Airway replacement using stented aortic matrices: Long-term follow-up and results of the TRITON-01 study in 35 adult patients.

Over the past 25 years, we have demonstrated the feasibility of airway bioengineering using stented aortic matrices experimentally then in a first-in-human trial (n = 13). The present TRITON-01 study analyzed all the patients who had airway replacement at our center to confirm that this innovative approach can be now used as usual care. For each patient, the following data were prospectively collected: postoperative mortality and morbidity, late airway complications, stent removal and status at last follow-up on November 2, 2021. From October 2009 to October 2021, 35 patients had airway replacement for malignant (n = 29) or benign (n = 6) lesions. The 30-day postoperative mortality and morbidity rates were 2.9% (n = 1/35) and 22.9% (n = 8/35) respectively. At a median follow-up of 29.5 months (range 1-133 months), 27 patients were alive. There have been no deaths directly related to the implanted bioprosthesis. Eighteen patients (52.9%) had stent-related granulomas requiring a bronchoscopic treatment. Ten among 35 patients (28.6%) achieved a stent free survival. The actuarial 2- and 5-year survival rates (Kaplan-Meier estimates) were respectively 88% and 75%. The TRITON-01 study confirmed that airway replacement using stented aortic matrices can be proposed as usual care at our center. Clinicaltrials.gov Identifier: NCT04263129.

« Sédation ¼ ou « pratiques sédatives à visée palliative en fin de vie ¼ ? Une étude linguistique des recommandations francophones en matière de sédation en soins palliatifs chez l'adulte.

Introduction : Despite the number and importance of French-language guidelines related to palliative sedation for adults, these texts have never been the subject of a linguistic analysis.Objectives : This study aimed to explore and analyze the terms used for sedation and their definitions in Belgian, French, Quebec, and Swiss guidelines.Methods : Current documents were subjected to textual, terminological, and conceptual analysis.Results : Belgian, Quebec, and Swiss guidelines use the same term to refer to sedation, without, however, conceptualizing it in a consistent way. By contrast, guidelines developed in France use various terms but define sedation in a similar (but not identical) way. Cultural specificities linked to end-of-life legislation in those countries and region were identified as a potential causal factor.Discussion and conclusion : The diversity of terms and definitions inevitably reinforces the imprecision of the medical language, and the terminology in particular. This is likely to have a negative impact on communication between healthcare professionals, patients, and their families. Efforts should be made to homogenize the terminology and definitions used in guidelines.

[Clinical ethics and uncertainty: an inseparable duo for the benefit of the patient]. / Éthique clinique et incertitude : un indissociable duo au bénéfice du patient.

Clinical ethics can be conceived as thought marked by uncertainty and on uncertainty. Its difficulties must be highlighted and discussed, in order to help guide the actions of caregivers, both on a scientific and human level, for the benefit of the patient. As an intellectual and moral virtue, humility is likely to favour a high standard of reflection and action.

[Doctor-patient relationship: teenagers prefer "tu" to "vous"]. / Les adolescents préfèrent être tutoyés par leur médecin.

The quality of the relationship is important for the medical care of adolescents. The choice of the pronoun of address, "tu" or "vous", could be a determining factor in this relationship. A study of 220 adolescents showed that they preferred to be addressed as "tu". They waited for the doctor to offer it to them.

Admission decisions to intensive care units in the context of the major COVID-19 outbreak: local guidance from the COVID-19 Paris-region area.

SARS-CoV-2 has caused a global pandemic unprecedented in size, spread, severity, and mortality. The influx of patients with severe or life-threatening disease means that in some cases, the available medical resources are not sufficient to meet the needs of all patients. Hence, healthcare providers may be forced to make difficult choices about which patients should be referred to the ICU. This document is intended to provide conceptual support to all healthcare teams currently engaged in the frontline management of the COVID-19 pandemic. It aims to assist physicians in the decision-making process for ICU admission and to help them provide uninterrupted and high-quality care.

Feasibility of Bioengineered Tracheal and Bronchial Reconstruction Using Stented Aortic Matrices.

