Systems and methods for treatment of ventricular arrhythmias

Abstract

Disclosed herein are systems and methods for comparing ECG information and relevant clinical data from prior patients against those of a current subject in need of ventricular arrhythmia therapy. The systems and methods provide accurate and rapid localization of VA therapy (e.g., ablation site) by way of determining a best match based on relevant clinical variables and correlating the actual location of treatment for the prior patient to a model of the current subject. By localizing the site of therapy to a specific region of the heart, the area to be mapped by the operator is limited, thereby reducing the time spent in performing the procedure.

Description

SYSTEMS AND METHODS FOR TREATMENT OF VENTRICULAR ARRHYTHMIASCROSS-REFERENCE

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 503,022, filed on May 18, 2023, the entire content of which is hereby incorporated by reference.TECHNICAL FIELD

[0002] The present disclosure is in the field of compositions, systems and methods of providing one or more cardiac medical interventions. More particularly, the present disclosure provides systems for planning and providing treatment for arrhythmias, including ventricular arrhythmias.BACKGROUND

[0003] Ventricular arrhythmias include premature ventricular complexes (PVCs), nonsustained ventricular tachycardia (NSVT), sustained ventricular tachycardia (VT) and ventricular fibrillation (VF). These conditions can occur in patients with or without structural heart disease. Ventricular tachycardia (VT) is a particularly challenging form of ventricular arrhythmia. Ventricular tachycardia (VT) is a type of arrhythmia, or abnormal heart rhythm, which occurs when the lower chambers of the heart, called the ventricles, beat too fast. This fast heart rate prevents the ventricles from filling and squeezing to pump enough blood to the body, which can lead to the body not receiving enough oxygenated blood. VT is a potentially life-threatening condition that is responsible for the majority of sudden cardiac deaths in the United States.

[0004] Treatment or suppression of VT is often accomplished with the use of one or more of anti-arrhythmic drugs, implantable cardioverter-defibrillators (ICDs), and catheter ablation. Anti arrhythmic drugs are considered the first line therapy due to their non-invasive nature, but they are not completely effective in preventing VT episodes and generally bring with them the risk of side-effects. Although ICDs can improve the prognosis for patients with VT, recurrent VT remains life-threatening. Catheter ablation offers a therapeutic treatment for certain typesof VT and has been suggested to have a benefit for patients who have suffered prior MI in many case studies.

[0005] Cardiac mapping refers to procedures that record electrocardiograms or endocardial / epi cardial electrograms of the cardiac action potential. This can be recorded from the body surface using conventional 12-lead electrocardiogram (ECG). Cardiac mapping provides a means of visualizing the pathophysiological mechanisms underlying ventricular tachycardia, which is crucial for locating and directing e.g., catheter ablation procedures.

[0006] Both conventional and advanced mapping techniques are utilized to help locate and perform a successful catheter ablation. However, many of these mapping techniques are hampered by a variety of factors endemic to external measurement of internal body processes and the transient nature of some arrhythmias / tachycardias. There is an unmet need for improved minimally-invasive means for diagnosing and treating cardiac arrhythmias.SUMMARY

[0007] The following is a brief summary of subject matter that is described in greater detail herein. This summary is not intended to be limiting as to the general inventive concepts or the scope of the claims.

[0008] Disclosed herein are various technologies pertaining to treatment for cardiac abnormalities including ventricular arrhythmias. VAs can lead to significant morbidity and mortality by disrupting the regular rhythm of the heart, impairing its ability to adequately pump blood to vital organs, and, in severe cases, resulting in sudden death. To counteract these abnormal electrical signals, radiofrequency (RF) intracardiac catheter ablation is often the therapy employed. This procedure utilizes energy to create scars in the problematic tissue, effectively preventing the occurrence of abnormal electrical activity within the heart. With its high effectiveness and low complication rates, RF catheter ablation has been proven successful in treating various VTs and PVCs. However, the current locating procedure faces challenges that need to be addressed, such as limited accuracy in localizing ventricular arrhythmias and time-consuming aspects of the processes.

