CONTEXT Perioperative red blood cell transfusion is commonly used to address anemia, an independent risk factor for morbidity and mortality after cardiac operations; however, evidence regarding ...optimal blood transfusion practice in patients undergoing cardiac surgery is lacking. OBJECTIVE To define whether a restrictive perioperative red blood cell transfusion strategy is as safe as a liberal strategy in patients undergoing elective cardiac surgery. DESIGN, SETTING, AND PATIENTS The Transfusion Requirements After Cardiac Surgery (TRACS) study, a prospective, randomized, controlled clinical noninferiority trial conducted between February 2009 and February 2010 in an intensive care unit at a university hospital cardiac surgery referral center in Brazil. Consecutive adult patients (n = 502) who underwent cardiac surgery with cardiopulmonary bypass were eligible; analysis was by intention-to-treat. INTERVENTION Patients were randomly assigned to a liberal strategy of blood transfusion (to maintain a hematocrit ≥30%) or to a restrictive strategy (hematocrit ≥24%). MAIN OUTCOME MEASURE Composite end point of 30-day all-cause mortality and severe morbidity (cardiogenic shock, acute respiratory distress syndrome, or acute renal injury requiring dialysis or hemofiltration) occurring during the hospital stay. The noninferiority margin was predefined at −8% (ie, 8% minimal clinically important increase in occurrence of the composite end point). RESULTS Hemoglobin concentrations were maintained at a mean of 10.5 g/dL (95% confidence interval CI, 10.4-10.6) in the liberal-strategy group and 9.1 g/dL (95% CI, 9.0-9.2) in the restrictive-strategy group (P < .001). A total of 198 of 253 patients (78%) in the liberal-strategy group and 118 of 249 (47%) in the restrictive-strategy group received a blood transfusion (P < .001). Occurrence of the primary end point was similar between groups (10% liberal vs 11% restrictive; between-group difference, 1% 95% CI, −6% to 4%; P = .85). Independent of transfusion strategy, the number of transfused red blood cell units was an independent risk factor for clinical complications or death at 30 days (hazard ratio for each additional unit transfused, 1.2 95% CI, 1.1-1.4; P = .002). CONCLUSION Among patients undergoing cardiac surgery, the use of a restrictive perioperative transfusion strategy compared with a more liberal strategy resulted in noninferior rates of the combined outcome of 30-day all-cause mortality and severe morbidity. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01021631
There are no reports of the systemic human pathology of the novel swine H1N1 influenza (S-OIV) infection.
The autopsy findings of 21 Brazilian patients with confirmed S-OIV infection are presented. ...These patients died in the winter of the southern hemisphere 2009 pandemic, with acute respiratory failure.
Lung tissue was submitted to virologic and bacteriologic analysis with real-time reverse transcriptase polymerase chain reaction and electron microscopy. Expression of toll-like receptor (TLR)-3, IFN-gamma, tumor necrosis factor-alpha, CD8(+) T cells and granzyme B(+) cells in the lungs was investigated by immunohistochemistry.
Patients were aged from 1 to 68 years (72% between 30 and 59 yr) and 12 were male. Sixteen patients had preexisting medical conditions. Diffuse alveolar damage was present in 20 individuals. In six patients, diffuse alveolar damage was associated with necrotizing bronchiolitis and in five with extensive hemorrhage. There was also a cytopathic effect in the bronchial and alveolar epithelial cells, as well as necrosis, epithelial hyperplasia, and squamous metaplasia of the large airways. There was marked expression of TLR-3 and IFN-gamma and a large number of CD8(+) T cells and granzyme B(+) cells within the lung tissue. Changes in other organs were mainly secondary to multiple organ failure.
Autopsies have shown that the main pathological changes associated with S-OIV infection are localized to the lungs, where three distinct histological patterns can be identified. We also show evidence of ongoing pulmonary aberrant immune response. Our results reinforce the usefulness of autopsy in increasing the understanding of the novel human influenza A (H1N1) infection.
OBJECTIVES:To evaluate the effects of goal-directed therapy on outcomes in high-risk patients undergoing cardiac surgery.
DESIGN:A prospective randomized controlled trial and an updated metaanalysis ...of randomized trials published from inception up to May 1, 2015.
SETTING:Surgical ICU within a tertiary referral university-affiliated teaching hospital.
PATIENTS:One hundred twenty-six high-risk patients undergoing coronary artery bypass surgery or valve repair.
INTERVENTIONS:Patients were randomized to a cardiac output–guided hemodynamic therapy algorithm (goal-directed therapy group, n = 62) or to usual care (n = 64). In the goal-directed therapy arm, a cardiac index of greater than 3 L/min/m was targeted with IV fluids, inotropes, and RBC transfusion starting from cardiopulmonary bypass and ending 8 hours after arrival to the ICU.
