Background: Endovascular aneurysm repair (EVAR) has become an accepted alternative to open repair (OR) for the treatment of abdominal aortic aneurysm (AAA) despite “hostile” anatomies that may reduce its effectiveness. Guidelines suggest refraining from EVAR in such circumstances, but in clinical practice, up to 44% of EVAR procedures are performed using stent grafts outside their instruction for use (IFU), with acceptable outcomes. Starting from this “inconsistency” between clinical practice and guidelines, the aim of this contribution is to report the technical results of the use of EVAR in challenging anatomies as well as the ethical aspects to identify the criteria by which the “best interest” of the patient can be set. Materials and Methods: A literature review on currently available evidence on standard EVAR using commercially available endografts in patients with hostile aortic neck anatomies was conducted. Medline using the PubMed interface and The Cochrane Library databases were searched from 1 January 2000 to 6 May 2021, considering the following outcomes: technical success; need for additional procedures; conversion to OR; reintervention; migration; the presence of type I endoleaks; AAA-related mortality rate. Results: A total of 52 publications were selected by the investigators for a detailed review. All studies were either prospective or retrospective observational studies reporting the immediate, 30-day, and/or follow-up outcomes of standard EVAR procedures in patients with challenging neck anatomies. No randomized trials were identified. Fourteen different endo-grafts systems were used in the selected studies. A total of 45 studies reported a technical success rate ranging from 93 to 100%, and 42 the need for additional procedures (mean value of 9.04%). Results at 30 days: the incidence rate of type Ia endoleak was reported by 37 studies with a mean value of 2.65%; 31 studies reported a null migration rate and 32 a null conversion rate to OR; in 31 of the 35 studies that reported AAA-related mortality, the incidence was null. Mid-term follow-up: the incidence rate of type Ia endoleak was reported by 48 studies with a mean value of 6.65%; 30 studies reported a null migration rate, 33 a null conversion rate to OR, and 28 of the 45 studies reported that the AAA-related mortality incidence was null. Conclusions: Based on the present analysis, EVAR appears to be a safe and effective procedure—and therefore recommendable—even in the presence of hostile anatomies, in patients deemed unfit for OR. However, in order to identify and pursue the patient’s best interest, particular attention must be paid to the management of the patient’s informed consent process, which—in addition to being an essential ethical-legal requirement to legitimize the medical act—ensures that clinical data can be integrated with the patient’s personal preferences and background, beyond the therapeutic potential of the proposed procedures and what is generically stated in the guidelines.

Scopo del presente contributo è delineare il perimetro entro il quale articolare una riflessione critica relativa alla questione della responsabilità giuridica connessa all’attività di Consulenza Etica in Ambito Sanitario (CEAS). Innanzitutto, saranno illustrate le ragioni per le quali ritenere che, al momento attuale, in Italia, la CEAS resa da un Consulente Etico singolo rappresenti il modello che meglio risponde all’esigenza di garantire un servizio di qualità ai pazienti e agli operatori sanitari. In secondo luogo, saranno analizzati gli elementi in base ai quali possa considerarsi ascrivibile in capo al Consulente Etico una responsabilità giuridica per violazione di una norma civile o penale. Infine, a partire dall’analisi dell’evoluzione giurisprudenziale e degli interventi legislativi di riforma in ambito sanitario, verrà avanzata una proposta in ordine alla disciplina applicabile all’operato del Consulente Etico in caso di danno procurato al paziente. Alla luce di quanto esposto, si tenterà di sostenere come il formale riconoscimento, anche giuridico, della figura del Consulente Etico possa risultare funzionale sia a dare contenuto all’effettivo ruolo svolto dal consulente nel processo di cura, sia a incentivare la stessa diffusione della cultura della CEAS, intesa come processo dialogico che ha lo scopo di contribuire al miglioramento dell’assistenza sanitaria mediante l’individuazione, l’analisi e la risoluzione dei dilemmi etici riconducibili alla pratica clinica.

"Disorders of Consciousness (DOCs) identify a diverse group of dysfunctions affecting individuals who have survived severe brain damage. Although the clinical evaluation of patients with DOC normally depends on their residual ability to create a connection with the outside world through motor behavior, in the last ten years neuroscientists have made a great effort to better characterize the patient’s consciousness even in the case of reduced or no motor reactivity. Often, in fact, patients with DOCs are not able to perform any type of movement or adequately understand the command required but they might be still conscious or at least minimally conscious. The gap between patients’ motor capability and their residual brain complexity raises important moral issues, especially about appropriateness and proportionality of interventions and treatments. We argue that Clinical Ethics Consultation may be crucial in addressing these clinical scenarios, which assume aspects of further drama when the DOC derives from a sudden and unexpected acute event such as a trauma or a cerebrovascular accident in healthy patients. In these situations, given the particular vulnerability of the patients and the unpredictability of the diseases, Ethics Consultants should be involved in the therapeutic process in order to improve the standard of care, ensuring compliance with the inclinations and desires of the patients. Moreover, Ethics Consultants should monitor that the procedures are rigorously managed in the context of fully understood consent of those who are legally entitled to make decision. "

Between December 2020 and March 2021, the US Food and Drug Administration and the European Medicines Agency issued Emergency Use Authorizations and Conditional Marketing Authorizations for the distribution of the first COVID-19 vaccines. Although these vaccines were thoroughly assessed before their approval, regulators required companies to continue ongoing placebo-controlled clinical trials in order to gather further reliable scientific information on their safety and efficacy, as well as to start new studies to evaluate additional candidates. The aim of this paper is to present and discuss the ethical issues raised by the tension between the need to continue these types of clinical trials and the obligations related to the protection of the rights and well-being of research participants. Specifically, we question whether—how, and to what extent—fundamental principles governing research involving human beings can be applied to the current pandemic situation. We argue that continuing ongoing placebo-controlled clinical trials can be considered ethically justifiable only if all participants are adequately informed of any developments that may affect their willingness to remain enrolled, including the current situation of resource scarcity and the prioritization criteria established for vaccination. However, we also argue that currently approved vaccines, which are considered safe and effective enough to be administered to millions of people as part of the vaccination campaign, necessarily represent the “best proven intervention” currently available and, therefore, should be used as comparators in future studies instead of placebo.

"Therapeutic Misconception (TM) occurs when clinical trial participants believe that the central purpose of the trial is therapeutic and that they will personally benefit from participation. If individuals who are entitled to consent to participation in a specific clinical trial do not understand that the defining purpose of clinical research is to produce generalizable knowledge, regardless of whether the subjects enrolled may potentially benefit from the intervention under study, this false belief may motivate them to participate, and in extreme cases may disqualify their consent. TM is especially frequent in fields in which the patients are highly vulnerable, such as when they are children and require parental consent. The informed consent is an essential ethical prerequisite before enrolling each and every participant in research that should protect patients through a process of dialog about a planned course of action. We argue that Ethics Consultant’s competencies may be crucial in avoiding TM: The Ethics Consultant should be involved in neonatal and paediatric clinical trials in order to face the unique vulnerability of children as research subjects, and to ensure that parental consent procedures are rigorously managed, enhancing recruitment in research trials in the context of fully understood consent. "