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Patients who exhibit high systemic inflammation after cardiac surgery may benefit most from pre-emptive anti-inflammatory treatments. In this secondary analysis ( n  = 813) of the randomised, double-blind Intraoperative High-Dose Dexamethasone for Cardiac Surgery trial, we set out to develop an inflammation risk prediction model and assess whether patients at higher risk benefit from a single intraoperative dose of dexamethasone (1 mg/kg). Inflammation risk before surgery was quantified from a linear regression model developed in the placebo arm, relating preoperatively available covariates to peak postoperative C-reactive protein. The primary endpoint was the interaction between inflammation risk and the peak postoperative C-reactive protein reduction associated with dexamethasone treatment. The impact of dexamethasone on the main clinical outcome (a composite of death, myocardial infarction, stroke, renal failure, or respiratory failure within 30 days) was also explored in relation to inflammation risk. Preoperatively available covariates explained a minority of peak postoperative C-reactive protein variation and were not suitable for clinical application (R 2  = 0.058, P  = 0.012); C-reactive protein before surgery (excluded above 10 mg/L) was the most predictive covariate ( P <  0.001). The anti-inflammatory effect of dexamethasone increased as the inflammation risk increased (-0.689 mg/L per unit predicted peak C-reactive protein, P  = 0.002 for interaction). No treatment-effect heterogeneity was detected for the main clinical outcome ( P  = 0.167 for interaction). Overall, risk predictions from a model of inflammation after cardiac surgery were associated with the degree of peak postoperative C-reactive protein reduction derived from dexamethasone treatment. Future work should explore the impact of this phenomenon on clinical outcomes in larger surgical populations., Competing Interests: Declaration of conflicting interestsThe authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Convalescent plasma is a promising therapy for coronavirus disease 2019 (COVID-19), but its efficacy in intensive care unit (ICU) patients in low- and middle-income country settings such as Suriname is unknown. Bedside plasma separation using the HemoClear device made convalescent plasma therapy accessible as a treatment option in Suriname. Two hundred patients with severe SARS-CoV-2 infection requiring intensive care were recruited. Fifty eight patients (29%) received COVID-19 convalescent plasma (CCP) treatment in addition to standard of care (SOC). The CCP treatment and SOC groups were matched by age, sex, and disease severity scores. Mortality in the CCP treatment group was significantly lower than that in the SOC group (21% versus 39%; Fisher's exact test P = 0.0133). Multivariate analysis using ICU days showed that CCP treatment reduced mortality (hazard ratio [HR], 0.35; 95% confidence interval [CI], 0.18 to 0.66; P = 0.001), while complication of acute renal failure (creatinine levels, >110 mol/L; HR, 4.45; 95% CI, 2.54 to 7.80; P < 0.0001) was independently associated with death. Decrease in chest X-ray score in the CCP treatment group (median -3 points, interquartile range [IQR] -4 to -1) was significantly greater than that in the SOC group (median -1 point, IQR -3 to 1, Mann-Whitney test P = 0.0004). Improvement in the PaO 2 /FiO 2 ratio was also significantly greater in the CCP treatment group (median 83, IQR 8 to 140) than in the SOC group (median 35, IQR -3 to 92, Mann-Whitney P = 0.0234). Further research is needed for HemoClear-produced CCP as a therapy for SARS-CoV-2 infection together with adequately powered, randomized controlled trials. IMPORTANCE This study compares mortality and other endpoints between intensive care unit COVID-19 patients treated with convalescent plasma plus standard of care (CCP), and a control group of patients hospitalized in the same medical ICU facility treated with standard of care alone (SOC) in a low- and middle-income country (LMIC) setting using bedside donor whole blood separation by gravity (HemoClear) to produce the CCP. It demonstrates a significant 65% survival improvement in HemoClear-produced CCP recipients (HR, 0.35; 95% CI, 0.19 to 0.66; P = 0.001). Although this is an exploratory study, it clearly shows the benefit of using the HemoClear-produced CCP in ICU patients in the Suriname LMIC setting. Additional studies could further substantiate our findings and their applicability for both LMICs and high-income countries and the use of CCP as a prepared readiness method to combat new viral pandemics.