Importance: Airway transplantation could be an option for patients with proximal lung tumor or with end-stage tracheobronchial disease. New methods for airway transplantation remain highly controversial. Objective: To establish the feasibility of airway bioengineering using a technique based on the implantation of stented aortic matrices. Design, Setting, and Participants: Uncontrolled single-center cohort study including 20 patients with end-stage tracheal lesions or with proximal lung tumors requiring a pneumonectomy. The study was conducted in Paris, France, from October 2009 through February 2017; final follow-up for all patients occurred on November 2, 2017. Exposures: Radical resection of the lesions was performed using standard surgical techniques. After resection, airway reconstruction was performed using a human cryopreserved (-80°C) aortic allograft, which was not matched by the ABO and leukocyte antigen systems. To prevent airway collapse, a custom-made stent was inserted into the allograft. In patients with proximal lung tumors, the lung-sparing intervention of bronchial transplantation was used. Main Outcomes and Measures: The primary outcome was 90-day mortality. The secondary outcome was 90-day morbidity. Results: Twenty patients were included in the study (mean age, 54.9 years; age range, 24-79 years; 13 men [65%]). Thirteen patients underwent tracheal (n = 5), bronchial (n = 7), or carinal (n = 1) transplantation. Airway transplantation was not performed in 7 patients for the following reasons: medical contraindication (n = 1), unavoidable pneumonectomy (n = 1), exploratory thoracotomy only (n = 2), and a lobectomy or bilobectomy was possible (n = 3). Among the 20 patients initially included, the overall 90-day mortality rate was 5% (1 patient underwent a carinal transplantation and died). No mortality at 90 days was observed among patients who underwent tracheal or bronchial reconstruction. Among the 13 patients who underwent airway transplantation, major 90-day morbidity events occurred in 4 (30.8%) and included laryngeal edema, acute lung edema, acute respiratory distress syndrome, and atrial fibrillation. There was no adverse event directly related to the surgical technique. Stent removal was performed at a postoperative mean of 18.2 months. At a median follow-up of 3 years 11 months, 10 of the 13 patients (76.9%) were alive. Of these 10 patients, 8 (80%) breathed normally through newly formed airways after stent removal. Regeneration of epithelium and de novo generation of cartilage were observed within aortic matrices from recipient cells. Conclusions and Relevance: In this uncontrolled study, airway bioengineering using stented aortic matrices demonstrated feasibility for complex tracheal and bronchial reconstruction. Further research is needed to assess efficacy and safety. Trial Registration: clinicaltrials.gov Identifier: NCT01331863.

'Spiritual care is not the hospital's business': a qualitative study on the perspectives of patients about the integration of spirituality in healthcare settings.

BACKGROUND: Several studies have investigated the relationship between spirituality and health. They claim the need to develop spiritual care to answer patients' spiritual suffering and to promote spiritual well-being. However, the present study critically analyses the following idea: we ought to take care of the spiritual dimension of patients. Does this interest for spirituality not come from healthcare professionals' desire more than from the patients themselves? OBJECTIVE: To answer this question, we explored the perspectives of individuals with cancer regarding the integration of spirituality in the healthcare setting. DESIGN: Qualitative design using semistructured interviews to focus on subjective experience. SETTING: One of the major public hospitals of Paris, France. PARTICIPANTS: 20 participants (n=11 men and n=9 women) with advanced cancer (stage IV). Age ranges from 37 to 80 years with a mean age of 58.7 years. RESULTS: Findings demonstrated that participants do not expect help from the hospital to handle spiritual issues but they wish for their spiritual dimension to be simply recognised as a part of their identity and dignity. CONCLUSIONS: Findings invite us to view the question of spirituality not as a new dimension of care but as a new challenge for healthcare institutions to recognise that the persons they are working for are not just 'patients' but human beings with a precious interior life.

Association Between Early Patient Characteristics and IgE-Mediated Allergy in the Perioperative Setting.

BACKGROUND: Early recognition of perioperative anaphylaxis, a life-threatening, usually IgE-mediated, immediate hypersensitivity, is essential, but bedside diagnosis is not always straightforward because clinical presentation may vary. OBJECTIVES: To describe early characteristics of perioperative immediate hypersensitivity, with special attention to cutaneous phenotypes, and identify risk factors for IgE-mediated allergy. METHODS: We retrospectively analyzed data from adults with suspected perioperative immediate hypersensitivity who were investigated in two academic medical centers. Multivariable logistic regression was conducted to evaluate associations among patient, clinical, and paraclinical characteristics and IgE-mediated allergy. RESULTS: Of 145 enrolled patients, 99 (68.3%) and 46 (31.7%) were respectively categorized in the IgE-mediated allergy and non-allergy groups. Cutaneous vasoconstriction phenotype (pallor, piloerection, thelerethism, and sweating with or without cyanosis) occurring within minutes (or even 1 minute) of drug exposure was strongly associated with IgE-mediated allergy (adjusted odds ratio [aOR] = 28.02; 95% CI, 4.41-305.18). IgE-mediated allergy was always life-threatening in this setting. Other early factors associated with allergy were low end-tidal carbon dioxide 25 mm Hg or less (aOR = 5.45; 95% CI, 2.39-26.45), low mean arterial pressure 60 mm Hg or less (aOR = 3.82; 95% CI, 1.28-17.31), and early cutaneous vasodilation (erythema, urticaria, and/or angioedema) (aOR = 2.78; 95% CI, 0.73-20.54). Late cutaneous vasodilation after restoration of hemodynamics corroborated the diagnosis of allergy (aOR = 23.67; 95% CI, 4.94-205.09). The best-fit model including three readily available variables (cutaneous phenotype involving the three modalities [reference lack of cutaneous signs], low mean arterial pressure, and low end-tidal carbon dioxide) had an area under the curve of 0.91. CONCLUSIONS: Cutaneous vasoconstriction phenotype is associated with the strongest risk of life-threatening allergy and thus may be regarded as pathognomonic of perioperative IgE-mediated anaphylaxis.

