Novel concept and device for lead extraction, utilizing vibration energy: results from bench, animal and a first-in-human experiments

Abstract Background Lead extraction is a complex and potentially hazardous procedure. Most lead extractions use an "over-the-lead" cutting tool (sheath), to separate the electrode from surrounding vessels and cardiac tissue. However, these tools pose significant risks, including collateral damage and major bleeding. Objective We introduce a novel, "minimally invasive" approach for lead extraction. Vibrations delivered through a locking stylet detach the electrode from the surrounding tissue without using cutting tools. Methods ●Bench Experiments: A three-dimensional model of central veins was developed. Using a strong biological glue, the pacing lead was attached to a silicone sphere representing the heart, which was suspended in air by a metal spring. Vibration waves of varying frequencies and amplitudes were applied to the lead to determine the optimal detachment parameters. ●Animal Studies: Five sheep with ICD or pacemaker leads implanted in the atrium and ventricle underwent lead extraction using the vibration-based device, 3 to 7 months post-implantation. Additionally, four beagle dogs with ventricular pacing leads implanted for 4 to 6 years underwent extraction with this device. ●First-in-Human Study: Ten consecutive patients scheduled for lead extraction, per current guidelines, were enrolled in this study. Inclusion criteria were ages 18 to 80 and lead indwelling times of 1 to 10 years. Procedures were conducted in two countries at two tertiary academic hospitals. All patients were monitored one month post-procedure. Results All leads in the animal and human studies were successfully extracted using vibration-based method, with physical parameters defined by bench experiments. Cardio-respiratory monitoring revealed no significant disturbances during the procedures. ●Animal Studies: Of the 9 leads extracted (7 pacing leads, 2 ICD leads), no significant damage to the heart or vessels was observed through anatomical and histological examination. ●First-in-Human Study: In ten patients, sixteen leads (9 pacing leads, 5 ICD leads, and 2 CS lead) were extracted, with an average indwelling time of 4.2±1.9 years (range: 2–7.5 years).Six patients had device and lead infections, and four required system upgrades or replacement of malfunctioning leads. Extraction times ranged from 4 to 176 seconds, with a median time of 15 seconds. In three patients, additional short vibrations were applied after distal detachment, to aid in pulling the lead through proximal narrowing. In-hospital and one-month follow-ups indicated no significant adverse effects from using the experimental device. No patients required additional procedures or unplanned hospitalizations. Conclusion This new lead extraction device offers a fast and straightforward procedure using vibrations via a locking stylet, eliminating the need for an external cutting sheath. Initial experiments demonstrate high efficiency and safety with this innovative approach.Seven year ICD Lead and Vibration Handle