Development and Publication of Clinical Practice Parameters, Reviews, and Meta-analyses: A Report From the Society of Cardiovascular Anesthesiologists Presidential Task Force.

The Society of Cardiovascular Anesthesiologists (SCA) is committed to improving the quality, safety, and value that cardiothoracic anesthesiologists bring to patient care. To fulfill this mission, the SCA supports the creation of peer-reviewed manuscripts that establish standards, produce guidelines, critically analyze the literature, interpret preexisting guidelines, and allow experts to engage in consensus opinion. The aim of this report, commissioned by the SCA President, is to summarize the distinctions among these publications and describe a novel SCA-supported framework that provides guidance to SCA members for the creation of these publications. The ultimate goal is that through a standardized and transparent process, the SCA will facilitate up-to-date education and implementation of best practices by cardiovascular and thoracic anesthesiologists to improve patient safety, quality of care, and outcomes.

Morbidity and mortality in patients managed with high compared with low blood pressure targets during on-pump cardiac surgery: a systematic review and meta-analysis of randomized controlled trials.

PURPOSE: Many believe that blood pressure management during cardiac surgery is associated with postoperative outcomes. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to determine the impact of high compared with low intraoperative blood pressure targets on postoperative morbidity and mortality in adults undergoing cardiac surgery on cardiopulmonary bypass (CPB). Our primary objective was to inform the design of a future large RCT. SOURCE: We searched MEDLINE, EMBASE, Web of Science, CINAHL, and CENTRAL for RCTs comparing high with low intraoperative blood pressure targets in adult patients undergoing any cardiac surgical procedure on CPB. We screened reference lists, grey literature, and conference proceedings. PRINCIPAL FINDINGS: We included eight RCTs (N =1,116 participants); all examined the effect of blood pressure management only during the CPB. Trial definitions of high compared with low blood pressure varied and, in some, there was a discrepancy between the target and achieved mean arterial pressure. We observed no difference in delirium, cognitive decline, stroke, acute kidney injury, or mortality between high and low blood pressure targets (very-low to low quality evidence). Higher blood pressure targets may have increased the risk of requiring a blood transfusion (three trials; n = 456 participants; relative risk, 1.4; 95% confidence interval, 1.1 to 1.9; P = 0.01; moderate quality evidence) but this finding was based on a small number of trials. CONCLUSION: Individual trial definitions of high and low blood pressure targets varied, limiting inferences. The effect of high (compared with low) blood pressure targets on other morbidity and mortality after cardiac surgery remains unclear because of limitations with the body of existing evidence. Research to determine the optimal management of blood pressure during cardiac surgery is required. STUDY REGISTRATION: PROSPERO (CRD42020177376); registered: 5 July 2020.

RéSUMé: OBJECTIF: Pour beaucoup, la prise en charge de la pression artérielle pendant la chirurgie cardiaque serait associée aux issues postopératoires. Nous avons réalisé une revue systématique et une méta-analyse d'études randomisées contrôlées (ERC) afin de déterminer l'impact de cibles peropératoires de pression artérielle élevées par rapport à des cibles basses sur la morbidité et la mortalité postopératoires d'adultes bénéficiant d'une chirurgie cardiaque sous circulation extracorporelle (CEC). Notre objectif principal était d'orienter la conception d'une future ERC d'envergure. SOURCES: Nous avons analysé les bases de données MEDLINE, EMBASE, Web of Science, CINAHL et CENTRAL afin d'en tirer les ERC comparant des cibles de pression artérielle peropératoire élevées à des cibles basses chez des patients adultes bénéficiant d'une intervention chirurgicale cardiaque sous CEC. Nous avons passé au crible les listes de références, la littérature grise et les travaux de congrès. CONSTATATIONS PRINCIPALES: Nous avons inclus huit ERC (N = 1116 participants); toutes les études ont examiné l'effet de la prise en charge de la pression artérielle uniquement pendant la CEC. Les définitions d'une pression artérielle élevée ou basse variaient d'une étude à l'autre et, dans certains cas, un écart a été noté entre la pression artérielle cible et la pression artérielle moyenne atteinte. Nous n'avons observé aucune différence dans les taux de delirium, de déclin cognitif, d'accident vasculaire cérébral, d'insuffisance rénale aiguë ou de mortalité entre les cibles de pression artérielle élevée et basse (données probantes de qualité très faible à faible). Des cibles de pression artérielle plus élevées pourraient avoir augmenté le risque de transfusion sanguine (trois études; n = 456 participants; risque relatif, 1,4; intervalle de confiance à 95 %, 1,1 à 1,9; P = 0,01; données probantes de qualité modérée), mais ce résultat se fondait sur un petit nombre d'études. CONCLUSION: Les définitions individuelles des cibles d'hypertension et d'hypotension artérielle variaient, ce qui a limité les inférences. L'effet de cibles de pression artérielle élevée (par rapport à une pression artérielle basse) sur d'autres mesures de la morbidité et de la mortalité après une chirurgie cardiaque demeure incertain en raison des limites de l'ensemble des données probantes existantes. Des recherches visant à déterminer la prise en charge optimale de la pression artérielle pendant la chirurgie cardiaque sont nécessaires. ENREGISTREMENT DE L'éTUDE: PROSPERO (CRD42020177376); enregistrée le 5 juillet 2020.

