Systems and methods for assessing valve-in-valve risk

Abstract

Systems and methods for evaluating a proposed valve-in-valve procedure for a patient in which a replacement transcatheter aortic valve is to be deployed within a first bioprosthetic aortic valve. The method includes selecting a predetermined reference measurement of a lobe-in-lobe combination. An image of the patient's anatomy is received. An anatomical measurement of the first bioprosthetic valve is obtained from the received image. The predetermined reference measurement and the anatomical measurement are examined. Based at least in part on the examination, a risk of a valve-in-valve procedure is evaluated for the patient. The methods of the present disclosure may be used for baseline scanning of a patient without implanting a first bioprosthetic valve; in these cases, the size of the first valve is determined from a reference measurement. When the method of the present disclosure is used for a first post-implant scan, the size of the first valve is determined from the post-implant scan.

Description

Technical Field

[0001] The present disclosure relates to systems and methods for assessing or predicting potential problems associated with a proposed valve-in-valve procedure. More specifically, the present disclosure relates to systems and methods for assessing or predicting risk for a patient who is considering receiving a replacement transcatheter aortic valve within a first or initial bioprosthetic aortic valve. Background Art

[0002] The human heart includes four heart valves that determine the path of blood flow through the heart: the mitral valve, tricuspid valve, aortic valve, and pulmonary valve. The mitral valve and tricuspid valve are atrioventricular valves, located between the atria and ventricles, while the aortic valve and pulmonary valve are semilunar valves, located in the arteries leaving the heart. Ideally, when the heart valve is in the open position, the natural leaflets of the valve move apart from each other, and when the valve is in the closed position, the natural leaflets meet or "engage". Problems that may occur with the valve include stenosis in which the valve does not open properly and / or insufficiency or regurgitation in which the valve does not close properly. Stenosis and insufficiency may occur simultaneously in the same valve. The effects of valve dysfunction vary, with regurgitation or backflow typically causing relatively severe physiological consequences for the patient.

[0003] Various different types of heart valve surgery can be used to repair or replace a diseased or otherwise defective heart valve. One conventional technique involves an open heart surgical approach performed under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine.

[0004] Recently, minimally invasive methods have been developed to facilitate catheter-based implantation of valve prostheses on a beating heart, aiming to eliminate the need to use a classic sternotomy and cardiopulmonary bypass. Generally speaking, an expandable prosthetic heart valve is compressed around or within a catheter, inserted inside a patient's body lumen (such as the femoral artery), and then delivered to the desired location in the heart.

[0005] Typically, a heart valve prosthesis used with a catheter-based or transcatheter procedure includes an expandable multilayer frame or stent that supports a valve structure with multiple leaflets. This frame can be contracted during percutaneous intraluminal delivery and expanded when deployed at or within a natural valve. A valve stent can initially be set in an expanded or uncurled state, and then curled or compressed around the balloon portion of the catheter. Subsequently, the balloon is inflated to expand and unfold the prosthetic heart valve. For other stented prosthetic heart valve designs, the stent frame is formed to be self-expanding. Through these systems, the valved stent is curled down to the desired size and kept compressed in a sheath for transluminal delivery. Retracting the sheath from this valved stent allows the stent to self-expand to a larger diameter to be fixed to the natural valve site. Then, more generally, once the prosthetic valve is positioned at the treatment site (e.g., in an insufficient natural valve), the stent frame structure can be expanded to firmly hold the prosthetic valve in place. One example of a stented prosthetic valve is disclosed in US Pat. No. 5,957,949 to Leonhardt et al., which is incorporated herein by reference in its entirety.

[0006] In recent years, more and more prosthetic heart valves have been implanted, and in the near future, more and more patients will need reoperation due to reasons such as anatomical changes, structural deterioration, etc. In these and other cases, valve-in-valve transcatheter valve replacement ("TAV-in-TAV") has emerged as a safe and effective alternative to surgery.

[0007] Screening patients for valve-in-valve transcatheter prosthetic aortic heart valves can be challenging due to the anatomical complexity of the patient population. Some screening procedures can be costly, time-consuming, subjective, and not sufficiently predictive. For example, some screening procedures may not adequately assess or predict the risk of coronary artery isolation and / or access challenges. The leaflets of a previously implanted prosthetic valve become displaced, creating a cylinder effect (or “neo-skirt”) that can lead to sinus isolation and occlusion of coronary artery blood flow.

[0008] The present disclosure solves the problems and limitations associated with the related art. Summary of the invention

[0009] Some aspects of the present disclosure relate to methods for evaluating a proposed valve-in-valve procedure in which a replacement transcatheter aortic valve is to be deployed within a first or initial bioprosthetic aortic valve. The method includes selecting predetermined baseline measurements of a valve-in-valve combination that includes a known transcatheter aortic valve deployed within a known bioprosthetic aortic valve. An image of the patient's anatomical structure is received. Anatomical measurements of the first bioprosthetic valve relative to the anatomical structure are obtained from the received image. The predetermined baseline measurements and the anatomical measurements are examined. The risk of the valve-in-valve procedure to the patient is evaluated based at least in part on the examination. In some embodiments, the methods of the present disclosure take into account the risk of sinus isolation and / or coronary access obstruction presented by the proposed transcatheter aortic valve-in-transcatheter aortic valve ("TAV-in-TAV") procedure. In some embodiments, the predetermined baseline measurement includes the height of the new skirt of the combined valve-in-valve. In some embodiments, checking the predetermined benchmark measurement and the anatomical measurement includes one or more of: comparing the new skirt height value of the predetermined benchmark measurement with the coronary ostium height value of the anatomical measurement; comparing the new skirt height value of the predetermined benchmark measurement with the sinotubular junction height of the anatomical measurement; evaluating the residual area or volume or distance between the first bioprosthetic aortic valve and the native anatomical structure at the level of the native sinotubular junction; and evaluating the residual area or volume or distance between the first bioprosthetic aortic valve and the native anatomical structure at the level corresponding to the new skirt height value of the predetermined benchmark measurement. In some embodiments, the evaluation is performed for a patient who has previously received a bioprosthetic aortic valve and is being considered for receiving a candidate replacement transcatheter aortic valve; in these and related embodiments, the evaluation step includes determining whether the candidate replacement transcatheter aortic valve is suitable for the patient. In other embodiments, the evaluation is performed for a patient who has not previously received a bioprosthetic aortic valve and is being considered for receiving a candidate initial bioprosthetic aortic valve. For these and related embodiments, the evaluation step includes determining whether the candidate initial bioprosthetic aortic valve is suitable for the patient; the baseline assessment may also include assumptions about how the initial bioprosthetic valve will be implanted, such as the depth of implantation and centering of the valve within the sinus duct. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Figure 1 is a schematic cross-sectional view of a mammalian heart having a native valve structure;

