Sensor guided structural heart procedures

Abstract

A system for guiding prosthetic heart valve procedures is provided that includes a console having a display and a processor and a tubular body supporting pressure sensor. The tubular body is configured to be inserted into a blood vessel (e.g., an artery) and advanced into a heart chamber (e.g., a ventricle). The processor is configured to: (a) receive fluoroscopic image data of a cardiovascular region that includes vascular segment adjacent to the heart (e.g., an aortic root) of a patient; (b) receive pressure signal data from the pressure sensor positioned in the cardiovascular region; (c) determine a marker indicating a location of a device positioning feature based at least in part on at least one of pressure signal data from the pressure sensor and analysis of the fluoroscopic image data; and (d) cause presentation of a user interface on the display that includes the fluoroscopic image and the marker.

Description

SENSOR GUIDED STRUCTURAL HEART PROCEDURESINCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

[0001] Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. For example, this application claims the benefit of U.S. Provisional Application No. 63 / 667,645, filed July 3, 2024, titled SENSOR GUIDED STRUCTURAL HEART PROCEDURES, the entire contents of which is incorporated by reference herein and forms a part of this specification for all purposes.BACKGROUNDField

[0002] This application is generally directed to systems and methods for streamlining structural heart procedures performed using catheters by providing visual guidance during such procedures.Description of the Related Art

[0003] In one type of structural heart procedure, a poorly functioning aortic valve is treated in a less invasive manner by implanting a prosthetic heart valve using catheter devices. Two access points into the arterial vasculature are created to advance two separate catheters toward the heart. A first or main arterial access point enables a cardiologist to insert a catheter having a heart valve mounted thereto into the vasculature and to advance the heart valve through the aorta to an implantation position in the aortic root. A second arterial access point enables a pigtail catheter to be advanced to the ascending aorta. The pigtail catheter can perform a diagnostic function near the aortic valve.

[0004] Traditionally a third vascular access site is typically needed to advance a third catheter device to the heart. The third catheter device can be a device configured to induce rapid pacing in the heart by applying electrical stimulus to the heart to facilitate the procedure. The third access site can be in the venous vasculature.

[0005] Catheter based heart valve procedures have grown rapidly over the past twenty years, due to rapid advances in design of devices and novel methods. However, suchprocedures are complex and mitigating some risks of surgical intervention of such procedures can introduce new costs and challenges.SUMMARY

[0006] There are several aspects of traditional techniques for transcatheter aortic valve repair (TAVR) that would benefit from innovation. While a three access point approach, as described above, has been shown to work for many patients, reducing the number of vascular access points would reduce vascular complications and greatly improve outcomes for many patients. Eliminating one or more secondary arterial access points would also greatly improve outcomes for many patients.

[0007] In one embodiment, a method for performing a transcatheter procedure on an aortic valve of a heart is provided. A catheter is advanced from an arterial access point to an ascending aorta of a patient. A contrast agent is injected into the ascending aorta. In one variation, this can be done through the main arterial access. By delivering contrast through the main access, the use of a pigtail catheter through a second arterial access site can be eliminated. First two dimensional image data of a cardiovascular region including a portion of the ascending aorta and an aortic root of the patient is generated while the contrast agent is present in the cardiovascular region. A pressure sensing device is positioned in a selected portion of the cardiovascular region. Second two dimensional image data of the cardiovascular region including the portion of the ascending aorta and the aortic root of the patient is generated when a pressure signal of the pressure sensing device indicates that the pressure sensing device is positioned in the selected portion of the cardiovascular region. A location of a device positioning feature is determined based at least in part on pressure signals obtained from the pressure sensing device. A marker indicating the determined location is merged with third two dimensional image data taken subsequent to the second two dimensional image data to create a merged image configured to guide a structural heart procedure, such as deployment of a prosthetic aortic valve. The merged image is displayed on a user interface. The merged image provides visual guidance of a location useful in the transcatheter procedure. For example, the merged image can show a landing zone for an aortic heart valve so that the cardiologist can line up a portion of the valve with the landing zone maker to assure proper placement. Prior procedures relied upon a cardiologists visual estimate of the proper position based on onlyvi ewing the fluoroscopic image of the anatomy. The addition of the visual markers can improve procedure efficiency and outcomes. For example, in some embodiments, the pigtail catheter reference is no longer needed, and the second arterial access can be eliminated.

[0008] In another embodiment, a method for performing a transcatheter procedure on a heart valve, e.g., an aortic valve replacement procedure, is provided. A pressure sensor is positioned in a chamber of a heart (e.g., in a left ventricle). A cardiovascular region adjacent to the heart chamber is imaged. The imaging involves generating two dimensional image data of the cardiovascular region. For example, a cardiovascular region including a portion of an ascending aorta and an aortic root of a patient is imaged. In other examples, the left ventricle and the left atrium are in a cardiovascular region that is imaged. In other examples, the right ventricle and the right atrium are in a cardiovascular region that is imaged. In other examples, the right ventricle and the pulmonary artery are in a cardiovascular region that is imaged. In some variations, the imaging can be facilitated by inj ecting contrast through a catheter disposed in the ascending aorta through the main access, providing a single arterial access site procedure. A location of a device positioning feature is determined based at least in part on at least one of pressure signals from the pressure sensor and image analysis of the two dimensional image data of the cardiovascular region. A composite image including a visual representation of the two dimensional image data and a marker indicating the determined location is output to a display. The positioning feature can be for guiding the positioning a device, such as a line or other overlaid mark indicating a landing zone for a prosthetic aortic valve. The positioning feature can be a line or other overlaid mark indicating a landing zone for guiding the positioning a prosthetic mitral valve. The positioning feature can be a line or other overlaid mark indicating a landing zone for guiding the positioning a prosthetic pulmonary valve. The positioning feature can be a line or other overlaid mark indicating a landing zone for guiding the positioning a prosthetic tricuspid valve. Prior procedures relied on presenting on a display a fluoroscopic image of the anatomy but without any specific indication of the location of a landing zone or other guidance. Prior procedures relied upon a cardiologists visual estimate of the proper position.

[0009] In another embodiment, a system for guiding placement of prosthetic heart valve is provided. The system can include a tubular body having a pressure sensor disposed on a distal end and a console. The tubular body can have a length between a proximal and thedistal end such that the tubular body can be inserted into vasculature (e.g., arterial vasculature) and advanced to a heart valve (e.g., to an aortic valve) or into a chamber (e.g., into a left ventricle) of a heart. The console can include a display and a processor. The processor is configured to receive a fluoroscopic image data of a cardiovascular region. The cardiovascular region can include an aortic root of a patient. The cardiovascular region can include a left ventricle and a left atrium of a patient. The cardiovascular region can include a right ventricle and a right atrium of a patient. The cardiovascular region can include a right ventricle and a pulmonary artery. The processor can receive pressure signal data from the pressure sensor positioned in a selected portion of the cardiovascular region. The processor can determine a marker indicating a determined location of a device positioning feature based at least in part on at least one of pressure signal data from the pressure sensor and analysis of the fluoroscopic image data. The processor can cause presentation of a user interface generated from the fluoroscopic image and the marker that is determined. Compared to prior systems, the system herein can guide placement of a prosthetic heart valve in a method that requires only a single arterial access point. Compared to prior systems, the system herein can provide a visual marker indicating the location of a landing zone for an aortic valve or other visual guidance for a heart valve procedure in a user interface that includes fluoroscopic images, improving procedure efficiency and outcomes. This benefit can be obtained even when more than one arterial access point is used.

[0010] In another embodiment, a method for performing a procedure on an aortic valve is provided. A catheter is advanced from an arterial access point to an ascending aorta of a patient. A contrast agent is injected into the ascending aorta. Advantageously, in some variations the contrast can be or optionally is injected through the access sheath enabling a single arterial access point procedure rather than requiring a second arterial access point for a contrast delivery catheter. The cardiovascular region including the portion of the ascending aorta and the aortic root is imaged while the contrast agent is present in the cardiovascular region. The imaging of the cardiovascular region includes generating a plurality of two dimensional images of the cardiovascular region including the aortic root. A coronary ostium plane or coronary risk plane is determined based on the two dimensional image. A pressure sensing device is advanced through the catheter to a cardiovascular region of the patient including a portion of an ascending aorta and an aortic root. A coaptation point of the aorticvalve is determined based at least in part on pressure signals from the pressure sensing device. An indicator of a coronary ostium obstruction risk is output by comparing a valve leaflet size and location as determined from the coaptation point with a distance of a coronary ostium from an annulus plane of the aortic valve. The presentation of an indicator provides a cardiologist with an objective, visual guidance of a possible complication in a procedure which can be mitigated during the procedure.

[0011] In various embodiments, systems and / or computer systems are disclosed that comprise a computer readable storage medium having program instructions embodied therewith, and one or more processors configured to execute the program instructions to cause the one or more processors to perform operations comprising one or more aspects of the above- and / or below-described embodiments (including one or more aspects of the appended claims).

[0012] In various embodiments, computer-implemented methods are disclosed in which, by one or more processors executing program instructions, one or more aspects of the above- and / or below-described embodiments (including one or more aspects of the appended claims) are implemented and / or performed.

[0013] In various embodiments, computer program products comprising a computer readable storage medium are disclosed, wherein the computer readable storage medium has program instructions embodied therewith, the program instructions executable by one or more processors to cause the one or more processors to perform operations comprising one or more aspects of the above- and / or below-described embodiments (including one or more aspects of the appended claims).BRIEF DESCRIPTION OF THE DRAWINGS

[0014] These and other features, aspects and advantages are described below with reference to the drawings, which are intended for illustrative purposes and should in no way be interpreted as limiting the scope of the embodiments. Furthermore, various features of different disclosed embodiments can be combined to form additional embodiments, which are part of this disclosure. In the drawings, like reference characters denote corresponding features consistently throughout similar embodiments. The following is a brief description of each of the drawings.

[0015] FIG. 1 is one example of a console with one display area providing a fluoroscopic image at a time of locating a valve annulus or coaptation point and another display area illustrating pressure traces at that time as well as several heartbeats before

[0016] FIG. 2A is an illustration of a structural heart procedure guidance system that can process signals to output a user interface to the display in FIG. 1.

[0017] FIGS. 2B and 2C are further diagrams of the system of FIG. 2A.

[0018] FIGS. 3A-3C illustrate some steps of a structural heart procedure that can be facilitated using the system of FIG. 2A and a variant of the display of FIG. 1.

[0019] FIG. 4 is a flow diagram of a method of generating and outputting a merged image to the display of FIG. 1, the merged image including a fluoroscopic image and a marker to guide a structural heart procedure.

[0020] FIG. 5 is a root shot fluoroscopic image that highlights an outline of aortic root anatomy.

[0021] FIGS. 6A-6E illustrate a techniques for locating an aortic valve structure including but not limited to the valve annulus, coaptation point, line, and plane.

[0022] FIG. 7A is a flow diagram for performing single-access valve gradient assessment with a pressure guidewire, with or without pre-procedural hemodynamic measurements.

[0023] FIGS. 7B-7E illustrate various techniques for equalizing pressure sensors in the process of FIG. 7A.

