MIAMI—Transcatheter aortic valve replacement (TAVR) continued to hold its lead over medical therapy in patients with symptomatic severe aortic stenosis, researchers reported Oct. 24 at the 2012 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, in a presentation on the three-year outcomes.
E. Murat Tuzco, MD, vice-chairman of the department of cardiology in the Sydell and Arnold Heart & Vascular Institute at the Cleveland Clinic, presented the three-year data from the PARTNER Cohort B trial. This was the first study to look at the long-range outcomes of TAVR.
Tuzco and colleagues randomly assigned patients with severe symptomatic aortic stenosis (AS) who were deemed ineligible for surgery to receive either transfemoral TAVR or standard therapy, which often included balloon aortic valvuloplasty. Conditions for inclusion in the study were severe calcific aortic stenosis, New York Heart Association functional class greater than or equal to II, and risk of death or serious irreversible morbidity exceeding 50 percent.
With a cohort of 358 patients, 179 received TAVR and 179 standard treatment. After three years, all-cause mortality among TAVR patients was 41.4 percent, compared to 74.5 percent among patients receiving standard treatment. The rehospitalization rate was 42.3 percent in TAVR patients and 75.7 percent in the other group. The group who received standard treatment was at 33 percent higher risk of death or rehospitalization than the TAVR group.
In a finding that Tuzco characterized as “very rewarding,” the researchers reported that TAVR patients largely maintained the improvement in mitral valve area at the three-year mark.
The three-year findings build on previous Cohort B results that found TAVR superior to standard therapy. As reported at TCT.11, the two-year rate of all-cause mortality was 18.2 percent in the TAVR group vs. 35.1 percent in the standard therapy group. The rate of rehospitalization was 35 percent in the TAVR group vs. 72.5 percent in the standard therapy group. TAVR's survival advantage was also observed at one year.
Addressing concern about the impact of the procedure on the quality of life of such very sick patients, Tuzco pointed out that at the three-year marker, TAVR patients had a mean of 544 days out of hospital, compared to 368 days for patients who received standard treatment. But Tuzco conceded that it was important to better define the population of patients who are likely to derive the most benefit from the procedure.
Tuzco also responded to a question about the practical implications of the PARTNER Cohort B data and the possibility that the procedure will be performed on an increasing number of very old, sick patients who may derive minimal benefits. Tuzco asserted that multidisciplinary heart teams are best able to appropriately design a care plan for high-risk patients with serious cardiac valve disease. He also noted the American College of Cardiology and the Society of Thoracic Surgeons has developed a national registry for TAVR, which will enable the profession to monitor quality and protect against “indication creep.”