A team of doctors with Piedmont Heart Institute’s Marcus Heart Valve Center performed the first REPRISE IV clinical trial Transcatheter Aortic Valve Replacement (TAVR) procedure in the United States using the LOTUS Edge Aortic Valve System for a patient with bicuspid valve disease. The LOTUS Edge valve is a medical device for patients with severe aortic valve stenosis, a narrowing of the aortic valve that affects 7% of all people older than age 65.
Christopher U. Meduri, M.D., an interventional cardiologist, is a national primary investigator for the REPRISE IV clinical trial, which is designed to evaluate the safety and effectiveness of the LOTUS Edge Valve System in patients who are considered at intermediate risk for surgical valve replacement. The device has U.S. Food and Drug Administration approval for high- or greater-risk patients.
The study is expected to enroll nearly 900 patients, with between 50 and 100 procedures performed at Piedmont Atlanta Hospital. Vivek Rajagopal, M.D., and James R. Kauten, M.D., program director of the Marcus Heart Valve Center, are also participating in the study, with Dr. Rajagopal serving as the local principal investigator.
“We are very excited that the Marcus Heart Valve Center was the first to use the LOTUS Edge Valve System for patients who have bicuspid valve disease,” Dr. Meduri said. “We believe the device could become best-in-class for bicuspid valve disease. With the new implant technique, the pacemaker rate should be minimized.”
As a non-surgical alternative for these patients, often with complex anatomical challenges, the LOTUS Edge valve is delivered via a minimally invasive procedure to restore proper valve function. Dr. Meduri said the procedure lasts between 35 and 40 minutes.
The Boston Scientific LOTUS Edge valve is the only aortic valve approved by the FDA that is 100% repositionable, which enables physicians to precisely place the new valve into an optimal position in the heart; thereby helping to improve outcomes for the patient. The device features a braided valve frame and an adaptive seal that minimizes paravalvular regurgitation or leaking (PVL) by conforming to the patient’s native aortic valve.
The only effective treatment for aortic valve stenosis is to replace the aortic valve. Left untreated, severe aortic stenosis can eventually lead to heart failure, severe infection and even sudden death.
The aortic valve, which is located between the heart’s left ventricle and the aorta, typically has three leaflets that ideally function like a one-way door, allowing blood to flow into the aorta but not backwards into the left ventricle. Patients with bicuspid aortic valves have only two leaflets, which can make TAVR procedures more challenging. Aortic valve disease occurs when the valve does not open or close properly, causing patients with the condition to suffer from a variety of symptoms, including breathlessness, chest pain, fainting, palpitations and decline in activity level.