The contributing factors to suicide in Italian prisons: An 11-year analysis (2010-2020).

BACKGROUND: Suicide is a leading cause of death globally, with approximately 800,000 deaths annually and accounting for 1.5% of all deaths. Risk factors are multifaceted, encompassing individual factors (such as genetics, family history and mental illnesses) and environmental factors (such as economic conditions, social support and life events). In prisons, suicide rates are markedly higher than in the general population, particularly in Italy, where the prisoner suicide rate is approximately 20 times that of the non-incarcerated population. There is, however, little research on suicide in Italian prisons. AIMS: To analyse the characteristics of all people who died by suicide in Italian prisons between 2010 and 2020. METHODS: We carried out a records-based cohort study analysing official data from the Italian Ministry of Justice on prison suicides between 2010 and 2020. The data were cross-referenced and, when required, supplemented with information from Ristretti Orizzonti, a journal specialising in health and living conditions in prisons, as well as from the website of ISTAT (Italian National Statistical Institute), newspapers, radio broadcasts and news agencies. RESULTS: Factors associated with an increased risk of suicide in prisons were nighttime periods, the months of June, July and October, a relatively brief duration of detention (<6 months), having been convicted of murder, male gender, being about 40 years old, having access to hanging materials and being interned (i.e. subjected to the execution of custodial security measures) or awaiting trial. Prison overcrowding was not a risk factor for suicide. CONCLUSION: Our findings hold substantial implications for suicide prevention in Italian prisons as they suggest both characteristics of individuals and characteristics of the institutions that could be taken as risk indicators. This knowledge can inform the development of targeted interventions to manage both individual and environmental factors better, leading to improved prison conditions and reduced suicide rates. Furthermore, our research establishes a foundation for more systematic and in-depth investigations that could further improve suicide prevention strategies in Italian prisons, ultimately influencing policy changes in both practice and research, including perhaps establishing a national database on every completed suicide in prisons.

In silico, in vitro, and in vivo human metabolism of acetazolamide, a carbonic anhydrase inhibitor and common "diuretic and masking agent" in doping.

Acetazolamide (ACZ) is a carbonic anhydrase inhibitor prescribed for the treatment of various pathologies. It is also used in doping and is prohibited in and out of sportive competitions. ACZ was reported not to undergo metabolization. However, the detection of ACZ metabolites may be critical for documenting ACZ use. We aimed to further investigate ACZ metabolic fate in humans. ACZ putative metabolites were generated in silico to assist in metabolite identification. ACZ was incubated with primary human hepatocytes to identify in vitro metabolites (10 µmol/l ACZ and 106 cells/ml), and urine and plasma samples from patients receiving a single 5.0 mg/kg BW PO ACZ dose were analyzed to confirm the results in vivo. Analyses were performed with reversed-phase liquid chromatography and hydrophilic interaction chromatography coupled with high-resolution tandem mass spectrometry (RPLC-HRMS/MS and HILIC-HRMS/MS, respectively). Data were screened with a software-assisted targeted/untargeted workflow. ACZ was quantified in urine samples with creatinine normalization. We identified two metabolites in hepatocyte incubations and three additional metabolites in urine and plasma. Major transformations included cysteine conjugation, glucuronidation, and N-acetylation. All metabolites were detected in plasma, 1.5 h after intake. Major metabolites were detected in urine from 0.25 to 24 h (last collection) after intake. As opposed to the literature, ACZ does undergo metabolization in humans. We propose ACZ, ACZ-Cys, and N-acetyl-ACZ in urine, and ACZ and N-acetyl-ACZ in plasma as specific biomarkers of ACZ intake in doping.

Ethical and Legal Challenges of Telemedicine in the Era of the COVID-19 Pandemic.

