Complications of leadless vs conventional (lead) artificial pacemakers - a retrospective review

J Community Hosp Intern Med Perspect. 2020 Aug 2;10(4):328-333. doi: 10.1080/20009666.2020.1786901.

Abstract

Background: Leadless pacemakers (LPM) are introduced in cardiovascular market with a goal to avoid lead- and pocket-associated complications due to conventional artificial pacemakers (CPM). The comparison of LPM and CPM complications is not well studied at a case by case level.

Methods: Comprehensive literature was searched on multiple databases performed from inception to December 2019 and revealed 204 cases that received LPM with a comparison of CPM. The data of complications were extracted, screened by independent authors and analyzed using IBM SPSS Statistics for Windows, Version 22.0 (Armonk, NY: IBM Corp.).

Results: The complications of CPM were high in comparison to LPM in terms of electrode dislodgement (56% vs 7% of cases, p-value < .0001), pocket site infection rate (16% vs 3.4%, p-value = 0.02), and a lead fracture rate (8% vs 0%, p-value = 0.04). LPMs had a statistically non-significant two-times high risk of pericardial effusion (8%) compared to CPMs (4%) with a p-value = 0.8.

Conclusion: LPMs appear to have a better safety profile than CPMs. There was a low pocket site and lead-related infections in LPM as compared to CPM. However, LPM can have twice the risk of pericardial effusion than CPMs, but this was not statistically significant.

Keywords: Conventional pacemaker; Micra transcatheter pacing system (Medtronic); Nanostim® leadless cardiac pacemaker; St. Jude Medical; St. Paul; leadless pacemaker; traditional pacemaker.

Publication types

  • Review