Balloon‐expandable versus self‐expanding valves for transcatheter aortic valve replacement using new generation devices. an analysis of the Brazilian RIBAC‐NT registry

Background: Conflicting data yet exists regarding the clinical outcomes of transcatheter aortic valve replacement (TAVR) using balloon-expandable (BEV) and self-expanding valves (SEV). Aim: To compare the in-hospital outcomes of TAVR performed with new-generation BEV vs. SEV in a real-world population. Methods: Retrospective study using data from the Brazilian TAVR registry. All consecutive native tricuspid TAVR procedures using new-generation valves were included. Transapical procedures were excluded. Patients were analyzed according to the type of prosthesis implanted (BEV vs. SEV). Unadjusted and propensity-score matching comparisons were made. Primary outcome was in-hospital mortality. Secondary outcomes included major vascular complication, major or life-threatening bleeding, any stroke, and new pacemaker implantation. Results: A total of 1706 patients from 25 centers were included in the analysis, 887 in the BEV and 819 in the SEV groups. Mean age was 80.7 +/- 7.2 years and 48.9% were women. The SEV group had a higher proportion of female patients (53.5% vs. 44.6%, p <= 0.001) and more comorbidities, yielding a higher EuroSCORE-2 (3.4 [2-6.4] vs. 4.5 [2.5-8.2], p < 0.001). The Sapien 3/Ultra (Edwards Lifescience, Irvine, CA, USA) and the Evolut R/PRO (Medtronic, Minneapolis, MN, USA) accounted for 97.8% and 72.6% of BEV and SEV cases, respectively. Pre- and postdilatation was more common for SEV (both p < 0.001). Valve embolization, the need for a second valve, and coronary occlusion were rare but more frequent for SEV. There was no difference in the unadjusted in-hospital mortality (BEV = 3.6% vs. SEV = 4.8%, p = 0.27) and after propensity-score matching (3.5% vs. 5.0%, p = 0.16). There were also no significant differences between groups in vascular complications, bleeding, stroke, and the need for a new pacemaker. Logistic regression adjusted for sex, EuroSCORE-2, and vascular access also indicated similar mortality between both valves (OR 1.22, p = 0.4). Sensitivity analysis, including only Sapien 3 and Evolut cases, showed consistent results with the primary analysis. Conclusion: In real-world all-comers TAVR patients, from Brazil procedures performed with newer generation BEV and SEV devices had comparable in-hospital outcomes.