[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.

Blood products use in France: a nationwide cross-sectional survey.

BACKGROUND: Blood products use has increased in France between 2000 and 2011. To understand the reasons for this increase, data about transfused patients and transfusion practices needed to be updated. STUDY DESIGN AND METHODS: A nationwide cross-sectional survey was performed with health care establishments. Diagnoses and indication for the transfusion, pretransfusion laboratory results, and blood products used were collected during a randomly selected 24-hour period in 2011. All patients who received at least one blood product delivered on the survey day were included. RESULTS: A total of 10,794 blood products were requested for 4720 patients: 8688 red blood cell (RBC) units, 842 platelet (PLT) concentrates, and 1264 fresh-frozen plasma (FFP) units. Hematologic and cancer pathologies included 46% of transfused patients, 34% of the patients had transfusions in a surgical context, and 32.4% of transfused patients were receiving medication with an impact on transfusion. Nearly half of RBC transfusions were performed with hemoglobin levels of less than 8 g/dL. PLT transfusions for prophylactic indication were prescribed with PLT counts of less than 20 × 109 and 50 × 109 /L in 56.9 and 86.6% of patients, respectively. RBCs and PLTs transfusion practices were in agreement with national guidelines. FFP units were involved in 8.0% of all prescriptions. Among these, 57.4% were requested in the context of an acute hemorrhage and 8.4% for plasma exchange. The median of FFP use (n = 2) in a nonsurgical context, excluding plasma exchange, suggests an insufficient dosing of FFP. CONCLUSION: Except for insufficient FFP dosing per patient and limitations on assessment of indications for prescribing, transfusion practices were in agreement with national guidelines.

Perioperative Patient Blood Management (excluding obstetrics): Guidelines from the French National Authority for Health.

The French National Authority for Health (HAS) recently issued guidelines for patient blood management (PBM) in surgical procedures. These recommendations are based on three usual pillars of PBM: optimizing red cell mass, minimizing blood loss and optimizing anemia tolerance. In the preoperative period, these guidelines recommend detecting anemia and iron deficiency and taking corrective measures well in advance of surgery, when possible, in case of surgery with moderate to high bleeding risk or known preoperative anemia. In the intraoperative period, the use of tranexamic acid and some surgical techniques are recommended to limit bleeding in case of high bleeding risk or in case of hemorrhage, and the use of cell salvage is recommended in some surgeries with a major risk of transfusion. In the postoperative period, the limitation of blood samples is recommended but the monitoring of postoperative anemia must be carried out and may lead to corrective measures (intravenous iron in particular) or more precise diagnostic assessment of this anemia. A "restrictive" transfusion threshold considering comorbidities and, most importantly, the tolerance of the patient is recommended postoperatively. The implementation of a strategy and a program for patient blood management is recommended throughout the perioperative period in healthcare establishments in order to reduce blood transfusion and length of stay. This article presents an English translation of the HAS recommendations and a summary of the rationale underlying these recommendations.

Blood coagulation test abnormalities in trauma patients detected by sonorheometry: a retrospective cohort study.

Background: Traumatic hemorrhage guidelines include point-of-care viscoelastic tests as a standard of care. Quantra (Hemosonics) is a device based on sonic estimation of elasticity via resonance (SEER) sonorheometry to assess whole blood clot formation. Objectives: Our study aimed to assess the ability of an early SEER evaluation to detect blood coagulation test abnormalities in trauma patients. Methods: We conducted an observational retrospective cohort study with data collected at hospital admission of consecutive multiple trauma patients from September 2020 to February 2022 at a regional level 1 trauma center. We performed a receiving operator characteristic curve analysis to determine the ability of the SEER device to detect blood coagulation test abnormalities. Four values on the SEER device were analyzed: clot formation time, clot stiffness (CS), platelet contribution to CS, and fibrinogen contribution to CS. Results: A total of 156 trauma patients were analyzed. The clot formation time value predicted an activated partial thromboplastin time ratio of >1.5 with an area under the curve (AUC) of 0.93 (95% CI, 0.86-0.99). The AUC of the CS value in detecting an international normalized ratio of prothrombin time of >1.5 was 0.87 (95% CI, 0.79-0.95). The AUC of fibrinogen contribution to CS to detect a fibrinogen concentration of <1.5 g/L was 0.87 (95% CI, 0.80-0.94). The AUC of platelet contribution to CS to detect a platelet concentration of <50 G/L was 0.99 (95% CI, 0.99-1.00). Conclusion: Our results suggest that the SEER device may be useful for the detection of blood coagulation test abnormalities at trauma admission.