Safety and performance of vibration-assisted extraction of chronic cardiac implantable electronic device leads: A preclinical ovine study.

BACKGROUND

Transvenous extraction of chronic cardiac implantable electronic device leads is challenged by fibrotic adhesions and procedural risks. Novel technologies aim to improve safety and efficacy. A high-frequency mechanical vibration system aims to disrupt adhesions.

OBJECTIVE

This study aimed to evaluate the initial safety, performance, and usability of a novel vibration-assisted lead extraction system in a preclinical Good Laboratory Practice ovine model.

METHODS

9 leads implanted for >2 years (range 2.9-5.25 years) were extracted from 6 sheep using the vibration system under fluoroscopy. The internal lumen of the leads was used to deliver a customized locking stylet. The stylet was used to deliver vibration energy to the lead, applied for up to 20 minutes/animal. Assessments included procedural success, lead integrity, intraprocedural monitoring, 3-day clinical follow-up, laboratory tests, necropsy, and histopathology (heart, lungs, central veins).

RESULTS

Procedural success (lead removal) was 100% without adjunctive tools: external cutting sheath was not required for adhesion dissection in all of the cases. Lead release occurred within ∼1 minute in 8 of 9 leads. Primary safety endpoints were met: no central vein or myocardial perforation and no pulmonary embolism. No blood pressure drops, significant arrhythmias, or worsening tricuspid regurgitation occurred. 1 lead fracture (1 of 9) resulted in a retained distal screw (<1 cm) associated with mild localized myocardial necrosis. Anchor device malfunctions required intraprocedural replacement in 2 cases.

CONCLUSION

Vibration-assisted extraction of chronic cardiac implantable electronic device leads was feasible with a remarkable acute safety profile in this ovine model, meeting primary safety endpoints. The procedure was characterized by notable technical simplicity and rapid lead release via the internal lumen, successfully obviating the requirement for potentially hazardous external cutting sheaths. Lead fracture and anchor malfunctions indicate areas for further technological assessment and clinical trial.