Background and objective: Telemedicine or telehealth services has been increasingly practiced in the recent years. During the COVID-19 pandemic, telemedicine turned into and indispensable service in order to avoid contagion between healthcare professionals and patients, involving a growing number of medical disciplines. Nevertheless, at present, several ethical and legal issues related to the practice of these services still remain unsolved and need adequate regulation. This narrative review will give a synthesis of the main ethical and legal issues of telemedicine practice during the COVID-19 pandemic. Material and Methods: A literature search was performed on PubMed using MeSH terms: Telemedicine (which includes Mobile Health or Health, Mobile, mHealth, Telehealth, and eHealth), Ethics, Legislation/Jurisprudence, and COVID-19. These terms were combined into a search string to better identify relevant articles published in the English language from March 2019 to September 2021. Results: Overall, 24 out of the initial 85 articles were considered eligible for this review. Legal and ethical issues concerned important aspects such as: informed consent (information about the risks and benefits of remote therapy) and autonomy (87%), patient privacy (78%) and confidentiality (57%), data protection and security (74%), malpractice and professional liability/integrity (70%), equity of access (30%), quality of care (30%), the professional-patient relationship (22%), and the principle of beneficence or being disposed to act for the benefit of others (13%). Conclusions: The ethical and legal issues related to the practice of telehealth or telemedicine services still need standard and specific rules of application in order to guarantee equitable access, quality of care, sustainable costs, professional liability, respect of patient privacy, data protection, and confidentiality. At present, telemedicine services could be only used as complementary or supplementary tools to the traditional healthcare services. Some indications for medical providers are suggested.

Telemedicine Practice: Review of the Current Ethical and Legal Challenges.

Background: Telemedicine involves medical practice and information and communications technology. It has been proven to be very effective for remote health care, especially in areas with poor provision of health facilities. However, implementation of these technologies is often hampered by various issues. Among these, ethical and legal concerns are some of the more complex and diverse ones. In this study, an analysis of scientific literature was carried out to identify the ethical and legal challenges of telemedicine. Materials and Methods: English literature, published between 2010 and 2019, was searched on PubMed, Scopus, and Web of Science by using keywords, including "Telemedicine," "Ethics," "Malpractice," "Telemedicine and Ethics," "Telemedicine and Informed consent," and "telemedicine and malpractice." Different types of articles were analyzed, including research articles, review articles, and qualitative studies. The abstracts were evaluated according to the selection criteria, using the Newcastle-Ottawa Scale criteria, and the final analysis led to the inclusion of 22 articles. Discussion: From the aforementioned sample, we analyzed elements that may be indicative of the efficacy of telemedicine in an adequate time frame. Ethical aspects such as informed consent, protection data, confidentiality, physician's malpractice, and liability and telemedicine regulations were considered. Conclusions: Our objective was to highlight the current status and identify what still needs to be implemented in telemedicine with respect to ethical and legal standards. Gaps emerged between current legislation, legislators, service providers, different medical services, and most importantly patient interaction with his/her data and the use of that data.

Metabolic syndrome, hypertension, and nervous system injury: Epidemiological correlates.

Metabolic syndrome (MetS) is a common and complex disorder combining hypertension, obesity, dyslipidemia, and insulin resistance. MetS represents a risk factor for changes in cognitive functions in older age, and several studies have suggested that MetS may be linked to dementia. This article reviews the main evidences about the relationship between MetS and neurodegenerative disease. Starting from an epidemiological point of view, the article analyzes medico-social aspects related to MetS, considering the reduction of work capacity and the condition of disability that it involves. Some authors affirm that on the basis of current Italian legislation, it is possible to consider the syndrome as a disability. This is because all the diseases that make up MetS are high-risk clinical pathological conditions. For these reasons, a joint action is required to contain the incidence of MetS, the high social costs, and the loss of productivity related to the syndrome. In conclusion, healthcare initiatives could be adopted in order to increase the understanding of the pathogenic contributions of each element on MetS and how they can be modified. These actions will be useful to reduce healthcare costs and can lead to more effective prevention of metabolic disease, thus promoting good health. ABBREVIATIONS: MetS: Metabolic syndrome; WHO: World Health Organization; CVD: cerebrovascular diseases; AD: Alzheimer's Disease; VaD: Vascular Dementia; IDF: International Diabetes Federation; T2DM: type 2 diabetes mellitus; CAD: coronary artery disease; MCI: mild cognitive impairment; NCDs: Non Communicable Diseases; BMI: Body Mass Index; ICIDH: International classification of impairments, disabilities and handicaps.

MEDICALLY ASSISTED PROCREATION, A DISCUSSION STILL OPEN IN ITALY.

