In-Hospital Outcomes and Peri-Procedural Complications of Leadless Pacemaker Compared to Traditional Transvenous Pacemaker in Patients With End-Stage Renal Disease.

Abstract

Background: End-stage renal disease (ESRD) is an independent predictor of morbidity and mortality in patients undergoing invasive procedures, including permanent pacemaker implantation. Leadless pacemakers (L-VVI) have emerged as an alternative to traditional transvenous pacemakers (TV-VVI), especially in ESRD patients to reduce infection rates and preserve vasculature for dialysis access. However, there is limited data comparing the safety and procedural complications following L-VVI and TV-VVI implantation in ESRD patients.

Methods: We utilized the National Inpatient Sample (NIS) database between January 1, 2016 and December 31, 2019, to identify patients with ESRD using ICD-10 CM codes. The L-VVI implantation was identified using ICD-10 PCS code "02HK3NZ." TV-VVI implantation was identified with following ICD-10 PCS codes: 0JH604Z, 0JH605Z, 02HK3JZ, 02HK4JZ, 02HK3MZ, and 02HK4MZ. Propensity score matching was used to balance the baseline covariates between L-VVI and TV-VVI groups. An absolute standardized mean difference of < 5% (0.05) was considered an acceptable difference for adequate balance between two groups. Logistic regression was used to analyze the association. All statistical analyses were performed using weighted values.

Results: During our study period, we identified 2065 (11.5%) hospitalizations for L-VVI implantation and 15,880 (88.5%) hospitalizations for TV-VVI implantation in patients with ESRD. After 1 to 2 propensity matching, 2065 hospitalizations in L-VVI group and 4130 hospitalizations in TV-VVI group were included in the analysis. ESRD patients who underwent l-VVI had higher rates of device infection (OR 1.93, 95% CI 1.52-2.44, p < 0.001), device thrombus (OR 1.95, 95% CI 1.47-2.57, p < 0.001), pericardial effusion (OR 1.42, 95% CI 1.10-1.83, p = 0.007), vascular complications (OR 4.02, 95% CI 1.88-8.62, p < 0.001), and venous thromboembolism (OR 2.79, 95% CI 1.96-3.97, p < 0.001) when compared to patients who underwent TV-VVI. The odds of all-cause in-hospital mortality (OR 1.2, 95% CI 0.97-1.49, p = 0.09), cardiac arrest (OR 1.0, 95% CI 0.82-1.20, p = 0.99), cardiac tamponade (OR 0.56, 95% CI 0.28-1.15, p = 0.11), and bleeding complications (OR 1.01, 95% CI 0.87-1.14, p = 0.99) were similar between the two groups.

Conclusion: In patients with ESRD, those who underwent L-VVI implantation had higher likelihood of peri-procedural complications, but similar all-cause in-hospital mortality compared to those who underwent TV-VVI implantation. Larger prospective observational data are needed to validate these findings, which can help guide in appropriate patient selection for L-VVI implantation.