Self-Expanding Valves Associated With Increased Risk Following TAVR
NOVEMBER 16, 2019
Eric Van Belle, MD, PhD
Results of a study presented at American Heart Association (AHA) 2019 Scientific Sessions in Philadelphia revealed self-expanding transcatheter heart valves were associated with a higher risk of paravalvular discharge, a higher risk of in-hospital mortality, a higher risk of 2-year mortality compared to balloon-expanding transcatheter heart valves.
With an apparent lack of information regarding the topic, investigators conducted the present study in an effort to illustrate risks associated with balloon-expanding and self-expanding transcatheter heart valves. The current study was designed as a prospective analysis using the FRANCE-TAVI registry, which investigators used to evaluate the impact of design on paravalvular regurgitation, intra-hospital mortality, and 2-year mortality using propensity score matching analysis.
From FRANCE-TAVI, a cohort of 12,804 patients who underwent TAVR between 2013 and 2015 were identified for inclusion. After application of exclusion criteria, which included patients referred for a valve-in-valve procedure and patients treated with other valve designs, a group of 12,141 patients were included in the analysis.
Investigators pointed out the specific valves included in the study were the BE-THV SAPIEN-XT or BE-THV SAPIEN 3 valves and the SE-THV Corevalve family.
The study included 2 different co-primary endpoints. Co-primary endpoints included paravalvular regurgitation at discharge or all-cause in-hospital mortality and 2-year all-cause mortality. Secondary endpoints of the study included each individual component of the first co-primary endpoint, procedural and in-hospital events, and post-procedural trans prosthetic gradient by echocardiography.
Upon analyses, investigators found self-expanding valves (19.8%) had a significantly higher rate of the first co-primary endpoint compared to balloon-expanding valves (11.9%) (matched-OR 1.83; 95% CI: 1.57-2.12, P<0.0001). When examined separately, investigators noted increased rates of moderate or greater paravalvular regurgitation (15.5% versus 8.3%, matched-OR 2.02; 95% CI: 1.69-2.41, P<0.0001) and in-hospital mortality (5.6% versus 4.2%, matched-OR 1.34; 95% CI=1.07-1.69, P=0.01) in patients who underwent TAVR with self-expanding valves.
When assessing the second co-primary endpoint, investigators found self-expanding valves were associated with an increased risk of 2-year all-cause mortality in a propensity-score matched cohort (29.8 versus 26.6, P=0.002). Investigators noted the relation between occurrence of outcome and valve design was consistent across key subgroups, except for delivery approach and year of intervention.
This study, “Balloon-Expandable versus Self-Expandable TAVR on Paravalvular Regurgitation and 2-Year Mortality: A Propensity-Matched Comparison From the FRANCE-TAVI Registry,” was presented by Eric Van Belle, MD, PhD, at AHA 2019.