Rate and nature of complications with leadless transcatheter pacemakers compared with transvenous pacemakers: results from an Italian multicentre large population analysis. Issue 1 (29th August 2022)

• Record Type: Journal Article
• Authors: Palmisano, Pietro; Facchin, Domenico; Ziacchi, Matteo; Nigro, Gerardo; Nicosia, Antonino; Bongiorni, Maria Grazia; Tomasi, Luca; Rossi, Andrea; De Filippo, Paolo; Sgarito, Giuseppe; Verlato, Roberto; Di Silvestro, Michele; Iacopino, Saverio
• Is Part Of: Europace. Volume 25:Issue 1(2023)
• Page Start: 112
• Page End: 120
• Publication Date: 2022-08-29
• Subjects: Leadless pacemaker -- Transvenous pacemaker -- Complications -- Lead-related complications -- Pocket-related complications -- Device infection; Arrhythmia -- Treatment -- Periodicals; Cardiac pacing -- Periodicals; Catheter ablation -- Periodicals; Heart -- Physiology -- Periodicals; Electrophysiology -- Periodicals; 617.4120645
• DOI: 10.1093/europace/euac112
• Languages: English
• ISSNs: 1099-5129

Abstract

Abstract: Aims: The safety and efficacy of leadless intracardiac-permanent pacemaker (L-PM) have been demonstrated in multiple clinical trials, but data on comparisons with conventional transvenous-permanent pacemaker (T-PM) collected in a consecutive, prospective fashion are limited. The aim of this analysis was to compare the rate and the nature of device-related complications between patients undergoing L-PM vs. T-PM implantation. Methods and results: Prospective, multicentre, observational project enrolling consecutive patients who underwent L-PM or T-PM implantation. The rate and nature of device-related complications were analysed and compared between the two groups. Individual 1:1 propensity matching of baseline characteristics was performed. A total of 2669 ( n = 665 L-PM) patients were included and followed for a median of 39 months, L-PM patients were on average older and had more co-morbidities. The risk of device-related complications at 12 months was significantly lower in the L-PM group (0.5% vs. 1.9%, P = 0.009). Propensity matching yielded 442 matched pairs. In the matched cohort, L-PM patients trended toward having a lower risk of overall device-related complications ( P = 0.129), had a similar risk of early complications (≤30 days) ( P = 1.000), and had a significantly lower risk of late complications (>30 days) ( P = 0.031). All complications observed in L-PM group were early. Most (75.0%) of complications observed in T-PM group were lead- or pocket-related. Conclusion: In this analysis, the risk of device-related complications associated with L-PM implantation tended to be lower than that of T-PM. Specifically, the risk of early complications was similar in two types of PMs, while the risk of late complications was significantly lower for L-PM than T-PM.