Study Compares TAVR Outcomes in Patients With Bicuspid and Tricuspid Aortic Stenosis
March 18, 2017—Patients with bicuspid aortic valve stenosis (AS) who received transcatheter aortic valve replacement (TAVR) had a significantly lower device success rate than TAVR patients with tricuspid AS, reported Sung-Han Yoon, MD, in a presentation at the American College of Cardiology's (ACC) 66th annual scientific session in Washington, DC.
By stratifying the data from the Bicuspid AS TAVR Registry according to device type, the study investigators found procedural differences between the two groups treated with early generation devices; however, no differences were found between those treated with new generation devices.
The investigators included 561 patients with bicuspid AS treated across 33 participating centers from Europe, North America, and Asia-Pacific. Data on 4,546 patients with tricuspid AS were collected from 12 participating centers during the same period, between April 2005 and May 2016. Propensity-score matching assembled 546 pairs of patients with similar baseline characteristics.
As summarized by ACC, the investigators found that all-cause mortality rates at the 2-year mark were comparable (17.2% bicuspid AS vs 19.4% tricuspid AS). With early generation devices, bicuspid AS patients had more frequent adverse procedural events than tricuspid AS patients: aortic root injury with Edwards Lifesciences Sapien XT (4.5% vs 0.0%; P = .0015); moderate-so-severe paravalvular leak with the Medtronic CoreValve (19.4% vs 10.5%, P = .02).
In the ACC summary, the investigators stated, "The accumulation of [a] large multicenter database has for the first time allowed comparisons of matched cohorts, as well as the potential impact of differences in device type." They added, "The new generation devices were developed to mitigate the critical limitations of the early generation devices: significant paravalvular leak, difficulty with optimal positioning, and vascular complications. The present study showed that the initial attempt of device advancement succeeded in overcoming the procedural limitations in tricuspid AS and now must go beyond the challenges in treating bicuspid AS."