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

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.