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Anticoagulantes , Procedimientos Quirúrgicos Cardíacos , Resistencia a Medicamentos , Heparina , Trombosis , Humanos , Heparina/uso terapéutico , Heparina/efectos adversos , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Trombosis/prevención & control , Trombosis/sangre , Anticoagulantes/uso terapéutico , Hemostasis/efectos de los fármacos , Adulto , Cuidados Críticos , Atención PerioperativaRESUMEN
Given the growing number of patients receiving direct oral anticoagulant (DOAC), patients requiring rapid neutralization is also increasing in case of major bleedings or urgent surgery/procedures. Idarucizumab is commercialized as a specific antidote to dabigatran while andexanet alfa has gained the Food and Drug Administration and the European Medicines Agency approval as an oral anti-factor Xa inhibitors antidote. Other antidotes or hemostatic agents are still under preclinical or clinical development, the most advanced being ciraparantag. DOAC plasma levels measurement allows to appropriately select patient for antidote administration and may prevent unnecessary prescription of expensive molecules in some acute clinical settings. However, these tests might be inconclusive after some antidote administration, namely andexanet alfa and ciraparantag. The benefit of laboratory monitoring following DOAC reversal remains unclear. Here, we sought to provide an overview of the key studies evaluating the safety and efficacy of DOAC reversal using the most developed/commercialized specific antidotes, to discuss the potential role of the laboratory monitoring in the management of patients receiving DOAC specific antidotes and to highlight the areas that deserve further investigations in order to establish the exact role of laboratory monitoring in the appropriate management of DOAC specific antidotes.
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Anticuerpos Monoclonales Humanizados , Anticoagulantes , Antídotos , Factor Xa , Proteínas Recombinantes , Humanos , Antídotos/uso terapéutico , Anticoagulantes/uso terapéutico , Administración Oral , Inhibidores del Factor Xa/uso terapéutico , Monitoreo de Drogas/métodosRESUMEN
Background: Despite the wide use of bleeding scores and the reliability of clotting factor level measurement, bleeding risk stratification before surgery remains challenging in patients with rare inherited bleeding disorders. Objectives: This multicenter observational prospective study assessed in patients with rare coagulation factor deficiency, the perioperative hemostatic management choices by hemostasis experts and the bleeding outcomes after surgery. Methods: One hundred seventy-eight patients with low coagulation activity level (factor [F] II, FV, combined FV-FVIII, FVII, FX, or FXI <50%) underwent 207 surgical procedures. The bleeding outcome, Tosetto's bleeding score, and perioperative hemostatic protocols were collected. Results: Among the 81 procedures performed in patients with severe factor deficiency (level ≤10%), 27 were done without factor replacement (including 6 in patients at high bleeding risk), without any bleeding event. Factor replacement therapy was used mainly for orthopedic procedures. In patients with mild deficiency, 100/126 surgical procedures were carried out without perioperative hemostatic treatment. In patients with FVII or FXI deficiency, factor replacement therapy was in function of the procedure, bleeding risk, and to a lesser extent previous bleeding history. Tranexamic acid was used in almost half of the procedures, particularly in case of surgery in tissues with high fibrinolytic activity (76.8%). Conclusions: The current perioperative hemostatic management of patients with rare bleeding disorders appears to be adapted. Among the 207 procedures, only 6 were associated with excessive bleeding. Our findings suggest that rather than the bleeding score, factor level and surgery type are the most relevant criteria for perioperative factor replacement therapy.
