Clinical performance of a new bidirectional rotational mechanical lead extraction sheath

Abstract

Aims: We investigated the safety and efficacy of a new bidirectional rotational mechanical extraction sheath (Evolution RL, Cook Medical, USA).

Methods and results: From April 2013 until September 2014, we performed lead extraction procedures in 71 patients with 112 leads scheduled for extraction. During this time period, we used the new Evolution RL rotational sheath in 40 patients on 52 leads (24 pacemaker leads and 28 implantable cardioverter-defibrillator leads) scheduled for extraction. The mean lead implant duration in these patients was 100.2 (22-271) months. Forty leads were right ventricular leads, 10 right atrial leads, and 2 coronary sinus leads. Clinical success among the leads approached with the Evolution RL device was 98.1%. Operative mortality was zero. Major complications did not occur. Four minor complications were encountered (all pocket haematomas). No device-related complications were noted. In cases with multiple leads in situ, no wrapping of companion leads was seen. The average number of extraction tools used per lead was 2.4 (2-4) in the Evolution RL cohort.

Conclusion: Based on the presented results of our initial experience with the new bidirectional rotational mechanical extraction device, its use is safe and efficient with high success rates in long implanted leads.

Keywords: ICD; Lead extraction; Pacemaker.