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

Abstract

AbstractBackgroundConflicting data yet exists regarding the clinical outcomes of transcatheter aortic valve replacement (TAVR) using balloon‐expandable (BEV) and self‐expanding valves (SEV).AimTo compare the in‐hospital outcomes of TAVR performed with new‐generation BEV vs. SEV in a real‐world population.MethodsRetrospective 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.ResultsA 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.ConclusionIn real‐world all‐comers TAVR patients, from Brazil procedures performed with newer generation BEV and SEV devices had comparable in‐hospital outcomes.