关键词: EVAR EVAR outcomes IFU abdominal aortic aneurysm ethical considerations hostile anatomy informed consent instruction for use physician modified endograft (PMEG)

来  源:   DOI:10.3390/jpm14070759   PDF(Pubmed)

Abstract:
Standard endovascular aortic repair (EVAR) has become the standard of care for treating infrarenal abdominal aortic aneurysms (AAAs) in patients with favorable anatomies, while patients with challenging AAA anatomies, and those with suprarenal or thoraco-abdominal aneurysms, still need alternative, more complex, solutions, including custom-made branched or fenestrated grafts, which are constrained by production delay and costs. To address urgent needs and complex cases, physicians have proposed modifying standard endografts by manually creating graft fenestrations. This allows for effective aneurysm exclusion and satisfactory patency of visceral vessels. Although physician-modified grafts (PMEGs) have demonstrated high technical success, standardized creation processes and long-term safety data are still lacking, necessitating further study to validate their clinical and legal standing. The aim of this article is to illustrate the state of the art with regard to this surgical technique, summarizing its origin, evolution, and the main clinical evidence supporting its effectiveness. The paper also aims to discuss the main medico-legal issues related to the use of PMEGs, with particular reference to the issue of safety related to the standardization of the surgical technique, medical liability profiles, and informed consent.
摘要:
标准的血管内主动脉修复术(EVAR)已成为治疗具有良好解剖结构的患者的肾下腹主动脉瘤(AAAs)的护理标准。而具有挑战性的AAA解剖结构的患者,那些有肾上或胸腹动脉瘤的人,仍然需要替代,更复杂,解决方案,包括定制的分支或开窗移植物,受到生产延误和成本的制约。解决紧迫的需要和复杂的案件,医生建议通过手动创建移植物开窗来修改标准内移植物。这允许有效的动脉瘤排除和内脏血管的令人满意的通畅。尽管医师改良的移植物(PMEG)已经证明了很高的技术成功,仍然缺乏标准化的创建流程和长期安全数据,需要进一步研究以验证其临床和法律地位。本文的目的是说明有关这种手术技术的最新技术,总结它的起源,进化,以及支持其有效性的主要临床证据。本文还旨在讨论与使用PMEGs有关的主要医学法律问题,特别提到与外科技术标准化相关的安全问题,医疗责任简介,知情同意。
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