[0011] Figure 2 is a schematic cross-sectional view of the native aortic valve and surrounding anatomy;

[0012] Figure 3 is a schematic cross-sectional view of a bioprosthetic aortic valve implanted into a native aortic valve annulus;

[0013] Figure 4Ais a simplified side cross-sectional view of a first bioprosthetic aortic valve prepared for placement within a second bioprosthetic aortic valve;

[0014] Figure 4B yes Figure 4A a simplified side cross-sectional view of a bioprosthetic aortic valve of the invention during final deployment of the first bioprosthetic aortic valve within the second bioprosthetic aortic valve;

[0015] Figure 5A is a schematic cross-sectional view of a valve-in-valve arrangement at a native aortic valve;

[0016] Figure 5B is a schematic cross-sectional view of another valve-in-valve arrangement at a native aortic valve together with a surgical device;

[0017] Figure 6 is a block diagram illustrating a computing system for evaluating a patient for an indication for a transcatheter bioprosthetic aortic valve replacement procedure;

[0018] Figure 7 is a flow chart illustrating a method for evaluating a patient for an indication for a transcatheter aortic valve replacement procedure;

[0019] Figure 8 is a block diagram of a predetermined valve-in-valve reference measurement database that may be used with the systems and methods of the present disclosure;

[0020] Fig.9A is a simplified side cross-sectional view of a valve-in-valve combination and identifies benchmark measurement data that may be used with the systems and methods of the present disclosure;

[0021] Fig. 9B is a simplified side cross-sectional view of another petal-in-petal combination and identifies benchmark measurement data that may be used with the systems and methods of the present disclosure;

[0022] Fig.10 is an example table of benchmark measurements that may be used with the systems and methods of the present disclosure;

[0023] Fig.11 is a schematic cross-sectional view of a bioprosthetic aortic valve implanted into native anatomy and identifies anatomical measurements that may be used with the systems and methods of the present disclosure;

[0024] Fig.12 It is an example of the principle of the present disclosure and can be used for Figure 7 A flow chart of a method for evaluating the risk of sinus isolation;

[0025] Fig.13 It is an example of the principle of the present disclosure and can be used for Figure 7 A flowchart of another method for evaluating the risk of sinus isolation; and

[0026] Fig.14 It is an example of the principle of the present disclosure and can be used for Figure 7 Flow chart of a method for evaluating the risk of coronary artery access obstruction. DETAILED DESCRIPTION

[0027] Specific embodiments of the present disclosure are now described with reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements.

[0028] Figure 1 is a schematic cross-sectional view of a mammalian heart 10 depicting the four heart chambers (right atrium RA, right ventricle RV, left atrium LA, left ventricle LV) and native valve structures (tricuspid valve TV, mitral valve MV, pulmonary valve PV, aortic valve AV). Figure 2 is a schematic cross-sectional view of the aortic valve AV and surrounding anatomy. Figure 1 and Figure 2 , the heart 10 includes a left atrium LA that receives oxygenated blood from the lungs via the pulmonary veins. The left atrium LA pumps the oxygenated blood through the mitral valve MV and into the left ventricle LV during ventricular diastole. The left ventricle LV contracts during systole, and the blood flows outward through the aortic valve AV, into the aorta and to the rest of the body.

[0029] The patient's anatomical structures at and near the aortic valve AV include the aorta 20, the sinotubular junction ("STJ") 22, the native leaflets 24, the aortic valve annulus 26, the sinus region (or sinus of Valsalva) 28, the coronary arteries 30 each having a coronary orifice 32, and the left ventricle LV. Defects or diseases (e.g., aortic valve stenosis) may prevent the aortic valve AV from opening properly, thereby reducing blood flow from the heart to the patient's body. In these and other cases, the defective aortic valve can be replaced or repaired with a bioprosthetic aortic valve. Some bioprosthetic aortic valves are intended to be implanted surgically, while others are configured for placement based on a minimally invasive approach. For example, a transcatheter aortic valve (or "TAV") is installed for a patient via a transcatheter aortic valve replacement ("TAVR") procedure. The transcatheter aortic valve replacement procedure is sometimes also referred to as a transcatheter aortic valve implantation ("TAVI"). Figure 3 An example of a bioprosthetic aortic valve 40 deployed to a native aortic valve AV is illustrated in simplified form. Figure 3In the non-limiting example of the present invention, the bioprosthetic aortic valve 40 is a transcatheter aortic valve and generally includes a valve structure 50 (generally referred to as a stent) supported by a stent or stent frame 52. The stent frame 52 secures the bioprosthetic valve 50 to the native annulus 26. With some techniques, the native leaflets 24 remain in place but are spaced apart from or held away from (and thus not interfering with) the valve structure 50 by the stent frame 52. In other cases, some or all of the native leaflets 24 may be removed.

