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. 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). Noninfectious 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 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 of 230 (2.6%) procedures. No isolated superior vena cava 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.

The valuable interaction among cardiac surgeon and electrophysiologist for transvenous rotational mechanical lead extraction

“…Recently, single and multicenter studies reported that the second generation of the Evolution system (Evolution RL) has emerged as alternative mechanical TLE tool for extraction of chronically implanted leads. [7][8][9][10][11] The efficacy of the system, equal to that of laser powered sheaths, has led to an increase in its use in clinical practice as a firstline approach in centers with experienced operators when advanced TLE techniques are needed in complex cases and long lead implant duration. The present study not only confirmed and extended previous observations, demonstrating that the Evolution RL system is an effective TLE tool with high success rates, but also reported its use in combined procedure.…”

“…Complete procedural success, per lead, in our study was slightly lower compared with recent multicenter studies, such as the PROMET 10 and the RELEASE studies. 11 This may due to differences in patient populations. Indeed, our study population had higher infection indication for TLE and more passive leads.…”

“…[1][2][3][4][5][6] Recent studies have shown that Evolution RL bidirectional rotational mechanical sheath (Cook Medical, Bloomington, IN, USA) is an effective and safe technique for the extraction of chronically implanted leads. [7][8][9][10][11] Most lead extractions are performed using a percutaneous approach by electrophysiologists as part of a less invasive procedure. 1,2 However, in specific situations (highrisk procedures, large vegetations, refractory heart failure, valve diseases, implantation of epicardial leads), an open extraction with sternotomy and cardiopulmonary bypass or hybrid approaches may be preferred.…”

Performance and outcomes of transvenous rotational lead extraction: Results from a prospective, monitored, global clinical study—“An evolution in extraction”

“…This current study by Sharma and colleagues 6 compares favorably with these studies and includes clinical follow-up data at 4 weeks. It represents one of the largest international, prospective studies of mechanical TLE.…”

“…In this issue of Heart Rhythm O 2 , Sharma and colleagues 6 provide an insightful prospective study aimed at understanding the safety and efficacy of the Cook Medical Evolution® RL mechanical rotational TLE device (RELEASE study). Ten medical centers in the United States and Europe were involved, with 230 patients enrolled for a total of 460 leads extracted.…”