ClinicalDeviceClinical outcomes and predictors of complications in patients undergoing leadless pacemaker implantation
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.
Section snippets
Data source
Data were extracted from the National Readmission Database (NRD) between 2016 and 2018. Device implants during the month of December were excluded from getting an accurate estimate of 30-day readmissions. The NRD is part of the all-payer database developed by the Healthcare Research and Quality Agency for the Healthcare Cost and Utilization Project (HCUP). It is a nationally representative database comprising discharge records from 28 states, with approximately 35 million weighted discharges
Demographics, device indications, and hospital volumes
Our cohort comprised 7821 patients who underwent leadless pacemaker implantation during the study period. Mean age was 75.5 ±12.3 years, and 44.2% of patients were women. The majority of patients (89.6%) had an Elixhauser comorbidity index score of at least 3. The most common comorbidities were hypertension (82.1%), atrial fibrillation (53.2%), chronic heart failure (53.2%), and hyperlipidemia (53.0%) (Table 1).
The most frequent conduction diseases when leadless pacemakers were implanted were
Discussion
This large, contemporary, retrospective database study assessing leadless pacemaker implant procedures (n = 7821) is the most extensive cohort study to date. It characterizes the outcomes and rates of complications for patients during index admission and 30-day readmissions. The key findings of this report were as follows.(1) Total immediate procedure-related complications occurred in 7.5% of patients, with device dislodgment occurring in 0.51% and pericardial effusion requiring
Conclusion
In our large cohort, the rate of overall complications related to leadless pacemaker placement was slightly higher than in postapproval registry studies. Part of this finding might be attributed to the heterogeneity of these studies and the broader inclusion of complications in our study. However, the rate of serious complications remained relatively low and comparable to prior studies in a high-risk population with multiple comorbidities. This report supports the use of leadless pacemakers,
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Cited by (6)
Real-World Use of Leadless Pacing: Lessons Learned
2022, Canadian Journal of CardiologyPacing-induced cardiomyopathy after leadless pacemaker implant: It's all about location, location, location
2023, Journal of Cardiovascular ElectrophysiologyEndocardial versus epicardial pacing in pacemaker-dependent patients after device extraction: a meta-analysis
2023, Expert Review of Medical DevicesLeadless Pacing: Therapy, Challenges and Novelties
2023, Arrhythmia and Electrophysiology Review
Funding Sources: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Disclosures: The authors have no conflicts of interest to disclose.