CLINICAL TRIAL
JOURNAL ARTICLE
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Evolution in transvenous extraction of pacemaker and implantable cardioverter defibrillator leads using a mechanical dilator sheath.

BACKGROUND: With developing technology, transvenous lead extraction (TLE) has undergone an explosive evolution due to incremental problems related to lead infection and malfunction.

OBJECTIVE: We aimed to present our experience in TLE with the Evolution®Mechanical Dilator Sheath (Cook Medical, Grandegrift, PA, USA).

METHODS: Between June 2009 and July 2011, the Evolution®mechanical dilator sheath was used for the extraction of 140 pacemaker (PM) and implantable cardioverter-defibrillator (ICD) leads in 66 patients. Indications for extraction, procedural success, and complications were defined according to Heart Rhythm Society Guidelines.

RESULTS: Indications for TLE were infection in 39 patients (59.1%), lead malfunction in 26 patients (39.4%), and lead displacement in one patient (1.5%). Extracted devices were PM in 28 cases (42.3%), ICD in 26 cases (39.4%), and biventricular cardioverter defibrillator in 12 cases (18.2%). Among 140 leads, 31 (22.1%) were right ventricular, 49 (35.0%) were defibrillator coil, 47 (33.6%) were atrial, and 13 (9.3%) were coronary sinus electrodes. The median time interval from the lead implantation to lead extraction was 85 months (range 22-240 months). Complete procedural success with the Evolution®system alone was achieved in 58 (87.9%) patients and overall clinical success was 98.5%. Four leads were completely removed with the help of a femoral snare and partial success was achieved in three leads with a remaining small ventricular tip. Major complication was observed in only one (1.5%) patient without any mortality.

CONCLUSIONS: Our experience confirms that the hand-powered Evolution system is an effective extraction tool for chronically implanted PM/ICD leads. Randomized controlled studies are required to evaluate success and complication rates in comparison to other techniques.

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