Transvenous lead removal was associated with higher complication rates than previously reported, including 2.2% in-hospital mortality, 2.6% hemorrhage, and 2.4% postoperative respiratory failure.
Observational (n=91,890)
Yes
What are the trends in use and adverse outcomes associated with transvenous lead removal in the United States?
The overall complication rate for transvenous lead removal in real-world practice is higher than previously reported, with female sex and device infections predicting higher complications, while hospital volume was not associated with higher rates.
BACKGROUND: Transvenous lead removal (TLR) has made significant progress with respect to innovation, efficacy, and safety. However, limited data exist regarding trends in use and adverse outcomes outside the centers of considerable experience for TLR. The aim of our study was to examine use patterns, frequency of adverse events, and influence of hospital volume on complications. METHODS AND RESULTS: Using the Nationwide Inpatient Sample, 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, Ninth Revision, Clinical Modification 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 sex 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 sex 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.
Deshmukh et al. (2015) conducted an observational in Transvenous lead removal (n=91,890). Transvenous lead removal was evaluated on In-hospital complications including death, hemorrhage, vascular and pericardial complications, open heart surgery, and respiratory failure. Transvenous lead removal was associated with higher complication rates than previously reported, including 2.2% in-hospital mortality, 2.6% hemorrhage, and 2.4% postoperative respiratory failure.