Transvenous lead extraction: Efficacy and safety of the procedure in female patients

Luca Segreti; Maria Grazia Bongiorni; Valentina Barletta; Matteo Parollo; Andrea Di Cori; Federico Fiorentini; Mario Giannotti Santoro; Raffaele De Lucia; Stefano Viani; Gino Grifoni; Luca Paperini; Ezio Sodati; Lorenzo Mazzocchetti; Antonio Maria Canu; Giulio Zucchelli

doi:10.1016/j.hroo.2023.09.002

Transvenous lead extraction: Efficacy and safety of the procedure in female patients

Heart Rhythm O2. 2023 Sep 12;4(10):625-631. doi: 10.1016/j.hroo.2023.09.002. eCollection 2023 Oct.

Authors

Luca Segreti^{1

2}, Maria Grazia Bongiorni², Valentina Barletta², Matteo Parollo², Andrea Di Cori², Federico Fiorentini², Mario Giannotti Santoro², Raffaele De Lucia², Stefano Viani², Gino Grifoni², Luca Paperini², Ezio Sodati², Lorenzo Mazzocchetti², Antonio Maria Canu², Giulio Zucchelli²

Affiliations

¹ Department of Translational Research on New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
² Second Division of Cardiovascular Diseases, Cardiac and Thoracic Department, New Santa Chiara Hospital, University of Pisa, Pisa, Italy.

Abstract

Background: Existing data on the impact of sex differences on transvenous lead extraction (TLE) outcomes in cardiac device patients are limited.

Objective: The purpose of this study was to evaluate the safety and efficacy of mechanical TLE in female patients.

Methods: A retrospective evaluation was performed on 3051 TLE patients (group 1: female; group 2: male) from a single tertiary referral center. All individuals received treatment using single sheath mechanical dilation and various venous approaches as required.

Results: Our analysis included 3051 patients (group 1: 750; group 2: 2301), with a total of 5515 leads handled with removal. Female patients were younger, had a higher left ventricular ejection fraction, and lower prevalences of coronary artery disease and diabetes mellitus. Infection was more common in male patients, whereas lead malfunction or abandonment were more frequent in female patients. Radiologic success was lower in female patients (95.8% vs 97.5%; P = .003), but there was no significant difference in clinical success between groups (97.2% vs 97.5%; P = .872). However, major complications (1.33% vs 0.60%; P <.001) and procedural mortality (0.4% vs 0.1%; P <.001) were higher in females compared to male patients. After multivariate analysis, female sex emerged as the only predictor of major complications, including deaths (odds ratio 3.96; 95% confidence interval 1.39-11.24).

Conclusion: TLE using unpowered simple mechanical sheaths in female patients is safe and effective, but is associated with lower radiologic success and higher complication rates and mortality than in males. This finding underscores the importance of recognizing sex differences in TLE outcomes.

Keywords: Complication; Female sex; Safety outcomes; Sex differences; Transvenous lead extraction.