Effect of a national guideline on postoperative troponin surveillance: a retrospective cohort study.

PURPOSE: We aimed to evaluate the effect of the 2017 Canadian Cardiovascular Society (CCS) guidelines on troponin surveillance after noncardiac surgery. METHODS: This was a single-centre, retrospective, observational study. Patients aged 40 yr or older undergoing intermediate- to high-risk elective noncardiac surgery between 2016 and 2021 were included. We compared the number and percentage of troponin tests ordered before and after the guidelines were published and compared patient characteristics, specifically cardiovascular comorbidity, using odds ratio's (OR) with 95% confidence intervals (CIs). Outcomes were myocardial injury, myocardial infarction (MI), and in-hospital mortality. RESULTS: The cohort included 36,386 patients and the median age was 63 yr. Between 2016 and 2018, troponin surveillance was done in 2,461 (13%) of the 19,046 patients, compared with 2,398 (14%) of the 17,340 patients who had surgery between 2019 and 2021 (OR, 1.08; 95% CI, 1.02 to 1.15). Patients who had surgery in the second period had less cardiovascular comorbidity; the adjusted OR for troponin surveillance was 1.14 (95% CI, 1.07 to 1.21). In the two periods, troponin was elevated in 561 (2.9%) and 470 (2.7%) patients, an MI was documented in 54 (0.3%) and 36 (0.2%) patients, and 95 (0.5%) and 73 (0.4%) patients died, respectively. After adjustment for baseline differences in the two periods, the ORs for MI and mortality were 0.83 (95% CI, 0.54 to 1.27) and 0.88 (95% CI, 0.64 to 1.19), respectively. CONCLUSION: Although the odds of troponin ordering were slightly but significantly higher after publication of the CCS guidelines, the odds for detecting an MI and for mortality did not change.

RéSUMé: OBJECTIF: Notre objectif était d'évaluer l'effet des lignes directrices 2017 de la Société canadienne de cardiologie (SCC) sur le monitorage de la troponine après une chirurgie non cardiaque. MéTHODE: Il s'agissait d'une étude observationnelle rétrospective monocentrique. Les patient·es âgé·es de 40 ans ou plus bénéficiant d'une chirurgie non cardiaque non urgente à risque intermédiaire à élevé entre 2016 et 2021 ont été inclus·es. Nous avons comparé le nombre et le pourcentage de tests de troponine prescrits avant et après la publication des lignes directrices et comparé les caractéristiques des patient·es, en particulier la comorbidité cardiovasculaire, en utilisant le rapport de cotes (RC) avec des intervalles de confiance (IC) à 95 %. Les critères d'évaluation comprenaient les lésions myocardiques, l'infarctus du myocarde (IM) et la mortalité hospitalière. RéSULTATS: La cohorte comprenait 36 386 personnes et l'âge médian était de 63 ans. Entre 2016 et 2018, le monitorage de la troponine a été réalisé chez 2461 (13 %) des 19 046 patient·es, contre 2398 (14 %) des 17 340 patient·es opéré·es entre 2019 et 2021 (RC, 1,08; IC 95%, 1,02 à 1,15). Les patient·es qui ont bénéficié d'une intervention chirurgicale au cours de la deuxième période présentaient moins de comorbidité cardiovasculaire; le RC ajusté pour le monitorage de la troponine était de 1,14 (IC 95 %, 1,07 à 1,21). Au cours des deux périodes, la troponine était élevée chez 561 (2,9 %) et 470 (2,7 %) patient·es, un IM a été documenté chez 54 (0,3 %) et 36 (0,2 %) patient·es, et 95 (0,5 %) et 73 (0,4 %) patient·es sont décédé·es, respectivement. Après ajustement pour tenir compte des différences initiales au cours des deux périodes, les RC pour l'IM et la mortalité étaient de 0,83 (IC 95 %, 0,54 à 1,27) et de 0,88 (IC 95 %, 0,64 à 1,19), respectivement. CONCLUSION: Bien que les probabilités de commande de troponine aient été légèrement mais significativement plus élevées après la publication des lignes directrices de la SCC, les probabilités de détection d'un IM et de mortalité n'ont pas changé.

Postoperative anemia in cardiac surgery patients: a narrative review.

PURPOSE: Anemia reduces the blood's ability to carry and deliver oxygen. Following cardiac surgery, anemia is very common and affects up to 90% of patients. Nevertheless, there is a paucity of data examining the prognostic value of postoperative anemia. In this narrative review, we present findings from the relevant literature on postoperative anemia in cardiac surgery patients, focusing on the incidence, risk factors, and prognostic value of postoperative anemia. We also explore the potential utility of postoperative anemia as a therapeutic target to improve clinical outcomes. SOURCE: We conducted a targeted search of MEDLINE, Embase, and the Cochrane Database of Systematic Reviews up to September 2022, using a combination of search terms including postoperative (post-operative), perioperative (peri-operative), anemia (anaemia), and cardiac surgery. PRINCIPAL FINDINGS: The reported incidence of postoperative anemia varied from 29% to 94% across the studies, likely because of variations in patient inclusion criteria and classification of postoperative anemia. Nonetheless, the weight of the evidence suggests that postoperative anemia is common and is an independent risk factor for adverse postoperative outcomes such as acute kidney injury, stroke, mortality, and functional outcomes. CONCLUSIONS: In cardiac surgery patients, postoperative anemia is a common and prognostically important risk factor for postoperative morbidity and mortality. Nevertheless, there is a lack of data on whether active management of postoperative anemia is feasible or effective in improving patient outcomes.

RéSUMé: OBJECTIF: L'anémie réduit la capacité du sang à transporter et à fournir de l'oxygène. Suite à une chirurgie cardiaque, l'anémie est très fréquente et touche jusqu'à 90 % des patient·es. Néanmoins, il existe peu de données examinant la valeur pronostique de l'anémie postopératoire. Dans ce compte rendu narratif, nous présentons les résultats de la littérature pertinente sur l'anémie postopératoire chez les patient·es ayant bénéficié d'une chirurgie cardiaque, en mettant l'accent sur l'incidence, les facteurs de risque et la valeur pronostique de l'anémie postopératoire chez les personnes ayant bénéficié d'une chirurgie cardiaque. Nous explorons également l'utilité potentielle de l'anémie postopératoire en tant que cible thérapeutique pour améliorer les devenirs cliniques. SOURCES: Nous avons réalisé une recherche ciblée dans MEDLINE, Embase et la base de données des revues systématiques Cochrane jusqu'en septembre 2022, en utilisant une combinaison de termes de recherche, notamment postopératoire (postoperative/post-operative), périopératoire (perioperative/peri-operative), anémie (anemia/anaemia) et chirurgie cardiaque (cardiac surgery). CONSTATATIONS PRINCIPALES: L'incidence rapportée de l'anémie postopératoire variait de 29 % à 94 % d'une étude à l'autre, probablement en raison des variations dans les critères d'inclusion des patient·es et la classification de l'anémie postopératoire. Néanmoins, le poids de la preuve suggère que l'anémie postopératoire est courante et constitue un facteur de risque indépendant pour les devenirs postopératoires indésirables tels que l'insuffisance rénale aiguë, les accidents vasculaires cérébraux, la mortalité et les devenirs fonctionnels. CONCLUSION: Chez la patientèle en chirurgie cardiaque, l'anémie postopératoire est un facteur de risque commun et pronostiquement important de morbidité et de mortalité postopératoires. Néanmoins, il y a un manque de données sur la faisabilité ou l'efficacité de la prise en charge active de l'anémie postopératoire pour améliorer les devenirs des patient·es.