Objectives: The introduction and use of a preincision safety check were associated with lower mortality after mixed adult cardiac surgery; however, an explanatory mechanism is lacking. Stroke, one of the most severe complications after cardiac surgery, with high mortality, may be reduced by adapting the surgical handling of the ascending aorta. This study assessed the prevalence and predictors of this adaptation after a preincision safety check and the subsequent effect on outcome., Design: A prospective, single-center, observational study comparing adaptation with no-adaptation. The primary outcome measure was 30-day mortality. Multivariate analyses were performed to determine independent predictors of adaptation. To study the effect of adaptation on outcome, a propensity score-matched cohort was constructed in a 1:3 intervention:control ratio., Setting: At Isala Zwolle (NL), a large, nonacademic teaching hospital., Participants: All consecutive cardiac surgery procedures from 2012 until 2015, including 4,752 surgeries., Interventions: The adaptation of surgical handling of the ascending aorta., Measurements and Main Results: In 283 cardiac surgeries (5.9%), adaptation was indicated. The most important independent predictors for adaptation were extracardiac atherosclerosis, current smoking, and increasing age. In the propensity score-matched cohort consisting of 1,069 procedures, there were no significant differences in outcome. After correction for propensity score, the hazard ratio of adaptation for 30-day mortality was 1.8 (0.85-3.79)., Conclusions: The adaptation of aortic surgical handling after a preincision safety check was necessary for 5.9% of cardiac surgeries, with extracardiac atherosclerosis as the strongest predictor. Outcome was not significantly different between patients with and without adaptation. Although promising, it remains unclear whether adaptation may fully explain mortality reduction after the use of a preincision safety check., (Copyright © 2022 Elsevier Inc. All rights reserved.)

Objectives: Our objectives were to determine the separation characteristics and blood product quality of a gravity-driven microfiltration blood separation system (HemoClear, The Netherlands)., Background: A range of centrifugal blood separation devices, including intraoperative cell salvage devices (cell savers) and apheresis machines, are available to assist in preparing both allogenic and autologous blood products. These devices are expensive to operate and require extensive training., Methods and Materials: Nine whole blood units were collected under standard conditions and analysed for haematological parameters, thromboelastographic properties, platelet morphology and activation, and red blood cell (RBC) deformability and morphology. Three whole blood units were separated by means of the HemoClear device, into a liquid and cellular component. The cellular component was diluted with SAGM and cold stored for 14 days. To simulate cell salvage six whole blood units were diluted with isotonic saline, followed by multiple HemoClear separation rounds., Results: The recovery of both RBCs (100 ± 1.6%) and white blood cells (99 ± 4.5%) after undiluted filtration were very high, while platelet recovery was high (83 ± 3.0%). During the filtration, and cold storage after filtration storage both the non-deformable RBC fraction and the RBC maximum elongation remained stable. Parameters of thromboelastography indicated that platelets remain functional after filtration and after 7 days of cold storage. In the cell salvage simulation the total protein load in the cellular fraction was reduced by 65 ± 4.1% after one washing round and 84 ± 1.9% after two consecutive washing rounds., Conclusion: The novel blood filter studied effectively separates whole blood into diluted plasma and platelet-rich RBCs. Moreover, the device effectively washed diluted whole blood, driving over 80% of proteins to the liquid component., (© 2021 The Authors. Transfusion Medicine published by John Wiley & Sons Ltd on behalf of British Blood Transfusion Society.)

