Abstract: Methods, systems, and apparatuses for treating a heart are provided. Methods can include obtaining and using an implant. One or more catheters can be used to properly position and attach the implant in a desired location in a chamber of the heart, for example, on a ventricular wall of the left ventricle between one or more papillary muscles of the left ventricle and the annulus. Then a distance along the implant or a region of the heart, for example, between the papillary muscle and the annulus, can be reduced by contracting the implant along its longitudinal axis by applying tension to a contraction member of the implant. Other embodiments are described.

Abstract: Methods and devices for increasing oxygenation levels in the blood supply and thereby treating the condition of hypoxemia. Multiple approaches such as pressure reduction in the pulmonary circulatory system, reducing triggering mechanisms in the main pulmonary artery and restricting flow in the pulmonary circulatory system are disclosed. Interventions associated with those approaches can including shunting, restrictors, compliance devices, pharmacologic substances, etc.

Abstract: A prosthetic heart valve can include a support stent, a valve assembly, and a connection structure. The support stent can have an inlet end portion and an outlet end portion, and can be configured to be radially expandable from a crimped configuration to an expanded configuration. The valve assembly can have an inlet, an outlet, and a plurality of leaflets. The connection structure supports the valve assembly in the support stent such that the inlet of the valve assembly is spaced radially inwardly of the support stent and forms an annular space between an inner surface of the support stent and the valve assembly at the inlet of the valve assembly when the support stent is in the expanded configuration. The annular space can have a width in a radial direction between 0.5 cm and 3 cm.

Abstract: Prosthetic valve systems for treating a native valve exhibiting regurgitation can include a support structure in which a separate prosthetic heart valve can be placed. A method for implant a prosthetic valve system can include advancing a first catheter delivery sheath through an introducer sheath and into a left ventricle of a patient's heart, deploying at least a portion of a support structure from the first catheter delivery sheath and positioning the support structure around native leaflets of the patient's native mitral valve, positioning a prosthetic heart valve in a radially collapsed configuration within the patient's native mitral valve, and expanding the prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration, wherein the prosthetic heart valve contacts the native leaflets from within the patient's native mitral valve and is separated from the support structure by the native leaflets.

Abstract: Prosthetic heart valves are described. Prosthetic heart valves can include radially expandable and compressible inner and outer metal frames. The inner frame can be disposed within a lumen of the outer frame and can be coupled to the outer frame. An outflow end of the inner frame can be coupled to and/or located at an outflow end of the outer frame. An end portion of the inner frame can be spaced radially inwardly from an inner surface of the outer frame, such that a radial gap exists between the inner surface of the outer frame and an outer surface of the inner frame. Prosthetic heart valves can further include a plurality of leaflets disposed within and supported by the inner frame, such as by commissure posts of the inner frame.

Abstract: A prosthetic heart valve assembly includes a self-expandable stent having an inlet end and an outlet end and a passageway extending therethrough. The stent includes a plurality of rows of prongs on the outer surface of the stent. A valve portion comprising a plurality of leaflets is positioned within the passageway for permitting blood to flow through the passageway from the inlet end to the outlet end while blocking flow in the opposite direction. The stent further includes a flared upper portion shaped for placement along a supra-annular surface of an annulus for preventing downward migration of the prosthetic valve assembly into a ventricle. Each of the prongs has a tip pointing toward the inlet end for penetrating surrounding tissue and preventing upward migration of the prosthetic heart valve assembly toward an atrium.

Abstract: A method of implanting a prosthetic mitral valve includes advancing a delivery apparatus into a left side of a patient's heart and deploying a support structure from the delivery apparatus. The support structure extends around native mitral valve leaflets such that the native leaflets are disposed radially within the support structure. The method also includes advancing a prosthetic heart valve within the native leaflets. The prosthetic heart valve is separate from the support structure and includes an annular frame and a valve structure positioned within the annular frame, and prosthetic heart valve is in a radially collapsed configuration. The method further includes expanding the prosthetic heart valve from the radially collapsed configuration to a radially expanded configuration. In the radially expanded configuration, the annular frame of the prosthetic heart valve engages the native leaflets and is separated from the support structure by the native leaflets.

Abstract: Using a delivery system, a disk is introduced into a left atrium (LA) of a heart of a subject. The left atrial appendage (LAA) is everted into the LA by, the from within the LAA, grasping tissue of the LAA, and pulling the LAA through an ostium of the LAA and into the LA. Within the LA, the disk is expanded, and the perimeter of the everted LAA is sandwiched between a periphery of the disk and the wall around the ostium such that the everted LAA covers the ostium. The everted LAA is secured covering the ostium by anchoring the periphery of the disk around the perimeter of the everted LAA. Other embodiments are also described.

Abstract: A deficient native mitral valve is treated by implanting a prosthetic mitral valve assembly valve in a patient's heart. The prosthetic mitral valve assembly includes a stent having a flared upper portion, an intermediate portion, and a lower portion. The diameter at the inflow end of the stent is larger than at the outflow end. The prosthetic mitral valve assembly also includes a valve portion formed with pericardial tissue leaflets. A tether has a first end attached to the stent and a second end attached to an anchor. The tether extends through a wall of the left ventricle and the tissue anchor is placed outside the left ventricle. After implantation, the flared upper portion resists movement in the downstream direction and the tether resists movement in the upstream direction for securing the prosthetic mitral valve assembly in the native mitral valve.

