Why the study?
Does the Evolution Mechanical Dilator Sheath system safely and effectively extract implanted cardiac device leads in patients requiring lead extraction?
Observational
No
Does the Evolution Mechanical Dilator Sheath system safely and effectively extract implanted cardiac device leads in patients requiring lead extraction?
The Evolution Mechanical Dilator Sheath system provides a high procedural success rate (95%) for extracting chronically implanted cardiac leads, though it carries a risk of complications requiring surgical backup.
No clinical data available to guide lead extraction; leaves open the safety and efficacy of the Evolution system.
OBJECTIVE: In recent years, there has been an increase in clinical situations requiring extraction of leads of implanted cardiac devices. This study aimed to evaluate the Evolution Mechanical Dilator Sheath system, presently in use in our clinic for lead extraction procedures. METHODS: Lead extraction procedures carried out on 20 patients (14 men, 6 women; mean age 61±19; range 23 to 85 years) between 2008 and 2013 using the Evolution system were retrospectively evaluated. Procedural success, and major and minor complications were determined by previously published guidelines. RESULTS: Mean implantation duration of the leads was 97±65 months (8-204). Fifteen (75%) patients had undergone pacemaker implantation and 5 (25%) had been implanted with a defibrillator. A total of 35 leads were removed from the patients. Seventeen (49%) were ventricular and 12 (34%) were atrial. Five (14%) were defibrillator coils and 1 a coronary sinus lead. Indications for lead extraction were device infection in 18 (90%) patients and lead dysfunction in 2 (10%). Complete procedural success was 95%. Failure occurred in 1 patient. The major complication rate was 5% and minor complications were seen in 25% of patients. No case of mortality was present. CONCLUSION: In this single centre study, it was shown that extraction of pacemaker and defibrillator leads of longer implant duration may be successfully carried out using the Evolution system. However, due to potentially serious complications it is advised that extraction be done by an experienced operator in centres with cardiovascular surgery facilities.
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Uğur Kocabaş (2016) conducted an observational in Lead extraction. Evolution Mechanical Dilator Sheath lead extraction system was evaluated.
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