Cold-stored platelets for acute bleeding in cardiac surgical patients: a narrative review.

PURPOSE: Cold-stored platelets (CSP) are an increasingly active topic of international research. They are maintained at 1-6 °C, in contrast to standard room-temperature platelets (RTP) kept at 20-24 °C. Recent evidence suggests that CSP have superior hemostatic properties compared with RTP. This narrative review explores the application of CSP in adult cardiac surgery, summarizes the preclinical and clinical evidence for their use, and highlights recent research. SOURCE: A targeted search of MEDLINE and other databases up to 24 February 2022 was conducted. Search terms combined concepts such as cardiac surgery, blood, platelet, and cold-stored. Searches of trial registries ClinicalTrials.gov and WHO International Clinical Trials Registry Platform were included. Articles were included if they described adult surgical patients as their population of interest and an association between CSP and clinical outcomes. References of included articles were hand searched. PRINCIPAL FINDINGS: When platelets are stored at 1-6 °C, their metabolic rate is slowed, preserving hemostatic function for increased storage duration. Cold-stored platelets have superior adhesion characteristics under physiologic shear conditions, and similar or superior aggregation responses to physiologic agonists. Cold-stored platelets undergo structural, metabolic, and molecular changes which appear to "prime" them for hemostatic activity. While preliminary, clinical evidence supports the conduct of trials comparing CSP with RTP for patients with platelet-related bleeding, such as those undergoing cardiac surgery. CONCLUSION: Cold-stored platelets may have several advantages over RTP, including increased hemostatic capacity, extended shelf-life, and reduced risk of bacterial contamination. Large clinical trials are needed to establish their potential role in the treatment of acutely bleeding patients.

RéSUMé: OBJECTIF: Les plaquettes conservées au froid (PCF) sont un sujet de recherche internationale de plus en plus populaire. Ces plaquettes sont maintenues à une température de 1-6 °C, contrairement aux plaquettes standard conservées à température ambiante (PTA), maintenues à 20­24 °C. Des données probantes récentes suggèrent que les PCF ont des propriétés hémostatiques supérieures aux PTA. Ce compte rendu narratif explore l'application de PCF en chirurgie cardiaque chez l'adulte, résume les données probantes précliniques et cliniques de leur utilisation, et met en évidence les recherches récentes. SOURCES: Une recherche ciblée dans MEDLINE et d'autres bases de données jusqu'au 24 février 2022 a été effectuée. Les termes de recherche combinaient des concepts en anglais tels que cardiac surgery, blood, platelet et cold-stored (soit chirurgie cardiaque, plaquette, et entreposage frigorifique). Des recherches dans les registres d'études ClinicalTrials.gov et le système d'enregistrement international des essais cliniques (ICTRP) de l'OMS ont été incluses. Les articles ont été inclus s'ils décrivaient des patient·es adultes de chirurgie en tant que population d'intérêt et une association entre les PCF et les issues cliniques. Les références des articles inclus ont fait l'objet d'une recherche manuelle. CONSTATATIONS PRINCIPALES: Lorsque les plaquettes sont conservées entre 1 et 6 °C, leur taux métabolique est ralenti, préservant la fonction hémostatique pour une durée d'entreposage accrue. Les plaquettes conservées au froid ont des caractéristiques d'adhésion supérieures dans des conditions de cisaillement physiologique et des réponses d'agrégation similaires ou supérieures aux agonistes physiologiques. Les plaquettes conservées au froid subissent des changements structurels, métaboliques et moléculaires qui semblent les « amorcer ¼ pour une activité hémostatique. Bien que préliminaires, les données probantes cliniques appuient la réalisation d'études comparant les PCF aux PTA chez la patientèle présentant des saignements liés aux plaquettes, tels que les personnes bénéficiant d'une chirurgie cardiaque. CONCLUSION: Les plaquettes conservées au froid peuvent présenter plusieurs avantages par rapport aux PTA, notamment une capacité hémostatique accrue, une durée de conservation prolongée et un risque réduit de contamination bactérienne. De grands essais cliniques sont nécessaires pour établir leur rôle potentiel dans le traitement de la patientèle en hémorragie aiguë.

A multidisciplinary comparison of transfusion and perioperative support for high-risk cardiac surgery at three large academic centres in North America.

Cardiac surgery is associated with numerous peri- and post-operative haemostatic complications and blood transfusion requirements. Complex procedures such as redo-sternotomy heart transplantation or type A aortic dissection repairs are at high-risk for severe coagulopathy and significant transfusion requirements. However, current practice guidelines do not specifically address high-risk surgeries, resulting in variable practice. To optimise outcomes, a multidisciplinary approach to blood transfusion and haemostasis is critical. How individual institutions construct these multidisciplinary teams, delegate responsibilities, and build procedures may differ depending on the institution and availability of resources. In this article, we compare how the transfusion medicine services support their cardiac surgery and transplant programs at three large medical centres-Vanderbilt University Medical Center (the largest heart transplant centre in the world by volume in 2021), Toronto General Hospital-University Health Network (a quaternary-care centre in Canada's most populous city, performing more >20 heart transplants annually), and Vancouver General Hospital (a quaternary-care centre that performs numerous high-risk cardiac surgeries). This article discusses management from multiple perspectives, including the blood bank and perioperative environments, and highlights how institutions have evolved their programs in accordance with nation-specific policies and provisions.

Complications of Factor V Leiden in Adults Undergoing Noncardiac Surgical Procedures: A Systematic Review.

Factor V Leiden is the commonest hereditary prothrombotic allele, affecting 1% to 5% of the world's population. The objective of this study was to characterize the perioperative and postoperative outcomes of patients with Factor V Leiden compared to patients without a diagnosis of hereditary thrombophilia. This was a focused systematic review of studies including adult (>18 years) patients with Factor V Leiden (heterozygous or homozygous) undergoing noncardiac surgery. Included studies were either randomized controlled trials or observational. The primary clinical outcomes of interest were thromboembolic events occurring from the perioperative period up to 1 year postoperatively, defined as deep venous thrombosis, pulmonary embolism, or other clinically significant thrombosis occurring during or after a surgical procedure. Secondary outcomes included cerebrovascular events, cardiac events, death, transplant-related outcomes, and surgery-specific morbidity. Pediatric and obstetrical patients were excluded, as were case reports and case series. Databases searched included MEDLINE and EMBASE from inception until August 2021. Study bias was assessed through the CLARITY (Collaboration of McMaster University researchers) Risk of Bias tools, and heterogeneity through analysis of study design and end points, as well as the I 2 statistic with its confidence interval and the Q statistic. A total of 5275 potentially relevant studies were identified, with 115 having full text assessed for eligibility and 32 included in the systematic review. On the whole, the literature suggests that patients with Factor V Leiden have an increased risk of perioperative and postoperative thromboembolic events compared to patients without the diagnosis. Increased risk was also seen in relation to surgery-specific morbidity and transplant-related outcomes, particularly arterial thrombotic events. The literature did not support an increased risk for mortality, cerebrovascular, or cardiac complications. Limitations of the data include predisposition toward bias due in many study designs and small sample sizes across the majority of published studies. Variable outcome definitions and durations of patient follow-up across different surgical procedures resulted in high study heterogeneity precluding the effective use of meta-analysis. Factor V Leiden status may confer additional risk for surgery-related adverse outcomes. Large, adequately powered studies are required to accurately estimate the degree of this risk by zygosity.