Abstract: A prosthetic heart valve can include a support stent, a valve assembly, and a connection structure. The support stent can have an inlet end portion and an outlet end portion, and can be configured to be radially expandable from a crimped configuration to an expanded configuration. The valve assembly can have an inlet, an outlet, and a plurality of leaflets. The connection structure supports the valve assembly in the support stent such that the inlet of the valve assembly is spaced radially inwardly of the support stent and forms an annular space between an inner surface of the support stent and the valve assembly at the inlet of the valve assembly when the support stent is in the expanded configuration. The annular space can have a width in a radial direction between 0.5 cm and 3 cm.

Abstract: Methods and techniques are disclosed for performing transcatheter procedures on a patient that result in similar blood flow changes to the surgical Blalock-Taussig procedure, the Glenn procedure, and the Fontan procedure. Since these transcatheter procedures do not necessarily involve open chest surgery, they tend to be less traumatic for the patient, quicker and easier to perform, and may result in better patient outcomes.

Abstract: Prosthetic heart valves are described. Prosthetic heart valves can include radially expandable and compressible inner and outer metal frames. The inner frame can be disposed within a lumen of the outer frame and can be coupled to the outer frame. An outflow end of the inner frame can be coupled to and/or located at an outflow end of the outer frame. An end portion of the inner frame can be spaced radially inwardly from an inner surface of the outer frame, such that a radial gap exists between the inner surface of the outer frame and an outer surface of the inner frame. Prosthetic heart valves can further include a plurality of leaflets disposed within and supported by the inner frame, such as by commissure posts of the inner frame.

Abstract: Embodiments of a heart shape preserving anchor are disclosed herein. The heart shape preserving anchor can include a frame having one or more wings extending from a lower end of the frame. The frame can be sized and shaped to distribute forces over a large surface area thereby reducing pressures applied on the heart. The anchor can include a tether for coupling to a prosthesis, such as a replacement heart valve prosthesis. In some embodiments, the anchor can include a tether adjustment mechanism which can be wirelessly operated to adjust a length of the tether relative to the frame.

Abstract: Disclosed replacement heart valves can be designed to be delivered to a native valve site while crimped on a delivery catheter. The crimped profile of the replacement valve can be minimized by, for example, separating a frame or stent structure from a leaflet structure, along the axial direction. Disclosed replacement valves can be transitioned from a delivery configuration, in which the crimped profile can be minimized, to an operating configuration. The replacement valve can be fully assembled in both the delivery and operating configurations. In some embodiments, the leaflets can be positioned outside of the stent in the delivery configuration, and positioned inside of the stent lumen in the operating configuration. Disclosed replacement valves can include a flexible sleeve coupling the leaflets to the stent and facilitating the transition to the operating configuration. Methods of implanting said replacement valves are also disclosed.

Abstract: A prosthetic heart valve can include an expandable support stent, a valve assembly, and a connecting membrane. The support stent can have first and second end portions and can be configured to be radially expandable from a first configuration to a second configuration. The valve assembly can have an inlet portion, an outlet portion, and a plurality of leaflets, and the valve assembly can be supported in the support stent. The connecting membrane can be disposed radially between the support stent and the valve assembly, wherein the support stent and the valve assembly can be connected to the connecting membrane.

Abstract: Prosthetic valve systems for replacing a native valve exhibiting regurgitation include a support structure and a transcatheter heart valve (THV) that is separate from the support structure. The support structure can be configured to be positioned such that it extends annularly around the native valve leaflets. After the support structure is deployed around the native valve leaflets, the THV can be expanded within the support structure such that the native valve leaflets are engaged between the support structure and the THV.

Abstract: Methods and devices for increasing oxygenation levels in the blood supply and thereby treating the condition of hypoxemia. Multiple approaches such as pressure reduction in the pulmonary circulatory system, reducing triggering mechanisms in the main pulmonary artery and restricting flow in the pulmonary circulatory system are disclosed. Interventions associated with those approaches can including shunting, restrictors, compliance devices, pharmacologic substances, etc.

Abstract: This application relates to methods, systems, and apparatus for replacing native heart valves with prosthetic heart valves and treating valvular insufficiency. In a representative embodiment, a support frame configured to be implanted in a heart valve comprises a main body formed by formed by a plurality of inner members forming an inner clover and a plurality of outer members forming an outer clover. The support frame can include gaps located between inner members of the plurality of inner members and outer members of the plurality of outer members. The inner clover can be radially inside the outer clover, and the outer clover can have larger dimensions than the inner clover. The support frames herein can be radially expandable and collapsible.

Abstract: A method of implanting a prosthetic mitral heart valve includes advancing a guidewire through a femoral vein, an atrial septum, and a native mitral valve. A guide catheter is advanced over the guidewire and a delivery catheter is advanced through the guide catheter. A mitral valve assembly is disposed along a distal end of the delivery catheter. The mitral valve assembly includes a stent and a valve having three leaflets. The stent has a flared inlet end, an outlet end, and an intermediate portion with a plurality of prongs disposed along its outer surface. The mitral valve assembly is deployed with the flared inlet end positioned in a left atrium and the intermediate portion positioned between native mitral valve leaflets. The prongs penetrate surrounding tissue for preventing upward migration of the mitral valve assembly and the flared inlet end is shaped for preventing downward migration.

Abstract: Devices and methods of treating conditions cause or exacerbated by excessive fluid pressures or retentions, such as pulmonary hypertension, that involves shunting excessive fluid pressure from one bodily chamber or vessel to another bodily chamber or vessel.