure, a new artificial valve is delivered through a catheter and implanted within the aortic valve, which is the main valve that regulates blood flow from the heart to the rest of the body. The new valve is usually placed inside the old, damaged valve.

[0207] The conduction system of the heart lies close to the aortic valve, and the placement of the new valve, as well as movement of tools during the procedure, can sometimes disrupt or injure the conduction pathways. The three main conduction pathways affected during a TAVR / TAVI procedure are the atrioventricular (AV) node, the bundle of His with its subcomponents (the nonbifurcating bundle and the penetrating bundle) and the bifurcating bundle that gives rise to the left and right bundles. The AV node is responsible for relaying electrical signals from the atria (upper chambers) to the ventricles (lower chambers), while the bundle of His helps transmit these signals further into the ventricles.

[0208] Potential complications and damage to the conduction system during a transcatheter procedure include:

[0209] • Heart block: If the electrical signals are interrupted or delayed due to the procedure, it can lead to heart block, where the transmission of impulses from the atria to the ventricles is impaired. Heart block can be temporary or permanent, depending on the severity of the damage. • Arrhythmias: Disruption of the conduction system can lead to irregular heart rhythms (arrhythmias) such as atrial fibrillation, ventricular tachycardia, or ventricular fibrillation.

[0210] • Pacemaker requirement: In cases where the damage to the conduction system is significant and causing symptoms like dizziness, fainting, or heart failure, a permanent pacemaker may be implanted to help regulate the heart's rhythm.

[0211] An aspect of some embodiments of the invention relates to correcting for (and / or identifying the magnitude of) a pose difference of a patient between pre-operative 3D imaging and intra-operative imaging (e.g., fluoroscopy). Optionally, the correction is based on identifying one or more features in the intra-operative image and identifying that feature in the pre-operative 3D image and finding a pose change which explains a difference in the image / orientation of such feature(s). In some embodiments of the invention, the feature comprises an annulus line detected using an injection of contrast material. Optionally or additionally, the feature(s) comprises calcifications (e.g., a calcification signature) or optionally the origin and path of the coronary arteries, or close by osseous structure such as vertebras or ribs or artificial objects, such as sutures or other implants.

[0212] An aspect of some embodiments of the invention relates to calculating an S -curve for determining a preferred angle of view for a cardiac procedure. In some embodiments of the invention, the S-curve is calculated based on a previously acquired 3D image, such as a CT image. In one example an annulus line is compared to an annulus line as expected from the previously acquired 3D image and a correction is calculated by finding a patient (or organ) posture change that recreates this discrepancy.

[0213] In TAVR procedures, especially where the annulus is a target of the imaging, the fluoroscopic s-curve is a fluoroscopic s-curve of the annulus, where the annulus image on the fluoroscopic image will not be deformed by the angulation of the fluoroscopic imager. In other SHD procedures, other objects in the heart, for example, other valve annuluses or cardiac features, may be the target of the fluoroscopic s-curve.

[0214] In some embodiments of the invention, an annulus line is created using a single injection of contrast material, without a “perfect” fluoroscopy imaging orientation. In one example, an annulus line is created based on the extent of contrast material in a fluoroscopy image (e.g., when most of the contrast material has not passed the valve and / or left the aortic root). The layout of this annulus line may be corrected based on a mapping between the fluoroscopy image and a previously acquired 3D image. This can be achieved, for example, by identifying in the fluoroscopic image the aortic annulus cusps’ silhouette and noting the C arm angulation around the patient. Then a reverse search is performed on simulated 2D projections of the CT data set, and identifying a simulation (and its associated angulations of projection) which result in a matching silhouette. In another example, the nadirs of 2 or more cusps are identified on the fluoroscopic image and a similar search method may be used to find a matching projection orientation of the 3D image that produces a similar configuration. Once a mapping is available between the fluoroscopic image and the CT image (or other pre-operative 3D image), the new mapped CT (in patient fluoroscopic coordinate system is optionally investigated to generate a new corrected S curve of all C arm positions that will yield a parallax view of the aortic valve.

[0215] While it may be less preferable to provide multiple injections, multiple images at different angles, optionally from a same imager (e.g., moved quickly or with multiple or extended injections) or using multiple simultaneous imagers, may be used as well. Optionally, the results from each image may be weighted. Optionally or additionally, the images are used to generate a stereoscopic-like feature (based on two views), for example a surface, which is compared to the 3D image.

[0216] In some embodiments of the invention, the annulus line is recalculated (e.g., and reshown on the fluoroscopy image) in response to contrast material injection (e.g., on either side of the valve) and / or in response to fluoroscopy parameters, especially angle or field of view, or in response to patient movement. A user input (e.g., a “patient moved” indication) may also be used to retrigger annulus line creation and optionally recalculation of the s-curve.

[0217] Optionally, the C-arm is repositioned according to the recommended angle on the s-curve (e.g., to match a pre-planning s-curve calculated based on the previously acquired 3D image). In some embodiments of the invention, the c-arm is moved automatically in response to such input, or is moved manually and an indicator (e.g., visual and / or auditory) indicates when the c-arm is correctly repositioned.

[0218] In some embodiments, having the c arm in an angulation that is member of the recalculated fluoroscopic S curve is indicated to the operator, or optionally, when the C arm angulation is not a member of the S curve (hence the image of the valve is not parallax) an alert or indicator is provided to the operator (optionally on the fluoroscopic image), showing, for example, a lack of parallax and / or a degree and / or direction of lack of parallax.

[0219] In some embodiments of the invention, a device s-curve is calculated, in addition to or instead of a fluoroscopic annulus s-curve. Optionally, a double s-curve (e.g., showing an intersection of the fluoroscopy s-curve and device s-curve) is calculated and used to guide fluoroscopy / c-arm adjustment.

[0220] In some embodiments of the invention, the device and / or double s-curve are used to guide device placement. For example, the imaging system can compare an actual measured device size and shape to expected measurements (e.g., based on catalog number or other user input). This measurement can be at one or more points along the path of the device. These measurements can be used to identify the S curve of the device at its current location. Optionally, when the device (closed or at various stages of opening) is within the area of the aortic valve, the momentary angulation of the C arm together with the device dimensions are used as an input to create a device S curve (e.g., the family of all C arm angulations that will yield a parallax view of the device).

[0221] In some embodiments of the invention, the intersection of the aortic valve fluoroscopic corrected S curve with the fluoroscopy generated device curve, is calculated and conveyed to the operator. Generally, if the C arm is angulated according to the parameters of this intersection between the two S-curves (aortic valve and device), the projected 2D fluoroscopic image will be parallax to both the device and the aortic valve and the image is effectively undeformed.

[0222] In some embodiments of the invention, the device s-curve is calculated based a current image and without reference to a pre-procedural image. In other embodiments, during planning, a device path is simulated and may be used for preplanning and calculation of an s-curve. However, this plan may be incorrect due to one or both of change in patient pose and variations in the actual path taken by the implanting system. Rather than calculate a de-novo s-curve, in such cases the actual device orientation may be used to correct the preplanned s-curve. It is noted that the s-curve may be different for different positions of the device.

[0223] In some embodiments of the invention, once a correct s-curve is created, measurement of the device on the fluoroscopy image may be used for device positioning, for example, a pitch of the device (rotation around an axis in the image plane and perpendicular to the device axis), a yaw of the device (rotation around an axis perpendicular to the image plane) and / or a depth relative to the annulus. Such information may be used, for example, to abort, to retract and advance the device and / or for other methods of repositioning.

[0224] It is noted that a useful definition of the double s-curve which may be used by some embodiments of the invention is a view in which both the aortic valve annulus and delivery catheter planes are displayed perpendicularly on fluoroscopy without foreshortening. Optimal projection according to the cusp-overlap technique may be retrospectively generated by overlapping the right and left cups on the multidetector computed tomography annular plane.

[0225] It is noted that by calculating an s-curve and recommending viewing angles, a procedure based on fluoroscopy can be made simpler, faster and / or with reduced error, due to the fluoroscopy image being less distorted and / or lack of need to reposition the fluoroscopy imager.

[0226] It is understood that similar embodiments can be used for minimally invasive procedure that patients have a pre procedure 3D image (e.g. CT, MRI) and fluoroscopy is used in the procedure. For example, other cardiac procedures such as mitral, tricuspid and atrial appendage interventions, other structural heart procedures and / or other vascular or surgical procedures where fluoroscopy is used.

[0227] Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and / or methods set forth in the following description and / or illustrated in the drawings and / or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0228] The present invention may be a system, a method, and / or a computer program product. The computer program product may include a computer readable storage medium (or media) having computer readable program instructions thereon for causing a processor to carry out aspects of the present invention.

[0229] The computer readable storage medium can be a tangible device that can retain and store instructions for use by an instruction execution device. The computer readable storage medium may be, for example, but is not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. A non-exhaustive list of more specific examples of the computer readable storage medium includes the following: a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), a static random access memory (SRAM), a portable compact disc read-only memory (CD-ROM), a digital versatile disk (DVD), a memory stick, a floppy disk, and any suitable combination of the foregoing. A computer readable storage medium, as used herein, is not to be construed as being transitory signals per se, such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through a waveguide or other transmission media (e.g., light pulses passing through a fiber-optic cable), or electrical signals transmitted through a wire.

[0230] Computer readable program instructions described herein can be downloaded to respective computing / processing devices from a computer readable storage medium or to an external computer or external storage device via a network, for example, the Internet, a local area network, a wide area network and / or a wireless network. The network may comprise copper transmission cables, optical transmission fibers, wireless transmission, routers, firewalls, switches, gateway computers and / or edge servers. A network adapter card or network interface in each computing / processing device receives computer readable program instructions from the network and forwards the computer readable program instructions for storage in a computer readable storage medium within the respective computing / processing device.

[0231] Computer readable program instructions for carrying out operations of the present invention may be assembler instructions, instruction-set-architecture (ISA) instructions, machine instructions, machine dependent instructions, microcode, firmware instructions, state-setting data, or either source code or object code written in any combination of one or more programming languages, including an object oriented programming language such as Smalltalk, C++ or the like, and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The computer readable program instructions may execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection may be made to an external computer (for example, through the Internet using an Internet Service Provider). In some embodiments, electronic circuitry including, for example, programmable logic circuitry, field-programmable gate arrays (FPGA), or programmable logic arrays (PLA) may execute the computer readable program instructions by utilizing state information of the computer readable program instructions to personalize the electronic circuitry, in order to perform aspects of the present invention.

[0232] Aspects of the present invention are described herein with reference to flowchart illustrations and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and / or block diagrams, and combinations of blocks in the flowchart illustrations and / or block diagrams, can be implemented by computer readable program instructions.

[0233] These computer readable program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions / acts specified in the flowchart and / or block diagram block or blocks. These computer readable program instructions may also be stored in a computer readable storage medium that can direct a computer, a programmable data processing apparatus, and / or other devices to function in a particular manner, such that the computer readable storage medium having instructions stored therein comprises an article of manufacture including instructions which implement aspects of the function / act specified in the flowchart and / or block diagram block or blocks.

[0234] The computer readable program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be performed on the computer, other programmable apparatus or other device to produce a computer implemented process, such that the instructions which execute on the computer, other programmable apparatus, or other device implement the functions / acts specified in the flowchart and / or block diagram block or blocks.

[0235] The flowchart and block diagrams in the Figures illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present invention. In this regard, each block in the flowchart or block diagrams may represent a module, segment, or portion of instructions, which comprises one or more executable instructions for implementing the specified logical function(s). In some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and / or flowchart illustration, and combinations of blocks in the block diagrams and / or flowchart illustration, can be implemented by special purpose hardware-based systems that perform the specified functions or acts or carry out combinations of special purpose hardware and computer instructions.

[0236] Reference is now made to FIG. 1, which is a pictorial illustration of an operating room equipped with a system for guiding a TAVI procedure, in accordance with some embodiments of the present invention. Reference is also made to FIG. 2, which is a block diagram of components of a system 100 for guiding a TAVI procedure, in accordance with some embodiments of the present invention. Reference is also made to FIG. 3, which is a flowchart of a process for guiding a TAVI procedure, in accordance with some embodiments of the present invention. Reference is also made to FIG. 4, which is a flowchart of a process for triggering a watchdog application during the TAVI procedure, in accordance with some embodiments of the present invention. Reference is also made to FIG. 5, which is a flowchart of a method for computing pose of the THV relative to pose of the annulus, in accordance with some embodiments of the present invention. Reference is also made to FIG. 6, which is a flowchart of a method of updating applications used during the TAVI procedure, in accordance with some embodiments of the present invention. Reference is also made to FIGs. 7A-7C, which are schematics of features that may be identified on a 3D image as part of the pre-procedure planning step, in accordance with some embodiments of the present invention. Reference is also made to FIG. 8, which is an image of a GUI 802 for monitoring a conduction system of a heart of a patient, in accordance with some embodiments of the present invention. Reference is also made to FIG. 9, which is a schematic of a protective balloon 902, in accordance with some embodiments of the present invention. Reference is also made to FIG. 10, which is a schematic of a sensing component 1002 of a mini-robot that includes a displacement sensor, that is connected to a guidewire and / or sheath 1004 for monitoring movement of the guidewire and / or sheath 1004 and / or for maintaining the position of the guidewire and / or sheath 1004, in accordance with some embodiments of the present invention. Reference is also made to FIG. 11, which is a schematic of an exemplary GUI indicating device depth 1102 and / or tilt 1104, in accordance with some embodiments of the present invention. Reference is also made to FIG. 12, which is a schematic of an annulus line 1202 and / or a conduction system 1204 displayed (e.g., as an overlay) over a fluoroscopic image 1206 during the procedure, optionally within a GUI, in accordance with some embodiments of the present invention. Reference is also made to FIG. 13, which is a schematic 1302 indicating a computed conduction system, and a table 1304 of empirical data obtained from subjects for computing the conduction system, in accordance with some embodiments of the present invention. Reference is also made to FIG. 14, which is a schematic 1402 depicting a LAAO transcatheter procedure, in accordance with some embodiments of the present invention.

[0237] Referring now back to FIG. 1, system 300 is depicted as being used guiding (e.g., automated tools, medical devices) the TAVI procedure. An exemplary environment for system 300 is now described. A catheter 15 may be percutaneously inserted into a living body 17 of a patient lying on a gurney 19. Catheter 15 may be controlled and manipulated by operator 70 (e.g., a surgeon). An imaging system 30 may be used to obtain an image of the inside of the body of the patient for guiding the aortic valve prosthesis device. For example, an image of the aorta in which the prosthetic valve is located. Imaging system 30 is shown to optionally include an image source 32, which may use, for example, magnetic resonance imaging (MRI), X-ray computed tomography (CT), fluoroscopy (i.e., 2D x-rays) and / or any suitable imaging technique to obtain the image(s) of the interior of the body, such as of the aorta. The image (e.g., of the aorta) may be digitized and / or sent to system 300 for processing. An image 18 (e.g., a fluoroscopic image of the aorta, enhanced image such as overlay tracking the annulus) may be displayed to operator 70 on an output display 50, and / or a copy of the image may be sent to system 300 for processing and / or generating a GUI 60 (e.g., as described herein). Referring now back to FIG. 2, system 100 may implement the acts of the method described with reference to FIGs. 3-6 optionally by one or more hardware processor(s) 102 of a computing device 104 executing code instructions stored in a memory 106.

[0238] Computing device 104 may be implemented as, for example, a client terminal, a server, a virtual server, a radiology workstation, a catheterization laboratory workstation, a virtual machine, a computing cloud, a mobile device, a desktop computer, a thin client, a Smartphone, a Tablet computer, a laptop computer, a wearable computer, glasses computer, and a watch computer. Computing device 104 may include an advanced visualization process that sometimes is add-on to a catheterization laboratory workstation and / or other devices for presenting computation results and / or for presenting overlays on fluoroscopic images, e.g., as described herein.

[0239] Computing device 104 may include locally stored software that performs one or more of the acts described with reference to FIGs. 3-6, and / or may act as one or more servers (e.g., network server, web server, a computing cloud, virtual server) that provides services (e.g., one or more of the acts described with reference to FIGs. 3-6) to one or more client terminals 108 (e.g., remotely located catheterization laboratory workstation) over a network 110, for example, providing software as a service (SaaS) to the client terminal(s) 108, providing an application for local download to the client terminal(s) 108, as an add-on to a web browser and / or a medical imaging viewer application, and / or providing functions using a remote access session to the client terminals 108, such as through a web browser.

[0240] Different architectures based on system 100 may be implemented. In one example, computing device 104 provides centralized services. Computing device 104 may obtain images from an image repository 122A (e.g., fluoroscopic images) storing images from each of multiple different imaging devices 112 (e.g., fluoroscopic machines). Each imaging device includes an image sensor that captures the images. The images 122A may be provided to computing device 104 for centralized analysis (e.g., one or more analysis features as described herein). Images 122A may be provided to computing device 104, for example, via an API, a local application, over a network 110, and / or transmitted using a suitable transmission protocol. The outcome of the analysis may be provided, for example, to client terminal(s) 108 for presentation on a display such as within a GUI and / or other indications (e.g., audio and the like) and / or local storage, stored in an electronic medical record (e.g., hosted by server 118), and / or stored by computing device 104.

