Academic Journal
Novel Approach to Lead Extraction, Utilizing Vibration Energy: From Bench Experiments to a First-in-Human Study.
| Τίτλος: | Novel Approach to Lead Extraction, Utilizing Vibration Energy: From Bench Experiments to a First-in-Human Study. |
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| Συγγραφείς: | Tomer O; Department of Cardiology, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel. Electronic address: orrtomer@gmail.com., Elitzur Y; Department of Cardiology, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel., Przybylski A; Clinical Department of Cardiology with the Acute Coronary Syndromes Subdivision, Clinical Provincial Hospital No. 2, Rzeszów, Faculty of Medicine, University of Rzeszow, Rzeszów, Poland., Romanek J; Clinical Department of Cardiology with the Acute Coronary Syndromes Subdivision, Clinical Provincial Hospital No. 2, Rzeszów, Faculty of Medicine, University of Rzeszow, Rzeszów, Poland., Stein U; Xtrac Medical O.S. Ltd, Raanana, Israel., Shafrir R; Xtrac Medical O.S. Ltd, Raanana, Israel., Shauer A; Department of Cardiology, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel., Love CJ; Johns Hopkins School of Medicine, Baltimore, Maryland, USA., Friedman PA; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA., Deshmukh AJ; Department of Cardiovascular Medicine, Mayo Clinic, Rochester, Minnesota, USA., Luria D; Department of Cardiology, Hadassah Medical Center and Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel. |
| Πηγή: | JACC. Clinical electrophysiology [JACC Clin Electrophysiol] 2026 Jul; Vol. 12 (7), pp. 1684-1693. Date of Electronic Publication: 2026 Apr 08. |
| Τύπος έκδοσης: | Journal Article; Research Support, Non-U.S. Gov't |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: Elsevier Inc Country of Publication: United States NLM ID: 101656995 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2405-5018 (Electronic) Linking ISSN: 2405500X NLM ISO Abbreviation: JACC Clin Electrophysiol Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [New York, NY] : Elsevier Inc., [2015]- |
| Ιατρικοί όροι (MeSH): | Vibration*/therapeutic use , Device Lead Extraction*/methods , Device Lead Extraction*/adverse effects , Device Lead Extraction*/instrumentation , Defibrillators, Implantable*/adverse effects , Pacemaker, Artificial*/adverse effects , Device Removal*/methods, Humans ; Animals ; Female ; Male ; Middle Aged ; Aged ; Adult |
| Περίληψη: | 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. (Copyright © 2026 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.) |
| Competing Interests: | Funding Support and Author Disclosures Dr Przybylski has received lecture fees from HammerMed (distributor of Cook Medical) and a research grant from Xtrac O.S. Ltd. Dr Romanek has received a research grant from Xtrac O.S. Ltd. Dr Stein is the founder, Chief Executive Officer, board member, and shareholder of Xtrac O.S. Ltd. Dr Love is a consultant for Medtronic, Abbott, Convatec, and Orchestra BioMed. Dr Deshmukh is a consultant for GE Healthcare. Dr Luria is the Chief Medical Officer and shareholder of Xtrac O.S. Ltd. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. |
| Contributed Indexing: | Keywords: novel extraction method; transvenous lead extraction; vibration energy |
| Entry Date(s): | Date Created: 20260409 Date Completed: 20260729 Latest Revision: 20260824 |
| Update Code: | 20260825 |
| DOI: | 10.1016/j.jacep.2026.02.039 |
| PMID: | 41954554 |
| Βάση Δεδομένων: | MEDLINE |
| ISSN: | 2405-5018 |
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| DOI: | 10.1016/j.jacep.2026.02.039 |