In 2018, NYU Langone spearheaded research efforts in transcatheter and robot-assisted procedures for valve disease that improved outcomes and enabled a greater number of structural heart patients to benefit from lifesaving interventions.
New Milestone in Transcatheter Valve Procedures
Transcatheter replacement of aortic and mitral valves took a significant step forward this year through the participation of NYU Langone’s Heart Valve Center in more than a dozen clinical trials.
Among the most notable recent research was the Cardiovascular Outcomes Assessment of the MitraClip® Percutaneous Therapy for Heart Failure for Patients with Functional Mitral Regurgitation, or COAPT, study, in which 614 patients with severe heart failure in the United States and Canada were randomly assigned to receive either a MitraClip®—a tiny device, manufactured by Abbott Vascular, that clips together the mitral valve’s two leaflets to reduce regurgitation—or standard care.
Over a two-year period, 151 patients who received only medical treatment were hospitalized for heart failure and 61 died, compared with only 92 hospitalizations and 28 deaths among those who received the MitraClip®.
“This is a game-changer,” says Mathew R. Williams, MD, associate professor of cardiothoracic surgery and medicine, chief of the Division of Adult Cardiac Surgery, and director of the Heart Valve Center. “Studies have estimated that up to 49 percent of patients with severe mitral regurgitation are denied surgery due to their high-risk features. We now know that a minimally invasive technique can keep many of these patients out of the hospital and significantly prolong their lives.”
High-Volume Transcatheter Valve Procedure Center
Led by Dr. Williams, who has performed more than 3,500 transcatheter valve procedures—more than any other surgeon in the nation—the Heart Valve Center is a national training site for transcatheter aortic valve replacement (TAVR) best practices and home to the busiest transcatheter mitral valve replacement (TMVR) program on the East Coast. Cardiac valve device trials at NYU Langone often involve close collaboration between the Heart Valve Center and the Heart Failure Advanced Care Center.
“We leverage the strength and expertise of multidisciplinary specialists as we select the appropriate treatment for each patient,” notes Aubrey Galloway, MD, the Seymour Cohn Professor of Cardiothoracic Surgery and chair of the Department of Cardiothoracic Surgery.
NYU Langone’s research has helped provide evidence prompting regulators to approve TAVR devices for a growing number of patients—beginning with those at high risk for adverse effects from open surgery, then expanding to those at intermediate risk.
“We leverage the strength and expertise of multidisciplinary specialists as we select the appropriate treatment for each patient.”—Aubrey Galloway, MD
The center currently serves as the third-largest enroller in the PARTNER 3 trial, studying the safety and effectiveness of the Edwards SAPIEN 3 device in low-risk patients with aortic stenosis. And as national principal investigator for the PRELUDE early feasibility study, Dr. Williams has now implanted 12 Caisson TMVR devices—almost half of the international total.
Robotic Mitral Valve Surgery Safely Stands Up to Complex Cases
Although the first robotic mitral valve repair was performed 20 years ago, many cardiac centers still use robotic approaches for only the simplest such procedures, relying on open heart surgery for more complex cases.
But a new study led by Didier F. Loulmet, MD, associate professor in the Department of Cardiothoracic Surgery, chief of cardiac surgery at Tisch Hospital, and director of robotic cardiac surgery, shows that robotic surgery can be performed safely and effectively on the great majority of mitral valve patients—including those with such challenging conditions as multi-scallop myxomatous degeneration, anterior leaflet involvement, and severe mitral annular calcification (MAC).
“Robotic mitral valve repair is far less invasive than open surgery while allowing greater precision,” explains Dr. Loulmet, who was part of the French team that performed the first, groundbreaking robotic repair in 1998. “Patients have much less pain and bleeding, fewer infections, and go home sooner—typically in two days rather than a week. And we’ve now demonstrated that even the most complex patients consistently benefit from this approach.”