[0241] In another architecture, computing device 104 provides localized services, by locally analyzing the images 122 A. For example, computing device 104 is implemented as code executed by a processor of a catheterization laboratory workstation that analyses fluoroscopic image captured by a fluoroscopic machine of the catheterization laboratory. System 100 and / or computing device 104 described with reference to FIG. 2 may include and / or be implemented as system 300 described with reference to FIG. 1.

[0242] Imaging device 112 provides the medical images. Optionally, imaging device 112 is a 2D fluoroscopic and / or x-ray machine, as commonly used in catheterization labs (e.g., cardiac).

[0243] Imaging device 112 described with reference to FIG. 2 may include and / or be implemented as imaging system 30 and / or imaging source 32 described with reference to FIG. 1.

[0244] Images 122A may be stored in a data repository 114 and / or data storage device 122, for example, a storage server, a computing cloud, virtual memory, and a hard disk. Images 122 A may be analyzed as described herein. It is noted that images 122A may be stored by a server 118, accessible by computing device 104 over network 110.

[0245] Computing device 104 may receive images 122A using one or more data interfaces 120, for example, a wire connection (e.g., physical port), a wireless connection (e.g., antenna), a local bus, a port for connection of a data storage device, a network interface card, other physical interface implementations, and / or virtual interfaces (e.g., software interface, virtual private network (VPN) connection, application programming interface (API), software development kit (SDK)), and / or a network interface 124.

[0246] Processor(s) 102 may be implemented, for example, as a central processing unit(s) (CPU), a graphics processing unit(s) (GPU), field programmable gate array(s) (FPGA), digital signal processor(s) (DSP), and application specific integrated circuit(s) (ASIC). Processor(s) 102 may include one or more processors (homogenous or heterogeneous), which may be arranged for parallel processing, as clusters and / or as one or more multi core processing units.

[0247] Memory 106 (also referred to herein as a program store, and / or data storage device) may store code instruction for execution by hardware processor(s) 102, for example, a random access memory (RAM), read-only memory (ROM), and / or a storage device, for example, non-volatile memory, magnetic media, semiconductor memory devices, hard drive, removable storage, and optical media (e.g., DVD, CD-ROM). For example, memory 106 may store code 106A that implement one or more acts and / or features of the method described with reference to FIGs. 3-6.

[0248] Computing device 104 may include a data storage device 122 for storing data, for example, an image repository 122A storing images (e.g., 2D, 3D), machine learning (ML) model(s) repository 122B storing one or more ML models described herein, watchdog repository 122C storing watchdog applications, and / or other code for other features, as described herein. Data storage device 122 may be implemented as, for example, a memory, a local hard-drive, a removable storage device, an optical disk, a storage device, and / or as a remote server and / or computing cloud (e.g., accessed over network 110). Exemplary ML model architectures include a detector architecture, a classifier architecture, and / or a pipeline combination of detector(s) and / or classifier(s), for example, statistical classifiers and / or other statistical models, neural networks of various architectures (e.g., convolutional, fully connected, deep, encoder-decoder, recurrent, transformer, graph), support vector machines (SVM), logistic regression, k-nearest neighbor, decision trees, boosting, random forest, a regressor, and / or any other commercial or open source package allowing regression, classification, dimensional reduction, supervised, unsupervised, semi- supervised, and / or reinforcement learning. Machine learning models may be trained using supervised approaches and / or unsupervised approaches.

[0249] Computing device 104 may include network interface 124 for connecting to network 110, for example, one or more of, a network interface card, a wireless interface to connect to a wireless network, a physical interface for connecting to a cable for network connectivity, a virtual interface implemented in software, network communication software providing higher layers of network connectivity, and / or other implementations. Computing device 104 may access one or more remote servers 118 using network 110.

[0250] It is noted that data interface 120 and network interface 124 may exist as two independent interfaces (e.g., two network ports), as two virtual interfaces on a common physical interface (e.g., virtual networks on a common network port), and / or integrated into a single interface (e.g., network interface). Computing device 104 may communicate using network 110 (or another communication channel, such as through a direct link (e.g., cable, wireless) and / or indirect link (e.g., via an intermediary computing device such as a server, and / or via a storage device) with one or more of:

[0251] * Client terminal(s) 108, for example, when computing device 104 acts as a server providing image analysis services (e.g., SaaS) to remote catheterization laboratory workstations, for analyzing remotely obtained images 122A (e.g., fluoroscopic images) for computing of the state of marker(s) of an aortic valve prosthesis device and / or commissure alignment state of the aortic valve prosthesis device.

[0252] * Server 118, for example, implemented in association with a PACS, which may store captured images 122A used to compute the state of marker(s) of an aortic valve prosthesis device and / or commissure alignment state of the aortic valve prosthesis device.

[0253] * Imaging device 112 and / or data repository 114 that store images acquired by imaging device 112.

[0254] Computing device 104 and / or client terminal(s) 108 and / or server(s) 118 may include and / or may be in communication with a user interface(s) 126 that includes a mechanism designed for a user to enter data (e.g., enter patient data) and / or to view data (e.g., trend, direction and / or amount of rotation to perform) such as an overlay over the fluoroscopic image indicating location of markers and / or overlay of the conduction system of the heart and / or overlay of the annulus line over the images. Exemplary user interfaces 126 include, for example, one or more of, a touchscreen, a display, a keyboard, a mouse, and voice activated software using speakers and microphone.

[0255] Referring now back to FIG. 3, features which are performed prior to the procedure are now described.

[0256] At 302, patients to undergo an aortic valve replacement procedure may be selected.

[0257] Patient selection for aortic valve replacement (AVR) may involve a comprehensive evaluation to determine the suitability of the procedure and / or the optimal approach for each patient. Patient selection for AVR may be a complex process that requires a multidisciplinary approach involving cardiologists, cardiac surgeons, and other specialists. The goal may be to identify the most appropriate candidates for AVR and tailor the treatment approach to each individual patient's needs and circumstances.

[0258] Examples of factors considered in patient selection include:

[0259] • Aortic Valve Disease: AVR is typically indicated for patients with significant aortic valve disease, such as aortic stenosis (narrowing of the valve opening) or aortic regurgitation (leakage of blood back into the heart). The severity of the valve disease, as assessed through echocardiography or other imaging modalities, is an important consideration.

[0260] • Symptoms and Functional Status: The presence and severity of symptoms associated with aortic valve disease may be assessed, including shortness of breath, chest pain, fatigue, dizziness, or fainting. Functional status, determined by the patient's ability to perform daily activities, exercise tolerance, and quality of life, may be evaluated.

[0261] • Prognosis and Fife Expectancy: The patient's overall prognosis and life expectancy are considered. This assessment helps determine the potential benefits of AVR in terms of improving symptoms, quality of life, and long-term survival.

[0262] At 304, the patient may be assessed to determine whether the aortic valve is to be replaced surgically or using TAVI.

[0263] The size, calcification, and suitability for repair or replacement may be assessed. Other factors, such as the presence of a bicuspid valve, may also influence the choice of treatment.

[0264] The patient's overall health and / or surgical risk may be evaluated. This includes an assessment of comorbidities, such as lung disease, kidney disease, and prior cardiac surgeries, as well as the patient's age and frailty. The risk assessment helps determine the most appropriate surgical approach, such as traditional open -heart surgery or minimally invasive techniques, including transcatheter procedures.

[0265] Patient preferences, values, and / or expectations may be taken into account. The decisionmaking process may involve a thorough discussion between the patient, the cardiac surgeon, and other members of the healthcare team. Patients may be educated about the benefits, risks, and expected outcomes of AVR, as well as alternative treatment options.

[0266] TAVI requires accessing the heart through the blood vessels, typically via the femoral artery in the groin. Adequate vascular access is crucial for a successful procedure. The size, quality, and calcification of the blood vessels may be evaluated to determine if an alternative access site, such as the transapical (through the chest wall) or transaortic (through a small incision in the chest) approach, may be necessary.

[0267] At 306, preoperative imaging studies, such as echocardiography, cardiac CT, or MRI scans, may be performed to evaluate the anatomy and function of the aortic valve.

[0268] Alternatively or additionally, 3D images (e.g., CT, MRI) of the aortic valve, aortic root, and / or aorta (e.g., ascending, aortic arch, descending) may be obtained.

[0269] At 308, a risk assessment of the patient may be performed. The risk assessment may be for assessing risk of the TAVI procedure. When the risk assessment indicates that the patient is suitable for TAVI, the method may proceed, for example, to the pre-processing step. When the risk assessment indicates that the patient is unsuitable for TAVI, the patient may be referred to surgery.

[0270] Risk assessment may be based on the specific conduction system of the patient as inferred from the anatomy of the patient. For example, nerves of the conduction system may pass through different location of the heart of different patients, making what is safe for one patient (e.g., deployment of the THV in a certain orientation) risky for another patient.

[0271] Optionally, the area of conduction system at risk, is computed. The area of conduction system at risk may be computed by feeding in a combination of at least one personal parameter of the subject and at least one procedure parameter of the transcatheter procedure into a machine learning model. The area of the conduction system at risk may be obtained as an outcome of the machine learning model. The machine learning model may be trained on a training dataset of records. Each record includes the combination of one or more personal parameters of a sample individual, and one or more procedure parameters of the transcatheter procedure performed on the sample individual, and a ground truth indication of the conduction system at risk.

[0272] The personal parameter(s) of the subject may include the location of the conduction system (e.g., AV node, bundle of His and its components) computed from the 3D image (e.g., CT scan). Since the anatomical location of the conduction system or parts thereof (e.g., passing in and / or in proximity to the membranous septum) may vary between individuals, the location for each patient undergoing the transcatheter procedure may be computed using the CT scan.

[0273] Examples of personal parameters include one or more of the following: patient demographics (e.g., age, biological gender), mapping data (e.g., location of conduction system computed using the 3D image obtained pre-procedure), patient history (e.g., smoking history, previous procedures, cardiovascular history, family history, medications), and ECG conduction analysis (e.g., manual and / or automated, such a detection of arrhythmia and conduction disturbances, risk of arrhythmia, other ECG abnormalities).

[0274] Examples of procedure parameter(s) include one or more of the following: procedure related incidence of conduction disturbances, procedure specific tools related incidence of conduction disturbances, type and size of the tools used in the procedure, indication of stress-strain of the tools being used (e.g., extracted from imaging during procedure), indication of the stressstrain of the tools being used extracted from a strain stress sensor on the tool itself during procedure, and ECG conduction analysis during the procedure.

[0275] The area of the conduction system at risk may include one or more regions of the conduction system which are at risk of being damaged during the transcatheter procedure, for example, due to application of high pressure by a tool used during the procedure, and / or due to puncture by a tool during the procedure.

[0276] The area of the conduction system at risk may include one or more of: sinoatrial (SA) node, atrioventricular (AV) node, the HIS bundle including the non-bifurcating bundle, the penetrating bundle, the bifurcating bundle, the right bundle, the left bundle, and / or the branches of the left bundle (e.g., approximated location).

[0277] Optionally, the location of the SA node, is estimated to be at the juncture of the superior vena cava with the upper portion of the crista terminalis of the right atrium. Alternatively or additionally, the location of AV node is estimated to be the middle of the infra-septal recess. Alternatively or additionally, the location of AV node is estimated to be within the intraventricular septum adjacent to the septal commissure between the posterior and the anterior leaflets of the mitral valve.

[0278] Alternatively or additionally, the location of AV node is estimated to be within the intraventricular septum at the left most proximal part of the posterior leaflet adjacent to the septal commissure between the posterior and the anterior leaflets of the mitral valve. Optionally, the location of the non bifurcating bundle (including the HIS bundle), is estimated to be between the estimated location of the AV node to the most posterior part of the floor of the membranous septum.

[0279] Optionally, the location of the penetrating bundle, is estimated to be between the most posterior part of the floor of the membranous septum to the most anterior part of the floor of the membranous septum tracking over the floor of the membranous septum.

[0280] Optionally, the location of the bifurcating bundle, is estimated to be toward the left ventricle next to the most anterior part of the floor of the membranous septum.

[0281] Optionally, the location of the right bundle, is estimated to be across from the estimated location of the penetrating bundle on the right ventricle wall.

[0282] Optionally, the estimated location of the left bundle, is on the left ventricle toward the apex.

[0283] Optionally, the estimated location of the left anterior bundle, is estimated to be below the location of the left bundle oriented toward the anterior papillary muscle.

[0284] Optionally, the estimated location of the left posterior bundle, is estimated to be below the location of the left bundle toward the posterior papillary muscle.

[0285] Optionally, the estimated location of the left central bundle, is estimated to be below the location of the bifurcating bundle oriented toward the apex of the left ventricle with a path that passes between the two papillary muscles.

[0286] Optionally, the location of the floor of the membranous septum is detected. This path as well as the estimated location of the AV Node is identifying may be fed one or more of them into the ML model to determine the area of the conduction system at risk.

[0287] In other embodiments, the area of conduction system at risk, is computed from a subject anatomical image, e.g., based on one of more rules and / or identification of anatomical structures in the heart. The anatomical structures in the heart may be computing by ML methods and / or computer vision.

[0288] The location of the membranous septum may be detected, for example, by obtaining orientation of a NRL and / or depth of the aorta. Using this data the membranous septum may be detected, for example, according to the calculations described with reference to Figs. 7A-C of the paper "Vulnerability of the ventricular conduction axis during transcatheter aortic valvar implantation: A translational pathologic study” by Tretter et al. dated Jan 2023, incorporated herein in its entirety. The location of the membranous septum may be computed, for example, according to the publication “The atrioventricular conduction axis and the aortic root — Inferences for transcatheter replacement of the aortic valve”, by Yolanda Macias et at., Clinical Anatomy. 2022;35: 143-154, incorporated herein by reference in its entirety. The location of one or more regions of the conduction system, which may be used for determination of the area of the conduction system at risk may be computed, for example, according to the following exemplary process, using the 3D image (e.g., CT) which may be obtained pre-procedure:

[0289] 1. Identification of the nadir of each of the aortic cusps (the right coronary cusp, the left coronary cusp, and the non-coronary cusp), which may be used for defining the Virtual Aortic Annulus plane.

[0290] 2. Identifying the location of the right and the left fibrous trigones, which are fibrous connective tissue regions near the aortic cusps.

[0291] 3. Identifying the triangular attachment of the atrial septum. The triangular attachment of the atrial septum may serve as an anatomical reference point.

[0292] 4. Drawing a first line in a posterior anterior direction from step #3 (e.g., across the Aortic Root).

[0293] 5. Drawing a second line connecting the center of the non-coronary cusp to the area of apposition of apposition (e.g., where the left and right coronary cusps meet).

[0294] 6. Measuring the rotation angle of the aorta by recording the angle between the center of non- coronary cusp to apposition area (step #5) and the atrial septum to posterior-anterior direction (step# 4).

[0295] 7. Comparing the angle of rotation (of step #6) to nomograms and / or guideline indicating normal and / or expected values.

[0296] 8. Identifying the width of the roof of the infero-septal recess at the level of the virtual aortic valve plane.

[0297] 9. Identifying the location of the apex of the infero-septal recess in section of the preprocedure CT that are parallel and lower (toward the apex of the left ventricle) than the apex.

[0298] 10. Measuring the virtual aortic valve plane.

[0299] One or more of the following, which may be used for computing the area of the conduction system at risk (e.g., fed into the ML model as personal parameters), may be computed:

[0300] • A counter clockwise rotation of the aortic root increases vulnerability to new onset conduction disturbance (NOCD) during TAVR.

[0301] • A broader infero septal recess roof decreases vulnerability to NOCD during TAVR.

[0302] • The location and the area of the supra ventricular membranous above the virtual aortic plane. The depth of the of the infero septal recess.

[0303] Embodiments described herein which may be used for computing the area of the conduction system at risk may simplify the aforementioned process, which may be complex, and the result of which may still not necessarily show the location of the conduction system path. The detection of the floor of the membranous septum and / or the estimated location on the AV node may be relatively simple computational tasks for image vision technologies and / or NRL. The outcome generated by at least some embodiments described herein, i.e., the location of the conduction system and / or the area of the conduction system at risk, may be in a format that is ready to be converted into 2D image (s) that can be presented to the operator on a fluoroscopy screen, for example, as an overlay on the fluoroscopic images.

[0304] In some embodiment, displaying the conduction system at risk may include presenting the membranous septum on a display (e.g., by projection of the location on the 3D image to a 2D plane registered with a fluoroscopic image obtained during the procedure, as described herein); and or by identifying one or more anatomical structures in the heart.

[0305] Referring now back to FIG. 13, schematic 1302 indicates an example process for computing a location of a conduction system of a patient, using the 3D image (e.g., CT) obtained pre-procedure. The area of the conduction system at risk may be computed using the determined location of the conduction system, for example, by feeding into the ML model, as described herein; and or by identifying one or more anatomical structures in the heart.

[0306] Dot 1306 indicates an exemplary location for coordinate origin (CO), for example, middle of NCC (non-coronary cusp). Dotted line 1308 may indicate a virtual basal ring (also referred to herein as an annulus perimeter), i.e., the virtual annulus and / or annulus line described herein. The capital letters “A”, “B”, and “C” indicate distance from CO along the annulus perimeter. The lower case letters “a”, “b”, and “c” indicate a distance from the annulus line to the conduction system.

[0307] A location of one or more of: a nadir of a right coronary sinus 1310, a ventricular conduction axis 1312, a descent of a superior fascicle 1314, and atrioventricular node 1316, may be computed, which may be used, for computing the location of the conduction system and / or for computing the area of the conduction system at risk (e.g., the membranous septum), as described herein.

