Clinical predictors of adverse patient outcomes in an experience of more than 5000 chronic endovascular pacemaker and defibrillator lead extractions

Background: It is difficult to predict adverse patient outcomes associated with transvenous lead extraction (TLE) procedures.

Objective: The purpose of this study was to examine the safety and efficacy of chronic endovascular pacemaker and implantable cardioverter-defibrillator (ICD) lead extraction and risk factors associated with adverse patient outcomes.

Methods: Consecutive patients undergoing TLE at the Cleveland Clinic between August 1996 and August 2011 were included in the analysis. Univariate and multivariable logistic regression analyses were performed to evaluate for associations with outcomes. Continuous data are given as median (25th, 75th percentile). Categorical data are given as number (percentage).

Results: In total, 5521 leads (4137 [74.9%] pacemaker, 1384 [25.1%] ICD) were extracted during 2999 TLE procedures (patient age 67.2 [55.2, 76.2] years, 30.2% female). Lead implant duration was 4.7 (2.4, 8.3) years, and 2.0 (1.0, 2.0) leads were extracted per procedure. Powered sheaths were used in 74.9% of procedures. Overall, there was 95.1% complete procedural success, 98.9% clinical success, and 1.1% failure, with 3.6% minor complications and 1.8% major complications. All-cause mortality within 30 days of TLE was 2.2%. Multivariable predictors of major complications included cerebrovascular disease, ejection fraction ≤15%, lower platelet count, international normalized ratio ≥1.2, mechanical sheaths, and powered sheaths. Multivariable predictors of all-cause mortality within 30 days of TLE included body mass index <25 kg/m(2), end-stage renal disease, higher New York Heart Association functional class, lower hemoglobin, higher international normalized ratio, lead extraction for infection, and extraction of a dual-coil ICD lead.

Conclusion: TLE in this single-center experience was highly successful. Risk factors associated with adverse patient outcomes were identified.