Bryn Mawr Hospital, part of Main Line Health’s Lankenau Heart Institute, on August 18, 2020 became the first site in the world to successfully enroll a patient and complete the protocol in JANUS, a landmark clinical trial for sleep apnea. The trial seeks to explore whether transvenous stimulation can improve airway physiology. In this first patient, Sheetal Chandhok, MD, the investigator and implanting physician, was able to demonstrate feasibility in this novel approach for managing sleep apnea.
Sleep apnea---when prolonged pauses in breathing occur during sleep---is a serious health issue for many Americans. An estimated 22 million Americans suffer from some degree of sleep apnea, a condition that causes breathing to abruptly stop and restart during sleep. In addition to poor sleep quality, sleep apnea can lead to high blood pressure, heart failure, atrial fibrillation, stroke and other health issues.
The primary objective of the JANUS trial, sponsored by Respicardia, is to assess acute changes in respiration and airway physiology during sleep. The trial is being conducted in patients with central sleep apnea who are undergoing a Remedé system implant, which uses transvenous stimulation to reduce the periods of the breathing pauses. The JANUS trial is conducted during the implantation of commercially available device called the Remede® System, a diaphragm pacemaker that works to stimulate breathing in the same way that the brain would. The Remede® System was first implanted at Bryn Mawr Hospital by Dr. Sheetal Chandhok, a cardiac electrophysiologist, in January 2019.
“Central sleep apnea occurs when the brain temporarily stops sending signals to the muscles that control our breathing. When that happens, this pacemaker (the Remede® System) sends a signal to the phrenic (diaphragm) nerve to trigger breathing. This prevents the risk of interrupted breathing at night, and currently is the only approved treatment for central sleep apnea,” explains Sheetal Chandhok, MD, an electrophysiologist with Bryn Mawr Medical Specialists Association and a member of Lankenau Heart Institute. “In the JANUS trial we hope to show that an alternative transvenous lead location can affect respiration and airway physiology during a commercial Remedē® System implant procedure”.
Dr. Chandhok is one of three primary investigators for the JANUS trial and was the first clinician in the world to enroll a subject and complete the objective for the trial. “The potential success of JANUS trial may have far-reaching implications for a broader set of sleep apnea patients for whom there are only limited treatments,” he said.
The JANUS trial is currently enrolling subjects who are undergoing transvenous phrenic nerve stimulation for moderate to severe central sleep apnea using the Remedē® System. Participants must be over 18. To learn more about this trial or to enroll, visit clinicaltrials.gov.
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.
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 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.