Background: In 2013, the World Health Organization reported a shortage of 17 million red blood cell units, a number that remains growing. Acts to relieve this shortage have primarily focused on allogeneic blood collection. Nevertheless, autologous transfusion can partially alleviate the current pressure and dependence on blood banking systems. To achieve this, current gold standard autotransfusion devices should be complemented with widely available, cost-efficient, and time-efficient devices. The novel HemoClear cell salvage device (HemoClear BV, Zwolle, Netherlands), a gravity-driven microfilter, potentially is widely employable. We evaluated its performance in the cardiac postoperative setting compared to the centrifugal XTRA™ autotransfusion device., Methods: In a split-unit study ( n  = 18), shed blood collected 18 hours after cardiothoracic surgery was divided into two equal volumes. One-half was processed by the XTRA™ device and the other with the HemoClear blood separation system. In this paired set-up, equal washing volumes were used for both methods. Washing effectivity and cellular recovery were determined by measuring of complete blood count, free hemoglobin, complement C3, complement C4, and D-dimer in both concentrate as filtrate. Also, processing times and volumes were evaluated., Results: The HemoClear and XTRA™ devices showed equal effectiveness in concentrating erythrocytes and leucocytes. Both methods reduced complement C3, complement C4, and D-dimer by ≥90%. The centrifugal device reduced solutes more significantly by up to 99%. Free hemoglobin load was reduced to 12.9% and 15.5% by the XTRA™ and HemoClear, respectively., Conclusion: The HemoClear device effectively produced washed concentrated red blood cells comparably to the conventional centrifugal XTRA™ autotransfusion device. Although the centrifugal XTRA™ device achieved a significantly higher reduction in contaminants, the HemoClear device achieved acceptable blood quality and seems promising in settings where gold standard cell savers are unaffordable or unpractical., Competing Interests: Arno P. Nierich is the inventor of the HemoClear filter and holds stock ownership in HemoClear BV, Dr. Stolteweg 70, 8025 AZ Zwolle, Netherlands., (Copyright © 2020 Anneloes Hoetink et al.)

Introduction: In cardiac surgery, a preincision safety checklist may decrease complications and improve survival. Until now, it has not been demonstrated whether the implementation of such a checklist indeed reduces mortality., Objective: Introduction of a preincision safety checklist on mortality was studied in a large adult cardiac surgery population., Methods: This prospective, multicenter cohort study included 5937 consecutive adult patients, undergoing cardiac surgery, between January 2015 and December 2015, in 7 Dutch non-academic cardiac centers. The Isala Safety Check (ISC) is a short checklist addressing specific cardiac surgery safety items, in combination with a concise postinduction transesophageal echocardiography, which was gradually over time introduced in the 7 hospitals during 2015. We compared 120-day mortality and major complications between patients undergoing surgery with or without the use of the ISC. Propensity matching and Cox regression analyses were performed to adjust for potential confounders., Results: The ISC was applied in 2718 patients (46%). Comorbidity and age were comparable in both groups. In the ISC group, 120-day mortality was significantly lower (1.7% vs 3.0%; P < .01). Both after propensity matching (hazard ratio, 0.44; 95% confidence interval, 0.22-0.87) and Cox regression analysis (hazard ratio, 0.56; 95% confidence interval, 0.35-0.90), the use of the ISC was still associated with reduced 120-day mortality. Deep sternal wound infection, surgical re-exploration, and stroke were not significantly different between both groups., Conclusions: Application of a short preincision safety checklist in a mixed population of adult cardiac surgery patients is associated with significantly reduced 120-day mortality., (Copyright © 2019 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Prophylactic intra-operative administration of dexamethasone may improve short-term clinical outcomes in cardiac surgical patients. The purpose of this study was to evaluate long-term clinical outcomes and cost effectiveness of dexamethasone versus placebo. Patients included in the multicentre, randomised, double-blind, placebo-controlled DExamethasone for Cardiac Surgery (DECS) trial were followed up for 12 months after their cardiac surgical procedure. In the DECS trial, patients received a single intra-operative dose of dexamethasone 1 mg.kg -1 (n = 2239) or placebo (n = 2255). The effects on the incidence of major postoperative events were evaluated. Also, overall costs for the 12-month postoperative period, and cost effectiveness, were compared between groups. Of 4494 randomised patients, 4457 patients (99%) were followed up until 12 months after surgery. There was no difference in the incidence of major postoperative events, the relative risk (95%CI) being 0.86 (0.72-1.03); p = 0.1. Treatment with dexamethasone reduced costs per patient by £921 [€1084] (95%CI £-1672 to -137; p = 0.02), mainly through reduction of postoperative respiratory failure and duration of postoperative hospital stay. The probability of dexamethasone being cost effective compared with placebo was 97% at a threshold value of £17,000 [€20,000] per quality-adjusted life year. We conclude that intra-operative high-dose dexamethasone did not have an effect on major adverse events at 12 months after cardiac surgery, but was associated with a reduction in costs. Routine dexamethasone administration is expected to be cost effective at commonly accepted threshold levels for cost effectiveness., (© 2017 The Association of Anaesthetists of Great Britain and Ireland.)

