For High-Risk Heart Patients, A New Valve-In-Valve Procedure Via Catheter
Heart & Vascular Institute patients who are too ill for open-heart surgery now have access to the expanded use of a heart-valve replacement technology.
The first successful procedure happened at Hartford Hospital in August 2017, just two months after the expanded use received approval from the Food and Drug Administration.
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 FDA’s approval applies 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, “and only for patients who have already undergone previous surgical mitral valve replacement.”
The Sapien 3 Transcatheter Heart Valve from Edwards Lifesciences.
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 use in inoperable patients and in October 2012 for use in high-risk patients. The procedure, which places a new aortic valve within the existing valve, is also being used now in moderate-risk cases.