Bedside Allogeneic Erythrocyte Washing with a Cell Saver to Remove Cytokines, Chemokines, and Cell-derived Microvesicles
BACKGROUND Removal of cytokines, chemokines, and microvesicles from the supernatant of allogeneic erythrocytes may help mitigate adverse transfusion reactions. Blood bank-based washing procedures present logistical difficulties; therefore, we tested the hypothesis that on-demand bedside washing of allogeneic erythrocyte units is capable of removing soluble factors and is feasible in a clinical setting. METHODS There were in vitro and prospective, observation cohort components to this a priori planned substudy evaluating bedside allogeneic erythrocyte washing, with a cell saver, during cardiac surgery. Laboratory data were collected from the first 75 washed units given to a subset of patients nested in the intervention arm of a parent clinical trial. Paired pre- and postwash samples from the blood unit bags were centrifuged. The supernatant was aspirated and frozen at -70°C, then batch-tested for cell-derived microvesicles, soluble CD40 ligand, chemokine ligand 5, and neutral lipids (all previously associated with transfusion reactions) and cell-free hemoglobin (possibly increased by washing). From the entire cohort randomized to the intervention arm of the trial, bedside washing was defined as feasible if at least 75% of prescribed units were washed per protocol. RESULTS Paired data were available for 74 units. Washing reduced soluble CD40 ligand (median [interquartile range]; from 143 [1 to 338] ng/ml to zero), chemokine ligand 5 (from 1,314 [715 to 2,551] to 305 [179 to 488] ng/ml), and microvesicle numbers (from 6.90 [4.10 to 20.0] to 0.83 [0.33 to 2.80] × 106), while cell-free hemoglobin concentration increased from 72.6 (53.6 to 171.6) mg/dl to 210.5 (126.6 to 479.6) mg/dl (P < 0.0001 for each). There was no effect on neutral lipids. Bedside washing was determined as feasible for 80 of 81 patients (99%); overall, 293 of 314 (93%) units were washed per protocol. CONCLUSIONS Bedside erythrocyte washing was clinically feasible and greatly reduced concentrations of soluble factors thought to be associated with transfusion-related adverse reactions, increasing concentrations of cell-free hemoglobin while maintaining acceptable (less than 0.8%) hemolysis.
The association of prothrombin complex concentrates with postoperative outcomes in cardiac surgery: an observational substudy of the FIBRES randomized controlled trial
Canadian journal of anaesthesia = Journal canadien d'anesthesie. 2021
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.
Evaluation of a novel Cardiac Peri-Operative Transfusion Trigger Scoring system in patients with coronary artery disease
BMC cardiovascular disorders. 2021;21(1):40
BACKGROUND A simple and accurate scoring system to guide perioperative blood transfusion in patients with coronary artery disease (CAD) undergoing cardiac surgery is lacking. The trigger point for blood transfusions for these patients may be different from existing transfusion guidelines. This study aimed to evaluate the safety and efficacy of a new scoring strategy for use in guiding transfusion decisions in patients with CAD. METHODS A multicenter randomized controlled trial was conducted at three third-level grade-A hospitals from January 2015 to May 2018. Data of 254 patients in a Cardiac Peri-Operative Transfusion Trigger Score (cPOTTS) group and 246 patients in a group receiving conventional evaluation of the need for transfusion (conventional group) were analysed. The requirements for transfusion and the per capita consumption of red blood cells (RBCs) were compared between groups. RESULTS Baseline characteristics of the two groups were comparable. Logistic regression analyses revealed no significant differences between the two groups in primary outcomes (1-year mortality and perioperative ischemic cardiac events), secondary outcomes (shock, infections, and renal impairment), ICU admission, and ICU stay duration. However, patients in the cPOTTS group had significantly shorter hospital stays, lower hospital costs, lower utilization rate and lower per capita consumption of transfused RBCs than controls. Stratified analyses revealed no significant differences between groups in associations between baseline characteristics and perioperative ischemic cardiac events, except for hemofiltration or dialysis and NYHA class in I. CONCLUSIONS This novel scoring system offered a practical and straightforward guideline of perioperative blood transfusion in patients with CAD. Trial registration chiCTR1800016561(2017/7/19).