Cost-effectiveness of Fibrinogen Concentrate vs Cryoprecipitate for Treating Acquired Hypofibrinogenemia in Bleeding Adult Cardiac Surgical Patients.

Importance: Excessive bleeding requiring fibrinogen replacement is a serious complication of cardiac surgery. However, the relative cost-effectiveness of the 2 available therapies-fibrinogen concentrate and cryoprecipitate-is unknown. Objective: To determine cost-effectiveness of fibrinogen concentrate vs cryoprecipitate for managing active bleeding in adult patients who underwent cardiac surgery. Design, Setting, and Participants: A within-trial economic evaluation of the Fibrinogen Replenishment in Surgery (FIBERS) randomized clinical trial (February 2017 to November 2018) that took place at 4 hospitals based in Ontario, Canada, hospitals examined all in-hospital resource utilization costs and allogeneic blood product (ABP) transfusion costs incurred within 28 days of surgery. Participants included a subset of 495 adult patients from the FIBERS trial who underwent cardiac surgery and developed active bleeding and acquired hypofibrinogenemia requiring fibrinogen replacement. Interventions: Fibrinogen concentrate (4 g per dose) or cryoprecipitate (10 units per dose) randomized (1:1) up to 24 hours postcardiopulmonary bypass. Main Outcomes and Measures: Effectiveness outcomes included number of ABPs administered within 24 hours and 7 days of cardiopulmonary bypass. ABP transfusion (7-day) and in-hospital resource utilization (28-day) costs were evaluated and a multivariable net benefit regression model built for the full sample and predefined subgroups. Results: Patient level costs for 495 patients were evaluated (mean [SD] age 59.2 [15.4] years and 69.3% male.) Consistent with FIBERS, ABP transfusions and adverse events were similar in both treatment groups. Median (IQR) total 7-day ABP cost was CAD $2280 (US dollars [USD] $1697) (CAD $930 [USD $692]-CAD $4970 [USD $3701]) in the fibrinogen concentrate group and CAD $2770 (USD $1690) (IQR, CAD $1140 [USD $849]-CAD $5000 [USD $3723]) in the cryoprecipitate group. Median (interquartile range) total 28-day cost was CAD $38 180 (USD $28 431) $(IQR, CAD $26 350 [USD $19 622]-CAD $65 080 [USD $48 463]) in the fibrinogen concentrate group and CAD $38 790 (USD $28 886) (IQR, CAD $26 180 [USD $19 495]-CAD $70 380 [USD $52 409]) in the cryoprecipitate group. After exclusion of patients who were critically ill before surgery (11%) due to substantial variability in costs, the incremental net benefit of fibrinogen concentrate vs cryoprecipitate was positive (probability of being cost-effective 86% and 97% at $0 and CAD $2000 (USD $1489) willingness-to-pay, respectively). Net benefit was highly uncertain for nonelective and patients with critical illness. Conclusions and Relevance: Fibrinogen concentrate is cost-effective when compared with cryoprecipitate in most bleeding adult patients who underwent cardiac surgery with acquired hypofibrinogenemia requiring fibrinogen replacement. The generalizability of these findings outside the Canadian health system needs to be verified.

Improved Re-estimation of Perioperative Cardiac Risk Using the Surgical Apgar Score: A Retrospective Cohort Study.

OBJECTIVE: To assess whether the Surgical Apgar Score (SAS) improves re-estimation of perioperative cardiac risk. BACKGROUND: The SAS is a novel risk index that integrates three relevant and easily measurable intraoperative parameters (blood loss, heart rate, mean arterial pressure) to predict outcomes. The incremental prognostic value of the SAS when used in combination with standard preoperative risk indices is unclear. METHODS: We conducted a retrospective cohort study of adults (18 years and older) who underwent elective noncardiac surgery at a quaternary care hospital in Canada (2009-2014). The primary outcome was postoperative acute myocardial injury. The SAS (range 0-10) was calculated based on intraoperative estimated blood loss, lowest mean arterial pressure, and lowest heart rate documented in electronic medical records. Incremental prognostic value of the SAS when combined with the Revised Cardiac Risk Index was assessed based on discrimination (c-statistic), reclassification (integrated discrimination improvement, net reclassification index), and clinical utility (decision curve analysis). RESULTS: The cohort included 16,835 patients, of whom 607 (3.6%) patients had acute postoperative myocardial injury. Addition of the SAS to the Revised Cardiac Risk Index improved risk estimation based on the integrated discrimination improvement [2.0%; 95% confidence interval (CI): 1.5%-2.4%], continuous net reclassification index (54%; 95% CI: 46%-62%), and c-index, which increased from 0.68 (95% CI: 0.65-0.70) to 0.75 (95% CI: 0.73-0.77). On decision curve analysis, addition of the SAS to the Revised Cardiac Risk Index resulted in a higher net benefit at all decision thresholds. CONCLUSIONS: When combined with a validated preoperative risk index, the SAS improved the accuracy of cardiac risk assessment for noncardiac surgery. Further research is needed to delineate how intraoperative data can better guide postoperative decision-making.

Practice patterns of ABO-matching for cryoprecipitate and patient outcomes after ABO-compatible versus incompatible cryoprecipitate.

BACKGROUND AND OBJECTIVES: This sub-study of the FIBRES trial sought to examine the patterns of ABO-compatible cryoprecipitate administration and to identify adverse consequences of ABO-incompatible cryoprecipitate. MATERIALS AND METHODS: This was a post hoc analysis of data collected from the FIBRES randomized clinical trial comparing fibrinogen concentrate with cryoprecipitate in the treatment of bleeding related to hypofibrinogenemia after cardiac surgery. The primary outcome was the percentage of administered cryoprecipitate that was ABO-compatible. Secondary outcomes were adverse events at 28 days. A follow-up survey was distributed to the FIBRES participating sites to examine the rationale behind the identified cryoprecipitate ABO-matching practice patterns. RESULTS: A total of 363 patients were included: 53 (15%) received ABO-incompatible cryoprecipitate and 310 (85%) received ABO-compatible cryoprecipitate. There was an increased incidence of post-operative anaemia in the ABO-incompatible group (15; 28.3%) in comparison to the ABO-compatible (44; 14.2%) group (p = 0.01) at 28 days, which was unrelated to haemolysis, without a significant difference in transfusion requirement. In the multivariable logistic regression models accounting for clustering by site, there was no observed statistically significant association between the administration of ABO-incompatible cryoprecipitate and any other adverse outcomes. Nine out of 11 sites did not have a policy requiring ABO-matched cryoprecipitate. CONCLUSION: This sub-study demonstrated that most cryoprecipitate administered in practice is ABO-compatible, despite the absence of guidelines or blood bank policies to support this practice. A signal towards increased risk of post-operative anaemia may be explained by higher rates of urgent surgery (vs. elective) in the ABO-incompatible group. Future studies should prospectively examine the impact of ABO-compatible versus incompatible cryoprecipitate to conclusively establish if there is a meaningful clinical impact associated with the administration of ABO-incompatible cryoprecipitate.

