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.