Predictors of perforation during lead extraction: Results of the Canadian Lead ExtrAction Risk (CLEAR) study

BACKGROUND Transvenous lead extraction can have serious adverse events, such as cardiac or vascular perforation. Risk factors have not been well characterized. OBJECTIVE The purpose of this study was to identify factors associated with perforation and death, and to characterize lead extraction in a large contemporary population. METHODS We performed a retrospective multicenter study examining patients undergoing lead extraction at 8 Canadian institutions from 1996 through 2016. Demographic and clinical data were used to identify variables associated with perforation and mortality using logistic regression modeling. RESULTS A total of 2325 consecutive patients (age 61.9 +/- 16.5 years) underwent extraction of 4527 leads. Perforation rate was 2.7% (63/2325) and 30-day mortality was 1.6% (38/2325), with mortality of 0.4% due to perforation (10/2325). Variables associated with perforation included no previous cardiac surgery (odds ratio [OR] 3.33; 95% confidence interval [CI] 1.54-7.19; P = .002), female sex (OR 3.27; 95% CI 1.91-5.60; P<.001); left ventricular ejection fraction >= 40% (OR 2.81; 95% CI 1.28-6.14; P =.010); lead age >8 years (OR 2.64; 95% CI 1.52-4.60; P<.001); >= 2 leads extracted (OR 2.49; 95% CI 1.23-5.04; P = .011); and diabetes (OR 2.12; 95% CI 1.16-3.86; P = .014). Variables associated with death included infection as indication for extraction (OR 3.85; 95% CI 1.38-10.73; P = .010); anemia (OR 3.14; 95% CI 1.38-6.61; P = .003), and patient age (OR 1.04; 95% CI 1.01-1.07; P = .012). CONCLUSION Risk factors associated with perforation in lead extraction include no history of cardiac surgery, female sex, preserved left ventricular ejection fraction, lead age >8 years, >= 2 leads extracted, and diabetes.