[0009] Catheter ablation remains one of the most challenging procedures in clinical cardiac electrophysiology. Scar-related VTs, in particular, are often poorly tolerated hemodynamically,difficult to induce, and can carry with them the risk of transforming into other tachycardias during catheter mapping. The introduction of three-dimensional (3D) substrate mapping has greatly enhanced the capabilities and insights of targeting catheter ablation for VT. However, the procedure is still limited by the constraints of point-by-point catheter mapping, even with the utilization of newer multipolar catheter rapid mapping techniques. Therefore, it is essential to identify the specific (malfunctioning) tissue responsible for scar-related VTs accurately to ensure successful ablation using RF catheter modality.

[0010] Many important advances have been made in the field of VT ablation; however, the identification of ablation therapeutic location still relies on invasive electro-anatomical substrate mapping, which can be time-consuming and complicated by other factors. The non- invasive technology described herein can be used to guide the medical practitioner to the target area pre-procedurally to decrease the amount of time needed to search for the site and increase accuracy of the intervention.

[0011] The general inventive concepts are based, in part, on the discovery that determining similarity between a subject and prior patients that have undergone a successful VA therapy (i.e., catheter ablation to treat VT) can provide insight on location of treatment and enable faster and more accurate treatment. Such similarity can be found by comparing and assessing one or more relevant clinical variables from the prior patient with those of a subject who will undergo VA therapy. The most appropriate match is determined by an algorithm that weighs various relevant clinical variables from the prior patients and compares those to that of the subject to form a (similarity) match. By determining an appropriate match by similarity of relevant clinical variables, comparing ECG of the prior patient with that of the current subject, and knowing the location of therapy of the prior patient, a map / model of therapeutic location can be assembled to aid in locating a point of VA origin or exit for treatment. In certain embodiments, the method comprises an initial comparison of an ECG of the prior patients with that of the current subject for finding a prior patient whose ECG is the most appropriate match (i.e., best similarity). Subsequently, the method comprises accessing and assessing the prior patient’s procedure to determine a best mapping location for the current subject based on these known mapping locations of therapy of the prior patient.

[0012] In certain embodiments, the map of location can be displayed as a 3D model of the subject’s heart (a whole LV-RV patient-specific ventricle model) for the user on e.g.,augmented reality glasses. By localizing the site of therapy to a specific region of the heart, the area to be mapped by the operator is limited, thereby reducing the time spent in performing the procedure.

[0013] In an exemplary embodiments, the general inventive concepts contemplate a method of identifying an estimated location for ablation therapy. The method comprises receiving an ECG from a subject. Comparing relevant clinical variables from the subject to relevant clinical variables of prior patients who have received ablation therapy. Identifying a match based on similarity parameters from the comparison of relevant clinical variables. Locating an estimated therapeutic location based on the identified prior patient’s therapeutic location with the current subject’s clinical variables. Displaying the estimated therapeutic location.

[0014] In certain exemplary embodiments, the general inventive concepts contemplate a method of localizing a treatment site to an area of the heart of a subject. The method comprises acquiring patient specific clinical variables from the subject, accessing a library comprising patient specific clinical variables for a plurality of prior patients, identifying at least one patient that most closely resembles the subject based on the patient specific clinical variables (a VT- match), acquiring imaging of the subject (e.g., CT / MRI), mapping treatment location of the at least one prior patient to the imaging of the subject, calculating a case-specific catheter mapping based on the matching, and outputting the case-specific catheter mapping. In certain embodiments, the output is in the form of a model that is displayed for a medical provider.

[0015] There is a significant unmet need for technological advancements to enhance VA ablation procedures and outcomes, including catheter mapping. At present, the success rate of such procedures is only moderately satisfactory.BRIEF DESCRIPTION OF THE DRAWINGS

[0016] These and other features of the present disclosure will become better understood with regard to the following description and accompanying drawings in which:

[0017] Figure 1 shows an exemplary paper ECG tracing, which is then digitized to form a searchable digital version of the ECG for comparison according to certain embodiments of the general inventive concepts.

[0018] Figure 2 shows a recorded ECG that can be used for comparison according to certain embodiments of the general inventive concepts. As shown in the figure, various portions of the ECG are highlighted for comparison with other ECGs.

[0019] Figure 3 shows a general embodiment of a VT-match platform according to the general inventive concepts.

[0020] Figure 4A shows a generic heart model wherein the ventricle is divided into 16 segments, the generic LV was subdivided into 238 triangles, with a therapeutic localization (marked with bullseye) based on comparison of relevant clinical variables.

