Impact of permanent pacemaker on mortality after transcatheter aortic valve implantation: the PRAGMATIC (Pooled Rotterdam-Milan-Toulouse in Collaboration) Pacemaker substudy

Aims: We sought to evaluate the impact of permanent pacemaker (PPM) implantation on two-year mortality and one-year left ventricular ejection fraction recovery (ALVEFR=one-year LVEF baseline LVEF) after transcatheter aortic valve implantation (TAVI). Methods and results: We pooled patient-level data from four European institutions with significant TAVI volume. Outcomes were compared between patients without PPM (no-PPM), patients with PPM prior to TAVI (old-PPM) and patients with PPM implanted after TAVI (new-PPM). Out of 1,062 patients included in the pooled data set, 783 (73.7%) were in the no-PPM group, 164 (15.4%) in the new-PPM group and 115 (10.8%) in the old-PPM group. All-cause and cardiovascular mortality at two years were similar for patients with no-PPM and new-PPM (adjusted HR 1.11, 95% CI: 0.74-1.67; p=0.62; and adjusted HR 1.16, 95% CI: 0.68-1.98; p=0.59). Conversely, old-PPM was associated with increased risk of both all-cause and cardiovascular mortality vs. no-PPM. By multivariable analysis new-PPM did not affect LVEFR, while old PPM did. We observed a multiplicative interaction, between new-PPM and post-procedural aortic regurgitation >1+ on two-year mortality and one-year LVEFR, with increased risk of death and impaired, LVEFR in patients with new-PPM and post-procedural aortic regurgitation (PPAR) >= 1+ (both p(interaction)<0.0001). Conclusions: In patients undergoing TAVI, the presence of a PPM at baseline yielded a negative effect on long-term prognosis while new-PPM did not. The combination of new-PPM with PPAR adversely impacts on survival and LV function recovery.