[0024] FIG. 8A is an example of a console with one display area illustrating a merged image including a fluoroscopic image and a marker to guide a structural heart procedure and another display area illustrating pressure data.

[0025] FIGS. 8B-8C illustrate embodiments of displaying and updating a merged image for guiding a structural heart procedure.

[0026] FIG. 9A is a flow diagram of a method of determining and outputting an obstruction prediction to a display.

[0027] FIG. 9B shows a model of an aortic root region that illustrates a method of determining an obstruction prediction value.

[0028] FIG. 9C illustrates an output showing a merged image including an outline of a coronary ostium and guidance for performing a structural heart procedure near the coronary ostium.

[0029] FIG. 9D illustrates an output showing a merged image including an outline of a coronary ostium and markings of a leaflet and an aortic valve prosthesis, the merged image indicating a likelihood of the aortic valve prosthesis obstructing the coronary ostium following placement of an aortic valve prosthesis.

[0030] FIG. 9E illustrates an output showing a merged image including an outline of a coronary ostium, the merged image showing markings of a leaflet and an aortic valve prosthesis, the merged image indicating a likelihood of the aortic valve prosthesis not obstructing the coronary ostium following placement of the valve.

[0031] FIG. 10 is a flow diagram of a method of determining and outputting merged image including a marking for a coronary ostium plane within a fluoroscopic image of an aortic root.DETAILED DESCRIPTION

[0032] This application is generally directed to providing enhanced guidance during a structural heart procedure, particularly a procedure treating valve deficiencies. Although the primary discussion below is of facilitating deployment of an aortic valve from a catheter, the concepts herein are applicable to catheter-based delivery of other valves, such as a mitral valve, a tricuspid vale, or a pulmonary valve. Additionally, the procedures herein can be generally applied to situations where a procedure would be improved by enhanced visibility of a point of coaptation of a valve, one or more points at or adjacent to the valve annulus, a location corresponding to a leaflet commissure, a valve annulus plane or a clinically significant landmark that is located relative to these anatomic features. As such, a valve repair or treatment procedure could also benefit from the concepts disclosed herein.

[0033] FIG. 1 is one view of a portion of a structural heart procedure guidance system 100, showing a user interface component thereof. The structural heart procedure guidance system 100 includes a display 104. In one embodiment, the display 104 is configured to display information in multiple windows or a portion thereof. The display 104 can include an x-ray image user interface 108 and a pressure data user interface 112. The x-ray image userinterface 108 illustrates a region of interest of the patient. In particular, in a fluoroscopic imaging modality a contrast K is injected into the region to be imaged. In this case, the contrast K is introduced into the aorta. In particular, the contrast K is introduced into the ascending aorta of the patient. With the use of an appropriately sized catheter, this contrast injection could be done even in the presence of a guidewire within the catheter. In some embodiments, the guidewire may be a stiff guidewire used for valve delivery and may integrate a pressure sensor. In some embodiments, the guidewire may be introduced further in the anatomy (e.g., in the left ventricle) than the tip of the catheter (e.g., in the ascending aorta). As discussed in further detail below, the structural heart procedure guidance system 100 is configured to locate, confirm the location of and / or track the location of the aortic annulus plane or other cardiovascular anatomy of relevance based, at least in part, upon a coaptation point, line or plane location. The coaptation point is the location at which leaflets of the aortic valve come together at the end of systole in each heartbeat cycle. As discussed further below, locating the coaptation point and annulus plane enables user interface outputs to be generated that guide a cardiologist in placement of a prosthetic valve.

[0034] The x-ray image user interface 108 can show a pressure guidewire 204 that has been placed across the aortic valve. The pressure guidewire 204 has a pressure sensor 254. The pressure sensor 254 can be a high fidelity sensor, such as an optical sensor as discussed further below. The pressure sensor 254 generates signals that are interpreted by the structural heart procedure guidance system 100 to display pressures detected at the location of the sensor. The displayed pressures are displayed as pressure (Y-axis) over time (X-axis). These pressures are sometimes described as pressure traces herein.

[0035] By having a radiopaque pressure sensor as discussed further below, the location of the coaptation point can be identified by analysis of the image data, or of both the pressure traces and image data. The pressure data user interface 112 can visually display the pressure traces and the coaptation point can be readily seen in this display. In one output, the traces in the pressure data user interface 112 include pressure in the aorta and the left ventricle over ten full beats. A first trace shows pressure from a pressure guidewire 204 that is moved in the anatomy. A second trace shows the aortic pressure measured at a fixed position in the aorta by an external sensor, not depicted. The second trace could show a pressure measured from a second sensor 254C located on a pressure guidewire 204A, as discussed further inconnection with FIG. 6D. In some embodiments, the first trace showing ventricular pressure during the first four beats reflects a lower minimum pressure during diastole than a second trace showing aortic pressure. The second trace has higher minimum pressures during diastole than the first trace during the first four beats. During these four beats, the pressure sensor 254 of the pressure guidewire 204 is located in the ventricle. The lower minimum pressure of the first trace reflects that the aortic valve is closed during diastole and the left ventricle is at a relatively low pressure following pumping of blood out of the ventricle during systole. Pressure begins to rise as the left ventricle fills. During the fifth beat the pressure sensor 254 is pulled into the aorta, crossing the aortic valve. As a result, from the fifth beat to the tenth beat, the first and second pressure traces are substantially identical. The pattern 610 of a beat with a much lower minimum pressure detected from pressure data from the pressure sensor 254 than aortic pressure sensor to a subsequent beat with approximately equal pressure detected from pressure data from the pressure sensor 254 and from the aortic pressure sensor is a pattern that is recognizable by the processor 172 executing program instructions.

[0036] Various methods can be used for detecting ventricular versus aortic pressure signals or to detect if two pressure curves are similar. For example, detecting ventricular versus aortic pressure can be achieved by comparing the difference between the minimum (diastolic pressure) of the two curves with a threshold value or by comparing the minimum of each curve with a threshold value. In another approach, detecting ventricular versus aortic pressure can be achieved by calculating the difference between the two curves during a certain time period, (e g., during the systolic time period, calculating the presence of an aortic gradient), and comparing the calculated difference with a threshold value. In another approach, detecting ventricular versus aortic pressure can be achieved by calculating a correlation factor between the two curves and comparing this value to a threshold value. In another approach, detecting ventricular versus aortic pressure can be achieved by determining a shape factor of a pressure curve during a certain time period (e.g., during the diastolic time period, determining if the pressure curve is asymmetrical). The difference between the shape factors of the two curves can be compared with a threshold value. In another approach, the shape factor of each curve can be compared to a threshold value.

[0037] The x-ray image user interface 108 can show the instant when the pressure sensor 254 is at the coaptation point. The pressure guidewire 204 is configured such thatpressure sensor 254 is visible in the x-ray image user interface 108. For example, a radiopaque metal structure, or other detectable structure, can be exposed to the x-ray imaging at this location. As a result, particular locations of the pressure sensor 254 can be detected in x-ray images and registered to pressure measurements made at the particular locations. The structural heart procedure guidance system 100 is configured to process both the pressure traces shown in the pressure data user interface 112 and the location information from the x- ray image user interface 108 to accurately locate the coaptation point in the images shown in the x-ray image display. As discussed further below, this method of locating the position of the coaptation point enables a merged image to be created that provide guidance to a cardiologist during the process of deploying a prosthetic valve, such as an aortic or other transcatheter valve. The guidance can include a display in real time of a landing zone, a display of a prediction of obstruction risk, and other clinically relevant metrics.

[0038] FIG. 2A shows example components of the structural heart procedure guidance system 100, including an imaging system 202A and a diagnostic system 202B. The imaging system 202A generates images such as the image incorporated into the x-ray image user interface 108. The imaging system 202A can generate images via any imaging technique. As illustrated, the imaging system 202A includes a c-arm 220 coupled to an x-ray image user interface 108A via a signal conveyance and circuitry 228. The x-ray image user interface 108A is the same as the x-ray image user interface 108 in some embodiments. In other embodiments, the x-ray image user interface 108 A is integrated into a dedicated console that is separate from a housing for a pressure data display.

[0039] The diagnostic system 202B includes the pressure guidewire 204 and the pressure data user interface 112A. The pressure data user interface 112A can be similar to the pressure data user interface 112. In one variation the pressure data user interface 112A is mounted in a separate housing than the x-ray image user interface 108 A. The pressure guidewire 204 can be coupled to the pressure data user interface 112A by a handle 212 and an interface cable 216. The pressure guidewire 204 can have a tubular body 240 disposed between a proximal end 244 and a distal end 248. The inner lumen of the tubular body 240 can house a signal relaying component such as an optical fiber to relay the signal of the pressure sensor 254 to the handle 212. The proximal end 244 can be releasably coupled with the handle 212 to allow access to the low profile proximal end 244. A length of the tubular body 240 can besufficient to allow the pressure guidewire 204 to traverse the vasculature between an access point and the aortic valve. The pressure guidewire 204 can have an outer layer 266 that provides insulation between an internal current conveying structure and the patient along the tubular body 240. This allows electrical current to be delivered to the patient through a pacing connection portion 262. The pacing connection portion 262 can be disposed proximal to the pressure sensor 254. By allowing electrical current delivery to the patient with the pressure guidewire 204 the venous access point typically used for pacing can be eliminated. This is a great advantage for patient recovery. A coil 258 can be provided distal to the pressure sensor 254. The coil 258 provides spacing from the interior walls of the ventricle when deployed, as discussed further below.

[0040] FIGS. 2B and 2C illustrate the structural heart procedure guidance system 100 in further aspects. The structural heart procedure guidance system 100 is configured to receive one or more inputs 124, to process the inputs 124 and to generate one or more output 128. The inputs 124 can include x-ray images, such as fluoroscopic (or “fluoro”) images. Such images can come from the imaging system 202A or another type of imaging. The inputs 124 can include planning information. Planning information can include anatomic measurements generated by a pre-procedure CT scan or other patient-specific information useful in generating outputs. The inputs 124 can include pressure data. Pressure data can be obtained from the diagnostic system 202B. Pressure data can come from other types of monitoring systems, such as pressure sensors operating on electrical circuits. The output 128 can include output images that merge x-ray images with markers or markings that provide guidance to cardiologists. A merged image can denote a location of a landing zone for an aortic valve or another valve or prosthesis. A merged image can include an x-ray image and a marker or marking denoting the location of an anatomical feature. The output 128 can include a metric or index of use to guide a procedure. One metric can include a coronary obstruction risk metric. The output 128 can include diagnostic information about the condition of a natural valve or a prosthetic valve before, after, or before and after placement of the valve. The output 128 can include pressure waveforms, such as are shown in the pressure data user interface 112.

