Abstract: A fully automatic method for segmentation of the mitral leaflets in 3D transesophageal echocardiographic (3D TEE) images is provided. The method combines complementary probabilistic segmentation and geometric modeling techniques to generate 3D patient-specific reconstructions of the mitral leaflets and annulus from 3D TEE image data with no user interaction. In the model-based segmentation framework, mitral leaflet geometry is described with 3D continuous medial representation (cm-rep). To capture leaflet geometry in a target 3D TEE image, a pre-defined cm-rep template of the mitral leaflets is deformed such that the negative log of a Bayesian posterior probability is minimized. The likelihood of the objective function is given by a probabilistic segmentation of the mitral leaflets generated by multi-atlas joint label fusion, while the validity constraints and regularization terms imposed by cm-rep act as shape priors that preserve leaflet topology and constrain model fitting.

Abstract: The present disclosure relates to valve replacement devices that are foldable for catheter-based deployment to the site of implantation, as well as systems for the delivery of valve prostheses, including prostheses having the special characteristics of the disclosed valve replacement devices. The devices include highly effective adhering mechanisms for secure and enduring precision implantation. The adhering mechanisms may employ a unique sealing mechanism that includes a cuff that expands slowly whereby the device is not secured in place until the completion of the implantation procedure. The implanted device, optionally together with the cuff, prevents perivalvular leaks and incorporate an appropriate leaflet system for reliable functioning in situ.

Abstract: The present disclosure relates to valve replacement devices that are foldable for catheter-based deployment to the site of implantation, as well as systems for the delivery of valve prostheses, including prostheses having the special characteristics of the disclosed valve replacement devices. The devices include highly effective adhering mechanisms for secure and enduring precision implantation. The adhering mechanisms may employ a unique sealing mechanism that includes a cuff that expands slowly whereby the device is not secured in place until the completion of the implantation procedure. The implanted device, optionally together with the cuff, prevents perivalvular leaks and incorporate an appropriate leaflet system for reliable functioning in situ.

Abstract: The present disclosure relates to valve replacement devices that are foldable for catheter-based deployment to the site of implantation, as well as systems for the delivery of valve prostheses, including prostheses having the special characteristics of the disclosed valve replacement devices. The devices include highly effective adhering mechanisms for secure and enduring precision implantation. The adhering mechanisms may employ a unique sealing mechanism that includes a cuff that expands slowly whereby the device is not secured in place until the completion of the implantation procedure. The implanted device, optionally together with the cuff, prevents perivalvular leaks and incorporate an appropriate leaflet system for reliable functioning in situ.

Abstract: A method is provided for measuring or estimating stress distributions on heart valve leaflets by obtaining three-dimensional images of the heart valve leaflets, segmenting the heart valve leaflets in the three-dimensional images by capturing locally varying thicknesses of the heart valve leaflets in three-dimensional image data to generate an image-derived patient-specific model of the heart valve leaflets, and applying the image-derived patient-specific model of the heart valve leaflets to a finite element analysis (FEA) algorithm to estimate stresses on the heart valve leaflets. The images of the heart valve leaflets may be obtained using real-time 3D transesophageal echocardiography (rt-3DTEE). Volumetric images of the mitral valve at mid-systole may be analyzed by user-initialized segmentation and 3D deformable modeling with continuous medial representation to obtain, a compact representation of shape.

Abstract: Provided are methods and kits for safe and effective therapy that can be administered early after a heart attack in order to prevent progressive heart dilatation and resultant loss of function. The therapy includes the administration of particulate compositions to a region comprising an infarct or a portion thereof.

