In 2021, the Centers for Medicare and Medicaid Services (CMS) is expected to approve Medicare coverage of the MitraClip™ transcatheter valve repair device for patients with functional mitral valve regurgitation (MR)—a potentially transformative change for structural heart practices across the nation. NYU Langone’s Heart Valve Center helped pioneer this technique, and remains in the forefront of research and clinical practice for other mitral valve repair and replacement technologies.
A Promising Approach to Functional MR
Manufactured by Abbott Vascular, the MitraClip™—which clips together the mitral valve’s two leaflets to reduce regurgitation—was approved by the U.S. Food and Drug Administration (FDA) in 2013 for treating degenerative MR in patients judged too high-risk for open heart surgery. Functional MR, however, is more common, has a poor prognosis, and is the leading indication for MitraClip™ outside the United States.
The Heart Valve Center participated in the multicenter COAPT (Cardiovascular Outcomes Assessment of the MitraClip™ Percutaneous Therapy for Heart Failure for Patients with Functional Mitral Regurgitation) study, which investigated the device’s safety and efficacy for treating functional MR. Researchers randomly assigned 614 patients to receive either a MitraClip™ or standard care. Over a 2-year period, 151 patients who received only medical treatment were hospitalized for heart failure and 61 died, compared with just 92 hospitalizations and 28 deaths among those who received the MitraClip™. Beyond the encouraging mortality and morbidity benefits, patients who underwent a mitral valve clip procedure also had a better quality of life than medical therapy alone.
In August 2019, these results led the FDA to approve the device for functional MR in high-risk patients. In July 2020, CMS released proposed changes to the national coverage determination for catheter-based mitral valve repair, which would expand coverage to include treatment of this condition by the use of transcatheter edge-to-edge repair (TEER). Because the MitraClip™ is the only TEER device approved by the FDA to date, its expanded use will be covered when the new rules are approved in the coming year.
“Once CMS signs off on coverage, our team will be well-positioned to bring this lifesaving technology, and our proven model of care, to a new population of patients,” says Heart Valve Center director Mathew R. Williams, MD, associate professor of cardiothoracic surgery and medicine, chief of the Division of Adult Cardiac Surgery, and director of interventional cardiology at NYU Langone.
Outstanding Outcomes in MitraClip Procedures
The Heart Valve Center is the highest-volume practice in the tri-state area for MitraClip™ procedures, as well as the most experienced, and its outcomes place it far ahead of most U.S. practices. Over the past year, median procedure time at the center was 65.5 minutes, versus 113 minutes for patients participating in a national registry. The center’s rate for any complications was 3.2 percent, versus 10.6 percent nationally; for major bleeding, 0.0 percent, versus 1.9 percent nationally; and for device complications, 0.0 percent, versus 1.4 percent nationally. The mean length of stay in the intensive care uint (ICU) for Heart Valve Center patients was 0.0 hours, versus 23.6 for patients nationally. And the mean length of stay in the hospital was 1 day, versus 2.8 days nationally.
“These results reflect the skills and experience of a specialized team of surgeons, cardiologists, radiologists, anesthesiologists, and nurses who have performed these highly complex procedures together thousands of times,” says Dr. Williams. “We’ve developed protocols that enable patients to recover and go home much more quickly than the national norm, without spending time in the intensive care unit. Because patients selected for transcatheter valve procedures are inherently sicker than those eligible for open heart surgery, they benefit greatly from this lower-impact approach.”
Eliminating ICU time has provided additional benefits during the coronavirus disease (COVID-19) pandemic, Dr. Williams notes, by lessening the potential for exposure and freeing up critical-care resources for other patients.
Pioneering New Frontiers in Valve Replacement and Repair
In recent years, the Heart Valve Center has been a pioneer of many other advanced devices, including first implantations of the Caisson TMVR (transcatheter mitral valve replacement), Medtronic’s CoreValve Evolut™ PRO TAVR (transcatheter aortic valve replacement) System, and the Meridian Transcatheter Aortic Valve.
Dr. Williams and his team continue to investigate novel technologies for treating heart valve disease, such as the next-generation mitral valve clip and a transcatheter chordal implantation device. The center is also a study site for the APOLLO trial of Medtronic’s Intrepid mitral valve replacement device, which is implanted through a transapical approach on a beating heart. In addition, the center is currently enrolling patients in a pivotal trial of Abbott’s Tri-Clip™ device—the first transcatheter treatment for severe tricuspid valve disease.
Achieving Excellence in a Broad Range of Clinical Procedures
A national training site for transcatheter aortic valve replacement (TAVR) best practices, the Heart Valve Center offers a full array of other minimally invasive, open, and robotic procedures. Dr. Williams, who was the first surgeon in the United States to be dual-trained in interventional cardiology and cardiac surgery, brings an uncommon versatility to his clinical approach. “I tend to be less biased toward one modality or the other than might otherwise be the case,” he says. “My training enables me to understand the nuances of both the surgical and transcatheter approaches, and to pick what’s best for the patient.”