Study population
Our clinic is a high volume tertiary referral center for TLE procedure
(>130/year) in our country. The study was designed as a
single-center observational cohort study. The study included a total of
302 patients who underwent TLE procedure in our Electrophysiology
Laboratory by using a hand-powered rotating mechanical dilator sheaths
marketed as the Evolution® (Cook Medical) and the
TightRailTM (Spectranetics Corp.) in between July 2009
and June 2018. Patients in whom the TLE has been performed by manual
traction or with a locking stylet were excluded from the study. The
indications for TLE were based on the recent European Heart Rhythm
Association (EHRA) and Heart Rhythm Society (HRS) recommendations1.
The study population was categorized into two as; the
Evolution® group and the TightRailTMgroup. First-generation Evolution® mechanical dilator
sheath was used between July 2009 and September 2014 and
TightRailTM mechanical dilator sheath was used between
September 2014 and June 2018 because of the availability and
reimbursement policy of National Social Security System. There is no
patient cross-over between the two groups. Laser-assisted sheaths or the
second-generation EvolutionR/L mechanical dilator
sheath were unavailable and not re-imbursed during the study period in
our country. The study data were collected by using electronic medical
records, files, and National Death Reporting System. The study complied
with the principles outlined in the Declaration of Helsinki and approved
by our local institutional ethics committee.