[0030] Regardless of type or design, over time, the bioprosthetic valve 40 may deteriorate and / or may no longer be optimal for the patient's changing anatomy (e.g., where the bioprosthetic valve 40 is implanted in a younger patient). One potentially viable approach to addressing these and other issues is to deploy a second or replacement transcatheter aortic valve within a previously implanted bioprosthetic valve 40 (also known as a "valve-in-valve"). As a point of reference, Figure 4A , a simplified representation of a previously implanted bioprosthetic valve 40 and a second or replacement transcatheter valve 70 is shown. As mentioned above, the previously implanted bioprosthetic valve 40 includes a stent frame 52 that holds a valve structure 50, which originally includes or provides two or more leaflets 54. The arrangement of the leaflets 54 relative to the stent frame 52 produces an inflow side I opposite to the outflow side O. With this flow direction in mind, the stent frame 52 extends between a first or inflow end 56 and a second or outflow end 58. The leaflets 54 are fixed relative to the stent frame 52 at a base 60 and extend from the stent frame 52 to a free edge 62. A skirt material 64 is typically provided along the stent frame 52, which extends from the inflow end 56. The replacement transcatheter valve 70 can have a variety of designs and typically includes a valve structure 80 supported by a stent or stent frame 82. As part of a valve-in-valve procedure, the replacement transcatheter valve 70 is deployed within the previously implanted bioprosthetic valve 40, such as Figure 4B As generally shown. Upon final deployment, the stent frame 82 of the replacement transcatheter valve 70 secures some or all of the leaflets 54 of the previously implanted bioprosthetic valve 40 to the stent frame 52 of the previously implanted bioprosthetic valve 40. Because the previously implanted bioprosthetic valve 50 and the replacement transcatheter valve 70 may not have the same design or footprint, and / or due to changes in the position of the replacement transcatheter valve 70 relative to the previously implanted bioprosthetic valve 40, the leaflets 54 may be partially or completely secured between the stent frames 52, 82. In any event, the secured leaflets 54 combine with the skirt 64 to effectively form a barrier or "new skirt" along the stent frame 82 of the replacement transcatheter valve 70. For ease of understanding, the new skirt is Figure 4B The new skirt 90 is generally designated as “90” in FIG.

[0031] Although the valve-in-valve procedure is feasible for many patients, it may raise certain issues. For example, Figure 5A The shading in FIG. generally reflects the amount of fluid that is present during deployment of the replacement transcatheter valve 70 ( Figure 5A In some cases, such as where the new skirt 90 extends to or above the STJ 22, the new skirt 90 may act to partially or completely separate or "isolate" the coronary sinus 28 from the aorta 20, thereby partially or completely blocking blood flow to the coronary arteries ( Figure 5A Alternatively or in addition, the new skirt 90 may render access to one or more of the coronary ostia 30 extremely challenging even while maintaining coronary perfusion around the nested valves 40, 70. For example, a clinician may desire to access one or more of the coronary ostia 30 via the aorta 20 (e.g., a percutaneous coronary intervention (PCI) procedure). Figure 5B , in which a new skirt 90 (indicated by shading) blocks or partially obstructs the intended path of a surgical device 92 from within a previously implanted bioprosthetic valve 40 (e.g., through the cell openings of a stent frame 52), and access to one or more coronary artery ostia 30 is undesirably restricted.

[0032] Coronary artery isolation and access problems associated with valve-in-valve placement are not limited to any specific type or design of bioprosthetic aortic valve or replacement transcatheter valve and may vary from patient to patient. FIG. 4A to FIG. 5B The general representation of different prosthetic valve configurations occurs. In addition, the native patient anatomy and / or the implantation location of the initial bioprosthetic heart valve may also play a major role in whether coronary artery isolation and / or coronary artery access obstruction occurs after deployment of a replacement transcatheter valve.

[0033] Against the foregoing background, some embodiments of the present disclosure relate to systems (e.g., computing systems) and methods for evaluating a patient's risk associated with a potential valve-in-valve procedure. The systems and methods may be useful for different types or categories of patients. In some examples, embodiments of the present disclosure are useful for a first category of patients, such as patients with a previously implanted prosthetic heart valve and an indication for receiving a candidate replacement transcatheter aortic valve to be deployed within a previously implanted bioprosthetic aortic valve. In other examples, embodiments of the present disclosure are useful for a second category of patients, such as those who are first-time candidates for a bioprosthetic aortic valve (i.e., a bioprosthetic aortic valve has not yet been implanted in the patient). In the case of this second category, it may be useful to assess the valve-in-valve risk posed by the first or initial bioprosthetic aortic valve under consideration before the patient receives the first or initial bioprosthetic aortic valve. Then, in either scenario or patient category, the evaluation of the present disclosure takes into account the risks associated with the possible deployment of a second or replacement transcatheter aortic valve within the first bioprosthetic aortic valve. For the first category of patients (i.e., patients who have received a bioprosthetic aortic valve), "first bioprosthetic aortic valve" refers to a previously implanted bioprosthetic aortic valve. For the second category of patients (i.e., patients who are first-time candidates for receiving a bioprosthetic aortic valve), "first bioprosthetic aortic valve" refers to a bioprosthetic aortic valve that is currently under consideration.

[0034] In general, some methods of the present disclosure require obtaining measurements of various anatomical features of a first bioprosthetic aortic valve relative to the patient's native anatomy. The obtained measurements are compared to measurements determined for a baseline or replacement transcatheter aortic valve deployed within a bioprosthetic aortic valve that is otherwise substantially identical to the first bioprosthetic aortic valve (e.g., the baseline measured bioprosthetic aortic valve is the same style / type / size as the first bioprosthetic aortic valve). Based on the examination, an evaluation is made as to whether the replacement transcatheter aortic valve is suitable for the patient, for example, if the evaluation indicates that there may be a risk or problem of coronary sinus isolation or coronary artery access obstruction. Utilizing the systems and methods of the present disclosure, a highly actionable risk assessment or prediction associated with a proposed valve-in-valve procedure (e.g., a transcatheter aortic valve in a transcatheter aortic valve (or "TAV-in-TAV")) is provided for a specific patient.

[0035] Figure 61 is a block diagram illustrating a computing system 100 for evaluating a patient for indication to receive a replacement transcatheter aortic valve in a first biological aortic valve (e.g., a transcatheter aortic valve) according to one embodiment. The system 100 includes a processor 102, a memory 104, an input device 106, an output device 108, and a display 110. The processor 102, the memory 104, the input device 106, the output device 108, and the display 110 are communicatively coupled to each other via a communication link 112.

[0036] Input device 106 may include one or more of a keyboard, a mouse, a data port, a stylus, and / or other suitable devices for inputting information into system 100. Output device 108 may include one or more of a speaker, a data port, and / or an external suitable device for outputting information from system 100. Display 110 may be any type of display device that displays information to a user of system 100.

