Background: Transcatheter aortic valve implantation (TAVI) is valid therapy for patients with severe symptomatic aortic stenosis. Permanent pacemaker implantation (PPMI) still complicates these procedures with some reports associating between PPMI and poor outcome. Second generation TAVI systems were designed with the intention to decrease complication. We explored if the use of second generation TAVI systems is associated with a lower rate of PPMI compared with the first generation of valves.
Methods: We retrospectively analyzed data collected prospectively in a multicenter TAVI registry. Data collected included baseline, procedural and post-procedural outcomes. Included were patients that underwent transfemoral TAVI with balloon expandable valve (Edwards’ SAPIEN (1st generation) or S3 (2nd generation)) and self-expandable valve (Medtronic CoreValve (1st generation) or Evolut-R (2nd generation). Excluded were patients that underwent valve-in-valve procedures. PPMI rates were compared between the two generations and multivariate analyses were performed for indices associated with PPMI and indices associated with 1-year mortality.
Results: Included were 1,417 patients that underwent TAVI Between 2008-2016. Of them, 508 (35.8%) underwent TAVI with balloon expandable valve while the rest had self-expandable TAVI. The median age was 83.18 [79.25-86.72] years with 43% of male gender. PPMI rates for SAPIEN vs. S3 were 15.1% vs. 16.8% (p=0.65) while the rates for CoreValve vs. Evolut-R were 23.2% vs. 20.0% (p=0.27). For balloon expandable valves, RBBB, 1st degree AV-block, past-CVA/TIA and depth of implantation were independently associated with PPMI while RBBB, pre-dilatation and depth of implantation were the independent indices for PPMI in self-expandable valves. PPMI was not associated with 1-year mortality.
Conclusions: The use of second generation of TAVI is not associated with a significant decrease in the PPMI rate. Known predictors (e.g. RBBB and depth of implantation) are still relevant determinants of this complication and effort for decreasing these rates should focus on these indices.