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.

Physician-modified endografts for repair of complex abdominal aortic aneurysms: clinical perspectives and medico-legal profiles / Ricci, Giovanna; Gibelli, Filippo; Sirignano, Ascanio; Taurino, Maurizio; Sirignano, Pasqualino. - In: JOURNAL OF PERSONALIZED MEDICINE. - ISSN 2075-4426. - 14:7(2024). [10.3390/jpm14070759]

Physician-modified endografts for repair of complex abdominal aortic aneurysms: clinical perspectives and medico-legal profiles

Taurino, Maurizio
Writing – Review & Editing
;
Sirignano, Pasqualino
Ultimo
Conceptualization
2024

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.
2024
abdominal aortic aneurysm; ethical considerations; evar; evar outcomes; hostile anatomy; ifu; informed consent; instruction for use; physician modified endograft (pmeg)
01 Pubblicazione su rivista::01g Articolo di rassegna (Review)
Physician-modified endografts for repair of complex abdominal aortic aneurysms: clinical perspectives and medico-legal profiles / Ricci, Giovanna; Gibelli, Filippo; Sirignano, Ascanio; Taurino, Maurizio; Sirignano, Pasqualino. - In: JOURNAL OF PERSONALIZED MEDICINE. - ISSN 2075-4426. - 14:7(2024). [10.3390/jpm14070759]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1720012
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