Sunday, March 15, 2015, San Diego: Elderly patients once considered too frail or tool sick for aortic valve replacement surgery are living longer, with better quality of life, following a minimally invasive surgery, compared to patients who did not undergo surgery, according a study published in The Lancet today.
Researchers at 21 medical centers followed 358 patients with severe aortic stenosis for five years. The patients, with a mean age of 83, were evenly divided into two study groups - one that underwent minimally invasive transcatheter aortic valve replacement (TAVR) surgery and one that followed standard therapy, which involved balloon aortic valvuloplasty but no surgery.
Those undergoing TAVR lived longer, with better symptom management, fewer hospital readmissions and better functional status. At the five-year mark, 28.2 percent of the TAVR group were still alive, compared to only 6.4 percent of those undergoing standard therapy.
"This trial is the first--and will probably be the only--randomized aortic stenosis trial that includes a group of patients not treated with aortic valve replacement, since these results will make it unethical to treat severe aortic stenosis patients with medical therapy alone," said Samir Kapadia, M.D., the study's primary author and director of the Sones Cardiac Catheterization Laboratories at Cleveland Clinic.
Aortic stenosis is the most common heart valve disease, causing the aortic valve not to open fully and decreasing blood flow from the heart. For decades, the gold standard treatment was considered aortic valve replacement, though many older patients in their 80s and 90s were considered too sick or too frail to undergo the rigorous surgery. For those patients, TAVR became an option. This study was the first to compare five-year TAVR outcomes with standard therapy.
###
About Cleveland Clinic
Cleveland Clinic is a nonprofit multispecialty academic medical center that integrates clinical and hospital care with research and education. Located in Cleveland, Ohio, it was founded in 1921 by four renowned physicians with a vision of providing outstanding patient care based upon the principles of cooperation, compassion and innovation. Cleveland Clinic has pioneered many medical breakthroughs, including coronary artery bypass surgery and the first face transplant in the United States. U.S.News & World Report consistently names Cleveland Clinic as one of the nation's best hospitals in its annual "America's Best Hospitals" survey. More than 3,000 full-time salaried physicians and researchers and 11,000 nurses represent 120 medical specialties and subspecialties. The Cleveland Clinic health system includes a main campus near downtown Cleveland, eight community hospitals, more than 75 Northern Ohio outpatient locations, including 16 full-service Family Health Centers, Cleveland Clinic Florida, the Lou Ruvo Center for Brain Health in Las Vegas, Cleveland Clinic Canada, and, scheduled to begin seeing patients in 2015, Cleveland Clinic Abu Dhabi. In 2013, there were 5.5 million outpatient visits throughout the Cleveland Clinic health system and 157,000 hospital admissions. Patients came for treatment from every state and from more than 130 countries. Visit us at http://www.clevelandclinic.org. Follow us at http://www.twitter.com/ClevelandClinic.
Journal
The Lancet