Comparison of in-hospital outcomes and complications of leadless pacemaker and traditional transvenous pacemaker implantation

Abstract

Abstract Aims Since their introduction in 1958, traditional cardiac pacemakers have undergone considerable upgrades over the years, but they continue to have a complication rate of ∼3.8%–12.4%. There are no randomized controlled trials comparing outcomes of leadless pacemakers (LPM) with single-chamber transvenous pacemakers (TV-VVI). The aim is to assess the differences in the procedural complications and in-hospital outcomes between LPM and TV-VVI implants. Methods and results We queried the national inpatient database from 2016 to 2019 to include adult patients undergoing LPM and TV-VVI. Admissions for leadless and single-lead transvenous pacemakers were identified by their appropriate ICD-10 codes. Complications were identified using ICD-10 codes that mostly represent initial encounter. The difference in outcomes was assessed using multivariable logistic regression and 1:1 propensity score matching between the two cohorts. Thirty-five thousand four hundred thirty expanded samples of admissions were retrieved of which 27 650 (78%) underwent TV-VVI with a mean age 81.3 ± 9.4 years and 7780 (22%) underwent LPM with a mean age of 77.1 ± 12.1 years. The LPM group had a higher likelihood of in-hospital mortality [adjusted odds ratio (aOR): 1.63, 95% CI (1.29–2.05), P < 0.001], vascular complications [aOR: 7.54, 95% CI (3.21–17.68), P < 0.001], venous thromboembolism [aOR: 3.67, 95% CI (2.68–5.02), P < 0.001], cardiac complications [aOR: 1.79, 95% CI (1.59–2.03), P < 0.001], device thrombus formation [aOR: 5.03, 95% CI (2.55–9.92), P < 0.001], and need for a blood transfusion [aOR: 1.54, 95% CI (1.14–2.07), P < 0.005]. The TV-VVI group had higher likelihood of in-hospital pulmonary complications [aOR:0.68, 95% CI (0.54–0.87), P < 0.002] and had a need for device revisions [aOR:0.42, 95% CI (0.23–0.76), P < 0.004]. Conclusion There is a higher likelihood of all-cause in-hospital mortality and complications following LPM implantation in comparison to TV-VVI. This could be related to higher co-morbidities in the LPM group. Clinical trials aimed to accurately compare these two groups should be undertaken.