[0041] The structural heart procedure guidance system 100 can execute various processes for processing inputs 124 and / or for generating outputs 128. The structural heart procedure guidance system 100 can execute a pressure equalization process 132. The pressureequalization process 132 can be configured to equalize differences in pressure between different pressure sensors. The pressure equalization process 132 can also be configured to equalize differences in pressure from a location in the ascending aorta to another location in the aorta, such as a location in the descending aorta. The valve feature detection process 136 can include an image processing protocol whereby valve features are derived from x-ray or other images of the valve. The valve feature detection process 136 can include a technique for segmenting the image to locate boundaries of portions of the leaflets and other anatomical structures of a valve. The valve feature detection process 136 can be configured to locate the pressure sensor 254 when a pattern in pressure data is recognized in the ventricular pressure trace. The valve feature detection process 136 can use an artificial intelligence (Al) technique to improve the accuracy of identifying one or more patterns in the pressure data generated by the pressure sensor 254 at a point of time crossing the coaptation point. These techniques can reduce the incidence of the process 136 recording an erroneous coaptation point based on data recorded during another physiological event, such as pressure fluctuation corresponding to heartbeat cycle transitions (e.g., at / related to a dicrotic notch) or an ectopic beat. The aortic root feature detection process 140 can use image processing to locate, characterize and reproduce the shape, form, and / or location of portions of an ascending aorta, including the walls of the ascending aorta, the location and shape of the sinuses of Valsalva, the location of the coronary ostium, among others.

[0042] The structural heart procedure guidance system 100 can also have a procedure guidance service 152. The procedure guidance service 152 can process inputs 124 to generate outputs 128. The procedure guidance service 152 can include a landing zone locator process 156. The landing zone locator process 156 can determine a location of a coaptation plane. The coaptation plane can be a plane containing a coaptation point that is parallel to the annulus plane, according to the present disclosure. Further the coaptation plane can refer to a line parallel to the annulus plane passing through the valve leaflet coaptation point, according to the present disclosure. The coaptation point may refer to any point determined by the passage of a pressure sensor through a heart valve, at the point where multiple valve leaflets meet or at any point along the commissure between two leaflets, according to the present disclosure. As discussed further below, the coaptation plane can be located based upon a location of a coaptation point. The landing zone can be determined basedupon any suitable methodology. For example, a cardiologist can input to the structural heart procedure guidance system 100 that the landing zone should be shown as a fixed distance from the coaptation plane in a direction away from the ascending aorta. For example, the landing zone can be between 2 and 10 mm below the coaptation plane (i.e., towards the left ventricle). The landing zone can be between 3 and 6 mm below the coaptation plane (i.e., towards the left ventricle). The landing zone can be about 3mm below the coaptation plane (i.e., towards the left ventricle). The landing zone can be about 5mm below the coaptation plane (i.e., towards the left ventricle). Alternatively, a cardiologist can input to the structural heart procedure guidance system 100 that the landing zone should be shown as a fixed distance from the annulus plane. For example, the landing zone can be between 0 and 8 mm below the annulus plane. The location of the annulus plane relative to the coaptation plane can be calculated by the structural heart procedure guidance system 100 using the process inputs 124. The landing zone can be configured to be merged with an image to overlay the image so that the anatomy and the landing zone marker are displayed simultaneously in the x-ray image user interface 108. The landing zone locator process 156 can be configured to track motion of the patient and to update the location of the landing zone to be merged with an image generated by the x- ray imaging modality.

[0043] The procedure guidance service 152 can include a coronary ostium locator process 160. The coronary ostium locator process 160 can use image processing techniques to analyze x-ray images to locate the coronary ostium. The x-ray images can be segmented and the segmentation can show the location of the coronary ostium CO. FIG. 5 shows the anatomy following a root shot where contrast K causes the anatomy to be more visible. In FIG. 5, the coronary ostium CO is shown as branching off of the ascending aorta AA. The form of the coronary ostium CO is visible by being darkened due to the contrast K flowing into the coronary ostium CO. The coronary ostium CO can be located a distance from the coaptation point and / or a distance from the aortic valve annulus plane AP. As discussed further below, the length of leaflet of the aortic valve AV can be compared to the distance from the coaptation plane to the coronary ostium CO to assess the likelihood of obstruction of the coronary ostium CO during a procedure. The structural heart procedure guidance system 100 can output various displays to guide the user in assessing this likelihood or risk. An obstruction risk estimatorprocess 164 can be included in the procedure guidance service 152 to perform this comparison and to output an obstruction risk merged image and / or indicator.

[0044] FIG. 2C is a block diagram that illustrates example components of the structural heart procedure guidance system 100. While the structural heart procedure guidance system 100 of FIG. 2C is depicted as a single device, the structural heart procedure guidance system 100 may be implemented in a server cluster, server farm, data center, mainframe, cloud computing environment, or the like. The structural heart procedure guidance system 100 can include any number of devices that operate as distributed computing resources that provides services, such as storage, computing, networking, and so on.

[0045] The structural heart procedure guidance system 100 can include a hardware processor 172, a data storage device 176, a memory device 180, a bus 192, a display or displays 184, and one or more input / output devices 188. The processor 172 can also be implemented as a combination of computing devices, e.g., a combination of a digital signal processor and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a digital signal processor, or any other such configuration. The processor 172 can be configured, among other things, to process data or to execute instructions to perform one or more functions. The data storage device 176 can include a magnetic disk, optical disk, or flash drive, etc., and may be provided and coupled to the bus 192 for storing information and instructions. The memory 180 can include one or more memory devices that store data, including without limitation, random access memory (RAM) and read-only memory (ROM). The structural heart procedure guidance system 100 may be coupled via the bus 192 to a display or displays 184, such as a LCD display or touch screen, for displaying information to a user, such as a patient. The structural heart procedure guidance system 100 may be coupled via the bus 192 to one or more input / output devices 188. The input device 188 can include, but is not limited to, a keyboard, mouse, digital pen, microphone, touch screen, gesture recognition system, voice recognition system, imaging device (which may capture eye, hand, head, or body tracking data and / or placement), gamepad, tablet, accelerometer, or gyroscope.

[0046] The structural heart procedure guidance system 100 can include one or more software engines (or services) for performing the processes and functions described herein. The software engines can include programming instructions for performing processes as discussed herein (and illustrated in flowcharts) for detection of input conditions, such as fluoroimages and pressure signals and generation of output conditions, such as a value indicative of an obstruction risk and / or locations for a marker in a merged image. The engines can be executed by the one or more hardware processors 172. The programming instructions can be stored in the data storage device 176 and / or loaded into the memory 180. The programming instructions can be implemented in C, C++, JAVA, or any other suitable programming languages. In some embodiments, some or all of the portions of the structural heart procedure guidance system 100 including the engines can be implemented in hardware processors of application specific circuitry such as ASICs and FPGAs. Some aspects of the functionality of the structural heart procedure guidance system 100 can be executed remotely on a server (not shown) over a network. Furthermore, some aspects of the functionality of the structural heart procedure guidance system 100 can be executed in one or more sensors or external devices.

[0047] The structural heart procedure guidance system 100 can be in communication with one or more pressure sensor devices as described herein, such as a pressure guidewire 204, 204A, an external pressure transducer 738 connected to a fluid-filled tubing such as a pigtail catheter 300 or a sheath 304, a prosthesis delivery system 316 instrumented with a pressure sensor 254B, an instrument 312 (for example, a catheter) instrumented with a pressure sensor 254A, or a sheath 304 instrumented with a pressure sensor 254D.

[0048] FIGS. 3A-3C provide a graphical illustration of a procedure on a heart, which can be performed with the assistance of the structural heart procedure guidance system 100. FIG. 3 A shows a heart with a portion of the ventricle wall hidden to improve visualization of the procedure. A sheath 304 is positioned in the descending (abdominal) aorta DA. Crossing of the aortic valve and access to the left ventricle is achieved using a combination of guidewires and catheters such as the access catheter or instrument 312, exchanged through the sheath 304. The pressure guidewire 204 is placed through access catheter or instrument 312, over the aortic arch and into the ventricle V through the aortic valve AV. In this position, the coil 258 is unfurled and pressure sensor 254 can be positioned in the ventricle V. The coil 258 can be unfurled by retracting the access catheter or instrument 312 over the outside of the pressure guidewire 204.

[0049] In some variations, a pigtail catheter 300 is also positioned in the ascending aorta. The pigtail catheter 300 can be connected to an external pressure transducer 738 and / orcan be used to deliver contrast to the ascending aorta A A. The pigtail catheter 300 can be pushed onto the valve leaflets, in the aortic root as a radiopaque reference for the location of the valve leaflets and annulus plane. The pigtail catheter 300 can be placed through a separate arterial access point or through the sheath 304 in a single arterial access point procedure. In some variations, the pigtail catheter 300 is not used at all.

[0050] In one such variation, a pressure sensor 254A is provided on the instrument 312, e.g., at a distal end 314 of the instrument 312. The pressure sensor 254A can enable sensing of pressure in the aorta, as discussed further below. The pressure sensor 254A can enable a method where a coaptation point is located by first sensing pressure in the aorta with the pressure sensor 254A and then advancing the pressure sensor 254A into the ventricle V to sense pressure in the ventricle and to enable a pattern to be recognized in a pressure trace as discussed further herein.

[0051] FIGS. 3B and 3C show that in a later phase of a procedure a delivery system 316 can be advanced to the ascending aorta AA and then across the aortic valve AV. The delivery system 316 can include a nose cone assembly 320 and a proximal support 324. The nose cone assembly 320 and the proximal support 324 can hold the prosthetic valve during delivery and can allow the valve to be expanded in a controlled manner. The nose cone assembly 320 can have a pressure sensor 254B coupled therewith. The pressure sensor 254B can enable a clinician to obtain pressure readings in the aorta in connection with any of the techniques discussed below. The pressure sensor 254B can enable a method where a coaptation point is located by first sensing pressure in the aorta with the pressure sensor 254B and then advancing nose cone assembly 320 and the pressure sensor 254B into the ventricle V to sense pressure in the ventricle and to enable a pattern to be recognized in a pressure trace as discussed further herein. This coaptation point verification step can be performed immediately before deploying an aortic valve prosthesis 328 such that less time for patient movements elapses between locating the coaptation point and deploying the prosthesis.

[0052] In some embodiments, the sheath 304 can be coupled with or integrated with a pressure sensor 254D, as shown in FIG. 3A. Optionally, the pressure sensor 254D can be an optical pressure sensor. The incorporation of the pressure sensor 254D with the sheath 304 can eliminate the connecting of an external pressure transducer to the sheath 304. Theincorporation of the sensor 254D with the sheath 304 can allow for continuous access to the descending aorta pressure.

[0053] FIG. 4 shows a flow diagram of an illustrative process 400 that is a computer-implemented method executed by the processor 172. Aspects of the process 400 can be executed in a processor of the imaging system 202A and / or in a processor of the diagnostic system 202B to facilitate operation of these systems, collection of data thereby, and generation of advantageous outputs to be provided to a user, such as on a user interface output display. The processor 172 can be contained in one of the imaging system 202A and the diagnostic system 202B or in a separate console connected to these systems.

[0054] The process 400 may begin in response to an event, such as when the processor 172 begins operation. When the process 400 is initiated, a set of executable program instructions stored on a storage device 176, which may be one or more non-transitory computer-readable media (e.g., flash memory, removable media, etc.) may be loaded into memory (e.g., random access memory or “RAM”) of the imaging system 202A, the diagnostic system 202B or a system of which the processor 172 is a component. The memory may be the memory 180. In some embodiments, the process 400 or portions thereof may be implemented on multiple processors or computing devices, serially or in parallel.