[0308] Table 1304 presents empirical data from different patients, using respective 3D images. Table 1304 indicates that the conduction system is at different locations in different patients. Therefore, the area of the conduction system at risk may be different for different patients. The data to generate these measurements is described above. In one preferred embodiment the machine vision analyzes the heart volume acquired under contrast enhanced CT with single or multiphase sequence. The acquired volume is than segmented to deliver several anatomical structures that may include one or more of the following structures: the mitral annulus, the tricuspid annulus the left ventricle, the right ventricle, the right atrium, the intraventricular septum, the infra-septal recess, the mitral valve commissures.

[0309] Referring now back to FIG. 3, at 308, risk assessment may play a crucial role in determining the suitability of patients for TAVI. The goal may be to evaluate the patient's overall health status, comorbidities, and / or procedural risks to ensure optimal outcomes. Some examples of factors considered during TAVI risk assessment include:

[0310] • Surgical Risk Scoring Systems: Various scoring systems, such as the Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) and the EuroSCORE, may be used to assess the operative risk of traditional open-heart surgery. These scoring systems may take into account factors, for example, age, comorbidities, previous surgeries, and clinical characteristics to estimate the risk of adverse outcomes. TAVI-specific risk scores, such as the STS / ACC TAVR In-Hospital Mortality Risk model, have also been developed to assess the procedural risk for TAVI.

[0311] • Advanced Age: Advanced age alone is not a contraindication for TAVI. In fact, TAVI is often preferred over open-heart surgery for elderly patients due to its less invasive nature. However, the presence of other comorbidities and frailty associated with age may be considered when assessing overall risk.

[0312] • Frailty and Functional Status: Frail patients are more susceptible to complications and may have increased mortality rates. Assessment tools, such as the Clinical Frailty Scale, may be used to evaluate the patient's frailty status. Additionally, the patient's functional status and ability to perform activities of daily living are assessed to determine their ability to withstand the procedure and recover postoperatively.

[0313] • Comorbidities and Organ Function: The presence of comorbidities, such as lung disease, kidney disease, liver disease, and neurologic disorders, may be evaluated to assess the patient's overall health status. Poor organ function may increase the risk of complications and impact the patient's ability to tolerate the procedure.

[0314] • Vascular Access and Anatomy: The suitability of the patient's vasculature for TAVI may be assessed. The size, quality, and calcification of the blood vessels are evaluated to determine the feasibility of femoral artery access. Alternative access routes, such as transapical or transaortic, may be considered if the femoral artery is unsuitable. • Procedural Risks: The specific procedural risks associated with TAVI, such as the risk of stroke, valve malpositioning, coronary artery obstruction, or vascular complications, may be evaluated. The presence of additional risk factors, such as heavily calcified aortic valve, small annulus size, or the need for valve-in-valve procedures, may influence the overall procedural risk.

[0315] At 310, TAVI pre-procedure planning may be performed.

[0316] The TAVI procedure preplanning may include capturing a 3D image of the subject, that includes at least the aortic valve and anatomical features in proximity, for example, a cardiac CT scan.

[0317] The 3D image may be analyzed to identify, one or more of: the patient's coronary arteries, coronary ostia (the terms coronary ostia and coronary arteries may be used interchangeably such as with respect to alignment of the THV to avoid blocking the coronary ostia) commissures, annulus line, conduction system (e.g., from heart morphology), and / or calcification signature, which may be used for precise and accurate planning of the TAVI procedure such as for tracking of the annulus, as described herein. The conduction system may be displayed as an overlay on the image (e.g., fluoroscopic image) obtained during the procedure, for example, so the physician can see the conduction system and avoid causing damage to it. For example, by analyzing the CT images, the openings to the patient's coronary arteries may be identified and / or evaluated to avoid interference during valve deployment. The identification of patient-specific commissures may aid in determining the optimal positioning and alignment of the prosthetic valve. Additionally, analyzing the patient's conduction system may be used for the identification of potential risks and / or considerations related to the electrical pathways within the heart. Furthermore, the assessment of the patient's calcification signature may be used, for example, in annulus tracking, facilitating the selection and / or positioning of the appropriate valve size and / or minimizing the risk of complications during the procedure. Using the 3D image for preplanning may enhance the precision and / or individualization of the TAVI procedure, optimizing patient outcomes and minimizing potential risks.

[0318] Referring now made to FIGs. 7A-7C, schematics of features that may be identified on a 3D image as part of the pre-procedure planning step, in accordance with some embodiments of the present invention.

[0319] FIG. 7A is a 3D image 702 of a left ventricle and aorta. Openings of the coronary arteries 704 may be identified. A customized path 706 for delivery of the THV from the descending aorta to arrive aligned (i.e., the commissures of the THV) relative to the openings of the coronary arteries may be computed. FIG. 7B is a 3D image 710 of a left ventricle, where an annulus line 712 is computed and presented. Annulus line 712 may be projected to any position of the C-arm of the fluoroscopic machine during the procedure, as described herein.

[0320] FIG. 7C is a 3D image 720 of a left ventricle and ascending aorta, where a location of a conduction system 722 is marked.

[0321] Referring now back to FIG. 3, at 310, the 3D image may be used for computing an optimal 2D projection for implantation of the THV according to the double S curve. The double S-curve is a view in which both the aortic valve annulus and delivery catheter planes are displayed perpendicularly on fluoroscopy without foreshortening. Using the 3D image obtained preprocedure, comparable projections to that of the double S-curve model may preclude the need for intraprocedural image processing. The S-curve of the aortic valve annulus, representing the perpendicular views of the annular plan, may be generated using pre-procedural CT analysis. During the procedure, the operator may be informed of the optimal pose of the fluoroscopic device to obtain the optimal 2D projection for implantation. In another example, during the projection, the operator may use any pose, which is then registered to the 3D image and compared to the optimal 2D projection. An indication of correctness may be generated, as described herein.

[0322] Optionally, the most suitable transcatheter heart valve for the TAVI procedure may be selected. The selection may be performed, for example, by feeding in one or more features into a machine learning model trained on a training dataset of records and obtaining the selection as the outcome of the ML model. A record may include the feature(s) of sample patients labelled with a ground truth of the most suitable THV. Examples of features include: the patient's anatomy (e.g., image(s), measurements, etc..) and other factors. The ground truth may include, one or more of: valve design, size, delivery system, and / or manufacturer. Other data that may be included in the training of the ML model include the THV's durability, expansion mechanism, ease of deployment, and / or compatibility with the patient's anatomy. The ML may be trained to select a device that is predicted to provide effective valve replacement with minimal risks and / or optimal outcomes.

[0323] Optionally, an anatomy-based risk assessment for evaluating the patient's anatomical characteristics to assess the potential procedural risks associated with TAVI may be performed, for example, by a trained ML model. The assessment may be performed, for example, by feeding in one or more anatomical features into a machine learning model trained on a training dataset of records, and obtaining the assessment as an outcome of the ML model. A record may include the feature(s) of sample patients labelled with a ground truth of risks. Examples of anatomical features include aortic valve calcification, aortic root morphology, coronary artery anatomy, vessel size, and / or tortuosity. The ground truth may include potential challenges and / or complications that may arise during the TA VI procedure. The outcome of the ML model may allow for the development of appropriate strategies to mitigate risks and / or improve patient safety.

[0324] Optionally, the 3D image is analyzed, optionally automatically, for identifying locations of the two coronary ostia. For example, the 3D image may be a cardiac CT, depicting blood vessels. The coronary ostia may be automatically detected as the intersection of the coronary arteries with the aorta.

[0325] Optionally, a target orientation for alignment of the aortic valve prosthesis device relative to the two coronary ostia is computed. Optionally, a mid-point between the two ostia along a circumference (e.g., of the aortic root) is computed. The target orientation may indicate alignment of a first commissure (of three commissures) of the aortic valve prosthesis device with the midpoint. The target orientation may indicate alignment of a second commissure and a third commissure relative to the first commissure. The alignment of the second and third commissures may be automatically determined based on the construction of the aortic valve prosthesis device, for example, the second and third commissures are located 120 degrees away from the first commissure.

[0326] The annulus plane may be computed on the 3D image by detecting three nadirs of the three cusps of the aortic valve. The annulus plane intersects the three nadirs.

[0327] Calcification deposits may be detected on the 3D image. A pattern of calcification deposits may be referred to herein as a calcium signature. The calcium may be deposited in multiple clumps, which may be “randomly” distributed, in the sense that each patient is expected to have their own unique pattern of distribution of calcium deposits. The calcification deposits may be detected, for example, according to a voxels having Hounsfield values within a range that defines calcium.

[0328] The pre-procedure image may be used for generating a template which may be registered (e.g., substantially matched and / or correlated) with a signature of a 2D image (e.g., fluoroscopic image) obtained during the procedure. The registration between the 2D image obtained during the procedure (e.g., in real time or near real time) and the 3D image (e.g., obtained pre-procedure) enables mapping anatomical features found in the 3D image to the 2D image, even when the anatomical features are not visible or not sufficiently visible on the 2D image.

[0329] Optionally, commissure alignment and / or coronary alignment during the TAVI procedure is planned. During the TAVI procedure, achieving proper alignment of the transcatheter heart valve with the native commissures and avoiding interference with the coronary arteries is crucial. A GUI may present an indication of different scenarios, for example, by presenting different colors indicating different scenarios, for example, red, green, and purple. Red may indicates misalignment and / or improper positioning of the valve with respect to the commissures and / or coronary arteries. This scenario may pose a risk of obstruction or interference with the coronary blood flow or valve function. Green may represents the desired alignment and / or positioning of the valve with the commissures and / or the coronary arteries. Green may indicate a favorable outcome where the valve is properly placed, allowing for unobstructed coronary blood flow and / or optimal valve function. Purple may represents an intermediate situation where there might be some degree of compromise and / or suboptimal alignment, but it is not severely problematic. Purple may suggest the need for careful evaluation and consideration of the potential impact on coronary artery patency and valve function.

[0330] Optionally, a path for the aortic valve prosthesis device from a descending aorta, across an aortic arch, to an ascending aorta for deployment, may be computed. When the aortic valve prosthesis device is displaced along the path, the aortic valve prosthesis device may be predicted to arrive aligned for deployment. For aortic valve prosthesis devices that cannot be rotated at the ascending aorta (e.g., the guidewire bending over the aortic arch prevents the rotation) but can be rotated at the descending aorta (e.g., the guidewire does not have significant curves), the path indicates how the aortic valve prosthesis device is to be oriented at the descending aorta in order to arrive at the target orientation such that after deployment the commissures are aligned relative to the coronary ostia for non-blocking of the coronary ostia. The path may be computed by back tracking, from the target orientation relative to the coronaries, back to the descending aorta, for indicating the initial orientation of the aortic valve prosthesis device for delivery for deployment.

[0331] Optionally, the computed path includes one or more target locations, along the descending aorta, across the aortic arch, and to the ascending aorta (for deployment at the target orientation), indicating optional location of the commissures of the aortic valve prosthesis device along the path, in order to reach the location for deployment at the ascending aorta at the target orientation. For example, the path includes three lines along the circumferences of the descending aorta, aortic arch, and ascending aorta, indicating the path each of the three commissures is to follow, by being aligned with each path, to arrive for deployment at the target orientation. In another example, the path includes a single line, indicating the path of one (of the three) commissures is to follow, by being aligned with the path, to arrive for deployment at the target orientation. The path may be for the commissure which is to be aligned with the mid-point between the coronary ostia.

[0332] Optionally, the path is computed by simulating the aortic valve prosthesis device located in the ascending aortic for deployment at the target orientation, and back tracking the aortic valve prosthesis device along the ascending aorta to the descending aorta while maintaining the target orientation. Optionally, 2D projections of the 3D image are computed. The 2D projections may be used as templates, which are registered with the 2D fluoroscopic image(s), which may be used to map features of the 3D image to the 2D fluoroscopic image(s), for example, location of the annulus. In another example the pose of the THV may be determined using markers on the THV that are projected to the 3D image via the 2D projections.

[0333] The 3D image may be used for performing a registration of the 2D fluoroscopy image(s) obtained during the procedure to a 2D projection of the 3D image. This registration process may be used to correlate the preplanned anatomical information defined on the 3D image (e.g., location of the coronary arteries, annulus plane) with the actual patient anatomy visible on the 2D fluoroscopy images during the TAVI procedure. The registration may guide the procedural steps and / or ensures accurate valve deployment according to the preplanned strategy.

[0334] Optionally, the output of the TAVI preplanning process may be a data vector, which is a machine-readable representation of the preplanned procedural strategy. This data vector may include the relevant information described herein, for example, valve sizing, access route selection, anatomical measurements, alignment guidelines, and other parameters. The data vector may be compared against real time data obtained during the procedure, for generating the indication of correctness (e.g., presented within the GUI) for the planned steps, positioning, and / or deployment. The GUI confirmation may provide assurance to the healthcare team that the procedure is proceeding as intended, with positive outcomes in terms of valve placement, alignment, and functional integrity.

[0335] Optionally, the 3D image may be analyzed to identify a parallax view for the annulus plane. The annulus plane may be identified on the 3D image by automatically detecting the nadirs of the three cusps of the aortic valve. The annulus plane may be defined as the plane that intersects the three nadirs. Valve parallax occurs since the valve is depicted differently in different 2D images captured at different poses of the image sensor. An optimal pose of the image sensor may be computed for optimal viewing of the annulus plane, for example, for viewing the annulus plane as a 2D line.

[0336] At 312, a pre-procedure recommendation for a pacemaker may be performed, for example, by a trained ML model. The recommendation may be performed, for example, by feeding in one or more features into a machine learning model trained on a training dataset of records, and obtaining the recommendation as an outcome of the ML model. A record may include the feature(s) labelled with a ground truth of the recommendation. Examples of features include factors that may cause damage to the conduction system, as described herein. Examples of ground truth include whether a pacemaker is predicted to be require, and / or types of pacemaker such as the conduction abnormality which the pacemaker is to fix.

[0337] At 314, component(s) for the TAVI procedure flow may be selected, for example, by a trained ML model. The selection may be performed, for example, by feeding in one or more features into a machine learning model trained on a training dataset of records, and obtaining the selection as an outcome of the ML model. A record may include the feature(s) labelled with a ground truth of the selection. Examples of features include factors that impact the component selection. Examples of ground truth include type of THV, balloon size, wire type, and the like.

[0338] At 316, scheduling of patients in a room used for the TAVI procedure flow may be performed, for example, by a trained ML model. The scheduling may be performed, for example, by feeding in one or more features into a machine learning model trained on a training dataset of records, and obtaining the scheduling, for example, order of patient and / or timing for scheduling the patient, as an outcome of the ML model. A record may include the feature(s) labelled with a ground truth of the selection. Examples of features include factors that indicate expected complexity of the TAVI procedure, such as co-morbidities, age, and previous medical complications. Examples of ground truth include morning, around noon, afternoon, evening, and the like. The ML model may be trained for scheduling patients for which the TAVI procedure is predicted to be simple earlier in the day, and / or scheduling patients for which the TAVI procedure is predicted to be complex later on in the day. This may be because, for example, to prevent pushing out other patients by the patient with complex TAVI procedure which may take longer than expected.

[0339] The TAVI procedure may begin. Features described with reference to 318 may be performed on the patient on the table in the catheterization laboratory, after the TAVI procedure has begun.

[0340] At 318, monitoring of the conduction system of the patient may begin. Monitoring the conduction system before a TAVI procedure may be used to assess the integrity and / or function of the patient's cardiac conduction system during the TAVI procedure. The conduction system is responsible for the electrical signaling that coordinates the contraction and relaxation of the heart muscles. Since TAVI involves the placement of a prosthetic valve within the aortic valve, which is located in close proximity to the conduction system, the conduction system may be monitored to minimize the risk of conduction abnormalities and / or disturbances during the procedure.

[0341] The conduction system may be monitored by recording ECG signals during the procedure, and / or by analyzing images of tissues in proximity to the conduction system to identify risky movements, such as tight curves of the guidewire which may damage the conduction system. Alternatively or additionally, the conduction system may be monitored by monitoring the area of the conduction system at risk. Optionally, personal parameter(s) of the subject and / or procedure parameter(s) obtained during the procedure are dynamically fed into the machine learning model for monitoring the area of the conduction system at risk. For example, images captured during the procedure (e.g., fluoroscopic images) are fed into the machine learning model and / or other dynamic data obtained during the procedure is fed into the machine learning model (e.g., real time ECG).

[0342] The area of the conduction system at risk may be presented on a display, optionally as an overlay over 2D images captured during the procedure, for example, fluoroscopic images. The location of the area of the conduction system may be determined on the 3D image (e.g., CT obtained pre -procedure). The location of the area on the 3D image may be projected to a 2D plane registered with a 2D image obtained during the procedure. The 2D plane may be obtained, for example, based on an indication of a pose of the image sensor (e.g., C-arm), and / or calcification signature, and / or marker(s) on a transcatheter device (e.g., the THV), as described herein. The projection on the 2D plane registered with the 2D image (e.g., fluoroscopic image) may be used as the overlay.

[0343] Region(s) of the area of the conduction system at risk may be presented with an indication of risk, such as by using a visual coding. For example, regions at high risk of damage are coded such as using a color (e.g., red) and / or pattern, and regions at low risk of damage are coded with another color (e.g., green) and / or pattern. The coding may be dynamically updated according to real time risk during the procedure, for example, location of the guidewire and / or THV. Risk level may be, for example, categorical (e.g., high, low) and / or numerical (e.g., probability of damage).