MEASUREMENTS AND MAIN RESULTS:The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications. Patients from the goal-directed therapy group received a greater median (interquartile range) volume of IV fluids than the usual care group (1,000 625–1,500 vs 500 500–1,000 mL; p < 0.001, with no differences in the administration of either inotropes or RBC transfusions. The primary outcome was reduced in the goal-directed therapy group (27.4% vs 45.3%; p = 0.037). The goal-directed therapy group had a lower occurrence rate of infection (12.9% vs 29.7%; p = 0.002) and low cardiac output syndrome (6.5% vs 26.6%; p = 0.002). We also observed lower ICU cumulative dosage of dobutamine (12 vs 19 mg/kg; p = 0.003) and a shorter ICU (3 3–4 vs 5 4–7 d; p < 0.001) and hospital length of stay (9 8–16 vs 12 9–22 d; p = 0.049) in the goal-directed therapy compared with the usual care group. There were no differences in 30-day mortality rates (4.8% vs 9.4%, respectively; p = 0.492). The metaanalysis identified six trials and showed that, when compared with standard treatment, goal-directed therapy reduced the overall rate of complications (goal-directed therapy, 47/410 11% vs usual care, 92/415 22%; odds ratio, 0.40 95% CI, 0.26–0.63; p < 0.0001) and decreased the hospital length of stay (mean difference, –5.44 d; 95% CI, –9.28 to –1.60; p = 0.006) with no difference in postoperative mortality9 of 410 (2.2%) versus 15 of 415 (3.6%), odds ratio, 0.61 (95% CI, 0.26–1.47), and p = 0.27.
CONCLUSIONS:Goal-directed therapy using fluids, inotropes, and blood transfusion reduced 30-day major complications in high-risk patients undergoing cardiac surgery.
OBJECTIVE:To assess whether a restrictive strategy of RBC transfusion reduces 28-day mortality when compared with a liberal strategy in cancer patients with septic shock.
DESIGN:Single center, ...randomized, double-blind controlled trial.
SETTING:Teaching hospital.
PATIENTS:Adult cancer patients with septic shock in the first 6 hours of ICU admission.
INTERVENTIONS:Patients were randomized to the liberal (hemoglobin threshold, < 9g/dL) or to the restrictive strategy (hemoglobin threshold, < 7g/dL) of RBC transfusion during ICU stay.
MEASUREMENTS AND MAIN RESULTS:Patients were randomized to the liberal (n = 149) or to the restrictive transfusion strategy (n = 151) group. Patients in the liberal group received more RBC units than patients in the restrictive group (1 0–3 vs 0 0–2 unit; p < 0.001). At 28 days after randomization, mortality rate in the liberal group (primary endpoint of the study) was 45% (67 patients) versus 56% (84 patients) in the restrictive group (hazard ratio, 0.74; 95% CI, 0.53–1.04; p = 0.08) with no differences in ICU and hospital length of stay. At 90 days after randomization, mortality rate in the liberal group was lower (59% vs 70%) than in the restrictive group (hazard ratio, 0.72; 95% CI, 0.53–0.97; p = 0.03).
CONCLUSIONS:We observed a survival trend favoring a liberal transfusion strategy in patients with septic shock when compared with the restrictive strategy. These results went in the opposite direction of the a priori hypothesis and of other trials in the field and need to be confirmed.
There is scarce information about the relationships between postoperative pulmonary hemodynamics, inflammation, and outcomes in pediatric patients with congenital cardiac communications undergoing ...surgery. We prospectively studied 40 patients aged 11 (8–17) months (median with interquartile range) with a preoperative mean pulmonary arterial pressure of 48 (34–54) mmHg who were considered to be at risk for postoperative pulmonary hypertension. The immediate postoperative pulmonary/systemic mean arterial pressure ratio (PAP/SAPIPO, mean of first 4 values obtained in the intensive care unit, readings at 2-hour intervals) was correlated directly with PAP/SAP registered in the surgical room just after cardiopulmonary bypass (r=0.68, p<0.001). For the entire cohort, circulating levels of 15 inflammatory markers changed after surgery. Compared with patients with PAP/SAPIPO≤0.40 (n=22), those above this level (n=18) had increased pre- and postoperative serum levels of granulocyte colony-stimulating factor (p=0.040), interleukin-1 receptor antagonist (p=0.020), interleukin-6 (p=0.003), and interleukin-21 (p=0.047) (panel for 36 human cytokines) and increased mean platelet volume (p=0.018). Using logistic regression analysis, a PAP/SAPIPO>0.40 and a heightened immediate postoperative serum level of macrophage migration inhibitory factor (quartile analysis) were shown to be predictive of significant postoperative cardiopulmonary events (respective hazard ratios with 95% CIs, 5.07 (1.10–23.45), and 3.29 (1.38–7.88)). Thus, the early postoperative behavior of the pulmonary circulation and systemic inflammatory response are closely related and can be used to predict outcomes in this population.
