Allegheny General Hospital New Clinical Trial Explores Effectiveness of Non-Surgical Treatment for Low-Risk Patients with Aortic Valve Stenosis

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Allegheny General Hospital (AGH), part of Allegheny Health Network (AHN), is the only medical center in western Pennsylvania participating in a clinical trial to see if a less-invasive technique called transcatheter aortic valve replacement (TAVR) is as effective as open heart surgery for patients with severe aortic stenosis at low-risk for surgery.

Dr. Stephen Bailey

This trial has the potential to change the standard of care in low-risk patients.

Continuing its tradition of being at the forefront of cardiac care in the region, Allegheny General Hospital (AGH), part of Allegheny Health Network (AHN), is the only medical center in western Pennsylvania participating in a clinical trial to see if a less-invasive technique called transcatheter aortic valve replacement (TAVR) is as effective as open heart surgery for patients with severe aortic stenosis at low-risk for surgery.

The Edwards Lifesciences PARTNER 3 trial will include approximately 1,200 patients at up to 65 sites across the country, including AGH. Patients who qualify will receive the SAPIEN 3 valve via TAVR or undergo open heart surgical valve replacement, which is currently the standard of care.

“This trial has the potential to change the standard of care in low-risk patients,” said Stephen Bailey, MD, Director of Cardiac Surgery at AGH and the hospital’s principal investigator for the trial. “If TAVR is found to be an effective treatment alternative in this new subset of patients, it could expand its utilization considerably across the country. Patients will be followed for 10 years to help ensure that this newer approach has comparable, exceptional, long-term performance.”

Aortic stenosis – a severe narrowing of the aortic valve of the heart – forces the heart to work harder to push blood through the damaged aortic valve, eventually weakening the heart muscle. Aortic stenosis can cause fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), and cardiac arrest.

TAVR is a less-invasive treatment for heart valve disease that involves replacing the damaged aortic valve with a new one while the heart continues to beat on its own. The U.S. Food and Drug Administration (FDA) originally approved TAVR in 2011, providing a new viable option for patients with severe aortic stenosis at high-risk for undergoing open heart surgery. Last year, the FDA approved TAVR for patients with severe aortic stenosis at intermediate-risk for undergoing open heart surgery.

According to organizers of the PARTNER 3 trial, nearly 80 percent of all surgical aortic valve replacements (SAVR) are currently done in patients with severe aortic stenosis at low-risk for surgery.

“TAVR means no major chest incision, less pain, a shorter hospital stay and a quicker return to normal activity,” said David Lasorda, DO, Director of Interventional Cardiology at AGH. “It could become the new preferred approach for patients.”

In October, doctors at AGH performed the hospital’s 500th TAVR procedure, and in 2015 they were the first in western Pennsylvania to implant the latest-generation SAPIEN 3 transcatheter heart valve (THV), which includes a major design change to minimize leakage around the valve.

AGH was among the first medical centers in the country to offer two varieties of the minimally invasive valve replacement technique.

In transfemoral TAVR, the femoral artery serves as a conduit to access the heart. Surgeons make a small incision in the groin and use a catheter to guide the replacement valve through the femoral artery to the heart. With transapical or transaortic TAVR, a catheter is inserted through a small chest incision that provides direct access into the heart, providing a new option for patients with smaller or diseased peripheral blood vessels who may not be candidates for the transfemoral approach.

For more information about the trial at AGH, please contact Kenneth Rayl at kenneth.rayl(at)ahn.org or call 412.359.6860.

About Allegheny Health Network

Allegheny Health Network, part of Highmark Health, is an integrated healthcare delivery system serving the Western Pennsylvania region. The Network is comprised of eight hospitals, including its flagship academic medical center Allegheny General Hospital, Allegheny Valley Hospital, Canonsburg Hospital, Forbes Hospital, Jefferson Hospital, Saint Vincent Hospital, Westfield Memorial Hospital and West Penn Hospital; a research institute; Health + Wellness Pavilions; an employed physician organization, home and community based health services and a group purchasing organization. The Network employs approximately 17,000 people and has more than 2,400 physicians on its medical staff. The Network also serves as a clinical campus for Temple University School of Medicine, Drexel University College of Medicine and the Lake Erie College of Osteopathic Medicine.

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Doug Braunsdorf
Allegheny Health Network
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