Abstract: Disclosed herein is a valve system with an original deployed diameter that is suitable for a child and/or young adult and that can accommodate the patient's growth by a one-time balloon expansion to attain an expanded diameter in that patient. This novel valve addresses an unmet need for children with valve dysfunction and to stop valve-related progressive ventricular dysfunction, and ultimately avoid heart failure in children and young adults.

Abstract: A network of electrodes configured to sense and/or pace the heart, wherein the network of electrodes are in contact with an epicardial surface of the heart, within a wrapping sleeve that assist the heart as a whole, wherein the network of electrodes sense the heart by quantifying intrinsic electrical activities of the heart, and wherein the network of electrodes pace the heart by inducing an electrical impulse to the heart to control its contractile activities. The network may be interfaced with a controller system, wherein the controller uses spatial and temporal electrical activities of the heart muscles to generate electrical impulse to synchronize the wrapping sleeve around the heart with the heart. Also disclosed is a system configured to construct space-time mapping of cardiac electrical activities and/or propagation, and sensing effects of a first assist event of a prior beat and controlling a second assist event.

Abstract: Described is an apparatus for transcatheter detachment of a stent from a delivery device. A single-ended draw line with loops is inserted through a restraining hole in a glide and a release line is inserted through the loops. The single-ended draw line is thus prevented from pulling through the restraining hole while the release line is through the loops. The single-ended draw line is free to pass through the restraining hole after the release line is pulled out of the loops and thereafter pulled free of stent holes formed through a stent, thereby detaching the stent at a desired location.

Abstract: A percutaneous heart valve delivery system including a valve delivery catheter coupled with a first inflatable balloon positioned at a distal end of the valve delivery catheter, wherein the first inflatable balloon is configured to fracture a previously implanted prosthetic heart valve; and a replacement transcatheter heart valve positioned proximal to the first inflatable balloon, wherein the replacement transcatheter heart valve is configured to be implanted subsequently within the previously implanted, fractured prosthetic heart valve, following fracture of the previously implanted heart valve without withdrawal of the percutaneous heart valve delivery system. Also disclosed are methods of implantation of a new heart valve within a previously implanted prosthetic heart valve and methods of valvuloplasty of a native heart valve.

Abstract: Devices, systems and methods related to techniques for performing four-chamber segmentation of echocardiograms are disclosed. In one example aspect, a method for generating segmented image data based on an input echocardiogram includes receiving an input echocardiogram that includes information associated with four chambers of a heart, performing segmentation on the information associated with the four chambers using an adversarial model that comprises a first artificial neural network with multiple layers, and combining data from selected layers of the first artificial neural network to generate an output image that includes the segmented four chambers of the heart.

Abstract: Described is a collapsible atrial cage for percutaneous delivery and implantation of an atrioventricular valve within an atrium of the heart. The atrial cage includes an atrial portion and a ventricular portion. The ventricular portion is attached with and separated from the atrial portion by a valve juncture portion. Notably, the cage includes at least one interlock shaped to lock with and secure an atrioventricular valve proximate the valve juncture portion. Thus, when deployed and expanded, the atrioventricular valve is secured at the atrioventricular juncture.

Abstract: A gimbal handle assembly including: an inner gimbal and an outer gimbal that are concentrically linked and have pivot axes that are orthogonal relative to each other, a spool coupled to and rotatable around the outer gimbal, and a plurality of draw lines attached to the spool in a circumferential configuration, wherein rotation of the spool and/or rotation of the spool and the outer and inner gimbals increases or reduces tension in the draw lines. Also disclosed are a transcatheter valve delivery assembly that includes the gimbal handle assembly, a multi-lumen catheter, a sleeve attached to a distal end of the multi-lumen catheter, and a transcatheter heart valve including an expandable valve frame. Methods of delivering the transcatheter valve to a subject are described, wherein pitch and yaw orientations of the transcatheter valve can be precisely controlled with enhanced degrees of freedom.

Abstract: A hybrid tissue engineered heart valve leaflet including a polyurethane core, such as a polycarbonate-based thermoplastic polyurethane like carbothane. The polyurethane core is enclosed within one or more layer of a patient's cells and collagen. Also disclosed are hybrid tissue engineered heart valves, including a frame; and at least two leaflets attached thereto in a configuration of a heart valve, wherein the leaflets are hybrid tissue engineered heart valve leaflets, and methods of making a hybrid tissue engineered heart valve for deployment in a patient.

Abstract: Described is a delivery system for percutaneous delivery and implantation of a heart valve. The delivery system includes a handle with a sheath extending therefrom. A splay shaft extends from the handle through the sheath. At least two arms extend from the handle through the splay shaft. The at least two arms are operable for holding a heart valve. A sheath controller is housed within the handle and is operable for selectively advancing or retracting the sheath to constrain or expose a heart valve as attached with the at least two arms. A splay shaft controller is housed within the handle for allowing the user to selectively advance or retract the splay shaft to constrain or expose the at least two arms. Finally, a valve release is attached with the handle to allow a user to selectively release a heart valve as attached with the at least two arms.

