With more than a half dozen clinical trials under its belt, a record-breaking number of procedures performed, a partnership with the National Heart, Lung and Blood Institute, and a growing multidisciplinary team on board, MHVI is among the nation’s premier centers for transcatheter aortic valve replacement (TAVR).
As more patients become viable candidates for the procedure, experience matters. MHVI has been the site for every major clinical trial testing TAVR’s efficiency for more than a decade. Specialists perform nearly 500 TAVR procedures each year. In the pages that follow, we share how our robust team of providers work closely with each other, with referring physicians, and with patients, to continue to pioneer new ways to improve processes toward achieving superior outcomes.
TAVR Process Streamlined for Best Outcomes and Patient Satisfaction
Despite the full array of commercial and experimental devices available, and the various techniques we employ, the process in evaluating patients for TAVR must be customized by our team. From evaluation to treatment, the process takes two to three weeks.
Increasing Usage Across the Risk Spectrum
MedStar Heart & Vascular Institute has set the standard of care and played a critical role in advancing technology and expanding the use of TAVR for an increasing subset of patients. This began with participation in the 2007 PARTNER I study, which led to the U.S. Food & Drug Administration approval for the application of TAVR in otherwise inoperable patients. In subsequent studies, MHVI played a lead role in testing updated devices and innovative approaches. The CoreValve® study opened the door to TAVR for thousands more patients—those at intermediate risk for morbidity and mortality during open surgery. In 2018, results of the prospective multicenter Low-Risk TAVR clinical trial, for which MHVI served as the primary hub, found TAVR to be a valid treatment alternative for patients at low risk of death from open surgery. The FDA approved the use of TAVR for these low-risk surgical patients this year. A separate international study of low-risk patients was conducted at MedStar Union Memorial Hospital. MHVI is participating in the EARLY TAVR study evaluating the use of TAVR compared to surveillance for patients with aortic stenosis who are asymptomatic. Eventually, we will be able to cover any need and any risk level.
An unusual but often fatal complication of valve-in-valve TAVR is coronary artery obstruction caused by mechanical displacement of the old valve leaflets. The BASILICA procedure, developed by MHVI’s Toby Rogers, MD, PhD, and a team from the National Heart, Lung, and Blood Institute was created to address this devastating problem. The procedure employs an electrified guidewire to fenestrate the leaflet of the bio-prosthetic aortic valve to allow blood flow into the coronary artery.
In another example, MHVI was one of just four centers in the U.S. to participate in an FDA early feasibility study testing a first-ever dedicated occluder device for use in transcaval TAVR, also designed by Dr. Rogers. Transcaval access is a unique alternative approach for patients in whom transfemoral TAVR is infeasible due to small or diseased iliofemoral arteries.
Finally, MHVI is testing the use of the JenaValve™ System for patients without aortic stenosis, but in whom the aortic valve is leaking.
For more information about TAVR devices and trials across the region, contact: Washington, D.C. region: Lowell Satler, MD 202-877-5975 Director, Coronary Interventions MedStar Washington Hospital Center Medical Director Cardiovascular Training and Educational Center Baltimore region: John C. Wang, MD 410-554-2332 Chief, Cardiac Catheterization Laboratory MedStar Union Memorial Hospital Scientific Director Baltimore Cardiovascular Research