[0055] At block 402, the processor 172 may cause an aortographic image, sometimes called a fluoroscopy or “fluoro” image, to be obtained, recorded, or retrieved. The image can be obtained or recorded using the imaging system 202A and the c-arm 220. FIG. 5 shows an example of a fluoro image that has been obtained. To make the anatomy in the image more visible, a volume of contrast media K can be injected into the ascending aorta AA by a clinician. Upon doing so, the outline of the ascending aorta AA and the aortic valve AV are more visible. Other relevant structures can also be shown including the sinuses of Valsalva SOV, the coronary ostium CO, and location of leaflets of the aortic valve AV. Images obtained and recorded in the block 402 can be in a static two-dimensional image, a plurality of static two-dimensional images taken over time in a live video feed of images or a combination of any of the foregoing.

[0056] At block 404, the processor 172 can implement a routine by which images obtained and recorded in block 402 can be analyzed to detect the cardiovascular anatomy discussed above. The processor 172 can execute the routine to analyze and detect the walls ofthe ascending aorta, the aortic valve annulus plane, the sinuses of Valsalva, the coronary ostium CO, and other anatomy. The image analysis routine can include a step of segmenting the image obtained in the block 402. The segmentation of the image can create an array of pixels that can be analyzed to locate the relevant anatomy, including the aortic valve annulus plane position. Segmentation can be performed using U-Net architecture or another neural network approach. Other approaches that could be used include machine learning algorithms like randomForest. YOLO real time object detection also could be used for instance segmentation. In another imaging approach, distinctive points or keypoints of the relevant anatomy (e.g., the valve annulus plane) could be detected and tracked as part of generating a useful user interface, as described herein.

[0057] At a block 406, the processor 172 can sample, e.g., obtain and / or record, pressure values in a ventricle. The processor 172 can sample pressure in a ventricle by way of the pressure sensor 254 disposed in the ventricle V as illustrated in FIG. 6A. The pressure guidewire 204 is shown positioned across the aortic valve AV. Contrast K within the ascending aorta AA can make a portion of the anatomy more visible. The pressure is sensed by the pressure sensor 254 of the pressure guidewire 204. As discussed above, the pressure signals generated by the pressure sensor 254 can be high fidelity signals captured using an optical sensing device. The pressure within the ventricle V can be varying due to the beating of the heart, e g., varying in a stable manner. The ventricular pressure can be displayed as a trace as shown in FIG. 6C. The trace can vary from a peak or maximum that is typically higher than the peak aortic pressure to a minimum that is typically much lower than aortic pressure, as shown in FIG. 6C. In the event of a stenosed valve, the max trace of the ventricular pressure can be much higher than the peak aortic pressure. In the event of a leaking valve, the minimum trace of the ventricular pressure can be similar to the minimum aortic pressure.

[0058] At a block 408, the processor 172 can sample, obtain, or process pressure data from within the aorta. The pressure in the aorta can be sampled in any of several different ways. First, the pressure in the aorta could be sampled by moving the pressure sensor 254 from a position in the ventricle to a position in the aorta, as indicated by the arrow al in FIGS. 6B and 6E. Movement of the pressure sensor 254 within the ventricle V toward the ascending aorta along the arrow al can be performed without noticeable change in the pressure trace of the pressure sensor 254 until the sensor is at and then crosses over the coaptation point of theaortic valve. A pattern 610 corresponding to a change in the detected pressure and / or a change in the pressure trace displaying the detected pressure can be recognized. One example of the pattern 610 can be seen in a visual output as in FIG. 6C.

[0059] In another technique, pressure in the aorta can be sampled by a separate device. For example, the pressure sensor 254A coupled with the instrument 312 can be disposed in the aorta. Pressure signals from the pressure sensor 254A can be recorded while the distal end 314 of the instrument 312 is in the ascending aorta. The instrument 312 can be moved toward the aortic valve. The instrument 312 can be moved to the coaptation point and thereafter can cross into the ventricle V. The pattern 610 can be recognized in a reverse in this manner. The display would show the aortic and ventricular pressures as substantially the same until the instrument 312 crosses the coaptation point. At that moment, the shape of the pressure waveform would change, similar to the first four beats of FIG. 6C. That is, the pressure of the aorta can be sensed up until the pressure sensor 254A crosses the coaptation point at which time the pattern 610 can be recognized by code executed by the processor 172.

[0060] In another approach the pressure of the aorta can be sensed by the pigtail catheter 300. The pigtail catheter 300 can be moved across the coaptation point to enable recognition of the pattern 610. The aortic pressure by the pressure sensor 254A or the pigtail catheter 300 can be first sensed after the same device is used to sense the pressure in the ventricle V. For example, the instrument 312 can be moved across the coaptation point. Thereafter, the pressure in the ventricle V can be sensed, detected, and recorded. Then, the distal end 314 can be pulled proximally to the coaptation point and out of the ventricle V. The pattern 610 can then be recognized by the code executed by the processor 172. The pigtail catheter 300 can similarly be moved through the aortic valve, then ventricular pressure can be sensed, and finally the pigtail catheter 300 can be withdrawn to enable the pressure in the aorta to be sensed. The pattern 610 can then be detected by code executed by the processor 172. Sensing a change in pressure indicative of crossing the aortic plane could be achieved while pulling the pigtail catheter 300 proximally from the ventricle into the aorta. In one method, data recorded while advancing the pigtail may or may not be used given the round shape of the tip of the pigtail and the presence of holes in the tip, which could confound the data recorded when the pigtail tip is across or contacting the aortic valve. In another method, a guidewire could be used to straighten the pigtail which could improve the reliability of data recordedwhile advancing the pigtail from the aorta to the left ventricle. This approach could be used if a pressure sensor is integrated into the pigtail catheter 300, for example. The guidewire could be advanced into the pigtail tip for distal crossing (aorta to ventricle), then withdrawn during proximal crossing (ventricle to aorta). In this way changes in pressure would be more closely tied to the movement of the pigtail 300 relative to the anatomy and less impacted by the deflection of the tip of the pigtail during such movement. Whatever sensor is being used, multiple passes through the aortic valve can be performed to gather additional data of the location of coaptation points and of the coaptation plane.

[0061] The block 408 can also involve steps performed with a valve deployment system, such as the delivery system 316. The delivery system 316 can have a nose cone assembly 320 with a pressure sensor 254B disposed thereon, as discussed above. The block 408 can involve positioning the nose cone assembly 320 in the ascending aorta AA. Pressure can be sensed in the ascending aorta AA by the pressure sensor 254B. Before releasing the aortic valve prosthesis 328, the nose cone assembly 320 can be pushed to the ventricle side of the aortic valve. By monitoring the pressure traces and / or pressure data generated by the pressure sensor 254B, the pattern 610 can be recognized. The pattern 610 can be indicative of the location of the coaptation point. After the coaptation point is detected the guidance information (such as the location of a landing zone based on an offset from the coaptation point) can be provided to a cardiologist, as discussed below. The aortic valve prosthesis 328 which is held by one or both of the nose cone assembly 320 and a proximal support 324 can be released with reference to the guidance information as discussed below.

[0062] While the foregoing variants of block 408 involve moving a same pressure sensor from the ventricle V to the aorta (or vice-versa) to make the pattern 610 in a pressure signal generated by the pressure sensors 254, 254A, 254B recognizable, a pressure sensor 254C could be provided that remains within the aorta to enable calculation of a pressure gradient, e.g., a ratio of pressure in the aorta to pressure in the ventricle V. The pressure sensor 254C can be located in the aorta while the pressure sensor 254 is located in the ventricle, as in FIG. 6D. This allows simultaneous measurement of pressure by the pressure guidewire 204A. In another technique, the pressure in the aorta can be sampled by the pigtail catheter 300 disposed in the aorta while the pressure sensor 254 (or another pressure sensor disclosed herein) is disposed in the ventricle, as shown in FIG. 3A and 3B. In this approach the pigtail catheter300 can be left in the aorta while the pressure guidewire 204 moves back across the coaptation point. In another technique, the pressure in the aorta can be sampled by a pressure sensor 254A coupled with a distal end 314 of an instrument 312 as shown in FIG. 3A. In this approach the pressure sensor 254A can be left in the aorta while the pressure sensor 254 moves back across the coaptation point. These techniques can allow a pressure gradient to be displayed and a pattern in the pressure gradient can be recognized that indicates a crossing of the coaptation point.

[0063] In some cases, for a particular patient or anatomy, the measured aortic pressure gradient may vary with the distance between the pressure sensor in the ventricle and the aortic valve. In such cases the pressure can decrease when the sensor is moved closer to the aortic valve, e.g., within the left ventricular outflow tract (LVOT). That is, there can be a pressure gradient sensed within the ventricle before the pressure sensor reaches and crosses the aortic valve. This pressure gradient may be referred to as a sub-valvular pressure gradient. This can be explained by a sub-valvular flow restriction that is caused by a narrow LVOT, for example. In some cases, it is important to distinguish between the component of the pressure gradient caused by an aortic valve (e g., a malfunctioning aortic valve) and the component caused by a narrow sub-valvular anatomy or LVOT obstruction. The presence of such subvalvular pressure gradient may warrant different intervention or precautions during the procedure. Detecting a sub-valvular pressure gradient can also explain poorer hemodynamics results than expected after a successful valve replacement. While moving the pressure sensor from the ventricle V to the aorta, two components of the pressure gradient (e g., along the LVOT and at the point of crossing the aortic valve) may be separately calculated and displayed separately on the user interface. The total pressure gradient could also be displayed with an additional display of a sub-valvular gradient component. A user interface can display total pressure gradient, sub-valvular gradient component and aortic valve crossing pressure gradient component. Analogous gradients can be calculated in connection with crossing any heart valve on the left or right side, e.g., the mitral valve, the tricuspid valve, and / or the pulmonary valve. Any such gradients that are determined could be indicated by a user interface similar to those of FIG. 8A-8C, such as by providing a line, pointer marking, shading, color-coding or other visual cue as to the location and extent of such a gradient.

[0064] In some cases, for a particular patient or anatomy, the measured aortic pressure gradient may vary with the distance between the pressure sensor in the aorta and the aortic valve, the pressure gradient decreasing when the aortic sensor is moved farther from the aortic valve. This can be explained by the pressure recovery effect above the aortic valve. Depending on the geometry of the aortic valve and the sinus of valsalva, kinetic energy in secondary blood flow patterns near the aortic valve (recirculation zones, lateral flow, turbulence, etc.) may be recovered into pressure, in the main blood flow higher in the aorta, farther from the aortic valve. In those cases, the valve gradient with aortic pressure measured higher in the ascending aorta, at a location where the pressure has recovered, is representative of the real, total pressure loss caused by the aortic valve, or the true recovered valve gradient. The presence of such pressure recovery effect can explain poorer hemodynamics results than expected after a successful valve replacement and may change diagnosis. The user could be instructed to move the pressure sensor in the aorta from a position close the annulus plane to a position farther away from the valve in the ascending aorta. For example, the user can move the pressure sensor to a position about 1 cm to about 15 cm above the aortic valve, about halfway up the ascending aorta, or into the aortic arch. The pressure recovery component of the pressure gradient may be separately calculated and displayed separately on the user interface. The total pressure gradient could also be displayed with an additional display of a pressure recovery effect gradient component. In some cases, total pressure gradient, the pressure recovery component, and the pressure gradient as measured close to the annulus plane can be displayed. In some instances, the user can pull back until the pressure sensor is in the aortic arch. During and / or after the pullback to the aortic arch, the software can be used to detect when and / or where the pressure gradient stabilizes. Analogous pressure recovery components can be quantified on the downstream side of any heart valve, e g., tricuspid, pulmonary or mitral valve. Any such pressure recovery gradients, components or effects that are determined could be indicated by a user interface similar to those of FIG. 8A-8C, such as by providing a line, pointer marking, shading, color-coding or other visual cue as to the location and extent of such a pressure recovery gradient, component or effect.