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BACKGROUND: Centrifugation-based autotransfusion devices only salvage red blood cells while platelets are removed. The same™ device (Smart Autotransfusion for ME; i-SEP, France) is an innovative filtration-based autotransfusion device able to salvage both red blood cells and platelets. The authors tested the hypothesis that this new device could allow a red blood cell recovery exceeding 80% with a posttreatment hematocrit exceeding 40%, and would remove more than 90% of heparin and 75% of free hemoglobin. METHODS: Adults undergoing on-pump elective cardiac surgery were included in a noncomparative multicenter trial. The device was used intraoperatively to treat shed and residual cardiopulmonary bypass blood. The primary outcome was a composite of cell recovery performance, assessed in the device by red blood cell recovery and posttreatment hematocrit, and of biologic safety assessed in the device by the washout of heparin and free hemoglobin expressed as removal ratios. Secondary outcomes included platelet recovery and function and adverse events (clinical and device-related adverse events) up to 30 days after surgery. RESULTS: The study included 50 patients, of whom 18 (35%) underwent isolated coronary artery bypass graft, 26 (52%) valve surgery, and 6 (12%) aortic root surgery. The median red blood cell recovery per cycle was 86.1% (25th percentile to 75th percentile interquartile range, 80.8 to 91.6) with posttreatment hematocrit of 41.8% (39.7 to 44.2). Removal ratios for heparin and free hemoglobin were 98.9% (98.2 to 99.7) and 94.6% (92.7 to 96.6), respectively. No adverse device effect was reported. Median platelet recovery was 52.4% (44.2 to 60.1), with a posttreatment concentration of 116 (93 to 146) · 109/l. Platelet activation state and function, evaluated by flow cytometry, were found to be unaltered by the device. CONCLUSIONS: In this first-in-human study, the same™ device was able to simultaneously recover and wash both platelets and red blood cells. Compared with preclinical evaluations, the device achieved a higher platelet recovery of 52% with minimal platelet activation while maintaining platelet ability to be activated in vitro.
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Transfusión de Sangre Autóloga , Procedimientos Quirúrgicos Cardíacos , Adulto , Humanos , Plaquetas , Eritrocitos , Hemoglobinas , HeparinaRESUMEN
INTRODUCTION: Haemolysis and inflammation contribute to cardiac surgery-associated acute kidney injury (CS-AKI). We aimed to assess the performance of plasma haemolysis index (HI) and interleukine-6 (IL-6) for the prediction of all-stage CS-AKI. We also assessed their ability to predict moderate-to-severe CS-AKI and to discriminate persistent from transient CS-AKI. METHODS: Adult patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) were prospectively included. Haemolysis index and IL-6 were measured immediately after the end of CPB and 6 hours later. Correction for haemodilution relied upon changes in albuminaemia. Persistent CS-AKI was defined as a steady/increasing CS-AKI stage between the 48th and the 60th postoperative hour as compared with the worst stage observed within the 48 first hours. RESULTS: Among 82 patients, CS-AKI occurred in 37 (45%) patients. Postoperative HI and IL-6 were positively correlated to the duration of CPB (r ≤ 0.51, p ≤ 0.0003). Whether we considered isolated measurements of HI or IL-6, their indexation to haemodilution or not, their kinetics and/or their combination, the prediction of all stage CS-AKI was inaccurate (area under the receiver operating characteristic curve [AUCROC]≤ 0.68) whereas moderate-to-severe CS-AKI (6 patients only) was predicted with an honourable performance (AUCROC = 0.77 [95%CI 0.67;0.86] and 0.87 [95%CI 0.77;0.93] for HI and IL-6, respectively). The persistent/transient nature of CS-AKI was inaccurately predicted (AUCROC ≤ 0.68). CONCLUSIONS: In a population in which most CS-AKI cases were mild, although they frequently (41%) persisted >48 hours, CS-AKI was inaccurately predicted by HI and/or IL-6. A better performance for moderate-to-severe CS-AKI prediction is likely. These preliminary findings are yet to be validated.
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Lesión Renal Aguda , Procedimientos Quirúrgicos Cardíacos , Adulto , Humanos , Lipocalina 2 , Interleucina-6 , Proteínas Proto-Oncogénicas , Hemólisis , Proteínas de Fase Aguda , Biomarcadores , Valor Predictivo de las Pruebas , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Lesión Renal Aguda/diagnóstico , Lesión Renal Aguda/etiología , Puente Cardiopulmonar/efectos adversos , Creatinina , Complicaciones PosoperatoriasRESUMEN
INTRODUCTION: Sample freezing is a part of routine laboratory tasks because some coagulation parameters are analysed in batches to optimize reagent consumption. The coagulation parameter stability in fresh and frozen samples has been described, but data are scarcer after thawing. This study objective was to determine the stability of the main coagulation parameters (from blood withdrawn on siliconized CTAD tubes and double-centrifuged) after one freeze/thaw cycle to generate procedures for appropriate handling, storage and testing. METHODS: Prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, D-dimers, clotting factors (F), protein C, protein S, antithrombin, lupus anticoagulant (LA)-sensitive aPTT and diluted-Russel's viper venom time (dRVVT) were assessed in 60 plasma samples (n=30, normal range and n=30, outside the normal range). Thirty samples from anticoagulated patients [unfractionated heparin (UFH), low-molecular weight heparin (LMWH), apixaban or rivaroxaban] were assessed using specific anticoagulant assays. Frozen samples were thawed, and assays were performed at 15 min, 2, 4 and 6 h after thawing. The coagulation parameter stability was assessed with the method of rejection limit. RESULTS: After thawing, aPTT, PT, fibrinogen, D-dimers, FII, FV, FX, FIX, FXI, FXII, PC and UFH anti-Xa activity remained stable for at least 6 h, FVII for 5 h, PS, AT, dRVVT screen assay and LMWH anti-Xa activity for 4 h, and LA-sensitive aPTT and apixaban-specific anti-Xa activity for 3 h. FVIII, dRVVT confirm assay and rivaroxaban specific anti-Xa activity were stable for 2 h. CONCLUSION: These results suggest that sample stability for some haemostasis assays is limited after thawing.
