White Timothy G, Shah Kevin A, Koul Prateeka, Link Thomas, Dehdashti Amir R, Katz Jeffrey M, Patsalides Athos, Woo Henry H
Department of Neurosurgery, Donald and Barbara Zucker School of Medicine at Hofstra Northwell, Manhasset, United States.
Department of Neurology, Donald and Barbara Zucker School of Medicine at Hofstra Northwell, Manhasset, United States.
Interv Neuroradiol. 2024 Feb;30(1):14-21. doi: 10.1177/15910199221084398. Epub 2022 Apr 4.
Current methods for angioplasty and stenting of the intracranial vasculature for neurointervention are limited. The Wingspan Stent System is Food and Drug Administration (FDA) approved with human device exemption for a limited patient group and despite numerous prospective registries and trials demonstrating reasonable safety, still carries warnings from the FDA for its use. Given these limitations, we present the technical nuances and outcomes of the off-label use of the Resolute Onyx drug-eluting stent (DES) for neurointerventional purposes.
Retrospective chart review of all patients undergoing a neurointerventional procedure with the Resolute Onyx DES was done from January 2017-2021. The Resolute Onyx is a coronary balloon-mounted drug-eluting (zotarolimus) single wire laser cut stent. Technical details and procedural outcomes were collected.
In total 40 patients had attempted placement of the Resolute Onyx DES with procedural success in 95% of patients. The most common vessel stented was the basilar artery, 30% (12/40). The most common indication was intracranial atherosclerotic disease in 62.5% (25/40) patients, followed by acute stroke in 17.5% (7/40) of patients. The technical and procedural outcomes were excellent with only one technical complication (2.5%).
This series describes the initial technical safety and utility of utilizing a new generation balloon-mounted drug-eluting stent for neurointerventional purposes. This stent offers the potential for improved navigability, delivery, and outcomes compared to current neurointerventional options and warrants further study.
目前用于神经介入的颅内血管成形术和支架置入术的方法有限。Wingspan支架系统已获得美国食品药品监督管理局(FDA)批准,针对有限的患者群体可免除人体设备试验,尽管众多前瞻性登记研究和试验表明其安全性合理,但FDA仍对其使用发出警告。鉴于这些局限性,我们介绍了用于神经介入目的的Resolute Onyx药物洗脱支架(DES)的非标签使用的技术细节和结果。
对2017年1月至2021年期间所有接受Resolute Onyx DES神经介入手术的患者进行回顾性病历审查。Resolute Onyx是一种冠状动脉球囊载药(佐他莫司)单丝激光切割支架。收集技术细节和手术结果。
共有40例患者尝试置入Resolute Onyx DES,95%的患者手术成功。置入支架最常见的血管是基底动脉,占30%(12/40)。最常见的适应证是颅内动脉粥样硬化疾病,占62.5%(25/40)的患者,其次是急性卒中,占17.5%(7/40)的患者。技术和手术结果良好,仅出现1例技术并发症(2.5%)。
本系列描述了利用新一代球囊载药洗脱支架进行神经介入的初步技术安全性和实用性。与目前的神经介入选择相比,这种支架在可操作性、输送性和治疗效果方面具有改善的潜力,值得进一步研究。