Titrated versus conventional anticoagulation management for thrombin generation in cardiac surgery: a randomized controlled trial.

PURPOSE: Optimal heparin titration during cardiopulmonary bypass (CPB) may reduce coagulation system activation and preserve hemostatic function post-CPB. Our objective was to assess if the Heparin Management System (HMS) Plus improves heparin titration, thereby leading to higher thrombin generation post-CPB compared with activated clotting time (ACT)-guided management. METHODS: We conducted a randomized controlled trial of 100 patients undergoing cardiac surgery with CPB at a single center. A total of 50 patients were randomized to conventional ACT-guided management, and 50 to the HMS Plus system. The primary outcome was change in thrombin generation post-CPB compared with baseline, as assessed by calibrated automated thrombography. Secondary outcomes included intraoperative blood loss, chest drain output up to 72 hr, and transfusions. In an exploratory analysis, we compared the quintile of patients with the highest average heparin concentration on CPB (≥ 4.0 mg⋅kg-1) with the rest of the cohort. RESULTS: A total of 100 patients were included in an intent-to-treat analysis. We observed no difference in post-CPB thrombin generation or secondary outcomes. However, patients in the HMS Plus group had higher average heparin concentrations while on CPB than patients in the conventional management group did (mean difference, -0.21; 95% confidence interval, -0.42 to -0.01). The quintile of patients with the highest average heparin concentration (4.0 mg⋅kg-1) had higher thrombin generation post-CPB than the rest of the cohort did. CONCLUSIONS: The HMS Plus system did not show significant benefits in thrombin generation, bleeding outcomes, or transfusion in patients undergoing cardiac surgery with CPB. Higher average heparin concentrations on CPB were associated with higher post-CPB thrombin generation. STUDY REGISTRATION: www. CLINICALTRIALS: gov (NCT03347201); first submitted 12 October 2017.

RéSUMé: OBJECTIF: Un titrage optimal de l'héparine pendant la circulation extracorporelle (CEC) peut réduire l'activation du système de coagulation et préserver la fonction hémostatique après la CEC. Notre objectif était d'évaluer si le système de gestion de l'héparine HMS Plus améliorait le titrage de l'héparine, entraînant ainsi une génération de thrombine plus élevée après la CEC par rapport à la gestion guidée par le temps de coagulation activé (ACT). MéTHODE: Nous avons réalisé une étude randomisée contrôlée de 100 patients bénéficiant d'une chirurgie cardiaque sous CEC dans un seul établissement. Au total, 50 patients ont été randomisés à une gestion conventionnelle guidée par l'ACT et 50 à une gestion guidée par le système HMS Plus. Le critère d'évaluation principal était la variation de la génération de thrombine post-CEC par rapport aux valeurs de base, telles qu'évaluées par thrombographie calibrée automatisée. Les critères secondaires comprenaient les pertes sanguines peropératoires, le drainage thoracique jusqu'à 72 heures et les transfusions. Dans une analyze exploratoire, nous avons comparé le quintile de patients ayant la concentration moyenne d'héparine la plus élevée sous CEC (≥ 4,0 mg⋅kg-1) au reste de la cohorte. RéSULTATS: Au total, 100 patients ont été inclus dans une analyze en intention de traiter. Nous n'avons observé aucune différence dans la génération de thrombine post-CEC ou dans nos critères d'évaluation secondaires. Cependant, les patients du groupe HMS Plus présentaient des concentrations moyennes d'héparine plus élevées sous CEC que les patients du groupe de gestion conventionnelle (différence moyenne, -0,21; intervalle de confiance à 95 %, -0,42 à -0,01). Le quintile de patients ayant la concentration moyenne d'héparine la plus élevée (4,0 mg⋅kg-1) avaient une génération de thrombine post-CEC plus élevée que le reste de la cohorte. CONCLUSION: Le système HMS Plus n'a pas montré d'avantages significatifs dans la génération de thrombine, les issues hémorragiques ou la transfusion chez les patients bénéficiant d'une chirurgie cardiaque sous CEC. Des concentrations moyennes d'héparine plus élevées sous CEC ont été associées à une génération de thrombine post-CEC plus élevée. ENREGISTREMENT DE L'éTUDE: www.ClinicalTrials.gov (NCT03347201); soumis pour la première fois le 12 octobre 2017.

Impact of cardiopulmonary bypass duration on efficacy of fibrinogen replacement with cryoprecipitate compared with fibrinogen concentrate: a post hoc analysis of the Fibrinogen Replenishment in Surgery (FIBRES) randomised controlled trial.

BACKGROUND: Coagulopathy in cardiac surgery is frequently associated with acquired hypofibrinogenaemia, which can be treated with either purified fibrinogen concentrate (FC) or cryoprecipitate. Because the latter is not purified and therefore contains additional coagulation factors, it is thought to be more effective for treatment of coagulopathy that occurs after prolonged cardiopulmonary bypass (CPB). We examined the impact of CPB duration on the efficacy of the two therapies in cardiac surgery. METHODS: This was a post hoc analysis of the Fibrinogen Replenishment in Surgery (FIBRES) RCT comparing FC (4 g) to cryoprecipitate (10 U) in adult patients undergoing cardiac surgery and experiencing bleeding with acquired hypofibrinogenaemia (n=735). The primary outcome was allogeneic blood products transfused within 24 h after CPB. Subjects were stratified by CPB duration (≤120, 121-180, and >180 min). The interaction of treatment assignment with CPB duration was tested. RESULTS: Subjects with longer CPB duration experienced more bleeding and transfusion. With CPB time ≤120 min (FC, n=134; cryoprecipitate, n=146), the ratio of least-squares means between the FC and cryoprecipitate groups for total allogeneic blood products at 24 h was 0.90 (one-sided 97.5% confidence interval [CI]: 0.00-1.12); P=0.004. For subjects with CPB time 121-180 min, it was 1.00 ([one-sided 97.5% CI: 0.00-1.22]; P=0.03], and for CPB time >180 min it was 0.91 ([one-sided 97.5% CI: 0.00-1.12]; P=0.005). Results were similar for all secondary outcomes, with no interaction between treatment and CPB duration for all outcomes. CONCLUSIONS: The haemostatic efficacy of FC was non-inferior to cryoprecipitate irrespective of CPB duration in cardiac surgery. CLINICAL TRIAL REGISTRATION: NCT03037424.

Albumin use for fluid resuscitation in cardiac surgical patients: a survey of Canadian perioperative care providers.

