Impact of Sapien 3 Balloon-Expandable Versus Evolut R Self-Expandable Transcatheter Aortic Valve Implantation in Patients With Aortic Stenosis

Abstract

Background: Two competing transcatheter aortic valve replacement (TAVR) technologies are currently available. Head-to-head comparisons of the relative performances of these 2 devices have been published. However, long-term clinical outcome evaluation remains limited by the number of patients analyzed, in particular, for recent-generation devices. Methods: Based on the French administrative hospital-discharge database, the study collected information for all consecutive patients treated with a TAVR device commercialized in France between 2014 and 2018. Propensity score matching was used for the analysis of outcomes during follow-up. The objective of this study was to analyze the outcomes of TAVR according to Sapien 3 balloon-expandable (BE) versus Evolut R self-expanding TAVR technology at a nationwide level in France. Results: A total of 31 113 patients treated with either Sapien 3 BE or Evolut R self-expanding TAVR were found in the database. After matching on baseline characteristics, 20 918 patients were analyzed (10 459 in each group with BE or self-expanding valves). During follow-up (mean [SD], 358 [384]; median [interquartile range], 232 [10–599] days), BE TAVR was associated with a lower yearly incidence of all-cause death (relative risk, 0.88; corrected P =0.005), cardiovascular death (relative risk, 0.82; corrected P =0.002), and rehospitalization for heart failure (relative risk, 0.84; corrected P <0.0001). BE TAVR was also associated with lower rates of pacemaker implantation after the procedure (relative risk, 0.72; corrected P <0.0001). Conclusions: On the basis of the largest cohort available, we observed that Sapien 3 BE valves were associated with lower rates of all-cause death, cardiovascular death, rehospitalization for heart failure, and pacemaker implantation after a TAVR procedure.

Overcoming the transcatheter aortic valve replacement Achilles heel: conduction abnormalities—a systematic review

“…Rates of new PPI across propensity-matched studies were slightly higher when using the Evolut R/PRO valve in comparison with the Sapien 3 valve (23.8% Evolut vs. 18.4% Sapien 3). Three out of 5 studies reported significant differences regarding 30-day or post-procedural new PPI, all of them favoring the Sapien 3 valve (15,17,18). Contrarily, the only randomized trial (19) did not find any differences in PPI rates between the two valves (22.9% Evolut R vs. 19% Sapien 3, P=0.34) ( Figure 1).…”

Early and Midterm Outcomes of Transcatheter Aortic-Valve Replacement with Balloon-Expandable Versus Self-Expanding Valves: A Systematic Review and Meta-Analysis

“…We included 15 studies—3 RCTs (6-8) and 12 PSM studies (9-11, 17-25)—with 37,958 patients (19,053 with BEV and 18,905 with SEV) (Figure 1). The mean age was 82.6 years and 42.4% were male.…”

“…Potential publication bias was examined by visual inspection of the asymmetry in funnel plots. Both the studies of Deharo (11) and Van Belle (9) originated from national registries of French; we extracted data before last quarter 2014 in the study of Van Belle to avoid overlap with the study of Deharo. All meta-analyses were conducted with the R statistical programming environment, version 4.0.0 and the Review Manager, version 5.3, and a 2-tailed P value<0.05 was considered statistically significant.…”

“…All these trials were underpowered to detect rare outcomes such as mortality. A number of larger-scale propensity-score matched (PSM) studies (9-11) were recently published and might provide complementary insights for RCTs. In this context, we performed a meta-analysis of head-to-head RCTs and PSM studies to determine the early and midterm performances of TAVR with BEV versus SEV.…”

Conduction disturbances following trancatheter aortic valve implantation: increasing the ‘pace’ towards prospective evidence

“…In particular, the exact role of electrophysiological studies, patch ECG recorders, and implantable loop recorders in the management of new-onset LBBB or transient high-degree atrioventricular block should be delineated (Take-home Figure). Moreover, some recent studies questioned the class effect of TAVI, suggesting that not all transcatheter heart valve's designs are equal, especially regarding conduction disturbances 13,14 . Collectively, these observational data, along with the meta-analysis by Faroux et al 12 , should ultimately spur adequately-powered randomized comparisons of the commercially-available valves most commonly implanted in routine practice.…”