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Lankenau Heart Institute first in the Philadelphia region to treat patient in landmark transcatheter mitral valve replacement (TMVR) pivotal trial

August 13, 2018 Research News

Global APOLLO trial now underway at Lankenau Medical Center with the Intrepid™ TMVR system for patients with severe mitral regurgitation

Main Line Health’s Lankenau Heart Institute is the first in the Philadelphia region to treat a patient in the APOLLO trial—the pivotal trial designed to evaluate the Intrepid™ TMVR system in patients with severe, symptomatic mitral valve regurgitation. As the first-ever pivotal trial for a non-surgical transcatheter mitral valve replacement therapy, the study will evaluate the safety and efficacy of the Intrepid TMVR system in up to 1,200 patients globally.

The first patient treated at Lankenau Heart Institute was implanted by Scott Goldman, MD, director, Structural Heart Program, Lankenau Heart Institute; William Gray, MD, system chief of the division of cardiovascular disease and president of Lankenau Heart Institute; and Sandra Abramson, MD, director, cardiovascular imaging, Lankenau Medical Center.

“We are thrilled to be participating in the APOLLO trial, and hope that this study will prove to be beneficial for patients suffering with severe mitral valve regurgitation,” says Dr. Goldman, who also serves as principal investigator of the trial. “As a leader of cardiac care in the region, Lankenau Heart Institute is honored to be selected as one of only 60 sites worldwide to participate in the trial, further fulfilling our commitment to provide the Philadelphia region with the most advanced heart therapies available.”

Mitral regurgitation occurs when the mitral valve fails to close adequately and allows blood to leak backward each time the heart beats. If left untreated, mitral regurgitation can lead to heart failure or death. The definitive treatment is open heart surgery and valve repair or replacement, but since many of these patients are older and have other medical illnesses, the risk of such surgery can be significant.

The Intrepid TMVR system allows treatment without an open-heart procedure. The valve is a self-expanding replacement tissue heart valve that enables a catheter-based implantation. The Intrepid valve is compressed inside a hollow delivery catheter and is inserted between the ribs to enter the heart. The new replacement valve is expanded directly into the malfunctioning mitral valve without the need for additional sutures, tethers, or anchors.

“It’s exciting to have the prospect of new technology to arm physicians with when treating mitral valve regurgitation,” says Dr. Gray, who also serves as co-investigator of the trial. “Advances in cardiac treatment such as this will help us to expand the scope of what we can do using interventional approaches for patients with cardiovascular diseases.”

The APOLLO trial design consists of two groups and will be conducted at up to 60 sites to evaluate these two distinct patient populations. The primary endpoint of the trial is a composite endpoint rate of all-cause mortality, all-stroke, reoperation (or reintervention) and cardiovascular hospitalization at one year with secondary endpoints that measure quality of life and valve performance in patients with severe symptomatic mitral regurgitation.

The Intrepid TMVR system is available for investigational use only and it is not approved for use outside of clinical research studies. Other structural heart team physicians included in the trial: Paul Coady, MD; Eric Gnall, DO; Kate Hawthorne, MD; and Roberto Rodriguez, MD.

About Main Line Health

Founded in 1985, Main Line Health is a not-for-profit health system serving Philadelphia and its western suburbs. Main Line Health's commitment—to deliver advanced medicine for treating and curing disease, playing an important role in prevention and disease management as well as training physicians and other health care providers—reflects our intent to be the region's premier choice for clinical care, research, and education. A team of more than 10,000 employees, 3,000 nurses 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 premier 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 U.S. News & World Report's Best Hospitals, 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, equity, and inclusion, has proudly received awards in this area and has 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 patients stay healthy and live their best lives.

For more information, visit mainlinehealth.org and connect with us on social media:

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About Lankenau Heart Institute

The Lankenau Heart Institute is Main Line Health's premier, comprehensive cardiovascular medicine and surgery program. 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, 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 an innovator 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, complex aortic surgery and heart rhythm disorders. 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 and expand the use of minimally invasive approaches and procedures.

With a collaborative team of expert consultative cardiologists, interventional cardiologists, electrophysiologists, cardiovascular surgeons and specially trained advance practice nurses and technologists, Lankenau Heart Institute is dedicated to managing and treating patients with simple to complex cardiovascular disease, including 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.