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Síndrome Antifosfolípido , Rivaroxabán , Anticoagulantes/farmacología , Anticoagulantes/uso terapéutico , Pruebas de Coagulación Sanguínea/métodos , Fibrinógeno , Congelación , Heparina , Heparina de Bajo-Peso-Molecular , Humanos , Inhibidor de Coagulación del Lupus , Tiempo de Tromboplastina Parcial , TemperaturaRESUMEN
Idiopathic purpura fulminans (IPF) is a rare but severe prothrombotic coagulation disorder that can occur after chickenpox or human herpesvirus 6 (HHV-6) infection. IPF leads to an autoantibody-mediated decrease in the plasma concentration of protein S. We conducted a retrospective multicenter study involving patients with IPF from 13 French pediatric centers and a systematic review of cases in published literature. Eighteen patients were included in our case series, and 34 patients were included as literature review cases. The median age was 4.9 years, and the diagnostic delay after the first signs of viral infection was 7 days. The lower limbs were involved in 49 patients (94%) with typical lesions. In all, 41 patients (78%) had a recent history of varicella-zoster virus infection, and 7 patients (14%) had been infected by HHV-6. Most of the patients received heparin (n = 51; 98%) and fresh frozen plasma transfusions (n = 41; 79%); other treatment options were immunoglobulin infusion, platelet transfusion, corticosteroid therapy, plasmapheresis, and coagulation regulator concentrate infusion. The antithrombin level and platelet count at diagnosis seemed to be associated with severe complications. Given the rarity of this disease, the creation of a prospective international registry is required to consolidate these findings.
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Varicela , Púrpura Fulminante , Varicela/complicaciones , Niño , Preescolar , Diagnóstico Tardío/efectos adversos , Humanos , Estudios Multicéntricos como Asunto , Estudios Prospectivos , Proteína S , Púrpura Fulminante/diagnóstico , Púrpura Fulminante/etiología , Púrpura Fulminante/terapia , Estudios RetrospectivosRESUMEN
Argatroban is a direct anti-IIa (thrombin) anticoagulant, administered as a continuous intravenous infusion; it has been approved in many countries for the anticoagulant management of heparin-induced thrombocytopaenia (HIT). Argatroban was recently proposed as the non-heparin anticoagulant of choice for the management of patients diagnosed with Vaccine-induced Immune Thrombotic Thrombocytopaenia (VITT). Immunoglobulins are also promptly intravenously administered in order to rapidly improve platelet count; concomitant therapy with steroids is also often considered. An ad hoc committee of the French Working Group on Haemostasis and Thrombosis members has worked on updated and detailed proposals regarding the management of anticoagulation with argatroban, based on previously released guidance for HIT, and adapted for VITT. In case of VITT, the initial dose to be preferred is 1.0 µg × kg-1 × min-1, with further dose-adjustments based on iterative and frequent clinical and laboratory assessments. It is strongly advised to involve a health practitioner experienced in the management of difficult cases in haemostasis. The first laboratory assessment should be performed 4 h after the initiation of argatroban infusion, with further controls at 2-4-h intervals until steady state, and at least once daily thereafter. Importantly, full anticoagulation should be rapidly achieved in case of widespread thrombosis. Cerebral vein thrombosis (which is typical of VITT) should not call for an overly cautious anticoagulation scheme. Argatroban administration requires baseline laboratory assessment and should rely on an anti-IIa assay to derive argatroban plasma levels using a dedicated calibration, with a target range between 0.5 and 1.5 µg/mL. Target argatroban plasma levels can be refined based on meticulous appraisal of risk factors for bleeding and thrombosis, on frequent reassessments of clinical status with appropriate vascular imaging, and on the changes in daily platelet counts. Regarding the use of aPTT, baseline value and possible causes for alterations of the clotting time must be taken into account. Specifically, in case of VITT, an aPTT ratio (patient's/mean normal clotting time) between 1.5 and 2.5 is suggested, to be refined according to the sensitivity of the reagent to the effect of a direct thrombin inhibitor. The sole use of aPTT is discouraged: one has to resort to a periodical check with an anti-IIa assay at least, with the help of a specialised laboratory if necessary. Dose modifications should proceed in a stepwise manner with 0.1 to 0.2 µg × kg-1 × min-1 up- or downward changes, taking into account the initial dose, laboratory results, and the whole individual setting. Nomograms are available to adjust the infusion rate. Haemoglobin level, platelet count, fibrinogen plasma level and liver tests should be periodically checked, depending on the clinical status, the more so when unstable.
