Physician-Modified Endografts for Repair of Complex Abdominal Aortic Aneurysms: Clinical Perspectives and Medico-Legal Profiles.

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

Journal

Journal of personalized medicine
ISSN: 2075-4426
Titre abrégé: J Pers Med
Pays: Switzerland
ID NLM: 101602269

Informations de publication

Date de publication:
17 Jul 2024
Historique:
received: 07 06 2024
revised: 08 07 2024
accepted: 15 07 2024
medline: 27 7 2024
pubmed: 27 7 2024
entrez: 27 7 2024
Statut: epublish

Résumé

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.

Identifiants

pubmed: 39064014
pii: jpm14070759
doi: 10.3390/jpm14070759
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Auteurs

Giovanna Ricci (G)

Section of Legal Medicine, School of Law, University of Camerino, 62032 Camerino, Italy.

Filippo Gibelli (F)

Section of Legal Medicine, School of Law, University of Camerino, 62032 Camerino, Italy.

Ascanio Sirignano (A)

Section of Legal Medicine, School of Law, University of Camerino, 62032 Camerino, Italy.

Maurizio Taurino (M)

Vascular and Endovascular Surgery Unit, Sant'Andrea Hospital of Rome, Department of Molecular and Clinical Medicine, "Sapienza" University of Rome, 00185 Rome, Italy.

Pasqualino Sirignano (P)

Vascular and Endovascular Surgery Unit, Sant'Andrea Hospital of Rome, Department of General and Specialistic Surgery, "Sapienza" University of Rome, 00185 Rome, Italy.

Classifications MeSH