Performance and Outcomes of Transvenous Rotational Lead Extraction: Results from a Prospective, Monitored, International Clinical Study

Abstract Background Transvenous lead extraction (TLE) plays a critical role in managing patients with cardiovascular implantable electronic devices (CIED). Mechanical TLE tools including rotational sheaths are used to overcome fibrosis and calcification surrounding leads. Prospective clinical data are limited regarding the safety and effectiveness of use of mechanical TLE devices, especially rotational tools. Objective To prospectively investigate the safety and effectiveness of mechanical TLE in real-world usage. Methods Patients were enrolled at 10 sites in the United States and Europe to evaluate the use of mechanical TLE devices. Clinical success, complete procedural success, and complications were evaluated through follow-up (median, 29 days). Patient data were source verified and complications were adjudicated by an independent clinical events committee (CEC). Results Between October 2018 and January 2020, mechanical TLE tools, including rotational sheaths, were used to extract 460 leads with a median indwell time of 7.4 years from 230 patients (mean age 64.3 ± 14.4 years). Non-infectious indications for TLE were more common than infectious indications (61.5% vs 38.5%, respectively). The extracted leads included 305 pacemaker leads (66.3%) and 155 implantable cardioverter-defibrillator (ICD) leads (33.7%), including 85 leads with passive fixation (18.5%). A bidirectional rotational sheath was needed for 368 leads (88.0%). Clinical success was obtained in 98.7% of procedures; complete procedural success was achieved for 96.3% of leads. CEC-adjudicated device-related major complications occurred in 6/230 (2.6%) procedures. No isolated superior vena cava (SVC) injury or procedural death occurred. Conclusion This prospective clinical study demonstrates that use of mechanical TLE tools, especially bidirectional rotational sheaths, are effective and safe.