Abstract

Current lead extraction (LE) devices can harm the blood vessel endothelium, increasing the risk of perforation. Proof of concept for using a solid-state pulsed laser at 355 nm with a hybrid catheter in LE. A hybrid catheter was used comprising optical fibers for the delivery of 355 nm laser pulses at 30 Hz and 6 J/cm(2) combined with a blunt mechanical blade. Specific parameters were chosen to enable selectivity in ablation, thereby reducing the risk of blood vessel perforation. The design exploits differences in the mechanical properties of the fibrotic tissue and the normal blood vessel. Ex vivo ablation was performed to evaluate a hybrid catheter operation on various tissues. Two ex/in vivo pig studies used a free-floating electrode to which three bovine tendon pieces were glued. Finally, two in vivo dog model studies were performed on specimens with 4-5-year-old pacing lead implants, followed by a histopathology study. Catheter penetration rate in the ex vivo experiments was 0.1 mm/seconds for bovine tendon, 0.025 mm/seconds for porcine superior vena cava and 0.033 mm/seconds for porcine aorta. In the ex/in vivo pig study, the three tissue blocks were successfully dissected. In the in vivo dog study, the two leads were successfully extracted. In all in vivo tests, hemodynamic stability was maintained. Gross histopathology did not reveal any injury. Ablation using 355 nm laser pulses in combination with a mechanical blunt blade may potentially constitute a viable alternative for LE.

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