New Study Shows Improved Outcomes for Next-Generation Minimally Invasive Heart Valve Replacement Device

The study, co-authored by cardiologists from NewYork-Presbyterian/Columbia University Medical Center, found that use of the SAPIEN 3 transcatheter heart valve resulted in lower mortality rates

Apr 3, 2016

New York

A new study presented at the American College of Cardiology (ACC) conference shows improved one-year outcomes for transcatheter aortic valve replacement (TAVR) compared with surgery in intermediate risk patients utilizing the SAPIEN 3 valve. The study, co-authored by researchers from NewYork-Presbyterian/Columbia University Medical Center, is simultaneously published in this month’s The Lancet.

“We’re seeing significant improvements in outcomes for procedures performed with this new device,” said Dr. Martin Leon, director of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center, professor of medicine at Columbia University Medical Center and lead author of the study. “There’s strong evidence that SAPIEN 3, compared with earlier versions of TAVR devices, can further reduce the risk of mortality, stroke and para-valvular regurgitation.”

The study was embedded in the groundbreaking PARTNER II Trial for patients with severe aortic stenosis. Researchers found the 1,078 patients who were treated with the new device, called SAPIEN 3, experienced lower rates of stroke (4.6 percent), moderate or severe aortic regurgitation (1.5 percent) and mortality (7.4 percent) than patients who underwent traditional open heart surgery.

“This latest study shows that TAVR is quickly becoming not just a viable alternative for aortic valve replacement, but the preferred, safer method for many patients who require valve replacement or repair,” said Dr. Susheel Kodali, director of the Structural Heart and Valve Center at NewYork-Presbyterian/Columbia, associate professor of medicine at Columbia University Medical Center and co-principle investigator for the study. “We expect it to have an impact on clinical guidelines for treating this condition across the country.”

The device utilized is the latest iteration of transcatheter heart valves, which have emerged as a viable alternative to traditional open heart surgery for many patients over the last decade. NewYork-Presbyterian/Columbia conducted the clinical trial that led to FDA approval of the original SAPIEN TAVR device in 2011 and performed the first procedure after its approval. NewYork-Presbyterian/Columbia doctors have performed more TAVR procedures than any other institution in the United States.

Drs. Leon and Kodali will be available for comment after the study is presented on April 3.

The aortic valve replacement devices used in the study are manufactured by Edwards Lifesciences of Irvine, CA, which also funded the study.

NewYork-Presbyterian/Columbia University Medical Center

NewYork-Presbyterian/Columbia University Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and its academic partner, Columbia University College of Physicians and Surgeons. NewYork-Presbyterian/Columbia provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, research, education and community service. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian/Weill Cornell Medical Center, NewYork-Presbyterian/Morgan Stanley Children’s Hospital, NewYork-Presbyterian Hospital/Westchester Division, NewYork-Presbyterian/The Allen Hospital and NewYork-Presbyterian/Lower Manhattan Hospital. The hospital is also closely affiliated with NewYork-Presbyterian/Hudson Valley Hospital, NewYork-Presbyterian/Lawrence Hospital and NewYork-Presbyterian/Queens. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area, according to U.S. News & World Report, and consistently named to the magazine’s Honor Roll of best hospitals in the nation. For more information, visit

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