[0021] Figure 4B is an image of a 3D model of the subject’s heart with a therapy location based on comparison and matching according to the general inventive concepts.

[0022] Figure 5 is an image of an exemplary display showing the results of a comparison of two ECG recordings. The image also shows an indicator of total correlation coefficient average score of 84. The specific image shows a correlation coefficient of 0.78 and a shift of 36.

[0023] Figure 6 is an image of a practitioner wearing display glasses for viewing an output of the VT-match results. In certain embodiments, the display glasses provide an augmented reality display showing a model of the subject’s heart and the treatment location (e.g., as shown in Figure 4B.

[0024] Figure 7 is a flow chart for a method of VT -matching according to the general inventive concepts.

[0025] Figure 8A is an image of an exemplary paper ECG trace.

[0026] Figure 8B is an image of a digitized version of the paper ECG trace of Figure 8 A.

[0027] Figure 8C shows an image of a section of the digitized ECG trace of Figure 8B, wherein a PVC beat is selected, and compared it with prior patients in the database.

[0028] Figure 8D shows an image of a generic sectioned heart model with a therapeutic location marked based on calculations from Figure 8C and the comparison of relevant clinicalvariables. In this image, a location of the inferior papillary muscle of the left ventricle is estimated and displayed.

[0029] Figure 9 is an illustration of an exemplary computing device for use with the systems and methods of the general inventive concepts.DETAILED DESCRIPTION

[0030] Various technologies pertaining to a device, system, and for method treating VA, including methods for catheter mapping leading to catheter ablation. In certain aspects, the general inventive concepts contemplate addressing the assisted catheter mapping and guidance of catheter ablation procedures for VAs.

[0031] The terminology as set forth herein is for description of the embodiments only and should not be construed as limiting the disclosure as a whole. All references to singular characteristics or limitations of the present disclosure shall include the corresponding plural characteristic or limitation, and vice versa, unless otherwise specified or clearly implied to the contrary by the context in which the reference is made. Unless otherwise specified, “a,” “an,” “the,” and “at least one” are used interchangeably. Furthermore, as used in the description and the appended claims, the singular forms “a,” “an,” and “the” are inclusive of their plural forms, unless the context clearly indicates otherwise.

[0032] As used herein, the term “or” is intended to mean an inclusive “or” rather than an exclusive “or.” That is, unless specified otherwise, or clear from the context, the phrase “X employs A or B” is intended to mean any of the natural inclusive permutations. That is, the phrase “X employs A or B” is satisfied by any of the following instances: X employs A; X employs B; or X employs both A and B. In addition, the articles “a” and “an” as used in this application and the appended claims should generally be construed to mean “one or more” unless specified otherwise or clear from the context to be directed to a singular form.

[0033] Ranges as used herein are intended to include every number and subset of numbers within that range, whether specifically disclosed or not. Further, these numerical ranges should be construed as providing support for a claim directed to any number or subset of numbers in that range. For example, a disclosure of from 1 to 10 should be construed as supporting a rangeof from 2 to 8, from 3 to 7, from 5 to 6, from 1 to 9, from 3.6 to 4.6, from 3.5 to 9.9, and so forth.

[0034] Any combination of method or process steps as used herein may be performed in any order, unless otherwise specified or clearly implied to the contrary by the context in which the referenced combination is made.

[0035] Further, as used herein, the terms “component” and “system” are intended to encompass computer-readable data storage that is configured with computer-executable instructions that cause certain functionality to be performed when executed by a processor. The computerexecutable instructions may include a routine, a function, or the like. It is also to be understood that a component or system may be localized on a single device or distributed across several devices. Further, as used herein, the term “exemplary” is intended to mean serving as an illustration or example of something and is not intended to indicate a preference.

[0036] The term “ameliorate” as used herein, unless otherwise specified, means to eliminate, delay, or reduce the prevalence or severity of symptoms associated with a condition.

[0037] The terms “susceptible” and “at risk” as used herein, unless otherwise specified, mean having little resistance to a certain condition or disease relative to the general population, including being genetically predisposed, having a family history of, and / or having symptoms of the condition or disease. The term refers to those having a vulnerability higher than the general population.

[0038] The terms “treating”, and “treatment” as used herein, unless otherwise specified, includes delaying the onset of a condition, reducing the severity of symptoms of a condition, or eliminating some or all of the symptoms of a condition.