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Trombocitopenia , Trombosis , Vacunas , Arginina/análogos & derivados , Humanos , Ácidos Pipecólicos , Sulfonamidas , Trombocitopenia/inducido químicamente , Trombocitopenia/terapiaRESUMEN
BACKGROUND: Despite their usefulness in perioperative and acute care settings, factor-Xa inhibitor-specific assays are scarcely available, contrary to heparin anti-Xa assay. We assessed whether the heparin anti-Xa assay can (1) be used as a screening test to rule out apixaban, rivaroxaban, fondaparinux, and danaparoid levels that contraindicate invasive procedures according to current guidelines (>30 ng·mL-1, >30 ng·mL-1, >0.1 µg·mL-1, and >0.1 IU·mL-1, respectively), (2) quantify the anticoagulant level if found significant, that is, if it exceeded the abovementioned threshold. METHODS: In the derivation cohort then in the validation cohort, via receiver operating characteristics (ROC) curve analysis, we evaluated the ability of heparin anti-Xa assay to detect levels of factor-Xa inhibitors above or below the abovementioned safety thresholds recommended for an invasive procedure (screening test). Among samples with relevant levels of factor-Xa inhibitor, we determined the conversion factor linking the measured level and heparin anti-Xa activity in a derivation cohort. In a validation cohort, the estimated level of each factor-Xa inhibitor was thus inferred from heparin anti-Xa activity. The agreement between measured and estimated levels of factor-Xa inhibitors was assessed. RESULTS: Among 989 (355 patients) and 756 blood samples (420 patients) in the derivation and validation cohort, there was a strong linear relationship between heparin anti-Xa activities and factor-Xa inhibitors measured level (r = 0.99 [95% confidence interval {CI}, 0.99-0.99]). In the derivation cohort, heparin anti-Xa activity ≤0.2, ≤0.3, <0.1, <0.1 IU·mL-1 reliably ruled out a relevant level of apixaban, rivaroxaban, fondaparinux, and danaparoid, respectively (area under the ROC curve ≥0.99). In the validation cohort, these cutoffs yielded excellent classification accuracy (≥96%). If this screening test indicated relevant level of factor-Xa inhibitor, estimated and measured levels closely agreed (Lin's correlation coefficient close to its maximal value: 95% CI, 0.99-0.99). More than 96% of the estimated levels fell into the predefined range of acceptability (ie, 80%-120% of the measured level). CONCLUSIONS: A unique simple test already widely used to assay heparin was also useful for quantifying these 4 other anticoagulants. Both clinical and economic impacts of these findings should be assessed in a specific study.