[0344] Optionally, the visual presentation of the area of the conduction system at risk is dynamically updated (e.g., according to real time or near real time output of the ML model in response to input of data such as images captured during the procedure) during the procedure, for example, during deployment of the THV.

[0345] Alternatively or additionally, the area of the conduction system at risk is dynamically monitored during the procedure. The monitoring may be done, for example, by one or more watchdog processes (e.g., as described herein) and / or by the ML model that computes the area of the conduction system.

[0346] Optionally, estimated pressure and / or measured pressure (e.g., measured by a pressure system) applied by a device (e.g., guidewire, THV) to the area of the conduction system at risk is dynamically monitored. The pressure may be estimated using one or more parameters, for example, thickness of tissue above the nerves of the conduction system, and / or sensitivity of the region of the conduction system. The monitoring may verify that the estimated pressure and / or measured pressure remains below a predefined threshold. The pressure may be monitored by estimating a curvature of a guidewire and / or catheter, for example, as described herein. Wire pressure above the threshold may be detected, and one or more actions may be triggered in response for example, generating an alert presented on display, and / or automatic prevention by the mini-robot to move the guidewire to prevent further pressure and / or damage.

[0347] Optionally, a location of a transcatheter device (e.g., guidewire, THV) relative to the area of the conduction system at risk is monitored. The monitoring may be performed to detect when the device is too close to the area, for example, below a distance threshold, which may indicate high risk of damage. One or more actions may be taken when the location of the transcatheter device is below the distance threshold, for example, an alarm is raised, and / or the mini-robot automatically blocks further movement of the transcatheter device towards to the area of the conduction system at risk. The monitoring may be performed by ML means and / or by image processing means (e.g., by using one or more masks corresponding to the shape of the transcatheter device). The monitoring may be performed by ML means and / or by image processing means (e.g., by using one or more masks corresponding to the shape of the transcatheter device).

[0348] Optionally, a location of an accessory catheter (e.g., pigtail) is monitored for checking that the accessory catheter is not present during certain parts of the procedure that may damage the area of the conduction system at risk and / or that the accessory catheter is not placed in proximity to the area of the conduction system at risk where the accessory catheter can cause damage (e.g., in a cusp of the aortic valve).

[0349] Optionally, a recommendation for a safe location for placement of the accessory catheter for not damaging or reducing risk of damage (e.g., below a risk threshold) to the area of the conduction system at risk is computed. The recommendation may be for one or more phases of the procedure. The recommendation may be, for example, based on a prediction of the pressure that the accessory catheter is predicted to apply to tissue, to determine the safe regions where the accessory catheter can be placed.

[0350] Optionally, an alert is generated indicating that expanding the THV is safe according to the monitored location of the guidewire. Alternatively or additionally, the alert is generating indicating that expanding the THV is unsafe according to the monitored location of the guidewire. When the expanding the THV is unsafe, the mini-robot may automatically block expansion of the THV. Safety is with reference to risk of damage to the area of the conduction system at risk.

[0351] Optionally, a target range of the device depth (e.g., as described herein) for deployment of a device (e.g., THV) is adapted according to the location of the area of the conduction system at risk, for example of the specific patient. Since the area of the conduction system at risk may be different in different patients, the target range of the device depth where it is safe to deploy the THV may vary. A customized target range is computed for the patient according to the area of the conduction system at risk. The target range is selected for reducing or preventing damage to the area of the conduction system at risk when the THV is deployment within the target range. There may be two mechanisms affecting the conduction system during TAVR. A first mechanism relates to Atrio- Ventricular (AV) damage. AV damage may be caused, for example, by the THV and / or catheter and / or wires which interface with the Membranous Septum (MS) tissue. This mechanism of damage may be reflected as (e.g., detected by) longer PQ / AV block. A second mechanism relates to Intra- Ventricular (IV) damage. IV damage may be caused, for example, by the THV and / or catheter and / or wires which interface with the Bifurcating bundle as well with its branches. This mechanism may be reflected as (e.g., detected by) QRS duration increase and QRS axis change.

[0352] Referring now back to FIG. 8, GUI 802 and 804 is for monitoring the conduction system of the heart of the patient. GUI 802 and 804 may be used for monitoring risk of conduction disturbances during the procedure. Conduction disturbances, and / or risk of conduction disturbances, may be monitored during the procedure by analyzing ECG signals. ECG signals (e.g., high-resolution ECG) and / or fluoroscopy images may be recorded (e.g., continuously). The ECG signals may be analyzed, for example, beat by beat, to monitor ECG indicators of the heart conduction system, for example, PQ interval, QRS duration, and / or QRS axis. A conduction disturbance (CD) Event may be classified, for example, using the following set of one or more rules: Change in PQ, QRS duration > 10%; Change in QRS axis > 20 degrees; and / or Non- conductive P wave appears. Ovals marked by element 806 represent ECG signals that may indicate a CD event.

[0353] Referring now back to FIG. 3, at 320, vascular access may be obtained. The access port is a key component that allows the insertion and deployment of the THV. The access port typically consists of a sheath or introducer that provides a pathway for the delivery system to access the aorta. To secure and stabilize the access port during the TAVI procedure, a ring or anchor device may be used. The ring may be placed around the access port to prevent movement and / or dislodgement during the valve deployment process. The ring may provide stability and / or help maintain the position of the access port throughout the procedure, ensuring precise and accurate valve placement. The ring may be positioned proximally to the access port, close to the site where the sheath or introducer enters the vessel. It is designed to hold the access port firmly in place, preventing unintentional movement that could disrupt the procedural workflow or compromise the accuracy of the valve deployment. The specific design and / or technique for applying the ring may vary depending on the TAVI system and / or device used. Some systems may incorporate a dedicated ring or anchoring mechanism, while others may utilize external techniques to secure the access port. The purpose of placing a ring on the access port during TAVI may be to enhance procedural safety and efficiency. The ring may ensure stable access, minimizes the risk of dislodgement and / or vascular injury, and / or facilitate smooth delivery and / or deployment of the transcatheter heart valve.

[0354] At 322, a guidewire, optionally a soft guidewire, is inserted into the body of the patient.

[0355] A soft guidewire is a thin and flexible wire that is threaded through the patient's arterial system, for example, to reach the aorta and, eventually, the left ventricle. This may be done under fluoroscopic guidance and / or using injected contrast to visualize the blood vessels. The guidewire acts as a guide for the delivery system of the TAVI valve, for navigating through the complex vascular anatomy of the patient.

[0356] An exemplary procedure for inserting the soft guidewire may be as follows: A small incision may be made in the groin area to gain access to the femoral artery. A sheath may be placed into the femoral artery, which provides a pathway for the guidewire and other catheters. The soft guidewire may be inserted through the sheath and then threaded up into the aorta and across the aortic valve into the left ventricle. Proper positioning of the guidewire may be confirmed using fluoroscopy and / or injected contrast.

[0357] At 324, a pacing wire may be inserted into the patient. The pacing wire may be a temporary pacing wire placed in an anatomical location within the heart to monitor the patient's heart rhythm and to provide temporary pacing support if needed. The pacing wire may be placed via the femoral vein. The temporary pacing wire may serve as a safety measure during the TAVI procedure, for example, to control the beating of the heart during deployment of the TAVI procedure, and / or to pace the heart in case of damage to the conduction system arising from deployment of the TAVI.

[0358] At 326, optionally, an accessory catheter is not introduced into the patient, in particular to the aorta and / or native aortic valve and / or left ventricle during the TAVI procedure. The accessory catheter that is not introduced into the patient may be, for example, a catheter for injecting contrast and / or for being used as a marker, such as a pigtail catheter. In standard TAVI procedures, the pigtail catheter is introduced into the left ventricle and / or aorta (e.g., within the native aortic valve, such as within a cusp) for injection of contrast and / or to help locate the annulus. In contrast, in at least some embodiments described herein, the accessory catheter is not introduced at all, or is used for shorter intervals and / or for fewer steps of the TAVI procedure in comparison to standard TAVI procedures. Optionally, in at least some embodiments described herein, the accessory catheter (e.g., pigtail) is not needed to identify and / or track anatomical structure(s) of the native aortic valve, for example, the annulus and / or commissures and / or coronary ostia. The tracking of the anatomical structures may be done, for example, by identifying a 2D projection of a 3D image of the native aortic valve and surrounding tissues (e.g., obtained by a pre-procedure CT scan) where the anatomical structure(s) are indicated, registering the 2D fluoroscopic image(s) (obtained during the procedure) with the 2D projection, and mapping the location of the anatomical structure(s) on the 3D image, which are projected to the 2D projection, to the 2D fluoroscopic image(s). The location of the anatomical structure(s) may be visually indicated, for example, as an overlay, such as a line to indicate the annulus line.

[0359] Optionally, the 2D image depicting a native valve of a subject is obtained, where the 2D image excludes an accessory catheter, for example, a pigtail. The 2D image excludes contrast which would otherwise be injected from the accessory catheter. In some approaches the pigtail catheter is inserted into the left ventricle and / or aorta, for use as a marker and / or for injecting contrast. A calcification signature is detected in the 2D image. A 2D calcification template is selected from multiple calcification templates of the 3D image of the subject (e.g., pre-procedure CT scan) according to a pose of the image sensor that captured the 2D target image. An anatomical feature, for example, an annulus plane and / or coronary arteries, is indicated on the 3D image. The 2D image is registered to the calcification template. The anatomical feature(s) of the 3D image is mapped to a corresponding location of the anatomical feature on the calcification template, for example, the 3D anatomical feature is projected to the 2D plane of the calcification template. The anatomical feature on the calcification template is mapped to the registered 2D image, and optionally presented, for example, as an overlay, without using the accessory catheter.

[0360] The identification of the 2D projection and / or registration to the 2D fluoroscopic image may be performed using non-contrast 2D fluoroscopic images, using a detected calcification signature. The calcification deposits of the calcification signature may be identified without using contrast injected by the pigtail catheter.

[0361] Reducing using the accessory catheter or avoiding introducing the accessory catheter into the left ventricle and / or native aortic valve (e.g., cusp) during the TAVI procedure may reduce or avoid risk of damage to tissues, such as to the conduction system of the heart, which may lead to conduction block and / or other conduction problems which may require implantation of a pacemaker. Examples of risks of the presence of the accessory catheter (e.g., pigtail) include:

[0362] • Tissue damage (e.g., to the conduction system) may occur when the THV and / or delivery system is passed into and / or past the native aortic valve, while the accessory catheter (e.g., contrast catheter, pigtail catheter) is located in the left ventricle and / or while the accessory catheter is located in cusp(s) of the aortic valve (e.g., used as a marker). The advancing THV and / or delivery system may apply a force to the accessory catheter against the tissues of the heart, which may damage the tissues.

[0363] • Presence of the accessory catheter through the native aortic valve and into the left ventricle and / or located within a cusp of the native aortic valve may cause tissue damage when a balloon is inflated within the native aortic valve, for example, to perform a valvuloplasty to expand the opening diameter of the native aortic valve prior to implantation of the THV. The balloon, when inflated, applies pressure to the accessory catheter, which applies pressure to the tissue, which may damage the tissue, which may cause the conduction block.

[0364] At 328, one or more anatomical structures of the heart of the patient are detected, optionally the annulus (e.g., virtual annulus, annulus line) and / or commissures of the native aortic valve and / or openings of the coronary arteries (for alignment relative to the commissures of the THV).

[0365] Optionally, contrast material may be injected. Image(s) depicting the injected contrast may be analyzed, for example, 2D fluoroscopic images.

[0366] The images with contrast material may be analyzed to detect the annulus (e.g., virtual annulus) and / or coronary ostia. The contrast material may be injected via the pigtail catheter.

[0367] The annulus may be automatically detected by detecting the contour of the lower boundary of the contrast filled region (e.g., aortic bulb), which may include two or more cusps of the native valve. The nadirs of the two or more cusps may be automatically identified. The annulus, also referred to as the annulus line, may be defined as the line joining the two or more nadirs.

[0368] Alternatively, no contrast material is injected. The 2D images exclude contrast. The annulus and / or coronary ostia may be detected by registration of the 2D image that excludes contrast to the 3D image obtained in the pre-processing step.

[0369] The 3D image of the subject (e.g., CT, MRI) which may be obtained prior to the procedure, which depicts an annulus plane and / or cusps and / or nadir of cusps, may be projected to a 2D plane according to a pose of the image sensor that captured the contrast image. The 2D plane may be registered to the contrast image. The annulus line of the 2D plane may be mapped to the registered contrast image.

[0370] At 330, a change in settings may be detected. Examples of changes in settings include: zoom, subject orientation, and the pose of the imaging device.

[0371] The change in settings may be detected, for example, by monitoring input of the operator (e.g., user enters instructions to change the settings), based on output of a sensor measuring pose (e.g., position sensor, angulation sensor, accelerometer), optical character recognition of the pose added to the 2D image(s), and / or based on detecting a change of 2D projection (e.g., template) of the 3D image that is registered to the 2D fluoroscopic image.

[0372] At 332, the detected change may trigger a computation for correcting the mapping of the 2D fluoroscopic image to the 3D image, such as to a 2D projection of the 3D image.

[0373] The computation may be for finding a new 2D projection (e.g., template) of the 3D image that is registered with the 2D fluoroscopic image.

[0374] Alternatively or additionally, the computation may be for computing a transformation between the previous pose of the image sensor to the new pose of the image sensor. The transformation may be applied to the 2D projection of the 3D image. The 2D fluoroscopic image is registered to the transformed 2D projection.

[0375] In another example, the computation is for re-computing the combined mapping described herein. The new combined mapping may be used for subsequent images at the changed settings.

[0376] Alternatively or additionally, the combined mappings may be adapted according to the detected change, for example, by computing a transformation mapping to apply to the combined mappings where the transformation mapping is from the previous settings to the new settings.

[0377] Alternatively or additionally, the detected change is fed to one or more of the ML models described herein.

[0378] Alternatively or additionally, the detected change triggers a new search for the calcification signature on the 2D image fluoroscopic image, which is then matched to a projection of the 3D image.

[0379] The calcium deposits in the 3D image may be projected to a 2D plane which represents a template. The template may be matched to the 2D images captured during the procedure, for example, in real time or near real time. The template may be of a pattern of multiple calcium deposits, within the leaflets, annulus, native valve, heart muscle, aortic wall, and / or other nearby tissues. The template may include tissues that are not impacted by an event, such as inflation of a balloon within the native valve (e.g., valvuloplasty), to enable performing the registration after the event.

[0380] At 334, optionally, one or more structures depicted in the image(s), such as 2D fluoroscopic images, are tracked. The structures may be dynamically tracked on subsequent non-contrast images, which reduces the amount of contrast used. The structures may be dynamically tracked on subsequent non-contrast images, even as the pose of the image sensor is changed, which gives the operator freedom to adapt the pose as needed to guide the THV. Exemplary tracked structures include the location of the annulus line, catheter (e.g., pigtail) movement, catheter (e.g., pigtail) presence, coronary arteries (i.e., the coronary ostia), and / or conduction system. The tracked structure(s) may be displayed, for example, as an overlay on the fluoroscopic image.

[0381] One or more different approaches may be used for tracking the structure(s), for example, described as follows:

[0382] The structure(s) may be detected by using the calcification template. The calcification template may be computed by searching the calcification signature for a 2D calcification template of the 3D image according to a correlation requirement. Optionally, multiple 2D projections of the 3D image are pre-computed according to predicted poses of the image sensor. The search may be bone using the pre-computed 2D projections, to find the closest matching projection. For example, the 2D projection with highest correlation to the calcification signature of the 2D target image. The annulus plane (or other structure in 3D) is mapped to an annulus line (or 2D projection of the 3D structure) on the calcification template. For example, the annulus plane in the 3D image is projected to a 2D annulus line during the projection of the 3D image to the 2D plane of the calcification template. The 2D target image may be registered to the calcification template. Registration may be performed, for example, by matching features, and / or other approaches for image registration. The annulus line (or other structure) on the calcification template may be mapped to the registered 2D target image. The annulus line is provided, optionally presented on the 2D target image such as an overlay.

[0383] Alternatively or additionally, the structure(s) may be detected by analyzing a target image that excludes injected contrast (also referred to herein as a non-contrast image. The target image that excludes injected contrast may be captured after the contrast image that depicts contrast was captured, i.e., after the contrast has dispersed. The structure(s) may be automatically detected by detecting the fiducial object within the target image that excludes contrast, and applying a spatial relationship. The spatial relationship may be computed between the structure (e.g., annulus) and a center of mass of the accessory catheter (e.g., pigtail).

[0384] The structure(s) may be automatically detected by feeding the target image into a machine leaning model trained on a training dataset of sample images labeled with a ground truth indicating the structure(s).

[0385] Alternatively, or additionally, the structure(s) may be automatically detected by processing the target image by cross correlation the target image with the 3D image, and mapping the structure(s) found in the 3D image to the target image. A projection of the 3D image to a 2D plane is computed, were the 2D projection of the 3D image is registered with the 2D target image. The projection may be computed, for example, using the pose of the image sensor that captured the 2D image. The pose of the image sensor may be found, for example, using a pose sensor, and / or by optical character recognition to extract text of the target image indicating the pose of the image sensor. The structure(s) may be found on the 2D projection, and mapped to the target image using the registration.

