Prospective validation of the EuroSCORE II risk model in a single Dutch cardiac surgery centre.

OBJECTIVE: The EuroSCORE I was one of the most frequently used pre-operative risk models in cardiac surgery. In 2011 it was replaced by its successor the EuroSCORE II. This study aims to validate the EuroSCORE II and to compare its performance with the EuroSCORE I in a Dutch hospital. METHODS: The EuroSCORE II was prospectively validated in 2,296 consecutive cardiac surgery patients between 1 April 2012 and 1 January 2014. Receiver operating characteristic curves on in-hospital mortality were plotted for EuroSCORE I and EuroSCORE II, and the area under the curve was calculated to assess discriminative power. Calibration was assessed by comparing observed versus expected mortality. Additionally, analyses were performed in which we stratified for type of surgery and for elective versus emergency surgery. RESULTS: The observed mortality was 2.4% (55 patients). The discriminative power of the EuroSCORE II surpassed that of the EuroSCORE I (area under the curve EuroSCORE II 0.871, 95% confidence interval (CI) 0.832-0.911; area under the curve additive EuroSCORE I 0.840, CI 0.798-0.882; area under the curve logistic EuroSCORE I 0.761, CI 0.695-0.828). Both the additive and the logistic EuroSCORE I overestimated mortality (predictive mortality additive EuroSCORE I median 5.0%, inter-quartile range 3.0-8.0%; logistic EuroSCORE I 10.7%, inter-quartile range 5.8-13.9), while the EuroSCORE II underestimated mortality (median 1.6%, inter-quartile range 1.0-3.5). In most stratified analyses the EuroSCORE II performed better. CONCLUSION: Our results show that the EuroSCORE II produces a valid risk prediction and outperforms the EuroSCORE I in elective cardiac surgery patients.

Implementation of a new platelet pooling system for platelet concentrates led to a higher corrected count increment after transfusion: a comparative observational study of platelet concentrates before and after implementation.

OBJECTIVES: To study the effect of extended storage of platelet concentrates (PCs) and the implementation of a new platelet pooling system for PCs on corrected count increment (CCI) after transfusion. BACKGROUND: Due to new developments and changes in processes or procedures, one should remain alert for the effects of these changes. Besides in vitro studies and validation, in vivo studies are also important, as it has been shown that in vitro results do not always predict in vivo outcomes. METHODS/MATERIALS: After introduction of extended storage of PCs for 5-7 days prepared from five buffy coats and plasma, transfusion monitoring for transfusions of PCs in haemato-oncological patients was set up. After 9 months, a new pooling system for PCs was implemented, Composelect instead of Optipure PLT, and transfusion monitoring was continued for another 8 months. The CCI was used as primary outcome. RESULTS: In total, 93 patients were included and transfused with PCs prepared in the Optipure PLT system (262 transfusions) or in the Composelect system (127 transfusions). Extended storage of PCs for 7 days had no significant effect on CCI. Although the implementation of the Composelect system did not influence the CCI1 h (13.8 ± 6.0 vs. 13.0 ± 5.8; n.s.), it seemed to have a positive effect on CCI24 h (7.0 ± 4.9 vs. 4.7 ± 4.5; P < 0.05). CONCLUSION: Although the influence of confounders could not be excluded, it seemed that implementation of the Composelect system for PCs led to an improved CCI24 h and that extended storage of PCs did not influence the CCI.

Variation between hospitals in rates of reported transfusion reactions: is a high reporting rate an indicator of safer transfusion?

BACKGROUND AND OBJECTIVES: It has been suggested that the rate of reported transfusion reactions is positively correlated with safety of the transfusion chain in a hospital. We evaluated this assumption in the Transfusion Reactions in Patients Dutch National Hemovigilance Office database taking reported incorrect blood component transfused as a proxy for unsafe transfusion. METHODS: Reports from 2006 to 2010 and annual numbers of transfused blood components from the 103 hospitals were analysed. The rate of transfusion reactions per 1000 blood components was calculated per hospital. Logistic regression analysis was performed between reporting of at least one incorrect blood component and tertile of transfusion reaction rate. RESULTS: Out of the 103 hospitals, 101 had complete data in some and 93 in all 5years. In all, 72 had reported at least one incorrect blood component transfused; this was associated with blood use level and also with rate of reported transfusion reactions: odds ratio 4·2 (95% confidence interval, 1·3-13·7) in the highest vs. the lowest tertile after adjustment for blood use level. CONCLUSION: Hospitals in the Netherlands which report more transfusion reactions per 1000 units are also more likely to have reported incorrect blood component transfused. The data do not support that hospitals with a higher rate of transfusion reaction reports are safer.

Clinical effects of leucoreduction of blood transfusions.

