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.

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.

« 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.

[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.

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.

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.

Human transplantation of a biologic airway substitute in conservative lung cancer surgery.

BACKGROUND: Pneumonectomies for lung cancer are associated with a high postoperative mortality, especially when right-sided, after neoadjuvant radiochemotherapy, and in patients over 70 years of age. Preliminary studies in our laboratory have shown that aortic grafts could be valuable airway substitutes. We report the first human bronchial transplantation of a cryopreserved aortic allograft used as a biologic airway substitute to prevent a pneumonectomy for lung cancer. METHODS: The procedure was performed in a high-risk 78-year old patient with an extensive right bronchopulmonary malignant tumor pretreated with chemotherapy. After a complete resection of the lung cancer using an upper bilobectomy with lymph node removal, mobilization procedures did not allow for a primary end-to-end bronchial anastomosis. A stent-supported cryopreserved aortic allograft from a certified tissue bank was interposed to restore the bronchial continuity with sparing of the lower lobe. RESULTS: The postoperative course was eventful for a supraventricular arrhythmia leading to mild pulmonary edema that resolved using standard medical therapy, and a right lower lobe atelectasis with bacterial colonization that required fiberoptic bronchoscopies in addition to antibiotic treatment. A 1-year postoperative evaluation found a well-functioning reimplanted lower lobe with no complications related to the cryopreserved aortic allograft or the stent. The patient recovered to his baseline activity with a satisfying health-related quality of life. CONCLUSIONS: We demonstrate the feasibility of this surgical innovation to prevent the high-risk procedure of pneumonectomy in a single case. If confirmed in larger series of selected patients, it could bring new perspectives in conservative lung cancer surgery.

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.

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.

Clinical experience with the mini-extracorporeal circulation system: an evolution or a revolution?

PURPOSE: We studied a cohort of 150 patients operated on with a new cardiopulmonary bypass (CPB) system. This is the mini-extracorporeal circulation (MECC) system. DESCRIPTION: The MECC is a fully heparin coated closed-loop CPB system that includes a centrifugal pump and has a priming volume of 450 mL. Between March 2001 and September 2002, 150 consecutive patients were operated on using the mini-CPB (MECC) method. This includes 105 coronary artery bypass graft and 45 aortic valve replacement patients. The median age was 66.7 +/- 10.7 years with a gender ratio of 3.27 males to 1 female. EVALUATION: The 30-day operative mortality was 1.3%. The hemoglobin concentration was stable and perioperative transfusion was needed in only 6% of all patients. The renal and neuropsychiatric complications were less than 1%. CONCLUSIONS: In our experience, the MECC system is a reliable new concept for CPB with good clinical results.