Polycythaemia Vera and Coronary Artery Bypass Graft Surgery: A Systematic Review of the Literature
Heart, lung & circulation. 2021
OBJECTIVES Polycythaemia vera (PV) is a condition that may potentially put patients undergoing cardiac surgery at an increased risk of bleeding and thrombosis; however, there is currently a paucity of literature regarding the management of these patients. We aim to examine the literature in this systematic review to indicate the interventions that may be considered to minimise complications. METHODS We conducted a literature search using keywords and MeSH terms to identify articles discussing PV and cardiac surgery. The studies were identified and qualitatively analysed using the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) protocol. RESULTS In total, 10 case reports representing 11 patients were identified for this systematic review and were included in qualitative analysis. 63.6% of patients had preoperative intermittent phlebotomy, and the majority of patients received postoperative therapy that involved one antiplatelet and one anticoagulant. Generous perioperative fluid management, phlebotomy, preservation of core body temperature, early extubation, monitoring of myocardial ischaemia, infarction and vascular events, intense chest physiotherapy and patient mobilisation are important to consider to reduce the risk of complications arising from surgery. CONCLUSION These considerations should be systematically discussed in a multidisciplinary team, where the acute surgical need can be balanced appropriately against the risk of haemorrhage and thrombosis.
The synergistic effect of tranexamic acid and ethamsylate combination on blood loss in pediatric cardiac surgery
Annals of cardiac anaesthesia. 2021;24(1):17-23
BACKGROUND Pediatric patients are at risk for bleeding after cardiac surgery. Administration of antifibrinolytic agents reduces postoperative blood loss. OBJECTIVE Evaluation of the efficacy of combined administration of tranexamic acid (TXA) and ethamsylate in the reduction of postoperative blood loss in pediatric cardiac surgery. METHODS This prospective randomized study included 126 children submitted for cardiac surgery, and they were allocated into three groups: control group (n = 42); TXA group (n = 42):- received only TXA; and combined ethamsylate TXA group (n = 42):- received a combination of TXA and ethamsylate. The main collected data included sternal closure time, the needs for intraoperative transfusion of blood and its products, the total amount of blood loss, and the amount of the whole blood and its products transfused to the patients in the first 24 postoperative hours. RESULTS Blood loss volume in the first 24 postoperative hours was significantly smaller in combined group than the TXA and control groups and was significantly smaller in the TXA group than the control group. The sternal closure time was significantly shorter in the combined group than the other 2 groups and significantly shorter in TXA than the control group. The amount of whole blood transfused to patients in the combined group during surgery and in the first postoperative 24 h was significantly smaller than the other 2 groups and smaller in TXA group than the control group during surgery. CONCLUSION Combined administration of ethamsylate and TXA in pediatric cardiac surgery was more effective in reducing postoperative blood loss and whole blood transfusion requirements than the administration of TXA alone.
Simple risk-score model for in-hospital major bleeding based on multiple blood variables in patients with acute myocardial infarction
International journal of cardiology. 2021
BACKGROUND In-hospital bleeding is associated with poor prognosis in patients with acute myocardial infarction (AMI). We sought to investigate whether a combination of pre-procedural blood tests could predict the incidence of in-hospital major bleeding in patients with AMI. METHODS AND RESULTS A total of 1684 consecutive AMI patients who underwent primary percutaneous coronary intervention (PCI) were recruited and randomly divided into derivation (n = 1010) and validation (n = 674) cohorts. A risk-score model was created based on a combination of parameters assessed on routine blood tests on admission. In the derivation cohort, multivariate analysis revealed that the following 5 variables were significantly associated with in-hospital major bleeding: hemoglobin level < 12 g/dL (odds ratio [OR], 3.32), white blood cell count >10,000/μL (OR, 2.58), platelet count <150,000/μL (OR, 2.51), albumin level < 3.8 mg/dL (OR, 2.51), and estimated glomerular filtration rate < 60 mL/min/1.73 m(2) (OR, 2.31). Zero to five points were given according to the number of these factors each patient had. Incremental risk scores were significantly associated with a higher incidence of in-hospital major bleeding in both cohorts (P < 0.001). Receiver operating characteristic curve analysis of risk models showed adequate discrimination between patients with and without in-hospital major bleeding (derivation cohort: area under the curve [AUC], 0.807; 95% confidence interval [CI], 0.759-0.848; validation cohort: AUC, 0.793; 95% CI, 0.725-0.847). CONCLUSIONS Our novel laboratory-based bleeding risk model could be useful for simple and objective prediction of in-hospital major bleeding events in patients with AMI.
