Clinical outcomes and predictors of complications in patients undergoing leadless pacemaker implantation

Heart Rhythm. 2022 Aug;19(8):1289-1296. doi: 10.1016/j.hrthm.2022.03.1226. Epub 2022 Apr 28.


Background: Leadless pacemakers have emerged as a viable alternative for traditional transvenous pacemakers to reduce the risk of device-related complications.

Objective: The purpose of this study was to examine the real-world clinical outcomes and complications associated with the implantation of leadless pacemaker devices.

Methods: Using the National Readmission Database (NRD), we examined patient demographics, and in-hospital and 30-day procedural outcomes after leadless pacemaker implantation from 2016-2018. Our cohort comprised adults (≥18 years) with an ICD-10 procedural code for leadless pacemaker implantation.

Results: Our cohort included a total of 7821 patients who underwent leadless pacemaker implantation. Overall immediate procedure-related complications, as defined broadly in this study, occurred in 7.5% of patients. Pericardial effusion without the need for pericardiocentesis occurred in 1.9% of patients, with pericardiocentesis performed in 1.0%. Vascular complications occurred in 2.3% of patients; 0.33% required repair, and device dislodgment occurred in 0.51%. The most significant predictor for procedural complications was end-stage renal disease (odds ratio [OR] 1.65; 95% confidence interval [CI] 1.17-2.32; P = .004), congestive heart failure (OR 1.28; 95% CI 1.01-1.62; P = .04), and coagulopathy (OR 1.77; 95% CI 1.34-2.34; P <.001). All-cause readmission occurred in 17.9% of patients within 30 days from device implant, with 1.36% of readmissions being procedure related. At 30 days postimplant and after discharge, 0.25% of patients needed a new pacemaker, and 0.18% had pericardial complications.

Conclusion: In our large real-life cohort, we found the rate of serious complications after leadless pacemaker implantation to be relatively low and comparable to prior studies in a high-risk population with multiple comorbid conditions.

Keywords: Complications; Leadless pacemaker; Mortality; Outcomes; Transvenous pacemaker.

MeSH terms

  • Adult
  • Arrhythmias, Cardiac / etiology
  • Arrhythmias, Cardiac / therapy
  • Equipment Design
  • Humans
  • Kidney Failure, Chronic*
  • Pacemaker, Artificial* / adverse effects
  • Pericardial Effusion* / etiology
  • Treatment Outcome