In the wake of the US Food & Drug Administration’s (FDA) August 16 decision to expand access to transcatheter aortic valve replacement (TAVR) for low-risk surgical patients, the Sandra Atlas Bass Heart Hospital at North Shore University Hospital (NSUH) on Wednesday became the first hospital on Long Island to perform the minimally invasive procedure using a self-expanding transcatheter aortic valve outside of a clinical trial.
TAVR procedures are performed on cardiac patients to replace narrowed aortic valves that fail to open properly, interfering with blood flow from the heart and forcing it to work harder to supply blood to the rest of the body. Traditionally, TAVR has been offered to patients considered to be at higher risk for traditional open-heart surgery.
The FDA is now allowing a larger population of patients, including those who tend to be younger and more active, to undergo the procedure. This decision follows the completion of several landmark clinical trials demonstrating that TAVR is safe and effective in low-risk patients as compared to traditional surgery. North Shore University Hospital and Lenox Hill Hospital, both part of Northwell Health, participated in the Low Risk TAVR study using a self-expanding transcatheter heart valve.
“We are excited to have treated the first patient on Long Island with this life-changing technology,” said Bruce Rutkin, MD, director of structural heart disease at NSUH’s Sandra Atlas Bass Heart Hospital. “The FDA’s approval of TAVR for low-risk patients with severe aortic stenosis will enable our heart team to treat a wider spectrum of patients with this less invasive catheter-based approach.”
To date, surgeons at the Sandra Atlas Bass Heart Hospital have performed nearly 1,400 TAVR procedures. Throughout Northwell Health there have been nearly 3,000 TAVR implants performed at Lenox Hill Hospital, Staten Island University Hospital, Southside Hospital and NSUH. Thanks to the FDA’s clinical approval expanding the use of TAVR to the low-risk population of individuals with severe aortic stenosis, more patients will have access to this less-invasive treatment.
“As the largest provider of heart care in the state, Northwell Health is once again at the forefront of cardiac innovation,” said Alan Hartman, MD, senior vice president, executive director and chair of cardiothoracic services at Northwell Health.