Informed consent for special procedures: electroconvulsive therapy and psychosurgery.

PURPOSE OF REVIEW: Informed consent has become the cornerstone of the expression of patient's autonomy for ethical and sound patient-physician relationships. However, some severe psychiatric diseases markedly hinder the ability of selected patients to ensure a proper consent. Confronted with mentally disabled individuals whose condition may lead to violence or inflicting it on others, society must carry out its duty of protecting those who are particularly vulnerable, while respecting and protecting these disabled individuals. RECENT FINDINGS: The recent update in the indications and more detailed understanding of electroconvulsive therapy, and the technical ability of obtaining less invasive or reversible techniques of psychosurgery, has renewed interest in these impressive and efficient techniques. Specifically, the emergence of new and promising cerebral neurostimulation techniques for treating Parkinson's disease have led to considering their extension to severe psychiatric disorders. This method can mimic the effects of 'conventional' psychosurgery, but in a potentially reversible and adaptable way, thus avoiding many undesirable side-effects of lesional surgery. Ensuring an ethical decision-making process and the appropriateness of consent becomes of paramount importance. SUMMARY: Consent can be relatively easy to secure in selected patients who are often fully aware of their torments (such as those suffering from severe refractory depression of obsessive-compulsive disorders) whose suffering may be such that they are ready to accept, or for that matter demand, such actions. However, the duty of physicians is to realize that pains should always be taken to do as much good (and as little harm) as possible, while respecting the freedom of decision of those who seek to help.

Opt-in or opt-out for organ transplantation.

PURPOSE OF REVIEW: Opt-in or opt-out consent for organ transplantation is still a disputed subject and the determination of the more appropriate system is still debated. RECENT FINDINGS: Europe is still divided between countries where transplantation after brain death is governed by presumed consent and other where informed consent is mandatory. Recent debate, however, has emerged in each country to determine whether shifting systems might be beneficial for organ procurement. SUMMARY: Consent for organ donation in a brain dead patient represents an act of benevolence or of solidarity in favour of an unknown person. If one considers that the principle of autonomy must prevail over the principle of benevolence or of solidarity, the risk is depriving a potential recipient of a comparatively very important benefit. On the contrary, if one considers that the principles of benevolence should necessarily lead, the risk is high of exerting an excessive pressure to the detriments of autonomy and liberty of the individual. Whatever the system chosen, adequate and fair communication expressing loyally the way families are approached is essential.

Diagnosis Yield and Safety of Surgical Biopsy in Interstitial Lung Diseases: A Prospective Study.

BACKGROUND: Surgical lung biopsy is essential in the diagnostic algorithm of interstitial lung disease (ILD) of unknown cause. Safety concerns have been recently reiterated. This study prospectively assessed the yield of diagnosis and safety of video-assisted thoracoscopic surgical lung biopsy (VATS-LB) for ILD diagnosis. METHODS: This prospective study, conducted in 6 ILD-referral Paris hospitals, included 103 patients with ILD. VATS-LB was proposed after initial multidisciplinary discussion. A final diagnosis was made after the procedure, during a second multidisciplinary discussion. The main outcome was to determine the final diagnoses and their proportion after VATS-LB. Other outcomes were the percentage of change in diagnosis and treatment propositions after VATS-LB and adverse events during 3 months after the operation, postoperative pulmonary function, quality of life, and pain. RESULTS: A definite diagnosis was reached in 87 patients (84.4%), and 16 remained unclassifiable (15.6%). After VATS-LB, the hypothesized diagnosis changed in 65 patients (63.1%) and treatment changed in 41 patients (39.8%). One patient died of acute exacerbation. In-hospital complications were predicted by a shorter preoperative 6-minute walking test distance and by forced vital capacity lower than 77%. Postoperative quality of life was not modified at 3 months, whereas forced vital capacity decreased slightly. Postoperative neuropathic pain was revealed in 5% of patients at 1 month and in 2% at 3 months. CONCLUSIONS: VATS-LB dramatically changed preoperative hypothetical diagnoses and treatment in ILD of unknown cause, with good patient survival in ILD referral centers.

