Transcatheter Mitral Valve Replacement, or TMVR, allows doctors to replace a malfunctioning mitral valve -- either the patient's own or bioprosthetic valve from a previous surgery -- using a small tube called a catheter inserted into a large vein in the groin instead of conventional open-heart surgery.
The expanded use of this heart-valve replacement technology for patients too ill for open-heart surgery, approved in June 2017 by the Food and Drug Administration, was adopted quickly by doctors at the Heart & Vascular Institute. The FDA's approval applied specifically to the Sapien 3 Transcatheter Heart Valve from Edwards Lifesciences.
"Approval is limited to patients who are deemed a high risk for repeat open-heart surgery," says Dr. Raymond McKay, one of the doctors who performed the first TMVR procedure at the Heart & Vascular Institute in August 2017, "and only for patients who have already undergone previous surgical mitral valve replacement."
The mitral valve, two flaps between the left atrium and left ventricle, controls blood flow between the two chambers. It's a one-way valve, allowing blood from the left atrium into the left ventricle while preventing the reverse flow into the left ventricle. Mitral valve regurgitation, when the valve doesn't close properly and allows backward blood flow, can cause shortness of breath, fatigue, swollen ankles or feet and heart palpitations.
TMVR uses the same technology as as the Transcatheter Aortic Valve Replacement, or TAVR, approved by the FDA in November 2011 for inoperable patient with aortic stenosis. The TMVR procedure, places a new mitral valve within the existing surgically replaced valve.
This minimally invasive approach allows patients to avoid another open-heart surgery.