Heart failure patients with secondary mitral regurgitation who remain symptomatic despite optimized medical therapy face a poor prognosis. Now, Froedtert & the Medical College of Wisconsin Froedtert Hospital is able to extend its expertise in valvular repair to offer these patients MitraClip®, a promising new option.
The Food and Drug Administration recently approved transcatheter mitral-valve repair with MitraClip for patients who develop heart failure symptoms and moderate-to-severe or severe functional mitral regurgitation.
Functional vs. degenerative mitral regurgitation
Functional mitral regurgitation is distinct from degenerative mitral regurgitation, the indication MitraClip was originally approved to treat in 2013.
“With functional mitral regurgitation, the leaflets are anatomically normal but the heart muscle is not,” said Michael Salinger, MD, medical director of structural heart disease and MCW faculty member. “It usually involves stretching or dilatation of the annulus, so the leaflets don’t touch each other to seal.”
The heart muscle can become damaged from ischemic causes, as well as nonischemic causes, such as viral infections or certain infiltrative diseases. Leakage of blood backward through the mitral valve into the heart’s left atrium can cause heart failure symptoms, including shortness of breath, fatigue and swelling of the legs.
The expanded indication for MitraClip treatment will build on experience the Froedtert & MCW health network has in using MitraClip in patients with primary or degenerative mitral regurgitation.
A dramatic response
Dr. Salinger was part of the team that implanted the first MitraClip in the U.S., and he participated in the COAPT Trial (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation) that led to the new FDA indication for MitraClip. The trial, which enrolled 614 patients and was presented in September 2018, demonstrated a dramatic response of functional regurgitation to MitraClip.
“The multicenter trial showed a 50% reduction in the need for hospitalization for the next two years and a 50% improvement in the reduction in mortality over that period of time,” Dr. Salinger said. “It was heralded as a ‘home run’ study for functional mitral regurgitation.”
Before patients within this new indication are considered for MitraClip treatment, they should receive the maximum guideline-directed heart failure medical therapy. “This includes heart failure medications, and, in certain patients, rhythm resynchronization and biventricular pacing,” Dr. Salinger said.
For eligible patients, procedure planning involves a dedicated MitraClip transesophageal echocardiogram. Patients also should have a regurgitation of 3-4+, an ejection fraction >20%, and a left ventricle end-systolic dimension of less than 7 cm.
The MitraClip procedure
Placement of MitraClip is a minimally invasive, catheter-based procedure. Physicians enter through the femoral vein and guide MitraClip, a dime-sized device, into the heart’s left ventricle. There, it clasps the two leaflets of the mitral valve together, reducing the leakage of blood.
“It’s like two drapes that flap in the wind and don’t close properly,” Dr. Salinger said. “We pin them in the middle, which is what MitraClip does, and they don’t flap in the wind. The collagen-rich structure of the mitral valve gives it a great deal of strength to distribute the forces equally on the sides of the clip.”
MitraClip is just one of many leading-edge options — both clinical and investigational — available to heart patients at Froedtert Hospital.
“We welcome the opportunity to evaluate any patient with valvular heart concerns,” Dr. Salinger said. “We are a comprehensive valve program with a multidisciplinary team committed to providing our patients with the best evidence-based care.”
For Our Referring Physicians:
Multidisciplinary advantage to treating heart failure patients
The Froedtert & MCW health network gives patients and their referring physicians a distinct advantage.
Contact our physician liaison team for more information about our vascular and endovascular services or if you would be interested in meeting with any of the vascular surgeons.