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Lankenau Medical Center selected to participate in landmark clinical trial for severe aortic stenosis

Lankenau Medical Center October 6, 2016 News Releases

Lankenau Medical Center, part of Main Line Health’s Lankenau Heart Institute has been chosen to participate in PARTNER 3, a nationwide clinical trial that could transform the treatment of severe aortic stenosis. The focus of Edwards Lifesciences’ PARTNER 3 is TAVR, a non-surgical catheter-based therapy that has proven to be a safe and effective alternative to surgical aortic valve replacement in patients at moderate or higher risk for undergoing heart surgery. PARTNER 3 is the first large randomized clinical trial in the U.S. to assess whether these benefits also translate to patients at low risk for surgery.

Aortic stenosis is a narrowing of the valve that opens to let blood flow from the heart to the rest of the body. People with aortic stenosis usually have no symptoms until the disease has progressed and become life threatening, at which point valve replacement is usually recommended. Patients at low risk for surgery typically have low rates of complication from the valve replacement operation.

“The outcome of this trial could profoundly change treatment for many people suffering from aortic stenosis,” says interventional cardiologist Paul Coady, MD, Lankenau Heart Institute’s principal investigator for PARTNER 3. As he explains, “TAVR can significantly improve the quality of life for patients who suffer from the debilitating symptoms of aortic stenosis and the minimally invasive approach will allow these patients to recover more quickly than is possible with traditional treatment options.”

The aim of PARTNER 3 is to determine the safety and effectiveness of TAVR therapy using the SAPIEN 3 transcatheter heart valve in patients requiring aortic valve replacement and at low operative risk for surgical aortic valve replacement. The study will compare all forms of complications and rehospitalization rates with TAVR versus surgical aortic valve replacement at one year post-procedure.

Lankenau Heart Institute’s TAVR program is one of only a select the few programs in the nation chosen to participate in PARTNER 3 and is one of only two centers in the Philadelphia region.

“We’re gratified by the opportunity to contribute to this important research,” Dr. Coady says, speaking on behalf of Lankenau Heart Institute’s specialized team for structural heart disease. He says the team has worked hard to build a robust TAVR program, which has grown substantially since its launch in 2012 and is among the highest volume centers in the nation. “We just completed our 500th TAVR procedure, and we’re proud of the excellent patient outcomes we’ve achieved.”

Aortic stenosis usually develops later in life. Once symptoms start, the risk of death increases quickly—up to 50 percent of untreated patients die within two years of symptom onset. Although valve replacement is recommended for most patients with severe or symptomatic aortic stenosis, many who would benefit from the treatment do not undergo aortic valve replacement.

“One reason PARTNER 3 is important is because if it shows TAVR is safe and effective in low-risk patients, it could help break down barriers to non-surgical treatment,” says cardiac surgeon Scott Goldman, MD, surgical leader of Lankenau Heart Institute’s Structural Heart Program and a key member of the TAVR team.

In PARTNER 3, more than 1200 qualified low-risk patients will be enrolled and randomly assigned to treatment with TAVR or surgical aortic valve replacement. Study patients will be seen for follow-up at 30 days, six months, and one year post-procedure and then annually in years two through 10. Enrollment by Lankenau Heart Institute’s TAVR team began September 2016 and is occurring at Lankenau Medical Center. If evaluated as clinically appropriate, trial participants randomized to surgical aortic valve replacement will be offered a minimally invasive option.

To qualify for PARTNER 3, patients must have severe, calcific aortic stenosis and meet all study criteria. View the complete study criteria.

To learn more about PARTNER 3 or to discuss patient eligibility, please call 1.855.820.VALVE.

About Main Line Health

Founded in 1985,Main Line Health is a not-for-profit health system serving portions of Philadelphia and its western suburbs. Main Line Health’s commitment—to deliver advanced medicine to treat and cure disease while also playing an important role in prevention and disease management as well as training physicians and other health care providers—reflects our intent to keep our community and ourselves well ahead. A team of more than 10,000 employees and 2,000 physicians care for patients throughout the Main Line Health system.

At Main Line Health’s core are four of the region’s most respected acute care hospitals—Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital—as well as one of the nation’s recognized facilities for rehabilitative medicine, Bryn Mawr Rehabilitation Hospital.

Main Line Health also includes Mirmont Treatment Center for drug and alcohol recovery; Main Line Health HomeCare & Hospice, which includes skilled home health care, hospice and home infusion services; Main Line Health Centers, primary and specialty care, lab and radiology, and other outpatient services located in Broomall, Collegeville, Concordville, Exton, King of Prussia and Newtown Square; Lankenau Institute for Medical Research, a biomedical research organization; and Main Line HealthCare,one of the region’s largest multispecialty physician networks.

Main Line Health is the recipient of numerous awards for quality care and service, including System Magnet® designation, the nation’s highest distinction for nursing excellence and the Mid-Atlantic Alliance for Performance Excellence (MAAPE) Excellence Award. Main Line Health is committed to creating an environment of diversity, respect and inclusion and has proudly embraced the American Hospital Association’s #123forEquity Pledge to Act to eliminate disparities in care. We are dedicated to advancing patient-centered care, education and research to help our community stay healthy.

About Lankenau Heart Institute

The Lankenau Heart Institute is Main Line Health’s premier, comprehensive cardiovascular medicine and surgery program. The Lankenau Heart Institute brings together the clinical expertise of all four Main Line Health acute care hospitals and community cardiology practices to ensure that patients receive a level of quality, service, and experience that is unprecedented in the region. Through the system-wide coordination of services, the Lankenau Heart Institute delivers preventive, diagnostic, therapeutic, and rehabilitative cardiovascular services at each of our locations including Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital.

Lankenau Heart Institute continues to be a pioneer in the use of beating-heart techniques and robotic-assisted procedures for coronary artery revascularization, minimally invasive and transcatheter approaches for valve repair and replacement, and complex aortic surgeries. With our growing experience and focus on minimally invasive techniques, Lankenau Heart Institute has expanded participation in clinical trials year over year. Our physicians are frequently invited to participate in clinical/medical device trials, many of these designed to facilitate minimally invasive procedures/approaches.

With a collaborative team of expert consultative cardiologists, interventional cardiologists, electrophysiologists, cardiovascular surgeons and specially trained nurses and technologists, the Lankenau Heart Institute is dedicated to managing and treating patients with heart failure, aortic disease, coronary and peripheral vascular disease, heart rhythm disorders and valve disease. Our team of cardiologists and cardiac specialists provide patients and their families with expert cardiac care, close to home.