[0037] Processor 102 includes a central processing unit (CPU) or other suitable processor. In an example, memory 104 stores machine-readable instructions for operating system 100 executed by processor 102. Memory 104 includes any suitable combination of volatile and / or non-volatile memory, such as a combination of random access memory (RAM), read-only memory (ROM), flash memory, and / or other suitable memory. These are examples of non-transitory computer-readable media (e.g., non-transitory computer-readable storage media storing computer-executable instructions that, when executed by at least one processor, cause at least one processor to perform a method). Memory 104 is non-transitory in the sense that it does not encompass transient signals but is composed of at least one memory component to store machine-executable instructions for performing the techniques or methods described herein.

[0038] The memory 104 stores input 120, a reference module 122, a measurement module 124, a coronary blood flow evaluation module 126, a coronary access evaluation module 128, and an output 130. The processor 102 executes the instructions of the modules 122, 124, 126, 128 to perform the techniques described herein based on the input 120, thereby generating an output 130. In some embodiments, the input 120 includes an image of a previously implanted bioprosthetic aortic valve and surrounding anatomical structures of the patient. The reference module 122 selects or facilitates a user to select reference data or measurements corresponding to a replacement transcatheter aortic valve deployed in a bioprosthetic valve substantially identical to the first bioprosthetic aortic valve. The measurement module 124 obtains anatomical measurements of the first bioprosthetic aortic valve relative to the native anatomical structure, as described below. The coronary blood flow evaluation module 126 compares the obtained anatomical measurements with the selected reference data to assess the patient's risk of sinus isolation. The coronary access evaluation module 128 compares the obtained anatomical measurements with the selected reference data to assess the patient's coronary access risk. Results from one or more of modules 122 - 128 may be provided to a user as output 130 .

[0039] In some examples, various subcomponents or elements of system 100 may be embodied in multiple different systems, and modules may be grouped or distributed across multiple different systems. In order to achieve its desired functionality, system 100 may include various hardware components. Among these hardware components may be multiple processing devices, multiple data storage devices, multiple peripheral device adapters, and multiple network adapters. These hardware components may be interconnected using buses and / or network connections. The processing device may include a hardware architecture to retrieve executable code from a data storage device and execute the executable code. When executed by the processing device, the executable code may cause the processing device to perform some functionality disclosed herein.

[0040] Figure 7 is a flowchart illustrating method 200 according to certain embodiments. In some embodiments, computing system 100 ( Figure 6) is configured to perform one or more or all steps of method 200. It should be noted that in some embodiments, method 200 is a computer-implemented method or process. In addition, certain boxes may be automatically executed, manually executed by a user of the computing device, or partially manually and partially automatically executed, such as based on input from a user of the computing device. In addition, certain boxes may be optional, and portions of the described method may be performed as separate methods. At 202, method 200 includes selecting benchmark data or measurements from a plurality of available predetermined benchmark data or measurements based on a replacement transcatheter aortic valve and a first bioprosthetic aortic valve. The selection at 202 may be performed by the benchmark module 122. At 204, the method includes receiving anatomical images of the patient. These images include or relate to the actual or potential position of the first bioprosthetic aortic valve and the surrounding anatomical structures of the patient. At 206, the method includes obtaining anatomical measurements of the first aortic valve relative to the patient's native anatomical structures based on the images obtained. The measurements at 206 may be obtained by the measurement module 124, or the generation of the measurements may be facilitated by the measurement module. At 208, the obtained anatomical measurements are compared to the selected benchmark measurements to assess the patient's risk of sinus isolation if the replacement transcatheter aortic valve is installed or implanted within the first bioprosthetic aortic valve. The assessment at 208 may be performed or facilitated by the coronary blood flow assessment module 126. Optionally, at 210, the obtained anatomical measurements are compared to the selected benchmark measurements to assess the patient's risk of coronary access if the replacement transcatheter aortic valve is installed or implanted within the first bioprosthetic aortic valve. The assessment at 210 may be performed or facilitated by the coronary access assessment module 128. Based on the assessments at 208 and / or 210, the risk of a valve-in-valve procedure to the patient is assessed at 212. The assessment at 212 may be performed by one or both of the coronary blood flow assessment module 126 and the coronary access assessment module 128. Where the patient in question has previously received a bioprosthetic aortic valve and is being considered for a candidate replacement transcatheter aortic valve, the evaluation step 212 may include determining whether the candidate replacement transcatheter aortic valve is suitable for the patient. Where the patient in question has not previously received a bioprosthetic aortic valve and is being considered for a candidate initial bioprosthetic aortic valve, the evaluation step 212 may include determining whether the candidate initial bioprosthetic aortic valve is suitable for the patient.