This article analyses the current situation of medically assisted reproduction in Italy after the issuance of Law 40 in 2004. This law is actually completely different from its first version. In fact, the controversial points, like reproduction for couples with genetic diseases, prohibition of heterologous fertilization, cryoconservation of embryos, obligation to perform just one and simultaneous implant of all the embryos produced, are definitively not in force today. This new situation can be explained not only by rules issued by Italian courts but, in particular, by changes introduced by the European Court of Human Rights and by questions of constitutional legitimacy raised by some Italian Courts. After ten years from the issue of this law, Italy has returned to the pre-existing situation. The old law was only full of prohibitions. Now, heterologous fertilization is possible and this article gives a picture of the present situation in hospitals for assisted procreation in Italy.

Long-term care insurance in Italy: medico-legal and socio-economic profiles.

Long-term care insurance (LTCI) plays a crucial role in providing substantial aid in non-self-sufficient situations and complementing existing state protection mechanisms. With an aging population and increasing demand for healthcare services LTC policies have become indispensable. While individual LTCI policies face adoption challenges, group insurances offer a more streamlined alternative. However, realizing the full potential of these insurances necessitates targeted legislative intervention to improve accessibility and ensure sustainability. This article explores the evolution of LTCI policies in Italy, offering an overview of the current landscape and highlighting the socio-economic and medico-legal factors shaping the present scenario. By providing this analysis, we seek to offer insights into the dynamic evolution of LTCI policies and the crucial role of legislative measures in enhancing their effectiveness and accessibility.

Insight from an Italian Delphi Consensus on EVAR feasibility outside the instruction for use: the SAFE EVAR Study.

BACKGROUND: The SAfety and FEasibility of standard EVAR outside the instruction for use (SAFE-EVAR) Study was designed to define the attitude of Italian vascular surgeons towards the use of standard endovascular repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) outside the instruction for use (IFU) through a Delphi consensus endorsed by the Italian Society of Vascular and Endovascular Surgery (Società Italiana di Chirurgia Vascolare ed Endovascolare - SICVE). METHODS: A questionnaire consisting of 26 statements was developed, validated by an 18-member Advisory Board, and then sent to 600 Italian vascular surgeons. The Delphi process was structured in three subsequent rounds which took place between April and June 2023. In the first two rounds, respondents could indicate one of the following five degrees of agreement: 1) strongly agree; 2) partially agree; 3) neither agree nor disagree; 4) partially disagree; 5) strongly disagree; while in the third round only three different choices were proposed: 1) agree; 2) neither agree nor disagree; 3) disagree. We considered the consensus reached when ≥70% of respondents agreed on one of the options. After the conclusion of each round, a report describing the percentage distribution of the answers was sent to all the participants. RESULTS: Two-hundred-forty-four (40.6%) Italian Vascular Surgeons agreed to participate the first round of the Delphi Consensus; the second and the third rounds of the Delphi collected 230 responders (94.3% of the first-round responders). Four statements (15.4%) reached a consensus in the first rounds. Among the 22 remaining statements, one more consensus (3.8%) was achieved in the second round. Finally, seven more statements (26.9%) reached a consensus in the simplified last round. Globally, a consensus was reached for almost half of the proposed statements (46.1%). CONCLUSIONS: The relatively low consensus rate obtained in this Delphi seems to confirm the discrepancy between Guideline recommendations and daily clinical practice. The data collected could represent the source for a possible guidelines' revision and the proposal of specific Good Practice Points in all those aspects with only little evidence available.

Three-Dimensional Bioprinting of Human Organs and Tissues: Bioethical and Medico-Legal Implications Examined through a Scoping Review.

Three-dimensional bioprinting is a rapidly evolving technology that holds the promise of addressing the increasing demand for organs, tissues, and personalized medicine. By employing computer-aided design and manufacturing processes, 3D bioprinting allows for the precise deposition of living cells, biomaterials, and biochemicals to create functional human tissues and organs. The potential applications of this technology are vast, including drug testing and development, disease modeling, regenerative medicine, and ultimately, organ transplantation. However, as with any groundbreaking technology, 3D bioprinting presents several ethical, legal, and regulatory concerns that warrant careful consideration. As the technology progresses towards clinical applications, it is essential to address these challenges and establish appropriate frameworks to guide the responsible development of 3D bioprinting. This article, utilizing the Arksey and O'Malley scoping review model, is designed to scrutinize the bioethical implications, legal and regulatory challenges, and medico-legal issues that are intertwined with this rapidly evolving technology.