[0039] The term “therapeutic location”, as used to herein, refers to the identified portion of the heart for therapeutic intervention (e.g., ablation) and may refer to an origin or exit site of an ECG beat within the heart tissue. For example, localization points may refer to an onset point of PVC or an exit point of a VT beat.

[0040] Moreover, the acts described herein may be computer-executable instructions that can be implemented by one or more processors and / or stored on a computer-readable medium or media. The computer-executable instructions can include a routine, a sub-routine, programs,a thread of execution, and / or the like. Still further, results of acts of the methodologies can be stored in a computer-readable medium, displayed on a display device, and / or the like.

[0041] The general inventive concepts seek to provide rapid and more accurate targeting of treatment location for ventricular arrhythmias and ventricular tachycardias. To achieve this, the general inventive concepts contemplate: Converting ECG paper records into digital ECG data or an ECG VA has been recorded, which can be used for computing and search keyword to enable computer-assisted comparison between patients; To assist doctors and medical providers in quickly and non-invasively identifying the most similar and relevant location of a VA origin onto a model (e.g., a 3D model) of the patient’s heart geometry obtained from computerized tomography (CT) and / or Magnetic Resonance Imaging (MRI) scans, when the digital ECG VA / a recorded ECG VA is available; Searching a database of patients with similar ventricular problems to the current patient with the digital ECG VA / recorded ECG VA, identifying clinical variables and treatment options of relevance to the current subject based on the previous case analysis (preferably the previous cases underwent successful ablation therapy); return and display the best matching case(s) obtained from the large database for clinicians’ confirmation and review; then to register and overlay / projectthe best matching case onto the patient’s heart geometry obtained from CT / MRI scans (e.g., through an augmented reality (AR) glass) that combines the digital cardiac model with the real patient-specific geometry.

[0042] Catheter ablation (also known as cardiac ablation or radiofrequency ablation) is the treatment of choice in patients with VT and / or certain PVCs. It is a procedure wherein a tube is guided through a blood vessel to into or near the heart. The catheter uses hot or cold energy to destroy small areas of tissue and create scars in the heart tissue where the arrhythmia is occurring. The scars help block abnormal electrical impulses and prevent abnormal rhythms. While catheter ablation is a minimally invasive procedure that usually doesn’t require a prolonged hospital stay, it does pose risks. The procedure can result in blood clot formation, damage to the vein from the catheter, unwanted damage to the heart tissue or valves, or infection, and the success rate of such procedures is only moderately satisfactory. Furthermore, these procedures are typically carried out in large tertiary or academic centers as they require experienced operators. The prolonged duration of VA ablation procedures can also lead to adverse outcomes.

[0043] The targets for ablation are locations in the heart where the PVCs or VTs are occurring. Because the treatment envisions scarring and destruction of tissue within the heart, minimization of unwanted damage is a primary concern. Thus, location of a proper ablation location is essential to successful treatment. There is an unmet need for improvements in the procedures for catheter mapping and planning for these procedures. Improvements in the procedure would be expected to enhance patient outcomes in one or more of the aforementioned areas.

[0044] Similarly, there is a need for improved guidance in determining the proper location to ablate the ventricular arrhythmia in either the left ventricle (LV), right ventricle (RV), or both. One method for assisting in location of treatment is through comparing ECG (digitized or recorded) of prior patients with that of the current subject. An ECG is defined herein as any method that (non-invasively) measures and correlates electrical activity of the heart muscle to measured or derived (electrical activity) of the heart. In the case of a classical electrocardiogram, the differences in potential between electrodes on the body surface are correlated to the electrical activity of the heart.

[0045] Conventional systems and methods for planning and guidance of LV catheter ablation are described in US Pat. App. No. 20170340235, the content of which is hereby incorporated herein. This patent publication is limited to a Left Ventricular generic heart model for the purposes of localization. The instant technology expands and improves on this model by extend to a whole patient-specific ventricular model (LV and RV). This will enhance both the personalization of care and patient outcomes.

[0046] In certain embodiments, the general inventive concepts contemplate a non-invasive, data-driven method of contextualizing patient specific data (e.g., relevant clinical variables), comparing the patient specific data to a database of clinically relevant variable data from previously (successfully) treated patients, comparing relevant clinical variables of the subject to that of the prior patients to identify a similarity match, determining a proposed therapeutic location (e.g., VT exit site) based on the relevant clinical variables, and mapping the estimated / proposed therapeutic location.