[0041] In some embodiments, benchmark module 122 may have access to or maintain a library 150 of determined measurement data (e.g., obtained through benchmark testing) for at least one valve-in-valve ("VIV") combination of a known transcatheter aortic valve deployed within a known bioprosthetic aortic valve. In some embodiments, library 150 includes or provides determined measurement data for a plurality of different VIV combinations. For example, Figure 8The diagram shows a plurality of VIV combinations 2501, ..., 250 that can be provided by the library 150. n For ease of explanation, each VIV combination 2501, ..., 250 n The two valves are designated as inner valve 260 deployed within outer valve 262. VIV combination 2501, ..., 250 n The inner valve 260 of each VIV combination in is a known transcatheter aortic valve (identifiable at least by type or trade name and size). There are many different transcatheter aortic valves available, each with specific design features. Some examples include the CoreValve from Medtronic, Inc. TM The transcatheter aortic valve was obtained from Medtronic under the trade name Evolut TM The transcatheter aortic valve was purchased from Edwards Lifesciences, Inc. under the trade name Sapien TM The transcatheter aortic valve was purchased from Abbott under the trade name Portico TM A transcatheter aortic valve was obtained from Boston Scientific under the trade name Acurate TM Neo transcatheter aortic valves, etc. These and other transcatheter aortic valves are available in different specified sizes. Therefore, the inner valve 2601 of the first VIV combination 2501 can be Evolut TM PRO 26 mm transcatheter aortic valve; the inner valve 2602 of the second VIV combination 2502 may be an Evolut PRO 29 mm transcatheter aortic valve; the inner valve 2603 may be a transcatheter aortic valve of a specified size available from a manufacturer other than Medtronic; etc. VIV combinations 2501, ..., 250 n The outer valve 262 of each VIV combination in the embodiment is a known bioprosthetic aortic valve, which may or may not be a known transcatheter aortic valve (eg, VIV combinations 2501, . . . , 250 n The outer valve 262 of one or more VIV combinations in the embodiment may alternatively be a surgical prosthetic aortic valve). The VIV combinations 2501, ..., 250 n At least some of the VIV combinations in provide determined measurement information for a known transcatheter aortic valve deployed within a known transcatheter aortic valve (and thus represent a transcatheter aortic valve in a transcatheter aortic valve (or "TAV in a TAV") valve replacement arrangement). VIV combinations 2501, ..., 250 nThe determined measurement information for a known transcatheter aortic valve deployed with the same known transcatheter aortic valve may be included. For example, in the case of VIV combination 2501, the inner valve 2601 and the outer valve 2621 have the same construction, model, and size. VIV combinations 2501, ..., 250 n The determined measurement information for a known transcatheter aortic valve of a first size deployed within a known transcatheter aortic valve that is similar to the known transcatheter aortic valve but of a different size may be included. For example, in the case of VIV combination 2502, the inner valve 2602 and the outer valve 2622 have the same construction and model, but are of different sizes. VIV combinations 2501, ..., 250 n Determined measurement information may be included for a known transcatheter aortic valve from a first manufacturer deployed within a known transcatheter aortic valve from a second manufacturer. For example, in the case of VIV combination 2503, inner valve 2603 is a known transcatheter aortic valve produced by a first manufacturer, while outer valve 2622 is a known transcatheter aortic valve produced by a different manufacturer. Determined measurement data may be provided for a wide variety of VIV combinations.

[0042] Back to Figure 6 and Figure 7 , the determined measurement data may include various dimensional attributes associated with each VIV combination, such as a measurement representing the height of the fixed leaflet (or new skirt) relative to one or more points of interest (such as the inflow end of a known bioprosthetic aortic valve, a marking on the known bioprosthetic aortic valve, etc.). In some embodiments, measurement data may be provided relative to the plane in which the inflow end of the known bioprosthetic aortic valve is expected to be located upon final implant (e.g., the plane of the native aortic valve annulus). Other determined measurement data may include the diameter of the combined known transcatheter aortic valve deployed within a known bioprosthetic aortic valve at one or more locations (e.g., at the extent or level of the fixed leaflet or new skirt).

[0043] As a reference point, Fig.9A 2 is a simplified representation of a fiducial marker VIV combination 270 of a known transcatheter aortic valve 300 deployed within a known bioprosthetic aortic valve 302, and from which measurement data useful for the systems and methods of the present disclosure may be determined. The known bioprosthetic aortic valve 302 includes a stent frame 310 and leaflets 312 (whose thickness is exaggerated for ease of understanding) that have been secured by a stent frame 330 of the known transcatheter aortic valve 300 in final deployment to form a new skirt 340. Fig.9AAlso reflected in the known transcatheter aortic valve 300 are leaflets 332; the arrangement of the leaflets 332 establishes an inflow side I opposite to the outflow side O. The leaflets 312 of the known bioprosthetic aortic valve 302 are similarly arranged relative to the stent frame 310, so that the known bioprosthetic aortic valve 302 has the same inflow side I and outflow side O. Therefore, comparable to the above description, the stent frame 310 of the known bioprosthetic aortic valve 302 has an inflow end 314 opposite to the outflow end 316, wherein the leaflets 312 extend from a base 318 to a free edge 320, the base being otherwise fixed to the stent frame 310. Utilizing Fig.9A 310, 330. In the arrangement of the new skirt 340, the entire extent or length of the leaflet 312 (including the free edge 320) is fixed between the stent frames 310, 330. Therefore, the fixed edge 342 of the new skirt 340 is established at the free edge 320. With these conventions in mind, the height H of the new skirt 340 can be measured as the length or distance from the inflow end 314 to the fixed edge 342. Alternatively or in addition, the height H of the new skirt 340 can be measured as the length or distance from a mark or other known position along the stent frame 310 near the inflow side I (e.g., at or near the base 318 of the leaflet 312) to the fixed edge 342.

[0044] As a further reference point, Fig. 9B Another fiducial marker VIV combination 280 of a different known transcatheter aortic valve 300' is illustrated in simplified form as being deployed within a known bioprosthetic aortic valve 302 in a manner that forms a new skirt 340'. The stent frame 330' of the known transcatheter aortic valve 300' is substantially shorter than the stent frame 310 of the known bioprosthetic aortic valve 302. Then, in Fig. 9B In the arrangement, less than the entire length of the leaflet 312 is fixed between the stent frames 310, 330'. Although the base 318 is between the stent frames 310, 330', the free edge 320 is not therebetween. The extent of the stent frame 330' generates a fixed edge 342' along the leaflet 312. In the case of a partially fixed arrangement, the height H of the resulting new skirt 340' can be measured as the length or distance from the inflow end 314 to the fixed edge 342'. Alternatively or in addition, the height H of the new skirt 340' can be measured as the length or distance from a mark or other known position along the stent frame 310 near the inflow side I to the fixed edge 342'.

[0045] Back to Figure 6 and Figure 7, in some embodiments, the determined measurement data maintained by the library 150 and / or otherwise accessed by the benchmark library module 124 may take into account various implantation depths. As a reference point, because the determined measurement data (including the new skirt height) will be used to evaluate the position of the actual, previously implanted bioprosthetic aortic valve relative to the surrounding anatomy, "implantation depth" refers to the position of the implanted bioprosthetic aortic valve relative to the native anatomy, such as the distance between the inflow end of the implanted bioprosthetic aortic valve and the plane of the native aortic valve annulus. Implantation depth can and typically will vary from patient to patient. Because the determined measurement data (including the new skirt height) will be used to evaluate the actual, previously implanted bioprosthetic aortic valve, the determined measurement data may provide two or more potential implantation depths.