Abstract: A method of identifying and quantifying calcified regions of a tissue including obtaining an image of a cross-section of the tissue, wherein the image distinguishes between calcified regions and non-calcified regions of the cross-section of the tissue. Also disclosed are methods of detecting a change in size of a calcified region of a tissue over time including identifying and quantifying a first size of the calcified region of the tissue at a first time, identifying and quantifying a second size of the corresponding calcified region of the tissue at a second time, and detecting a change in size between the first and second size of the calcified region of the tissue in the image of a cross-section of the tissue. Some aspects relate to computer software program configured to construct a panoramic image from partial images, quantify RGB values for each pixel in the panoramic image, and calculate the total pixels of calcified and uncalcified regions and a calcification ratio.

Abstract: A method of altering energy metabolism in a recipient cell including: identifying the recipient cell as being in need of altering its oxidative phosphorylation status, obtaining exogenous mitochondria, and introducing into the recipient cell the exogenously obtained mitochondria, wherein the exogenously obtained mitochondria functions in the recipient cell to increase or decrease oxidative phosphorylation and/or glycolysis. Also disclosed are isolated cells that include an exogenous mitochondria, wherein the cell demonstrates increased energy metabolism compared to a control cell of the same type but wherein the control cell lacks exogenously added mitochondria.

Abstract: Described is a group of polymeric calcific heart valves with different levels of calcification that can be used for research and development studies related to transcatheter heart valve technologies. Using a heart flow simulator, the valves' function was studied in aortic position in the presence or absence of an implanted transcatheter aortic valve (valve-in-valve). Through multiple experiments based on echocardiography, it was found that these calcific valves can suitably mimic the function of a native calcified stenotic aortic valve and can be used for valve-in-valve studies. Using this novel polymeric calcified valve provides a desired cost-saving solution for testing the performance of new TAVR systems in vitro and in vivo.

Abstract: A method of detecting whether or not a body chamber has an abnormal structure or function including: (a) providing a stack of images as input to a system comprising one or more hardware processors configured to obtain a stack of medical images comprising at least a representation of the body chamber inside the patient; to obtain a region of interest using a convolutional network trained to locate the body chamber, wherein the region of interest corresponds to the body chamber from each of the medical images; and to infer a shape of the body chamber using a stacked auto-encoder (AE) network trained to delineate the body chamber, wherein the AE network segments the body chamber; (b) operating the system to detect the body chamber in the images using deep convolutional networks trained to locate the body chamber, to infer a shape of the body chamber using a stacked auto-encoder trained to delineate the body chamber, and to incorporate the inferred shape into a deformable model for segmentation; and (c) detecting

Abstract: Described is an apparatus for transcatheter detachment of a stent from a delivery device. A braided suture with an opening is inserted through a restraining hole in a glide (the opening is secured on one side by a knot or a series of knots) and a release line is inserted through the braided suture opening. The braided suture is thus prevented from pulling through the restraining hole while the release line is through the opening. The braided suture is free to pass through the restraining hole after the release line is pulled out of the opening and thereafter pulled free of stent holes formed through a stent, thereby detaching the stent at a desired location.

Abstract: A heart valve leaflet including a thermoplastic polyurethane (TPU) mesh material that has a stiffness that is comparable to a native heart valve leaflet, such that it functionally mimics a native heart valve leaflet. The heart valve leaflets optionally include one to three layers of cells cultured on each side of the mesh material. Also disclosed is a heart valve including the heart valve leaflet and a frame.

Abstract: Systems and methods are disclosed for automatically segmenting a heart chamber from medical images of a patient. The system may include one or more hardware processors configured to: obtain image data including at least a representation of the patient's heart; obtain a region of interest from the image data; organize the region of interest into an input vector; apply the input vector through a trained graph; obtain an output vector representing a refined region of interest corresponding to the heart based on the application of the input vector through the trained graph; apply a deformable model on the obtained output vector representing the refined region of interest; and identify a segment of a heart chamber from the application of the deformable model on the obtained output vector.

Abstract: A cardiac assist device including a sleeve configured to externally wrap around a native, intact heart; a motor, and a drive shaft that connects the motor to the sleeve, wherein, actuation of the motor and the drive shaft provides a synchronized assisting force to a pumping force of the native, intact whole heart, thereby helping contraction and expansion of the heart located within an internal volume defined by the sleeve. Some embodiments relate to a system for synchronizing the cardiac assist device with a heart including the cardiac assist device; a power supply connected to the motor; and an electrical connector-relay configured to receive electrical signals from the pacemaker and to generate actuating signals that are relayed to the motor and the drive shaft, wherein, during operation of the system in a subject, the heart is assisted in contracting synchronously with the pacemaker signal rhythm.

Abstract: Methods for synchronizing the actions of a pulsatile cardiac assist device with a dysfunctional heart using a cardiac pacemaker. Aspects include receiving a signal from the pacemaker and actuating the pulsatile cardiac assist device in response to the signal from the pacemaker to either help push blood out of the heart during systole or to help suck blood from the atria during diastole.

Abstract: The disclosure relates to method of processing three-dimensional images or volumetric datasets to determine a configuration of a medium or a rate of a change of the medium, wherein the method includes tracking changes of a field related to the medium to obtain a deformation or velocity field in three dimensions. In some cases, the field is a brightness field inherent to the medium or its motion. In other embodiments, the brightness field is from a tracking agent that includes floating particles detectable in the medium during flow of the medium.

Abstract: A multi-planar velocimetry approach to characterize 3D incompressible flows based on 2D perpendicular (or otherwise complementary) velocity fields is described. Two-dimensional velocity fields acquired on the planes are reconstructed into a 3D velocity field through interpolation and the imposition of a fluid incompressibility constraint.