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

Faris Haddadin, Monil Majmundar, Ahmad Jabri, Luke Pecha, Claire Scott, Marilyne Daher, Ashish Kumar, Ankur Kalra, Rand Fram, Farah Haddadin, Soufian Almahameed, Christopher V. DeSimone, Yong Mei Cha, Siva K. Mulpuru, Kenneth A. Ellenbogen, Mohammad Saeed, Mihail G. Chelu, Abhishek J. Deshmukh

Research output: Contribution to journalArticlepeer-review


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.

Original languageEnglish (US)
Pages (from-to)1289-1296
Number of pages8
JournalHeart rhythm
Issue number8
StatePublished - Aug 2022


  • Complications
  • Leadless pacemaker
  • Mortality
  • Outcomes
  • Transvenous pacemaker

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Physiology (medical)


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