A pilot randomized clinical trial of cryopreserved versus liquid-stored platelet transfusion for bleeding in cardiac surgery: The cryopreserved versus liquid platelet-New Zealand pilot trial
Vox sanguinis. 2021
BACKGROUND AND OBJECTIVES Platelets for transfusion have a shelf-life of 7 days, limiting availability and leading to wastage. Cryopreservation at -80°C extends shelf-life to at least 1 year, but safety and effectiveness are uncertain. MATERIALS AND METHODS This single centre blinded pilot trial enrolled adult cardiac surgery patients who were at high risk of platelet transfusion. If treating clinicians determined platelet transfusion was required, up to three units of either cryopreserved or liquid-stored platelets intraoperatively or during intensive care unit admission were administered. The primary outcome was protocol safety and feasibility. RESULTS Over 13 months, 89 patients were randomized, 23 (25.8%) of whom received a platelet transfusion. There were no differences in median blood loss up to 48 h between study groups, or in the quantities of study platelets or other blood components transfused. The median platelet concentration on the day after surgery was lower in the cryopreserved platelet group (122 × 10(3) /μl vs. 157 × 10(3) /μl, median difference 39.5 ×10(3) /μl, p = 0.03). There were no differences in any of the recorded safety outcomes, and no adverse events were reported on any patient. Multivariable adjustment for imbalances in baseline patient characteristics did not find study group to be a predictor of 24-h blood loss, red cell transfusion or a composite bleeding outcome. CONCLUSION This pilot randomized controlled trial demonstrated the feasibility of the protocol and adds to accumulating data supporting the safety of this intervention. Given the clear advantage of prolonged shelf-life, particularly for regional hospitals in New Zealand, a definitive non-inferiority phase III trial is warranted.
Adult cardiac surgery patients (n= 89).
Cryopreserved platelet transfusions (n= 49).
Liquid-stored platelet transfusion (n= 40).
There were no differences in median blood loss up to 48 hours between study groups, or in the quantities of study platelets or other blood components transfused. The median platelet concentration on the day after surgery was lower in the cryopreserved platelet group (122 × 10(3) /μl vs. 157 × 10(3) /μl, median difference 39.5 × 10(3) /μl). There were no differences in any of the recorded safety outcomes, and no adverse events were reported on any patient. Multivariable adjustment for imbalances in baseline patient characteristics did not find study group to be a predictor of 24 hours blood loss, red cell transfusion or a composite bleeding outcome.
