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

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.

Keywords: Evolution sheath, Lead extraction

Abbreviation: ICD, implantable cardioverter-defibrillator