Six-Month Outcomes after Restrictive or Liberal Transfusion for Cardiac Surgery.

BACKGROUND: We reported previously that, in patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive transfusion strategy was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or 28 days after surgery, whichever came first. We now report the clinical outcomes at 6 months after surgery. METHODS: We randomly assigned 5243 adults undergoing cardiac surgery to a restrictive red-cell transfusion strategy (transfusion if the hemoglobin concentration was <7.5 g per deciliter intraoperatively or postoperatively) or a liberal red-cell transfusion strategy (transfusion if the hemoglobin concentration was <9.5 g per deciliter intraoperatively or postoperatively when the patient was in the intensive care unit [ICU] or was <8.5 g per deciliter when the patient was in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis occurring within 6 months after the initial surgery. An expanded secondary composite outcome included all the components of the primary outcome as well as emergency department visit, hospital readmission, or coronary revascularization occurring within 6 months after the index surgery. The secondary outcomes included the individual components of the two composite outcomes. RESULTS: At 6 months after surgery, the primary composite outcome had occurred in 402 of 2317 patients (17.4%) in the restrictive-threshold group and in 402 of 2347 patients (17.1%) in the liberal-threshold group (absolute risk difference before rounding, 0.22 percentage points; 95% confidence interval [CI], -1.95 to 2.39; odds ratio, 1.02; 95% CI, 0.87 to 1.18; P=0.006 for noninferiority). Mortality was 6.2% in the restrictive-threshold group and 6.4% in the liberal-threshold group (odds ratio, 0.95; 95% CI, 0.75 to 1.21). There were no significant between-group differences in the secondary outcomes. CONCLUSIONS: In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy for red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis at 6 months after surgery. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898 .).

Oxygen Management During Cardiopulmonary Bypass: A Single-Center, 8-Year Retrospective Cohort Study.

OBJECTIVE: To characterize the institutional oxygen management practices during cardiopulmonary bypass (CPB) in patients undergoing cardiac surgery, including any potential changes during an 8-year study period. DESIGN: A retrospective cohort study. SETTING: A tertiary care cardiac surgical program. PARTICIPANTS: Patients who underwent cardiac surgery involving CPB, with or without hypothermic circulatory arrest (HCA), between January 1, 2010, and December 31, 2017. MEASUREMENTS AND MAIN RESULTS: In addition to baseline patient characteristics, the authors recorded the partial pressures of arterial oxygen (Pao2), fraction of inspired oxygen, and mixed venous oxygen saturation during CPB of 696 randomly selected patients during an 8-year study period. The overall mean Pao2 was 255 ± 48 mmHg, without any significant change during the 8-year study period (p = 0.30). The mean Pao2 of HCA patients was significantly higher than in patients without HCA (327 ± 93 mmHg v 252 ± 45 mmHg, respectively; p < 0.001). CONCLUSIONS: The current approach to oxygen management during CPB at the authors' institution is within the range of hyperoxemic levels, and these practices have not changed over time. The impact of these practices on patients' outcomes is not fully understood, and additional studies are needed to establish firm evidence to guide optimal oxygen management practice during CPB.

Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery.