[0386] Alternatively, or additionally, the structure (e.g., first anatomical structure) may be automatically co-located to a second anatomical structure. The automatic co-locating of the first anatomical structure to the second anatomical structure may be based on an identified spatial relationship between the first and second anatomical structures.

[0387] The first anatomical structure may be detected without requiring presence of the fiducial object in the image, i.e., the pigtail (or other accessory catheter) may not be required. The first anatomical structure may be detected using the combined mapping, which was computed using the presence of the fiducial object. The fiducial object may be moved and / or removed after the combined mapping has been computed.

[0388] Optionally, the co-locating is done by computing a first sub-mapping between the first anatomical structure and the fiducial object. The sub-mapping may be, for example, a spatial relationship, one or more distances (e.g., in pixels and / or millimeters), one or more vectors that indicate relative direction, a geometric shape of a defined size (e.g., triangle having a vertex at the center of mass and a base of the first anatomical structure), and / or a mapping function. A second sub-mapping between the second anatomical structure and the fiducial object depicted may be computed. A combined mapping between the first structure and the second structure may be computed according to a combination of the first sub-mapping and the second sub-mapping.

[0389] Optionally, the first mapping and the second mapping are computed for a pair of the noncontrast image and the contrast enhanced image captured at a same pose of an imaging device, same subject orientation, and same zoom.

[0390] The location of the annulus line (or other structure) may be dynamically tracked on subsequent images without contrast. The tracking may be done, by mapping the location of the annulus line detected on a baseline image without contrast to a subsequent image without contrast, based on a registration between the baseline image and subsequent image. For example, computing optical flow between the baseline image and the subsequent image, and applying the optical flow to map the annulus line from the baseline image to the subsequent image. The mapping from the baseline image to the subsequent image may be computationally efficient in comparison to recomputing the combined mapping for each new image, which may enable real-time tracking. Alternatively or additionally, pairs of sequentially obtained non-contrast images are fed a machine learning model for tracking a location of the annulus line. The pairs of images may include the initial image with identified annulus line, and subsequent image without identified annulus line, both of which may be non-contrast images. The ML model may be the dynamically trained ML model, and / or another ML model trained on a training dataset of records, where a record includes a pair of a sample initial image with detected annulus and a subsequent image without detected annulus, and the ground truth is the subsequent image with marked detected annulus.

[0391] Alternatively or additionally, the lower annulus is detected by detected a candidate location of the lower annulus of the native aortic valve by analyzing sample image(s) depicting the lower annulus of a native aortic valve that excludes presence of the THV within the native aortic valve. The sample image(s) may include contrast. The candidate location may be detected and / or learned from the sample image / s) of the subject obtained prior to placing the THV in the native aortic valve. The sample image may be registered with the target image (which depicts the partially expanded THV within the native aortic valve). The candidate location of the sample image(s) may be mapped to the target image to obtain the lower annulus of the target image. The mapping may be performed by computing a transformation from the sample image to the target image, and applying the transformation to the candidate location for obtaining the lower annulus. The sample image(s) may include injected contrast located within the cusps of the aortic valve and the ascending aorta. The target image may exclude injected contrast within the cusps of the aortic valve and the ascending aorta. The lower annulus detected in the sample image(s) may be mapped to the target image for identifying the lower annulus in the target image.

[0392] Referring now to Figs. 15 and 16, which show flowcharts of methods of computing an annulus line and s-curves and a double S-curve and a preferred imaging angle, in accordance with some embodiments of the invention.

[0393] In a typical TAVR procedure, preplanning is performed on a 3D CT image and that is used for planning viewing direction of a fluoroscopy imager (typically mounted on a C-arm). However, there is often a difference in patient pose between the CT image and the TAVR procedure. This may be due, for example, to patient propping, use of a pillow and / or other reasons. In accordance with some embodiments of the invention, a correction between the pre-operative pose and the intraoperative pose is provided using only a single injection of contrast material.

[0394] At 1502 a first injection of contrast material into the aortic root is performed. At 1504, system 100 generates a suggested aortic silhouette and / or annulus line. For example, this silhouette and / or line can be based on the extent which includes contrast material, ignoring leaks past the valve. Fig. 12 shows an example of such a showing.

[0395] At 1506, a user is optionally requested to confirm the suggested identification of the valve and / or aorta and / or annulus.

[0396] At 1508 the marking is made permanent and may now be applied to other images acquired at other time. Optionally, small movements in the image (e.g., due to breathing, heartbeat and / or patient movements are corrected automatically, for example, by registering or otherwise aligning the new image with the old image, for example, using landmarks.

[0397] At 1510, considering that the user approved the suggested annulus, the current c-arm parameters (especially orientation) can be recorded.

[0398] At 1512, the pose change is calculated, for example, by searching through the pre procedure CT volumetric imaging data set for a camera angulation that will generate a similar aortic valve outline and / or a similar arrangement of other tissue features, for example, calcifications and / or nadirs of cusps. It is noted that if, for example, calcifications are used, contrast injection is optionally avoided or reduced for this calibration, and the annulus is optionally displayed based on the aligned pre-procedure CT.

[0399] The difference between the actual C-arm angulation and a CT derived angulation of similar aortic annulus outline, is optionally used to calculate the deviation between the patient pose (orientation) during the CT to the pose during the fluoroscopy.

[0400] At 1514, this calculated difference is optionally used to generate a fluoroscopy corrected S curve.

[0401] At 1516, the s-curve is optionally used to recommend a c-arm movement and / or final location. While this may be done automatically (e.g., moving the c-arm or other fluoroscopy orientation means), for example using a motor or other actuator, in some embodiments, a user performs the movements.

[0402] Updated fluoroscopic S-curve calculation may be triggered during a procedure. In one example, when there is a new contrast injection (1520) in the aortic root, or in the ventricle (optionally detected by automatically identifying the general shape on the fluoroscopy image).

[0403] At 1522, an annulus line and / or silhouette may be recommended (e.g., as in 1504).

[0404] At 1524, a user may confirm and the annulus marked (1526), for example as in 1506 and 1508.

[0405] At 1528, fluoroscopy parameters may be read. At 1530, a deviation from an existing s-curve, for example, one calculated at 1514, may be determined and a recommendation of change of fluoroscopy imaging parameters may be made to a user (1532).

[0406] In another example, triggering may be caused by detection of changes in a fluoroscopy parameter (1540), for example, angle or orientation in general, of a c-arm or other imager type. This may be detected, for example, using a sensor or other input from the fluoroscopy aiming mechanism, such as the c-arm. Optionally or additionally, image analysis of a fluoroscopic image can show changes, for example, in bone shadow location and / or shape, which are significant enough to suggest movement of the fluoroscopy aiming point.

[0407] At 1542, the annulus line position is calculated based on the movement of the image. Optionally, the user is asked to confirm the new line. No movement of the c-arm (or fluoroscopy imager parameters in general) would be needed. If there is no agreement, a user may be requested to inject contrast material.

[0408] In some embodiments of the invention, system 100 confirms the indicated change in fluoroscopy parameters by comparing a silhouette of one or more features (e.g., bones, calcifications, contrast material) on the fluoroscopy image to the pre-operative CT image. Optionally, the comparison starts with projections of the CT image at the original fluoroscopy angle and / or the received new fluoroscopy angle and / or nearby angles (e.g., assuming a small change). For example, the comparison may compare a projection of cusps of the CT data set to the identification of the annulus line on the fluoroscopy image (1544).

[0409] In some embodiments of the invention, optionally pre-operatively, a plurality of projection images and / or associations between what annulus lines would be on such images and camera angulations are created. Then, when searching for a match between a current image and CT data (e.g., as described herein), only these pre-calculated images (or associations) need to be compared. A more precise angle may be calculated by interpolating between multiple such pre-calculated images and / or associations, for example, after one or more close matches are found. Optionally or additionally to using projects from the CT images, an MPR or other projection of raw or otherwise unreconstructed CT data may be used to generate 2D projections or feature sets which are compared to feature sets in 2D projections.

[0410] In some embodiments of the invention, an annulus corrected s-curve is created. For example, the observed silhouette of the aortic annulus and the location of the coronary ostia or the coronary path of the fluoroscopy image together with current C-arm angulation data are compared to CT data, for example, by comparing to pre-calculated or currently calculated projections or associations, e.g., as described above, to find a simulated angulation that is associated with the minimal error. The comparison between the simulated annulation and the actual angulation may be used to generate a set of fluoroscopy C arm angulations that generate the parallax views of the aortic annulus for the give patient anatomy and fluoroscopy bed pose.

[0411] A potential advantage of using features closer to the annulus is a better correction for pose. Optionally, one or more of the following features are used, with an optional preference to features close to the annulus: the valve itself, commissures, cusp nadirs, valve calcification patterns and also, but possibly less preferred in some embodiments, coronaries and osseous structures. The preference for certain structures may depend on the actual part of the heart where intervention happens and the structures used for alignment and / or the weight afforded to each structure when aligning may depends on where a greater precision is required and / or where more movement or deformation is expected.

[0412] In some embodiments of the invention, the methods are applied after a first correction of c-arm angulation for the standard view. For example, after a first injection and manual determination of a need to correct a c-arm orientation relative to a pre-planned (e.g., CT-derived) angulation. After such initial correction, system 100 records the current C arm angulation of the fluoroscopy corrected position, and calculates a difference between the CT derived S curve for said standard view and the actual acquired image. Using the deviation, system 100 calculates a Fluoroscopy-corrected new S curve and determines a correspondence (or deviation from) the CT derived S curve. This correspondence / deviation may be used to suggest C arm angulation of other standard views of the aortic annulus. Furthermore, the fluoroscopy corrected S curve may be used for generating the set of all C arm angulation that generate a parallax view of the aortic annulus.

[0413] In this and other embodiments, it is noted that system 100 can optionally calculate annulus line repositioning for other fluoroscopy imaging parameters, for example, using the fluoroscopy corrected S -curve.

[0414] After calculating a correction, the calculated s-curve and / or deviation may be confirmed. This may be done, for example, by moving (or asking the operator to move) the fluoroscopy imager to a different orientation and perform a reinjection and check (again) a correspondence between a re-positioned annulus line (or other image annotation) and what a human (or computer) suggests is the correct annulus line. Such checking can be manual or be perfumed by system 100.

[0415] Fig. 16 shows how a device s-curve may be created, potentially being used to create a double s-curve including both the device and the fluoroscopy s-curves.

[0416] The left side of Fig. 16 is the same as the leftmost flowchart in Fig. 15 and serves as input into the process represented by references 1602-1614. At 1602, the device type and / or orientation may be determined. Device type may be, for example, entered manually, reading of a code (e.g., QR or barcode) on a device / package, assumed to be the one recommended or selected during preplanning or recognized from the fluoroscopic image. Orientation may be detected form the image, using a rotation sensor on the catheter and / or entered manually.

[0417] At 1604, the device is segmented on the fluoroscopic image, for example, based on pattern matching (having an expected shape) and / or based on radio-opacity thereof.

[0418] At 1606, a user may provide device information, such as size and / or expansion state. At 1608, fluoroscopic parameters may be provided. It is noted that the device may be imaged, for example, in the ascending aorta or the descending aorta or possibly before entering the aorta. In some embodiments of the invention, the measurement is when the device approaches the aortic annulus level in its closed configuration.

[0419] At 1610, the device s-curve is calculated. In some embodiments of the invention, the captured image of the implant is analyzed to calculate the implant’s length and width. System 100 can then compares the size and model of the implant to the dimensions measured from the fluoroscopy together with the captured C arm momentary angulations. This can suggest the device angulations under the current view and be used to calculate an s-curve for the device.

[0420] At 1612, the fluoroscopic s-curve, for example determined as described above with reference to Fig. 15 is provided as an input and a double S-curve is provided, or at least one or more intersection points between the two curves.

[0421] At 1614, a recommend absolute or change in fluoroscopic imager angulations may be provided to an operator and / or applied automatically.

[0422] In either case, when the device is at a non-deforming view, its rotation around axes other than its longitudinal axis and its depth (distance from the annulus) can be calculated automatically, shown and / or used for modifying the device approach. Rotation around the longitudinal axis may be determined, for example as noted herein based on an identification of features of the device in the fluoroscopy image which change as the device is rotated, and taking in to account a known angulation of the fluoroscopy imager.

[0423] At 336, a GW, optionally a soft GW, is inserted into the left ventricle. Using the soft guidewire may avoid or reduces risk of damage to the left ventricle, and / or the conduction system, since the soft guidewire bends in response to being pushed against tissues, rather than puncturing and / or damaging the tissues as may likely occur by using the stiff guidewire.

[0424] At 338, optionally, a protector sheath that includes a protective balloon (or other intrabody tissue protection member such as expandable member or mechanical actuator) is advanced into the left ventricle over the soft GW. The sheath may be, for example, a classic sheath and / or may include a balloon for performing a valvuloplasty.

[0425] Optionally, the protective balloon is part of a hollow medical guide system for protecting a pressure sensitive intrabody area during the TAVI procedure, for example, protecting the annulus of the native aortic valve, left ventricular septal wall, and / or anatomical regions where the conduction system passes (e.g., trigone). The hollow medical system may include a hollow medical guide, a surgical tool disposed through the guide lumen, and an intrabody tissue protection member mounted on the distal end of the guide or the surgical tool or on a protective cover of the surgical tool or on a sheath of the surgical tool, for instance several centimeter before the tip, for protecting the pressure sensitive intrabody areas during the guidance of the surgical tool in the TAVI procedure.

[0426] The surgical tool is movably disposed through a guide lumen towards and away from the target tissue (e.g., aortic valve annulus) during the TAVI procedure. The surgical tool may include a flexible rod having a proximal end connected to a handle or a maneuvering element and a bendable tip or operative tip at a distal end. The surgical tool may be a guidewire or a pigtail catheter, and the hollow medical guide may be a catheter sheath or a channel in a catheter sheath, for instance on a sheath covering the tool is mounted therealong. The intrabody tissue protection member may be the inflatable balloon or an expandable member or mechanical actuator. It is adapted to radially expand and contract in relation to the longitudinal axis of the guide lumen and encircle the distal end of the hollow medical guide or the bendable portion of the surgical tool.

[0427] The aforementioned described embodiments may protect a pressure sensitive intrabody areas during the TAVI procedure, and may several advantages. For example, by detecting when the distal end of the hollow medical guide is in proximity to the pressure sensitive intrabody area and expanding the intrabody tissue protection member in response, the balloon may protect against excessive pressure being applied to the pressure sensitive area, reducing the risk of injury and / or damage to the organ or tissue which are in proximity to the target area treated by the tip of the surgical tool. Additionally, by expanding the intrabody tissue protection member in relation to the longitudinal axis of the surgical tool or the hollow medical guide, the embodiments allow precise guidance of the surgical tool to the target area, improving the overall outcome of the procedure.

[0428] At 340, the soft guidewire may be pulled from the left ventricle, optionally via a catheter and / or sheath having a distal end within the left ventricle. A pressure sensor may be passed into the left ventricle via the catheter and / or sheath. Alternatively, the existing distal end of the catheter and / or sheath within the left ventricle is used for measuring pressure and / or has a pressure sensor therein. Optionally, another catheter is passed into the aorta (e.g., ascending aorta, aortic root) and / or is pre-located in the aorta. The other catheter may include a pressure sensor and / or may be used to measure pressure in the aorta.

[0429] Optionally, the catheters in the left ventricle and / or aorta are implemented as pigtail catheters.

[0430] At 342, pressures in the aorta (e.g., ascending aorta, aortic root) and in the left ventricle are measured using the pressure sensor(s) may be measured, optionally using the catheters. The pressures may be measured over one or more cardiac cycles, for example, multiple pressure measurements are obtained over a single cardiac cycle.

[0431] A pressure differential across the aortic valve may be computed, as the difference between the pressures simultaneously sensed at the aorta and the left ventricle.

[0432] The pressure differential may be used, for example, for assessing the severity of the aortic stenosis. The pressure differential measured for the native aortic valve may be compared to the pressure differential measured for the THV after implantation, for assessing the improvement obtained by the implantation of the THV.

[0433] At 344, the protective balloon is inflated. The protective balloon of the hollow medical guide system described herein (also referred to herein as protector sheath) may allow the operator to avoid applying extensive force or pressure on the intrabody sensitive areas which can be damaged temporarily or permanently by the stiffness of the surgical tool during the TA VI procedure.

[0434] Referring now back to FIG. 9, the schematic of protective balloon 902 is depicted. Protective balloon 902 may be placed over a guidewire (e.g., stiff) 904, for example, for safeguarding against conduction disturbances during insertion of the stiff wire insertion and / or positioning. Protecting balloon 902 may be implemented as a small and / or non-compliant balloon. In some embodiments, the protective balloon 902 include several balloons at spaced apart positions. The several balloons may be of the same size, length, material and or of different sizes, lengths and materials.

