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There have been big advances in transcatheter aortic valve replacement (TAVR) technology in recent years and now two such valves are on the U.S. market, but there has been little progress toward a transcatheter mitral valve. The U.S. Food and Drug Administration (FDA) cleared the Mitraclip mitral valve leaflet repair system last fall, but for patients requiring a full valve replacement, there is no FDA-cleared option. Due to the complexity of the mitral valve anatomy, development of transcatheter treatments for mitral regurgitation has been lacking in comparison to transcatheter aortic valve devices. This did not stop cardiologists at Henry Ford Hospital in Detroit, who recently used an Edwards Lifesciences Sapien TAVR device to replace a mitral valve that was narrowed with calcium buildup. William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital, estimates this new technique could help thousands of patients a year.

“The success of this innovative procedure, developed by my team member Dr. Mayra Guerrero, brings new options to physicians for mitral valve repair,” O’Neill said in a statement. “Not only did our team implant a different replacement valve than would normally be used in this part of the heart, but we needed to develop a new technique to do it. We were able to implant a different valve, as it was the only way to save the patient.” 

An FDA-approved trial is being planned at Henry Ford Hospital to further investigate using the Sapien in the mitral valve position. The patient, Lee Young, 72, of Detroit, has diabetes and had two previous open-heart surgeries. With calcific mitral stenosis, the narrowed mitral valve of his heart was causing shortness of breath, but he was not a candidate for a third open-heart surgery, so the heart team devised a procedure using a Sapien valve.

The team of specialists modified the route that is usually used for mitral valvuloplasty, a balloon procedure to open narrowed heart valves. The procedure had been attempted on Young, with little success at sufficiently opening the mitral valve. However, the balloon allowed the team to measure the valve annulus to ensure that the new valve would fit before placement. 

The route involves threading a catheter from the femoral vein, passing through the right ventricle into the right atrium and through the septum into the left atrium. The balloon-expandable Sapien valve is delivered through the catheter to the mitral valve. A minimally invasive incision allowed a wire to pass through the chest to the mitral valve, providing stability during the placement of the new valve. Young was feeling well for the six weeks following his procedure.

Similar Sapien procedures to replace the mitral valve have been performed in Europe since 2011. The next generation Edwards Lifesciences Sapien XT is cleared in Europe for TAVR and for use in the mitral valve and for valve-in-valve mitral procedures. 

Neovasc has developed the Tiara device, a dedicated mitral valve replacement device using a selfexpanding frame with attached bovine pericardial tissue leaflets mounted inside, similar to a Medtronic CoreValve device. It is delivered through the apex of the heart. The first-in-human implantation of the Tiara was successfully performed in January at St. Paul’s Hospital in Vancouver.

CardiAQ Valve Technologies is also developing a transcatheter mitral valve that uses a foreshortening frame designed to address the challenges of the mitral anatomy. It uses numerous proximal and distal anchors, which upon radial expansion causes the ends of the anchors on both ends to draw closer together.