According to a new study, a new minimally-invasive heart valve replacement procedure not only avoids open-heart surgery but also has a higher survival rate one year after the operation. The findings were published on May 8 in The New England Journal of Medicine.
The researchers compared a transcatheter aortic valve replacement, using a self-expanding artificial valve with aortic valve replacement via open-heart surgery in patients with severe aortic stenosis and an increased risk of death during surgery. They assessed the use of the CoreValve device, manufactured by Medtronic, Inc., in patients with severe aortic stenosis who were at increased surgical risk, as determined by the heart team at each study center. They assessed surgical risk by the Society of Thoracic Surgeons Predictor Risk of Mortality estimate; in addition, they considered other key risk factors. The eligible patients were randomly assigned on a one-to-one basis to undergo valve replacement with the CoreValve or to surgical aortic valve replacement (surgical group). The primary outcome measurement was the rate of death from any cause at one year after the surgery.
The study group comprised 795 patients who were enrolled in the study at 45 US facilities. The investigators found that the rate of death from any cause at one year was significantly lower in the CoreValve group, compared to the surgical group (14.2% vs. 19.1%); the absolute reduction in risk was 4.9 percentage points. The investigators found similar results with an intention-to-treat analysis. They also found that the patients who received the CoreValve device had similar findings in regard to echocardiographic measurements of valve stenosis, functional status, and quality of life. In addition, compared to the surgery group, an exploratory analyses revealed a reduction in the rate of major adverse cardiovascular and cerebrovascular events and no increase in the risk of stroke.
The authors concluded that in patients with severe aortic stenosis who are at increased surgical risk, valve replacement with a self-expanding transcatheter aortic valve device was associated with a significantly higher rate of survival at one year, compared to surgical aortic valve replacement.
The researchers were affiliated with Mount Sinai Medical Center, (New York, New York), St. Francis Hospital (Roslyn, New York), Beth Israel Deaconess Medical Center (Boston, Massachusetts), Houston Methodist DeBakey Heart and Vascular (Houston, Texas), Texas Heart Institute at St. Luke's Medical Center (Houston, Texas), Riverside Methodist Hospital (Columbus, Ohio), University of Michigan Medical Center (Ann Arbor, Michigan), Spectrum Health Hospitals (Grand Rapids, Michigan), University of Pittsburgh Medical Center (Pittsburgh, Pennsylvania), Palo Alto Veterans Affairs Medical Center (Palo Alto, California), St. Vincent Medical Center (Indianapolis, Indiana), University of Kansas Hospital (Kansas City, Kansa), Duke University Medical Center (Durham, North Carolina), Johns Hopkins Hospital (Baltimore, Maryland), Pinnacle Health (Harrisburg, Pennsylvania), and Mayo Clinical Foundation (Rochester, Minnesota).