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

Abstract

Introduction Since their introduction in 1958, traditional cardiac pacemakers have undergone considerable upgrades over the years, but they continue to have a complication rate of around 3.8% to 12.4%. There are no randomized controlled trials comparing outcomes of leadless pacemakers (LPM) with single chamber transvenous pacemakers (TV-VVI). Objective Assess the differences in the procedural complications and in-hospital outcomes between LPM and TV-VVI implants. Methods We queried the national inpatient database from 2016–2019 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. Results 35,430 expanded sample of admissions was retrieved of which 27,650(78%) underwent TV-VVI with a mean age 81.3±9.4 years and 7,780(22%) underwent LPM with a mean age of 77.1±12.1 years. LPM group had a higher likelihood of in-hospital mortality (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, respectively). TV-VVI group had higher likelihood of in-hospital pulmonary complications (aOR:0.68, 95%CI[0.54–0.87], p<0.002) and 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 between these two groups should be undertaken.

Impact of omitting the intravenous heparin bolus on outcomes of leadless pacemaker implantation

“…This range is consistent with prior studies that have reported an incidence of LP-associated thrombus ranging from 0.2% to 4.2%. 2,9,10 In our cohort, the clinical importance of a numerically higher incidence of device-associated thrombus is unclear but serves as the basis for our conclusion that heparin bolus should still be considered in long cases or high-risk patients.…”

Prognosis and Predictor Factors of Permanent Pacemaker Implantation after Transcatheter Aortic Valve Replacement: A Retrospective Analysis of the Post-Transcatheter Aortic Replacement Clairval Hospital Registry

“…Some studies have highlighted safety and efficacity, supporting their utilization [ 22 ]. However, recent findings underscore potential concerns, with evidence suggesting higher inhospitality rates compared to traditional transvenous devices [ 23 ]. Given these conflicting findings, larger randomized trials are essential to elucidate the true benefits and risks associated with the use of leadless pacemakers in this setting.…”