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

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.

Introduction

An estimated 250,000 pacemakers are implanted annually in the United States for treatment of bradyarrhythmias, which are not without associated complications.¹ Approximately 1 in 8 patients receiving a transvenous pacemaker have an early complication, frequently related to the device lead or an issue with the generator pocket.² Complications and limitations of transvenous pacemakers in specific patient populations have spurred innovation in developing leadless pacemakers with the entire unit implanted in the right ventricle. Two models have been in use in the past few years: Nanostim™ (St. Jude Medical Inc., Saint Paul, MN; now Abbott Medical Inc., Abbott Park, IL) and Micra™ pacemaker (Medtronic, Minneapolis, MN), although there has been a halt on Nanostim implants.3, 4, 5 The initial studies showed improved safety, but more extensive studies are needed to assess complication rates in a real-world setting outside of clinical trials.3, 4, 5, 6

In November 2021, the United States Food and Drug Administration (FDA) issued a reminder about the risk of significant complications during leadless pacemaker implantation.⁷ The reminder emphasized the severe consequences of cardiac perforation, leading to major complications or even death. The FDA mentions an overall risk of cardiac perforation associated with leadless pacemakers of about 1%, which is relatively similar to the risk associated with transvenous pacemaker systems. However, it seems to be more severe for patients who received a leadless pacemaker.

We conducted a retrospective study to investigate demographic characteristics, and in-hospital and 30-day procedural outcomes of leadless pacemaker implantation, and evaluated for predictors of immediate procedural complications of leadless pacemaker placement.