Europace. 2023 Sep 15:euad269. doi: 10.1093/europace/euad269. Online ahead of print.
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.
PMID:37712644 | DOI:10.1093/europace/euad269