Incidence and Predictors of Peri-procedure Complications with Transvenous Lead Extractions in the Real World: Data from NCDR ICD Registry

Introduction: Transvenous lead extraction (TLE) is integral to device management. The incidence and predictors of peri-procedural complications in a large cohort undergoing TLE in the “real world” is not yet reported. Methods: Data from NCDR ICD Registry Version 2.0 (both implant and lead-only procedures, 4/10-6/12) was analyzed. “Lead Extraction” was defined as removal of leads implanted for > 1 year. Clinical characteristics were available for 8228 patients. High-voltage (HV) leads were analyzed separately for lead related factors predicting major complications. Major complications were defined as any of: cardiac arrest, cardiac perforation, coronary venous dissection, conduction block, hemothorax, pericardial tamponade, pneumothorax, urgent cardiac surgery and death. Multivariable logistic regression analyses were performed to evaluate for predictors of peri-procedural complications. Results: Among 11,304 patients, 8362 (74%) had HV +/-pacing lead/s, and 2942 (26%) pacing-lead/s only, extracted at 762 centers. There were 258 (2.3%) major peri-procedural complications reported: 200 in patients undergoing HV TLE (2.39%), and 58 in patients with pacing (2%) lead TLE. Urgent cardiac surgery was required in 41 patients (16%). Of the 41 patients undergoing cardiac surgery, 14 (34%) died either intra- or post-operatively. There were 98 (0.9%) in-hospital deaths reported with 18 (0.16%) of these occurring during TLE. Female sex, infection leading to extraction, ≥3 leads extracted, lead dislodgement during procedure, history of heart failure, and older lead age were significant multivariate predictors of major peri-procedural complications. Smaller lead diameter, flat vs. round coil shape and greater proximal surface coil area were multivariate predictors of major peri-procedural complications specific to HV leads. Conclusion: Many US centers are now performing TLE. The rate of major complications and mortality is higher in this “real world” population than that reported in studies/series from high volume specialized extraction centers. Urgent cardiac surgery is frequently required in patients with major complications during TLE and it is imperative for centers to plan for immediately available cardiothoracic surgical support.