For many years filtration for removal of leucocytes from red blood cell (RBC) and platelet transfusions was applied for selected patients to prevent cytomegalovirus (CMV) (re)activation, HLA immunisation and recurrent febrile nonhaemolytic transfusion reactions (FNHTR ). Since the 1980s, there was also growing concern about cancer recurrence and postoperative infections. In this review we discuss the studies on possible benefits of leucoreduction. In 2001 the Dutch Health Council decided that all blood products should undergo leucoreduction by filtration, as a precautionary measure to reduce possible transmission of variant Creutzfeld-Jacob disease (vCJD). The incidences of transfusion-transmitted CMV infection, HLA immunisation and FN HTR are decreased by universal leucoreduction. However, transfusion-related immunomodulation with presumed negative effects on cancer immunosurveillance, postoperative infections or aggravating organ failure, investigated in randomised controlled trials, revealed no support for extended indications for leucoreduction. An exception was seen in cardiac surgery where leucoreduction reduced short-term mortality by approximately 50%. The exact mechanism(s) for this effect is (are) not known. Pro-inf lammatory cytokines induced by eucocytecontaining RBC transfusions in combination with the inflammatory response after cardiac surgery may aggravate morbidity and could lead to mortality. In this review we discuss the evidence for the benefits of universal leucoreduction. Based on the available evidence, reversal to the use of buffy-coat depleted RBCs and restricted indications for leucoreduction by filtration (extended with open-heart surgery) is a safe option.

The effect of RBC transfusions on cytokine gene expression after cardiac surgery in patients developing post-operative multiple organ failure.

AIM: To determine the effect of red blood cell (RBC) transfusions during cardiac surgery on cytokine gene expression (GE) in relation to multiple organ failure (MOF) development after systemic inflammatory response syndrome (SIRS). BACKGROUND: RBC transfusion in cardiac surgery patients is dose-dependently associated with post-operative MOF, possibly acting as a second hit after cardiopulmonary bypass. METHODS: For this observational study, 29 patients divided into four groups of cardiac surgery patients were selected from a randomised controlled trial (RCT). Group 1: no-RBC, no-MOF (N = 8); group 2: MOF, no-RBC (N = 7); group 3: RBC, no-MOF (N = 6); group 4: RBC and MOF (N = 8). Selection was based on age, gender, number of (leukocyte-depleted) RBC transfusions, type and duration of surgery. A 114 cytokine GE array was applied to blood samples withdrawn before and 24 h after surgery. Expression of selected genes was confirmed with reverse transcriptase real time-polymerase chain reaction (RT-PCR). RESULTS: Nineteen of the 39 detectable genes showed a significant change in GE after surgery. Confirmed by RT-PCR, transfused MOF patients exhibit significantly less downregulation of CD40 ligand than control patients. Patients who would develop MOF show significantly larger increases in GE of transforming growth factor-α (TGF-α), tumour necrosis factor (TNF)-superfamily members 10 and 13B (TNFsf10/13B). CONCLUSIONS: When tested at 24 h after surgery, cytokine GE in peripheral blood leucocytes showed no significant differences between those transfused and those not transfused. Some alterations were seen in those developing MOF compared to those who did not, but the findings offer no role of leukocyte depleted (LD) RBC transfusion in the development of MOF.

Leucocyte depletion of perioperative blood transfusion does not affect long-term survival and recurrence in patients with gastrointestinal cancer.

BACKGROUND: Perioperative red blood cell (RBC) transfusion may be associated with a poor prognosis in cancer surgery. Allogeneic leucocytes are assumed to play a causal role. This study evaluated the long-term effect of transfusion with leucocyte-depleted (LD) blood in patients with gastrointestinal cancer. METHODS: The Transfusion Associated Complications = Transfusion Induced Complications? (TACTIC) study is a multicentre randomized controlled trial evaluating the short-term benefits of LD versus non-LD RBC transfusions. The present study evaluated 5-year survival and cancer recurrence among 512 patients with gastrointestinal cancer included in the TACTIC study. RESULTS: Some 89.2 per cent of patients had a primary tumour and 79.7 per cent underwent surgery with curative intent; 243 patients received perioperative RBC transfusion (median 3 units). The 5-year overall survival rate of patients with any type of gastrointestinal cancer was 50.8 per cent in the LD group and 45.8 per cent in the non-LD group (P = 0.191). Corresponding 5-year disease-free survival rates were 60.0 and 56.6 per cent (P = 0.482), and recurrence rates 32.9 and 34.3 per cent (P = 0.864). CONCLUSION: Leucocyte depletion is not associated with better long-term survival and lower recurrence rates in patients with gastrointestinal cancer.

Is increased mortality associated with post-operative infections after leukocytes containing red blood cell transfusions in cardiac surgery? An extended analysis.

