Ricci Giovanna, Gibelli Filippo, Sirignano Ascanio, Taurino Maurizio, Sirignano Pasqualino
Section of Legal Medicine, School of Law, University of Camerino, 62032 Camerino, Italy.
Vascular and Endovascular Surgery Unit, Sant'Andrea Hospital of Rome, Department of Molecular and Clinical Medicine, "Sapienza" University of Rome, 00185 Rome, Italy.
J Pers Med. 2024 Jul 17;14(7):759. doi: 10.3390/jpm14070759.
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.
标准血管内主动脉修复术（EVAR）已成为治疗解剖结构适宜患者的肾下腹主动脉瘤（AAA）的标准治疗方法，而解剖结构复杂的AAA患者以及患有肾上或胸腹主动脉瘤的患者仍需要替代的、更复杂的解决方案，包括定制的分支或开窗移植物，这些受到生产延迟和成本的限制。为满足紧急需求和处理复杂病例，医生们提出通过手动制作移植物开窗来修改标准血管内移植物。这可实现有效的动脉瘤隔绝和内脏血管令人满意的通畅性。尽管医生修改的移植物（PMEG）已显示出较高的技术成功率，但仍缺乏标准化的制作流程和长期安全性数据，因此需要进一步研究以验证其临床和法律地位。本文旨在阐述这种手术技术的现状，总结其起源、演变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PMEG相关的主要医疗法律问题，特别是与手术技术标准化、医疗责任情况和知情同意相关的安全性问题。
