New Edwards Partner 3 Trial will evaluate TAVR as treatment option in patients at low risk for surgery
(Wynnewood, PA October 6, 2016)—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 1-year post-procedure.
Lankenau Heart Institute’s TAVR program is one of only a select thefew 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’veachieved.”
Aortic stenosis usually develops later in life. Once symptoms start, the risk of death increases quickly—up to 50% of untreated patients diewithin 2 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. Complete study criteria are available at: mainlinehealth.org/tavrtrial.
To learn more about PARTNER 3 or to discuss patient eligibility, please contact PARTNER 3 Study Coordinator Jennifer Porter, RN, at484.476.8085 or Lankenau Heart Institute Structural Heart Program Coordinator Lisa Igidbashian, CRNP, at 610.547.8184.
About Main Line Health
Founded in 1985, Main Line Health (MLH) is a not-for-profit health system serving portions of Philadelphia and its western suburbs. At its core are four of the region’s respected acute care hospitals—Lankenau Medical Center, Bryn Mawr Hospital, Paoli Hospital and Riddle Hospital—as well as one of the nation’s premier facilities for rehabilitative medicine, Bryn Mawr Rehabilitation Hospital; Mirmont Treatment Center for drug and alcohol recovery; and Main Line Health HomeCare & Hospice, a home health service. Main Line Health also consists of Main Line HealthCare, one of the region’s largest multi-specialty physician networks, and the Lankenau Institute for Medical Research, a non-profit biomedical research organization located on the campus of Lankenau Medical Center. Main Line Health is also comprised of four outpatient health centers located in Broomall, Collegeville, Exton and Newtown Square.
Main Line Health hospitals, with more than 10,000 employees and 2,000 physicians, are the recipients of numerous awards for quality care and service, including System Magnet® designation, the nation’s highest distinction for nursing excellence, and being named among the nation’s best employers by Forbes magazine. Main Line Health is among the area’s leaders in medicine, providing advanced patient-centered care, education and research to help our community stay healthy.
About Lankenau Heart Institute
The Lankenau Heart Institute is Main Line Health System’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.
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.