Crossley George H, Mason Pamela K, Hansky Bert, De Filippo Paolo, Shah Maully J, Philippon Francois, Sholevar Darius, Richardson Travis D, West Michael B, Dinerman Jay, Dawson James, Himes Adam, Severseike Leah, Thompson Amy E, Sanders Prashanthan
Vanderbilt University Medical Center, Nashville, Tennessee.
University of Virginia Medical Center, Charlottesville, Virginia.
Heart Rhythm. 2025 Feb;22(2):302-310. doi: 10.1016/j.hrthm.2024.09.005. Epub 2024 Sep 26.
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.
We aimed to project the 10-year fracture-free survival of the OmniaSecure defibrillation lead using reliability modeling.
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.
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.
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.
NCT04863664.
除颤导线仍然是植入式心脏复律除颤器的致命弱点。随着植入式心脏复律除颤器患者的寿命延长以及电池续航时间增加，需要更耐用的导线。LEADR试验评估了新型、无内腔、小直径的OmniaSecure除颤导线，并在12.7±4.8个月的时间内证明了其良好的安全性和有效性，且无骨折发生，目前仍在临床随访中。为了扩大临床试验，采用了先进的心脏导线可靠性模型来预测长期导线耐用性。
我们旨在使用可靠性模型预测OmniaSecure除颤导线10年无骨折生存率。
使用经过验证的可靠性模型，该模型纳入了患者和台架试验数据，来预测OmniaSecure导线10年无骨折生存率。LEADR试验的一部分患者在心脏和患者运动期间接受了双平面荧光透视成像，以评估导线在体内的弯曲曲率。然后台架试验以比患者观察到的更大的弯曲曲率再现这些使用条件，以夸大导线上的应力并评估导线的疲劳强度。
可靠性模型预测OmniaSecure导线在10年时的无骨折生存率为98.2%，其中青少年的10年无骨折生存率为97.9%，超过了高度可靠的较大直径Sprint Quattro导线的模型预测和临床10年性能。
与早期临床试验经验一致，模型预测OmniaSecure导线具有高度耐用的10年性能，包括在活跃的青少年儿科人群中，这可能特别受益于专为可靠性设计的新型4.7F除颤导线。
NCT04863664。