Abstract: A series of rt-3DE images of the mitral valve are quantitatively analyzed so as to enable, for example, prediction of the degree of recurrent ischemic mitral regurgitation (IMR) and comprehensive assessments of leaflet tethering and “tenting” for the entire mitral valve. In accordance with the method, first, the rt-3DE images are registered with symmetric diffeomorphism to obtain information about how the mitral valve deforms over time. Second, the mitral valve is segmented with the level sets or other known segmentation method at each time point in the cardiac cycle with minimal user interaction. Third, the information about mitral valve structure is reduced into a 3D medial model, a compact representation of shape. In other words, a volumetric segmentation of the mitral valve is condensed to a form that is amenable to clinically relevant morphometry.

Abstract: A fully automatic method for segmentation of the mitral leaflets in 3D transesophageal echocardiographic (3D TEE) images is provided. The method combines complementary probabilistic segmentation and geometric modeling techniques to generate 3D patient-specific reconstructions of the mitral leaflets and annulus from 3D TEE image data with no user interaction. In the model-based segmentation framework, mitral leaflet geometry is described with 3D continuous medial representation (cm-rep). To capture leaflet geometry in a target 3D TEE image, a pre-defined cm-rep template of the mitral leaflets is deformed such that the negative log of a Bayesian posterior probability is minimized. The likelihood of the objective function is given by a probabilistic segmentation of the mitral leaflets generated by multi-atlas joint label fusion, while the validity constraints and regularization terms imposed by cm-rep act as shape priors that preserve leaflet topology and constrain model fitting.

Abstract: A stent-based vascular reducer platform adapted for percutaneous delivery to and anchoring in a pulmonary or tricuspid valve annulus and a valved-stent prosthetic device adapted to be percutaneously delivered to the pulmonary or tricuspid valve annulus for mounting in the vascular reducer platform. The vascular reducer platform includes an at least partially self-expanding stent and a cuff made of an absorbent material disposed at least partially circumferentially around the outer and inner surfaces of the stent. Upon placement at an implantation site such as the pulmonary or tricuspid valve annulus, the absorbent material expands by absorption of a fluid to substantially adhere and seal the stent at the implantation site. Preferably, the cuff expansion is delayed for a time sufficient to permit positioning of the stent at the implantation site. The stent and cuff may also be used as a space-reducer for venous insufficiency, aortic aneurysms, and hydroureter treatment.

Abstract: A transvenously deployed myocardial restraint device provides mechanical restraint of a dilated left ventricle and improves heart function. The device includes a delivery wire with a restraining coil that is straightened for percutaneous delivery to the heart and recoiled once positioned in a pericardial space adjacent a ventricular heart wall. Alternatively, a balloon on the end of the delivery wire is delivered similarly to the coil and is then inflated in the pericardial space to restrain the dilated portion of the left ventricle. A trailing end of the coil forms a tether that is anchored to the left ventricular free wall and to the ventricular septum by an intraventricular septal anchor and connected by the tether through the ventricular septum using the same delivery system.

Abstract: A method and device are provided for non-blood contact mechanically assisting an injured (e.g., infarcted) ventricle by coupling an inflatable bladder or other volume adjustable device to the injured ventricle and selectively inflating the bladder or increasing the size of the volume in systole to apply force against the injured ventricle and deflating the bladder or reducing the size of the volume in diastole to remove force against the injured ventricle. When no mechanical assistance is being provided to the injured ventricle, the inflatable bladder or volume adjustable device is preferably maintained at a predetermined pressure so as to selectively stiffen the injured tissue and alter ventricular geometry a desired amount.

Abstract: A mitral valve prosthesis is percutaneously and/or transapically deployed in at least two stages. In a first stage, a mitral annular ring platform adapted for percutaneous delivery is delivered to and anchored in the mitral valve annulus. In the second stage, a valved-stent mitral valve prosthetic device adapted for percutaneously delivery is delivered to the mitral valve annulus for mounting in the mitral annular ring platform. This approach provides a consistent platform for accepting valved-stent mitral valve prosthetic devices from different vendors to be used.

