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