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Pruebas de Coagulación Sanguínea , Coagulación Sanguínea/efectos de los fármacos , Sulfatos de Condroitina/sangre , Dermatán Sulfato/sangre , Monitoreo de Drogas , Inhibidores del Factor Xa/sangre , Fondaparinux/sangre , Heparitina Sulfato/sangre , Pirazoles/sangre , Piridonas/sangre , Rivaroxabán/sangre , Francia , Humanos , Valor Predictivo de las Pruebas , Reproducibilidad de los Resultados , Estudios RetrospectivosAsunto(s)
Eritrocitos/parasitología , Trasplante de Pulmón/efectos adversos , Malaria/transmisión , Plasmodium ovale/aislamiento & purificación , Enfermedad Relacionada con los Viajes , África , Diagnóstico Precoz , Femenino , Humanos , Huésped Inmunocomprometido , Trasplante de Hígado/efectos adversos , Malaria/sangre , Masculino , Persona de Mediana Edad , Enfermedad Pulmonar Obstructiva Crónica/cirugía , Enfisema Pulmonar/cirugía , Donantes de TejidosRESUMEN
Mechanical thrombectomy (MT) is one of the main treatments for acute ischemic stroke (AIS) in patients on effective anticoagulation. The use of direct oral anticoagulants (DOA) has increased, given their efficacy and safety profile compared to vitamin K antagonists (VKA). We compared procedural and clinical outcomes of MT in patients on DOA and VKA treatment before stroke onset. We analyzed 2 groups from the Endovascular Treatment in Ischemic Stroke prospective registry: patients on DOA and patients on VKA treated by MT without thrombolysis. Generalized linear mixed models including center as random effect were used to compare angiographic (rates of reperfusion at end of procedure, number of passes >2, procedural complications) and clinical (favorable and excellent outcome, 90-day all-cause mortality, and hemorrhagic complications) outcomes according to anticoagulation subgroups. Comparisons were adjusted for prespecified confounders (age, admission NIH Stroke Scale score) as well as for meaningful baseline between-group differences. Among 221 patients included, more DOA-treated patients (n = 115, 52%) achieved successful (modified Thrombolysis in Cerebral Infarction score [mTICI] 2b/3) or near complete (mTICI 2c/3) reperfusion at the procedure end than did VKA-treated patients, with an adjusted odds ratio (OR) for DOA vs VKA of 3.27 (95% confidence interval [CI], 1.40-7.65) and 2.00 (95% CI, 1.08-3.73), respectively. DOA-treated patients had a lower 90-day mortality risk with an adjusted OR of 0.47 (95% CI, 0.24-0.89) and a better excellent outcome OR of 2.40 (1.10-5.27). There was no significant between-group difference in hemorrhagic or procedural complications. The study highlights the benefits of DOA compared to VKA. Regarding mortality, excellent outcomes, and recanalization rate, DOA appears to provide a favorable setting for MT treatment in AIS.
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Anticoagulantes/uso terapéutico , Hemorragia/epidemiología , Accidente Cerebrovascular/tratamiento farmacológico , Trombectomía/estadística & datos numéricos , Vitamina K/antagonistas & inhibidores , Anciano , Anticoagulantes/efectos adversos , Dabigatrán/efectos adversos , Dabigatrán/uso terapéutico , Femenino , Humanos , Masculino , Pirazoles/efectos adversos , Pirazoles/uso terapéutico , Piridonas/efectos adversos , Piridonas/uso terapéutico , Sistema de Registros , Reperfusión/estadística & datos numéricos , Rivaroxabán/efectos adversos , Rivaroxabán/uso terapéutico , Accidente Cerebrovascular/mortalidad , Accidente Cerebrovascular/cirugía , Resultado del TratamientoRESUMEN
INTRODUCTION: During cardiac surgery-associated bleeding, the early detection of coagulopathy is crucial. However, owing to time constraints or lack of suitable laboratory tests, transfusion of haemostatic products is often inappropriately triggered, either too late (exposing to prolonged bleeding and thus to avoidable administration of blood products) or blindly to the coagulation status (exposing to unnecessary haemostatic products administration in patients with no coagulopathy). Undue exposition to transfusion risks and additional healthcare costs may arise. With the perspective of secondary care-related costs, the IMOTEC study (Intérêt MédicO-économique de la Thrombo-Elastographie, dans le management transfusionnel des hémorragies péri-opératoires de chirurgies Cardiaques sous circulation extracorporelle) aims at assessing the cost-effectiveness of a point-of-care viscoelastic haemostatic assay (VHA: RoTem or TEG)-guided management of bleeding. Among several outcome measures, particular emphasis will be put on quality of life with a 1-year follow-up. METHODS AND ANALYSIS: This is a multicentre, prospective, pragmatic study with stepped-wedge cluster randomised controlled design. Over a 36-month period (24 months of enrolment and 12 months of follow-up), 1000 adult patients undergoing cardiac surgery with cardiopulmonary bypass will be included if a periprocedural significant bleeding occurs. The primary outcome is the cost-effectiveness of a VHA-guided algorithm over a 1-year follow-up, including patients' quality of life. Secondary outcomes are the cost-effectiveness of the VHA-guided algorithm with regard to the rate of surgical reexploration and 1-year mortality, its cost per-patient, its effectiveness with regard to haemorrhagic, infectious, renal, neurological, cardiac, circulatory, thrombotic, embolic complications, transfusion requirements, mechanical ventilation free-days, duration of intensive care unit and in-hospital stay and mortality. ETHICS AND DISSEMINATION: The study was registered at Clinicaltrials.gov and was approved by the Committee for the Protection of Persons of Nantes University Hospital, The French Advisory Board on Medical Research Data Processing and the French Personal Data Protection Authority. A publication of the results in a peer-reviewed journal is planned. TRIAL REGISTRATION NUMBER: NCT02972684; Pre-results.
