Summary Background Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality. Steroids suppress inflammatory responses ...and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass. Methods The Steroids In caRdiac Surgery (SIRS) study is a double-blind, randomised, controlled trial. We used a central computerised phone or interactive web system to randomly assign (1:1) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone (250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass) or placebo. Patients were assigned with block randomisation with random block sizes of 2, 4, or 6 and stratified by centre. Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6. Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days. Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcomes were 30-day mortality and a composite of death and major morbidity (ie, myocardial injury, stroke, renal failure, or respiratory failure) within 30 days, both analysed by intention to treat. Safety outcomes were also analysed by intention to treat. This study is registered with ClinicalTrials.gov , number NCT00427388. Findings Patients were recruited between June 21, 2007, and Dec 19, 2013. Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone (n=3755) and to placebo (n=3752). Methylprednisolone, compared with placebo, did not reduce the risk of death at 30 days (154 4% vs 177 5% patients; relative risk RR 0·87, 95% CI 0·70–1·07, p=0·19) or the risk of death or major morbidity (909 24% vs 885 24%; RR 1·03, 95% CI 0·95–1·11, p=0·52). The most common safety outcomes in the methylprednisolone and placebo group were infection (465 12% vs 493 13%), surgical site infection (151 4% vs 151 4%), and delirium (295 8% vs 289 8%). Interpretation Methylprednisolone did not have a significant effect on mortality or major morbidity after cardiac surgery with cardiopulmonary bypass. The SIRS trial does not support the routine use of methylprednisolone for patients undergoing cardiopulmonary bypass. Funding Canadian Institutes of Health Research.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Objectives A systematic review of the European System for Cardiac Operative Risk Evaluation (euroSCORE) II performance for prediction of operative mortality after cardiac surgery has not been ...performed. We conducted a meta-analysis of studies based on the predictive accuracy of the euroSCORE II. Methods We searched the Embase and PubMed databases for all English-only articles reporting performance characteristics of the euroSCORE II. The area under the receiver operating characteristic curve, the observed/expected mortality ratio, and observed-expected mortality difference with their 95% confidence intervals were analyzed. Results Twenty-two articles were selected, including 145,592 procedures. Operative mortality occurred in 4293 (2.95%), whereas the expected events according to euroSCORE II were 4802 (3.30%). Meta-analysis of these studies provided an area under the receiver operating characteristic curve of 0.792 (95% confidence interval, 0.773-0.811), an estimated observed/expected ratio of 1.019 (95% confidence interval, 0.899-1.139), and observed-expected difference of 0.125 (95% confidence interval, −0.269 to 0.519). Statistical heterogeneity was detected among retrospective studies including less recent procedures. Subgroups analysis confirmed the robustness of combined estimates for isolated valve procedures and those combined with revascularization surgery. A significant overestimation of the euroSCORE II with an observed/expected ratio of 0.829 (95% confidence interval, 0.677-0.982) was observed in isolated coronary artery bypass grafting and a slight underestimation of predictions in high-risk patients (observed/expected ratio 1.253 and observed-expected difference 1.859). Conclusions Despite the heterogeneity, the results from this meta-analysis show a good overall performance of the euroSCORE II in terms of discrimination and accuracy of model predictions for operative mortality. Validation of the euroSCORE II in prospective populations needs to be further studied for a continuous improvement of patients' risk stratification before cardiac surgery.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Objectives To investigate the potential beneficial effects of posterior pericardial drainage in patients undergoing heart surgery. Methods Multiple online databases and relevant congress ...proceedings were screened for randomized controlled trials assessing the efficacy and safety of posterior pericardial drainage, defined as posterior pericardiotomy incision, chest tube to posterior pericardium, or both. Primary endpoint was in-hospital/30 days' cardiac tamponade. Secondary endpoints comprised death or cardiac arrest, early and late pericardial effusion, postoperative atrial fibrillation (POAF), acute kidney injury, pulmonary complications, and length of hospital stay. Results Nineteen randomized controlled trials that enrolled 3425 patients were included. Posterior pericardial drainage was associated with a