Transvenous lead extraction outcomes using a novel hand-powered bidirectional rotational sheath as a first-line extraction tool in a low-volume centre.

Abstract

Extraction of cardiovascular implantable electronic devices in low-volume medical centres with limited clinical experience and an evolving lead extraction programme may be challenging. We aimed to evaluate the safety and efficacy of stepwise transvenous lead extraction (TLE) using a novel type of hand-powered rotational sheath as a first-line tool for extraction of chronically implanted devices in a single, low-volume centre. Sixty-seven consecutive patients undergoing a TLE procedure using the novel Evolution® RL rotational sheath as the first-line extraction tool between 2015 and 2019 at our institution were enrolled in the study. Their short-term and 30-day outcomes were observed. Sixty-nine devices and 131 leads were explanted. Procedural and clinical success rates were 92.4% and 98.5%, respectively. Two procedures were classified as failures due to lead remnants >4 cm remaining in patients' vascular systems. One major (1.5%) and 3 minor (4.4%) adverse events and no deaths were observed. TLE procedures, performed in a stepwise manner, using the Evolution RL sheath as a first-line extraction device and conducted by an experienced, surgically well-trained operator, offer excellent results with clinical and procedural success rates comparable to those, achieved in dedicated, high-volume institutions. Opting for optimal lead extraction approach in low-volume centres or institutions with evolving TLE programmes, a stepwise extraction strategy using the Evolution RL sheath by skilled operator may provide the optimal scheme with an excellent ratio between clinical and/or procedural success and complications.