Mount Sinai Medical Center was one of 45 national sites that participated in a landmark study, the Medtronic CoreValve® U.S. Pivotal Trial, which evaluated patients with severe aortic stenosis who were considered to be at “high risk” for surgery and predicted to have more than a 15 percent chance of death from open-heart surgery within 30 days.
Results from the groundbreaking study showed that the CoreValve non-surgical procedure is a highly recommended option for patients who have narrowed, failing aortic heart valves, called severe aortic stenosis.
Aortic stenosis is a common heart problem caused by a narrowing of the heart’s aortic valve due to excessive calcium deposited on the valve leaflets. When the valve narrows, it does not open or close properly, making the heart work harder to pump blood throughout the body. Eventually, this causes the heart to weaken and function poorly, which may lead to heart failure and increased risk for sudden cardiac death.
Patients who replaced diseased valves in their heart using this non-surgical approach saw significant improvements in their quality of life. In addition, they had fewer complications, shorter hospital stays and quicker recoveries.
The CoreValve System typically is inserted via an artery in the leg and then guided through the arteries into the heart at the site of the original aortic valve. Once in place, the CoreValve System expands into the place of the original valve and takes over its function.
Mount Sinai is among the first in the United States to offer the CoreValve System to patients at extreme risk for surgery. The CoreValve System was approved by the U.S. Food and Drug Administration (FDA) in January 2014 for patients considered extreme risk; the device is not currently approved in the U.S. for use with patients considered high risk for surgery.