[0065] Any of these approaches for sampling pressure in the aorta can include or be preceded by a process for equalizing pressure signals generated by the pressure sensor 254with pressure signals generated by a pressure sensor in the aorta. Techniques for equalizing are discussed in connection with FIGS. 7A-7E.

[0066] At block 410, the processor 172 can detect a position in an image of the pressure sensor 254 at the time of an occurrence of the pattern 610 in pressure sensed by the pressure sensor as the sensor crosses the coaptation plane. FIGS. 1 and 6C show that the pattern 610 can be detected by the signal from the pressure sensor 254 changing waveform shape for a portion of the heartbeat cycle to following or nearly following the aortic pressure trace throughout the heartbeat cycle. As shown in FIG. 6C, the first four beats show two pressure signals having significantly different waveform shapes. In the fifth beat, the pressure signal from the sensor that had been in the ventricle follows the aortic pressure sensor pressure trace. Because the processor 172 has access to images over time as the pressure sensor 254 moves, the image corresponding to the fifth beat when the pressure signal from the pressure sensor 254 and the aortic pressure sensor are substantially the same can be determined. The location of the pressure sensor 254 can be stored as one point along the coaptation point. In various embodiments, the pressure sensor 254, 254A, 254B, 254C can be configured to be radiopaque, e.g., formed with or of metal or other material that provides high contrast in an x- ray image. This facilitates program instructions executed by the processor 172 to detect the location of the sensor. For example, the image can be segmented. In doing so, pixels corresponding to the body of a housing of the sensor and the edges thereof can be assigned. The location of the pixels can be mapped to the image to provide a location for the coaptation point of the aortic valve leaflets.

[0067] The foregoing describes locating one coaptation point of the heart valve. The process described above can be repeated one or more times to provide a second coaptation point or additional coaptation points. FIG. 6E shows that following moving the portion of the pressure guidewire 204 with the pressure sensor 254 between the ventricle and the aorta through the aortic valve AV as indicated by the arrows al, a2 and a3, the position of the guidewire within the aortic valve may vary, e.g. may be more peripheral or radial along lines of coaptation between the leaflets of the valve, as shown by arrows al and a3. This is due at least in part to the stiffness of the distal portions of the guidewire 204 and the interaction thereof with the tissue of the heart and aorta. The position of the pressure sensor 254 when the pattern 610 is recognized from the fluoroscopic image taken at the same moment of the pattern610. The coaptation point presented to the user can be corrected if the wire is off-center when the pattern 610 is detected, e.g., if the wire is being advanced through the valve and as a result is more peripheral in a valve line of coaptation. Note that FIG. 6E is a simplified representation of the aortic valve AV and the shape of the valve is more accurately depicted in FIG. 5, where the leaflets curve distally from the valve annulus to the point of coaptation (where the three leaflets meet). The curvature of the leaflets can be estimated to provide for correction of the detected point of coaptation and an actual point of coaptation calculated based on the degree to which the wire is off-center (detected from the fluoroscopic image) and the curvature of the leaflet (measured or estimated from imaging of the patient, a population average or otherwise). In some techniques two or three points can be sampled. The coaptation points samples may be used to either determine a 2D coaptation plane, 3D coaptation plane, or processed (e.g., averaged or a proximal-most location chosen) to calculate a likely coaptation point, which in turn can allow for updating the location of the reference makers (e.g. the annulus plane or the landing zone plane). In some techniques more than three points can be sampled. Program instructions executed by the processor 172 can determine if one or more points are outliers and may be based on a spurious change in the pressure signal or based on the centering of the guidewire. If four coaptation points are sampled, the three coaptation points that form a plane most likely to correspond to the coaptation plane can be the basis for determining the coaptation plane. If five coaptation points are sampled, the three coaptation points that form a plane most likely to correspond to the coaptation plane can be the basis for determining the coaptation plane. Any number of coaptation points can be sampled.

[0068] Guidewires can have varying stiffness along their length. Locating or positioning the pressure sensor 254 on a portion of the guidewire with a higher flexibility may result in the guidewire being able to center itself within the valve when the portion with the higher flexibility is positioned at (e.g., pulled or pushed to) the level of the valve (e.g., moved toward where the three leaflets come closest together (point of coaptation), as indicated by arrow a2).

[0069] At block 412, the processor 172 can obtain a vector or distance indicating the offset between the coaptation plane and the aortic valve annulus plane. The offset can be a variable stored in memory, e.g., in the storage device 176. The offset can be a patient specific variable that is obtained by a pre-operative diagnostic step. The offset can be calculated byfirst performing a CT scan of the patient and analyzing the imaging from that modality to calculate the distance, for the particular patient, between the coaptation plane and the aortic valve annulus plane. In some variations, the offset can be based on a relevant population, e.g., the average offset for adult of the same gender, overall body size, or relevant cardiac anatomy dimension. In some instances, the offset can be based, at least in part, by the valve circumference. The valve circumference can be provided by a CT scan or from a contrast angio.

[0070] At block 414, the processor 172 can determine or update the aortic valve annulus plane position. The aortic valve annulus plane position can be determined by adding the offset determined in block 412 to the position of the coaptation plane based on locating one or more coaptation points as at block 410. In some embodiments, the aortic valve annulus plane position can be determined or updated without the use of a pressure signal. For example, the aortic valve annulus plane position can be determined or updated based on the use of angio images or the aortic valve annulus plane position can be determined or updated based on the use of subsequent contrast injections during the procedure.

[0071] At block 416, the processor 172 can merge a marker with an aortographic or fluoro image. The marker can be merged by overlaying the marker onto the image. FIG. 6A shows that two arrows can be placed at the edge of the anatomy at the location of the aortic valve annulus plane AP. The two arrows are just one non-limiting example of a marker. Any type of visual, audio, or other indication can be used as a marker. The arrows point to each other and provide an adjacent indicator to the cardiologist of the location of the aortic valve annulus plane AP. The arrows are positioned outside the valve space so that they do not obstruct the view of valve for the cardiologist. The image onto which the marker is merged can be the most recent image obtained by or available to the processor 172. The image can be the latest frame of a live feed x-ray image.

[0072] At block 418, the processor 172 can output the merged marker and image to one or more display(s) 184. In some embodiments, the processor 172 can output the merged marker and image prior to or independently of obtaining pressure values at block 406. For example, the processor 172 can output the merged marker and image to the pressure data user interface 112A, to the x-ray image user interface 108 A, or to the x-ray image user interface 108 of the display 104. If the processor 172 outputs the merged marker and image to the pressure data user interface 112A, the screen could switch from a mode of displaying pressuretraces (as shown in FIG. 2A) to a screen including merged x-ray images. Advantageously, pressure traces and x-ray images can be displayed on the display 104 at the same time.

[0073] FIGS. 8A and 8B show additional displays and markers that can be merged into a fluoro image. FIG. 8A shows that the block 418 can result in a display that includes not only the arrows indicating the aortic valve annulus plane AP being applied to the margin of the aortic valve, but also shows a landing zone LZ. The landing zone LZ can be a second line that is not indicative of specific anatomy so much as it is indicating a location to place the aortic valve prosthesis 328. The processor 172 can calculate the position of the landing zone LZ relative to anatomy determined by the process 400, e.g., 0-8 mm from the aortic valve annulus plane AP. FIG. 8A shows that the merged image can include peripheral arrows (or other marks) indicating the location of the aortic valve annulus plane AP and the landing zone LZ line spaced distal thereto. FIG. 8B shows that in some configurations it can be preferable for the marker of the aortic valve annulus plane AP to be overlaid within the valve space. The marker can include a first line at the aortic valve annulus plane AP and a second line at the landing zone LZ. Other markings can be used that are more or less obstructive of the view of the aortic valve anatomy.

[0074] Providing a single merged image displaying clinically relevant guidance overlaid onto a fluoro image can provide significant clinical value. Additionally, it may be further useful to update this image over time. At block 420, the processor 172 employs a process for updating the merged image. In one approach, the processor 172 executes program instructions that detects the location of a feature that is present in a fluoro image, such as a high contrast background feature. One example of a high contrast background feature is a calcification within the fluoro image. A calcification can be found on or around an aortic valve leaflet. In one approach, the processor 172 executes code that segments images and locates a calcification. By comparing the position of a detectable calcification in an initial image, such as may be used to form the merged image in block 416, with a new image obtained after the block 416, the marker can be merged onto the new image in a corrected position. In this way, even if there is movement of the patient, of the tissue within the fluoro image or of both, the display can show the marker in the proper location. At block 422, the processor 172 updates the marker position for movement. At block 424 the processor 172 merges the marker updated for position corresponding to movement with the new fluoro image.

[0075] At block 426, the processor 172 outputs the merged image to the display(s) 184, e.g., to the pressure data user interface 112A, to the x-ray image user interface 108A, or to the x-ray image user interface 108 of the display 104. If the processor 172 outputs the updated merged marker and image to the pressure data user interface 112A, the screen could be instructed to switch from a mode of displaying pressure traces (as shown in FIG. 2A) to a screen including x-ray images, as discussed above. The merged marker and image can be continuously visible to a user and automatically updated as the marker is updated relative to movement of the anatomy. FIG. 8C illustrates the updating in that the dashed arrows were indicative of the location of the aortic valve annulus plane AP at time T-l and the solid arrows are indicative of the aortic valve annulus plane AP at time TO, where T-l is one or more frames earlier in time than at time TO. The dashed arrows may not be displayed to a user but are shown to illustrate the shifting of the markers as needed to update the displayed image. FIG. 4 shows that blocks 420 - 426 can be repeated periodically to provide second and subsequent updated images, e.g., to provide “real time” updates. The repeating of these blocks can be fast enough to cause the merged image to be displayed on a live video feed or stream.

