Background

Permanent pacemaker implantation (PPI) remains a relevant complication after transcatheter aortic valve replacement (TAVR) with need for further improvement. Its impact on outcome is still controversial in the current literature.

Objective

This study aims to analyze the development of implantation depth and incidence of PPI at 30 days after TAVR over a five-year experience, as well as to assess the impact of new PPI on outcome with a latest generation device.

Methods

Between 2014 and 2018, 841 patients without previous pacemaker undergoing transfemoral TAVR with the balloon-expandable Sapien 3 prosthesis (Edwards Lifesciences) were included. Implantation depth was measured as distance from the aortic annulus to the distal part of the prosthesis protruding in the left ventricle on the post-implant angiogram. To better assess its impact on PPI implantation depth was divided in Quintiles. Survival rates during follow-up according to need for PPI were calculated as Kaplan-Meier estimates and comparison between groups was performed by log-rank test. Further, to identify significant predictors of all-cause mortality, univariate Cox regression analysis was performed for all variables; clinically relevant variables yielding a p<0.05 in univariate analysis were used for multivariate Cox regression analysis. 

Results

Overall incidence of PPI at 30 days was 9.7%. Implantation depth decreased constantly from a median of 6.7mm [5.55-8.0] in 2014 to 2.7mm [2.3-3.55] in 2018 (p<0.001). When considering Quintiles of implantation depth, incidence of PPI significantly increased in higher Quintiles and risk for PPI was significantly lower for the 1. Quintile compared to the 5. Quintile (Figure 1A).

Patients requiring PPI at 30 days displayed a significantly higher mortality at 4 years compared to patients without PPI (47.5% vs. 26.5%; log-rank = 0.002) (Figure 1B). In a multivariate analysis, increased logistic EuroScore, atrial fibrillation and need for PPI at 30 days remained independent predictors of all-cause mortality at 4 years (Table 1).

Conclusions

Need for PPI at 30 days with the Sapien 3 prosthesis significantly decreased with higher prothesis implantation. New PPI at 30 days negatively affects outcome and is an independent predictor of all-cause mortality at 4 years after TAVR.

Table.  Significant univariate and multivariate Cox regression for death at 1500 days