Groundbreaking Heart Valve Procedure Tested by Dauerman and Colleagues Gains FDA Approval
- By Michael Carrese
A procedure tested during a clinical trial at the University of Vermont and Fletcher Allen Health Care to replace heart valves using catheters instead of open heart surgery has received approval from the Food and Drug Administration for use in two categories of patients. The American Heart Association and the American College of Cardiology have also added Transcatheter Aortic Valve Replacement (TAVR) to their guidelines.
Severe narrowing of the aortic valve can lead to chest pain, shortness of breath and death due to heart failure. Thirty percent of patients diagnosed with this condition are not eligible for surgery and there are no other successful treatment options, leading to a mortality rate of 50 percent within one year of diagnosis. In addition to the significant drop in mortality for inoperable patients undergoing TAVR (also known as TAVI), rates were reduced in high risk patients as compared to standard open heart surgery.
Due to UVM/Fletcher Allen’s participation in the Medtronic CoreValve® U.S. Pivotal Trial in 2012, patients from Vermont and northern New York who had failing heart valves but could not tolerate open heart surgery (the current standard of care for valve replacement) or were at “high risk” for complications or death during surgery were among the first in the country to receive this groundbreaking treatment. The Burlington, Vt., site was one of only 45 sites in trial, which produced these results:
- TAVR was proven to be safe and effective in inoperable patients
- TAVR was found to be superior to surgical aortic valve replacement in high risk patients (those with at least a 15 percent risk of mortality or serious complications within 30 days of surgery).
- Mortality was cut in half in inoperable patients
During TAVR, an artificial valve is placed on a catheter and is advanced to the heart from a vessel in the leg or chest, similar to what happens when inserting a stent. When the new valve is released, it pushes the diseased valve out of the way and begins functioning immediately. Benefits over open heart surgery include quicker recovery time.
“TAVR is truly a lifesaving treatment and we’re very pleased the Fletcher Allen heart team was involved in determining its effectiveness,” said Harry Dauerman, M.D., UVM professor of medicine and an interventional cardiologist at Fletcher Allen. “It’s a great example of the value of having an academic medical center in our region – we not only have the expertise and resources to deliver the most advanced treatments, but we are also involved in developing them.”
“The TAVR trial demonstrates great teamwork among our interventional cardiologists and cardiothoracic service, and the strong coordination we have among members of Fletcher Allen Partners (Central Vermont Medical Center, CVPH Medical Center and Elizabethtown Hospital), as well as nearly all of the other hospitals in our region who referred patients,” said David Schneider, M.D., director of Cardiovascular Services at Fletcher Allen Partners and professor at the UVM College of Medicine.
In addition to the FDA approvals, TAVR was recently incorporated into the valvular heart disease guidelines of the American Heart Association and American College of Cardiology for patients who are inoperable or high risk for surgery and would be expected to survive longer than a year after an intervention. Surgical valve replacement remains the recommended option for patients with low or intermediate surgical risk.
Fletcher Allen and UVM are currently enrolling patients in a national, randomized clinical trial comparing the safety and effectiveness of TAVR versus standard surgery in these lower risk patients. For more information on this trial, contact the Cardiology Research office at (802) 847-4746.
For more information on TAVR treatment at Fletcher Allen visit www.fletcherallen.org/TAVI