significant 90% reduction of the odds of cardiac tamponade compared with the control group: odds ratio (95% confidence interval) 0.13 (0.07-0.25); P < .001. The corresponding event rates were 0.42% versus 4.95%. The odds of early and late pericardial effusion were reduced significantly in the intervention arm: 0.20 (0.11-0.36); P < .001 and 0.05 (0.02-0.10); P < .001, respectively. Posterior pericardial drainage significantly reduced the odds of POAF by 58% ( P < .001) and was associated with significantly shortened (by nearly 1 day) overall length of hospital stay ( P < .001). Reductions in postoperative complications translated into significantly reduced odds of death or cardiac arrest ( P = .03) and numerically lower odds of acute kidney injury ( P = .08). Conclusions Posterior pericardial drainage is safe and simple technique that significantly reduces not only the prevalence of early pericardial effusion and POAF but also late pericardial effusion and cardiac tamponade. These benefits, in turn, translate into improved survival after heart surgery.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Abstract Objectives To assess safety and effectiveness of different periprocedural antithrombotic strategies in patients receiving long-term oral anticoagulation and undergoing coronary angiography ...with or without percutaneous coronary intervention (PCI). Methods Studies comparing uninterrupted oral anticoagulation (UAC) with vit. K antagonists vs interrupted oral anticoagulation (IAC) with or without bridging anticoagulation before coronary procedures were eligible for inclusion in the current meta-analysis. Endpoints selected were 30-day composite of major adverse cardiovascular or cerebrovascular and thromboembolic events (MACCE) and major bleeding. Results Eight studies (7 observational and 1 randomized controlled trial N = 2325pts.) were included in the analysis. There was no difference in MACCE between UAC and IAC; RR (95%CIs): 0.74 (0.34–1.64); p = 0.46 but there was a statistically significant MACCE risk reduction with UAC as compared to IAC with bridging: 0.52 (0.29–0.95); p = 0.03. Likewise, there were no statistically significant differences between UAC vs IAC in regard to major bleeding: 0.62 (0.16–2.43); p = 0.49; but as compared to IAC with bridging, UAC was associated with statistically significant 65% lower risk of major bleeding: 0.35 (0.13–0.92); p = 0.03. Additionally, meta-regression analysis revealed significant linear correlation between log RR of MACCE ( β = − 4.617; p < 0.001) and major bleeding ( β = 6.665; p = 0.022) and mean value of target INR suggestive of higher thrombotic and secondary haemorrhagic risk below estimated INR cut-off of 2.17–2.27 within 30 days. Conclusions Uninterrupted OAC is at least as safe as interrupted OAC, and seems to be much safer than interrupted OAC with bridging anticoagulation in patients undergoing coronary angiography with or without PCI.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
Objective Myocardial damage occurs after valve surgery, but its prognostic implication has not been evaluated. The aim of the present study was to assess the influence of myocardial damage on ...mortality and morbidity in patients undergoing aortic surgery (AVS) and mitral valve surgery (MVS). Methods In a prospective multicenter study from the cardiac surgery registry of the Puglia region, cardiac troponin I (cTnI) was measured immediately after and the morning after the intervention in consecutive patients undergoing AVS or MVS. The percentile ranks of the cTnI peak values within each center were analyzed. Results Of 965 patients (age, 67 ± 12 years; 45.5% women), 579 had undergone AVS and 386 MVS. cTnI release was significantly greater in the MVS group than in the AVS group and in the nonsurvivors than in the survivors in both groups. The cTnI cutoff with the greatest sensitivity and specificity (60th percentile for AVS and 91st for MVS) in predicting hospital mortality (2.6%) was also associated with a greater rate of postoperative complications and mortality within 3 months postoperatively (multivariate hazard ratio, 3.38; P = .005). Compared with the reference model, which included the multivariate predictors of hospital mortality (active endocarditis, New York Heart Association class III-IV, left ventricular ejection fraction ≤ 30%, and cardiopulmonary bypass duration), the addition of cTnI greater than the cutoffs showed significant improvement in model performance (likelihood ratio test, P = .009; net reclassification improvement, 0.751; P < .001; integrated discrimination improvement, 0.048; P = .002; c-index 0.832 vs 0.838). Conclusions An elevated postoperative cTnI level was an independent risk factor for mortality and morbidity. Measurement of the cTnI level improved the risk reclassification of patients undergoing AVS or MVS.