PURPOSE: To evaluate the perceptions and practices of Canadian cardiovascular anesthesiologists and intensivists towards intravenous albumin as a resuscitation fluid in patients undergoing cardiac surgery. METHODS: We conducted a cross-sectional survey of cardiac anesthesiologists and intensivists involved in the care of cardiac surgical patients. The 22-item survey included seven open-ended questions and assessed practice patterns and attitudes towards albumin. Descriptive statistics were analyzed using counts and proportions. Qualitative data were analyzed to identify themes describing albumin use patterns in Canada. RESULTS: A total of 133 respondents from seven provinces participated, with 83 (62%) using albumin perioperatively. The majority of respondents (77%) felt a low fluid balance in cardiac surgical patients was important, and that supplementing crystalloids with albumin was helpful for this objective (67%). There was poor agreement among survey respondents regarding the role of albumin for faster vasopressor weaning or intensive care discharge, and ≥ 90% did not feel albumin reduced mortality, renal injury, or coagulopathy. Nevertheless, cardiac surgical patients were identified as a distinct population where albumin may help to minimize fluid balance. There was an acknowledged paucity of formal evidence supporting possible benefits. Fewer than 10% of respondents could identify institutional or national guidelines for albumin use. A lack of evidence supporting albumin use in cardiac surgical patients, especially those at highest risk of complications, was a frequently identified concern. CONCLUSIONS: The majority of Canadian anesthesiologists and intensivists (62%) use albumin in cardiac surgical patients. There is clinical equipoise regarding its utility, and an acknowledged need for higher quality evidence to guide practice.

RéSUMé: OBJECTIF: Évaluer les perceptions et les pratiques des anesthésiologistes et intensivistes cardiovasculaires canadiens à l'égard de l'albumine intraveineuse comme liquide de réanimation pour les patients bénéficiant d'une chirurgie cardiaque. MéTHODE: Nous avons mené un sondage transversal auprès d'anesthésiologistes et d'intensivistes cardiaques impliqués dans les soins aux patients de chirurgie cardiaque. Le sondage en 22 éléments comprenait sept questions ouvertes et évaluait les habitudes de pratique et les attitudes des praticiens à l'égard de l'albumine. Les statistiques descriptives ont été analysées à l'aide de dénombrements et de proportions. Des données qualitatives ont été analysées pour identifier des thèmes décrivant les tendances d'utilisation de l'albumine au Canada. RéSULTATS: Au total, 133 répondants de sept provinces ont participé, et 83 (62 %) utilisent l'albumine en périopératoire. La majorité des répondants (77 %) estimaient qu'un bilan liquidien négatif était important chez les patients en chirurgie cardiaque et que la supplémentation en cristalloïdes par de l'albumine était utile pour atteindre cet objectif (67 %). Il y avait un faible accord parmi les répondants concernant le rôle de l'albumine pour accélérer le sevrage des vasopresseurs ou la sortie de soins intensifs, et ≥ 90 % ne pensaient pas que l'albumine réduisait la mortalité, les lésions rénales ou la coagulopathie. Néanmoins, les patients en chirurgie cardiaque ont été identifiés comme une population distincte pour laquelle l'albumine pourrait contribuer à minimiser le bilan liquidien. Il y avait un manque reconnu de données probantes formelles à l'appui des avantages possibles. Moins de 10 % des répondants ont pu trouver des lignes directrices institutionnelles ou nationales portant sur l'utilisation de l'albumine. Le manque de données probantes à l'appui de l'utilisation de l'albumine chez les patients en chirurgie cardiaque, en particulier chez ceux présentant le risque le plus élevé de complications, était une préoccupation fréquemment identifiée. CONCLUSION: La majorité des anesthésiologistes et intensivistes canadiens (62 %) utilisent l'albumine chez les patients en chirurgie cardiaque. Il existe un équilibre clinique quant à son utilité et un besoin reconnu de données probantes de meilleure qualité pour guider la pratique.

Intraoperative transfusion management, antifibrinolytic therapy, coagulation monitoring and the impact on short-term outcomes after liver transplantation-A systematic review of the literature and expert panel recommendations.

BACKGROUND: Liver transplantation (LT) is frequently complicated by coagulopathy associated with end-stage liver disease (ESLD), that is, often multifactorial. OBJECTIVES: The objective of this systematic review was to identify evidence based intraoperative transfusion and coagulation management strategies that improve immediate and short-term outcomes after LT. METHODS: PRISMA-guidelines and GRADE-approach were followed. Three subquestions were formulated. (Q); Q1: transfusion management; Q2: antifibrinolytic therapy; and Q3: coagulation monitoring. RESULTS: Sixteen studies were included for Q1, six for Q2, and 10 for Q3. Q1: PRBC and platelet transfusions were associated with higher mortality. The use of prothrombin complex concentrate (PCC) and fibrinogen concentrate (FC) were not associated with reductions in intraoperative transfusion or increased thrombotic events. The use of cell salvage was not associated with hepatocellular carcinoma (HCC) recurrence or mortality. Cell salvage and transfusion education significantly decreased blood product transfusions. Q2: Epsilon-aminocaproic acid (EACA) and tranexamic acid (TXA) were not associated with decreased blood product transfusion, improvements in patient or graft survival, or increases in thrombotic events. Q3: Viscoelastic testing (VET) was associated with decreased allogeneic blood product transfusion compared to conventional coagulation tests (CCT) and is likely to be cost-effective. Coagulation management guided by VET may be associated with increases in FC and PCC use. CONCLUSION: Q1: A specific blood product transfusion practice is not recommended (QOE; low | Recommendation; weak). Cell salvage and educational interventions are recommended (QOE: low | Grade of Recommendation: moderate). Q2: The routine use of antifibrinolytics is not recommended (QOE; low | Recommendation; weak). Q3: The use of VET is recommended (QOE; low-moderate | Recommendation; strong).

Weight-adjusted dosing of fibrinogen concentrate and cryoprecipitate in the treatment of hypofibrinogenaemic bleeding adult cardiac surgical patients: a post hoc analysis of the Fibrinogen Replenishment in cardiac surgery randomised controlled trial.

Background: Hypofibrinogenaemia is associated with excessive bleeding after cardiac surgery. Our aim was to compare the efficacy and safety of weight-adjusted vs empiric dosing of fibrinogen replacement in cardiac surgery. Methods: In the Fibrinogen Replenishment in Cardiac Surgery (FIBRES) RCT, patients (n=735) received fibrinogen concentrate (4 g) or cryoprecipitate (10 units). In this post-hoc analysis, patients were grouped into quartiles based on increasing weight-adjusted dosing. Generalised estimating equations were used to account for hospital site, age, sex, surgical complexity, urgency, and critical preoperative status. The primary outcome was the number of units of red blood cells transfused within 24 h of cardiopulmonary bypass. Secondary outcomes included allogeneic blood components within 24 h, tamponade or major bleeding, and thromboembolic complications, ischaemic complications, or both within 28 days of cardiopulmonary bypass. Results: The median weight-adjusted doses were 52 mg kg-1 of fibrinogen concentrate (inter-quartile range [IQR], 45-61; n=372) and 1.30 units per 10 kg of cryoprecipitate (IQR, 1.11-1.54; n=363). When patients were divided into quartiles of lowest to highest weight-adjusted dosing, no differences were seen in the primary outcome of red blood cell units transfused within 24 h of cardiopulmonary bypass between the lowest and highest quartiles in either the fibrinogen group (adjusted relative risk [RR]=0.90; 95% confidence interval [CI], 0.71-1.13; P=0.36) or the cryoprecipitate group (adjusted RR=1.04; 95% CI, 0.76-1.43; P=0.80). Results were similar for all secondary outcomes. Conclusion: Outcomes for the lowest and highest weight-adjusted doses of fibrinogen replacement were comparable. Weight-adjusted dosing does not appear to offer advantages over empiric dosing in this context. Clinical trial registration: NCT03037424.

