Rutgers Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital (RWJUH) recently treated their first patient with a next generation investigational transcatheter heart valve designed to treat mitral regurgitation as part of a new clinical trial – The ENCIRCLE Clinical Trial studies the Edwards SAPIEN M3 system – an investigational device to replace the mitral valve in patients with severe mitral regurgitation.
It was the first procedure in this trial performed in the New York-New Jersey area.
With their participation in this clinical trial, Rutgers-RWJMS and Robert Wood Johnson University Hospital now have the capacity to offer this minimally invasive treatment option to patients who meet the inclusion/exclusion criteria.
Mitral regurgitation (MR) is a condition where there is a leak in the mitral valve. It is one of the most common heart valve diseases. A leak in the mitral valve occurs when the leaflets, or flaps, of the mitral valve do not close completely, allowing blood to flow back into the heart as it pumps. The heart has to work harder, as a result, to keep blood flowing and can raise the risk for life-threatening stroke and heart failure. When MR becomes severe, it can profoundly affect a person’s quality of life by causing shortness of breath, extreme fatigue, and other debilitating symptoms. If left untreated, MR can ultimately lead to heart failure and death.
The SAPIEN M3 system is designed to replace the mitral valve through a minimally invasive procedure called transcatheter mitral valve replacement. The system has two parts: the SAPIEN M3 dock, which is designed to encircle the native mitral valve to provide a suitable anchoring location for the SAPIEN M3 valve; and the SAPIEN M3 valve, which is a bioprosthetic valve adapted for use in the mitral position.
“Rutgers Robert Wood Johnson Medical School and Robert Wood Johnson University Hospital continue to serve as a national leader in treating valve disease. Our focus on less invasive approaches and rapid recovery have helped us maintain outcomes that far exceed national benchmarks in safety, life expectancy, and risks of complications,” said Dr. Leonard Lee, chair and professor of Surgery at Rutgers Robert Wood Johnson Medical School and Chief of Surgical Services at RWJUH.
“While transcatheter aortic valve replacement has become commonplace, there is currently no FDA- approved catheter-based replacement device for treating mitral valve disease. By providing a potentially groundbreaking therapy, the SAPIEN M3 valve may change the paradigm for the treatment of mitral regurgitation,” Dr. Mark Russo professor of Surgery and Chief of Cardiac Surgery at Rutgers Robert Wood Johnson Medical School and a Cardiac Surgeon at RWJUH and a member of RWJBarnabas Health Medical Group said. “As one of only a few sites in the region—and the first in New Jersey—to able to offer this important therapy, Robert Wood Johnson University Hospital continues to pioneer new treatments in an effort to offer life saving therapies for more patients in our communities.”