Initial experience with larger laser sheaths for the removal of transvenous pacemaker and implantable defibrillator leads

Background-In a previous randomized trial, the 12F laser sheath removed pac ing leads via the implant vein more successfully than traditional mechanica l tools alone. Two larger sizes of laser sheath, the 14F and 16F models, we re developed to extract defibrillator leads and large-diameter pacing leads implanted For the chronic. These devices use pulsed ultraviolet laser ligh t to core though fibrotic tissue grown over the lead body to free the lead from the vasculature, A mandatory prospective registry studied the safety a nd effectiveness profiles of the larger laser sheaths vis-a-vis the 12F las er sheath. Methods and Results-In this study, 863 patients underwent extraction of 128 5 leads at 52 sites. Patients treated with the 14F device tended to have ol der leads than the 12F population; the 16F population, which comprised most ly defibrillator patients, were younger, had younger leads, and were more o ften 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 fur all device sizes. The overall complication rate was 3.6%, wi th 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 la rger long-term transvenous pacemaker and defibrillator leads that is as saf e and effective as the 12F laser sheath.