Incidence, Predictors, and Outcomes of Permanent Pacemaker Implantation Following Transcatheter Aortic Valve Replacement: Analysis From the U.S. Society of Thoracic Surgeons/American College of Cardiology TVT Registry

Abstract

Objectives: The purpose of this study was to evaluate the incidence, predictors, and clinical outcomes of permanent pacemaker (PPM) implantation following transcatheter aortic valve replacement (TAVR).

Background: Conduction abnormalities leading to PPM implantation are common complications following TAVR. Whether PPM placement can be predicted or is associated with adverse outcomes is unclear.

Methods: A retrospective cohort study of patients undergoing TAVR in the United States at 229 sites between November 2011 and September 2014 was performed using the Society of Thoracic Surgeons/American College of Cardiology TVT Registry and the Centers for Medicare and Medicaid Services database.

Results: PPM placement was required within 30 days of TAVR in 651 of 9,785 patients (6.7%) and varied among those receiving self-expanding valves (25.1%) versus balloon-expanding valves (4.3%). Positive predictors of PPM implantation were age (per 5-year increment, odds ratio: 1.07; 95% confidence interval [CI]: 1.01 to 1.15), prior conduction defect (odds ratio: 1.93; 95% CI: 1.63 to 2.29), and use of self-expanding valve (odds ratio: 7.56; 95% CI: 5.98 to 9.56). PPM implantation was associated with longer median hospital stay (7 days vs. 6 days; p < 0.001) and intensive care unit stay (56.7 h vs. 45.0 h; p < 0.001). PPM implantation was also associated with increased mortality (24.1% vs. 19.6%; hazard ratio [HR]: 1.31; 95% CI: 1.09 to 1.58) and a composite of mortality or heart failure admission (37.3% vs. 28.5%; hazard ratio HR: 1.33; 95% CI: 1.13 to 1.56) at 1 year but not with heart failure admission alone (16.5% vs. 12.9%; HR: 1.23; 95% CI: 0.92 to 1.63).

Conclusions: Early PPM implantation is a common complication following TAVR, and it is associated with higher mortality and a composite of mortality or heart failure admission at 1 year.

Keywords: aortic stenosis; heart failure; mortality; pacemaker; registry; transcatheter aortic valve replacement.