Transvenous extraction of pacemaker and implantable cardioverter defibrillator leads using Evolution® mechanical dilator sheath: a single center confirmatory experience

Abstract

ObjectiveIn recent years there has been an increase in clinical situations requiring lead extraction procedures of implanted cardiac devices. In our clinic, extraction procedures are performed with Evolution® mechanical lead extraction system. In this manuscript we aimed to evaluate our lead extraction procedures.MethodsWe retrospectively evaluated lead extraction procedures carried out on 41 patients [30 male, 11 female patient; mean age 61.5 ± 18.5 median 67 (23–85)] between 2008 and 2015 using Evolution® system. Procedural success, major and minor complications are determined according to previously published guidelines.ResultsMean duration of the lead implantation was 88.4 ± 62.5 months (6–240). Implanted device was a pacemaker in 27 (65.8 %) and ICD in 14 (34.2 %) of patients. Total 67 leads were extracted from the patients, 22 (32.8 %) were atrial, 30 (44.2 %) were ventricular, 14 (21.5 %) were dual coil defibrillator and 1 (1.5 %) was coronary sinus lead. Indications for lead removal were pacemaker decubitis and infection in 29 (70.8 %), lead dysfunction in 11 (26.8 %) and subclavian vein thrombosis in 1 (2.4 %) patient. Success rate with Evolution® system without using snare was 85.3 %. Clinical success rate was 97.5 % procedural success rate was 95.1 % and failure occured in one patient. Major complications occured in 2 (4.8 %) patients, 1 (2.4 %) was procedure related mortality. Minor complications were seen in 5 (12.2 %) of patients.ConclusionsIn our single center study it is shown that extraction of pacemaker and defibrillator leads of relatively long implantation duration and in an older age patient group may be successfully carried out using the Evolution® system. However due to potentially serious complications it is adviced to be done by experienced operators in centers with cardiovascular surgery backup.

Multicenter experience with the Evolution RL mechanical sheath for lead extraction using a stepwise approach: Safety, effectiveness, and outcome

“…Although our approach could make the TLE procedure less cost‐effective, the use of different ancillary tools supporting lead extraction procedures, with a systematic stepwise approach, may explain the higher effectiveness with a very low additional use of a snare (2%) using a femoral and/or jugular approach when comparing with previous studies . In particular, at variance with other centers, our protocol implied the systematic use of the Evolution Shortie RL to reduce difficulty in cutting through the fibrous tissue under the clavicle, advancing the sheath, and finally facilitate the use of the longer Evolution RL sheath when required.…”

“…Thus, “hand‐powered” mechanical rotational sheaths were developed as potential viable alternative to laser sheath especially in case of calcified fibrosis. The Evolution system has emerged as a mechanical TLE tool and few preliminary single center studies reported its safety and high efficacy (clinical success rate: 97.9–100%) using both the first‐ and second‐generation sheath (Evolution RL) . Recently, our group in a multicenter prospective study reported that the Evolution RL bidirectional rotational mechanical sheath is an effective and safe tool for extraction of chronically implanted leads without major complications and lead wrapping or lead damage .…”

Efficacy and mortality of rotating sheaths versus laser sheaths for transvenous lead extraction: a meta-analysis

“…The causes of deaths for patients who underwent rotating or laser sheath lead extraction are shown in Table 2 . The one patient death associated with a rotating sheath resulted from cardiovascular injury [ 17 ]. The portion of deaths due to cardiovascular injury following laser sheath procedures was 39.4% (26/66).…”

Coronary Venous Lead Extraction

“…The 12-Fr sheath is suitable for currently available coronary venous sheaths, but larger sheaths may be required when working with early models or may be used for other leads within the same procedure. There are limited published data on the Evolution s mechanical rotating tip sheath (Cook Medical, Bloomington, IN, USA) for coronary venous lead extraction [11][12][13][14] and a single series on the TightRailt sheath (Spectranetics, Colorado Springs, CO, USA). 15 Nonetheless, these tools are useful options, either alone or in selected cases, or as adjunctive tools for use in areas of lead binding or heavy calcification.…”