Informed Consent in Paediatric Telemedicine: Challenge or Opportunity? A Scoping Review.

The fundamental importance of informed consent as a prerequisite for the lawfulness of the medical act is an indisputable cornerstone of clinical practice. However, the provision of effective information and the collection of informed consent presents important critical issues in the underage patient, even considering that in general terms he or she does not have the power to directly express consent, which must be provided by parents or legal guardians. These critical issues are amplified in the context of telemedicine. The present study aims, through a scoping review of the literature of the past 10 years, to outline the operational practices adopted in the collection of informed consent from children in the context of telemedicine and to identify solutions devised to address the critical issues related to the provision of adequate information to the child in this particular care setting. The results of the research show that the activity of delivering adequate information to the child, itself complex, is made even more complex by the particular setting of telemedicine, which, however, could be effectively exploited to facilitate communication with the child patient.

The role of digital literacy in achieving health equity in the third millennium society: A literature review.

Healthcare in the third millennium is largely delivered through systems involving the use of the technological devices and services, foremost among them telemedicine. For the adequate delivery of digital medicine services, however, it is necessary for users to be digitally literate, that is, able to consciously make use of technology. In order to understand how relevant digital literacy is in determining the effectiveness of e-Health services, we performed a traditional literature review on 3 major databases by combining the terms "Digital Literacy" and "Computer Literacy" with the terms "Telemedicine" and "Telehealth". Starting from an initial library of 1,077 papers, we selected 38 articles. At the outcome of the search, we found that digital literacy is a pivotal element in conditioning the effectiveness of telemedicine and digital medicine services in general, however, with some limitations.

COVID-19 Compulsory Vaccination: Legal and Bioethical Controversies.

The imposition of compulsory health treatments has always been a subject of animated legal and bioethical debate. What is at stake are two opposing interests that are in their own way protected by international treaties and constitutional provisions: the right to individual self-determination and the duty to defend and preserve collective safety. The global health crisis related to the COVID-19 pandemic has placed the issue of the legitimacy of imposing compulsory vaccination at the center of the multifaceted debate on pandemic health policies. Indonesia, Tajikistan, Turkmenistan, and the Federated States of Micronesia are currently the only four countries in the world where the COVID-19 vaccine is mandatory for all citizens. Italy was the first country in the European Union to introduce this obligation, effective from 8 January 2022 by virtue of the decree-law approved on 5 January 2022, which imposed vaccination compulsory for everyone over the age of 50. Similar paths have been undertaken by Greece and Austria, where the obligation will start respectively on 16 January 2022 (for citizens aged over 60) and 1 February 2022 (for citizens of all ages). However, in many civilized countries, "selective" forms of compulsory vaccination, i.e., aimed at specific categories of individuals, especially healthcare professionals, are already provided for. The present work aims to offer a concise and as much as possible exhaustive overview of the main ethical and legal issues related to compulsory COVID-19 vaccination, with reference to both the Italian and the international context, mainly European.

Electronic unified therapy record as a clinical risk management tool in the Italian healthcare system.

Digitization of health records is still struggling to take hold in the Italian healthcare context, where medical records are still largely kept manually on paper. Besides being anachronistic, this practice is particularly critical if applied to the drug chart. Poor handwriting and transcription errors can generate medication errors and thus represent a potential source of adverse events. In the present study, we attempt to test the hypothesis that the application of a computerized medical record model may represent a useful tool for managing clinical risk and medical expenditure. We shall do so through the analysis of the preliminary results of the application of such a model in two private hospitals in Northern Italy. The results, although preliminary, are encouraging. Among the benefits of digitizing drug records, we recorded a greater accuracy and adequacy of prescriptions, a reduction in the overall workload for nurses (no longer required to manually transcribe the list of drugs from one chart to another), as well as an optimization of the management of drug stocks by hospital pharmacies. The results in terms of clinical risk reduction will be monitored through a prospective cohort study that will take place in the coming months.

Pressure Ulcers from the Medico-Legal Perspective: A Case Report and Literature Review.

