Bryn Mawr Hospital, part of Main Line Health’s Lankenau Heart Institute, is the first center on the East Coast to enroll patients in the FDA-approved AMAZE clinical trial that is studying left atrial appendage (LAA) closure with the LARIAT Suture Delivery Device as an adjunct to ablation in patients with persistent and long-standing persistent atrial fibrillation (AF).
“This is a milestone in the treatment of atrial fibrillation” said Sheetal Chandhok, MD, Bryn Mawr Hospital cardiologist, part of Lankenau Heart Institute, who is one of the primary investigators and the first physician on the East Coast to enroll a patient in the trial. “AF is a life-changing disorder that causes devastating consequences, including stroke and congestive heart failure. Using the LARIAT device as an adjunct to conventional ablation could become the standard of care option for patients with persistent and/or long-standing persistent AF. Current ablation strategies for persistent atrial fibrillation which target the pulmonary veins are only successful between 20–40 percent of the time. The LAA has recently been shown to be an important trigger for atrial fibrillation and ablation of the LAA has been successful in reducing atrial fibrillation. The LARIAT device provides complete closure and electrical isolation of the LAA without the risks and difficulty associated with ablation, thus eliminating a potential source of AF.”
AF is an irregular heartbeat, a rapid heartbeat, or a quivering of the upper chambers of the heart, called the atria, due to a malfunction in the heart's electrical system. It is the most common heart rhythm disorder in the United States, affecting more than five million people. By causing rapid and irregular heart beats, AF can lead to fatigue, shortness of breath, palpitations, chest pain and weakening of the heart muscle called cardiomyopathy. In addition, atrial fibrillation can lead to two potentially life-threatening conditions: stroke and congestive heart failure.
“Lankenau Heart Institute’s participation in this trial is a testament to our commitment to serve as a leader in the prevention and treatment of cardiovascular disease in the region,” says William A Gray, System Chief of the Division of Cardiovascular Disease at Main Line Health and President of Lankenau Heart Institute. “The AMAZE trial enables us to study the benefits of using advanced technology to offer AF patients a treatment option that has the potential to improve quality of life by restoring normal electrical function of the heart. This is one example of the many research endeavors that Lankenau Heart Institute participates in as we work with our colleagues at other renowned institutions across the country to advance the field of cardiovascular medicine.”
In a recently published study, the LARIAT used as an adjunct to ablation in patients with persistent or long-standing persistent AF showed a 65 percent freedom from AF at one year versus 39 percent in patients with ablation only. Other studies have demonstrated that the LARIAT device not only closes the LAA mechanically, but can also isolate electrical activity within the LAA, a known trigger for AF, shown to contribute abnormal electrical activity in a significant percentage of patients. The objective of the AMAZE trial is to demonstrate that the LARIAT will reduce or eliminate these LAA triggers and when combined with PVI ablation will lead to a reduced incidence of recurrent AF compared to ablation alone, with a high safety profile.
The LARIAT is a permanent, non-implant solution to LAA closure that is being studied for its capabilities to both mechanically and electrically isolate the LAA in patients with AF. The LARIAT utilizes remote suture delivery to close the LAA from the outside of the heart in a precise and controlled manner without open surgery.
The AMAZE trial is a rigorously designed study to validate the mechanical and electrical isolation benefits of the LARIAT device. The study is comprised of two stages. The overall study plan is to enroll a maximum of 600 persistent or longstanding persistent AF patients who are candidates for PVI catheter ablation at up to 50 centers. The first stage of the AMAZE Trial will enroll up to 175 patients at 15 centers.
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.
About Bryn Mawr Hospital
Bryn Mawr Hospital, a member of Main Line Health, is a 234-bed, not-for-profit acute-care teaching hospital dedicated to helping the community stay well ahead on the path to lifelong health. Boasting a brand new Patient Pavilion that opened in February 2019, Bryn Mawr Hospital has received both regional and national recognition for its excellence in providing state-of-the-art, quality care. Bryn Mawr Hospital was named among the top 10 hospitals in the Philadelphia region, and the top 20 hospitals in Pennsylvania, in U.S. News & World Report’s Best Hospitals rankings for 2018–19, and Bryn Mawr Hospital has earned Magnet® designation for the third time for its superior nursing staff. The hospital offers a full range of services, including cancer care, orthopaedic care, cardiovascular care, behavioral health, maternity care, bariatric surgery, neurovascular and a level III neonatal intensive care unit, all aided by a dedicated team of health care professionals and innovative technologies. Through Bryn Mawr Hospital’s collaboration with the Jefferson Hospital for Neuroscience, the university-affiliated Neurovascular Center is an accredited thrombectomy-capable stroke center that offers rapid access to advanced diagnostics and treatment options for stroke care. Bryn Mawr Hospital has also collaborated with Nemours/Alfred I. duPont Hospital for Children to include round-the-clock pediatric care for the pediatric unit and in the pediatric emergency department with additional board-certified, fellowship trained pediatric emergency medicine physicians.