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Observational Study
. 2016 Jul;18(7):1043-8.
doi: 10.1093/europace/euv245. Epub 2015 Oct 14.

Initial experience with the TightRail™ Rotating Mechanical Dilator Sheath for transvenous lead extraction

Kudret Aytemir  1 , Hikmet Yorgun  1 , Uğur Canpolat  2 , M Levent Şahiner  1 , Ergün Barış Kaya  1 , Banu Evranos  1 , Necla Özer  1
Affiliations
Observational Study

Initial experience with the TightRail™ Rotating Mechanical Dilator Sheath for transvenous lead extraction

Kudret Aytemir et al. Europace. 2016 Jul.

Abstract

Aims: In parallel with increasing implantation rates and patients' longer life expectancy, the need for transvenous lead extraction (TLE) as a specialized procedure has shown a significant growth over years. Herein, we aimed to present our initial experience in TLE by using a novel TightRail™ Rotating Mechanical Dilator Sheath.

Methods and results: Between October 2014 and March 2015, a total of 42 leads in 23 patients were removed at our tertiary referral centre. All of the extracted leads were >12 months old and indications for extraction were based on the recommendations of the Heart Rhythm Society. The leads were removed by using the TightRail™ Mechanical Dilator Sheath (Spectranetics Corporation) with the rotational cutting force only. Indications for lead removal included cardiac device infection in 12 (52.2%) cases, lead malfunction in the 10 (43.5%) cases, and upgrade to cardiac resynchronization therapy-defibrillator (CRT-D) in the remaining 1 case (4.3%). The extracted devices were pacemaker in 10 (43.4%) cases, implantable cardioverter-defibrillator (ICD) in 7 (30.4%) cases, and CRT in the remaining 6 (26.0%) subjects. Among 42 leads, 10 (23.8%) were right ventricular, 14 (33.3%) were atrial, 13 (31.0%) were defibrilator, and 5 (11.9%) were coronary sinus electrodes. The median time from implantation was 72 (18-216) months. Complete procedural success with TightRail™ system alone was achieved in 22 (95.7%) patients (41/42 leads) and overall clinical success was 100%. One right ventricular lead was completely removed with the help of femoral snare. All the patients were discharged uneventfully without any complication.

Conclusion: Our preliminary data with small sample size show that TightRail™ Mechanical Dilator Sheath is a new useful tool for chronically implanted pacemaker (PM)/ICD leads. Continued investigation including large patient cohort is required to evaluate success and complication rates in comparison to other tools and techniques.

Keywords: Lead extraction; TightRail™ Mechanical Dilator Sheath.

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