Predictors of Permanent Pacemaker Implantations and New-Onset Conduction Abnormalities With the SAPIEN 3 Balloon-Expandable Transcatheter Heart Valve

Abstract

Objectives: This study investigates the influence of implantation depth and prosthesis oversizing on conduction abnormalities (CA) and permanent pacemaker implantation (PPI) after SAPIEN 3 (Edwards Lifesciences, Irvine, California) implantation.

Background: CA and PPIs are frequent complications after transcatheter aortic valve replacement with a next-generation balloon-expandable transcatheter heart valve (SAPIEN 3). The potential underlying mechanisms are incompletely understood.

Methods: Of 244 patients treated with SAPIEN 3,208 without a previous pacemaker and 184 without baseline CA were analyzed. We assessed the association of angiographic implantation depth (% of frame height below the annulus) and degree of oversizing with PPI and CA.

Results: New PPI and new or worsened CA or PPI occurred in 16% (34 of 208) and 31% (57 of 184), respectively. Patients requiring PPI had a higher prevalence of atrial fibrillation (44% vs. 24%; p = 0.017), complete right bundle branch block (27% vs. 5%; p = 0.001), and bradycardia (<60 beats/min, 38% vs. 21%; p = 0.034). In patients with new CA or PPI, implantation depth was lower (at septal side: 29 ± 8% vs. 25 ± 7%; p = 0.003), and rate of oversizing was higher (19% [11 of 57] vs. 6% [8 of 126]; p = 0.007). Independent predictors of new or worsened CA or PPI were implantation depth at septal side (odds ratio [OR]: 1.063 [95% confidence interval (CI): 1.017 to 1.110]; p = 0.006 per % of frame below the aortic annulus), oversizing (OR: 3.489 [95% CI: 1.236 to 9.848]; p = 0.018), and QRS duration (OR: 1.033 [95% CI: 1.011 to 1.056]; p = 0.003 per ms).

Conclusions: Implantation depth and prosthesis oversizing were associated with a higher rate of new CA or PPI using the SAPIEN 3. Thus, avoidance of deep implantation and extreme oversizing may reduce these complications.

Keywords: conduction abnormalities; permanent pacemaker implantation; predictors; transcatheter aortic valve replacement.