Seventy-five percent of those diagnosed are deemed high risk or ineligible for open-heart surgery – the standard therapy.
Mark Robbins, M.D., left, John Byrne, M.D., and David Zhao, M.D., perform the new trans-catheter valve-replacement procedure in Vanderbilt’s hybrid OR. (photo by Daniel Dubois)
Now, doctors at Vanderbilt are able to use a minimally invasive catheter procedure to help this group of patients. Fifteen patients are currently enrolled in the Medtronic CoreValve System U.S. Clinical Trial at Vanderbilt.
George Ellenberg, 85, of Crossville, Tenn., was VUMC’s first recipient of the novel valve replacement technique. Acceptance into the trial saved his life.
“There are no other options for this group of patients,” said David Zhao, M.D., director of the Cardiovascular Catherization Lab and Interventional Cardiology. “With this new procedure, there will be a 20 percent reduction in mortality. This is transformational technology and can potentially save thousands of lives.”
Ellenberg, who was discharged from Vanderbilt University Hospital earlier this month, feels “very fortunate” to be given another chance at life.
“He is doing wonderfully,” said Carol Ellenberg, his wife. “I really don’t know what we would have done had he not had this procedure. Over the last two months, his breathing was getting really, really bad. This was his only chance.”
Earlier this month, the VHVI team, comprised of Zhao, John Byrne, M.D., Joseph Fredi, M.D., Mark Robbins, M.D., and Marshall Crenshaw, M.D., successfully replaced valves in three patients and all are doing well.
The multi-disciplinary team also includes Lisa Mendes, M.D., Mike Baker, M.D., Robert Deegan, M.D., Susan Eagle, M.D., and teams from the cath lab and operating rooms. The procedures are performed in Vanderbilt’s hybrid OR.
A total of five cases have already been performed thus far. Zhao anticipates performing at least four valve replacement procedures a week using the newest technology.
The valve is a Nitinol-frame with hand-sewn bits of bovine heart tissue. Using trans-catheter aortic valve implantation, an artificial aortic heart valve is attached to a wire frame and guided by catheter through the groin to the heart.
Once in place, the wire frame expands, allowing the new aortic valve to open and begin to pump blood.
Compared to the four to six hours typical in open-heart surgeries, this procedure calls for a smaller incision and takes about 90 minutes to complete.
It is too soon to determine quantitative cost savings, but they will be substantial, according to Byrne, the William S. Stoney Professor and chair of the Department of Cardiac Surgery.
Major factors contributing to savings include reduced hospitalizations, lower infection rates and shortened procedural times.
“Although we don’t have the data yet, there will probably be a significant cost savings,” said Byrne. “The length of stay for patients who received the newest technology is three to four days compared to a seven to 10-day hospital stay for open heart procedures. This is the single most important and transformational advancement in cardiovascular care in more than 30 years,” he said.
Zhao and Byrne, principal investigators for the Vanderbilt trial, agree the non-surgical valve replacement technique will become a standard therapy in the next three to five years.
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