BACKGROUND: The effect of a restrictive versus liberal red-cell transfusion strategy on clinical outcomes in patients undergoing cardiac surgery remains unclear. METHODS: In this multicenter, open-label, noninferiority trial, we randomly assigned 5243 adults undergoing cardiac surgery who had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) I of 6 or more (on a scale from 0 to 47, with higher scores indicating a higher risk of death after cardiac surgery) to a restrictive red-cell transfusion threshold (transfuse if hemoglobin level was <7.5 g per deciliter, starting from induction of anesthesia) or a liberal red-cell transfusion threshold (transfuse if hemoglobin level was <9.5 g per deciliter in the operating room or intensive care unit [ICU] or was <8.5 g per deciliter in the non-ICU ward). The primary composite outcome was death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis by hospital discharge or by day 28, whichever came first. Secondary outcomes included red-cell transfusion and other clinical outcomes. RESULTS: The primary outcome occurred in 11.4% of the patients in the restrictive-threshold group, as compared with 12.5% of those in the liberal-threshold group (absolute risk difference, -1.11 percentage points; 95% confidence interval [CI], -2.93 to 0.72; odds ratio, 0.90; 95% CI, 0.76 to 1.07; P<0.001 for noninferiority). Mortality was 3.0% in the restrictive-threshold group and 3.6% in the liberal-threshold group (odds ratio, 0.85; 95% CI, 0.62 to 1.16). Red-cell transfusion occurred in 52.3% of the patients in the restrictive-threshold group, as compared with 72.6% of those in the liberal-threshold group (odds ratio, 0.41; 95% CI, 0.37 to 0.47). There were no significant between-group differences with regard to the other secondary outcomes. CONCLUSIONS: In patients undergoing cardiac surgery who were at moderate-to-high risk for death, a restrictive strategy regarding red-cell transfusion was noninferior to a liberal strategy with respect to the composite outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis, with less blood transfused. (Funded by the Canadian Institutes of Health Research and others; TRICS III ClinicalTrials.gov number, NCT02042898 .).

Personal protective equipment (PPE) for both anesthesiologists and other airway managers: principles and practice during the COVID-19 pandemic.

Healthcare providers are facing a coronavirus disease pandemic. This pandemic may last for many months, stressing the Canadian healthcare system in a way that has not previously been seen. Keeping healthcare providers safe, healthy, and available to work throughout this pandemic is critical. The consistent use of appropriate personal protective equipment (PPE) will help assure its availability and healthcare provider safety. The purpose of this communique is to give both anesthesiologists and other front-line healthcare providers a framework from which to understand the principles and practices surrounding PPE decision-making. We propose three types of PPE including: 1) PPE for droplet and contact precautions, 2) PPE for general airborne, droplet, and contact precautions, and 3) PPE for those performing or assisting with high-risk aerosol-generating medical procedures.

RéSUMé: Les professionnels de la santé sont confrontés à une pandémie de coronavirus 2019 (COVID-19). Cette pandémie pourrait durer plusieurs mois, soumettant le système de santé canadien à des pressions jusqu'alors méconnues. Il est essentiel de garder les professionnels de la santé en sécurité, en santé et disponibles tout au long de cette pandémie. Une utilisation cohérente des équipements de protection individuelle (EPI) adaptés nous aidera à garantir leur disponibilité et la sécurité des professionnels de la santé. L'objectif de ce communiqué est de fournir aux anesthésiologistes et aux autres professionnels de la santé de première ligne un cadre leur permettant de comprendre les principes et les pratiques entourant la prise de décision par rapport aux EPI. Nous proposons trois types d'EPI, soit 1) les EPI pour prendre des précautions contre les gouttelettes et le contact; 2) les EPI pour prendre des précautions générales contre les suspensions aériennes, les gouttelettes et le contact; et 3) les EPI pour les professionnels réalisant ou assistant des interventions médicales à haut risque de génération d'aérosols.

The effect of restrictive versus liberal transfusion strategies on longer-term outcomes after cardiac surgery: a systematic review and meta-analysis with trial sequential analysis.

