High predicted durability for the novel small-diameter OmniaSecure defibrillation lead.

Autor:	Crossley GH 3rd; Vanderbilt University Medical Center, Nashville, Tennessee. Electronic address: george.crossley@vumc.org., Mason PK; University of Virginia Medical Center, Charlottesville, Virginia., Hansky B; Städtische Kliniken, Bielefeld, Germany., De Filippo P; ASST Papa Giovanni XXIII, Bergamo, Italy., Shah MJ; The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania., Philippon F; Institut Universitaire de Cardiologie et de Pneumologie de Québec, Quebec, Canada., Sholevar D; Virtua Cardiology Group, Cherry Hill, New Jersey., Richardson TD; Vanderbilt University Medical Center, Nashville, Tennessee., West MB; Presbyterian Heart Group, Albuquerque, New Mexico., Dinerman J; Heart Center Research, Huntsville, Alabama., Dawson J; Medtronic, Inc, Minneapolis, Minnesota., Himes A; Medtronic, Inc, Minneapolis, Minnesota., Severseike L; Medtronic, Inc, Minneapolis, Minnesota., Thompson AE; Medtronic, Inc, Minneapolis, Minnesota., Sanders P; Centre for Heart Rhythm Disorders, University of Adelaide and Royal Adelaide Hospital, Adelaide, South Australia, Australia.
Jazyk:	angličtina
Zdroj:	Heart rhythm [Heart Rhythm] 2024 Sep 26. Date of Electronic Publication: 2024 Sep 26.
DOI:	10.1016/j.hrthm.2024.09.005
Abstrakt:	Background: Defibrillation leads remain the Achilles heel of implantable cardioverter-defibrillators. As patients with implantable cardioverter-defibrillators are living longer and battery longevity increases, more durable leads are needed. The LEADR trial evaluated the novel, lumenless, small-diameter, OmniaSecure defibrillation lead and demonstrated favorable safety and efficacy profile as well as zero fractures through 12.7 ± 4.8 months and remains in clinical follow-up. To augment the clinical trial, advanced cardiac lead reliability modeling was used to project long-term lead durability. Objective: We aimed to project the 10-year fracture-free survival of the OmniaSecure defibrillation lead using reliability modeling. Methods: The validated reliability model, which incorporates patient and bench test data, was used to project the 10-year fracture-free survival of the OmniaSecure lead. A subset of LEADR trial patients underwent biplane fluoroscopy imaging during cardiac and patient motion to evaluate the lead's bending curvature in vivo. Bench tests then reproduced these use conditions with greater bending curvatures than observed in patients to exaggerate stress on the lead and to evaluate the lead fatigue strength. Results: The reliability modeling projects a 98.2% fracture-free survival rate of the OmniaSecure lead at 10 years, including a 10-year fracture-free survival rate of 97.9% in adolescents, exceeding both the modeled and clinical 10-year performance of the highly reliable, larger diameter Sprint Quattro lead. Conclusion: Consistent with early clinical trial experience, modeling projects highly durable 10-year performance of the OmniaSecure lead, including within the active adolescent pediatric population, which may uniquely benefit from a novel 4.7F defibrillation lead designed for reliability. Gov Identifier: NCT04863664. Competing Interests: Disclosures G.H.C.: speaker at Medtronic and Philips; consultant for Medtronic and Boston Scientific. P.K.M.: consultant for Medtronic, Boston Scientific, and Cook as well as honoraria from Medtronic and Cook. B.H.: reports funding from Medtronic and CVRx. P.D.F.: consultant fees and travel support from Medtronic, Boston Scientific, Abbott, and Biotronik; honoraria and advisory board participation for Medtronic, Abbott, and Biotronik. M.J.S.: consultant for Medtronic and Tenaya Therapeutics. F.P.: speaker at Medtronic and Boston Scientific; consultant for Medtronic and Boston Scientific; research funding from Medtronic and Boston Scientific. D.S.: institutional funding from Medtronic. T.D.R.: consultant for Medtronic, Johnson and Johnson, and Philips; research funding from Medtronic and Abbott. M.B.W.: consultant for Medtronic. JayD.: consultant for Boston Scientific, Abbott, and Medtronic. J.D., A.H., L.S., and A.E.T: employees of Medtronic, Inc. P.S.: reports having served on the advisory boards of Medtronic, Abbott, Boston Scientific, PaceMate, and CathRx; the University of Adelaide has received on his behalf lecture and/or consulting fees from Medtronic, Abbott, and Boston Scientific; and the University of Adelaide has received on his behalf research funding from Medtronic, Abbott, Boston Scientific, and Becton-Dickson. (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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