INTRODUCTION: The identification of professional liability profiles related to the development of pressure injuries is a very thorny issue from a medico-legal perspective. This is because no matter how strict the applied prevention protocols applied may be, the development of such injuries is largely dependent on endogenous factors. This paper aims to investigate the medico-legal issues related to this topic through the exposition of one case of medico-legal litigation and a traditional review of the literature. METHODS: We performed a literature search using three databases (Pubmed, Scopus, and Web Of Science), restricting the search to the period between 2001 and 2021. We used "pressure ulcers" and "jurisprudence" as the main keywords. From an initial library of 236 articles, our selection resulted in 12 articles, which were included in the review. RESULTS: We identified the ever-increasing expectations of patients and the concept of automatic attribution of responsibility when a pressure ulcer develops as the primary reasons for the increase in litigation over the past 20 years. The related corrective measures are numerous: a strict adherence to guidelines, an adequate documentation of preventive measures, a risk assessment, family involvement, and a successful collaboration between physicians and government institutions. CONCLUSIONS: The biological complexity of the pathogenetic development of pressure ulcers makes the subject very delicate from the medico-legal point of view. In principle, it is possible to state that a very large proportion of such injuries are preventable, but that there remains a percentage of them that cannot be prevented. In such cases, only a proper documentary demonstration of the adequacy of preventive measures can exclude liability profiles.

Verbal Autopsy as a Tool for Defining Causes of Death in Specific Healthcare Contexts: Study of Applicability through a Traditional Literature Review.

Autopsy examination, the gold standard for defining causes of death, is often difficult to apply in certain health care settings, especially in developing countries. The COVID-19 pandemic and its associated difficulties in terms of implementing autopsy examinations have made the need for alternative means of determining causes of death even more evident. One of the most interesting alternatives to the conventional autopsy is the verbal autopsy, a tool that originated in Africa and Asia in the 1950s and consists of a structured interview with the deceased's family members concerning the symptoms manifested by the person and the circumstances of death. In the early 1990s, the first doubts emerged about the validity of verbal autopsies, especially about the real reliability of the cause of death identified through this tool. The objective of the review was to identify studies that had assayed the validity of verbal autopsies through a rigorous comparison of the results that emerged from it with the results of conventional autopsies. When starting from an initial pool of 256 articles, only 2 articles were selected for final review. These are the only two original research articles in which a verbal autopsy validation process was performed by employing the full diagnostic autopsy as the gold standard. The two papers reached opposite conclusions, one suggesting adequate validity of verbal autopsy in defining the cause of death and the other casting serious doubts on the real applicability of this tool. Verbal autopsy undoubtedly has extraordinary potential, especially in the area of health and demographic surveillance, even considering the implementation that could result from the use of artificial intelligence and deep learning. However, at present, there appears to be a lack of solid data to support the robust reliability of this tool in defining causes of death.

Fourth Generation of Synthetic Cannabinoid Receptor Agonists: A Review on the Latest Insights.

BACKGROUND: Over the past few years, an emerging number of new psychoactive substances (NPSs) entered the illicit market. NPSs are designed to resemble the effects of classical drugs of abuse, reinforcing their effects and duration. Among the most abused NPS, synthetic cannabinoids are cannabinoid receptor agonists (SCRAs) that mimic the effect of the main psychotropic phytocannabinoid Δ9-tetrahydrocannabinol (THC). METHODS: We herein reviewed the international literature to provide available information on the newest SCRAs generation. RESULTS: Compared to the previous SCRAs generations, the structures of the last generation result in increased affinity for and efficacy at cannabinoid CB1 receptors, which are thought to be mainly responsible for the psychoactive effects of THC and its analogues. Accordingly, these more potent cannabimimetic effects may increase the number of adverse reactions such as neurological disorders (e.g., psychosis, agitation, irritability, paranoia, confusion, and anxiety), psychiatric episodes (e.g., hallucinations, delusions, self-harm), other physical conditions (e.g., tachycardia, hypertension, arrhythmia, chest pain, nausea, vomiting, and fever) and deaths. In the last decade, more than a hundred SCRAs from different chemical classes emerged on the illicit web market. SCRAs have been thoroughly studied: they were physico-chemically characterized, and pharmaco-toxicological characteristics were investigated. The last SCRAs generations include increasingly potent and toxic compounds, posing a potential health threat to consumers. CONCLUSION: From November 2017 to February 2021, at least 20 new "fourth-generation" SCRAs were formally reported to international drug agencies. Our understanding of the neurotoxicity of these compounds is still limited due to the lack of global data, but their potency and their toxicity are likely higher than those of the previous generations.

