Trends in Utilization and Adverse Outcomes Associated with Transvenous Lead Removal in the United States
Background—Transvenous lead removal (TLR) has made significant progress with respect to innovation, efficacy and safety. However, limited data exist regarding trends in utilization and adverse outcomes outside the centers of considerable experience for TLR. The aim of our study was to examine utilization patterns, frequency of adverse events and influence of hospital volume on complications.
Methods and Results—Using the Nationwide Inpatient Sample (NIS), we identified 91,890 TLR procedures. We investigated common complications including pericardial complications (hemopericardium, cardiac tamponade, or pericardiocentesis), pneumothorax, stroke, vascular complications (consisting of hemorrhage/hematoma, incidents requiring surgical repair, and accidental arterial puncture), and in-hospital deaths described with TLR, defining them by the validated International Classification of Diseases (9th Edition) Clinical Modification (ICD-9-CM) diagnosis code. We specifically assessed in-hospital death (2.2%), hemorrhage requiring transfusion (2.6%), vascular complications (2.0%), pericardial complications (1.4%), open heart surgery (0.2%), and postoperative respiratory failure (2.4%). Independent predictors of complications were female gender and device infections. Hospital volume was not independently associated with higher complications. There was a significant rise in overall complication rates over the study period.
Conclusions—The overall complication rate in patients undergoing TLR was higher than previously reported. Female gender and device infections are associated with higher complications. Hospital volume was not associated with higher complication rates. The number of adverse events in the literature likely underestimates the actual number of complications associated with TLR.
- Lead extraction
- hospital volume
- quality of care
- cardiac electrophysiology
- implanted cardioverter defibrillator
- Received October 17, 2014.
- Revision received September 13, 2015.
- Accepted September 17, 2015.