Novel Approach to Lead Extraction, Utilizing Vibration Energy: From Bench Experiments to a First-in-Human Study.

BACKGROUND

Lead extraction procedures typically use "over-the-lead" cutting tools (sheaths) to separate leads from the surrounding fibrotic, vascular, and cardiac tissue. These methods carry significant risks of collateral damage and major bleeding complications.

OBJECTIVES

The goal of this study was to evaluate the safety and efficacy of a novel vibration-based lead extraction technique that eliminates the need for cutting tools. The study included comprehensive preclinical testing and initial human experience.

METHODS

Development included 3 phases: 1) bench experiments; 2) animal studies (N = 13) with varying lead implant durations; and 3) a first-in-human study enrolling 10 consecutive patients requiring a total of 18 lead extractions. The primary endpoints were complete procedural success and absence of major complications. The secondary endpoint was successful extraction of all leads without conventional tools.

RESULTS

The bench experiments established optimal vibration parameters for lead extraction. The animal studies confirmed the safety of high-frequency vibration application to an implanted pacing lead. In 9 animals with long-term implants (up to 5 years), all leads (6 pacing and 3 implantable cardiac-defibrillator) were successfully extracted without significant tissue damage on anatomical and histologic examination. In the human study, complete extraction was achieved in all 10 cases (18 leads [12 pacing, 4 implantable cardiac-defibrillator, and 2 coronary sinus]) with a mean dwell time of 48.6 ± 21.74 months (21-78 months). Mean lead vibration time was 40 seconds (6-176 seconds). No device-related complications occurred during the procedure or at 1-month follow-up.

CONCLUSIONS

This novel vibration-based extraction technique exhibited excellent safety and efficiency profiles in preclinical and initial human study, potentially offering a simple, rapid, and safe alternative to conventional extraction methods.