Academic Journal
Safety and performance of vibration-assisted extraction of chronic cardiac implantable electronic device leads: A preclinical ovine study.
| Τίτλος: | Safety and performance of vibration-assisted extraction of chronic cardiac implantable electronic device leads: A preclinical ovine study. |
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| Συγγραφείς: | Ramot Y; Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel; Department of Dermatology, Hadassah Medical Center, Jerusalem, Israel., Tomer O; Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel; Department of Cardiology, Hadassah Medical Center, Jerusalem, Israel., Zilberman Barzilai D; Pre-clinical Research and Development Unit, Shamir Medical Center, Zerifin, Israel., Willenz U; Pre-clinical Research and Development Unit, Shamir Medical Center, Zerifin, Israel., Beer O; Pre-clinical Research and Development Unit, Shamir Medical Center, Zerifin, Israel., Tov YS; Pre-clinical Research and Development Unit, Shamir Medical Center, Zerifin, Israel., Luria D; Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel; Department of Cardiology, Hadassah Medical Center, Jerusalem, Israel., Nyska A; Consultant in Toxicologic Pathology, Tel Aviv and Tel Aviv University, Israel. Electronic address: anyska@nyska.net. |
| Πηγή: | Heart rhythm [Heart Rhythm] 2026 Oct; Vol. 23 (10), pp. e2343-e2351. Date of Electronic Publication: 2026 Jul 02. |
| Τύπος έκδοσης: | Journal Article |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Elsevier Country of Publication: United States NLM ID: 101200317 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1556-3871 (Electronic) Linking ISSN: 15475271 NLM ISO Abbreviation: Heart Rhythm Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: New York, NY : Elsevier, c2004- |
| Ιατρικοί όροι (MeSH): | Device Lead Extraction*/methods , Vibration*/therapeutic use , Pacemaker, Artificial*/adverse effects , Defibrillators, Implantable*/adverse effects , Device Removal*/methods, Animals ; Sheep ; Disease Models, Animal ; Equipment Design ; Female |
| Περίληψη: | 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. (Copyright © 2026 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.) |
| Competing Interests: | Disclosures David Luria is Chief Medical Officer and shareholder of Xtrac O.S. Ltd. Orr Tomer holds share options in Xtrac O.S. Ltd. The other authors have no conflicts of interest to disclose. |
| Contributed Indexing: | Keywords: Cardiac implantable electronic device leads; Chronic leads; Fibrosis; Lead extraction; Mechanical vibration; Ovine model; Preclinical safety |
| Entry Date(s): | Date Created: 20260702 Date Completed: 20260925 Latest Revision: 20260925 |
| Update Code: | 20260926 |
| DOI: | 10.1016/j.hrthm.2026.06.042 |
| PMID: | 42392473 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 1556-3871 |
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| DOI: | 10.1016/j.hrthm.2026.06.042 |