The association of thrombin generation with bleeding outcomes in cardiac surgery: a prospective observational study.

BACKGROUND: Cardiac surgery with cardiopulmonary bypass (CPB) is associated with coagulopathic bleeding. Impaired thrombin generation may be an important cause of coagulopathic bleeding but is poorly measured by existing hemostatic assays. We examined thrombin generation during cardiac surgery, using calibrated automated thrombography, and its association with bleeding outcomes. METHODS: We conducted a prospective observational study in 100 patients undergoing cardiac surgery with CPB. Calibrated automated thrombography parameters were expressed as a ratio of post-CPB values divided by pre-CPB values. The association of thrombin generation parameters for bleeding outcomes was compared with conventional tests of hemostasis, and the outcomes of patients with the most severe post-CPB impairment in thrombin generation (≥ 80% drop from baseline) were compared with the rest of the cohort. RESULTS: All 100 patients were included in the final analysis, with a mean age of 63 (12) yr, 31 (31%) female, and 94 (94%) undergoing bypass and/or valve surgery. Post-CPB, peak thrombin decreased by a median of 73% (interquartile range [IQR], 49-91%) (P < 0.001) and total thrombin generation, expressed as the endogenous thrombin potential (ETP), decreased 56% [IQR, 30-83%] (P < 0.001). In patients with ≥ 80% decrease in ETP, 21% required re-exploration for bleeding compared with 7% in the rest of the cohort (P = 0.04), and 48% required medical or surgical treatment for hemostasis compared with 27% in the rest of the cohort (P = 0.04). CONCLUSIONS: Thrombin generation is significantly impaired by CPB and associated with higher bleeding severity. Clinical studies aimed at the identification and treatment of patients with impaired thrombin generation are warranted.

RéSUMé: CONTEXTE: La chirurgie cardiaque avec circulation extracorporelle (CEC) est associée à des saignements sur coagulopathie. L'altération de la génération de thrombine peut constituer une cause importante de saignement sur coagulopathie, mais elle est mal mesurée par les tests d'hémostase existants. Nous avons examiné la génération de thrombine pendant la chirurgie cardiaque à l'aide d'une thrombographie automatisée calibrée ainsi que son association avec les issues hémorragiques. MéTHODE: Nous avons réalisé une étude observationnelle prospective portant sur 100 patients bénéficiant d'une chirurgie cardiaque sous CEC. Les paramètres de thrombographie automatisée calibrée ont été exprimés sous forme du rapport entre les valeurs post-CEC divisées par les valeurs pré-CEC. L'association des paramètres de génération de thrombine pour les issues hémorragiques a été comparée aux tests conventionnels de l'hémostase, et les issues des patients présentant l'altération post-CEC la plus prononcée dans la génération de thrombine (baisse ≥ 80 % par rapport aux valeurs de base) ont été comparées au reste de la cohorte. RéSULTATS: Les 100 patients ont tous été inclus dans l'analyse finale, avec un âge moyen de 63 (12) ans, 31 (31 %) femmes et 94 (94 %) subissant une chirurgie de pontage et / ou une chirurgie valvulaire. Après la CEC, le pic de thrombine a diminué d'une médiane de 73 % (écart interquartile [ÉIQ], 49 à 91 %) (P < 0,001) et la génération de thrombine totale, exprimée en potentiel de thrombine endogène (PTE), a diminué de 56 % [ÉIQ, 30­83 %] (P < 0,001). Chez les patients présentant une diminution ≥ 80 % du PTE, 21 % ont nécessité une nouvelle exploration pour dépister les saignements, comparativement à 7 % dans le reste de la cohorte (P = 0,04), et 48 % ont nécessité un traitement médical ou chirurgical pour l'hémostase, comparativement à 27 % dans le reste de la cohorte (P = 0,04). CONCLUSION: La génération de thrombine est significativement altérée par la CEC et associée à des saignements plus graves. Des études cliniques visant à identifier et à traiter les patients présentant une altération de la génération de thrombine sont recommandées.

The association of prothrombin complex concentrates with postoperative outcomes in cardiac surgery: an observational substudy of the FIBRES randomized controlled trial.

PURPOSE: The mainstay of therapy for coagulation factor deficiency in cardiac surgical patients is frozen plasma (FP); however, prothrombin complex concentrates (PCCs) may offer logistical and safety advantages. As there is limited comparative evidence, we conducted this study to explore the association of comparable PCC or FP doses with transfusion and outcomes. METHODS: This was a post hoc analysis of a multicentre randomized trial comparing fibrinogen concentrate with cryoprecipitate (FIBRES trial) in bleeding cardiac surgical patients. This analysis included 415 patients who received only PCC (n = 72; 17%) or only FP (n = 343; 83%) for factor replacement. The main outcomes of interest were red blood cell (RBC) and platelet transfusion within 24 hr of cardiopulmonary bypass. Secondary outcomes included postoperative adverse events. Associations were examined by hierarchical generalized estimating equation models adjusted for demographic and surgical characteristics. RESULTS: The median [interquartile range (IQR)] PCC dose was 1,000 [1,000-2,000] units, while the median [IQR] FP dose was 4 [2-6] units. Each unit of FP was independently associated with increased adjusted odds of RBC (1.60; 95% confidence interval [CI], 1.36 to 1.87; P < 0.01) and platelet transfusion (1.40; 95% CI, 1.15 to 1.69; P < 0.01) while each 500 units of PCC was independently associated with reduced adjusted odds of RBC (0.67; 95% CI, 0.50 to 0.90; P < 0.01) and platelet transfusion (0.80; 95% CI, 0.70 to 0.92; P < 0.01). Adverse event rates were comparable. CONCLUSIONS: In cardiac surgical patients with post-cardiopulmonary bypass bleeding, PCC use was associated with lower RBC and platelet transfusion than FP use was. Prospective, randomized clinical trials comparing FP with PCC in this setting are warranted.

RéSUMé: OBJECTIF: Le pilier du traitement du déficit en facteur de coagulation chez les patients de chirurgie cardiaque est le plasma congelé (PC); cependant, les concentrés de complexe prothrombinique (CCP) peuvent offrir des avantages en matière de logistique et de sécurité. Comme il existe peu de données probantes comparatives, nous avons réalisé cette étude pour explorer l'association de doses comparables de CCP ou de PC avec la transfusion et les issues postopératoires. MéTHODE: Il s'agit d'une analyse post-hoc d'une étude randomisée multicentrique comparant le concentré de fibrinogène au cryoprécipité (étude FIBRES) chez des patients avec hémorragies en chirurgie cardiaque. Cette analyse a inclus 415 patients qui n'ont reçu que du CCP (n = 72; 17 %) ou du PC (n = 343; 83 %) pour le remplacement des facteurs. Les principaux critères d'évaluation étaient la transfusion d'érythrocytes et de plaquettes dans les 24 heures suivant la circulation extracorporelle (CEC). Les critères d'évaluation secondaires comprenaient les événements indésirables postopératoires. Les associations ont été examinées par des modèles d'équation d'estimation généralisée hiérarchiques ajustés en fonction des caractéristiques démographiques et chirurgicales. RéSULTATS: La dose médiane de CCP [écart interquartile (ÉIQ)] était de 1000 [1000 à 2000] unités, tandis que la dose médiane [ÉIQ] de PC était de 4 [2-6] unités. Chaque unité de PC était indépendamment associée à une augmentation de la probabilité ajustée de transfusion d'érythrocytes (1,60; intervalle de confiance [IC] à 95 %, 1,36 à 1,87; P < 0,01) et de plaquettes (1,40; IC 95 %, 1,15 à 1,69; P < 0,01), alors que chaque 500 unités de CCP étaient indépendamment associées à une réduction de la probabilité ajustée de transfusion d'érythrocytes (0,67; IC 95 %, 0,50 à 0,90; P < 0,01) et de plaquettes (0,80; IC 95 %, 0,70 à 0,92; P < 0,01). Les taux d'événements indésirables étaient comparables. CONCLUSION: Chez les patients de chirurgie cardiaque présentant un saignement post-CEC, l'utilisation de CCP a été associée à un taux de transfusion plus faible d'érythrocytes et de plaquettes que lors de l'utilisation de PC. Des études cliniques randomisées prospectives comparant le PC au CCP dans ce type de contexte sont nécessaires.

