[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.

[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.