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objectives To assess the incidence of incomplete heparin reversal and heparin rebound after cardiac surgery with cardiopulmonary bypass (CPB) and the ability of the activated coagulation time (ACT) ...and thromboelastography (TEG) to detect these phenomena. Design Prospective single-center study. Setting University hospital. Participants Forty-one patients undergoing elective cardiac surgery with CPB and with normal preoperative TEG parameters. Interventions ACT, TEG, and plasma heparin levels were measured in all patients at 5 different times between 20 minutes and 3 hours after protamine administration. The variability of TEG reaction time (R) with and without heparinase (delta-R DR) was used to detect the presence of residual heparin. Measurements and Main Results Plasma heparin expressed as anti-FXa activity was detected in 180 (88%) samples. At univariate analysis, ACT, R-kaolin (R-k), and DR significantly correlated with plasma heparin concentration (respectively, p = 0.007, p = 0.006, and p = 0.002). At multivariate analysis, R-k and DR remained associated with plasma heparin concentration (respectively, p = 0.014 and p = 0.004). Greater quartiles of heparin were associated with higher values of R-k and DR. Combined procedures had significantly lower DR than isolated procedures (p = 0.017), and CPB time and heparinization time positively correlated with R-k (respectively, p = 0.044 and p = 0.022). No association was observed between heparin concentration, ACT, and TEG parameters with postoperative bleeding and need for blood and blood components transfusions. Conclusions Heparin rebound and incomplete heparin reversal are very common phenomena after cardiac surgery with CPB; ACT is not able to detect residual heparin activity, whereas TEG analysis with and without heparinase allows the diagnosis of heparin rebound.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Surgery for acute aortic dissection (AAD) is frequently complicated by excessive postoperative bleeding and blood product transfusion. Blood flow through the nonendothelialized false lumen ...is a potential trigger for the activation of the hemostatic system; however, the physiopathology of the aortic dissection induced coagulopathy has never been precisely studied. The aim of the present study is the evaluation of the coagulation and fibrinolytic systems and platelet activation in patients undergoing surgery for AAD. Methods Eighteen patients undergoing emergent surgery for Stanford type A AAD were enrolled in the study. The activation of the coagulation and fibrinolytic systems and platelet activation were evaluated at 6 different time points before, during, and after the operation, measuring prothrombin fragment 1.2 (F1.2), plasmin-antiplasmin complex, and platelet factor 4, respectively. Results All measured biomarkers were increased before, during, and after the operations indicating a systemic activation of coagulation, fibrinolysis, and platelets. These changes were pronounced even preoperatively (T0), and soon after the beginning of cardiopulmonary bypass (T1) when the influence of hypothermia and prolonged cardiopulmonary bypass time were not yet involved. Time from symptom onset to intervention inversely correlated with preoperative F1.2 (r = −0.75; p = 0.002) and plasmin-antiplasmin levels (r = −0.57; p = 0.034). Conclusions Blood flow through the false lumen is a powerful activator of the hemostatic system even before the operation. This remarkable activation may influence postoperative outcome of AAD patients.
Background Steroids may improve outcomes in high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CBP). There is a need\ for a large randomized controlled trial to ...clarify the effect of steroids in such patients. Methods We plan to randomize 7,500 patients with elevated European System for Cardiac Operative Risk Evaluation who are undergoing cardiac surgery with the use of CBP to methylprednisolone or placebo. The first coprimary outcome is 30-day all-cause mortality, and the most second coprimary outcome is a composite of death, MI, stroke, renal failure, or respiratory failure within 30 days. Other outcomes include a composite of MI or mortality at 30 days, new onset atrial fibrillation, bleeding and transfusion requirements, length of intensive care unit stay and hospital stay, infection, stroke, wound complications, gastrointestinal complications, delirium, postoperative insulin use and peak blood glucose, and all-cause mortality at 6 months. Results As of October 22, 2013, 7,034 patients have been recruited into SIRS in 82 centers from 18 countries. Patient’s mean age is 67.3 years, and 60.4% are male. The average European System for Cardiac Operative Risk Evaluation is 7.0 with 22.1% having an isolated coronary artery bypass graft procedure, and 66.1% having a valve procedure. Conclusions SIRS will lead to a better understanding of the safety and efficacy of prophylactic steroids for cardiac surgery requiring CBP.
Full text
Available for:
GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
10.
Invited Commentary Paparella, Domenico, MD
The Annals of thoracic surgery,
2011, Volume:
92, Issue:
6
Journal Article
PDF
