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

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.

Keywords: Cardiac arrest; Leadless pacemaker; Mortality; Pericardial effusion; TV-VVI; Venous thromboembolism.