[0047] In one aspect, the general inventive concepts contemplate a system for assisting in catheter mapping and calculating and / or planning of a cardiac ablation procedure for a subject. The system comprises an algorithm for correlating clinically relevant variable data from priorpatients to those of the current subject, a database of clinically relevant variable data of the prior patients, means for acquiring patient specific data of the individual (e.g., ECG, MRI, CT), a processor for processing and comparing the patient specific data of the current subject to that in the database, and means for outputting / displaying the comparison data.

[0048] In one aspect, the database of the system and method comprises data from e.g., electrocardiogram (ECG) measurements of prior patients (including simulations) that have been converted to digital data form. In certain aspects, an ECG VA has been recorded. In certain aspects, the digital ECG data is modified or augmented for computing and search keyword. See e.g., Figures 1 and 2. In certain embodiments, the ECG is a beat ECG with an emphasis on the QRS complex. As can be seen in Figure 2, a box is sown to highlight a 120 ms window of QRS complex.

[0049] In certain aspects, the database also includes clinically relevant variable information regarding the individual patients for which data has been recorded in the database. The clinically relevant variable data allows medical personnel (via the system and method) to more accurately compare and match (e.g., VT-Match) the individual’s case-specific catheter mapping to one or more of the most relevant model treatment(s) (including to a combination of mapping).

[0050] In certain exemplary embodiments, the general inventive concepts contemplate a method of localizing a treatment site to an area of the heart of a subject. The method comprises acquiring patient specific clinical variables from the subject, accessing a library or database comprising patient specific clinical variables for a plurality of patients, identifying at least one patient that most closely resembles the subject based on the patient specific clinical variables, acquiring imaging of the subject, matching treatment location of the at least one patient to the imaging of the subject, calculating a case-specific catheter mapping based on the matching, and outputting the case-specific catheter mapping. In certain embodiments, the prior patient database is made up of patients for whom the VT exit site was clinically identified by entrainment mapping for hemodynamically-tolerated VTs or by combining substrate mapping and pace-mapping for hemodynamically unstable VTs.

[0051] In certain aspects, clinically relevant variables include but are not limited to four categories: 1) age, gender, left ventricular ejection fraction (%), implantable cardioverterdefibrillator present, Heart Failure (%), Medication; 2) De-identified Raw MR.I / CT Images:CT / MRI imaging was performed within 24 hours before a catheter ablation procedure; 3) Induced VT 12-lead ECG: for each patient (at least have one or more monomorphic VT 12- lead ECG). Electroanatomic mapping (EAM) data: Carto 3 (Biosense Webster) or Ensite (Abbott) electroanatomic mapping system was used to map the VT by using standard techniques; 4) Clinically-identified VT exit sites: In certain embodiments, the VT exit site was clinically identified by entrainment mapping for hemodynamically-tol erated VTs or by combining substrate mapping and pace-mapping for hemodynamically unstable VTs. In certain exemplary embodiments, the individual variables are ranked by weighting relative to one- another. In certain embodiments, a VT 12-lead ECG has the most weight of the parameters / variables. In certain embodiments, the clinically relevant variables discussed herein are stored in and accessible in the database. In certain embodiments, a score is determined for each category to determine the most similar case for VT-matching and location of the therapy.

[0052] In another aspect, the system and method comprises quickly and non-invasively identifying the exact location of a VA origin onto the patient’s heart geometry obtained from imaging (e.g., computerized tomography (CT) and / or Magnetic Resonance Imaging (MRI) scans) when the digital ECG VA / a recorded ECG VA is available.

[0053] In another aspect, the system and method comprises searching the database of prior patients with similar clinical variables (e.g., age, heart disease, ventricular problems) to that of the current subject patient with the digital ECG VA / recorded ECG VA and identifying clinical variables and treatment options that could be relevant for a match. In certain aspects, the system and method contemplate use of a smaller subset of clinically relevant variables based on a weighted score.

[0054] In another aspect, the system and method includes display means for displaying one or more identified relevant matching case(s) obtained after comparison with the database. Such comparison of relevant matching cases can then be reviewed by medical personnel based on one or more criteria to determine the course / map of therapy or displayed.

