In the past, the best such patients could hope for was to control their symptoms with medications.
Now they can live longer thanks to a new minimally invasive treatment that involves inserting an artificial valve that takes over the work of the diseased valve. The University of Florida is among a limited number of facilities around the country initially approved to offer the procedure.
“It’s exciting — this technology opens an option for patients who otherwise do not have a repair option,” said cardiologist Dr. Anthony A. Bavry, an assistant professor in the UF College of Medicine’s department of medicine. “Previously we had to treat these patients with medications, and unfortunately many did not do well. This is a big change.”
The new valve replacement technique, called transcatheter aortic valve replacement, or TAVR, was approved by the U.S. Food and Drug Administration in November 2011. Medical practices approved to perform the procedure had to demonstrate high levels of expertise and collaboration in cardiology and surgery, as well as high-quality facilities for conducting the procedure and collecting data for patient care and monitoring.
Bavry and Dr. R. David Anderson, director of interventional cardiology at UF, will team with thoracic and cardiovascular surgeons Dr. Thomas M. Beaver, and Dr. Charles T. Klodell, to do the procedure at UF&Shands, the University of Florida Academic Health Center. Working in such multidisciplinary teams streamlines and speeds patient evaluation and decisions about the best course of action.
“You have both a surgeon and a cardiologist seeing a patient, reviewing the data and making the best decision about how to treat,” Bavry said.
Among the elderly, severe aortic stenosis is the most common abnormality of the heart valves. But up to one-third of such patients are considered ineligible for surgery. They are instead given medicines to control heart rate and blood pressure, and their heart volume is monitored in order to head off congestive heart failure. Medical treatments ease symptoms but do not prolong life.
In the new TAVR procedure, the artificial valve — framed by a stent and wrapped around a balloon — is transported up to the aortic valve via a large catheter in the leg. The new valve is then anchored into position inside the diseased valve by inflation of the balloon. Placement of the stent is monitored with X-ray and ultrasound imaging.
Patients’ survival chances improve with the new technique. In clinical trials involving 700 patients, treatment with the new procedure cut the death rate nearly in half after one year of having the implanted device, compared with medical therapy alone.
“This is one of the best things that has happened in the last 10 years in interventional cardiology,” said Dr. Samir Kapadia, an interventional cardiologist at the Cleveland Clinic who is one of the leaders in clinical trials of the new technique. “Procedurally, it’s like a miracle — patients are sick, you do the critical part of the valve replacement in 15 to 30 seconds and all of a sudden the heart starts working more efficiently. It has changed the way we do things and has provided treatment options for lots of people who did not have an option before.”
The procedure has also been compared with traditional open surgery in patients who were operable but had a high risk of dying if they did have surgery. After a year, patient outcomes were comparable to those of surgery patients. Additional studies are being carried out to see how the procedure works among patients who are at lower risk of death if they have surgery.
The UF team has begun evaluating patients to see who might be good candidates for the procedure. Tests include chest CT scans, cardiac catheterization and EKGs. They are also reaching out to physicians whose patients might benefit.
Research continues on new ways to insert the valve, as well as on new types of valves, including one that can be repositioned after it has been placed inside the body.
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