Des Moines, IA – August 17 – Iowa Heart Center, a member of Mercy Medical Center – Des Moines and the largest provider of cardiovascular care in Iowa, today announced its first patient implants in the Medtronic CoreValve® U.S. Clinical Trial. Mercy is the only site in Iowa, and one of 40 hospitals across the U.S., to participate in the trial evaluating a revolutionary non-surgical, less-invasive procedure as a treatment alternative to open-heart surgery for patients with severe aortic stenosis.
A 95-year-old male from South Dakota was the first patient at Mercy to receive the CoreValve replacement valve on July 15. He suffers from aortic stenosis, which prevents the heart’s aortic valve from opening completely, thereby preventing healthy blood flow from the aorta to the rest of the body. Untreated, aortic valve stenosis leads to serious heart problems. A 78-year-old female from Des Moines was also implanted the same day.
“There is significant need for a new treatment option for patients with aortic stenosis, and it is enormously rewarding that Mercy and Iowa Heart Center can be part of evaluating this revolutionary new treatment option in our community,” said Atul Chawla, M.D., interventional cardiologist and primary investigator in the clinical trial. “As the population ages, the need for this procedure will continue to grow, as aortic stenosis is a condition that develops with age, and many people who are otherwise healthy could benefit significantly.”
Worldwide, approximately 300,000 people have been diagnosed with this condition (100,000 in the U.S.), and approximately one-third of these patients are deemed at too high a risk for open-heart surgery,[i] the only therapy with significant clinical effect that is currently available in the United States.
In the clinical trial, physicians channel a catheter (thin tube) with a prosthetic valve through a small opening in the patient’s femoral artery to reach the heart. The physician guides the CoreValve System to the aortic valve, where it self-expands to replace the diseased aortic valve; the procedure is completed without open-heart surgery or surgical removal of the native valve.
In the U.S., the CoreValve System will not be commercially available until the successful completion of this clinical trial and approval by the U.S. Food and Drug Administration (FDA). The CoreValve System received CE (Conformité Européenne) Mark in Europe in 2007.
“Because open-heart surgery is currently the only available treatment option for these patients, and because the risks of surgery can be significant for many patients, the medical community is enthusiastic about the less-invasive option for these patients,” said Dr. Chawla.
For more information about the Medtronic CoreValve U.S. Clinical Trial, see www.aorticstenosistrial.com or call (515) 802-4057.
About Aortic Stenosis
Aortic stenosis, which is most prevalent in the elderly population, inhibits blood flow between the heart and the body and causes symptoms such as shortness of breath, chest pain, fatigue and heart palpitations. While the heart initially compensates for stenosis by thickening its walls to help push blood through the valve, eventually this extra work weakens the heart and leads to an insufficient supply of oxygen-rich blood and sometimes causes a back-up of blood into the lungs. Untreated, aortic valve stenosis can lead to serious heart problems including heart failure and even death. Other than surgery, patients with this condition have had few, if any, successful treatment options.
[i] Iung B, Cachier A, Baron G, et al. Decision-making in elderly patients with severe aortic stenosis: Why are so many denied surgery? Eur Heart J. 2003;26:2714-2720.