[0055] In another aspect, the system and method comprise means for registering and overlay / projecting identified relevant matching case(s) onto a model of the individual’s heart geometry obtained from one or more relevant imaging procedures (e.g., CT / MRI scans). In certain aspects, the general inventive concepts contemplate displaying the identified therapeutic location on a variety of display means including, but not limited to an augmentedreality (AR) means (glasses), wherein the digital cardiac model is displayed with the real patient-specific geometry.

[0056] Alternatively, or additionally, a 3D anatomical heart model having the closest similarity to the subject’s heart may be selected from a database including a plurality of 3D anatomical models. In some embodiments, the heart model may be optionally modified to include patientspecific features. The selected and optionally modified 3D anatomical heart model may serve as the patient-specific 3D heart model. Such a model may include detailed structures of the heart such as the aortic cusps, aortic root, aorta, aortic arch, coronary vascular structures, among others.

[0057] For example, the 3D heart model (see e.g., FIG. 4B) may be based on CT scans of the subject. This subject specific 3D heart model may be generated by comparing the subject’s digital to reference heart models obtained from a database of such models The best fitting reference heart model may be selected from the database and then adjusted (e.g., edited) to match to the subject’s geometry. There are two geometries registered together to show a clinically-identified VT exit site (marked by a yellow star): one is a colorful geometry that is a patient-specific electroanatomic mapping geometry, the other one is a patient’s 3D CT geometry. As can be seen from the figure, the edited subject-specific heart model may include a color-coding scale to represent various features of the heart muscle (e.g., electroanatomic mapping geometry (purple is >1.5 mv, red is < 0.5 mv, between red to purple is named border zone between 0.5 mv to 1.5 mv).

[0058] Figure 3 shows a general embodiment of a VT-match platform according to the general inventive concepts. The platform comprises an algorithm for localization of VA treatment and a VT ablation patient library / database. The database includes data on a predetermined set of variables for prior patients including, but not limited to VT ablation data, 12-lead VT ECG, non-specific relevant clinical variables (e.g., age, gender, heart disease status, among others), and CT and / or MRI images. The information in the database is accessed and compared by way of the algorithm to calculate / generate a similarity match, which then leads to a target location based on the identified prior patient’s location of therapy.

[0059] Figure 4A shows a generic heart model with a localization (marked with bullseye) marked based on comparison of relevant clinical variables. As can be seen from the figure,the heart model shows the ventricle chambers divided into numbered segments. Here, the three-dimensional prototype model of the ventricles of the human heart is represented using planar triangles and divided into anatomical segments.

[0060] Figure 4B is an image of a 3D model of the subject’s heart with a therapy location estimated / determined based on comparison and matching according to the general inventive concepts. The therapeutic location is identified with a star in the figure.

[0061] Figure 5 is an image of an exemplary display showing the results of a comparison of two ECG recordings. The image also shows an indicator of total correlation coefficient average score of 84. The specific image shows a correlation coefficient of 0.78 and a shift of 36. Here, quantitative correlation to an ECG template was assessed. A QRS window is used for calculating the correlation coefficient between two ECGs from a same ECG lead. The shift of 36 means a horizontal shift to maximize overlap and correlation. The correlation coefficient provides information on selecting a VT -match from prior patient data.

[0062] Figure 6 is an image of a practitioner wearing display glasses for viewing an output of the VT -match results. In certain embodiments, the display glasses provide an augmented reality display showing a model of the subject’s heart and the treatment location (e.g., as shown in Figure 4B.

