Fletcher Allen, a Vermont university hospital and medical center, serves all of
Vermont and the northern New York region. Located in Burlington, Fletcher Allen is a regional, academic healthcare center and teaching hospital in alliance with the University of Vermont.
New Heart Surgery Clinical Trial (TAVI)
Fletcher Allen Begins New Heart Surgery Trial
On February 22, 2012 a team of specialists led by Dr. Harold Dauerman and Dr. Joseph Schmoker replaced the aortic valves of two patients at Fletcher Allen Health Care. Fletcher Allen is one of a select group of clinical sites now participating in a new U.S. clinical trial to evaluate a revolutionary treatment for a common heart disease, severe aortic stenosis. These procedures are part of a research study that is designed to determine whether this treatment can be approved for use in the U.S.
What is aortic stenosis?
Primarily affecting the older population, aortic stenosis is a heart condition that occurs when the aortic valve does not properly open and close. Normally, the aortic valve opens when the left ventricle contracts to send blood throughout the body. Wear and tear on that valve can lead to scarring that causes thickening and calcification. This process reduces flexibility of the valve and limits its ability to open. As the severity of the thickening gets worse, the heart must work harder and harder to open the valve.
What symptoms can you expect, and what are the outcomes?
This condition restricts blood flow from the heart to the rest of the body. The reduced blood flow increases pressure within the heart, causing the heart to weaken and function poorly. Symptoms of the disease can include fatigue, dizziness, chest pain or pressure, heart murmur, shortness of breath during activity, heart palpitations and fainting.
When aortic stenosis becomes severe and symptoms develop, it is life-threatening. According to research, without effective treatment, as many as 50 percent of aortic stenosis patients with severe symptoms die within one year. Approximately 100,000 Americans and 300,000 people worldwide have been diagnosed with severe aortic stenosis, and approximately one-third of these patients are deemed at too high a risk for open-heart surgery.
What are your treatment options?
We are fortunate that skilled surgeons can replace these valves with prosthetic valves that work very effectively. The surgery is life-saving, but the rigors of open-heart surgery are too much for some people, especially some older individuals. For those individuals in whom the risk of surgery was too great, no options were available until now.
Introducing TAVI: a minimally-invasive treatment option being evaluated at Fletcher Allen
Fletcher Allen is one of only 45 hospitals nationally that is taking part in the TAVI (transcatheter aortic valve implantation) research study sponsored by Medtronic to evaluate whether the CoreValve System can be approved for use in the U.S. for treating older patients with aortic stenosis.
During the TAVI procedure, a prosthetic valve device is advanced to the heart from a vessel in the leg of a patient called the femoral artery. First the device is compressed and loaded into a thin tube called a catheter and inserted into the opening in the femoral artery. While the heart is beating, this valve is carefully threaded up through the body and positioned inside the patient’s native aortic valve. When released, this valve expands spontaneously and takes over the function of the aortic valve.
Recovery from this procedure is much shorter than open-heart surgery, because the heart has not been stopped and the chest has not been opened in the manner necessary to replace the aortic valve surgically.
Where can you learn more?
The Heart Team at Fletcher Allen is participating in a clinical trial evaluating this potentially life-saving therapy to patients in our region. If you are interested in learning more about the clinical trial, please contact the Cardiology Research Office at (802) 847-4746. Additional information about the U.S. CoreValve study is available at www.clinicaltrials.gov and www.aorticstenosistrial.com.