Abstract Body (Do not enter title and authors here): Background: Transvenous lead extraction (TLE) is a well-established procedure with expanding indications in contemporary practice. However, sex-specific outcomes remain understudied, and women are typically underrepresented in TLE cohorts. Most available data emphasize overall procedural safety and efficacy, without stratifying by sex.
Hypothesis: We hypothesized that TLE outcomes are comparable between female and male patients.
Methods: All patients who underwent TLE between August 1996 and September 2022 at a high-volume US tertiary center were included in a prospectively maintained registry and stratified by sex. Baseline characteristics, procedural parameters, and outcomes were compared. Multivariable logistic regression models were computed with sex as the independent variable, adjusting for age, infection indication, ICD presence, hypertension, diabetes mellitus, ischemic cardiomyopathy, coronary artery disease, NYHA class ≥ III, number of extracted leads, dwell time of the oldest lead, and coronary sinus lead position.
Results: Among 5,090 patients (1,617 women; 3,473 men), women were younger (62 vs. 67.7 years) and had higher LVEF (50% vs. 38%), both p<0.001. They had lower rates of hypertension, diabetes mellitus, ischemic cardiomyopathy, and coronary artery disease (all p<0.001). Malfunction was the leading indication in women (40.4% vs. 31.2%), while infection predominated in men (43.7% vs. 32.3%), both p<0.001. The number of extracted leads (p=0.7), dwell time of the oldest lead (p=0.4) and fluoroscopy time (p=0.5) were similar between sexes. Use of advanced extraction tools, including mechanical sheaths (p=0.5), laser sheaths (p=0.2) and femoral workstations (p=0.4) were similar. Complete extraction (94.5% vs. 94.9%, p=0.2) and clinical success (97.1% vs. 97.2%, p=0.6) were high and comparable. With the exception of pocket infection or bleeding, which was more common in men (1.5% vs. 0.6%, p=0.008), complication rates did not significantly differ. Major complications occurred in 3.1% of women and 2.3% of men (p=0.1), and minor complications occurred in 2.3% and 3.2%, respectively (p=0.09). On multivariable analysis, sex was not an independent predictor of any complication.
Conclusion: In one of the largest single-center TLE cohorts to date, sex was not an independent predictor of procedural risk. Despite differing baseline characteristics and extraction indications, women experienced equivalent safety and efficacy outcomes compared to men.