[0063] Figure 7 shows a flow chart of an exemplary method according to the general inventive concepts. According to the Figure an ECG of the subject is recorded, either in digital form or a paper readout is translated into digital form to aid in comparison. The method includes accessing patient specific variables. These include the categories of relevant clinical variables discussed above, such as age, left ventricular ejection fraction (%), heart failure (%), among others. The patient specific variables are compared and correlated against similar data of the current subject based on predetermined metrics to determine a match (e.g., by correlation coefficients). This step also contemplates specifically comparing ECG to determine similarity of therapy. Therapeutic details (e.g., ablation site for successful patient treatments) are accessed to locate where successful ablation procedures were performed on the identified prior patients. This can take the form of identification of heart segment of the LV, RV, or both (i.e., a whole patient-specific ventricle model) or may be more specifically detailed, as shown in Figure 4A. In certain embodiments, the therapeutic detail is a VT exit site. In certain embodiments, the VT exit site was clinically identified by either entrainmentmapping for hemodynamically-tol erated VTs or by combining substrate mapping and pacemapping for hemodynamically unstable VTs. After the therapeutic detail (location) has been determined for the prior patient, this information is correlated with imaging (CT / MRI) of the current subject to give an estimated location for the ablation. This estimated / calculated location is then outputted for a user. This outputting can take the form of a visual display on a screen or an augmented reality display (e.g., glasses). The general inventive concepts contemplate the output will include overlaying / superimposing the estimated location on a model (e.g., 3D model, including a whole patient-specific ventricle model) of the subject’s heart and highlighting the estimated location.

[0064] Referring now to Fig. 9, a high-level illustration of an exemplary computing device 900 that can be used in accordance with the systems and methodologies disclosed herein is illustrated. For instance, the computing device 900 may be used in a system for guiding planning / guiding a cardiac procedure such as catheter ablation (e.g., system shown in Figure 1). The computing device 900 includes at least one processor 902 that executes instructions that are stored in a memory 904. The instructions may be, for instance, instructions for implementing functionality described as being carried out by one or more components discussed above or instructions for implementing one or more of the methods described above. The processor 902 may access the memory 904 by way of a system bus 906.

[0065] The computing device 900 additionally includes a database 908 that is accessible by the processor 902 by way of the system bus 906. The data store 908 may include executable instructions and / or clinically relevant variable data.

[0066] The computing device 900 also includes an input interface 910 that allows external devices to communicate with the computing device 900. For instance, the input interface 910 may be used to receive instructions from an external computer device, from a user, etc. The computing device 900 also includes an output interface 912 that interfaces the computing device 900 with one or more external devices. For example, the computing device 900 may display text, images, etc. by way of the output interface 912.

[0067] It is contemplated that the external devices that communicate with the computing device 900 via the input interface 910 and the output interface 912 can be included in an environment that provides substantially any type of user interface with which a user can interact. Examples of user interface types include graphical user interfaces, natural userinterfaces, AR interfaces, and so forth. For instance, a graphical user interface may accept input from a user employing input device(s) such as a keyboard, mouse, remote control, or the like and provide output on an output device such as a display. Further, a natural user interface may enable a user to interact with the computing device 900 in a manner free from constraints imposed by input devices such as keyboards, mice, remote controls, and the like. Rather, a natural user interface can rely on speech recognition, touch and stylus recognition, gesture recognition both on screen and adjacent to the screen, air gestures, head and eye tracking, voice and speech, vision, touch, gestures, machine intelligence, and so forth.

[0068] Additionally, while illustrated as a single system, it is to be understood that the computing device 900 may be a distributed system. Thus, for instance, several devices may be in communication by way of a network connection and may collectively perform tasks described as being performed by the computing device 900.

[0069] Various functions described herein can be implemented in hardware, software, or any combination thereof. If implemented in software, the functions can be stored on or transmitted over as one or more instructions or code on a computer-readable medium. Computer-readable media includes computer-readable storage media. A computer-readable storage media can be any available storage media that can be accessed by a computer. By way of example, and not limitation, such computer-readable storage media can comprise RAM, ROM, EEPROM, CD- ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer. Disk and disc, as used herein, include compact disc (CD), laser disc, optical disc, digital versatile disc (DVD), floppy disk, and Blu- ray disc (BD), where disks usually reproduce data magnetically and discs usually reproduce data optically with lasers. Further, a propagated signal is not included within the scope of computer-readable storage media. Computer-readable media also includes communication media including any medium that facilitates transfer of a computer program or data from one place to another. A connection, for instance, can be a communication medium. For example, if the software is transmitted from a website, server, or other remote source using a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave, then the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio and microwave are included in thedefinition of communication medium. Combinations of the above should also be included within the scope of computer-readable media.

[0070] Alternatively, or in addition, the functionally described herein can be performed, at least in part, by one or more hardware logic components. For example, and without limitation, illustrative types of hardware logic components that can be used include Field-programmable Gate Arrays (FPGAs), Application-specific Integrated Circuits (ASICs), Application-specific Standard Products (ASSPs), System-on-a-chip systems (SOCs), Complex Programmable Logic Devices (CPLDs), etc.

