Study shows new transcatheter heart valve saves more lives than open-heart surgery at one year
Results revealed at American College of Cardiology 2014 meeting and in New England Journal of Medicine
OhioHealth interventional cardiologist Steven Yakubov, MD, was part of a team that presented the results from a groundbreaking study at the American College of Cardiology's 2014 Scientific Sessions and simultaneously published in The New England Journal Medicine.
OhioHealth Riverside Methodist Hospital is one of 45 national sites that participated in this 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.
The study showed that more patients were alive at one year if they received a new transcatheter heart valve, compared to patients who had traditional open-heart surgery. This is the first time a prospective, randomized study has shown a transcatheter aortic valve to be superior to surgery. Patients in the trial had narrowed, failing aortic heart valves, called severe aortic stenosis.
"This absolutely change the way patients are treated," said Dr. Yakubov, a co-author of the study and system chief of structural heart disease at OhioHealth. "More patients will now have access to a less invasive option to replace the aortic valve."
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.
In the study, physicians replaced the diseased aortic valves in 747 patients, approximately half of whom were randomized to the minimally invasive CoreValve System, and half of whom were randomized to open-heart surgery. The all-cause mortality rate was only 14.2 percent in patients receiving the CoreValve System, compared to 19.1 percent in patients receiving surgery, a statistically significant finding at one year (the primary endpoint of the trial).
The rate of stroke - one of the complications most concerning to physicians and patients because it increases mortality - was low and not different between the two groups of patients.
Patients also saw significant improvements in their quality of life. Quality of Life scores improved 19.0 points for CoreValve patients and 3.7 points for surgical patients at 30 days, and at one year both patient groups improved significantly with CoreValve patients improving 23.2 points and surgical patients improving 21.9 points (as measured by KCCQ 100-point scale, where five points is considered important, and 20 points is considered a very large improvement).
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.
Riverside Methodist 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.
For more information about the Medtronic CoreValve U.S. Pivotal Trial, visit www.aorticstenosistrial.com.
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