Predictors and clinical outcomes of permanent pacemaker implantation after transcatheter aortic valve replacement: the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry

JACC Cardiovasc Interv. 2015 Jan;8(1 Pt A):60-9. doi: 10.1016/j.jcin.2014.07.022.

Abstract

Objectives: The purpose of this study was to identify predictors and clinical implications of permanent pacemaker (PPM) implantation after transcatheter aortic valve replacement (TAVR).

Background: Cardiac conduction disturbances requiring PPM are a frequent complication of TAVR. However, limited data is available regarding this complication after TAVR with a balloon-expandable valve.

Methods: The study included patients without prior pacemaker who underwent TAVR in the PARTNER (Placement of AoRtic TraNscathetER Valves) trial and registry and investigated predictors and clinical effect of new PPM.

Results: Of 2,559 TAVR patients, 586 were excluded due to pre-existing PPM. A new PPM was required in 173 of the remaining 1,973 patients (8.8%). By multivariable analysis, predictors of PPM included right bundle branch block (odds ratio [OR]: 7.03, 95% confidence interval [CI]: 4.92 to 10.06, p < 0.001), prosthesis diameter/left ventricular (LV) outflow tract diameter (for each 0.1 increment, OR: 1.29, 95% CI: 1.10 to 1.51, p = 0.002), LV end-diastolic diameter (for each 1 cm, OR: 0.68, 95% CI: 0.53 to 0.87, p = 0.003), and treatment in continued access registry (OR: 1.77, 95% CI: 1.08 to 2.92, p = 0.025). Patients requiring PPM had a longer mean duration of post-procedure hospitalization (7.3 ± 2.7 days vs. 6.2 ± 2.8 days, p = 0.001). At 1 year, new PPM was associated with significantly higher repeat hospitalization (23.9% vs. 18.2%, p = 0.05) and mortality or repeat hospitalization (42.0% vs. 32.6%, p = 0.007). There was no difference between groups in LV ejection fraction at 1 year.

Conclusions: PPM was required in 8.8% of patients without prior PPM who underwent TAVR with a balloon-expandable valve in the PARTNER trial and registry. In addition to pre-existing right bundle branch block, the prosthesis to LV outflow tract diameter ratio and the LV end-diastolic diameter were identified as novel predictors of PPM after TAVR. New PPM was associated with a longer duration of hospitalization and higher rates of repeat hospitalization and mortality or repeat hospitalization at 1 year. (THE PARTNER TRIAL: Placement of AoRtic TraNscathetER Valves Trial; NCT00530894).

Keywords: PARTNER; TAVR; cardiac conduction; pacemaker; transcatheter aortic valve replacement.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis / diagnosis
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / physiopathology
  • Aortic Valve Stenosis / therapy*
  • Aortic Valve* / physiopathology
  • Arrhythmias, Cardiac / diagnosis
  • Arrhythmias, Cardiac / etiology
  • Arrhythmias, Cardiac / mortality
  • Arrhythmias, Cardiac / physiopathology
  • Arrhythmias, Cardiac / therapy*
  • Cardiac Catheterization / adverse effects*
  • Cardiac Catheterization / instrumentation
  • Cardiac Catheterization / methods
  • Cardiac Catheterization / mortality
  • Cardiac Pacing, Artificial* / adverse effects
  • Cardiac Pacing, Artificial* / mortality
  • Female
  • Heart Valve Prosthesis
  • Heart Valve Prosthesis Implantation / adverse effects*
  • Heart Valve Prosthesis Implantation / instrumentation
  • Heart Valve Prosthesis Implantation / methods
  • Heart Valve Prosthesis Implantation / mortality
  • Humans
  • Kaplan-Meier Estimate
  • Length of Stay
  • Logistic Models
  • Male
  • Multivariate Analysis
  • Odds Ratio
  • Pacemaker, Artificial*
  • Patient Readmission
  • Prosthesis Design
  • Randomized Controlled Trials as Topic
  • Registries
  • Retrospective Studies
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT00530894