[0076] FIG. 7A illustrates a process 700 by which the pressure guidewire 204 can be prepared for and used during a single-access TAVR procedure. A block 702 is a first or early step of the process 700 in which the pressure guidewire 204 is zeroed to the atmospheric pressure and flushed prior to insertion in the body. In the block 702, an external transducer 738 is also zeroed to the atmospheric pressure. In a block 704 the pressure guidewire 204 is advanced into the left ventricle V. At a block 706 the external transducer 738 is connected to the sheath 304 extending to the descending aorta and flushed such that pressure in the fluid column can be detected. In prior procedures, the transducer 738 would be connected to the pigtail catheter 300 passing through a second vascular access and extending to the ascending aorta. In a single-access procedure, the transducer 738 is instead connected to the sheath 304 to allow aortic pressure measurement. The difference of pressure between the ascending and descending aorta needs to be compensated with the equalization processes of blocks 714 and 718 described below. This allows real-time measurement of the aortic valve gradient in a single-access scenario. At block 708, the process 700 determines whether a pre-procedure pressure measurement is to be made. If not, at block 710, the cardiologist may connect an external pacemaker to the pressure guidewire 204 to induce rapid pacing of the heart. Block710 is optional. The connection can be made through the pacing connection portion 262 of the pressure guidewire 204 as discussed above. The rapid pacing facilitates valve replacement procedures (TAVR), balloon aortic valvuloplasty procedure (BAV) or Valve-in-Valve procedure (ViV), which can be performed in block 712. As the activities in block 712 are being performed, the processor 172 can cause a merged display output to be provided pursuant to the process 400, discussed above. In a block 714, the processor 172 or a processor of the diagnostic system 202B can cause the pressure sensed by the pressure sensor 254 to be equalized with another sensor within the aorta. For example, as illustrated in FIGS. 7D-7E, the pressure sensor 254 can be pulled back into the ascending aorta and the pressure can be equalized with the pressure as measured in by the external transducer 738 in the descending aorta 742, e.g., at the tip of the sheath 304 such as by detecting pressure in a fluid column. In a block 716, the process can proceed to advancing the pressure sensor 254 back into the ventricle V as shown in FIG. 7E. Once positioned in the ventricle V, the pressures measured in the ventricle V and in the aorta can be compared to provide an assessment of the hemodynamics (pressure gradient, etc.) of the valve implanted pursuant to block 712.

[0077] If in the process 700 the hemodynamics are to be measured prior to and after the procedure, then block 718 provides for equalizing the pressure sensor 254 with an aortic pressure sensor. FIGS. 7B and 7C show this block in more detail. The pressure sensor 254 is pulled back into the aorta as shown in FIG. 7B. The pressures output by the pressure sensor 254 and the external transducer 738 are compared and equalized. At block 720, the pressure sensor 254 is then moved back into the ventricle V and pressure can be sensed. As shown in FIG. 7C, a comparison of the pressure traces in the ventricle V and in the aorta can be provided in an output display. After pre-procedure hemodynamics are recorded, at block 722, the cardiologist subjects the patient to rapid pacing. The pacing can be through the pacing connection portion 262 as discussed above. Block 722 is optional. In some embodiments, rapid pacing can be performed along with contrast injection during the rapid pacing to help identify an updated position of the coaptation plane. In some embodiments, an update position of the coaptation plane can be determined solely on a subsequent contrast injection performed during the procedure. At block 724, the intervention is performed. Rapid pacing may continue at block 724 to facilitate accurate placement of the valve. As the activities at block 724 are being performed, the processor 172 can cause a merged display output to be provided pursuantto the process 400, discussed above. Once the aortic valve prosthesis 328 has been placed or other intervention has been made, at block 726, a post-procedure measurement of hemodynamics can be performed by the structural heart procedure guidance system 100. The post-procedure measurement can be performed by comparing the pressures output by the pressure guidewire 204 to a pressure detected in the aorta, e.g., by the external transducer 738 as shown in FIG. 7E. In embodiments, where the pressure read by the external transducer 738 has been previously equalized to the pressure in the ascending aorta in block 718, the pressure level of the external transducer 738 will be representative of the pressure in the ascending aorta and an accurate aortic valve gradient may be calculated. The steps performed at block 726 can also include another equalization as illustrated in FIG. 7D, as described above.

[0078] FIGS. 9A-9E illustrate additional methods that can be performed with the structural heart procedure guidance system 100 in a process 900. The process 900 can commence by the processor 172 executing program instructions. At block 902, the processor 172 can obtain an aortographic, e.g., a fluoro, image of the patient. The image can be created by the imaging system 202A, e.g., using the c-arm 220. At block 904, the processor 172 executes instructions to detect features in the anatomy, such as one or more coronary ostium CO and sinuses of Valsalva SOV. These features can be detected by segmenting the image and by analyzing the intensity of the pixels in the segmented image. At block 906, the processor 172 executes instructions to obtain data or records related to the coronary ostium, the sinuses of Valsalva SOV, and valve leaflet geometry. The block 906 can involve accessing records in the memory 180 / data storage device 176. The records in the memory 180 / data storage device 176 can be saved from a pre-procedural diagnostic test, such as a CT scan. The images in a CT scan can be analyzed to measure locations, sizes, and dimensions of one or more of these or other anatomical features of relevance. At block 908, the processor 172 can execute instructions to sample pressures in a ventricle. In this step the pressure guidewire 204 can be positioned such that the pressure sensor 254 is within the ventricle V such that high fidelity signals generated thereby are transferred to the processor 172 or a processor of the diagnostic system 202B for processing. At block 910, the processor 172 can sample pressures in the aorta of the patient. The pressures can be sensed in any of the manners discussed above, including moving the pressure sensor 254 from the ventricle V to the aorta. The pressures can be sensed by placing the pressure sensor 254A, the pressure sensor 254B or the pressure sensor254C in the aorta. The pressures can be sensed by placing the pigtail catheter 300 in the aorta. In a block 912, the processor 172 executes instructions to determine the coaptation point of the aortic valve. The processor 172 can determine a time when the pattern 610 is recognized in the pressure data or trace generated by or from the signals from the pressure sensor 254. The structural heart procedure guidance system 100 can determine a point of coaptation or one or more points at or adjacent to a leaflet commissure which can locate the valve annulus and / or be used to determine the point of coaptation of the valve. This can involve multiple passes through the aortic valve, as discussed above. At block 914, the processor 172 executes instructions to determine a leaflet obstruction prediction parameter. The leaflet obstruction prediction parameter can be a variable that predicts how likely it is that performing a procedure with the aortic valve prosthesis 328 will result in blocking the coronary ostium CO. The processor 172 can determine a leaflet obstruction prediction based on the leaflet obstruction prediction parameter. At block 916, the processor 172 can output the valve leaflet obstruction prediction to the display(s) 184.

[0079] FIGS. 9B-9E illustrate how the processor 172 can calculate the leaflet obstruction prediction parameter and how the procedure can be performed based on the leaflet obstruction prediction parameter. FIG. 9B shows a diagram of the aortic valve and environs. The aortic valve may be a native aortic valve in the context of a standard valve replacement procedure (TAVR), or a previously implanted valve prosthesis, in the context of a Valve-in- Valve procedure (ViV). The aortic valve includes leaflets L that open and close with each heartbeat cycle. The leaflets L extend from bases that are located at the aortic valve annulus plane AP. When the heart is in diastole the leaflets of an aortic valve touch each other at the free edges thereof when the valve is closed, a state called coaptation. The location where the leaflets touch is called the coaptation point and a plane including points of coaptation is labeled coaptation plane CP. The leaflets L move within a region of the ascending aorta AA called the sinuses of Valsalva SOV, which is the portion from which the aorta extends away from the heart. A coronary ostium CO branches from the ascending aorta AA at or just above the sinuses of Valsalva SOV. It is desirable to avoid blocking the coronary ostium CO with any valve leaflet when the aortic valve prosthesis 328 is deployed.

[0080] Some anatomical features of the heart can be measured pre-procedurally. For example, the location of the aortic valve annulus plane AP may be detectable in a CT scan.The location of the coronary ostium CO, e.g., the distance from aortic valve annulus plane AP to the coronary ostium CO (labeled “a” in FIG. 9B) may be measurable in a CT scan. The length of the leaflets L may be measurable in a CT scan. The location of the coaptation plane CP can be detected by the methods described herein. If the length of the leaflet L exceeds the “a” dimension there is a likelihood that the coronary ostium CO will be obstructed. In some embodiments, the distance between the annulus plane AP and the coaptation plane CP can correlate with a leaflet length. For example, the distance between the annulus plane AP and the coaptation plane CP can be used to confirm the actual leaflet length. Using the distance between the annulus plane AP and the coaptation plane CP with the distance a can help predict a coronary obstruction. Accordingly, the cardiologist can change strategy for deploying the aortic valve prosthesis 328, e g., by placing it more distally, choosing a different valve size or valve design, and / or orienting the valve to reduce the obstruction risk. The length of the leaflet L, the distance from the aortic valve annulus plane AP to the coronary ostium CO, and the distance between the annulus plane AP and the coaptation plane CP can also be obtained during a pre-procedural planning exam using either pressure guidewire 204 or instrumented catheter 312, along with imaging during contrast injection. An analysis of a CT scan may also be used to obtain the length of the leaflet L and / or the distance from the aortic valve annulus plane AP to the coronary ostium CO.

[0081] FIG. 9C provides an example of a display that may provide guidance to a cardiologist. A merged image including a frame of a fluoro image or video stream may be augmented with marker M showing a landing zone for a procedure. The display may include an overlay of the leaflets L illustrating the proximity of the leaflet L to the coronary ostium CO. By this, the cardiologist can adjust the placement of the aortic valve prosthesis 328, such as by moving the valve distally by an acceptable amount relative to the marker M (landing zone). The display may include other markers signifying obstruction risk, such as a color of red (obstruction likely), yellow (obstruction possible), and green (obstruction unlikely). The display may include a percentage value indicative of obstruction risk, based on statistical studies for predicting the same.

[0082] FIGS. 9D and 9E show additional ways to present guidance to a cardiologist by merging markings with an underlying fluoro image. FIG. 9D shows a situation in which a marker for a prosthetic valve PV is displayed over or merged with the fluoro image. The imageal so shows the marker M which may correspond to a landing zone for the prosthetic valve PV. The prosthetic valve PV is shown properly aligned with the marker M. The leaflet L is shown to be disposed between the prosthetic valve PV and the coronary ostium CO, which shows a likelihood of the leaflet L blocking the coronary ostium CO. In contrast, FIG. 9E shows a procedure for placing the prosthetic valve PV. The marker for the prosthetic valve PV shows how the valve would be deployed if properly aligned with the marker M. The markings show that the leaflet L is not between the prosthetic valve PV and the coronary ostium CO. The coronary ostium CO is unobstructed by the prosthetic valve PV.