[0046] With the foregoing in mind, the determined measurement data may take a variety of forms, and may include baseline information (eg, obtained through baseline testing) for two or more combinations of known transcatheter aortic valves deployed within known bioprosthetic aortic valves. Fig.10 A non-limiting example of determined measurement data or lookup table 350 is provided in . The determined measurement data includes baseline information for a first known transcatheter aortic valve T1 deployed within a first known bioprosthetic aortic valve B1 (column A), a second known transcatheter aortic valve T2 deployed within a second known bioprosthetic aortic valve B2 (column B), and a third known transcatheter aortic valve T3 deployed within a third known bioprosthetic aortic valve B3 (column C). The benchmark test used to generate the determined measurement data 350 may include arranging the known transcatheter aortic valve relative to the corresponding known bioprosthetic valve so that the leaflets of the known bioprosthetic valve are partially fixed or fully fixed. With this in mind, the benchmark measurement provides a new skirt height for the partially fixed leaflet (row 1), a new skirt height for the fully fixed leaflet (row 2), and a diameter at the fixed edge of the new skirt (row 3). Additionally, the determined measurement data 400 may include new skirt heights for different implant depths (for both partial and full fixation conditions), such as an implant depth of 1 mm (rows 1-1 and 2-1), an implant depth of 3 mm (rows 1-2 and 2-2), and an implant depth of 5 mm (rows 1-3 and 2-3). The determined measurement data of the present disclosure may take a wide variety of other forms.

[0047] Additional references Figure 6 and Figure 7, step 202 may include selecting determined measurement data corresponding to the patient's first bioprosthetic aortic valve and the replacement transcatheter aortic valve under consideration from library 150. For example, where the first bioprosthetic aortic valve (e.g., a previously implanted bioprosthetic aortic valve of a patient who has received a bioprosthetic aortic valve, a bioprosthetic aortic valve under consideration for a first candidate patient) is a known bioprosthetic aortic valve B2 and the replacement transcatheter aortic valve is a known transcatheter aortic valve T2, the measurement data provided by column B is selected.

[0048] The anatomical image of the patient provided at step 204 may be obtained in a variety of ways. In some embodiments, data representing a patient-specific three-dimensional (3D) image of a region of the heart where a first bioprosthetic aortic valve has been or may be implanted, obtained, for example, by computed tomography (CT) or magnetic resonance imaging (MRI), is provided to the processor 102. Thus, the data may be one or more 3D CT images and / or one or more 3D MRI images of a region of the heart of the subject. Thus, in some embodiments, the input 120 may include a medical imaging device and / or a database of acquired medical images (e.g., single-phase CT images or multi-phase CT images imported into the system 100). In the event that the patient in question has previously received a bioprosthetic aortic valve, the previously implanted bioprosthetic aortic valve will appear in the acquired image.

[0049] Step 206 of obtaining anatomical measurements of the first bioprosthetic aortic valve relative to the patient's native anatomy in the acquired images may include or be combined with various techniques or processes that generate information useful for subsequent evaluation. For example, the anatomical measurements may include one or more of the following: coronary inflow height, residual distance, diameter, or other parameters indicating the area or volume between the previously implanted bioprosthetic valve and the native anatomy (e.g., the aortic wall) at one or more locations, commissure alignment, etc. Fig.11(which otherwise illustrates a previously implanted bioprosthetic aortic valve 400 and surrounding anatomical structures in some non-limiting examples), the anatomical measurements may include a first measurement that provides the height or distance of each of the coronary ostia 32 from the native annulus 26. The ostial height measurement may be one or both of the lower ostial height M1a and the upper ostial height M1b. The anatomical measurements may also include: a second measurement M2 that provides the height or distance of the sinotubular junction ("STJ") 22 from the native annulus 26; a third measurement M3 that provides the diameter of the STJ 22; a fourth measurement M4 that provides the diameter of the previously implanted valve 400 at the STJ 22; and a fifth measurement M5 that provides a parameter indicating the size and / or shape of the aorta or aortic wall 20 (or other anatomical structure) at a distance from the native annulus 26 that corresponds to the new skirt height H obtained from the baseline measurement data. For example, the parameter of the fifth measurement M5 may be a diameter, a residual area, a residual volume, etc. With respect to the fifth measurement M5, the implantation depth DOI of the previously implanted valve 400 (i.e., the distance from the inflow end 402 of the previously implanted valve 400 to the annular plane AP of the native annulus 26) may be measured or determined; the DOI may be compared with a retrieved new skirt height reference measurement (which otherwise corresponds to a replacement transcatheter aortic valve deployed within a bioprosthetic aortic valve that is substantially identical to the previously implanted valve 400) to select a corresponding new skirt height H, optionally for fully fixed and partially fixed arrangements (if available). In other embodiments, the methods of the present disclosure may default to an implantation depth DOI of 3 millimeters. In any event, the obtained new skirt height H is then used to determine the location (e.g., distance from the annular plane AP) at which the fifth measurement M5 is determined.

[0050] For patients with a previously implanted bioprosthetic aortic valve, the above measurements may be obtained relative to the actual position and orientation of the previously implanted bioprosthetic aortic valve. For first-time candidate patients (i.e., patients who have not yet received a first bioprosthetic aortic valve and therefore do not have a first or previously implanted bioprosthetic aortic valve in the acquired anatomical image), a fifth measurement M5 may be obtained by measuring parameters indicative of the size and / or shape (e.g., diameter, area, volume, etc.) of the native aorta 20 at a height H or a plane in which the fixed leaflets are estimated to be located. Again, the estimation is made by using the new skirt height H obtained from the baseline measurement data relative to the expected or planned implantation depth DOI.