[0435] At 346, optionally, a stiff GW is initially inserted into the left ventricle to be used during the TAVI procedure. The stiff wire can apply pressure laterally to the walls of the left ventricle. Without the protection of the intrabody tissue protection member, the septal wall of the left ventricle harbor what is a significant and critical part of the heart conduction system responsible for the stimulation of both ventricles, can be damaged. This might lead to a permanent heart block. By mounting the intrabody tissue protection member in front of the septal wall of the left ventricle harbor and expanding it during the procedure, such damage may be avoided. Alternatively, a soft GW is passed into the left ventricle. A soft GW may not be initially passable through the stenotic aortic valve, for example, the soft guidewire may be too flexible, falling into one of the cusps rather than passing through the aperture of the stenotic aortic valve. When the distal end region of the catheter has been positioned in the left ventricle, the stiff guidewire may be exchanged for the soft GW. The exchange may be performed by retracting the stiff guidewire out of the body and inserting the distal end region of the soft guidewire though a distal end region of the catheter into the left ventricle. The catheter acts as the guide for positioning the soft guidewire within the left ventricle. The catheter may be the catheter of the THV delivery system, a pigtail catheter, and / or another catheter.

[0436] At 348, one or more parameters of the guidewire (e.g., stiff GW) may be monitored, for example, pressure, position, and / or movement.

[0437] Movement of the guidewire may be monitored as described above.

[0438] Pressure may be monitored by detecting a local curvature of the GW. The local curvature of a guidewire depicted in the image(s) may be detected. The guidewire for which the curvature is detected may be the guidewire used for navigation and / or deployment of the prosthetic valve. The detected curvature may be indicative of a potential high pressure applied by the guidewire to the interior of the heart, which may adversely impact the conduction system of the heart. The detected curvature may be below the native aortic annulus plane, optionally within a chamber of the heart. By detecting the curvature indicating high pressure, the operator may reduce the curvature for reducing the pressure, for reducing likelihood of adversely impacting the conduction system of the heart. The detected portion of the local curvature of the guidewire may be displayed, for example, marked with a different color or pattern to distinguish from other portions of the guidewire that do not have local curvatures.

[0439] The images depicting the guidewire may be monitored for detecting sudden changes in position, such as an abrupt jump in the position of the guidewire. The abrupt jump may be determined by detecting the guide wire in successive images, and determining whether a computed distance between the guide wire in successive images greater is greater than a threshold indicating abrupt jump.

[0440] At 350, when the accessory catheter (e.g., pigtail) has been inserted into the patient, such as into the left ventricle and / or native aortic valve, the accessory catheter may be placed in the non-coronary cusp of the native aortic valve. The accessory catheter may be placed in the noncoronary cusp, for example, for injection of contrast to identify the annulus line, and / or for acting as a marker for tracking the annulus line and / or location of the native aortic valve, such as for implantation of the THV. When the accessory catheter is located in the non-coronary cusp, the accessory catheter is located close to the conduction system. For example, the membranous septum is located between the right coronary cusp and the non-coronary cusp. Presence of the accessory catheter may lead to damage to the conduction system. The pigtail may be pulled from the non-coronary cusp to avoid damage to the conduction system, such as upon expansion of a balloon within the aortic valve (e.g., for a valvuloplasty).

[0441] When the accessory catheter is found to be positioned within the non-coronary cusp and / or other location close to the conduction system, the non-THV catheter may be removed or moved to another suitable location prior to inflating the balloon, optionally a left coronary cusp. The accessory catheter may be moved from tissues being compressed by expansion of the balloon during inflation to the other suitable location in which risk to tissue damage (e.g., conduction system) is reduced or eliminated, optionally the left coronary cusp. The left coronary cusp may be furthest away from the bundle of HIS and / or AV node which may be damaged by compression of the non-THV catheter, thereby reducing or preventing risk of damage to the bundle of HIS and / or AV node. The balloon may be expanded (i.e., inflated) in the new location. Removing or moving the accessory catheter (e.g., pigtail) reduces or avoids conduction system damage by the expanding balloon applying pressure to the accessory catheter against tissue.

[0442] At 352, an optional expansion of a balloon (e.g., to perform a valvuloplasty) for expansion of the opening area of the native aortic valve, disrupts some of the anatomy of the aortic valve. In particular, the patter of calcification depots of the calcification signature changes.

[0443] The balloon expansion within the native aortic valve may displace some of the calcification deposits in proximity to the leaflets and / or cusps and / or annulus of the native aortic valve. Some calcification deposits which are located further away from the native aortic valve may remain at their location. The balloon expansion has not displaced them. For example, calcification deposits in the wall of the ascending aorta, and / or in the muscle of the left ventricle may remain intact.

[0444] Optionally, the annulus line is re-located after the balloon expansion in the native aortic valve, optionally using the new calcification signature. The annulus line may be re-located using embodiments described herein, for example, finding a 2D projection of a 3D image by correlating to the calcification signature of the 2D fluoroscopic image.

[0445] At 354, optionally, the annulus line is tracked prior to an event that disrupts the annulus, for example, inflation of a balloon within the native valve (e.g., valvuloplasty) such as to crack calcifications and / or adhesions to increase the area of the native valve to enable deployment of the prosthetic heart valve. The annulus line may be detected after the event, using the spatial relationship computed prior to the event. The annulus line may be detected after the event using the same spatial relationship computed prior to the event, since the event disrupts the leaflets and / or calcifications adhering to the leaflets and surrounding tissues, but the annulus line remains substantially unaffected.

[0446] At 356, the protector sheath (e.g., with balloon) and / or GW (e.g., stiff and / or flexible) may be connected to a device designed for maintaining the intrabody position (also referred to herein as “mini-robot”) of the protector sheath and / or GW during the TAVI procedure. Movement of the guidewire and / or protector sheath from its intrabody position may cause damage to the conduction system of the heart and / or may cause damage to nearby tissues, for example, by shear forces applied to the tissues lining the interior of the heart. The mini-robot may monitor for movement of the guidewire and / or protector sheath, which may help to prevent and / or detect conduction disturbances. The mini-robot may include a displacement sensor and optionally a driving mechanism coupled to the guidewire for causing a movement compensating for movement of the guidewire from its target intrabody guidewire position measured using the displacement sensor. The displacement sensor may comprise one of more motion sensors selected from a group consisting of: accelerometers, radio frequency transceivers, ultrasound transceivers, optical sensors, electronic sensors, compass, magnetic encoders and gyroscopes

[0447] Referring now back to FIG. 10, sensing component 1002 of a mini-robot that includes the displacement sensor is depicted. Sensing component is connected to a guidewire and / or sheath 1004 for monitoring movement of the guide wire and / or sheath 1004 and / or for maintaining the position of the guidewire and / or sheath 1004.

[0448] Referring now back to FIG. 3, at 356, the device for maintaining intrabody position may be designed for enabling delivery of the protector sheath over the guidewire into the body (e.g., to the left ventricle) while maintaining the position of the guidewire within the body, as the protector sheath is being moved over the guidewire. Such motion is generally done manually, where one operator holds the guidewire in place and another operator displaces the protector sheath over the guidewire. The guidewire may be inadvertently displaced while the protector sheath is being moved over the guidewire, which may lead to damage of tissues, for example, damage the conduction system by shear forces and / or puncture the left ventricle by forward motion. Maintaining the position of the guidewire within the body while the delivery system is being retracted helps to avoid movement of the guidewire, which may damage tissues.

[0449] The device for maintaining intrabody position may track displacement of the protector sheath into the body relative to an initial baseline between the protector sheath and the guidewire, for example, zero initial displacement. The device may help ensure that the displacement of the protector sheath relative to the guidewire, after subtracting the displacement of the protector sheath into the body, remains at the initial baseline, optionally zero. In other words, that only the intrabody sheath is being displaced into the body, without displacing the guidewire deeper into the body and / or in a direction for being retracted from the body.

[0450] The device may be a synchronous guidewire single operator device, that includes a sensing and / or driving mechanism connecting between the proximal end of the device and the guidewire and / or protector sheath coming out from the handle of the device. The driving mechanism may compensate for motion and / or rotation of the guidewire and / or protector sheath, and the effector, due to non-deliberate movements such as tremor, and / or avoids the difficulty of synchronizing two or more operators. The handle may be suitable for hand holding and may include a motion sensor, and / or a driving mechanism coupled to the guidewire.

[0451] At 358, position of the GW may be monitored to detect movement. Movement of the GW may lead to damage of the conduction system and / or other tissues of the heart, for example, by shear forces applied by the moving GW, and / or the tip of the GW puncturing tissues.

[0452] Movement of the GW may be detected by different approaches. For example, a baseline movement of the guidewire during heartbeats and / or breathing cycles may be computed according to an analysis of multiple baseline images (e.g., 2D fluoroscopic images). Successive images of the guidewire may be monitored for detecting movement of the guidewire that deviates from the baseline movement. Such movement outside of the range of motion may represent undesired movement of the guidewire, that does not result from the heartbeats and / or breathing, but may result, for example, from an erroneous pull on the guidewire from outside of the body of the subject. An operator (e.g., physician) may prevent further undesired motion of the guidewire, and / or restore the guidewire to its previous target position.

[0453] In another example, a target position of the guidewire is obtained, for example, from a still pre-procedure image that excludes the guidewire and is captured at a random phase of the heartbeat cycle and / or breathing cycle, such as a CT scan. Images of the guidewire captured during the TA VI procedure over multiple heartbeats and / or breathing cycles may be analyzed for detecting a current position of the guidewire. The processor may determine when the current position of the guidewire deviates from the target position.

[0454] At 360, the delivery system, which includes the THV, may be inserted into the body of the subject. The delivery system may be connected to the device for maintaining the intrabody position of the delivery system.

[0455] The THV may be advanced to the descending aorta.

[0456] At 362, the THV may be tracked at and / or from the descending aorta, optionally along the predetermined path, across the aortic arch, to the ascending aorta, and to the native aortic valve. Optionally, the alignment of the THV with respect to the coronary ostia and / or commissures may be tracked.

[0457] The indication of alignment of the THV may be generated while the aortic valve prosthesis device is located in the descending aorta. This allows the operator to rotate the aortic valve prosthesis device for alignment with the coronary ostia while in the descending aorta, prior to advancing the aortic valve prosthesis device across the aortic arch and into the ascending aorta. The indication of alignment may be dynamically generated in real-time (or near real-time), during the procedure, to ensure that the alignment is maintained as the aortic valve prosthesis device is advanced. The indication of alignment may be dynamically computed for any pose of the image sensor. This allows the operator to adjust the pose of the image sensor as they wish, according to their visualization needs, without requiring a specific pose to determine the indication of alignment and / or orientation of the aortic valve prosthesis device such as according to rigid rules.

[0458] The current orientation of the aortic valve prosthesis device may be computed by analyzing one or more markers located on the aortic valve prosthesis device depicted in one or more 2D image (e.g., fluoroscopic images) and according to a pose of an image sensor that captured the 2D image(s). The pose of the image sensor may be obtained, for example, by optical character recognition (OCR) of the pose added to the 2D image, and / or obtained from a sensor associated with the image sensor, and the like.

[0459] Based on a known mapping between commissures and the marker(s), the location of the commissures, representing a current orientation of the commissures of the aortic valve prosthesis device, may be computed according to the determined location of the marker(s) from the 2D image.

[0460] The current orientation of the THV may compared to the target orientation, which may have been computed at the pre-processing phase using the 3D image. The target orientation may be for a location along the path where the aortic valve prosthesis device is currently located. The path may have been computed using the 3D image obtained during the pre-processing, as descried herein.

[0461] The comparison may be performed to determine whether there is a mismatch in the alignment between the current orientation (representing the current orientation of the commissures), and the target orientation (representing the orientation of the commissures during deployment relative to the coronary ostia, to avoid blocking of the coronary ostia). A mismatch may indicate a requirement to rotate the aortic valve prosthesis device to obtain an alignment. An alignment indicates that the aortic valve prosthesis device is predicted to reach the target location for deployment properly aligned. In another example, a current view of an image sensor capturing the image(s) at a current orientation is obtained, for example, by optical character recognition of the 2D fluoroscopic image (e.g., LAO, RAO view) and / or a post of the C-arm by a sensor. The current orientation of the aortic valve prosthesis device may be mapped to a transformed orientation according to a transformation between the current view and the 3D image. This may enable determining the state and / or commissural alignment state from different views of the fluoroscopic device using the 3D image, for example, presenting an indication for rotation of the aortic valve prosthesis device for alignment with the native aortic valve according to the transformed orientation. For example, how much to rotate and / or in what direction to rotate, optionally as a trend, as described herein.

[0462] In yet another example, the current orientation of the aortic valve prosthesis device (e.g., in the thoracic aorta and / or abdominal aorta) may be mapped to the target orientation for alignment, indicating whether the aortic valve prosthesis device is predicted to arrive at the ascending aorta in the commissural alignment state (e.g., rotation) that will result in alignment when implanted. Deviations from predicted alignment may be presented, optionally with indication of which direction to rotate and / or how much to rotate e.g., in the thoracic aorta and / or abdominal aorta) to obtain a state in which the aortic prosthesis valve is predicted to be aligned when implanted.

[0463] The indication of the mismatch may be presented on a display, optionally within a graphical user interface (GUI), as a visual element indicating whether the current orientation and the target orientation match (i.e., aligned) or do not match (i.e., non-aligned). When there is a mismatch, the visual element may indicate the extent of the mismatch.

[0464] Optionally, the indication of mismatch is presented as a category, for example, indicating lack of mismatch, or mismatch. A mismatch may be presented as a clockwise or counter clockwise mismatch, indicating how to rotate the aortic valve prosthesis device to obtain alignment. For example, the color green indicates an alignment, the color red indicates a clockwise mismatch, and the color blue indicates a counter clockwise mismatch. The intensity of the color may indicate the amount of mismatch, where a more intense color (e.g., away from green) indicates a larger mismatch (i.e., large rotation needed to fix) and a less intense color (e.g., closer to green) indicates a smaller mismatch (i.e., smaller rotation needed to fix).

[0465] It is noted that other indications may be used, for example audio (e.g., different sounds, frequency, patterns, may represent alignment or mismatch), patterns (e.g., shading, dots, dashes), text, video, and the like. At 364, when the THV has been advanced into the ascending aorta, the pose of the THV may be evaluated relative to the pose of the annulus, and / or relative to alignment with the coronary ostia and / or commissures of the native aortic valve.

[0466] The evaluation is patient-specific, according to the actual anatomy of the patient (e.g., location of coronary arteries, angulation (e.g., pose) of the annulus plane of the native aortic valve of the patient).

[0467] The evaluation may be automatically done, for example, by analyzing the pose of the THV using marker(s) of the THV, and evaluating the pose of the THV relative to the pose of the annulus, which may be determined by mapping the annulus plane of the 3D image to the 2D fluoroscopic image, optionally by projecting the 3D image (of the patient, such as pre-procedure CT) to a 2D plane that is registered to the 2D fluoroscopic image such that the 2D fluoroscopic image is at approximately the same pose of the 2D plane.

[0468] When the evaluation indicates alignment between the pose of the THV and the target pose for implantation relative to the annulus and / or relative to the coronary ostia and / or commissures, the THV may be implanted. When the evaluation indicates mis-alignment, the THV may be pulled back to the descending aorta for rotation to obtain alignment, or the THV may be rotated to obtain alignment at the ascending aorta for designs of THV that are torqueable at the ascending aorta.

[0469] The evaluation may be performed for any viewing angle of the 2D fluoroscopic image, independent of the pose of the image sensor capturing the 2D fluoroscopic images. This allows the operator to change the pose of the image sensor to a view that is suitable for the operator. The evaluation is performed for the new view.

[0470] At 366, the pose of the THV relative to the native aortic valve, such as relative to the annulus, may be monitored. The pose of the THV, optionally in 6 degrees of freedom (6 DOF) may be compared to a target pose of the annulus. A substantial match in poses may indicate optimal pose of the THV for implantation, for example, for reducing or eliminating paravalvular leaks, and / or for reducing likelihood of post implantation displacement of the THV.

[0471] An indication of the optimal pose of the image sensor for viewing the annulus may be presented. The indication of the optimal pose may have been computed using the 3D image which may be obtained pre-procedure, as described herein.

[0472] An indication for guiding the operator from the current pose to the optimal pose may be generated, for example, by determining the current pose (e.g., from OCR of the 2D image, from a pose sensor of the image sensor, from mapping the 2D image to the 3D image) and computing a transformation from the current pose to the optimal pose. At 368, device depth and / or tilt may be monitored. An indication of device depth may be presented on a display.

[0473] The terms tilt and orientation are used interchangeably.

[0474] The device tilt may be computed relative to a target orientation, optionally relative to the detected coronary ostia and / or commissures of the native valve. The device tilt may indicate the alignment of the THV relative to the coronary ostia, such that the coronary ostia will be nonblocked once the THV is deployed.