PURPOSE: Blood transfusions are frequently administered in cardiac surgery. Despite a large number of published studies comparing a "restrictive" strategy with a "liberal" strategy, no clear consensus has emerged to guide blood transfusion practice in cardiac surgery patients. The purpose of this study was to identify, critically appraise, and summarize the evidence on the overall effect of restrictive transfusion strategies compared with liberal transfusion strategies on mortality, other clinical outcomes, and transfusion-related outcomes in adult patients undergoing cardiac surgery. SOURCE: We searched MEDLINE (OvidSP), EMBASE (OvidSP) and Cochrane CENTRAL (Wiley) from inception to 1 December 2017 and queried clinical trial registries and conference proceedings for randomized-controlled trials of liberal vs restrictive transfusion strategies in cardiac surgery. PRINCIPAL FINDINGS: From 7,908 citations, we included ten trials (9,101 patients) and eight companion publications. Overall, we found no significant difference in mortality between restrictive and liberal transfusion strategies (risk ratio [RR], 1.08; 95% confidence interval [CI], 0.76 to 1.54; I2 = 33%; seven trials; 8,661 patients). The use of a restrictive transfusion strategy did not appear to adversely impact any of the secondary clinical outcomes. As expected, the proportion of patients who received red blood cells (RBCs) in the restrictive group was significantly lower than in the liberal group (RR, 0.68; 95% CI, 0.64 to 0.73; I2 = 56%; 5 trials; 8,534 patients). Among transfused patients, a restrictive transfusion strategy was associated with fewer transfused RBC units per patient than a liberal transfusion strategy. CONCLUSIONS: In adult patients undergoing cardiac surgery, a restrictive transfusion strategy reduces RBC transfusion without impacting mortality rate or the incidence of other perioperative complications. Nevertheless, further large trials in subgroups of patients, potentially of differing age, are needed to establish firm evidence to guide transfusion in cardiac surgery. TRIAL REGISTRATION: PROSPERO (CRD42017071440); registered 20 April, 2018.

RéSUMé: OBJECTIF: Les transfusions sanguines sont fréquentes après une chirurgie cardiaque. Malgré le nombre important d'études publiées comparant une stratégie « restrictive ¼ à une stratégie « libérale ¼, aucun consensus clair n'est apparu pour guider la pratique de la transfusion sanguine chez les patients de chirurgie cardiaque. L'objectif de cette étude était d'identifier, d'évaluer de façon critique et de résumer les données probantes sur l'effet global des stratégies de transfusion restrictives comparativement aux stratégies libérales sur la mortalité, les autres devenirs cliniques, et les devenirs liés à la transfusion chez des patients adultes subissant une chirurgie cardiaque. SOURCE: Nous avons réalisé des recherches dans les bases de données MEDLINE (OvidSP), EMBASE (OvidSP) et Cochrane CENTRAL (Wiley) de leur création jusqu'au 1er décembre 2017 et avons exploré les registres d'études cliniques et les actes de conférence pour en tirer les études randomisées contrôlées évaluant des stratégies transfusionnelles restrictives vs libérales en chirurgie cardiaque. CONSTATATIONS PRINCIPALES: Sur 7908 citations, nous avons inclus dix études (9101 patients) et huit publications connexes. Globalement, nous n'avons observé aucune différence significative en matière de mortalité entre les stratégies transfusionnelles restrictives et libérales (risque relatif [RR], 1,08; intervalle de confiance [IC] 95 %, 0,76 à 1,54; I2 = 33 %; sept études; 8661 patients). Le recours à une stratégie de transfusion restrictive n'a semblé avoir aucun impact négatif sur quelque résultat clinique secondaire que ce soit. Comme anticipé, la proportion de patients ayant reçu des érythrocytes dans le groupe restrictif était significativement plus basse que dans le groupe libéral (RR, 0,68; IC 95 %, 0,64 à 0,73; I2 = 56 %; 7 études; 8534 patients). Parmi les patients transfusés, une stratégie de transfusion restrictive a été associée à un nombre moindre d'unités d'érythrocytes transfusées par patient que dans une stratégie transfusionnelle libérale. CONCLUSION: Dans une population de patients adultes subissant une chirurgie cardiaque, une stratégie transfusionnelle restrictive réduit la transfusion d'érythrocytes sans avoir d'impact sur le taux de mortalité ou sur l'incidence d'autres complications périopératoires. D'autres grandes études sur différents sous-groupes de patients, peut-être d'âges différents, sont toutefois nécessaires afin d'établir des données probantes concluantes pour guider les transfusions en chirurgie cardiaque. ENREGISTREMENT DE L'éTUDE: PROSPERO (CRD42017071440); enregistrée le 20 avril 2018.

