[Temporary circulatory assistance by Impella™ in interventional cardiology: Observational study and medico-economic assessment after four years of use]. / Assistance circulatoire temporaire par Impella™ en cardiologie interventionnelle : étude observationnelle et bilan médicoéconomique après quatre ans d'utilisation.

OBJECTIVES: During life-threatening emergencies or risky cardiologic interventions, pharmacology can be limited and the use of appropriate medical devices is then necessary. The Impella™ catheter, CP and 2.5, has been referenced for the exclusive use of the interventional cardiology technical platform at Hôpital Nord (AP-HM) in the absence of rapid access to the Extracorporeal Circulation unit. It is a temporary mechanical circulatory support device mainly indicated in refractory cardiogenic shock and coronary angioplasty at high risk of hemodynamic instability. The objective of this study, observational and retrospective, is to carry out a clinical and economic assessment linked to the use of this device over a period of four years (2017-2020). METHODS: The criteria relating to the 71 patients (51 Impella™ CP and 20 Impella™ 2.5) and their clinical evolution as well as the costs and valuation of the stays were determined. RESULTS: In particular, the Impella™ CP enabled myocardial recovery in 18 out of 51 patients and it was an intermediary in the context of heavier care for 11 patients. The balance between expenditure and valuation shows a deficit of -819,937 euros over the study period, with however a probable margin for improvement. CONCLUSIONS: The Impella™ is of clinical interest under very specific conditions. Its high cost and the absence of inclusion on the list of reimbursements in addition to Homogeneous Groups of Stays represent a significant financial burden for health care establishments. Thus, optimizing the rating of future stays is a necessity.

[Overview of hospital city repay for paediatric preparations initiated within the Marseille Public University Hospital system]. / État des lieux des modalités de poursuite en ville des préparations pharmaceutiques à usage pédiatrique initiées au sein de l'Assistance publique des Hôpitaux de Marseille.

OBJECTIVES: Hospital internal-use pharmacies are required to make pharmaceutical preparations in order to obtain a medication in a dosage and/or Galenic form (FG) suitable for pediatric use. The aim of this study is to assess the procedures for continuing pharmaceutical preparations initiated within the Assistance Publique des Hôpitaux de Marseille in an outpatient setting. METHODS: Hospital discharge prescriptions and/or consultation prescriptions involving paediatric magistral preparations and issued by our Hospital Centre were collected from two pharmacies with significant preparation activity at national level. An analysis of regulatory compliance was carried out, as well as a comparison of the formulation of preparations made in the outpatient setting and in the hospital. RESULTS: Au total, 45 prescriptions were collected, representing 52 preparation lines. The regulatory analysis revealed that all the prescriptions contained at least one non-conformity, 60.8% of which related to drug treatments. The prepared FG differed in the outpatient setting compared to the hospital in 46.2% of cases, and in 56% of cases, the vehicle and concentration of the active ingredient used differed when the FG was a liquid oral form. CONCLUSIONS: The lack of clear and complete hospital prescriptions makes it difficult to carry out treatment initiated in hospital in the outpatient setting. The multiplicity of information systems between hospitals and outpatient settings are obstacles to the interoperability needed to coordinate patient treatment, particularly in paediatrics. The quality of discharge prescriptions needs to be improved to optimise the patient care pathway.

[Causality analysis of a low-viscosity bone cement in orthopaedic surgery following serious adverse events]. / Analyse d'imputabilité d'un ciment basse viscosité en orthopédie suite à la survenue d'événements indésirables graves.

OBJECTIVES: Low-viscosity bone cement impregnated with gentamicin is frequently used to fix femoral prostheses. Three cardiac arrests occured successively during cementoplasty oh hip replacements, leading to the death of two patients. The objective of this study is to describe the actions undertaken to establish a potential link between the use of the bone cement and the occurrence of these serious adverse events (SAE). METHODS: A mortality and morbidity review was organised in order to study the causality of bone cement and to propose improvement actions, following 3 considered SAE associated to materiovigilance reporting. RESULTS: All three SAE occurred following the injection of the same reference of bone cement. The incriminated batches were rapidly placed in quarantine. Analysis by the manufacturer revealed no defects in production quality requirements but suggested the possibility of Bone Cement Implantation Syndrome (BCIS). A literary review on BCIS confirmed that this rare intraoperative complication was plausible in all three cases. Management of these SAE via a health care safety process enabled to provide a rapid answer concerning the causality of the cement and practice deviations of its use. CONCLUSIONS: Systemic analysis completed by the manufacturer's analysis provided corrective actions for professional practices. Implementation and efficacy of these actions will be monitored as part of the facility's programme for the improvement of quality and patient safety.