Abstract: A self-expanding valved stent is constructed from a polytetrafluoroethylene (PTFE) covered nitinol or stainless steel wire frame. Anchoring is facilitated by arms emanating from the ventricular end of the device that are designed to atraumatically insinuate themselves around chordae and leaflets and trap them against the expanded stent body. The valve prosthesis includes a partially self-expanding stent having a wire framework defining outer and interior surfaces and anchoring arms. The stent has an unexpaneled and an expanded state and anchoring arms having an elbow region and a hook that clamps around mitral tissue of the patient when seated. An elastic fabric/cloth made of for example, PTFE material, is wrapped circumferentially around the wire framework. A valve having at least one leaflet is fixedly attached to the interior surface of the stent.

Abstract: The invention relates to compositions comprising (i) biocompatible hydrogel and (ii) one or more therapeutic agents contained within said hydrogel; wherein the hydrogel is cross-linked utilizing a cross-linker comprising a peptide sequence that is capable of being degraded by an enzyme; the therapeutic agent being effective as a treatment of a condition related to the presence of the enzyme.

Abstract: A series of rt-3DE images of the mitral valve are quantitatively analyzed so as to enable, for example, prediction of the degree of recurrent ischemic mitral regurgitation (IMR) and comprehensive assessments of leaflet tethering and “tenting” for the entire mitral valve. In accordance with the method, first, the rt-3DE images are registered with symmetric diffeomorphism to obtain information about how the mitral valve deforms over time. Second, the mitral valve is segmented with the level sets or other known segmentation method at each time point in the cardiac cycle with minimal user interaction. Third, the information about mitral valve structure is reduced into a 3D medial model, a compact representation of shape. In other words, a volumetric segmentation of the mitral valve is condensed to a form that is amenable to clinically relevant morphometry.

Abstract: Disclosed herein are devices for assessing mitochondrial function in a living subject comprising a catheter comprising a sheath defining a lumen, a distal end, and a proximal end comprising a light guide for radiating light onto a target within the subject and for receiving a fluorescence signal from the target; a light source, wherein the catheter is adapted for transmitting light from the light source to the light guide; and, a detector for receiving the fluorescence signal from the light guide and for correlating the fluorescence signal to the mitochondrial function of the target. Also disclosed are methods for assessing mitochondrial function in a living subject comprising placing a catheter proximate to a site of interest within the subject; using the catheter to acquire fluorescence signals from cells at the site of interest; and, correlating the fluorescence signals to the mitochondrial function of the cells.

Abstract: The present disclosure relates to valve replacement devices that are foldable for catheter-based deployment to the site of implantation, as well as systems for the delivery of valve prostheses, including prostheses having the special characteristics of the disclosed valve replacement devices. The devices include highly effective adhering mechanisms for secure and enduring precision implantation. The adhering mechanisms may employ a unique sealing mechanism that includes a cuff that expands slowly whereby the device is not secured in place until the completion of the implantation procedure. The implanted device, optionally together with the cuff, prevents perivalvular leaks and incorporate an appropriate leaflet system for reliable functioning in situ.

Abstract: Provided are methods of treating cardiac infarction by using an injectable material to influence cardiac structure and remodeling after infarction. Also provided are kits that comprise an injectable material to influence cardiac structure.

Abstract: Provided are methods and kits for safe and effective therapy that can be administered early after a heart attack in order to prevent progressive heart dilatation and resultant loss of function. The therapy includes the administration of particulate compositions to a region comprising an infarct or a portion thereof.

Abstract: Valve prostheses are disclosed that are adapted for secure and aligned placement relative to a heart annulus. The valve prostheses may be placed in a non-invasive manner, e.g., via transcatheter techniques. The valve prosthesis may include a resilient ring, a plurality of leaflet membranes mounted with respect to the resilient ring, and a plurality of positioning elements movably mounted with respect to the flexible ring. Each of the positioning elements defines respective proximal, intermediate, and distal tissue engaging regions cooperatively configured and dimensioned to simultaneously engage separate corresponding areas of the tissue of an anatomical structure, including respective first, second, and third elongate tissue-piercing elements.