Miami Cardiac & Vascular Institute Performs Rare Replacement of Mitral Valve as Part of Major Clinical Trial

A critically ill male patient in his 70s underwent a rare, minimally invasive procedure at Miami Cardiac & Vascular Institute to replace his diseased mitral valve, which separates the two chambers (atrium and ventricle) of the left side of the heart.

TheTranscatheter Mitral Valve Implantation (TMVI) was done using the Tendynesystem from Abbott. Miami Cardiac & Vascular Institute is one of 80 sitesworldwide taking part in the landmark SUMMIT clinical trial that will likelylead to regulatory approval of this procedure in the U.S. The Institute is thefirst in Florida to replace mitral valve using Tendyne.

Abbott's MitraClip is already an approved device torepair a leaking mitral valve. The Institute also took a leading role inimplanting the device to test its effectiveness.

Whileminimally invasive, aortic valve replacements, or TAVR, have been widely performedfor years, there are currently no approved minimally invasive therapies toreplace the mitral valve. Surgically speaking, the mitral valve is much morechallenging to repair and replace than the aortic valve.

"It's avery active area of research and this is the first trial using a specificreplacement valve for the mitral valve," says Ramon Quesada, M.D., medical director of Structural Heartand Complex Percutaneous Coronary Intervention at Miami Cardiac & VascularInstitute."This is very important because there are many patients that will requirethis procedure."

Dr. Quesada is principal investigator for the Institute on the SUMMIT trial. Niberto Moreno, M.D., cardiothoracic surgeon and chief emeritus of cardiovascular surgery at the Institute, was the surgeon in the mitral valve replacement. Interventional cardiologist Bernardo Lopez-Sanabria, M.D., who is on the SUMMIT trial team, also took part in the procedure.

The patient, who is recovering well, was suffering from severe mitral valve regurgitation (MR) — also called mitral insufficiency — a progressive and life-threatening condition in which the heart's mitral valve doesn't close tightly, allowing blood to flow backward within the heart. It can lead to heart failure and death.

At least 40patients were screened as possible candidates for the mitral valve replacement.A man in his 70s with a very poor prognosis was selected for the procedure inMarch, but it was delayed because of the coronavirus pandemic.

"So,he's been patiently waiting for months until now," says Dr. Quesada."Finally, he underwent the mitral valve replacement and it was verysuccessful. He has no leak in the valve. He had the combination of severemitral insufficiency and moderate mitral stenosis. Years ago, he had an aorticvalve replaced surgically -- and he had multiple comorbidities (more than onedisease/condition is present in a person at the same time).”

How is theTMVI procedure performed? The surgeon, in this case Dr. Moreno, does what iscalled a trans-apical incision to gain access into the heart's ventricle. This techniquerequires a highly skillful puncture, explains Dr. Quesada. Then, with crucialguidance from echocardiogram real-time imaging, the new valve is positioned anddeployed. The apical puncture is closed and the patient immediately experiencesdramatic improvements in reducing mitral regurgitation – in this case down tozero.

The TMVIsystem is the first and only mitral valve replacement device that can berepositioned and fully retrieved. Dr. Quesada says the Institute's patientexperienced "no leakage" -- or mitral valve regurgitation -- afterhis procedure. No leakage is rare after traditional surgical repairs to themitral valve.

Dr. Quesadastresses the vital teamwork was involved in this landmark procedure. While itmay be largely surgical, it is a team effort requiring close collaboration andcoordination among the research staff, the interventional cardiologists,anesthesia, cardiothoracic surgery, and the echocardiogram imagingcardiologist.

Moreover,Miami Cardiac & Vascular Institute has done pioneering structural heartprocedures for several years and has developed the necessary experience andstructure to provide this rare procedure in the future.

"Thisis not a technological breakthrough that's going to be done in every hospitalin the U.S.," he explains. "That's because it requires a substantialamount of dedication, expertise and an infrastructure. There's no question. Itwill be limited."