[0475] The indication of tilt, optionally, whether commissures of the THV, located in the aorta, are aligned relative to the coronary ostia, may be computed using the following process. The 3D image of the subject (e.g., CT, MRI), optionally obtained prior to the procedure, may be analyzed for identifying locations of the two coronary ostia, as described herein. A target orientation for alignment of the aortic valve prosthesis device relative to the two coronary ostia, may be computed. Optionally, the target orientation is for alignment of one (of three) commissures of the aortic valve prosthesis device with a mid-point (along the interior circumferential wall of the aorta) between the two identified coronary ostia. Optionally, the target orientation is computed along a path for deployment of the aortic valve prosthesis device, for example, from the descending aorta, across the aortic arch, and to the ascending aorta. During the procedure, such as when the aortic valve prosthesis device is located in the descending aorta, a current orientation of the aortic valve prosthesis device is determined. The current orientation may be determined by analyzing at least one marker disposed on the aortic valve prosthesis device depicted in 2D image(s) (e.g., fluoroscopic image) and according to a pose of an image sensor (e.g., C-arm of the fluoroscopic machine) that captured the 2D image. A mismatch between the current orientation and the target orientation is computed, and presented. For example, the mismatch may be presented as a categorical indication (e.g., color), where green indicates alignment, red indicates clockwise misalignment, and blue indicates anti-clockwise misalignment. An operator may rotate the aortic valve prosthesis device as necessary. Once the aortic valve prosthesis device is aligned in the descending aorta, the operator may advance the aortic valve prosthesis device towards the deployment site (e.g., within the aorta, within the annulus). The mismatch may be dynamically computed along the path during the advancement, to help ensure that the aortic valve prosthesis device arrives at the deployment site aligned, and ready for deployment. The mismatch may be dynamically computed during the procedure, such as the aortic valve prosthesis device is being advanced, independently of the pose of the image sensor. The mismatch may be dynamically computed for any pose of the image sensor. This allows the operator to adjust the pose of the image sensor as they wish, according to their visualization needs, without requiring a specific pose to determine the orientation.

[0476] Referring now back to FIG. 11, which is a schematic of an exemplary GUI 1100 indicating device depth 1102 and / or tilt 1104, in accordance with some embodiments of the present invention. Device depth 1102 may be presented visually, for example, an indication along a color coded bar, where green indicates the device depth is within a target suitable for deployment, red indicating the device depth is outside the target and the THV should not be deployed, and yellow indicating an intermediate state of close to the target but not within the target. Red and / or yellow may be presented with varying intensity, where a more intense color indicates further away from the target and a less intense color indicates closer to the target. A numerical value of the device depth may be computed. Tilt 1104 may be presented for one or more axes and / or degrees of freedom, for example, angular rotation and / or up / down tilt. Tilt may be presented using the color coded bar.

[0477] Referring now back to FIG. 3, at 368, a distal end of the partially expanded THV may be automatically detected by analyzing the target image.

[0478] Optionally, contrast enhanced image(s) of the subject depicting injected contrast located within the cusps of the aortic valve and the ascending aorta, are automatically analyzed to identify the lower annulus (e.g., annulus line).

[0479] The device depth of the THV may be computed. The device depth is a distance between the lower annulus and the distal end of the THV. The term device depth and distance are used interchangeably.

[0480] Optionally, the detected lower annulus is represented as a first line representing a plane of the lower annulus. The detected distal end of the THV is represented as a second line representing a plane of the distal end of partially expanded THV. The distance is computed between the first line and the second line.

[0481] Alternatively or additionally, a fiducial marker of the THV having a known dimension(s) is automatically detected. A calibrated distance is computed by calibrating the distance according to the known dimension. The fiducial marker may include, for example, a strut or portion thereof of a scaffold of the THV that remains the known fixed dimension throughout expansion of the THV. In another example, the fiducial marker may include a catheter (pigtail used to inject the contrast) located in the aorta have a fixed dimension such as of a marker.

[0482] An automatic determination may be made whether the distance is within a target range indicating correct positioning of the THV within the native aortic annulus. The target range may be defined according to an identifier of the THV. For example, different THV may have different identifiers and different target ranges. Optionally, an overlay over the target image that visually marks the lower annulus and / or the distal end may be generated.

[0483] Optionally, a visual and / or an audio indication of when the distance is within the target range may be presented. The visual indication may be presented, for example, in the form of a binary or tertiary indication, such as three colors. A first color indicates that the distance is within the target range. A second color indicates that the distance is external to the target range, optionally in a certain direction. For example, that the distance is lower than the target range. A third color may indicate that the distance is external to the target range in the other direction, for example, that the distance is greater than the target range. In another example, a coded bar is presented, representing the possible values of the distance, from low to higher. An indication on the coded bar represents the current distance. A region of the coded bar may indicate the target range.

[0484] Optionally, when no distal end of the partially expanded THV is detected, a visual and / or an audio indication of where to position a distal end of the THV in the compressed state for expansion of the THV such that the distal end of the THV when expanded is predicted to be located within the target range, may be presented.

[0485] At 370, a presentation of the pose of the THV relative to the plane of the annulus may be generated, optionally indicating the pose of the THV in 3D and / or in 6 degrees of freedom. Additional exemplary details of generating the presentation are described, for example, with reference to FIG. 5.

[0486] At 372, fast pacing of the heart may be started, using the previously inserted pacing catheter.

[0487] Fast pacing of the heart during Transcatheter Aortic Valve Implantation (TAVI) is a technique that may be used by the medical team to temporarily increase the heart rate of the patient. This method may be employed facilitate accurate positioning and deployment of the new THV within the native aortic valve.

[0488] Rapid ventricular pacing may be initiated when the THV valve is being deployed. Rapid ventricular pacing involves delivering a series of high-frequency electrical impulses to the ventricles of the heart. This temporarily increases the heart rate, causing the heart to beat faster than its normal rate. The main purpose of fast pacing during TAVI is to induce a condition known as "ventricular standstill" or "ventricular arrest." By rapidly pacing the heart, the ventricles are effectively paused, and they stop contracting momentarily. This temporary cessation of ventricular contractions creates a more stable environment for the precise placement and deployment of the new aortic valve. When the heart is rapidly paced and in ventricular standstill, the movement of blood through the aortic valve is reduced. This decreased blood flow minimizes the risk of the new valve being dislodged or moved during deployment. It allows the medical team to position the new valve accurately and ensure it is securely anchored in place.

[0489] At 374, a current pose of the THV relative to a target pose for deployment is computed. The target pose may include one or more of: alignment of commissures of the THV relative to commissures of the aortic valve, alignment of commissures of the THV relative to coronary ostia, device depth, and the like.

[0490] When the current pose substantially matches the target pose, the THV may be released and implanted. When the current pose is substantially different from the target pose, the release may be stopped and / or the THV may be retracted, for correcting the pose of the THV.

[0491] Optionally, the indication of the state of the markers and / or the commissure alignment state and / or amount of rotation, which are used to determine the current pose of the THV, may be computed without changing views of the imaging machine that captures the images, i.e., using images captured at a single view. For example, the indication of the state of the markers and / or the commissure alignment state and / or amount of rotation based on fluoroscopy images captured entirely (e.g., only) in the cusp overlap (COL) view without switching to another view such as the 3-cusp view.

[0492] In response to the indication of the state and / or the commissure alignment state, i.e., the pose, the aortic valve prosthesis device may be rotated in an attempt to arrive at the target state and / or to obtain a proper commissure alignment. Once the aortic valve prosthesis device is in the target state and / or the commissures are aligned, the aortic valve prosthesis device may be deployed in the native valve (or previously implanted valve) by expansion of the aortic valve prosthesis device from the compressed state.

[0493] At 376, after the THV is successfully deployed, the rapid pacing is discontinued, and the heart returns to its normal rhythm. The function and / or positioning of the THV may be assessed using various imaging techniques, such as fluoroscopy and echocardiography, to confirm its proper functioning and placement.

[0494] At 378, the device for maintaining intrabody position may be connected to the delivery system (e.g., catheter used to deliver and / or deploy the THV) and / or guidewire (e.g., stiff), for removing the delivery system from the body while maintaining the position of the guidewire within the body. Maintaining the position of the guidewire within the body while the delivery system is being retracted helps to avoid movement of the guidewire, which may damage tissues, for example, damage the conduction system by shear forces and / or puncture the left ventricle by forward motion. The guidewire (e.g., stiff) may be removed using the device for maintaining intrabody position.

[0495] At 380, a pressure differential across the implanted THV may be computed, as the difference between the pressures simultaneously sensed at the aorta and the left ventricle. The pressure differential may be measured by catheter(s), such as pigtail catheters optionally associated with pressure sensors, located in the aorta and in the left ventricle.

[0496] The pressure differential across the THV may be compared to the pressure differential measured across the native aortic valve (prior to implantation of the THVO, for assessing the improvement obtained by the implantation of the THV.

[0497] At 382, the catheter(s) and / or other components of the delivery system may be removed from the body of the patient. The access location may be closed (e.g., stitched). The TAVI procedure may be concluded.

[0498] Referring now back to FIG. 4, at 402, 2D images captured during the ongoing TAVI procedure for implantation of the THV are analyzed. Other data may be analyzed in combination with the 2D images, for example, ECG, a video of the operator, audio of the operator(s) speaking, and the like.

[0499] The 2D images may be analyzed to detect a start of a step of the TAVI procedure associated with increased likelihood of risk to the subject, for example, risk of damage to the conduction system, risk of perforation of the left ventricle, and risk of obstructing the coronary ostia.

[0500] The analysis may be performed, for example, by feeding the 2D images into a machine learning model, and obtaining the indication of the start of the step as an outcome of the ML model. The ML model may be trained on a training dataset of records, each including 2D images of a sample subject labelled with a ground truth of the step.

[0501] At 404, in response to the detection of the step, a watchdog application may be triggered. The watchdog application may be a specific application designed to monitor the specific step of the TAVI procedure for specific features and / or actions that are associated with increased risk to the subject.

[0502] The watchdog may be triggered automatically, for example, by monitoring images and / or other data of the procedure, to determine a step and / or event of the procedure, and activate the relevant watchdog for the step and / or event. Alternatively or additionally, the operator may manually trigger the watchdog. For example, in a certain phase of the procedure, the operator may wish to be assisted by a certain watchdog.

[0503] The watchdog application may analyze subsequent 2D images and / or other data obtained during the step of the TAVI procedure, to detect the features and / or actions. The watchdog application may trigger actions, for example, presenting an alert on a display and / or played on speakers, generating instructions on the display indicating how to perform the step (e.g., video of a previous step by another operator done safely), playing a video on the display indicating what not to do, and the like.

[0504] One or more watchdogs may be activated at one or more steps of the TAVI procedure, for example, as described with reference to FIG. 3. Some exemplary watchdogs are now described:

[0505] Optionally, the step of the TAVI indicates inflation of a balloon within a native aortic valve. The watchdog may analyze the 2D images to detect presence of an accessory catheter (e.g., pigtail) in an anatomical location linked to higher risk of damage to a conduction system of a heart of the subject. The watchdog may analyze the 2D images to detect presence the accessory catheter in general, when the accessory catheter should not be present in the ascending aorta and / or left ventricle.

[0506] Alternatively or additionally, the step of the TAVI indicates insertion of a guidewire into the left ventricle. The watchdog may analyze the 2D images to detect a curvature of the guidewire above a threshold (e.g., indicating a sharp curve that can damage the tissue), and / or monitor a balloon on a distal end of the guidewire for protecting and / or check whether the stiff guidewire should be a soft guidewire.

[0507] Alternatively or additionally, the step of the TAVI indicates presence of a guidewire in the left ventricle. The watchdog may analyze the 2D images to detect additional displacement motion of the guidewire greater than a baseline motion of the guidewire due to respiratory and / or cardiac cycles.

[0508] Alternatively or additionally, the step of the TAVI indicates start of expansion of the THV for deployment. The watchdog analyzes the 2D images to detect displacement of the THV in a partially expanded state.

[0509] Alternatively or additionally, the step of the TAVI indicates displacement of the THV from the descending aorta, across the aortic arch, to the ascending aorta. The watchdog monitoring for a mismatch in alignment between the THV and coronary ostia (and / or commissures of the native valve), optionally according to a pre-planned path based on a pre-procedure 3D image (e.g., CT).

[0510] Alternatively or additionally, the step of the TAVI indicates that the THV is located in the ascending aorta. The watchdog analyzes the 2D images for detecting a mismatch between a pose of the THV and a pose of an annulus line of the native aortic valve.

[0511] Alternatively or additionally, the step of the TAVI indicates that the THV is located in the ascending aorta. The watchdog analyzes the 2D images for computing a device depth of the THV relative to an annulus line, and monitoring for deviation of the device depth from a target range. The outcome of the watchdog may be presented as an indication on a display, for example, the mismatch, device depth, and other outcomes.

[0512] The watchdogs may use trained machine learning models, trained using suitable training datasets, for example, of records of 2D images with the corresponding ground truth, which is the outcome of the corresponding watchdog.

[0513] At 406, the watchdog application may monitor subsequent 2D images to detect an end of the step.

[0514] At 408, in response to the end of the step, the watchdog application may be terminated.

[0515] At 410, one or more features described with reference to 402-408 may be iterated over the steps of the TAVI procedure. Different watchdogs, each designed to monitor specific parts of the TAVI procedure for specific risky actions, may be activated and terminated at different steps of the TAVI procedure.

[0516] Referring now back to FIG. 5, the method described with reference to FIG. 5 may be used, for example, for aligning the pose of the THV with the pose of the annulus of the aortic valve, during maneuvering of the THV and / or during implantation of the THV. For example, from the ascending aorta, to the aortic arch, and / or to the descending aorta. Alignment of the pose of the THV with the pose of the annulus of the aortic valve for implantation of the THV may improve performance of the implanted THV, for example, reduced risk of paravalvular leaks, increased durability due to correct alignment of the THV, and / or reduced risk of displacement of the implanted valve due to secure contact with surrounding tissues within the annulus.

[0517] At 502, a 2D image depicting the THV in the aorta of the subject is obtained. The THV may be, for example, in the descending aorta, the ascending aorta, and / or the aortic arch.

[0518] At 504, a current pose of the THV in the aorta may be computed by analyzing one or more markers located on the THV and depicted in the 2D image and according to a pose of an image sensor that captured the 2D image. For example, by feeding the 2D image into a ML model trained on a training dataset of 2D images of the THV at different poses labelled with respective ground truths of the current pose.

[0519] The pose of the THV may be computed according to a predefined 3D space and / or 3D coordinate system, which corresponds to the 3D space and / or 3D coordinate system of the 3D image of the subject (e.g., CT image acquired pre-procedure, as described herein).

[0520] At 506, a pose of an annulus plane of the 3D image (e.g., CT image acquired pre-procedure, as described herein) is computed. The pose of the annulus plane may be automatically computed by identifying three nadirs of three cusps of the native aortic valve, and defining the plane as intersecting the three nadirs. At 508, the current pose of the THV relative to the pose of the annulus plane may be provided.

[0521] The current pose of the THV and / or the pose of the annulus plane may include one or more degrees of freedom, optionally each having 6 degrees of freedom, for example, one or more of: up, down, right, left, forward, backwards, pitch, roll, and yaw.

[0522] At 510, a presentation of the current pose of the THV relative to the pose of the annulus plane may be generated, for example, within a GUI.

[0523] Optionally, the presentation is based on the “artificial horizon” or “altitude indicator”! instrument of an aircraft, which may be extended to show pose in 3D. The baseline may be the annulus, for example, replacing the “earth’s horizon” in the instrument of the aircraft.

[0524] Alternatively or additionally, the presentation includes a first visual indication that indicates alignment between the current pose of the THV relative to the pose of the annulus. For example, the first visual indication is the color green, and / or zero position within a 3D space. The presentation may include a second visual indication of non-alignment between the current pose of the THV relative to the pose of the annulus. For example, the color red and / or non-zero position within the 3D space. There may be two or more sub-visual indications, each indicating a respective direction for changing the current pose of the THV to obtain alignment relative to the pose of the annulus, for example, rotate left, rotate right, tilt up, tilt down, and the like. For example, different colors for different directions and / or different axes, such as red to rotate clockwise and blue to rotate counter clockwise. In another example, the non-zero position along an axis of the 3D space indicate the direction to adjust. The two or more sub-visual indicates may indicate an amount of the change of the current pose to obtain alignment, for example, intensity of the color, and / or distance from the zero of the 3D space along an axis. There may be

[0525] At 512, one or more features described with reference to 502-510 may be iterated over time, during the TA VI procedure.

[0526] Optionally, a “single view” feature is provided for the operator during the TAVI procedures. The “single view” features allows the operator to maintain the same pose of the image sensor for capturing the 2D image as the THV is maneuvered in the aorta, for example, from the descending aorta to the ascending aorta. The “single view” feature is in contrast to existing approaches where the operator is required to change the pose of the image sensor multiple times to evaluate the pose of the THV, which is prone to error, inaccurate, and / or time consuming.

[0527] The iterations may be performed while the THV is maneuvered (e.g., advanced) in the aorta, and while the 2D images are being captured as the same “single view” for dynamically and iteratively computing the current pose of the THV relative to the pose of the annulus plane. This allows the operator to use the presentation to dynamically adjust the pose of the THV to substantially match the pose of the annulus plane without having to change the pose of the image sensor.

[0528] Referring now back to FIG. 6, the features of the method described with reference to FIG. 6 may be dynamically implemented with respect to features of the method described with reference to FIG. 3, for dynamically updating applications running at different stages of the method described with reference to FIG. 6.

[0529] At 602, outputs of one or more applications running during the ongoing TAVI procedure for implantation of the THV, for example as described with reference to FIG. 3, are monitored.

[0530] The application(s) may be running throughout the TAVI procedure. Alternatively, one or more applications are designed for being activated in response to detecting a specific step of the TAVI procedure and terminated in response to end of the specific step. For example, the application(s) may include the watchdogs described herein.

[0531] Optionally, the application(s) process 2D fluoroscopic images captured during the TAVI procedure. The output of the application(s) may include an enhanced visual presentation of the 2D fluoroscopic images, for example, an overlay over the 2D images, and / or a GUI based on the analysis of the 2D images (e.g., the artificial horizon described herein). Alternatively or additionally, the application(s) process other data and / or generate other outcomes as described herein.

