Comparison of two types of rotational mechanical dilatator sheath: Evolution® and TightRail™

INTRODUCTION: Powered extraction tools are usually needed in chronically implanted leads. Comparative data are essential among different rotating dilator sheaths. The aim of the study was to compare procedural/clinical outcomes and adverse events in patients underwent lead extraction utilizing two different rotating dilator sheaths. METHODS AND RESULTS: The current study was a retrospective review of consecutive patients at a single center. From December 2009 to August 2017, 163 lead extractions from 98 consecutive patients (median, 65 years; 71% male) utilizing a rotating mechanical sheath were analyzed for both efficacy (procedural and clinical success rates) and safety (adverse events). According to the type of the sheath used, the Evolution group (58 patients with 94 leads) and the TightRail group (40 patients with 69 leads) were determined. Extracted device was an implantable cardioverter-defibrillator (ICD) in two-thirds of patients. The majority of leads (87.7%) had passive-fixation mechanism. All ICD leads had dual-coil design. The median lead implant duration was 4 years, and no difference was found between the two groups. Infectious etiology was the main indication for extraction in 56.1% of patients. There were no statistically significant differences regarding the procedural success rate (96.6% vs 95.0%), clinical success rate (98.3% vs 97.5%), and total adverse event rate (5.2% vs 10.0%) between the Evolution and TightRail groups, respectively. Procedural success decreased with older leads and higher lead number. CONCLUSIONS: Procedural and clinical success rates utilizing both the Evolution and TightRail rotational extraction sheaths were high with low complication rate in chronically implanted leads.