McGowan Institute for Regenerative Medicine
affiliated faculty members William Anderson, M.D. (pictured top), director of Interventional Cardiology at University of Pittsburgh Medical Center (UPMC), and Thomas Gleason, M.D. (pictured bottom), director of the Center for Thoracic Aortic Disease of the UPMC Department of Cardiothoracic Surgery, recently performed heart implants in the first patient in the Medtronic CoreValve® U.S. Clinical Trial. The purpose of the trial is to evaluate a non-surgical, less-invasive procedure as a treatment alternative to open-heart surgery for patients who suffer from a serious narrowing of the heart’s aortic valve. Drs. Anderson and Gleason are co-principal investigators of the UPMC trial.
UPMC is one of 40 hospitals across the U.S. to participate in the trial for patients with severe aortic stenosis, which prevents the heart’s aortic valve from opening completely and in turn hampers healthy blood flow from the aorta to the rest of the body. Untreated, it can lead to serious heart problems.
“Aortic stenosis frequently occurs in elderly patients who have a higher risk of complications from standard valve-replacement surgery. This growing patient population may then have the most to gain from new, less invasive, catheter-based approaches to the implantation of a new aortic valve. The trial will allow us to explore this possibility,” Dr. Anderson said.
“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,” Dr. Gleason said.
A 66-year-old man, from New Alexandria, Pa., was one of the first patients at UPMC to receive the CoreValve implant. He suffered shortness of breath, which worsened when climbing stairs, and required oxygen nearly around-the-clock because of his aortic stenosis.
In early 2011, physicians channeled a catheter through a small opening in his femoral artery to reach the heart. The physician then guided the CoreValve System to the aortic valve, where the valve self-expanded to replace the diseased aortic valve; the procedure was completed without open-heart surgery or surgical removal of the aortic valve.
“Now I’m practically not using oxygen at all,” the patient said.
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, the only therapy with significant clinical effect that currently is available in the United States.
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. The CoreValve System received CE (Conformité Européenne) Mark in Europe in 2007.
For more information about the Medtronic CoreValve U.S. Clinical Trial, visit their site
Information about the clinical trial is available
Illustration: McGowan Institute for Regenerative Medicine.
UPMC Media Relations News Release (03/21/11)
Bio: Dr. William Anderson
Bio: Dr. Thomas Gleason