Objective Although hyperlactatemia after cardiac surgery is common, the implications of raised levels remain controversial. The aim of this study was to evaluate whether high lactate levels after ...cardiac surgery are predictors of major complications including mortality. Patients and Methods This was a substudy of TRACS (Transfusion Requirements After Cardiac Surgery), which was designed as a prospective, randomized, controlled trial evaluating the effects of a transfusion strategy on morbidity and mortality. Results Of the 502 patients enrolled, 52 (10%) had at least 1 major complication. Patients with complications were older, had a higher EuroSCORE, lower left ventricular ejection fraction, lower preoperative hemoglobin, a higher prevalence of renal disease, and received more blood transfusions than the group without complications. Lactate levels were higher in the group with complications at the end of surgery (3.6 mmol/L 2.8-5.1 vs 3.3 mmol/L 2.2-4.8; P = .018), immediately after intensive care unit (ICU) admission (0 hour) (4.4 mmol/L 3.1-8.4 vs 4 mmol/L 2.6-6.4; P = .048); 6 hours (4 mmol/L 2.7-5.8 vs 2.6 mmol/L 2-3.6, P < .001), and 12 hours after admission (2.3 mmol/L 1.8-3.2 vs 1.7 mmol/L 1.3-2; P < .001). In a multivariate model, higher age (odds ratio OR, 1.048, 95% confidence interval CI, 1.011-1.086; P = .010), left ventricular ejection fraction (LVEF) lower than 40% (OR, 3.03; 95% CI, 1.200-7.510; P = .019 compared with LVEF of 40%-59%; OR, 3.571; 95% CI, 1.503-8.196; P = .004 compared with LVEF higher than 60%), higher EuroSCORE (OR, 1.138; 95% CI; 1.007-1.285; P = .038), red blood cell transfusion (OR, 1.230; 95% CI, 1.086-1.393; P = .001), and lactate levels 6 hours after ICU admission (OR, 3.28, 95% CI; 1.61-6.69; P = .001) are predictors of major complications. Conclusions Hyperlactatemia 6 hours after ICU admission is an independent risk factor for worse outcomes in adult patients after cardiac surgery.
Objectives Acute acquired hypofibrinogenemia in children undergoing cardiac surgery is a major concern because it often results in perioperative bleeding and high rates of allogeneic blood ...transfusion. Fibrinogen concentrate has been proposed as an alternative to cryoprecipitate (the gold standard therapy), with minimal infectious and immunologic risks. Our objective was to investigate the efficacy and safety of fibrinogen concentrate in children undergoing cardiac surgery. Methods In this randomized pilot study, patients were allocated to receive fibrinogen concentrate (60 mg/kg) or cryoprecipitate (10 mL/kg) if bleeding was associated with fibrinogen levels <1 g/dL after cardiopulmonary bypass weaning. The primary outcome was postoperative blood losses during the 48 hours after surgery. Results A total of 63 patients were included in the study, 30 in the fibrinogen concentrate group and 33 in the cryoprecipitate group. The median 48-hour blood loss was not significantly different between the 2 groups (320 mL interquartile range, 157-750 vs 410 mL interquartile range, 215-510, respectively; P = .672). After treatment, plasma fibrinogen concentration increased similarly following administration of both products. There were no differences in allogeneic blood transfusion after intervention treatment. Conclusions A large trial comparing fibrinogen concentrate and cryoprecipitate in the management of children with acute acquired hypofibrinogenemia during heart surgery is feasible. The preliminary results of our study showed that the use of fibrinogen concentrate was as efficient and safe as cryoprecipitate in the management of bleeding children undergoing cardiac surgery.
Background
The intra-aortic balloon pump (IABP) is often used in high-risk patients undergoing cardiac surgery to improve coronary perfusion and decrease afterload. The effects of the IABP on ...cerebral hemodynamics are unknown. We therefore assessed the effect of the IABP on cerebral hemodynamics and on neurological complications in patients undergoing cardiac surgery who were randomized to receive or not receive preoperative IABP in the ‘Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery’ (IABCS) trial.
