Extraction of pacemaker and defibrillator leads using 14F and 16F laser sheaths achieved clinical success in 91-92% of cases with a 3.6% complication rate, comparable to the 12F sheath.
Observational (n=863)
Yes
Do 14F and 16F laser sheaths safely and effectively remove transvenous pacemaker and defibrillator leads compared to the 12F laser sheath in patients requiring lead extraction?
Larger 14F and 16F laser sheaths are as safe and effective as the 12F sheath for the extraction of transvenous pacemaker and defibrillator leads.
BACKGROUND: In a previous randomized trial, the 12F laser sheath removed pacing leads via the implant vein more successfully than traditional mechanical tools alone. Two larger sizes of laser sheath, the 14F and 16F models, were developed to extract defibrillator leads and large-diameter pacing leads implanted for the chronic. These devices use pulsed ultraviolet laser light to core though fibrotic tissue grown over the lead body to free the lead from the vasculature. A mandatory prospective registry studied the safety and effectiveness profiles of the larger laser sheaths vis-à-vis the 12F laser sheath. METHODS AND RESULTS: In this study, 863 patients underwent extraction of 1285 leads at 52 sites. Patients treated with the 14F device tended to have older leads than the 12F population; the 16F population, which comprised mostly defibrillator patients, were younger, had younger leads, and were more often male than the 12F population. Clinical success (extracting the entire lead or the lead body minus the distal electrode) was observed in 91% to 92% of cases for all device sizes. The overall complication rate was 3.6%, with 0.8% perioperative mortality. Incidence of complications was independent of laser sheath size. CONCLUSIONS: The 14F and 16F laser sheaths offer an extraction option for larger long-term transvenous pacemaker and defibrillator leads that is as safe and effective as the 12F laser sheath.
Epstein et al. (1999) conducted an observational in Transvenous pacemaker and implantable defibrillator lead extraction (n=863). 14F and 16F laser sheaths vs. 12F laser sheath was evaluated on Clinical success (extracting the entire lead or the lead body minus the distal electrode). Extraction of pacemaker and defibrillator leads using 14F and 16F laser sheaths achieved clinical success in 91-92% of cases with a 3.6% complication rate, comparable to the 12F sheath.