Albumin use in bleeding cardiac surgical patients and associated patient outcomes.

PURPOSE: Albumin solution is a colloid used for resuscitation in cardiac surgical patients, but it is unclear if it offers advantages over crystalloids. We examined current clinical practice across 11 cardiac surgical centres and the association of albumin with outcomes in a cohort of bleeding cardiac surgical patients. METHODS: This was a post hoc analysis of data from the Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery (FIBRES) trial. Multivariable regression models adjusted for demographic and surgical characteristics were used to examine predictors of early albumin administration (within the initial 24 perioperative hours), late albumin administration (from 24 hr to seven days after cardiopulmonary bypass), and the association of albumin use with 28-day acute kidney injury, mortality, and length of hospital and intensive care unit (ICU) stay. RESULTS: Of the 735 patients included, 525 (71%) received albumin, ranging from 4.8% to 97.4% of patients across institutions, with 475 (64.6%) receiving albumin early (5% or 25% solution). In the adjusted models, female sex and preoperative hospital admission were associated with early use, while heart failure, female sex, bleeding severity, older age, and prior albumin use were predictors of later administration. Early albumin use was not associated with differences in acute kidney injury (adjusted odds ratio [aOR] 1.77; 95% confidence interval [CI], 0.96 to 3.27; P = 0.07), mortality (aOR 1.66; 95% CI, 0.99 to 2.78; P = 0.05), or length of ICU stay (P = 0.11) or hospital stay (P = 0.67). CONCLUSIONS: Albumin use is common but highly variable within and across sites. Albumin use was not associated with improved outcomes. High quality randomized controlled trials should clarify its role in cardiac surgical patients.

RéSUMé: OBJECTIF: La solution d'albumine est un colloïde utilisé pour la réanimation des patients chirurgicaux cardiaques, mais nous ne savons pas si elle est avantageuse par rapport aux cristalloïdes. Nous avons examiné la pratique clinique actuelle dans 11 centres de chirurgie cardiaque et l'association entre l'albumine et les devenirs dans une cohorte de patients chirurgicaux cardiaques en état d'hémorragie. MéTHODE: Il s'agissait d'une analyse post hoc des données de l'étude FIBRES (Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery, soit 'Effet du concentré de fibrinogène vs cryoprécipité sur la transfusion de composants sanguins après une chirurgie cardiaque'). Des modèles de régression multivariée ajustés pour tenir compte des caractéristiques démographiques et chirurgicales ont été employés pour examiner les facteurs prédictifs d'une administration précoce d'albumine (dans les premières 24 heures périopératoires), d'une administration tardive d'albumine (entre 24 heures et sept jours après la circulation extracorporelle), et l'association entre l'utilisation d'albumine et l'insuffisance rénale aiguë à 28 jours, la mortalité, et la durée de séjour à l'hôpital et à l'unité de soins intensifs (USI). RéSULTATS: Parmi les 735 patients inclus, 525 (71 %) ont reçu de l'albumine, allant de 4,8 % à 97,4 % des patients dans tous les établissements, et 475 (64,6 %) ont reçu de l'albumine de manière précoce (solution à 5 % ou 25 %). Dans les modèles ajustés, le sexe féminin et l'admission préopératoire à l'hôpital ont été associés à une utilisation précoce, tandis que l'insuffisance cardiaque, le sexe féminin, la gravité des saignements, un âge plus avancé et l'utilisation antérieure d'albumine étaient des prédicteurs d'une administration tardive. L'utilisation précoce d'albumine n'a pas été associée à des différences en matière d'insuffisance rénale aiguë (rapport de cotes ajusté [RCA] 1,77; intervalle de confiance [IC] à 95 %, 0,96 à 3,27; P = 0,07), de mortalité (RCA = 1,66; IC 95 %, 0,99 à 2,78; P = 0,05), ou de durée de séjour à l'USI (P = 0,11) ou à l'hôpital (P = 0,67). CONCLUSION: L'utilisation de l'albumine est fréquente mais très variable au sein des établissements et entre ceux-ci. L'utilisation de l'albumine n'a pas été associée à une amélioration des devenirs. Des études randomisées contrôlées de haute qualité devraient clarifier son rôle chez les patients de chirurgie cardiaque.

Comparison of 4-Factor Prothrombin Complex Concentrate With Frozen Plasma for Management of Hemorrhage During and After Cardiac Surgery: A Randomized Pilot Trial.

