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.

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.

Background: In the last 40 years, moral distress among nurses and other healthcare professionals (HCPs) has gained considerable attention. Some scholars, including Morley et al., have proposed expanding the definition of moral distress to include distress from moral constraint, conflict, uncertainty, dilemma, and tension; yet debates about this conceptualization persist. Aim of the study: This study examines whether Morley’s moral distress categories effectively capture moral distress experiences among HCPs, with a specific focus on the Italian context. Research design: A convenience sample of 20 HCPs from a hospital in Northern Italy participated in semi-structured interviews describing morally distressing situations. Data were analyzed using deductive content analysis based on Morley’s framework. As some situations did not fit existing categories, an inductive analysis was also conducted to identify additional moral distress causes. Ethical considerations: This study was approved by the Ethics Committee of the University of Milan (approval no. #48/22) on 30 May 2022. Results: We identified 64 morally distressing situations, 41 aligning with Morley’s framework (26 constraints, 14 conflict, 1 uncertainty, and 0 dilemmas). Six situations involved multiple causes, while 17 stemmed from a new cause, namely, misconduct . We also found that all identified causes led to moral distress because they implied a perceived violation of professional values and norms . This violation emerged as a necessary condition for moral distress, leading us to develop a multi-layered model positioning violation of professional values and norms as the deep cause of moral distress, with constraint , conflict , uncertainty , and misconduct as surface causes. Conclusions: Our findings suggest that Morley’s framework does not fully capture moral distress’s complexity. Additional sources of moral distress, such as misconduct, suggest that other triggers may be identified depending on the context. Defining moral distress solely by its surface causes risks fragmenting the concept and overlooking its deeper cause: The perceived violation of professional values and norms that leads to distress.