Factors affecting mental health of seafarers on board merchant ships: a systematic review.

OBJECTIVES: Merchant ships represent a peculiar working environment with several challenges and risks. The specific situation on board of ships may affect the mental health of seafarers more remarkably than ashore workers. CONTENT: A systematic review of the literature has been carried out to identify the main causes of mood disorders among seafarers and the impact that these disorders have on their health. This review has analyzed the scientific literature published between January 2006 and December 2021 using the search engines PubMed, Web of Science (WoS) and Cumulative Index to Nursing and Allied Health Literature (CINAHL). SUMMARY: Social isolation, distance from families, fatigue, stress and long work shifts represent the main causes of mood disorders among seafarers. OUTLOOK: Strategies aimed at improving conditions of cohabitation on board, and a greater consideration of these problems are key for improving the mental health of workers at sea.

Ketamine: From Prescription Anaesthetic to a New Psychoactive Substance.

Discovered in the United States of America (USA) in the 1960s, ketamine was introduced as an anaesthetic drug to specifically replace phencyclidine. Briefly, the substance moved from the medical world to recreational users, since it was discovered that intense psychedelic experiences were obtained with dosages lower than those prescribed for anesthesia. At the end of the 90's, it was circulated in London nightclubs as a drug itself and as counterfeit 3,4-methylenedioxymethamphetamine tablets. In 1997, the Drug Enforcement Administration (DEA) alerted the United States (US) government about the increasing diffusion of ketamine in American 'clubs', and in 1999, the substance was added to Schedule III of drugs controlled by federal authorities. In 2002, ketamine epidemics moved to Europe, and the European Monitoring Centre for Drugs and Drug Addiction carried out a risk assessment monitoring of the phenomenon. An estimated ninety-nine percent of all global ketamine seizures occurred in Asia. Its growing popularity is due to the fact that this new psychoactive substance is cheaper than other stimulants, such as MDMA. Moreover, the amount used for recreational purposes does not cause respiratory depression and its legal use as a drug makes it widely available for a diversion towards illicit markets. Nevertheless, acute intoxication and several deaths have been related to exclusive ketamine use both in Europe and internationally. Since 2015, there has been an increasing rise in the illicit ketamine market, and currently, the drug is being used with unprecedented peaks and a consequent significant increase in seizures and clinical cases worldwide.

3F-α-pyrrolydinovalerophenone (3F-α-PVP) in vitro human metabolism: Multiple in silico predictions to assist in LC-HRMS/MS analysis and targeted/untargeted data mining.

Synthetic cathinones (SCs) constitute a heterogenous class of new psychoactive substances (NPS), structurally related to cathinone. SCs represent the widest NPS class, second to synthetic cannabinoids, accounting for approximately 160 different analogues with substitution at the phenyl group, the amine group, or the alkyl chain. In 2020, α-pyrrolidonophenone analogues were the most trafficked SCs, and were involved in many fatalities and intoxication cases. In particular, 3F-α-pyrrolidinovalerophenone (3F-α-PVP) was the cause of the highest number of SC-related fatal intoxications in Sweden in 2018. Minor structural modifications are used to avoid legal controls and analytical detection, but may also induce different toxicological profile. Therefore, the identification of specific markers of consumption is essential to discriminate SCs in clinical and forensic toxicology. In this study, we assessed 3F-α-PVP metabolic profile. 3F-α-PVP was incubated with 10-donor-pooled human hepatocytes, LC-HRMS/MS analysis, and software-assisted data mining. This well-established workflow was completed by in silico metabolite predictions using three different freeware. Ten metabolites were identified after 3 h incubation, including hydrogenated, hydroxylated, oxidated, and N-dealkylated metabolites. A total of 51 phase I and II metabolites were predicted, among which 7 were detected in the incubations. We suggest 3F-α-PVP N-butanoic acid, 3F-α-PVP pentanol, and 3F-α-PVP 2-ketopyrrolidinyl-pentanol as specific biomarkers of 3F-α-PVP consumption. This is the first time that an N-ethanoic acid is detected in the metabolic pathway of a pyrrolidine SC, demonstrating the importance of a dual targeted/untargeted data mining strategy.

Is Evar Feasible in Challenging Aortic Neck Anatomies? A Technical Review and Ethical Discussion.

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.