In two randomized trials in cardiac surgery we observed that leukoreduced allogeneic red blood cell (RBC) transfusions (LR) compared with standard buffy-coat-depleted RBC transfusions (BCD) resulted in lower rates of post-operative infections and mortality. To unravel whether this comprises two independent side effects or could be related complications of allogeneic leukocytes, we performed a re-analysis on the patients of these two trials. For all analyses, homogeneity tests were shown not to be significant. Data on characteristics of post-operative infections, nature of microorganisms, number of transfusions and causes of death in both studies were subjected to an integrated analysis. In both studies combined, 1085 patients had been assigned to prestorage leukoreduced RBCs (LR, n= 542) or standard buffy-coat-depleted RBCs (BCD, n= 543). Post-operative infections were significantly higher in the BCD group [BCD: 34.2% vs. LR: 24.0%, common odds ratios (COR): 1.65, 95% confidence interval (CI): 1.27-2.15], whereas the species of cultured microorganisms and the type of the infections were similar in both randomization arms. Mortality with infections was significantly higher in patients receiving BCD compared with LR (BCD: 5.5% vs. LR: 2.2%, COR: 2.59, 95% CI: 1.31-5.14), whereas mortality without infections was similar in both arms (BCD: 3.9% vs. LR: 3.1%, COR: 1.24, 95% CI: 0.65-2.38). The only cause of death that differed significantly between BCD and LR was the combination of multiple organ dysfunction syndrome with infections. This re-analysis shows that transfusion of leukocytes containing RBCs during cardiac surgery may be associated with more infections with fatal outcome. This should be confirmed in a larger extended analysis or a prospective study.

Cost-effectiveness of leucocyte-depleted erythrocyte transfusion in cardiac valve surgery.

Cost-effectiveness of leucodepleted erythrocytes (LD) over buffy-coat-depleted packed cells (PC) is estimated from the primary dataset of a recently reported randomized clinical trial involving valve surgery (+/-CABG) patients. Data on the patient level of 474 adult patients who were randomized double-blind to LD or PC were used in order to calculate the healthcare costs and longevity per patient. The incremental cost-effectiveness ratio (ICER) in net costs per life-year gained was established from the healthcare perspective. Bootstrapping and cost-effectiveness acceptability curves were used in order to determine the confidence interval (CI) of the ICER. The longevity of patients in the PC and LD group was 10.6 and 11.4 years, respectively. Relative to PC, LD yielded an estimated 0.8 (95% CI = -0.27 to 1.84) life-year in the baseline. Adjusted for age and sex differences, health gains for LD are 0.4 life-year gained (95% CI = -0.67 to 1.44). Healthcare costs per patient averaged 10163 US dollars per patient in the PC group and 9949 US dollars in the LD group. Average cost-savings were 214 US dollars (95% CI = -1536 to 1964) per patient. Acceptability curves constructed from bootstrap simulations showed a probability of being cost-saving of 59% for universal leucodepletion from the healthcare perspective. The probability of adopting leucodepletion regardless of the costs reaches 92.7%. LD in patients receiving four or more transfusions showed the highest cost-savings and health gains. Leucodepletion of erythrocytes is a cost-saving strategy in cardiac valve (+/-CABG) patients. However, probablistic analysis failed to show a significant difference with buffy-coat-depleted PC.

Double-blind, randomized controlled trial on the effect of leukocyte-depleted erythrocyte transfusions in cardiac valve surgery.

BACKGROUND: Leukocytes in allogeneic blood transfusions are believed to be the cause of immunomodulatory events. A few trials on leukocyte removal from transfusions in cardiac surgery have been conducted, and they showed inconclusive results. We found in a previous study a decrease in mortality rates and number of infections in a subgroup of more heavily transfused patients. METHODS AND RESULTS: Patients (n=496) undergoing valve surgery (with or without CABG) were randomly assigned in a double-blind fashion to receive standard buffy coat-depleted (PC) or prestorage, by filtration, leukocyte-depleted erythrocytes (LD). The primary end point was mortality at 90 days, and secondary end points were in-hospital mortality, multiple organ dysfunction syndrome, infections, intensive care unit stay, and hospital stay. The difference in mortality at 90 days was not significant (PC 12.7% versus LD 8.4%; odds ratio [OR], 1.52; 95% confidence interval [CI], 0.84 to 2.73). The in-hospital mortality rate was almost twice as high in the PC group (10.1% versus 5.5% in the LD group; OR, 1.99; 95% CI, 0.99 to 4.00). The incidence of multiple organ dysfunction syndrome in both groups was similar, although more patients with multiple organ dysfunction syndrome died in the PC group. LD was associated with a significantly reduced infection rate (PC 31.6% versus LD 21.6%; OR, 1.64; 95% CI, 1.08 to 2.49). In both groups, intensive care unit stay and hospital stay were similar, and postoperative complications increased with the number of transfused units. CONCLUSIONS: Mortality at 90 days was not significantly different; however, a beneficial effect of LD in valve surgery was found for the secondary end points of in-hospital mortality and infections.