In a groundbreaking, multi-centered randomized trial published in The New England Journal of Medicine, researchers, co-led by Mount Sinai’s David H. Adams, MD, determined that a catheter-based heart procedure to replace an aortic valve was superior to surgery for patients who have symptomatic severe aortic stenosis with increased risks. The findings, based on a clinical trial involving 795 patients treated at 45 institutions across the nation, were simultaneously presented by Dr. Adams at the 63rd Annual Scientific Session of the American College of Cardiology on Saturday, March 29, and represent a major advance for heart patients who are at high risk for surgery.
An estimated 100,000 individuals in the United States are affected by aortic stenosis, which results when the aortic valve narrows and is unable to open and close properly, causing diminished blood flow between the heart and body, and weakening heart function. Standard treatment for severe symptoms is surgical replacement of the aortic valve.
The Medtronic CoreValve® U.S. Pivotal Trial tested the safety and effectiveness of the self-expanding CoreValve prosthesis, which is folded in a catheter and guided through arteries and through the aorta to the site of the diseased valve. It is then deployed to replace the function of the diseased valve. The procedure often requires only a small puncture in the leg under local anesthesia and takes a few hours.
“Our key finding—that transcatheter aortic-valve replacement (TAVR) with CoreValve was associated with a higher rate of survival in patients who are at high risk for surgery—has significant and broad implications,” says Dr. Adams, the Marie-Josée and Henry R. Kravis Professor and Chair of the Department of Cardiothoracic Surgery. “We have created a new evidence base that will impact future recommendations and guidelines for patients with increased surgical risk requiring aortic valve replacement.”
Dr. Adams served as the national co-principal investigator of the clinical trial with Jeffrey Popma, MD, Professor of Medicine at Harvard Medical School.
Specifically, the study revealed that the rate of death from any cause after one year for the TAVR group was 14.2 percent compared to 19.1 percent for the surgically treated patients, representing a 26 percent survival advantage with TAVR. Secondary analyses of data indicated that patients in both groups had significant improvements in quality-of-life scores, and the TAVR group did not experience an increased risk of stroke. However, adverse events, including significant paravalvular regurgitation and the need for a permanent implantation of a pacemaker, were more frequent in the TAVR group.
This was the first clinical trial to suggest superiority of a transcatheter aortic-valve procedure compared to surgery. Says Dr. Adams: “The results are particularly impressive considering none of our heart teams had prior experience with TAVR before the start of the trial.”
Dr. Adams receives royalties through the Icahn School of Medicine at Mount Sinai for mitral and tricuspid valve repair products now owned by Edwards Lifesciences and Medtronic.