Methods
This is a prospectively planned analysis of the previously published IABCS trial. Patients undergoing elective coronary artery bypass surgery with ventricular ejection fraction ≤ 40% or EuroSCORE ≥ 6 received preoperative IABP (
n
= 90) or no IABP (
n
= 91). Cerebral blood flow velocity (CBFV) of the middle cerebral artery through transcranial
Doppler
and blood pressure through Finometer or intra-arterial line were recorded preoperatively (
T
1) and 24 h (
T
2) and 7 days after surgery (
T
3) in patients with preoperative IABP (
n
= 34) and without IABP (
n
= 33). Cerebral autoregulation was assessed by the autoregulation index that was estimated from the CBFV response to a step change in blood pressure derived by transfer function analysis. Delirium, stroke and cognitive decline 6 months after surgery were recorded.
Results
There were no differences between the IABP and control patients in the autoregulation index (
T
1: 5.5 ± 1.9 vs. 5.7 ± 1.7;
T
2: 4.0 ± 1.9 vs. 4.1 ± 1.6;
T
3: 5.7 ± 2.0 vs. 5.7 ± 1.6,
p
= 0.97) or CBFV (
T
1: 57.3 ± 19.4 vs. 59.3 ± 11.8;
T
2: 74.0 ± 21.6 vs. 74.7 ± 17.5;
T
3: 71.1 ± 21.3 vs. 68.1 ± 15.1 cm/s;
p
= 0.952) at all time points. Groups were not different regarding postoperative rates of delirium (26.5% vs. 24.2%,
p
= 0.83), stroke (3.0% vs. 2.9%,
p
= 1.00) or cognitive decline through analysis of the Mini-Mental State Examination (16.7% vs. 40.7%;
p
= 0.07) and Montreal Cognitive Assessment (79.16% vs. 81.5%;
p
= 1.00).
Conclusions
The preoperative use of the IABP in high-risk patients undergoing cardiac surgery did not affect cerebral hemodynamics and was not associated with a higher incidence of neurological complications.
Trial registration
http://www.clinicaltrials.gov
(NCT02143544).
•Dynamic cerebral blood flow autoregulation is impaired on the first day following cardiac surgery.•Autoregulation index before and after surgery is predictive of post-operative delirium.•Patients ...with impaired dynamic cerebral autoregulation at 24 h and 7 days after surgery had a higher incidence of delirium.
We investigated the potential association of cerebral autoregulation (CA) with postoperative delirium (PD), a common complication of cardiac surgery with cardiopulmonary bypass (CPB).
In patients undergoing coronary artery bypass graft (CABG) surgery with CPB, cerebral blood flow velocity (CBFV) and blood pressure (BP) were continuously recorded during 5-min preoperatively (T1), after 24 h (T2), and 7 days after procedure (T3). Prospective multivariate logistic regression analysis was performed to determine the independent risk factors of PD. Autoregulation index (ARI) was calculated from the CBFV response to a step change in BP derived by transfer function analysis.
In 67 patients, mean age 64.3 ± 9.5 years, CA was depressed at T2 as shown by values of ARI (3.9 ± 1.7), compared to T1 (5.6 ± 1.7) and T3 (5.5 ± 1.8) (p < 0.001). Impaired CA was found in 37 (55%) patients at T2 and in 7 patients (20%) at T3. Lower ARI at T1 and T2 were predictors of PD (p = 0.003).
Dynamic CA was impaired after CABG surgery with CPB and was a significant independent risk factor of PD.
Assessment of CA before and after surgery could have considerable potential for early identification of patients at risk of PD, thus reducing poor outcomes and length of stay.
Clinical trials registration: www.clinicaltrials.gov (NCT02143544, April 30, 2014).
Despite advances in surgical technique and postoperative care in congenital heart disease, cardiovascular morbidity is still high.
To evaluate the association between preoperative cardiovascular ...fitness of children and adolescents, measured by the 6-minute walk test (6MWT) and Heart Rate Variability (HRV), and the occurrence of cardiogenic, septic shock and death in the postoperative period.
Prospective, observational clinic study including 81 patients aged from 8 to 18 years. In the preoperative period, the 6MWT (distance walked and SpO2) and HRV were performed. The adjusted risk score for surgeries for congenital heart disease (RACHS-1) was applied to predict the surgical risk factor for mortality. The occurrence of at least one of the listed complications was considered as a combined event. P values < 0.05 were considered as significant.
Of the patients, 59% were male, with mean age of 12 years; 33% were cyanotic; and 72% had undergone previous cardiac surgery. Cardiogenic shock was the most common complication, and 31% had a combined event. Prior to surgery, type of current heart disease, RACHS-1, SpO2at rest, during the 6MWT and recovery were selected for the multivariate analysis. The SpO2at recovery by the 6MWT remained as an independent risk factor (OR 0.93, 95%CI 0.88 - 0.99, p=0.02) for the increasing occurrence of combined events.
SpO2after the application of the 6MWT in the preoperative period was an independent predictor of prognosis in children and adolescents undergoing surgical correction; the walked distance and the HRV did not present this association.
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