Postcardiac Surgery Acute Stroke Therapies: A Systematic Review.

OBJECTIVE: To identify interventions for the treatment of acute ischemic stroke after cardiac surgery and to report the efficacy of these treatments. DESIGN: Systematic review and narrative synthesis PARTICIPANTS: Patients with ischemic stroke after cardiac surgery. INTERVENTIONS: Treatment efficacy of intra-arterial thrombolysis (IAT) and/or endovascular mechanical thrombectomy (EMT). METHODS AND MAIN RESULTS: The MEDLINE (Ovid), Embase (Ovid), Scopus (Elsevier), and Cochrane Central Register of Controlled Trials (Wiley) databases were searched from January 1, 1990, until September 20, 2018. After reviewing 5,231 records, 8 case reports/series and 2 retrospective studies were included (n = 33). Three of these reports (n = 19) published between 2001 and 2003 described IAT, and 6 studies (n = 14) published between 2015 and 2019 reported the use of EMT. In the 19 patients who received IAT, 3 (16%) had good, 8 (42%) had moderate, and 8 (42%) had poor neurologic outcomes. In the 14 patients who received EMT, 7 (50%) had good, 5 (36%) had moderate, and 2 (14%) had poor neurologic outcomes. CONCLUSIONS: Endovascular thrombectomy, with or without IAT, is being used increasingly with success in patients presenting with postcardiac surgery stroke. However, the number of patients reported is too small to confidently understand its overall effect on neurologic outcomes in this setting.

Antimicrobial Prophylaxis for Patients Undergoing Cardiac Surgery: Intraoperative Cefazolin Concentrations and Sternal Wound Infections.

This study characterizes the pharmacodynamics of antimicrobial prophylaxis and sternal wound infections following cardiac surgery. Duration of surgery and cefazolin plasma concentration during wound closure were independently associated with surgical site infection at 30 days. Furthermore, a duration of surgery of >346 min and a total cefazolin closure concentration of <104 mg/liter were significant thresholds for an increased risk of infection. This study provides new data that informs dosing strategies for effective antimicrobial prophylaxis (AP) in patients undergoing cardiac surgery with cardiopulmonary bypass.

Intraoperative ketamine for prevention of postoperative delirium or pain after major surgery in older adults: an international, multicentre, double-blind, randomised clinical trial.

BACKGROUND: Delirium is a common and serious postoperative complication. Subanaesthetic ketamine is often administered intraoperatively for postoperative analgesia, and some evidence suggests that ketamine prevents delirium. The primary purpose of this trial was to assess the effectiveness of ketamine for prevention of postoperative delirium in older adults. METHODS: The Prevention of Delirium and Complications Associated with Surgical Treatments [PODCAST] study is a multicentre, international randomised trial that enrolled adults older than 60 years undergoing major cardiac and non-cardiac surgery under general anaesthesia. Using a computer-generated randomisation sequence we randomly assigned patients to one of three groups in blocks of 15 to receive placebo (normal saline), low-dose ketamine (0·5 mg/kg), or high dose ketamine (1·0 mg/kg) after induction of anaesthesia, before surgical incision. Participants, clinicians, and investigators were blinded to group assignment. Delirium was assessed twice daily in the first 3 postoperative days using the Confusion Assessment Method. We did analyses by intention-to-treat and assessed adverse events. This trial is registered with clinicaltrials.gov, number NCT01690988. FINDINGS: Between Feb 6, 2014, and June 26, 2016, 1360 patients were assessed, and 672 were randomly assigned, with 222 in the placebo group, 227 in the 0·5 mg/kg ketamine group, and 223 in the 1·0 mg/kg ketamine group. There was no difference in delirium incidence between patients in the combined ketamine groups and the placebo group (19·45% vs 19·82%, respectively; absolute difference 0·36%, 95% CI -6·07 to 7·38, p=0·92). There were more postoperative hallucinations (p=0·01) and nightmares (p=0·03) with increasing ketamine doses compared with placebo. Adverse events (cardiovascular, renal, infectious, gastrointestinal, and bleeding), whether viewed individually (p value for each >0·40) or collectively (36·9% in placebo, 39·6% in 0·5 mg/kg ketamine, and 40·8% in 1·0 mg/kg ketamine groups, p=0·69), did not differ significantly across groups. INTERPRETATION: A single subanaesthetic dose of ketamine did not decrease delirium in older adults after major surgery, and might cause harm by inducing negative experiences. FUNDING: National Institutes of Health and Cancer Center Support.

