Improved outcomes with leadless vs. single-chamber transvenous pacemaker in haemodialysis patients

Abstract

Aims: Cardiac conduction disorders are common in haemodialysis patients, with a relatively high rate of pacemaker implantations. Pacemaker-related complications, especially lead infections and central venous stenosis, pose significant challenges in this population. This study aims to compare single-chamber leadless pacemaker to single-chamber transvenous pacemakers in terms of survival and related complications in haemodialysis patients.

Methods and results: This retrospective study included adult haemodialysis patients who received a first single-chamber transvenous or leadless pacemaker between January 2017 and December 2020. Data were obtained from the French national REIN registry matched to the national health databases (Système National des Données de Santé). Propensity score matching was used to balance baseline characteristics. Survival and complications were compared between groups by Cox regression and by competitive risk models, respectively. One hundred and seventy-eight patients were included after propensity score matching, with 89 patients in each group. The median follow-up time was 24 (range 7-37) months. Leadless pacemakers were associated with significantly lower all-cause mortality rates compared to transvenous pacemakers [hazard ratio (HR) = 0.68, 95% confidence interval (CI) (0.47-0.99)]. Device-related infections are significantly lower with leadless pacemakers throughout the follow-up period (HR 0.43, 95% CI 0.21-0.86). Leadless pacemaker recipients also required fewer vascular access interventions [odds ratio 0.53, 95% CI (0.33-0.68)] on arteriovenous fistula.

Conclusion: With the limitations of its observational design, this study suggests that leadless pacemakers are associated with a lower rate of complications and better survival as compared with transvenous VVI pacemakers in haemodialysis patients, supporting to consider their preferential use in this population.

Keywords: Complications; Haemodialysis; Leadless pacemakers; Single-chamber transvenous pacemakers; Survival; Vascular access for haemodialysis.

Structured Graphical Abstract

Outcomes of haemodialysis patients implanted with a leadless pacemaker compared to single-chamber transvenous pacemaker. (A) The patient enrolment process and the constitution of propensity score-matched sample. (B) A comparison of survival between leadless and transvenous pacemakers in haemodialysis patients. (C) A comparison of adverse events related to pacemaker implantation between groups. 95% CI, 95% confidence interval; HR, hazard ratio; RR, relative risk; DVT/PE, deep vein thrombosis/pulmonary embolism.

Figure 1

Flowchart illustrating the study protocol for patient enrolment. Out of 168 273 ESKD patients aged ≥18 years recorded in the REIN database between 2009 and 2020, 118 666 were successfully matched with the SNDS database. Subsequently, 1593 patients received at least one leadless or single-chamber transvenous pacemaker. Among them, 80 patients were excluded due to a previous history of cardiac electronic devices, 732 were not on dialysis at the time of pacemaker implantation, and 406 were excluded because the implantation occurred before the availability of leadless pacemakers (before 2017). This resulted in a final cohort of 384 patients. REIN, Réseau Epidémiologique et Information en Néphrologie; SNDS, Système National des Données de Santé; CCAM, Common Classification of Medical Acts.

Figure 2

Comparison of survival after leadless and transvenous pacemaker implantation in the propensity score-matched sample. The hazard ratio presented here is derived from a univariate Cox regression model conducted after propensity score matching. Individual risk is accounted for by a random effect at the individual level. HR, hazard ratio.