[Current status of clinical practice guidelines on palliative sedation for adults in French-speaking countries]. / État des lieux des recommandations sur la sédation palliative chez l'adulte dans les pays francophones.

INTRODUCTION: Many clinical practice guidelines on palliative sedation have been developed. To date, studies on French-language guidelines are lacking, despite the specific and potentially influential end-of-life positions taken by some French-speaking countries. This study aimed to perform a systematic review of the guidelines related to palliative sedation for adults in French-speaking countries, taking a synchronic and diachronic approach (current and former guidelines). METHODS: Guidelines published in French since 2000 were searched for multiple databases. In addition, prominent palliative care experts in French-speaking countries were contacted individually. A content analysis of all guidelines was conducted. RESULTS: A total of 21 guidelines from 18 countries were identified. Among them, at the time of the data collection, 14 guidelines were effectively compiled in four countries or provinces: Belgium, France, Canada (Quebec) and Switzerland. No guidelines were found for African countries. The recommendations analyzed were very heterogeneous in form (simple proposals or formal guidelines) and in substance (i.e. different types of sedation). DISCUSSION AND CONCLUSION: The quantity and volume of the guidelines found and the heterogeneity of the terminology prevented a detailed analysis of the content of the texts. An analysis must be performed using a synchronic approach only and focusing on a specific element of one type of sedation.

Face mask ventilation in edentulous patients: a comparison of mandibular groove and lower lip placement.

BACKGROUND: In edentulous patients, it may be difficult to perform face mask ventilation because of inadequate seal with air leaks. Our aim was to ascertain whether the "lower lip" face mask placement, as a new face mask ventilation method, is more effective at reducing air leaks than the standard face mask placement. METHODS: Forty-nine edentulous patients with inadequate seal and air leak during two-hand positive-pressure ventilation using the ventilator circle system were prospectively evaluated. In the presence of air leaks, defined as a difference of at least 33% between inspired and expired tidal volumes, the mask was placed in a lower lip position by repositioning the caudal end of the mask above the lower lip while maintaining the head in extension. The results are expressed as mean +/- SD or median (25th-75th percentiles). RESULTS: Patient characteristics included age (71 +/- 11 yr) and body mass index (24 +/- 4 kg/m2). By using the standard method, the median inspired and expired tidal volumes were 450 ml (400-500 ml) and 0 ml (0-50 ml), respectively, and the median air leak was 400 ml (365-485 ml). After placing the mask in the lower lip position, the median expired tidal volume increased to 400 ml (380-490), and the median air leak decreased to 10 ml (0-20 ml) (P < 0.001 vs. standard method). The lower lip face mask placement with two hands reduced the air leak by 95% (80-100%). CONCLUSIONS: In edentulous patients with inadequate face mask ventilation, the lower lip face mask placement with two hands markedly reduced the air leak and improved ventilation.

Regulatory issues in xenotransplantation: recent developments.

PURPOSE OF REVIEW: This article reviews recent literature on regulatory issues of xenotransplantation, focusing primarily on current progress with transplantation of pancreatic islets for diabetic patients. The need for a global system that connects the national and international regulatory levels within a coherent framework is emphasized. RECENT FINDINGS: Recent progress in preclinical xenotransplantation of pancreatic islets has enhanced the hopes of providing patients with safe and effective treatments from animal cells and tissues in the near future. At the same time the increasing number of clinical trials proposed and sometimes authorized calls for attention from regulatory authorities. SUMMARY: Although the main regulatory aspects of xenotransplantation have been identified since the early 1990s, regulatory problems connected to the promising scientific data published in the field of pancreatic islets still require attention. In fact most normative issues, such as criteria for patients' enrollment in clinical trials and the management of safety measures have been primarily explored in relation to solid organ transplantation. Also the issue of animal rights has become more compelling in relation to the treatment of nonhuman primates in preclinical trials. In these rapidly evolving conditions the establishment of agreed guidelines at both the national and international levels remains the most urgent goal to be achieved.

Postoperative ketamine administration decreases morphine consumption in major abdominal surgery: a prospective, randomized, double-blind, controlled study.