[0071] The present invention provides a system and method for localizing therapeutic sites of origin, such as VT exit site or site of origin, based on algorithmic comparison of relevant clinical variables to determine a (best case) similarity match). The site of origin may first be localized to a segment or segments of the heart by comparing relevant clinical variables and successful therapies of prior patients (including therapeutic location of the prior patients) and then displayed to aid in providing a therapeutic intervention (i.e., ablation).

[0072] The following examples illustrate features and / or advantages of the compositions, systems, and methods according to the general inventive concepts. The examples are given solely for the purpose of illustration and are not to be construed as limitations of the general inventive concepts, as many variations thereof are possible without departing from the spirit and scope of the general inventive concepts.

[0073] Examples:

[0074] Figure 8A-D shows a paper ECG trace (8A) which is converted into digital form (8B). In Figure 8C, a beat premature ventricular contraction (PVC) is identified from the digitized ECG information and highlighted (shown in the box). This information is used to estimate a therapeutic location via the claimed algorithm and relevant clinical variables from prior patients. An image of a generic heart model with an estimated therapeutic location (bullseye) is then displayed as in Figure 8D (shown here in the inferior papillary muscle of the left ventricle).

[0075] The foregoing method descriptions and the process flow diagrams are provided merely as illustrative examples and are not intended to require or imply that the operations of the various embodiments must be performed in the order presented. As will be appreciated by oneof skill in the art the order of operations in the foregoing embodiments may be performed in any order. Words such as “thereafter,” “then,” “next,” etc. are not intended to limit the order of the operations; these words are simply used to guide the reader through the description of the methods.

[0076] The preceding description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the scope of the claims. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the following claims and the principles and novel features disclosed herein.

[0077] What has been described above includes examples of one or more embodiments. It is, of course, not possible to describe every conceivable modification and alteration of the above devices or methodologies for purposes of describing the aforementioned aspects, but one of ordinary skill in the art can recognize that many further modifications and permutations of various aspects are possible. Accordingly, the described aspects are intended to embrace all such alterations, modifications, and variations that fall within the spirit and scope of the appended claims. Furthermore, to the extent that the term “includes” is used in either the details description or the claims, such term is intended to be inclusive in a manner similar to the term “comprising” as “comprising” is interpreted when employed as a transitional word in a claim.

Claims

Claims1. A method for determining a therapeutic location to an area of the heart of a subj ect, the method comprising: recording an ECG tracing of a subj ect; accessing a plurality of patient-specific relevant clinical variables for prior patients from a database; correlating the relevant clinical variables of the prior patients with those of the subject to identify at least one prior patient similarity match; accessing therapeutic details of the identified prior patient; locating an estimated therapeutic location based on the match; displaying the estimated therapeutic location.

2. The method of claim 1, wherein the relevant clinical variables are selected from: age, gender, left ventricular ejection fraction (%), whether an implantable cardioverterdefibrillator is present, Heart Failure (%), medication (%); de-identified Raw MRI / CT Images: CT / MRI imaging was performed within 24 hours before a catheter ablation procedure; and induced VT 12-lead ECG.

3. The method of claim 1, wherein both LV and RV therapeutic locations are determined.

4. The method of claim 1, wherein the therapeutic location is location of catheter ablation.

5. The method of claim 4, wherein the catheter ablation is a hemodynamically successful catheter ablation.

6. The method of claim 1, wherein displaying comprises providing a patient-specific ventricle model.

7. The method of claim 6, wherein the patient-specific ventricle model comprises modeling of both LV and RV.

8. The method of claim 6, wherein displaying comprises superimposing the estimated therapeutic location on a model of the subject’s heart.

9. The method of claim 6, wherein the model is assembled using imaging selected from CT, MRI, and combinations thereof.

10. The method of claim 9, wherein the model is a 3D model.

11. The method of claim 10, wherein the display comprises augmented reality means.

12. The method of claim 11, wherein the augmented reality means is augmented reality glasses.

13. The method of claim 1, wherein the therapeutic location comprises a VT exit site and the VT exit site was clinically identified by: entrainment mapping for hemodynamically-tolerated VTs or by combining substrate mapping and pacemapping for hemodynamically unstable VTs.

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