Refractory Pseudomonas aeruginosa Bronchopulmonary Infection After Lung Transplantation for Common Variable Immunodeficiency Despite Maximal Treatment Including IgM/IgA-Enriched Immunoglobulins and Bacteriophage Therapy.

Recipients transplanted for bronchiectasis in the context of a primary immune deficiency, such as common variable immunodeficiency, are at a high risk of severe infection in post-transplantation leading to poorer long-term outcomes than other transplant indications. In this report, we present a fatal case due to chronic Pseudomonas aeruginosa bronchopulmonary infection in a lung transplant recipient with common variable immunodeficiency despite successful eradication of an extensively drug-resistant (XDR) strain with IgM/IgA-enriched immunoglobulins and bacteriophage therapy. The fatal evolution despite a drastic adaptation of the immunosuppressive regimen and the maximal antibiotic therapy strategy raises the question of the contraindication of lung transplantation in such a context of primary immunodeficiency.

Oropharyngeal and nasopharyngeal decontamination with chlorhexidine gluconate in lung cancer surgery: a randomized clinical trial.

PURPOSE: Respiratory complications are the leading causes of morbidity and mortality after lung cancer surgery. We hypothesized that oropharyngeal and nasopharyngeal decontamination with chlorhexidine gluconate (CHG) would be an effective method to reduce these complications as reported in cardiac surgery. METHODS: In this multicenter parallel-group randomized double-blind placebo-controlled trial, we enrolled consecutive adults scheduled for anatomical pulmonary resection for lung cancer. Perioperative decontamination consisted in oropharyngeal rinse solution (0.12% CHG) and nasopharyngeal soap (4% CHG) or a placebo. The primary outcome measure was the proportion of patients requiring postoperative invasive and/or noninvasive mechanical ventilation (MV). Secondary outcome measures included occurrence of respiratory and non-respiratory healthcare-associated infections (HAIs) and outcomes within 90 days. RESULTS: Between July 2012 and April 2015, 474 patients were randomized. Of them, 24 had their surgical procedure cancelled or withdrew consent. The remaining 450 patients were included in a modified intention-to-treat analysis: 226 were allocated to CHG and 224 to the placebo. Proportions of patients requiring postoperative MV were not significantly different [CHG 14.2%; placebo 15.2%; relative risks (RRs) 0.93; 95% confidence interval (CI) 0.59-1.45; P = 0.76]. Neither of the proportions of patients with respiratory HAIs were different (CHG 13.7%; placebo 12.9%; RRs 1.06; 95% CI 0.66-1.69; P = 0.81). The CHG group had significantly decreased incidence of bacteremia, surgical-site infection and overall Staphylococcus aureus infections. However, there were no significant between-group differences for hospital stay length, change in tracheal microbiota, postoperative antibiotic utilization and outcomes by day 90. CONCLUSIONS: CHG decontamination decreased neither MV requirements nor respiratory infections after lung cancer surgery. Additionally, CHG did not change tracheal microbiota or postoperative antibiotic utilization. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov, number NCT01613365.

Colony morphology switching of Candida lusitaniae and acquisition of multidrug resistance during treatment of a renal infection in a newborn: case report and review of the literature.

Candida lusitaniae is an emerging opportunistic pathogen which exhibits an unusual antifungal susceptibility pattern. We describe a case of fatal renal infection due to C. lusitaniae in a very low birth weight neonate who was treated with short courses of fluconazole given alternately with amphotericin B. A colony morphology switching was detected on the standard primary culture medium by changes in colony size. Switching was shown to affect deeply the susceptibility to amphotericin B. Afterwards, the switched phenotype developed a cross resistance to fluconazole and itraconazole. Several issues raised by this case are discussed in the light of an extensive review of the literature. Our observations point out the importance of both the detection of colony morphology switching and the close monitoring of antifungal susceptibility in the management of infections due to C. lusitaniae. A judicious therapeutic strategy should prevent the acquisition of multidrug resistance during antifungal therapy.