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Effect of red blood cell storage time in pediatric cardiac surgery patients: A subgroup analysis of a randomized controlled trial
Martin, S. M., Tucci, M., Spinella, P. C., Ducruet, T., Fergusson, D. A., Freed, D. H., Lacroix, J., Poirier, N., Sivarajan, V. B., Steiner, M. E., et al
JTCVS open. 2023;15:454-467
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Editor's Choice
Abstract
OBJECTIVE This study aimed to determine whether or not transfusion of fresh red blood cells (RBCs) reduced the incidence of new or progressive multiple organ dysfunction syndrome compared with standard-issue RBCs in pediatric patients undergoing cardiac surgery. METHODS Preplanned secondary analysis of the Age of Blood in Children in Pediatric Intensive Care Unit study, an international randomized controlled trial. This study included children enrolled in the Age of Blood in Children in Pediatric Intensive Care Unit trial and admitted to a pediatric intensive care unit after cardiac surgery with cardiopulmonary bypass. Patients were randomized to receive either fresh (stored ≤7 days) or standard-issue RBCs. The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured up to 28 days postrandomization or at pediatric intensive care unit discharge, or death. RESULTS One hundred seventy-eight patients (median age, 0.6 years; interquartile range, 0.3-2.6 years) were included with 89 patients randomized to the fresh RBCs group (median length of storage, 5 days; interquartile range, 4-6 days) and 89 to the standard-issue RBCs group (median length of storage, 18 days; interquartile range, 13-22 days). There were no statistically significant differences in new or progressive multiple organ dysfunction syndrome between fresh (43 out of 89 [48.3%]) and standard-issue RBCs groups (38 out of 88 [43.2%]), with a relative risk of 1.12 (95% CI, 0.81 to 1.54; P = .49) and an unadjusted absolute risk difference of 5.1% (95% CI, -9.5% to 19.8%; P = .49). CONCLUSIONS In neonates and children undergoing cardiac surgery with cardiopulmonary bypass, the use of fresh RBCs did not reduce the incidence of new or progressive multiple organ dysfunction syndrome compared with the standard-issue RBCs. A larger trial is needed to confirm these results.
PICO Summary
Population
Children admitted to a paediatric intensive care unit after cardiac surgery with cardiopulmonary bypass, enrolled in the Age of Blood in Children in Pediatric Intensive Care Unit trial (ABC-PICU), (n= 178).
Intervention
Fresh (stored ≤7 days) red blood cells (RBCs), (n= 89).
Comparison
Standard-issue RBCs (n= 89).
Outcome
The authors performed a preplanned subgroup analysis of the ABC-PICU trial. The primary outcome measure was new or progressive multiple organ dysfunction syndrome, measured up to 28 days post-randomization or at paediatric intensive care unit discharge, or death. There were no statistically significant differences in new or progressive multiple organ dysfunction syndrome between fresh (43 out of 89 [48.3%]) and standard-issue RBCs groups (38 out of 88 [43.2%]), with a relative risk of 1.12; 95% CI [0.81, 1.54] and an unadjusted absolute risk difference of 5.1%; 95% CI [-9.5%, 19.8%].
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Prevention of cardiac surgery-associated acute kidney injury: a systematic review and meta-analysis of non-pharmacological interventions
Hariri, G., Collet, L., Duarte, L., Martin, G. L., Resche-Rigon, M., Lebreton, G., Bouglé, A., Dechartres, A.
Critical care (London, England). 2023;27(1):354
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Editor's Choice
Abstract
BACKGROUND Cardiac surgery-associated acute kidney injury (CSA-AKI) is frequent. While two network meta-analyses assessed the impact of pharmacological interventions to prevent CSA-AKI, none focused on non-pharmacological interventions. We aim to assess the effectiveness of non-pharmacological interventions to reduce the incidence of CSA-AKI. METHODS We searched PubMed, Embase, Central and clinical trial registries from January 1, 2004 (first consensus definition of AKI) to July 1, 2023. Additionally, we conducted manual screening of abstracts of major anesthesia and intensive care conferences over the last 5 years and reference lists of relevant studies. We selected all randomized controlled trials (RCTs) assessing a non-pharmacological intervention to reduce the incidence of CSA-AKI, without language restriction. We excluded RCTs of heart transplantation or involving a pediatric population. The primary outcome variable was CSA-AKI. Two reviewers independently identified trials, extracted data and assessed risk of bias. Random-effects meta-analyses were conducted to calculate risk ratios (RRs) with 95% confidence intervals (CIs). We used the Grading of Recommendations Assessment, Development, and Evaluation to assess the quality of evidence. RESULTS We included 86 trials (25,855 patients) evaluating 10 non-pharmacological interventions to reduce the incidence of CSA-AKI. No intervention had high-quality evidence to reduce CSA-AKI. Two interventions were associated with a significant reduction in CSA-AKI incidence, with moderate quality of evidence: goal-directed perfusion (RR, 0.55 [95% CI 0.40-0.76], I(2) = 0%; P(het) = 0.44) and remote ischemic preconditioning (RR, 0.86 [0.78-0.95]; I(2) = 23%; P(het) = 0.07). Pulsatile flow during cardiopulmonary bypass was associated with a significant reduction in CSA-AKI incidence but with very low quality of evidence (RR = 0.69 [0.48; 0.99]; I(2) = 53%; P(het) < 0.01). We found high quality of evidence for lack of effect of restrictive transfusion strategy (RR, 1.02 [95% CI 0.92; 1.12; P(het) = 0.67; I(2) = 3%) and tight glycemic control (RR, 0.86 [95% CI 0.55; 1.35]; P(het) = 0.25; I(2) = 26%). CONCLUSIONS Two non-pharmacological interventions are likely to reduce CSA-AKI incidence, with moderate quality of evidence: goal-directed perfusion and remote ischemic preconditioning.