The effect of non-point-of-care haemostasis management protocol implementation in cardiac surgery: A systematic review
Transfusion medicine (Oxford, England). 2021
OBJECTIVES This systematic review aims to outline the evidence on the implementation of a non-point-of-care (non-point-of-care [POC]) haemostasis management protocol compared to experience-based practice in adult cardiac surgery. BACKGROUND Management of coagulopathy in cardiac surgery is complex and remains highly variable among centres and physicians. Although various guidelines recommend the implementation of a transfusion protocol, the literature on this topic has never been systematically reviewed. METHODS PubMed, Embase, Cochrane Library, and Web of Science were searched from January 2000 till May 2020. RESULTS A total of seven studies (one randomised controlled trial [RCT], one prospective cohort study, and five retrospective studies) met the inclusion criteria. Among the six non-randomised, controlled studies, the risk of bias was determined to be serious to critical, and the one RCT was determined to have a high risk of bias. Five studies showed a significant reduction in red blood cells, fresh frozen plasma, and/or platelet transfusion after the implementation of a structural non-POC algorithm, ranging from 2% to 28%, 2% to 19.5%, and 7% to17%, respectively. One study found that fewer patients required transfusion of any blood component in the protocol group. Another study had reported a significantly increased transfusion rate of platelet concentrate in the haemostasis algorithm group. CONCLUSION Owing to the high heterogeneity and a substantial risk of bias of the included studies, no conclusion can be drawn on the additive value of the implementation of a cardiac-surgery-specific non-POC transfusion and haemostasis management algorithm compared to experience-based practice. To define the exact impact of a transfusion protocol on blood product transfusion, bleeding, and adverse events, well-designed prospective clinical trials are required.
Self-care training and informational support of patients with a mechanical heart valve on the international normalized ratio and bleeding complications
Kardiochirurgia i torakochirurgia polska = Polish journal of cardio-thoracic surgery. 2021;18(2):80-86
AIM: The aim of the study was to determine the effect of self-care training and informational support of patients with a mechanical heart valve on the international normalized ratio (INR) and bleeding complications. MATERIAL AND METHODS Design: A quasi-experimental study. Participants were recruited via convenience sampling and were randomly divided into two groups: control (n = 80) and intervention (n = 80). Participants in the control group received only routine training; in addition, the intervention group received 6 sessions of self-care training and 6 months of informational support. Monthly the level of INR and incidence of bleeding were determined. Data were analyzed using the independent t-test and χ(2) in SPSS16 software at a significance level of 0.05. RESULTS During 6 months of follow-up, except for the third month, the frequency of INR levels in the therapeutic target range (2.5-3.5) in the intervention group was significantly higher than that in the control group (p < 0.05). Also in the intervention group, the incidence of bleeding complications was lower than that in the control group, but this difference was not statistically significant (p > 0.05). CONCLUSIONS Proper self-care training and informational support in patients with mechanical heart valve replacement have positive results. By maintaining self-care, the level of a therapeutic target range of INR can be maintained and the incidence of bleeding complications can be reduced.
Comparison of the Effects of Ringer's Lactate and 6% Hydroxyethyl Starch 130/0.4 on Blood Loss and Need for Blood Transfusion After Off-Pump Coronary Artery Bypass Graft Cardiac Surgery
Background Infusion of crystalloids fluid replacement therapy tends to cause a greater expansion of intravascular volume. However, colloids can affect blood coagulation leading to greater blood loss and transfusion requirements. This study compared the intraoperative and postoperative blood loss with Ringer's lactate (RL) versus 6% hydroxyethyl starch (HES) 130/0.4 as infusion fluid during cardiac surgery. Methods Eighty adult male and female patients undergoing elective cardiac surgery were randomly assigned to receive either RL or 6% HES 130/0.4 20 ml/kg during off-pump coronary artery bypass graft (OP-CABG) surgery. Intraoperative blood loss and 24 hours postoperative chest tube drainage were the primary outcomes. Simultaneously, blood transfusions, thromboelastometry variables, total fluid requirement, renal function, and intensive care unit (ICU) stay were assessed. Results The intraoperative blood loss was similar (p > 0.05) with HES (716 ml) and RL (658 ml). Postoperative chest tube drainage was higher (p < 0.05) with HES (513 ml) as against RL (449 ml). The total fluid requirement was higher in the RL group. Alteration of thromboelastometry variables, renal function, and ICU stay was comparable between the two groups. Postoperative chest tube drainage was less with the use of RL during cardiac surgery. A lesser total fluid requirement in the HES group did not lead to any improvement in renal function and the length of ICU stay. Conclusions Crystalloids (RL) provide similar outcomes to HES and can be used as substitutes to colloids during cardiac surgery. However, further large-scale multicenter studies with varied indications can be suggested to substantiate the equivalence of crystalloids to colloids in perioperative management.