France-TAVI Registry Comparison: Balloon-Expandable vs. Self-Expanding TAVR
What is the impact of transcatheter heart valve (THV) design (balloon-expandable [BE] and self-expanding [SE]) on the risk of paravalvular regurgitation (PVR), intrahospital mortality, and 2-year mortality?
The investigators included 12,141 patients in the FRANCE-TAVI nationwide registry undergoing BE-THV (Edwards, n = 8,038) or SE-THV (Medtronic, n = 4,103) for native aortic stenosis. Long-term mortality status was available in all patients (median 20 months, interquartile range, 14-30). Patients treated with BE-THV (n = 3,910) were successfully matched 1:1 with 3,910 patients treated with SE-THV by using propensity-score (25 clinical, anatomical, and procedural variables) and by date of the procedure (within 3 months). The first co-primary outcome was the occurrence of paravalvular regurgitation (PVR) ≥ moderate and/or in-hospital mortality. The second co-primary outcome was 2-year all-cause mortality. In a propensity-score matched cohort, between-group comparisons (SE vs. BE-THV) were done using a generalized estimating equation model with a compound symmetry working correlation structure for binary outcomes, a linear mixed model with the matched blocks as random effect for continuous, and Cox’s regression models for long-term outcomes with robust sandwich variance estimator to account for the matched design.
In matched-propensity analyses, the incidence of the first co-primary outcome was higher with SE-THV (19.8%) compared with BE-THV (11.9%; relative risk [RR], 1.68; 95% confidence interval [CI], 1.46-1.91; p < 0.0001). Each component of the outcome was also higher in SE-THV patients: PVR ≥ moderate (15.5% vs. 8.3%; RR, 1.90; 95% CI,1.63-2.22; p < 0.0001) and in-hospital mortality (5.6% vs. 4.2%; RR, 1.34; 95% CI, 1.07-1.66; p = 0.01). During follow-up, all-cause mortality occurred in 899 patients treated with SE-THV (2-year mortality was 29.8%) and in 801 patients treated with BE-THV (2-year mortality was 26.6%; HR, 1.17; 95% CI, 1.06-1.29; p = 0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis.
The authors concluded that use of SE-THV was associated with a higher risk of PVR and higher in-hospital and 2-year mortality as compared with BE-THV in the current analysis.
This propensity-score matched comparison of 7,820 patients with native aortic stenosis undergoing TAVR based on the nationwide FRANCE-TAVI registry reports that use of SE-THV was associated with higher risk of PVR, PVR and/or in-hospital mortality, and 2-year mortality as compared with use of BE-THV. Furthermore, the association of THV type with 2-year mortality remained after multivariable adjustment including PVR severity and other periprocedural events. As TAVR is quickly becoming the first-line treatment for patients with aortic stenosis, this study underscores the need for a randomized clinical study sufficiently powered to compare head-to-head on individual endpoints the efficacy of the SE and BE-THV and the need to simplify and optimize the grading of PVR and its long-term clinical impact. The study also highlights the importance of the right device (BE vs. SE) for the right patient, which will need an adequate level of experience and volume for a given heart team.
Keywords: AHA Annual Scientific Sessions, AHA19, Aortic Valve Insufficiency, Aortic Valve Stenosis, Heart Valve Diseases, Heart Valve Prosthesis, Risk, Secondary Prevention, Transcatheter Aortic Valve Replacement, Treatment Outcome
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