PICO Summary
Population
Adult patients undergoing cardiac surgery such as coronary artery bypass grafting and/or valve surgery (86 randomised controlled trials (RCTs) n= 25,855).
Intervention
Non-pharmacological interventions to reduce the incidence of cardiac surgery-associated acute kidney injury (CSA-AKI): Goal directed perfusion (GDP), pulsatile flow during cardiopulmonary bypass (CPB), minimally invasive extracorporeal circulation (MECC), epidural analgesia, remote ischemic preconditioning (RIPc), tight glycemic control, kidney disease improving global outcomes care bundle, hyperoxia during CPB, restrictive transfusion strategy, high target arterial pressure.
Comparison
Usual care.
Outcome
No intervention had high-quality evidence to reduce CSA-AKI. From the included studies, the most frequent intervention was RIPc (31 RCTs, n= 7,738), MECC, (14 RCTs, n= 1,617) and pulsatile blood flow during CPB (10 RCTs, n= 1,993). Three interventions were associated with a significantly reduced risk of CSA-AKI: GDP, RIPc and pulsatile flow during CPB.
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Health-related quality of life after restrictive versus liberal RBC transfusion for cardiac surgery: Sub-study from a randomized clinical trial
Hu RT, Royse AG, Royse C, Scott DA, Bowyer A, Boggett S, Summers P, Mazer CD
Transfusion. 2022
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Editor's Choice
Abstract
BACKGROUND Transfusion Requirements in Cardiac Surgery III (TRICS III), a multi-center randomized controlled trial, demonstrated clinical non-inferiority for restrictive versus liberal RBC transfusion for patients undergoing cardiac surgery. However, it is uncertain if transfusion strategy affects long-term health-related quality of life (HRQOL). STUDY DESIGN AND METHODS In this planned sub-study of Australian patients in TRICS III, we sought to determine the non-inferiority of restrictive versus liberal transfusion strategy on long-term HRQOL and to describe clinical outcomes 24 months postoperatively. The restrictive strategy involved transfusing RBCs when hemoglobin was <7.5 g/dl; the transfusion triggers in the liberal group were: <9.5 g/L intraoperatively, <9.5 g/L in intensive care, or <8.5 g/dl on the ward. HRQOL assessments were performed using the 36-item short form survey version 2 (SF-36v2). Primary outcome was non-inferiority of summary measures of SF-36v2 at 12 months, (non-inferiority margin: -0.25 effect size; restrictive minus liberal scores). Secondary outcomes included non-inferiority of HRQOL at 18 and 24 months. RESULTS Six hundred seventeen Australian patients received allocated randomization; HRQOL data were available for 208/311 in restrictive and 217/306 in liberal group. After multiple imputation, non-inferiority of restrictive transfusion at 12 months was not demonstrated for HRQOL, and the estimates were directionally in favor of liberal transfusion. Non-inferiority also could not be concluded at 18 and 24 months. Sensitivity analyses supported these results. There were no differences in quality-adjusted life years or composite clinical outcomes up to 24 months after surgery. DISCUSSION The non-inferiority of a restrictive compared to a liberal transfusion strategy was not established for long-term HRQOL in this dataset.
PICO Summary
Population
Patients undergoing cardiac surgery, enrolled in the Australian cohort of the randomised controlled trial: Transfusion Requirements in Cardiac Surgery III (TRICS III), (n= 617).
Intervention
Restrictive transfusion strategy (n= 311).
Comparison
Liberal transfusion strategy (n= 306).
