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.