Comparison of Acute and Long-term Outcomes of Evolution® and TightRail™ Mechanical Dilator Sheaths during Transvenous Lead Extraction

Background: Powered transvenous lead extraction (TLE) tools are commonly required in the removal of the leads that have long implant duration due to fibrotic adhesions. However, the comparative data are lacking among different types of TLE tools. Aim: To compare the efficacy and safety of two different rotational mechanical dilator sheaths in retrospectively analyzed patients who underwent TLE. Methods and results: A total of 566 lead extractions from 302 patients using TightRailTM (333 lead extractions from 169 patients) and Evolution® (233 lead extractions from 133 patients) mechanical dilator sheaths were performed between July 2009 and June 2018. Acute and long term outcomes of study groups were compared. There is no statistically significant difference between Evolution® and TightRailTM groups in procedural success (93.9% vs. 94%), clinical success (99.2% vs. 98%) and major complications (3.8% vs. 1.2%), respectively (p>0.05). In multivariate regression analysis, lead dwell time, number of extracted leads, and baseline leukocyte count were found as independent predictors of procedural success (p<0.05). During the median follow-up of 36.6 (0.2-118) months, all-cause mortality was observed in 73 patients (25.6% in the Evolution® vs. 23.1 in the TightRailTM group, p>0.05). Chronic renal disease, heart failure, and coagulopathy were shown as independent predictors of all-cause mortality in multivariate regression analysis (p<0.05). Conclusions: TLE using TightRailTM or Evoluation® mechanical dilator sheaths is a safe and effective therapeutic option. Both mechanical dilator sheaths showed similar efficacy, safety, and all-cause mortality at acute and long-term follow-up of patients who underwent TLE.