Outcome
Health-related quality of life (HRQOL) data were available for 208 (67%) patients in the restrictive and 217 (71%) patients in the liberal group. After multiple imputation, non-inferiority of restrictive transfusion at 12 months was not demonstrated for HRQOL, and the estimates were directionally in favor of liberal transfusion. Non-inferiority also could not be concluded at 18 and 24 months. Sensitivity analyses supported these results. There were no differences in quality-adjusted life years or composite clinical outcomes up to 24 months after surgery.
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Individualised or liberal red blood cell transfusion after cardiac surgery: a randomised controlled trial
Fischer MO, Guinot PG, Debroczi S, Huette P, Beyls C, Babatasi G, Bafi K, Guilbart M, Caus T, Lorne E, et al
British journal of anaesthesia. 2021
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Abstract
BACKGROUND Current practice guidelines for red blood cell (RBC) transfusion in ICUs are based on haemoglobin threshold, without consideration of oxygen delivery or consumption. We aimed to evaluate an individual physiological threshold-guided by central venous oxygen saturation ScvO(2). METHODS In a randomised study in two French academic hospitals, 164 patients who were admitted to ICU after cardiac surgery with postoperative haemoglobin <9 g dl(-1) were randomised to receive a transfusion with one unit of RBCs (haemoglobin group) or transfusion only if the ScvO(2) was <70% (individualised group). The primary outcome was the number of subjects receiving at least one unit of RBCs. The secondary composite outcome was acute kidney injury, stroke, myocardial infarction, acute heart failure, mesenteric ischaemia, or in-hospital mortality. One- and 6-month mortality were evaluated during follow-up. RESULTS The primary outcome was observed for 80 of 80 subjects (100%) in the haemoglobin group and in 61 of 77 patients (79%) in the individualised group (absolute risk -21% [-32.0; -14.0]; P<0.001). There was no significant difference in the secondary outcome between the two groups. Follow-up showed a non-significant difference in mortality at 1 and 6 months. CONCLUSIONS An individualised strategy based on an central venous oxygen saturation threshold of 70% allows for a more restrictive red blood cell transfusion strategy with no incidence on postoperative morbidity or 6-month mortality. CLINICAL TRIAL REGISTRATION NCT02963883.
PICO Summary
Population
Patients admitted to intensive care unit after cardiac surgery (n= 164).
Intervention
Transfusion with one unit of red blood cells (RBCs), (haemoglobin group), (n= 82).
Comparison
Transfusion only if the ScvO(2) was <70% (individualised group), (n= 82).
Outcome
The number of patients receiving at least one unit of RBCs was observed for 80 of 80 subjects (100%) in the haemoglobin group and in 61 of 77 patients (79%) in the individualised group. There was no significant difference in the secondary outcome between the two groups. Follow-up showed a non-significant difference in mortality at 1 and 6 months.
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Restrictive versus Liberal Transfusion in Patients with Diabetes Undergoing Cardiac Surgery: An Open-Label Randomized, Blinded Outcome Evaluation Trial
Mistry N, Shehata N, Carmona P, Bolliger D, Hu R, Carrier FM, Alphonsus CS, Tseng EE, Royse AG, Royse C, et al
Diabetes, obesity & metabolism. 2021
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Editor's Choice
Abstract
AIM: To characterize the association between diabetes and transfusion and clinical outcomes in cardiac surgery, and to evaluate whether restrictive transfusion thresholds are harmful in these patients. MATERIALS AND METHODS The multinational, open-label, randomized controlled TRICS-III trial assessed a restrictive transfusion strategy (hemoglobin [Hb] transfusion threshold <75 g/L) compared to a liberal strategy (Hb <95 g/L for operating room or ICU; or < 85 g/L for ward) in patients undergoing cardiac surgery on cardiopulmonary bypass with a moderate-to-high risk of death (EuroSCORE ≥6). Diabetes status was collected preoperatively. The primary composite outcome was all-cause death, stroke, myocardial infarction, and new-onset renal failure requiring dialysis at 6 months. Secondary outcomes included components of the composite outcome at 6 months, and transfusion and clinical outcomes at 28 days. RESULTS Of the 5092 patients analyzed, 1396 (27.4%) had diabetes (Restrictive: n = 679, Liberal n = 717). Patients with diabetes had more cardiovascular disease than patients without diabetes. Neither the presence of diabetes (OR [95%CI]1.10[0.93-1.31]) or the restrictive strategy increased the risk for the primary composite outcome (diabetes OR [95%CI]1.04[0.68-1.59] vs. no diabetes OR 1.02[0.85-1.22],p(interaction) = 0.92). In patients with versus without diabetes, a restrictive transfusion strategy was more effective at reducing red blood cell transfusion (diabetes OR [95%CI] 0.28[0.21-0.36]; no diabetes OR [95%CI] 0.40[0.35-0.47];p(interaction) = 0.04). CONCLUSIONS The presence of diabetes did not modify the effect of a restrictive transfusion strategy on the primary composite outcome, but improved its efficacy on red cell transfusion. Restrictive transfusion triggers are safe and effective in patients with diabetes undergoing cardiac surgery. This article is protected by copyright. All rights reserved.
