WASHINGTON – Now that transcatheter aortic valve replacement is approved in the United States and there’s a proposal for its Medicare reimbursement, more centers and cardiologists are turning their attention to the procedure.
"Valves are perhaps not in their infancy, but at least in their adolescence," said Dr. Spencer B. King, a cardiologist at Saint Joseph’s Heart and Vascular Institute, Atlanta, during his presentation at a symposium where valve replacement procedures, including transcatheter aortic valve replacement (TAVR), took center stage. The symposium was sponsored by the Cardiovascular Research Institute at MedStar Washington (D.C.) Hospital Center.*
TAVR "is adding another dimension to what interventional cardiologists can do," said Dr. Ron Waksman, chair of this year’s program and director of experimental angioplasty and emerging technologies for the Cardiovascular Research Institute.
One of the main features of the procedure that was established early on as a necessity is the implementation of a "Heart Team," and its importance was stressed during the presentations about TAVR.
"It takes a multidisciplinary approach to get this on the right track," said Dr. Eberhard Grube, chief of cardiology and angiology at Helios Heart Centre in Siegburg, Germany, during his presentation. He noted the importance of a team approach to patient management before and after the procedure.
In addition to discussions about the TAVR technique and imaging, leaders discussed issues surrounding patient selection and criteria.
The procedure is currently approved only for inoperable patients with severe aortic stenosis, on the basis of the PARTNER trial’s cohort B population. This cohort is flanked by cohort C, or inoperable patients with several comorbidities, and cohort A, or high-risk patients. It is expected that TAVR will eventually be approved for high-risk patients, but experts expressed concern about the procedure creeping up toward the very sick cohort C–type patients, and called for better disability and comorbidity indices.
"We can always make the aortic valve better," said Dr. Michael J. Reardon, chief of cardiac surgery at the Methodist Hospital, Houston. "But where do you draw the red line?" he asked.
"I think one of the real signs of a mature TAVR program is the number of people it turns down," said Dr. Reardon. "Early on, we want to help everybody; but as the Heart Team realizes that we’re going to give [patients] a new valve – not a new body – we’re going to start turning more patients down. I think that will actually improve the perception of TAVR as a whole."
The valve’s durability also remains in question, especially if it is eventually used in younger patients with more years ahead of them.
Dr. Paul Corso, director of cardiac surgery at, and associate director of, the cardiology division at MedStar Washington Hospital Center, erred on the side of caution, citing premature excitement surrounding previous valves.
"Let’s not jump on the bandwagon," he said. "I love the idea that [TAVR] is being done and I think it has great promise ... but we don’t have the data."
Financing TAVR is another issue. The procedure’s Medicare reimbursement is still unclear. The Centers for Medicare and Medicaid Services has issued a coverage proposal, and it’s expected to issue a final decision in May.
"We’re still studying the document and understanding it," said Dr. Waksman, who is also associate director of the division of cardiology at MedStar Washington Hospital Center. "I think the societies and physicians like to work with CMS and like to work the FDA to find out what is logical, because hospitals won’t be able to carry the toll of financing without reimbursement, so we have to know exactly what the boundaries are."
CORRECTION: The name and location of the institution have been corrected.