A recent analysis of the FRANCE-TAVI registry presented at AHA 2019 has found self-expanding transcatheter heart valves were associated with an increased risk of all-cause mortality following TAVR.
Eric Van Belle, MD, PhD
New data is shedding light on risks of paravalvular regurgitation associated with different forms of transcatheter aortic valve replacement(TAVR) devices.
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.