BACKGROUND: Ketamine decreases postoperative morphine consumption, but its optimal dosing and duration of administration remain unclear. In this study, we compared the effects of ketamine administration on morphine consumption limited to the intraoperative period, or continued for 48 h postoperatively. METHODS: Eighty-one patients scheduled for abdominal surgery were prospectively randomized under double-blind conditions to three groups: (1) PERI group receiving intraoperative and postoperative ketamine for the first 48 h after surgery (2 microg x kg(-1) x min(-1) after a 0.5 mg/kg bolus); (2) INTRA group receiving intraoperative ketamine administration only (2 microg x kg(-1) x min(-1) after a 0.5 mg/kg bolus); and (3) CTRL group receiving placebo. Morphine consumption, visual analog scale scores and side effects (sedation score, nausea-vomiting score, nightmares, psychiatric disorders, or delusions) were recorded for the first 48 h. RESULTS: Cumulative morphine consumption 24 h after surgery was significantly lower in the PERI group (median = 27 mg, interquartile range = [19]) than in the INTRA group (48 mg [41.5]) and CTRL group (50 mg [21]) (P < 0.005). Postoperative visual analog scale scores were significantly lower in the PERI group and INTRA group than in the CTRL group (P < 0.001). A higher rate of nausea was observed in the CTRL group compared with the PERI group (27% vs 4%, P = 0.005). No difference in sedation scores or psychiatric disorders was observed among groups. CONCLUSIONS: Low-dose ketamine improved postoperative analgesia with a significant decrease of morphine consumption when its administration was continued for 48 h postoperatively, with a lower incidence of nausea and with no side effects of ketamine.

[The representation of the body in Islam]. / La représentation du corps en islam.

Science and Islamic culture incorporate the sacred and the profane. For a Muslim, science must be useful for humanity, and scientists must take responsibility, commensurate with their knowledge, for the potential consequences of their research. In this context, questions relating to the body in Islam take into account the Quran, hadiths and elements of established precedents.

Bilateral ilioinguinal nerve block decreases morphine consumption in female patients undergoing nonlaparoscopic gynecologic surgery.

BACKGROUND: Bilateral ilioinguinal nerve block may be useful to control postoperative pain in gynecologic surgery, especially hysterectomy. METHODS: In a prospective, randomized, double-blind study, we compared the combination of ropivacaine and clonidine (block group) versus saline (control group). The main objective of this study was to compare the total dose of morphine required during the first two postoperative days. All patients received antiemetic prophylaxis and multimodal IV analgesia. RESULTS: Seventy patients were randomized. The total morphine consumption during the first two postoperative days was decreased by 51% in the block group compared with the control group (21 +/- 9 mg vs 41 +/- 24 mg, P < 0.0001). This difference was not only due to morphine titration, but remained significant over the following 2 days. The course of the visual analog scale was equivalent between the two groups. No difference was observed in the side effects of morphine. CONCLUSION: The use of bilateral ilioinguinal nerve block for postoperative analgesia after hysterectomy decreased morphine consumption by one-half during the first two postoperative days without differences in side effects from morphine between groups.

Alternatives to evidence-based medecine / Les alternatives à l'evidence-based medicine

Alternatives to evidence based medecine. The evolution of patient-physician relationships, in addition to beneficence, implies to consider patient's autonomy as a relevant ethical factor. This infers to associate to the physician's scientific expertise, patient's wishes and preferences in a genuine personcentered medicine. The alternatives to evidence-based medicine mean here that it should not be considered exclusively or isolated from other factors. The physician should be aware that a fruitful dialogue with his patient include both the benefits of a scientific and sound medicine, based on solid evidences, as well as the careful consideration of patient's preferences, for the good of both..

Les alternatives à l'évidence - based medecine. L'évolution des relations médecin-malade impose, en plus d'une évidente bienfaisance, de considérer l'autonomie des patients comme un facteur éthique essentiel. Cela impose d'associer à l'expertise médicale les volontés et préférences du patient en une médecine scientifique, mais centrée sur la personne. Les alternatives à l'evidence-based medicine signifient ici qu'elle n'est pas exclusive ou isolée. Le médecin doit comprendre que le dialogue avec son patient s'enrichit à la fois des bénéfices d'une médecine fondée sur les preuves ainsi que de la prise en compte des préférences du patient, pour le bien propre du patient, mais aussi du soignant.

[Ethics and medical simulation]. / Éthique et simulation médicale.

Simulation in health care helps to raise health professionals' awareness of medical ethics and to understand the mechanisms involved in a difficult situation. They can thereby adopt a suitable form of behaviour and communication.