Evaluation of cefazolin antimicrobial prophylaxis during cardiac surgery with cardiopulmonary bypass.

Objectives: Although clinical practice guidelines recommend standard cefazolin antimicrobial prophylaxis (AP) dosing for cardiac surgery, limited data exist as to whether adequate concentrations are achieved in this patient population. The goal of our study was to characterize intraoperative cefazolin concentrations particularly at wound closure with regards to maintaining target cefazolin closure concentrations ≥40 mg/L. Methods: Adults undergoing cardiac surgery with cardiopulmonary bypass (CPB) and receiving cefazolin AP according to protocol were studied. Blood samples were collected after the preoperative cefazolin dose, prior to intraoperative cefazolin doses and at wound closure. Intraoperative trough and closure concentrations were characterized and evaluated against a target threshold of ≥ 40 mg/L (≥8 mg/L unbound, assuming 80% protein binding). Results: Fifty-five subjects (64.9 ±âŸ10.4 years, 89.7 ±âŸ16.5 kg, CLCR >50 mL/min/72 kg) completed the study. Total cefazolin concentrations were <40 mg/L in 40% (12 of 30) of intraoperative trough samples and 9.8% (5 of 51) of closure samples. Below-target concentrations at some time during surgery were documented in 30.9% (17 of 55) of subjects. In multivariate analyses, lower body weight (P = 0.027) and shorter duration of surgery (P = 0.045) were significant predictors of closure concentrations <40 mg/L. A total cefazolin exposure (preoperative and intraoperative doses) of ≥ 7.6 mg/kgdosing weight for every hour of surgery (intermittent dosing) was required to achieve target closure concentrations. Conclusions: The standard cefazolin AP regimen was not reliable in maintaining target closure concentrations ≥40 mg/L in patients with normal renal function undergoing elective cardiac surgery with CPB. The findings supported a cefazolin AP regimen consisting of at least 2 g preoperatively and every 3 h during surgery.

Comparison of Two Major Perioperative Bleeding Scores for Cardiac Surgery Trials: Universal Definition of Perioperative Bleeding in Cardiac Surgery and European Coronary Artery Bypass Grafting Bleeding Severity Grade.

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: Research into major bleeding during cardiac surgery is challenging due to variability in how it is scored. Two consensus-based clinical scores for major bleeding: the Universal definition of perioperative bleeding and the European Coronary Artery Bypass Graft (E-CABG) bleeding severity grade, were compared in this substudy of the Transfusion Avoidance in Cardiac Surgery (TACS) trial. METHODS: As part of TACS, 7,402 patients underwent cardiac surgery at 12 hospitals from 2014 to 2015. We examined content validity by comparing scored items, construct validity by examining associations with redo and complex procedures, and criterion validity by examining 28-day in-hospital mortality risk across bleeding severity categories. Hierarchical logistic regression models were constructed that incorporated important predictors and categories of bleeding. RESULTS: E-CABG and Universal scores were correlated (Spearman ρ = 0.78, P < 0.0001), but E-CABG classified 910 (12.4%) patients as having more severe bleeding, whereas the Universal score classified 1,729 (23.8%) as more severe. Higher E-CABG and Universal scores were observed in redo and complex procedures. Increasing E-CABG and Universal scores were associated with increased mortality in unadjusted and adjusted analyses. Regression model discrimination based on predictors of perioperative mortality increased with additional inclusion of the Universal score (c-statistic increase from 0.83 to 0.91) or E-CABG (c-statistic increase from 0.83 to 0.92). When other major postoperative complications were added to these models, the association between Universal or E-CABG bleeding with mortality remained. CONCLUSIONS: Although each offers different advantages, both the Universal score and E-CABG performed well in the validity assessments, supporting their use as outcome measures in clinical trials.