[0083] FIG. 10 shows a process 1000 that can be performed by the processor 172 executing instructions. At block 1002, the processor 172 executes instructions to obtain or causes to be obtained an aortographic image, e.g., a fluoro image. At block 1004, the processor 172 executes instructions to detect one or more of the coronary ostium CO, sinuses of Valsalva SOV and other relevant aortic anatomies. At block 1006, the processor 172 executes instructions to obtain anatomical data for the coronary ostium CO, the valve leaflet geometry, and other relevant anatomical variables. The block 1006 retrieves data that can be generated and saved pre-procedurally, e.g., using a CT image scanner. At block 1008, the processor 172 executes instructions to determine a location of a plane corresponding to the coronary ostium CO. The processor 172 executes instructions to generate a marker configured to illustrate the coronary ostium CO plane location. The process 1000 can also, or alternatively, include generating markers such as those shown in and described with reference to FIGS. 9C-E. For example, a marker showing a landing zone and a marker for a prosthetic valve PV. At block 1010, the processor 172 executes instructions to merge a marker with the aortographic image. At block 1012, the processor 172 executes instructions to output the merged image to a display such as the display(s) 184, the display 104 or any other monitor or display as discussed herein. At block 1014, the processor 172 executes instructions to detect a background feature (e.g., a calcification of a leaflet portion or other anatomy) in the aortographic image. At block 1016, the processor 172 executes instructions to update the coronary ostium marker for movement of the background feature detected by the processor. The processor 172 can compare the position of the background feature in a new image relative to the image obtained at the block 1002. At block 1018, the processor 172 executes instructions to update the merged aortography image to include the image and the marker of the coronary ostium CO. At block1020, the processor 172 executes instructions to output the updated merged image to the display(s) 184, the display 104 or any other monitor or display as discussed herein.Terminology

[0084] As used herein, the relative terms “proximal” and “distal” are used to describe locations relative to the user and the patient. The term “proximal” refers to being nearer towards the user. Conversely, the term “distal” refers to being farther towards or into the patient.

[0085] As used herein, the relative terms “upstream” and “downstream” shall be defined from the perspective of blood flow. Thus, downstream refers to the direction toward the aorta relative to the left ventricle.

[0086] Conditional language, such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, and / or steps. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way required for one or more embodiments.

[0087] The terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list.

[0088] The terms “approximately,” “about,” “generally,” and “substantially” as used herein represent an amount close to the stated amount that still performs a desired function or achieves a desired result. For example, the terms “approximately,” “about,” “generally,” and “substantially” may refer to an amount that is within less than 5% of the stated amount, as the context may dictate.

[0089] The ranges disclosed herein also encompass any and all overlap, sub-ranges, and combinations thereof. Language such as “up to,” “at least,” “greater than,” “less than,” “between” and the like includes the number recited. Numbers preceded by a term such as“about” or “approximately” include the recited numbers. For example, “about four” includes “four.”

[0090] Any methods disclosed herein need not be performed in the order recited. The methods disclosed herein include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication. For example, actions such as “distally moving a locking element” include “instructing distal movement of the locking element.”

[0091] Although certain embodiments and examples have been described herein, it will be understood by those skilled in the art that many aspects of the humeral assemblies shown and described in the present disclosure may be differently combined and / or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or indispensable.

[0092] Some embodiments have been described in connection with the accompanying drawings. However, it should be understood that the figures are not drawn to scale. Distances, angles, etc. are merely illustrative and do not necessarily bear an exact relationship to actual dimensions and layout of the devices illustrated. Components can be added, removed, and / or rearranged. Further, the disclosure herein of any particular feature, aspect, method, property, characteristic, quality, attribute, element, or the like in connection with various embodiments can be used in all other embodiments set forth herein. Additionally, it will be recognized that any methods described herein may be practiced using any device suitable for performing the recited steps.

[0093] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. It is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, those skilled in the art will recognize that the disclosure may be embodied or carried out in a manner that achieves one advantage or a group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0094] Moreover, while illustrative embodiments have been described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions,combinations (e.g., of aspects across various embodiments), adaptations and / or alterations as would be appreciated by those in the art based on the present disclosure. The limitations in the claims are to be interpreted broadly based on the language employed in the claims and not limited to the examples described in the present specification or during the prosecution of the application, which examples are to be construed as non-exclusive. Further, the actions of the disclosed processes and methods may be modified in any manner, including by reordering actions and / or inserting additional actions and / or deleting actions. It is intended, therefore, that the specification and examples be considered as illustrative only, with a true scope and spirit being indicated by the claims and their full scope of equivalents.

Claims

WHAT IS CLAIMED IS:

1. A method for performing a transcatheter procedure on a valve of a heart, comprising:[a] advancing a catheter from an access point of a patient;[b] injecting a contrast agent into a cardiovascular region;[c] generating first two dimensional image data of the cardiovascular region while the contrast agent is present in the cardiovascular region;[d] positioning a pressure sensing device in a selected portion of the cardiovascular region;[e] generating second two dimensional image data of the cardiovascular region of the patient when a pressure signal of the pressure sensing device indicates that the pressure sensing device is positioned in the selected portion of the cardiovascular region;[f] determining a location of a device positioning feature based at least in part on pressure signals obtained from the pressure sensing device;[g] merging a marker indicating the determined location with a third two dimensional image data taken subsequent to the second two dimensional image data to create a merged image configured to guide a valve procedure; and[h] displaying the merged image on a user interface.

2. The method of Claim 1, wherein the valve is an aortic valve.

3. The method of Claim 1, wherein the marker is indicative of a location of a portion of a valve leaflet at a selected point of a heartbeat cycle.

4. The method of Claim 3, wherein the marker is indicative of the location of the valve leaflet at an onset of diastole.

5. The method of Claim 1, wherein the marker is indicative of a location of a valve annulus plane.

6. The method of Claim 1, further comprising repeating [d] to [h] to update the user interface over time.

7. The method of Claim 6, further comprising comparing a position of a background image feature in at least one of the first two dimensional image data and the second two dimensional image data to a position of the background image feature in the third twodimensional image data and correcting for movement of the background image feature in performing one or more of [f , [g], and [h],8. The method of Claim 7, wherein comparing the position of the background image feature comprises performing optical flow analysis.

9. The method of Claim 1, wherein the third two dimensional image data comprises a frame of a live video feed.

10. The method of Claim 1, further comprising deploying a prosthetic heart valve with reference to the marker.

11. The method of Claim 10, further comprising injecting a contrast agent into the cardiovascular region to confirm appropriate positioning of the prosthetic heart valve.

12. The method of Claim 10, further comprising injecting a contrast agent into the cardiovascular region to confirm proper functioning of the prosthetic heart valve.

13. The method of Claim 10, further comprising injecting a contrast agent into the cardiovascular region to assess a level of paravalvular leakage.

14. The method of Claim 10, further comprising assessing paravalvular leakage using signals generated by the pressure sensing device.

15. The method of Claim 1, wherein the device positioning feature comprises a valve landing zone and determining the location of the device positioning feature comprises determining the location of the valve landing zone.

16. The method of Claim 15, wherein determining the location of a valve landing zone comprises providing an offset between a valve annulus plane of the valve and the valve landing zone.

17. The method of Claim 1, wherein determining the location of a valve landing zone comprises providing an offset between a coaptation plane or coaptation point of the valve and the valve landing zone and.

18. The method of Claim 1, wherein determining the location of the device positioning feature comprises segmenting the first two dimensional image data to locate a valve annulus plane.

19. The method of Claim 1, wherein the marker comprises a line or arrow aligned with one or more edges of an annulus plane.

20. The method of Claim 19, wherein merging the marker indicating the determined location with the third two dimensional image data to create the merged image further comprises positioning the line or arrow peripherally of a valve structure in the third two dimensional image data.

21. The method of Claim 19, wherein the line or arrow is a first line or arrow and wherein the marker further comprises a second line or arrow offset from the first line or arrow, the second line or arrow displaying a landing zone recommended for placement of a valve.

22. The method of Claim 1, further comprising moving the pressure sensing device between a position in a left ventricle and a position in an aorta and wherein determining a location of a device positioning feature based at least in part on pressure signals from the pressure sensing device further comprises comparing a pressure reading of the pressure sensing device at a current time with a pressure reading at a prior time while moving the pressure sensing device from within the left ventricle to within the aorta.

23. The method of Claim 22, wherein the pressure sensing device comprises a first sensor and wherein comparing the pressure reading of the pressure sensing device comprises comparing a first pressure reading from the first sensor with a second pressure reading from a second pressure sensor positioned in the aorta.

24. The method of Claim 1, further comprising moving the pressure sensing device into an aortic arch and wherein determining a location of a device positioning feature based at least in part on pressure signals from the pressure sensing device further comprises comparing a pressure reading of the pressure sensing device at a current time with a pressure reading at a prior time while moving the pressure sensing device within the aortic arch.

25. The method of Claim 1, further comprising moving the pressure sensing device across a coaptation point and identifying a pattern in a pressure gradient indicating a crossing of the coaptation point.

26. The method of Claim 1, wherein the pressure sensing device is positioned in a ventricle and further comprising moving the pressure sensing device towards the valve and sensing a pressure gradient within the ventricle before the pressure sensing device reaches and crosses the valve.

27. The method of Claim 26, further comprising separately calculating a first component of the pressure gradient in the ventricle and a second component of the pressure gradient at a point of crossing the valve.

28. The method of Claim 1, wherein the pressure sensing device comprises a radiopaque structure and determining the location of the device positioning feature is based at least in part on identifying the location of the radiopaque structure in the second two dimensional image data.

29. The method of Claim 1, wherein the pressure sensing device comprises a first sensor capable of being moved between a position in a left ventricle and a position in an aorta and further comprising calculating a pressure gradient between a pressure reading of a second sensor disposed in an artery and a pressure reading of the first sensor.

30. The method of Claim 29, further comprising positioning the first sensor adjacent to the second sensor and equalizing pressure signals detected by the first sensor and the second sensor.

31. The method of Claim 29, further comprising positioning the first sensor in a first position in the aorta and positioning the second sensor in a second position in the aorta and equalizing pressure signals detected by the first sensor and the second sensor.

32. The method of Claim 31, wherein the first position is in an ascending aorta and the second position is in a descending aorta.

33. The method of Claim 29, wherein the second sensor is coupled with a prosthesis delivery catheter.

34. The method of Claim 33, wherein the second sensor is coupled with a nose cone of the prosthesis delivery catheter.

35. The method of Claim 29, wherein the second sensor comprises a fluid column, a body of the pressure sensing device extending along or within the fluid column.

36. The method of Claim 29, further comprising sliding a body enclosing a fluid column within an ascending aorta toward the heart to generate an aortic pressure signal.

37. The method of Claim 29, wherein the first sensor and the second sensor are fixed to a same elongate body of the pressure sensing device.

38. The method of Claim 29, wherein the pressure sensing device comprises a diagnostic or a guide catheter having a pressure sensor coupled thereto and whereindetermining the location of the device positioning feature based at least in part on pressure signals from the pressure sensing device comprises determining such location based upon signals from the pressure sensor while moving the pressure sensor of the diagnostic or the guide catheter toward or across a valve annulus plane a plurality of times to map the location and / or form of the valve annulus plane.

39. The method of Claim 1, further comprising implanting a transcatheter aortic valve prosthesis, wherein a single arterial or venous access can be used to perform the method.

40. The method of Claim 1, wherein determining a location of a device positioning feature based at least in part on pressure signals from the pressure sensing device further comprises recognizing a pattern in pressure data from the pressure sensing device while moving the pressure sensing device from within a ventricle to within an aorta and / or from within the aorta to within the ventricle.

41. The method of Claim 1 , further comprising comparing ventricular pressure data to aortic pressure data comprises calculating a valve gradient.

