Trends in Use and Adverse Outcomes for Transvenous Lead Removal
What are the utilization patterns, frequency of adverse events, and influence of hospital volume on complications associated with transvenous lead removal (TLR)?
A Nationwide Inpatient Sample was used to identify 91,890 TLR procedures and examine relevant adverse outcomes: pericardial complications, pneumothorax, stroke, vascular complications, and in-hospital deaths.
The rate of in-hospital death was 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 between 2006 and 2012.
The authors concluded that the overall complication rate in patients undergoing TLR is high. Female gender and device infections were 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.
The volume of TLR has been increasing, a consequence of recent defibrillator lead recalls and surging rates of cardiovascular implantable electronic device (CIED) infections. Much of the data pertaining to the safety and efficacy of TLR originated in specialized centers with investigators who have made device extraction a focus of their expertise. The current study offers the largest sample of the ‘real life’ extraction-related complications in the United States. In the present study, the rate of complications was 8.4%, much higher than in some previous clinical reports. Additionally, despite advancements in the extraction technology, the authors noted a worrisome rise in overall complication rates over the study period. The reasons for the increasing complication rate remain speculative.
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