[0532] Referring now back to FIG. 12, annulus line 1202 and / or conduction system 1204 are displayed (e.g., as an overlay) over fluoroscopic image 1206 during the procedure, optionally within a GUI.

[0533] Referring now back to FIG. 6, at 602, examples of application are described herein, for example, with reference to FIG. 3. Some examples of applications include:

[0534] • Detecting presence of an accessory catheter in an anatomical location linked to higher risk of damage to a conduction system of a heart of the subject.

[0535] • Detecting a curvature of the guidewire above a threshold.

[0536] • Monitoring a balloon on a distal end of the guidewire for protecting.

[0537] • Checking whether a stiff guidewire is present instead of a soft guidewire.

[0538] • Detecting additional displacement motion of the guidewire greater than a baseline motion of the guidewire due to respiratory and / or cardiac cycles.

[0539] • Detecting displacement of the THV in a partially expanded state.

[0540] • Detecting a mismatch between a pose of the THV and a pose of an annulus line of the native aortic valve. • Computing a device depth of the THV relative to an annulus line, and monitoring for deviation of the device depth from a target range.

[0541] Other examples of applications include:

[0542] • Planning a path for guiding a THV from a descending aorta for arriving in alignment with coronary ostia of the native aortic valve.

[0543] • Computing a pose for setting of an image sensor for viewing an annulus.

[0544] • Selecting the THV.

[0545] • Pre-procedure recommendation for pacemaker.

[0546] • Tracking the annulus.

[0547] • Tracking the accessory catheter.

[0548] • Tracking coronary ostia.

[0549] • Generating a presentation of a pose of the THV relative to a plane of the annulus.

[0550] • Monitoring device depth.

[0551] • Motoring alignment of the THV relative to the coronary ostia.

[0552] At 604, an indication of an outcome of the TAVI procedure is obtained. The indication of the outcome may be for the TAVI procedure as a whole, for example, duration of TAVI procedure, complications post TAVI procedure, indication of successful implant of the THV, and ECG indicating new conduction disturbance after the TAVI procedure.

[0553] Alternatively or additionally, the indication of the outcome of the TAVI procedure is for each specific step (e.g., when applications are activated and terminated for specific steps), for example, ECG indicating new conduction disturbance after the step, or no significant change in ECG between pre and post step.

[0554] At 606, the application(s) are updated using the outcome of the TAVI procedure.

[0555] The updated applications may help improve outcomes of the TAVI procedure. For example, the application for monitoring device depth may learn that certain device depths are associated with higher risk of post implantation dislodgement while other device depths have lower risk of post implantation dislodgement, and may shift the recommended target device depth to obtain better outcomes. In another example, the application that computes a path for obtaining an alignment between the THV and coronary ostia may learn a better path to obtain a better alignment. In yet another example, the application that tracks the location of the guidewire and / or accessory catheter may learn that certain actions by the operator for moving and / or placing the guidewire and / or accessory catheter lead to higher risk of conduction disturbance and may warn the operator when such actions are detected.

[0556] When the application is implemented a ML model, the application(s) may be updated by creating a new record and updating the application. For example, consider the case where the application is an ML model that is fed a 2D image and generates the output as an outcome of the ML model. A new record including the 2D image may be created, where the outcome of the TA VI procedure is a ground truth.

[0557] The ML model may be updated using the new record for generating the output for meeting a target outcome.

[0558] At 608, one or more features described with reference to 602-606 are iterated, for example, during the TAVI procedure and / or for other subjects and / or for different applications.

[0559] As used herein the term alignment, or commissure alignment state, may refer to a state in which the commissures (e.g., posts) of the aortic valve prosthesis device are aligned with the commissures of the native aortic valve and / or commissures of a previously implanted aortic valve prosthesis device (e.g., in a valve-in-valve procedure) such that the coronary ostia are non-blocked to enable introduction of a catheter therein (e.g., to perform a future trans-catheter coronary procedure such as angiogram and / or stent placement). Alternatively, the term alignment, or commissure alignment state, may refer to a state in which the commissures (e.g., posts) of the aortic valve prosthesis device are aligned relative to the coronary ostia (the openings into the coronary arteries from the aorta), such that the coronary ostia are non-blocked. Optionally, one of the commissures of the aortic valve prosthesis device (e.g., when there are three commissures) is aligned at a mid-point between the two coronary ostia, for example, at the mid-point along the wall of the aorta between the two coronary ostia. In some anatomical variations, the coronary ostia are not necessarily aligned with the commissures of the native aortic valve. In such cases, where the coronary ostia are separate by a value other than about 120 degrees (e.g., about 90 degrees, or 100, or 140, or other values), and / or where the coronary ostia are not located in the middle of the cusps (even when the coronary ostia are 120 degrees apart) aligning the commissures of the aortic valve prosthesis device relative to the mid-point between the coronary ostia may help ensure that the coronary ostia are non-blocked by the deployed aortic valve prosthesis device.

[0560] As used herein, the term mismatch (in alignment between the commissures of the aortic valve prosthesis device relative to the coronary ostia, such as between the current orientation and the target orientation described herein) may refer to no mismatch (which indicates alignment) or to a mismatch (which indicates non-alignment). The term non-alignment refers to a state in which the commissures (e.g., posts) of the aortic valve prosthesis device are non-aligned with the commissures of the native aortic valve and / or are non-aligned relative to the coronary ostia, and / or non-aligned relative to commissures of a previously implanted aortic valve prosthesis device (e.g., in a valve-in-valve procedure) such that the coronary ostia are blocked, preventing introduction of a catheter therein.

[0561] The alignment and / or commissure alignment state may be, for example, a binary value indicating alignment or non-alignment, a category indicating amount of alignment or non- alignment such as partial alignment, and / or a value indicating amount of alignment and / or non- alignment such as percentage blockage and / or probability of coronaries being blocked to future catheter access.

[0562] As used herein, the term state may refer to a pose of the aortic valve prosthesis device, for example, a rotation, and / or orientation. The term alignment or commiserate alignment state may be an example of the term state. The term state may be with respect to a certain frame of reference, such as a target rotation, a target alignment and the like. The term state may be implemented as, for example, a binary value such as proper state or improper state, categories indicating different possible states, and / or a number indicating a range of possible values of the state.

[0563] As used herein, the term aortic valve prosthesis device represents a not necessarily limiting and / or exemplary implementation. Other medical devices which are inserted via a trans-catheter procedure into lumen of the body may be used. The state of two or more markers on other medical devices may be determined using embodiments described herein, for example, correct orientation of a medical device for ablation, commissure alignment of a valve in another part of the body, and alignment of another medical device for another purpose in another anatomical location.

[0564] As used herein, the terms patient and subject are used interchangeably.

[0565] As used herein, the term pose (e.g., of the THV) may refer to the orientation of the THV, such as angular rotation, and / or optionally in six degrees of freedom (6 DOF).

[0566] As used herein, the term annulus, which is detected based on images as described herein, may refer to a virtual annulus. The term annulus, valve annulus, lower annulus, annulus contour, contour of the annulus, annulus line, annulus plane, annulus of the heart, annulus of the valve (e.g., aortic valve, tricuspid valve, pulmonary valve) and virtual annulus may be used interchangeably. Alternatively, the contour of the annulus may refer to one or more curves of the annulus, such as a border between the contrast enhanced aortic root and surrounding tissues (without contrast). The annulus line may refer to a line drawn at nadir of cusps of the aortic valve. The annulus line may be computed using a 2D image. The annulus plane may be computed using a 3D image. Referring now back to FIG. 14, schematic 1402 depicts the case of a LAAO via a transcatheter procedure which may be performed by adapting one or more features of one or more embodiments described herein. A 3D image 1404 (e.g., CT, dielectric imaging) of the heart may be generated, as a pre-planning step and / or during the procedure, as described herein. A shown, IVC refers to the inferior vena cava, RA refers to the right atrium, RV refers to the right ventricle, and LAA refers to the left atrial appendage which is to be closed using a transcatheter procedure. A trans septal alignment 1406 at an identified septum may be performed, for example, by adapting the coronary alignment step described herein with reference to the TAVI procedure. A catheter 1408 may be navigated for performing a trans septal procedure (e.g., puncture) by substantially placing catheter 1408 perpendicular to a plane of the septum, and / or for catheter 1408 may be navigated through the trans septal puncture. Navigation of catheter 1408 relative to septum 1406 may be performed, for example, by adapting features described herein with reference to pose and / or orientation of the THV relative to the coronary ostia described with reference to the TAVI procedure. Information from 3D image 1404 may be used for tracking a plane 1410 defining the Left Atrial Appendage (LAA) opening (OS) on 2D images (e.g., fluoroscopic images) obtained during the procedure, for example, by projecting the LAA OS found in the 3D image to plane 1410 on a 2D plane registered with the fluoroscopic images. Plane 1410 may be computed by adapting features described herein relating to tracking of annulus line during the TAVI procedure. Monitoring of LAA depth and / or width on fluoroscopic images, for performing the LAAO procedure using catheter 1408, may be performed by adapting features described with reference to the device depth and / or tilt of the THV (e.g., pose, orientation) of the TAVI procedure.

[0567] The descriptions of the various embodiments of the present invention have been presented for purposes of illustration, but are not intended to be exhaustive or limited to the embodiments disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein was chosen to best explain the principles of the embodiments, the practical application or technical improvement over technologies found in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

[0568] It is expected that during the life of a patent maturing from this application many relevant THVs will be developed and the scope of the term THV is intended to include all such new technologies a priori.

[0569] As used herein the term “about” refers to ± 10 %. The terms "comprises", "comprising", "includes", "including", “having” and their conjugates mean "including but not limited to". This term encompasses the terms "consisting of" and "consisting essentially of".

[0570] The phrase "consisting essentially of" means that the composition or method may include additional ingredients and / or steps, but only if the additional ingredients and / or steps do not materially alter the basic and novel characteristics of the claimed composition or method.

[0571] As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

[0572] The word “exemplary” is used herein to mean “serving as an example, instance or illustration”. Any embodiment described as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments and / or to exclude the incorporation of features from other embodiments.

[0573] The word “optionally” is used herein to mean “is provided in some embodiments and not provided in other embodiments”. Any particular embodiment of the invention may include a plurality of “optional” features unless such features conflict.

[0574] Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0575] Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging / ranges between” a first indicate number and a second indicate number and “ranging / ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

[0576] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

[0577] Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0578] It is the intent of the applicant(s) that all publications, patents and patent applications referred to in this specification are to be incorporated in their entirety by reference into the specification, as if each individual publication, patent or patent application was specifically and individually noted when referenced that it is to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is / are hereby incorporated herein by reference in its / their entirety.

Claims

WHAT IS CLAIMED IS:

1. A computer implemented method of generating angulation information for a fluoroscopic imager based on a 3D image, comprising:(a) identifying one or more features in a fluoroscopic image acquired with known angulation information;(b) identifying an angulation of projection of the 3D image which would produce a similar feature arrangement; and(c) generating an instruction or an alert to an operator based on a difference between said identified angulation and an angulation used to acquire the fluoroscopic image.

2. A method according to claim 1 , wherein identifying one or more features comprises identifying an annulus line.

3. A method according to any of the preceding claims, wherein identifying one or more features comprises identifying one or more of a cusp nadir, a calcification signature, a coronary feature and an aortic outline.

4. A method according to any of the preceding claims, comprising receiving a confirmation by user of said identified one or more feature.

5. A method according to any of the preceding claims, wherein said generating comprises generating a corrected fluoroscopic s-curve for imaging using said fluoroscopic imager.

6. A method according to any of the preceding claims, comprising generating a device s-curve based on identifying a device deformation in said fluoroscopic image as compared to an expected device geometry.

7. A method according to any of claims 1-5, comprising generating both a fluoroscopic s-curve of a valve annulus and a device s-curve and determining an intersection between the s-curves.

8. A method according to any of claims 5-7, wherein said alert comprises an alert regarding the imager angulation matching or not matching an s-curve.

9. A method according to any of claims 1-8, wherein said instruction comprises an instruction to said imager for repositioning thereof.

10. A method according to any of claims 1-9, wherein said identifying comprises identifying with only one contrast material injection to an aortic region for said identifying.

11. A method according to any of claims 1-10, wherein said identifying comprises identifying after a user correction for a pose mismatch between a patient pose during said fluoroscopic imaging and while acquiring said 3D image.

12. A method according to any of the preceding claims, wherein said 3D images comprises a preoperative CT image used for calculating an s-curve.

13. A method according to any of the preceding claims, comprising verifying by a user of said instruction or alert by performing another fluoroscopic imaging using said instruction.

14. A method according to any of the preceding claims, comprising using said instruction to correct data to be projected onto fluoroscopic images acquired by said imager.

15. A method according to any of the preceding claims, wherein (a)-(c) are performed during a structural heart catheter-based procedure.

16. A method according to any of the preceding claims, wherein said identifying an angulation comprises comparing said fluoroscopic image or a feature thereon to a set of projections of said 3D image, each with an associated angulation of projection.

17. A method according to any of the preceding claims, comprising triggering a recalculation of said angulation information in response to contrast injection or suspected or indicated movement of said fluoroscopic imager.

18. The method according to claim 17, further comprising iterating (b) and (c).

19. A computer implemented method of generating angulation information for a fluoroscopic imager based on a 3D image, comprising:(a) identifying a device in a fluoroscopic image acquired with known angulation information;(b) identifying an angulation of the device based on an expected device geometry;(c) generating at least one angulation value or an s-curve of such values for imaging the device in a parallel view.

20. A method according to claim 19, wherein said expected device geometry is retrieved from a data store based on an identification of the device and / or based on user input.

21. A method according to claim 19 or claim 20, comprising generating an intersection between said angulation value or s-curve and a fluoroscopic s-curve of a feature of interest in a cardiac procedure.

22. The method according to any one of claims 19-21, wherein the feature of interest is selected from: annulus line, coronary arteries, calcification signature, cusp or portion thereof, and aortic outline.

23. A system for generating angulation information for a fluoroscopic imager based on a 3D image, comprising: at least one processor executing a code for:(a) identifying one or more features in a fluoroscopic image acquired with known angulation information;(b) identifying an angulation of projection of the 3D image which would produce a similar feature arrangement; and(c) generating an instruction or an alert to an operator based on a difference between said identified angulation and an angulation used to acquire the fluoroscopic image.

24. A system according to claim 23, wherein identifying one or more features comprises identifying an annulus line.

25. A system according to any one of claims 23 or 24, wherein identifying one or more features comprises identifying one or more of a cusp nadir, a calcification signature, a coronary feature and an aortic outline.

26. A system according to any one of claims 23-25, comprising code for receiving a confirmation by user of said identified one or more feature.

27. A system according to any one of claims 23-26, wherein said generating comprises generating a corrected fluoroscopic s-curve for imaging using said fluoroscopic imager.

28. A system according to any one of claims 23-27, comprising code for generating a device s-curve based on identifying a device deformation in said fluoroscopic image as compared to an expected device geometry.

29. A system according to any one of claims 23-28, comprising code for generating both a fluoroscopic s-curve of a valve annulus and a device s-curve and determining an intersection between the s-curves.

30. A system according to any one of claims 23-29, wherein said alert comprises an alert regarding the imager angulation matching or not matching an s-curve.

31. A system according to any one of claims 23-30, wherein said instruction comprises an instruction to said imager for repositioning thereof.

32. A system according to any one of claims 23-31, wherein said identifying comprises identifying with only one contrast material injection to an aortic region for said identifying.

33. A system according to any one of claims 23-32, wherein said identifying comprises identifying after a user correction for a pose mismatch between a patient pose during said fluoroscopic imaging and while acquiring said 3D image.

34. A system according to any one of the claims 23-33, wherein said 3D images comprises a preoperative CT image used for calculating an s-curve.

35. A system according to any one of claims 23-34, comprising code for verifying by a user of said instruction or alert by performing another fluoroscopic imaging using said instruction.

36. A system according to any one of claims 23-35, comprising code for using said instruction to correct data to be projected onto fluoroscopic images acquired by said imager.

37. A system according to any one of claims 23-36, wherein (a)-(c) are performed during a structural heart catheter-based procedure.

38. A system according to any one of claims 23-37, wherein said identifying an angulation comprises comparing said fluoroscopic image or a feature thereon to a set of projections of said 3D image, each with an associated angulation of projection.

39. A system according to any one of claims 23-38, comprising code for triggering a recalculation of said angulation information in response to contrast injection or suspected or indicated movement of said fluoroscopic imager.

40. The system according to claim 39, further comprising code for iterating (b) and (c).

41. A system for generating angulation information for a fluoroscopic imager based on a 3D image, comprising: at least one processor executing a code for:(a) identifying a device in a fluoroscopic image acquired with known angulation information;(b) identifying an angulation of the device based on an expected device geometry;(c) generating at least one angulation value or an s-curve of such values for imaging the device in a parallel view.

42. A system according to claim 41, wherein said expected device information is retrieved from a data store based on an identification of the device and / or based on user input.

43. A system according to claim 41 or claim 42, comprising generating an intersection between said angulation value or s-curve and a fluoroscopic s-curve of a feature of interest in a cardiac procedure.

44. The system according to any one of claims 41-43, wherein the feature of interest is selected from: annulus line, coronary arteries, calcification signature, cusp or portion thereof, and aortic outline.

Images