42. The method of Claim 1, further comprising comparing a first pressure signal obtained at a first location adjacent to the heart valve and within a blood vessel directly connected to the heart with a second pressure signal obtained at a second location spaced downstream of the first location and outputting an indication of a pressure recovery gradient effect within the blood vessel directly connected to the heart based on the comparing.

43. The method of Claim 42, further comprising outputting one or more of an indication of total pressure gradient and an indication of valve gradient along with the indication of pressure recovery gradient effect.

44. The method of Claim 1, further comprising comparing a first pressure signal obtained at a first location within a ventricular outflow tract with a second pressure signal obtained at a second location spaced between the first location and the valve regulating flow between the ventricular outflow tract and a blood vessel outside the heart and outputting an indication of a sub-valvular pressure gradient within the ventricular outflow tract based on the comparing.

45. The method of Claim 44, further comprising outputting one or more of an indication of total pressure gradient and an indication of valve gradient along with the indication of sub-valvular pressure gradient.

46. The method of Claim 1 , further comprising comparing ventricular pressure data to aortic pressure data comprises calculating a regurgitation index.

47. The method of Claim 1, wherein determining a location of a device positioning feature based at least in part on pressure signals from the pressure sensing device comprises moving a pressure sensor of the pressure sensing device across a valve annulus plane a plurality of times to map the location and / or form of an aortic valve annulus plane.

48. The method of Claim 1, further comprising determining a location of a coronary ostium, wherein merging the marker with the third two dimensional image data comprises merging a coronary ostium marker indicating the location of the coronary ostium.

49. The method of Claim 1, further comprising: moving the pressure sensing device from a location within a left ventricle to a location within an ascending aorta to record a pressure signal on a ventricular side of an aortic valve and on an aorta side of the aortic valve; comparing the pressure signal to a threshold parameter; and updating a position of the marker within the merged image based on the comparing of the pressure signals to the threshold parameter.

50. The method of Claim 1, wherein prior to generating the first two dimensional image data of the cardiovascular region, positioning the pressure sensing device in a left ventricle of the heart.

51. A method for performing a transcatheter procedure on an aortic valve, comprising:[a] positioning a pressure sensor in a left ventricle of a heart;[b] imaging a cardiovascular region including a portion of an ascending aorta and an aortic root of a patient, the imaging further comprises generating two dimensional image data of the cardiovascular region;[c] determining a location of a device positioning feature based at least in part on at least one of pressure signals from the pressure sensor and image analysis of the two dimensional image data of the cardiovascular region; and[d] outputting to a display a composite image including a visual representation of the two dimensional image data and a marker indicating the determined location.

52. The method of Claim 51 , wherein the location of the device positioning feature comprises a location of a valve annulus plane and / or a landing zone for a prosthetic valve and the composite image comprises a line overlayed at or along the landing zone.

53. The method of Claim 51, wherein the location of the device positioning feature comprises a location of a coronary ostium and the composite image comprises a line overlayed at or along the location of the coronary ostium.

54. A system for guiding placement of prosthetic heart valve, comprising: a tubular body comprising a pressure sensor disposed on a distal end, the tubular body having a length between a proximal and the distal end such that the tubular body can be inserted into arterial vasculature and advanced to an aortic valve or into a left ventricle of a heart; and a console comprising: a display; and a processor configured to: receive a fluoroscopic image data of a cardiovascular region including an aortic root of a patient; receive pressure signal data from the pressure sensor positioned in a selected portion of the cardiovascular region; determine a marker indicating a determined location of a device positioning feature based at least in part on at least one of pressure signal data from the pressure sensor and analysis of the fluoroscopic image data; and cause presentation of a user interface on the display, the user interface including the fluoroscopic image data and the marker.

55. The system of Claim 54, wherein the processor is configured to determine a location of a coaptation point or a coaptation plane of the aortic valve by detecting a change in a pressure signal as the pressure sensor is moved from within the left ventricle to within an aorta and / or from within the aorta to within the left ventricle.

56. The system of Claim 55, wherein the processor is configured to determine from analysis of a fluoroscopic image the location of the coaptation point or the coaptation plane upon recognizing a pattern in the pressure signal data received from the pressure sensor.

57. The system of Claim 55, wherein the processor is configured to determine the location of the coaptation point or the coaptation plane upon recognizing a pattern in the pressure signal data received from the pressure sensor from each of a plurality of movements between the left ventricle and the aorta.

58. The system of Claim 57, wherein the processor is configured to determine the location of the coaptation point or the coaptation plane upon recognizing a pattern in the pressure signal data received from the pressure sensor from three movements between the left ventricle and the aorta.

59. The system of Claim 57, wherein the processor is configured to determine the location of the coaptation point or the coaptation plane following recognizing a pattern in the pressure signal data received from the pressure sensor during a proximal movement across the aortic valve from the left ventricle to the aorta and following recognizing a pattern in the pressure signal data received from the pressure sensor during a distal movement across the aortic valve form the aorta to the left ventricle.

60. The system of Claim 54, wherein the processor is configured to determine a position of the device positioning feature based on a location of an aortic valve leaflet during diastole.

61. The system of Claim 54, wherein the processor is configured to output a user interface to the display comprising a marker indicating a prosthetic valve landing zone.

62. The system of Claim 54, wherein the processor is configured to determine a location of a valve annulus plane and to calculate an offset distance from the location of the valve annulus plane to determine a location of a prosthetic valve landing zone and the marker indicates the prosthetic valve landing zone.

63. The system of Claim 62, wherein the marker indicates a location of the valve annulus plane, the marker being positioned in the fluoroscopic image data outside of a boundary of an aorta.

64. The system of Claim 56, wherein the processor is configured to receive an additional fluoroscopic image data of the cardiovascular region and to update the user interface over time based on comparing position of a feature detectable in the fluoroscopic image and in the additional fluoroscopic image data.

65. The system of Claim 56, wherein the pressure sensor is a first pressure sensor and the processor is configured to receive a pressure signal from a second pressure sensor configured to be positioned in a systemic arterial blood vessel outside the left ventricle and to calculate and display a pressure gradient from pressure readings from the first pressure sensor and the second pressure sensor.

66. The system of Claim 65, wherein the second pressure sensor is disposed on the tubular body proximal of the first pressure sensor.

67. The system of Claim 65, further comprising a second tubular body having a proximal end and a distal end, the second pressure sensor being disposed between proximal and distal ends of the second tubular body.

68. The system of Claim 67, wherein the second tubular body comprises a guide catheter.

69. The system of Claim 67, wherein the second tubular body comprises a portion of a prosthesis delivery system.

70. The system of Claim 67, wherein the second tubular body comprises a diagnostic catheter.

71. The system of Claim 54, wherein the tubular body and the console facilitate placement of a prosthetic aortic valve through a single arterial or venous access site.

72. The system of Claim 54, wherein the processor is configured to calculate a pressure gradient and to compare the pressure gradient to a threshold value to locate a point of coaptation.

73. The system of Claim 54, wherein the processor is configured to detect ventricular pressure as compared to aortic pressure by determining a shape factor of a pressure curve during a predetermined time period and comparing the shape factor of the pressure curve with a threshold value.

74. The system of Claim 72, wherein the pressure gradient is calculated from a first signal generated by the pressure sensor disposed on the distal end of the tubular body and a second signal generated by a second pressure sensor configured to be positioned within a systemic arterial vessel of the patient, the first signal and the second signal generated approximately simultaneously.

75. The system of Claim 54, wherein the processor is configured to output a user interface to the display comprising a marker indicating a position of a coronary ostium.

76. The system of Claim 54, wherein the processor is configured to output a user interface to the display comprising a probability of a heart valve leaflet obstructing a coronary ostium.

77. A method for performing a procedure on an aortic valve, comprising:[a] advancing a catheter from an arterial access point to an ascending aorta of a patient;[b] injecting a contrast agent into the ascending aorta;[c] imaging a cardiovascular region including a portion of the ascending aorta and an aortic root while the contrast agent is present in the cardiovascular region, the imaging further comprises generating a two dimensional image of the cardiovascular region including the aortic root;[d] determining a coronary ostium plane or coronary risk plane based on the two dimensional image;[e] advancing a pressure sensing device through the catheter to a cardiovascular region of the patient including a portion of the ascending aorta and an aortic root;[f] determining a coaptation point of the aortic valve based at least in part on at least one of a pressure signal from the pressure sensing device and the two dimensional image; and[g] outputting an indicator of a coronary ostium obstruction risk based on comparing a valve leaflet size and location as determined from the coaptation point with a distance of a coronary ostium from an annulus plane of the aortic valve.

78. The method of Claim 77, further comprising merging a marker with two dimensional image of the cardiovascular region.

79. The method of Claim 78, wherein merging the marker and the two dimensional image of the cardiovascular region shows the positioning of a valve leaflet relative to the marker and the coronary ostium.

80. The method of Claim 79, wherein the marker corresponds to a landing zone for a prosthetic valve.

81. A method for performing a transcatheter procedure on a valve of a heart, comprising:[a] advancing a catheter from an access point to a cardiovascular region adjacent the valve of a patient;[b] injecting a contrast agent into the cardiovascular region;[c] generating first image data of the cardiovascular region while the contrast agent is present in the cardiovascular region;[d] positioning a pressure sensing device in a selected portion of the cardiovascular region;[e] generating second image data of the cardiovascular region including a region at or near the valve of the patient when a pressure signal of the pressure sensing device indicates that the pressure sensing device is positioned in the selected portion of the cardiovascular region;[f] determining a location of a device positioning feature based at least in part on pressure signals obtained from the pressure sensing device; and[g] displaying a user interface including a representation of the selected portion of the cardiovascular region and a marker indicating or based on the determined location to guide a valve procedure.

82. The method of Claim 81, wherein the valve of the patient is a tricuspid valve of the patient.

83. The method of Claim 81, wherein the valve of the patient is a pulmonary valve of the patient.

84. The method of Claim 81, wherein the valve of the patient is a mitral valve of the patient.

85. A method for performing a transcatheter procedure on a valve of a heart, comprising:[a] advancing a catheter from an access point to a cardiovascular region adjacent the valve of a patient;[b] injecting a contrast agent into the cardiovascular region;[c] generating first image data of the cardiovascular region while the contrast agent is present in the cardiovascular region;[d] determining a location of a device positioning feature based at least in part on the first image data; and[g] displaying a user interface including a representation of a selected portion of the cardiovascular region and a marker indicating or based on the determined location to guide a valve procedure.

86. The method of Claim 85, wherein determining the location of the device positioning feature comprises segmenting the first image data to locate a coaptation plane, a coaptation point, a valve leaflet commissure, a valve edge, an ostium of a downstream vessel.

87. The method of Claim 85, wherein determining the location of the device positioning feature is based only on image data.

88. The method of Claim 85, wherein displaying the marker comprises displaying a landing zone location for a portion of the valve.

89. The method of Claim 85, wherein advancing the catheter comprises advancing a valve delivery catheter over a guidewire.

90. The method of Claim 89, further comprising advancing a pressure sensing guidewire from the access point to the heart and through the valve and thereafter advancing the catheter as recited in [a],91. The method of Claim 90, wherein determining the location of the device positioning features is based on pressure readings from the pressure sensing guidewire and the first image data.

Images