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Trastornos de la Coagulación Sanguínea/economía , Procedimientos Quirúrgicos Cardíacos/educación , Sistemas de Atención de Punto/economía , Pruebas en el Punto de Atención/economía , Hemorragia Posoperatoria/terapia , Tromboelastografía/economía , Trastornos de la Coagulación Sanguínea/terapia , Transfusión Sanguínea/economía , Toma de Decisiones Clínicas , Análisis Costo-Beneficio , Humanos , Sistemas de Atención de Punto/organización & administración , Ensayos Clínicos Pragmáticos como Asunto , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como AsuntoAsunto(s)
Recolección de Muestras de Sangre/métodos , Monitoreo de Drogas/métodos , Inhibidores del Factor Xa/sangre , Factor Xa/análisis , Pirazoles/sangre , Piridonas/sangre , Rivaroxabán/sangre , Temperatura , Administración Oral , Estabilidad de Medicamentos , Inhibidores del Factor Xa/administración & dosificación , Francia , Humanos , Valor Predictivo de las Pruebas , Estabilidad Proteica , Pirazoles/administración & dosificación , Piridonas/administración & dosificación , Reproducibilidad de los Resultados , Rivaroxabán/administración & dosificación , Factores de TiempoRESUMEN
The SFBC Working Group on critical care testing describes in this paper the SFBC recommendations for the determination of maximal turnaround times (TAT) for laboratory medicine examination in emergency conditions. The table presented in a previous paper was updated, taken into account the clinical situations, as well as the emergency response capabilities of the medical laboratory. These new French recommendations must to be based to each local situation in a clinical-biological context between the physicians and the specialist in Lab Medicine.
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Cuidados Críticos , Ciencia del Laboratorio Clínico/normas , Pruebas en el Punto de Atención/normas , Práctica Profesional/normas , Acreditación , Cuidados Críticos/clasificación , Cuidados Críticos/métodos , Cuidados Críticos/organización & administración , Cuidados Críticos/normas , Urgencias Médicas/clasificación , Francia , Humanos , Ciencia del Laboratorio Clínico/organización & administración , Sociedades Médicas/normasRESUMEN
BACKGROUND: The electro-hydraulically actuated Carmat total artificial heart (C-TAH) is designed to replace the heart in patients with end-stage heart failure, either as bridge to transplant or destination therapy. It provides pulsatile flow and contains bio-prosthetic blood contacting materials. A clinical feasibility study was conducted to evaluate the C-TAH safety and performance. METHODS: Hospitalized patients, at imminent risk of death from irreversible biventricular failure despite optimal medical management, and not eligible for transplant or eligible but on extracorporeal life support, were enrolled. The primary endpoint was 30-days survival. RESULTS: Four patients were implanted with the C-TAH, three as destination therapy (ages 76, 68, 74) and one as bridge to transplant (age 58). They had implant times of 74, 270, 254 and 20 days respectively. All patients were free from hemolysis, clinical neurologic events, clinical evidence of thrombus and device-related infections. Hemodynamic and physical recovery allowed two patients to be discharged home for a cumulative duration of 7 months. The anticoagulation management strategy comprised initial unfractionated heparin, from postoperative day 2, followed by low molecular weight heparin and aspirin. An increased D-dimer level was observed in all patients during months 1 to 4. Temporary suspension of heparin anticoagulation resulted in thrombocytopenia and increased fibrin monomer, reversed by resuming anticoagulation with heparin. Causes of death were device-related (2 cases), respiratory failure and multi-organ failure. CONCLUSIONS: Preliminary clinical results with the C-TAH demonstrated good safety and performance profiles in patients suffering from biventricular failure, which need to be confirmed in a pivotal study.