[0051] Back to Figure 6 and Figure 7The step 208 of comparing the obtained anatomical measurements to the selected benchmark measurements to assess the patient's risk of sinus isolation if the candidate replacement transcatheter aortic valve is to be installed or implanted within the first bioprosthetic aortic valve may include or be combined with a variety of techniques or processes. Fig.12 A non-limiting example of a coronary blood flow assessment method 500 for a patient with a previously implanted bioprosthetic aortic valve is provided in . Fig.11 At step 502, the coronary ostium heights (lower height measurement M1a, upper height measurement M1b, or both) are compared to the baseline new skirt (or fixed leaflet) height H of the two coronary arteries. In the event that all coronary ostium heights exceed the baseline new skirt height H by a predetermined value ("OK" at step 502) (e.g., 2 mm), it can be determined that the risk of sinus isolation is low, and the patient can be preliminarily approved to receive a candidate replacement transcatheter aortic valve at step 504.

[0052] If the coronary artery height does not exceed the new skirt height H ("No" at step 502), the STJ height (measurement M2) is compared to the baseline new skirt (or fixed leaflet) height H at step 506. In the event that the comparison shows that the STJ height is less than the new skirt height H ("No" at step 506), a parameter indicating the spacing between the previously implanted valve and the aorta at the sinotubular junction STJ is evaluated at step 508. The parameter evaluated can be the valve-to-aorta distance ("VTA"), residual area, residual volume, etc. For example, the sinotubular junction STJ diameter (measurement M3) can be compared to the diameter of the previously implanted valve at the level of the sinotubular junction STJ (measurement M4). In the event that the STJ diameter is determined to be no more than a predetermined value (e.g., 3 mm) of the diameter of the previously implanted valve at the level of the STJ ("No" at step 508), an increased risk of sinus isolation can be determined, and the patient can be preliminarily disapproved to receive a candidate replacement transcatheter aortic valve at step 510.

[0053] If the STJ height (M2) is greater than the baseline new skirt height H ("yes" at step 506) or the STJ diameter (M3) is determined to exceed the diameter of the previously implanted valve at the level of the STJ 22 ("yes" at step 508), then a parameter indicating the spacing between the previously implanted valve and the aorta 20 (or other native anatomical structure) at the level of the new skirt (or fixed leaflet) height H is evaluated at step 512. The evaluated parameter may be the valve-to-aorta distance ("VTA"), residual area, residual volume, etc. For example, the diameter of the aortic wall 20 (or other anatomical structure) at a distance from the native annulus 26 corresponding to the new skirt height H (measurement M5) may be compared to the baseline diameter. In the event that the diameter of the aortic wall 20 (or other anatomical structure) at the new skirt height H does not exceed a predetermined value of the baseline diameter ("no" at step 512) (e.g., 3 mm), an increased risk of sinus isolation may be determined, and the patient may be preliminarily disapproved to receive a candidate replacement transcatheter aortic valve at step 510.

[0054] In the event that the aortic wall (or other anatomical structure) at the new skirt height H exceeds a predetermined value of the baseline diameter ("OK" at step 512) (e.g., 3 mm), the residual or open area or distance between the previously implanted valve and each of the coronary ostia at the coronary ostia plane ("VTC") is evaluated at step 514. For example, the distance between the previously implanted valve and the ostium of each coronary artery may be determined and compared to the baseline distance. In the event that the VTC of each coronary ostium relative to the coronary ostium is greater than the baseline distance (e.g., 3 mm), it may be determined that the risk of sinus isolation is low, and the patient may be preliminarily approved to receive the candidate replacement transcatheter aortic valve at step 504. Conversely, in the event that the VTC of each coronary ostium relative to the coronary ostium does not exceed the baseline distance, it may be determined that there is an increased risk of sinus isolation, and the patient may be preliminarily disapproved to receive the candidate replacement transcatheter aortic valve at step 510.

[0055] The method for evaluating or assessing the risk of sinus sequestration in a patient having a previously implanted bioprosthetic aortic valve of the present disclosure may include one or more steps in addition to or in lieu of one or more steps of method 500. For example, Fig.13An alternative method 500' is illustrated for a patient with a previously implanted bioprosthetic aortic valve, which also includes an optional step 520 of checking the alignment of the commissures of the previously implanted valve relative to the coronary ostia. In the event that the commissures are found to be sufficiently offset from the ostia, for example at least 20 degrees ("yes" at step 520), then at step 502 the coronary ostia heights (measurements M1a, M1b, or both) are compared to the baseline new skirt (or fixed leaflet) height H of both coronary arteries, as described above. In the event that one or more commissures are determined to be closely aligned with one or more coronary ostia ("no" at step 520), then at step 506 the STJ height (measurement M2) is compared to the baseline new skirt (or fixed leaflet) height H, as described above. The remainder of method 500' may be similar to method 500.

[0056] Back to Figure 6 and Figure 7 The step 210 of comparing the obtained anatomical measurements to the selected benchmark measurements to assess coronary access risk may include or incorporate various techniques or processes. Fig.14 A non-limiting example of a coronary access assessment method 600 for a patient with a previously implanted bioprosthetic heart valve is provided in . Fig.11 , at step 602, the coronary ostium heights (lower height measurement M1a, upper height measurement M1b, or both) are compared to the baseline new skirt (or fixed leaflet) height H for both coronary arteries. In the event that all coronary ostium heights are greater than the baseline new skirt height H ("yes" at step 602), it can be determined that the risk of coronary access problems is low, and the candidate replacement transcatheter aortic valve can be designated as posing a minimal obstacle to a percutaneous coronary intervention (PCI) procedure at step 604. As a reference point, image 610 is an example comparison in which the baseline new skirt height or plane H1 is less than or "below" the upper aspect of the coronary ostium 620. In the event that at least one coronary ostium height is less than the baseline new skirt height H ("no" at step 602), it can be determined that the risk of coronary access problems is increased, and the candidate replacement transcatheter aortic valve can be designated as posing a minimal obstacle to a percutaneous coronary intervention (PCI) procedure at step 606. As a reference point, image 612 is an example comparison where the baseline new skirt height or plane H2 is greater than or "above" the upper aspect of the coronary ostium 620. Other optional coronary assessment methods of the present disclosure may include modeling coronary blood flow based on anatomy and baseline measurements.

