Objectives: The aim of this study was to investigate the safety and in-hospital outcomes of transcutaneous lead extraction (TLE) associated with device-related infection (DRI) in the United States from 2003 to 2015.
Background: DRI remains the most serious complication and the most common indication for lead extraction in patients with cardiac implantable electronic devices. The rates of DRI and associated lead extraction have been growing in line with the increasing number of cardiac implantable electronic device implantations worldwide.
Methods: Data for this study were drawn from the National (Nationwide) Inpatient Sample. The International Classification of Diseases-9th Revision-Clinical Modification coding system was used to identify hospitalizations with TLE for DRI and to investigate the rates of major adverse events.
Results: From a total of approximately 100 million unweighted hospitalizations over the 13-year study period, 12,257 unweighted observations were identified. This represents 59,082 (95% confidence interval [CI]: 58,982 to 59,182) patients who underwent TLE for DRI during the study period. A large majority of patients (75%) were older than 60 years. Patients were predominantly male (70%) and Caucasian (76%), and 80% had at least 1 comorbidity. The median length of stay was 8 days (interquartile range 5 to 14 days). At least 1 major adverse event occurred in 10.42% of procedures. The all-cause in-hospital mortality rate was 4.11%. Independent predictors of mortality were weight loss (adjusted odds ratio [aOR]: 4.02; 95% CI: 3.13 to 5.17), congestive heart failure (aOR: 3.28; 95% CI: 2.48 to 4.34), chronic kidney disease (aOR: 2.09; 95% CI: 1.70 to 2.56), pericardial complications (aOR: 2.87; 95% CI: 1.79 to 4.61), and procedure-related pulmonary injury (aOR: 2.06; 95% CI: 1.25 to 3.40).
Conclusions: These results reflect the high rate of complications and mortality for TLE due to DRI in real-world experience, highlighting the importance of comorbidities, especially congestive heart failure and chronic kidney disease, as significant predictors of mortality in these patients.
Keywords: cardiac implantable electronic device; complications; device-related infection; outcomes; safety; transvenous lead extraction.
Copyright © 2019 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.