The impact of hyperoxia on outcomes after cardiac surgery: a systematic review and narrative synthesis.

PURPOSE: Historically, cardiac surgery patients have often been managed with supraphysiologic intraoperative oxygen levels to protect against the risks of cellular hypoxia inherent in the un-physiologic nature of surgery and cardiopulmonary bypass. This may result in excessive reactive oxygen species generation and exacerbation of ischemia-reperfusion injury. In this review, we synthesize all available data from randomized controlled trials (RCTs) to investigate the impact that hyperoxia has on postoperative organ dysfunction, length of stay, and mortality during adult cardiac surgery. SOURCE: We searched Medline, Embase, Scopus, and Cochrane Central Register of Controlled Trials databases using a high-sensitivity strategy for RCTs that compared oxygenation strategies for adult cardiac surgery. Our primary outcome was postoperative organ dysfunction defined by postoperative increases in myocardial enzymes, acute kidney injury, and neurologic dysfunction. Secondary outcomes were mortality, ventilator days, and length of stay in the hospital and intensive care unit. PRINCIPAL FINDINGS: We identified 12 RCTs that met our inclusion criteria. Risk of bias was unclear to high in all but one trial. Significant heterogeneity in timing of the treatment period and the oxygenation levels targeted was evident and precluded meta-analysis. The large majority of trials found no difference between hyperoxia and normoxia for any outcome. Two trials reported reduced postoperative myocardial enzymes and one trial reported reduced mechanical ventilation time in the normoxia group. CONCLUSIONS: Hyperoxia had minimal impact on organ dysfunction, length of stay, and mortality in adult cardiac surgery. The current evidence base is small, heterogeneous, and at risk of bias. TRIAL REGISTRATION: International Prospective Register of Systematic Reviews (PROSPERO) (CRD42017074712). Registered 17 August 2017.

Point-of-care viscoelastic hemostatic testing in cardiac surgery patients: a systematic review and meta-analysis.

PURPOSE: Thromboelastography and rotational thromboelastometry are point-of-care (POC) viscoelastic tests used to help guide blood product administration. It is unclear whether these tests improve clinical or transfusion-related outcomes. The objective of this study was to appraise data from randomized trials evaluating the benefit of POC testing in cardiac surgery patients. Primary outcomes were the proportion of patients transfused with blood products and all-cause mortality. SOURCE: Medline (Ovid), EMBASE (Ovid), CENTRAL (the Cochrane Library-Wiley), Web of Science, Biosis, Scopus, and CINAHL databases, as well as clinical trial registries and conference proceedings were queried from inception to February 2018. PRINCIPAL FINDINGS: We identified 1,917 records, 11 of which were included in our analysis (8,294 patients). Point-of-care testing was not associated with a difference in the proportion of patients transfused with any blood product (risk ratio [RR], 0.90; 95% confidence interval [CI], 0.79 to 1.02; I2 = 51%; four trials, 7,623 patients), or all-cause mortality (RR, 0.73; 95% CI, 0.47 to 1.13; I2 = 5%; six trials, 7,931 patients). Nevertheless, POC testing was weakly associated with a decrease in the proportion of patients receiving red blood cells (RBC) (RR, 0.91; 95% CI, 0.85 to 0.96; I2 = 0%; seven trials, 8,029 patients), and heterogeneous reductions in frozen plasma (FP) (RR, 0.58; 95% CI, 0.34 to 0.99; I2 = 87%; six trials, 7,989 patients) and platelets (RR, 0.66; 95% CI, 0.49 to 0.90; I2 = 65%; seven trials, 8,029 patients). Meta-analysis of the number of units of RBCs and FP was not possible due to heterogeneity in reporting, however POC testing significantly reduced the units of platelets transfused (standard mean difference, -0.09; 95% CI, -0.18 to 0.00; four trials, 7,643 patients). CONCLUSION: Our review indicates that in cardiac surgery patients, POC viscoelastic hemostatic testing is not associated with a reduction in the proportion of patients receiving any blood product or all-cause mortality. However, viscoelastic testing is weakly associated with a reduction in proportion of patients transfused with specific blood products. Presently, the benefits associated with viscoelastic testing in cardiac surgery patients are insufficiently robust to recommend routine implementation of this technology. TRIAL REGISTRATION: PROSPERO (CRD4201706577). Registered 11 May 2017.