[0057] Equivalent to the above description, Figure 12 to Figure 14The methods and similar methods may be applicable to patients with previously implanted bioprosthetic aortic valves, for example, to assess or evaluate the risk of a potential valve-in-valve procedure. In other embodiments, the systems and methods of the present disclosure may be used in first-time bioprosthetic aortic valve candidates (i.e., patients who are being considered for, but have not yet received, a bioprosthetic aortic valve). For such patients, the methods of the present disclosure may be similar to Fig.12 and Fig.13 Method 500, 500', wherein the comparisons or assessments at steps 502, 506, 508, and 512 are performed relative to anatomical measurements and baseline measurement dimensions. Step 514 of assessing the VTC need not be performed. In any event, in the event that a first-time patient valve-in-valve assessment of a candidate first bioprosthetic aortic valve indicates an elevated risk of sinus sequestration, the clinician may select a different candidate first bioprosthetic aortic valve for the first-time patient (e.g., if the valve-in-valve risk assumed at baseline was too high for a supra-annular valve, the clinician may select a different (potentially shorter) first bioprosthetic aortic valve).

[0058] It should be understood that the various aspects disclosed herein may be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any of the processes or methods described herein may be performed in a different order, may be added, merged, or omitted entirely (e.g., not all described actions or events may be required to perform these techniques). In addition, although for clarity, certain aspects of the present disclosure are described as being performed by a single module or unit, it should be understood that the techniques of the present disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0059] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or a combination thereof. If implemented in software, the functions may be stored as one or more instructions or codes on a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may include a non-transitory computer-readable medium corresponding to a tangible medium, such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium accessible by a computer that can be used to store desired program code in the form of instructions or data structures).

[0060] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general purpose microprocessors, application specific integrated circuits (ASICs), field programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuit systems. Thus, the term "processor" as used herein may refer to any of the aforementioned structures or any other physical structure suitable for implementing the described techniques. Additionally, these techniques may be fully implemented in one or more circuits or logic elements.

[0061] The systems and methods of the present disclosure provide significant improvements over previous designs.By utilizing a method that compares measurements from a benchmark test (eg, TAV-in-TAV measurements) to the patient's anatomy, patients can be reliably evaluated or screened for replacement valve procedures.

[0062] Although the present disclosure has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the present disclosure.

Claims

1. A method for evaluating a proposed valve-in-valve procedure for a patient in which a replacement transcatheter aortic valve is to be deployed within a first bioprosthetic aortic valve, the method comprising: selecting predetermined benchmark measurements of a valve-in-valve combination comprising a known transcatheter aortic valve deployed within a known bioprosthetic aortic valve; receiving an image of an anatomical structure of the patient; obtaining anatomical measurements of the first bioprosthetic valve from the received images; checking the predetermined reference measurements and the anatomical measurements; as well as A risk of a valve-in-valve procedure is assessed for the patient based at least in part on the examination.

2. The method of claim 1, wherein the first bioprosthetic aortic valve is a bioprosthetic aortic valve previously implanted in the patient, and further wherein the evaluating step comprises determining whether the replacement transcatheter aortic valve is suitable for the patient.

3. The method of claim 1, wherein the patient has not yet received a bioprosthetic aortic valve, and further wherein the first bioprosthetic aortic valve is the bioprosthetic aortic valve being considered for implantation in the patient. The method of claim 1 , wherein the first bioprosthetic aortic valve is a transcatheter aortic valve.

5. The method of claim 1, wherein the known transcatheter aortic valve is substantially identical to the candidate transcatheter aortic valve, and the known bioprosthetic aortic valve is substantially identical to the first bioprosthetic aortic valve.

6. The method of claim 1, wherein the evaluating step comprises assessing the risk of sinus isolation.

7. The method of claim 1, wherein the evaluating step comprises assessing the risk of coronary artery access obstruction.

8. The method of claim 1, wherein the petal-in-petal combination defines a new skirt, and further wherein the predetermined reference measurements include a height of the new skirt and a diameter of the petal-in-petal combination.

9. The method of claim 8, wherein the new skirt is created by securing leaflets of the known bioprosthetic aortic valve between a stent frame of the bioprosthetic aortic valve and a stent frame of the known transcatheter aortic valve.

10. The method of claim 9, wherein the leaflets of the known bioprosthetic aortic valve are one of: fully secured between the stent frames or partially secured between the stent frames.

11. The method of claim 9, wherein the height of the new skirt is defined by the distance from an inflow end of the stent frame of the known bioprosthetic aortic valve to a fixed edge of the leaflet.

12. The method of claim 9, wherein the diameter is obtained at the plane of the fixed edge of the new skirt.

13. The method of claim 1, wherein the first bioprosthetic aortic valve is a previously implanted bioprosthetic aortic valve, and the anatomical measurements include the distance from each native coronary artery ostium to an inflow end of the previously implanted bioprosthetic aortic valve.

14. The method of claim 13, wherein the anatomical measurement further comprises the distance from the inflow end to the native sinotubular junction.

15. The method of claim 13, wherein the anatomical measurements further include a parameter indicative of a spacing between the previously implanted bioprosthetic aortic valve and a native aortic wall.

16. The method of claim 15, wherein the parameter is selected from the group consisting of: Distance, residual area, and residual volume.

17. The method of claim 1, wherein the checking step comprises comparing the predetermined reference measured new skirt height value with the anatomically measured coronary ostium height value.

18. The method of claim 1, wherein the checking step includes comparing the predetermined baseline measured new skirt height value to the anatomically measured sinotubular junction height.

19. The method of claim 1, wherein the examining step includes evaluating a parameter indicative of a spacing between the first bioprosthetic aortic valve and native anatomical structures at the level of a native sinotubular junction.

20. The method of claim 19, wherein the parameter is selected from the group consisting of: Distance, residual area, and residual volume.

21. The method of claim 1, wherein the examining step includes evaluating a parameter indicative of a spacing between the first bioprosthetic aortic valve and native anatomy at a level corresponding to a new skirt height value of the predetermined reference measurement.

22. The method of claim 21, wherein the parameter is selected from the group consisting of: Distance, residual area, and residual volume.

23. The method of claim 1, wherein the predetermined baseline measurement of the valve-in-valve combination is obtained via a baseline test.

24. The method of claim 1, wherein the predetermined reference measurement is obtained from a library, and further wherein the library maintains predetermined reference measurements for a plurality of different valve-in-valve combinations.

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