SAN FRANCISCO - Early valve replacement may be in the best interest of asymptomatic patients with severe aortic stenosis, possibly halving their 5-year risk of death, based on data from the CURRENT AS registry study.
Compared to watchful waiting, early surgical intervention also reduced by 81% the risk of hospitalization for heart failure, Dr. Tomohiko Taniguchi said at the Transcatheter Cardiovascular Therapeutics annual meeting. The study was simultaneously published in the Journal of the American College of Cardiology (Am Coll Cardiol. 2015. doi: 10.1016/j.jacc.2015.10.001).
Observation has been the byword for asymptomatic patients with severe aortic stenosis (AS). The American College of Cardiology recommends a conservative approach to the asymptomatic AS patient, but acknowledges the disorder inevitably progresses in nearly all patients. In the ACC’s 2014 treatment guidelines, survival during the asymptomatic phase is similar to that of age-matched controls when patients are carefully followed.
But the CURRENT AS registry results suggest that “the long-term outcome of asymptomatic patients with severe aortic stenosis was dismal when they were managed conservatively in real clinical practice,” Dr. Taniguchi said during a press briefing at the meeting, which was sponsored by the Cardiovascular Research Foundation.
“If you’re watching and waiting, and you wait for sudden death, then that is a problem,” said Dr. Ajay J. Kirtane, who moderated the briefing. Early intervention “potentially changes the game because we do have a less-invasive procedure we can offer – transcatheter aortic valve replacement (AVR),” said Dr. Kirtane of New York-Presbyterian Hospital.
In the CURRENT AS study, severe AS was considered a peak aortic jet velocity over 4.0 m/s, or a mean aortic pressure gradient greater than 40 mm Hg, or an aortic valve area less than 1.0 cm2. The registry includes 3,815 patients; Dr. Taniguchi of Kyoto University reported outcomes for a propensity-score matched cohort of 582 patients, 291 in the initial AVR group and 291 in the conservatively managed group. There was no treatment randomization; treatment decisions were made at the clinical level.
Patients in the matched cohort were in their early 70s; in 80%, the AS etiology was degenerative. The mean aortic pressure gradient was 54 mm Hg in the early intervention group and 45 mm Hg in the watchful waiting group. In 79% of the early intervention group and in 54% of the watchful waiting group, the mean aortic pressure gradient was below 40 mm Hg.
Among the patients who underwent AVR despite being asymptomatic, most (63%) had at least one surgical indication, including severe AS (41%), left ventricular dysfunction (7%), rapid hemodynamic progression (11%), or active infective endocarditis (0.3%). Other cardiac surgery indications were present in 8%. Many of the conservatively managed patients (41%) did eventually require AVR, Dr. Taniguchi noted.
By the end of the 5-year follow up period, 26% of the conservative therapy group and 15% of the early AVR group had died – a significant difference (hazard ratio, 0.64; P = .02).
The coprimary endpoint of heart failure hospitalization was also significantly more common among the conservatively treated group (19.9% vs. 3.8%; HR, 0.19; P less than .001).
The early intervention group also did significantly better on several secondary clinical outcomes, including cardiovascular death (10% vs. 18.6%), aortic valve-related death (5.3% vs. 13.5%), sudden death (3.6% vs. 5.8%), and emerging symptoms (3.2% vs. 46.3%).
Dr. Taniguchi had no financial disclosures. The study was sponsored by Kyoto University.