Initial experience with the Evolution mechanical dilator sheath for lead extraction: safety and efficacy

Abstract

Background: The Evolution mechanical dilator sheath is a new lead extraction tool that uses a rotational mechanism and a bladed tip to overcome fibrosis.

Objective: The purpose of this study was to report our initial experience with the Evolution system.

Methods: Between March 2008 (our first use of Evolution) and September 2009, the Evolution sheath was used for extraction of pacemaker or implantable cardioverter-defibrillator (ICD) leads in 29 patients (41 leads). Success and complications were defined according to the Heart Rhythm Society expert consensus document on lead extraction.

Results: Indications for extraction were infection in 20 patients and lead malfunction in 9 patients. Median implantation time was 65 months (range 12-409 months). Of the 41 leads, 18 (44%) were atrial and 23 (56%) were ventricular. ICD leads were extracted from 14 (48%) patients and pacemaker leads from 15 (52%) patients. Evolution was used as first choice in 12 patients (16 [39%] leads), with 100% clinical success. Complete procedural success was achieved in 11 patients; in 1 patient, only the distal electrode was retained. The system was used for "rescue" of 25 (61%) leads in 17 patients. Success with Evolution alone was achieved in 13 (77%) patients (Shortie Evolution sheath used in 2), for complete procedural success of 77%. However, in 4 (24%) patients, Evolution was useful but not sufficient for complete procedural success (femoral workstation required in 2, reuse of laser in 2). Overall, the Evolution system was successful in 25 (86%) patients (33 leads). Overall clinical success was 100%. No complications occurred.

Conclusion: Preliminary data suggest that the Evolution mechanical dilator sheath is a new useful tool among the instruments available for lead extraction.