PICO Summary
Population
Patients with diabetes undergoing cardiac surgery enrolled in the multinational TRICS-III trial (n= 1,396).
Intervention
Restrictive transfusion threshold strategy (n= 679).
Comparison
Liberal transfusion threshold strategy (n= 717).
Outcome
Of the 5,092 patients analysed, 1396 (27.4%) had diabetes. Patients with diabetes had more cardiovascular disease than patients without diabetes. Neither the presence of diabetes nor the restrictive strategy increased the risk for the primary composite outcome vs. no diabetes. In patients with vs. without diabetes, a restrictive transfusion strategy was more effective at reducing red blood cell transfusion.
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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
Kashani HH, Lodewyks C, Kavosh MS, Jeyaraman MM, Neilson C, Okoli G, Rabbani R, Abou-Setta AM, Zarychanski R, Grocott HP
Canadian journal of anaesthesia = Journal canadien d'anesthesie. 2020
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Abstract
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; I(2) = 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; I(2) = 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.
PICO Summary
Population
Adult patients undergoing cardiac surgery (10 studies, n= 9101).
Intervention
Restrictive transfusion strategies.
Comparison
Liberal transfusion strategies.
Outcome
No significant difference was found in mortality between restrictive and liberal transfusion strategies (risk ratio [RR], 1.08; I2 (2) = 33%. 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; I2 (2) = 56%. Among transfused patients, a restrictive transfusion strategy was associated with fewer transfused RBC units per patient than a liberal transfusion strategy.
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Effect of red blood cell storage duration on major postoperative complications in cardiac surgery: A randomized trial
Koch CG, Sessler DI, Duncan AE, Mascha EJ, Li L, Yang D, Figueroa P, Sabik JF 3rd, Mihaljevic T, Svensson LG, et al
The Journal of thoracic and cardiovascular surgery. 2019
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Abstract
BACKGROUND Although observational studies suggest an association between transfusion of older red blood cell (RBC) units and increased postoperative risk, randomized trials have not supported this. The objective of this randomized trial was to test the effect of RBC storage age on outcomes after cardiac surgery. METHODS From July 2007 to May 2016, 3835 adults undergoing coronary artery bypass grafting, cardiac valve procedures, or ascending aorta repair, either alone or in combination, were randomized to transfusion of RBCs stored for ≤14 days (younger units) or for ≥20 days (older units) intraoperatively and throughout the postoperative hospitalization. According to protocol, 2448 patients were excluded because they did not receive RBC transfusions. Among the remaining 1387 modified intent-to-treat patients, 701 were randomized to receive younger RBC units (median age, 11 days) and the remaining 686 to receive older units (median age, 25 days). The primary endpoint was composite morbidity and mortality, analyzed using a generalized estimating equation (GEE) model. The trial was discontinued midway owing to enrollment constraints. RESULTS A total of 5470 RBC units were transfused, including 2783 in the younger RBC storage group and 2687 in the older RBC storage group. The GEE average relative-effect odds ratio was 0.77 (95% confidence interval [CI], 0.50-1.19; P = .083) for the composite morbidity and mortality endpoint. In-hospital mortality was lower for the younger RBC storage group (2.1% [n = 15] vs 3.4% [n = 23]), as was occurrence of other adverse events except for atrial fibrillation, although all CIs crossed 1.0. CONCLUSIONS This clinical trial, which was stopped at its midpoint owing to enrollment constraints, supports neither the efficacy nor the futility of transfusing either younger or older RBC units. The effects of transfusing RBCs after even more prolonged storage (35-42 days) remains untested.
PICO Summary
Population
Adults undergoing coronary artery bypass grafting, cardiac valve procedures, or ascending aorta repair, either alone or in combination (n=3835).
Intervention
Younger red blood cell (RBC) units (median age, 11 days), (n=701).
Comparison
Older units (median age, 25 days), (n=686).
Outcome
A total of 5470 RBC units were transfused, including 2783 in the younger RBC storage group and 2687 in the older RBC storage group. The generalized estimating equation (GEE) average relative-effect odds ratio was 0.77 for the composite morbidity and mortality endpoint. In-hospital mortality was lower for the younger RBC storage group (2.1% [n = 15] vs 3.4% [n = 23]), as was occurrence of other adverse events except for atrial fibrillation.