Transfusion Requirements in Cardiac Surgery III (TRICS III): Study Design of a Randomized Controlled Trial.

OBJECTIVES: To determine if a restrictive transfusion threshold is noninferior to a higher threshold as measured by a composite outcome of mortality and serious morbidity. DESIGN: Transfusion Requirements in Cardiac Surgery (TRICS) III was a multicenter, international, open-label randomized controlled trial of two commonly used transfusion strategies in patients having cardiac surgery using a noninferiority trial design (ClinicalTrials.gov number, NCT02042898). SETTING: Eligible patients were randomized prior to surgery in a 1:1 ratio. PARTICIPANTS: Potential participants were 18 years or older undergoing planned cardiac surgery using cardiopulmonary bypass (CPB) with a preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more. INTERVENTIONS: Five thousand patients; those allocated to a restrictive transfusion group received a red blood cell (RBC) transfusion if the hemoglobin concentration (Hb) was less than 7.5 g/dL intraoperatively and/or postoperatively. Patients allocated to a liberal transfusion strategy received RBC transfusion if the Hb was less than 9.5 g/dL intraoperatively or postoperatively in the intensive care unit or less than 8.5 g/dL on the ward. MEASUREMENTS AND MAIN RESULTS: The primary outcome was a composite of all-cause mortality, myocardial infarction, stroke, or new onset renal dysfunction requiring dialysis at hospital discharge or day 28, whichever comes first. The primary outcome was analyzed as a per-protocol analysis. The trial monitored adherence closely as adherence to the transfusion triggers is important in ensuring that measured outcomes reflect the transfusion strategy. CONCLUSION: By randomizing prior to surgery, the TRICS III trial captured the most acute reduction in hemoglobin during cardiopulmonary bypass.

Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial.

BACKGROUND: Cardiac surgery is frequently complicated by coagulopathic bleeding that is difficult to optimally manage using standard hemostatic testing. We hypothesized that point-of-care hemostatic testing within the context of an integrated transfusion algorithm would improve the management of coagulopathy in cardiac surgery and thereby reduce blood transfusions. METHODS: We conducted a pragmatic multicenter stepped-wedge cluster randomized controlled trial of a point-of-care-based transfusion algorithm in consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at 12 hospitals from October 6, 2014, to May 1, 2015. Following a 1-month data collection at all participating hospitals, a transfusion algorithm incorporating point-of-care hemostatic testing was sequentially implemented at 2 hospitals at a time in 1-month intervals, with the implementation order randomly assigned. No other aspects of care were modified. The primary outcome was red blood cell transfusion from surgery to postoperative day 7. Other outcomes included transfusion of other blood products, major bleeding, and major complications. The analysis adjusted for secular time trends, within-hospital clustering, and patient-level risk factors. All outcomes and analyses were prespecified before study initiation. RESULTS: Among the 7402 patients studied, 3555 underwent surgery during the control phase and 3847 during the intervention phase. Overall, 3329 (45.0%) received red blood cells, 1863 (25.2%) received platelets, 1645 (22.2%) received plasma, and 394 (5.3%) received cryoprecipitate. Major bleeding occurred in 1773 (24.1%) patients, and major complications occurred in 740 (10.2%) patients. The trial intervention reduced rates of red blood cell transfusion (adjusted relative risk, 0.91; 95% confidence interval, 0.85-0.98; P=0.02; number needed to treat, 24.7), platelet transfusion (relative risk, 0.77; 95% confidence interval, 0.68-0.87; P<0.001; number needed to treat, 16.7), and major bleeding (relative risk, 0.83; 95% confidence interval, 0.72-0.94; P=0.004; number needed to treat, 22.6), but had no effect on other blood product transfusions or major complications. CONCLUSIONS: Implementation of point-of-care hemostatic testing within the context of an integrated transfusion algorithm reduces red blood cell transfusions, platelet transfusions, and major bleeding following cardiac surgery. Our findings support the broader adoption of point-of-care hemostatic testing into clinical practice. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT02200419.