Importance: Approximately 15% of patients undergoing cardiac surgery receive frozen plasma (FP) for bleeding. Four-factor prothrombin complex concentrates (PCCs) have logistical and safety advantages over FP and may be a suitable alternative. Objectives: To determine the proportion of patients who received PCC and then required FP, explore hemostatic effects and safety, and assess the feasibility of study procedures. Design, Setting, and Participants: Parallel-group randomized pilot study conducted at 2 Canadian hospitals. Adult patients requiring coagulation factor replacement for bleeding during cardiac surgery (from September 23, 2019, to June 19, 2020; final 28-day follow-up visit, July 17, 2020). Data analysis was initiated on September 15, 2020. Interventions: Prothrombin complex concentrate (1500 IU for patients weighing ≤60 kg and 2000 IU for patients weighing >60 kg) or FP (3 U for patients weighing ≤60 kg and 4 U for patients weighing >60 kg), repeated once as needed within 24 hours (FP used for any subsequent doses in both groups). Patients and outcome assessors were blinded to treatment allocation. Main Outcomes and Measures: Hemostatic effectiveness (whether patients received any hemostatic therapies from 60 minutes to 4 and 24 hours after initiation of the intervention, amount of allogeneic blood components administered within 24 hours after start of surgery, and avoidance of red cell transfusions within 24 hours after start of surgery), protocol adherence, and adverse events. The analysis set comprised all randomized patients who had undergone cardiac surgery, received at least 1 dose of either treatment, and provided informed consent after surgery. Results: Of 169 screened patients, 131 were randomized, and 101 were treated (54 with PCC and 47 with FP), provided consent, and were included in the analysis (median age, 64 years; interquartile range [IQR], 54-73 years; 28 [28%] were female; 82 [81%] underwent complex operations). The PCC group received a median 24.9 IU/kg (IQR, 21.8-27.0 IU/kg) of PCC (2 patients [3.7%; 95% CI, 0.4%-12.7%] required FP). The FP group received a median 12.5 mL/kg (IQR, 10.0-15.0 mL/kg) of FP (4 patients [8.5%; 95% CI, 2.4%-20.4%] required >2 doses of FP). Hemostatic therapy was not required at the 4-hour time point for 43 patients (80%) in the PCC group and for 32 patients (68%) in the FP group (P = .25) nor at the 24-hour time point for 41 patients (76%) in the PCC group and for 31 patients (66%) patients in the FP group (P = .28). The median numbers of units for 24-hour cumulative allogeneic transfusions (red blood cells, platelets, and FP) were 6.0 U (IQR, 4.0-11.0 U) in the PCC group and 14.0 U (IQR, 8.0-20.0 U) in the FP group (ratio, 0.58; 95% CI, 0.45-0.77; P < .001). After exclusion of FP administered as part of the investigational medicinal product, the median numbers of units were 6.0 U (IQR, 4.0-11.0 U) in the PCC group and 10.0 U (IQR, 6.0-16.0 U) in the FP group (ratio, 0.80; 95% CI, 0.59-1.08; P = .15). For red blood cells alone, the median numbers were 1.5 U (IQR, 0.0-4.0 U) in the PCC group and 3.0 U (IQR, 1.0-5.0 U) in the FP group (ratio, 0.69; 95% CI, 0.47-0.99; P = .05). During the first 24 hours after start of surgery, 15 patients in the PCC group (28%) and 8 patients in the FP group (17%) received no red blood cells (P = .24). Adverse event profiles were similar. Conclusions and Relevance: This randomized clinical trial found that the study protocols were feasible. Adequately powered randomized clinical trials are warranted to determine whether PCC is a suitable substitute for FP for mitigation of bleeding in cardiac surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04114643.

Albumin in adult cardiac surgery: a narrative review.

PURPOSE: Intravascular fluids are a necessary and universal component of cardiac surgical patient care. Both crystalloids and colloids are used to maintain or restore circulating plasma volume and ensure adequate organ perfusion. In Canada, human albumin solution (5% or 25% concentration) is a colloid commonly used for this purpose. In this narrative review, we discuss albumin supply in Canada, explore the perceived advantages of albumin, and describe the clinical literature supporting and refuting albumin use over other fluids in the adult cardiac surgical population. SOURCE: We conducted a targeted search of PubMed, Embase, Medline, Web of Science, ProQuest Dissertations and Theses Global, the Cochrane Central Register of Controlled trials, and the Cochrane Database of Systematic Reviews. Search terms included albumin, colloid, cardiac surgery, bleeding, hemorrhage, transfusion, and cardiopulmonary bypass. PRINCIPAL FINDINGS: Albumin is produced from fractionated human plasma and imported into Canada from international suppliers at a cost of approximately $21 million CAD per annum. While it is widely used in cardiac surgical patients across the country, it is approximately 30-times more expensive than equivalent doses of balanced crystalloid solutions, with wide inter-institutional variability in use and no clear association with improved outcomes. There is a general lack of high-quality evidence for the superiority of albumin over crystalloids in this patient population, and conflicting evidence regarding safety. CONCLUSIONS: In cardiac surgical patients, albumin is widely utilized despite a lack of high- quality evidence supporting its efficacy or safety. A well-designed randomized controlled trial is needed to clarify the role of albumin in cardiac surgical patients.

RéSUMé: OBJECTIF: Les liquides intravasculaires sont une composante nécessaire et universelle des soins aux patients de chirurgie cardiaque. Les cristalloïdes et les colloïdes sont utilisés pour maintenir ou restaurer le volume plasmatique en circulation et assurer une perfusion adéquate des organes. Au Canada, les solutions d'albumine humaine (concentration de 5 % ou 25 %) constituent un colloïde couramment utilisé à cette fin. Dans ce compte rendu narratif, nous discutons de l'approvisionnement en albumine au Canada, explorons les avantages perçus de l'albumine et décrivons la littérature clinique soutenant ou réfutant l'utilisation de l'albumine par rapport à d'autres solutions pour la population chirurgicale cardiaque adulte. SOURCES: Nous avons effectué une recherche ciblée dans les bases de données PubMed, Embase, Medline, Web of Science, ProQuest Dissertations and Theses Global, le Cochrane Central Register of Controlled trials et la Cochrane Database of Systematic Reviews. Les termes de recherche (en anglais) incluaient albumine, colloid, cardiac surgery, bleeding, hemorrhage, transfusion, et cardiopulmonary bypass (soit albumine, colloïde, chirurgie cardiaque, saignement, hémorragie, transfusion et circulation extracorporelle). CONSTATATIONS PRINCIPALES: L'albumine est fabriquée à partir de plasma humain fractionné et importée au Canada à partir de fournisseurs internationaux au coût d'environ 21 millions CAD par année. Bien qu'elle soit largement utilisée chez les patients de chirurgie cardiaque à travers le pays, elle est environ 30 fois plus coûteuse que des doses équivalentes de solutions cristalloïdes équilibrées, avec une grande variabilité interinstitutionnelle quant à son utilisation et aucune association claire avec des devenirs améliorés. Il n'existe en général pas de données probantes de qualité élevée confirmant la supériorité de l'albumine par rapport aux cristalloïdes dans cette population de patients, et les données probantes quant à son innocuité sont contradictoires. CONCLUSION: Chez les patients de chirurgie cardiaque, l'albumine est largement utilisée en dépit d'un manque de données probantes de haute qualité soutenant son efficacité ou son innocuité. Une étude randomisée contrôlée bien conçue est nécessaire pour clarifier le rôle de l'albumine chez les patients de chirurgie cardiaque.

Managing the coagulopathy associated with cardiopulmonary bypass.

Cardiopulmonary bypass (CPB) has allowed for significant surgical advancements, but accompanying risks can be significant and must be expertly managed. One of the foremost risks is coagulopathic bleeding. Increasing levels of bleeding in cardiac surgical patients at the time of separation from CPB are associated with poor outcomes and mortality. CPB-associated coagulopathy is typically multifactorial and rarely due to inadequate reversal of systemic heparin alone. The components of the bypass circuit induce systemic inflammation and multiple disturbances of the coagulation and fibrinolytic systems. Anticipating coagulopathy is the first step in managing it, and specific patient and procedural risk factors have been identified as predictors of excessive bleeding. Medication management pre-procedure is critical, as patients undergoing cardiac surgery are commonly on anticoagulants or antiplatelet agents. Important adjuncts to avoid transfusion include antifibrinolytics, and perfusion practices such as red cell salvage, sequestration, and retrograde autologous priming of the bypass circuit have varying degrees of evidence supporting their use. Understanding the patient's coagulation status helps target product replacement and avoid larger volume transfusion. There is increasing recognition of the role of point-of-care viscoelastic and functional platelet testing. Common pitfalls in the management of post-CPB coagulopathy include overdosing protamine for heparin reversal, imperfect laboratory measures of thrombin generation that result in normal or near-normal laboratory results in the presence of continued bleeding, and delayed recognition of surgical bleeding. While challenging, the effective management of CPB-associated coagulopathy can significantly improve patient outcomes.