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Bioprótesis , Insuficiencia Cardíaca/cirugía , Corazón Artificial , Anciano , Bioprótesis/efectos adversos , Estudios de Factibilidad , Insuficiencia Cardíaca/mortalidad , Corazón Artificial/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Proyectos Piloto , Diseño de Prótesis , Índice de Severidad de la Enfermedad , Tasa de SupervivenciaRESUMEN
SFBC working group on critical care testing describes in this paper guideline for the management of laboratory medicine examination process in emergency conditions. After a summary on French standards and regulations, the critical care testing perimeter and definitions of stat levels are presented in different contexts. The complete examination process is described. Guidelines are proposed for each step, to manage sub-process in a risk management approach. The following steps were studied: ordering (by specialties), sampling, transport, reception, analysis, validation and release. In summary, we proposed a list of examinations allowed to be prescribed in stat conditions with a short list and complementary tests as a function of clinical setting. These guidelines need to be adapted in clinicobiological contracts.
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Técnicas de Laboratorio Clínico/normas , Cuidados Críticos , Manejo de Especímenes/normas , Acreditación , Técnicas de Laboratorio Clínico/métodos , Cuidados Críticos/legislación & jurisprudencia , Cuidados Críticos/métodos , Cuidados Críticos/normas , Urgencias Médicas , Servicios Médicos de Urgencia/legislación & jurisprudencia , Servicios Médicos de Urgencia/normas , Francia , Humanos , Gestión de Riesgos/legislación & jurisprudencia , Gestión de Riesgos/normasRESUMEN
BACKGROUND: The development of artificial hearts in patients with end-stage heart disease have been confronted with the major issues of thromboembolism or haemorrhage. Since valvular bioprostheses are associated with a low incidence of these complications, we decided to use bioprosthetic materials in the construction of a novel artificial heart (C-TAH). We report here the device characteristics and its first clinical applications in two patients with end-stage dilated cardiomyopathy. The aim of the study was to evaluate safety and feasibility of the CARMAT TAH for patients at imminent risk of death from biventricular heart failure and not eligible for transplant. METHODS: The C-TAH is an implantable electro-hydraulically actuated pulsatile biventricular pump. All components, batteries excepted, are embodied in a single device positioned in the pericardial sac after excision of the native ventricles. We selected patients admitted to hospital who were at imminent risk of death, having irreversible biventricular failure, and not eligible for heart transplantation, from three cardiac surgery centres in France. FINDINGS: The C-TAH was implanted in two male patients. Patient 1, aged 76 years, had the C-TAH implantation on Dec 18, 2013; patient 2, aged 68 years, had the implantation on Aug 5, 2014. The cardiopulmonary bypass times for C-TAH implantation were 170 min for patient 1 and 157 min for patient 2. Both patients were extubated within the first 12 postoperative hours and had a rapid recovery of their respiratory and circulatory functions as well as a normal mental status. Patient 1 presented with a tamponade on day 23 requiring re-intervention. Postoperative bleeding disorders prompted anticoagulant discontinuation. The C-TAH functioned well with a cardiac output of 4·8-5·8 L/min. On day 74, the patient died due to a device failure. Autopsy did not detect any relevant thrombus formation within the bioprosthesis nor the different organs, despite a 50-day anticoagulant-free period. Patient 2 experienced a transient period of renal failure and a pericardial effusion requiring drainage, but otherwise uneventful postoperative course. He was discharged from the hospital on day 150 after surgery with a wearable system without technical assistance. After 4 months at home, the patient suffered low cardiac output. A change of C-TAH was attempted but the patient died of multiorgan failure. INTERPRETATION: This preliminary experience could represent an important contribution to the development of total artificial hearts using bioprosthetic materials. FUNDING: CARMAT SA.