March 30, 2014 – All-cause mortality rates at one year after the surgery were lower in the patients in the TAVR arm than patients who received the standard surgery.
At a late-breaking session at the 2014 American College of Cardiology Scientific Sessions, researchers shared results from the first trial to demonstrate lower mortality rates for transcatheter aortic valve replacement (TAVR) than the standard valve replacement surgery in high-risk patients with aortic stenosis. Duke’s Chad Hughes, MD, and Kevin Harrison, MD, (pictured) were among the study authors.
Results were published online in the New England Journal of Medicine.
Aortic stenosis is a debilitating disease, especially among elderly patients. It leaves them unable to exert themselves, easily fatigued, and makes it difficult to breathe. Mortality rates within a year after symptom onset are very high for these patients. The standard treatment has long been surgical aortic valve replacement. However, this surgery is a high-risk option for patients with multiple co-existing health conditions and other risk factors. A new transcather option, CoreValve by Medtronic, has previously been shown to reduce mortality rates compared with medical management in high-risk surgical patients.
For this study, researchers randomized 795 high-risk patients to either standard aortic valve replacement or a TAVR procedure with CoreValve at 45 sites throughout the United States. Duke University Medical Center was one of the top enrolling patient sites.
Researchers found that all-cause mortality rates at one year after the surgery were lower in the patients in the TAVR arm than patients who received the standard surgery. Patients in the TAVR arm also reported more improvement in quality of life than patients in the standard surgery arm of the trial.
“This was the first trial to show survival benefits with TAVR compared with traditional surgery in this high-risk patient population,” said Dr. Harrison. “This is a landmark trial with game-changing findings for high-risk patients with aortic stenosis.
Previous trials with TAVR have found an increased risk of stroke compared with the standard valve replacement surgery, but this trial found no greater risk of stroke in the TAVR arm than in the standard surgical arm.
“The results we presented today are positive and encouraging, although there is still room for improvements with this technology,” said Dr. Harrison.