Aims: Acute aortic dissection (AD) requires immediate treatment, but is a diagnostic challenge. We studied how often AD was missed initially, which patients were more likely to be missed and how this influenced patient management and outcomes., Methods: A retrospective cohort study including 200 consecutive patients with AD as the final diagnosis, admitted to a tertiary hospital between 1998 and 2008. The first differential diagnosis was identified and patients with and without AD included were compared. Characteristics associated with a lower level of suspicion were identified using multivariable logistic regression, and Cox regression was used for survival analyses. Missing data were imputed., Results: Mean age was 63 years, 39% were female and 76% had Stanford type A dissection. In 69% of patients, AD was included in the first differential diagnosis; this was less likely in women (adjusted relative risk [aRR]: 0.66, 95% CI: 0.44-0.99), in the absence of back pain (aRR: 0.51, 95% CI: 0.30-0.84), and in patients with extracardiac atherosclerosis (aRR: 0.64, 95% CI: 0.43-0.96). Absence of AD in the differential diagnosis was associated with the use of more imaging tests (1.8 vs. 2.3, p = 0.01) and increased time from admission to surgery (1.8 vs. 10.1 h, p < 0.01), but not with a difference in the adjusted long-term all-cause mortality (hazard ratio: 0.76, 95% CI: 0.46-1.27)., Conclusion: Acute aortic dissection was initially not suspected in almost one-third of patients, this was more likely in women, in the absence of back pain and in patients with extracardiac atherosclerosis. Although the number of imaging tests was higher and time to surgery longer, patient outcomes were similar in both groups.

Importance: Fibrinogen concentrate might partly restore coagulation defects and reduce intraoperative bleeding., Objective: To determine whether fibrinogen concentrate infusion dosed to achieve a plasma fibrinogen level of 2.5 g/L in high-risk cardiac surgery patients with intraoperative bleeding reduces intraoperative blood loss., Design, Setting, and Participants: A randomized, placebo-controlled, double-blind clinical trial conducted in Isala Zwolle, the Netherlands (February 2011-January 2015), involving patients undergoing elective, high-risk cardiac surgery (ie, combined coronary artery bypass graft [CABG] surgery and valve repair or replacement surgery, the replacement of multiple valves, aortic root reconstruction, or reconstruction of the ascending aorta or aortic arch) with intraoperative bleeding (blood volume between 60 and 250 mL suctioned from the thoracic cavity in a period of 5 minutes) were randomized to receive either fibrinogen concentrate or placebo., Interventions: Intravenous, single-dose administration of fibrinogen concentrate (n = 60) or placebo (n = 60), targeted to achieve a postinfusion plasma fibrinogen level of 2.5 g/L., Main Outcomes and Measures: The primary outcome was blood loss in milliliters between intervention (ie, after removal of cardiopulmonary bypass) and closure of chest. Safety variables (within 30 days) included: in-hospital mortality, myocardial infarction, cerebrovascular accident or transient ischemic attack, renal insufficiency or failure, venous thromboembolism, pulmonary embolism, and operative complications., Results: Among 120 patients (mean age; 71 [SD, 10] years, 37 women [31%]) included in the study, combined CABG and valve repair or replacement surgery comprised 72% of procedures and had a mean (SD) cardiopulmonary bypass time of 200 minutes (83) minutes. For the primary outcome, median blood loss in the fibrinogen group was 50 mL (interquartile range [IQR], 29-100 mL) compared with 70 mL (IQR, 33-145 mL) in the control group (P = .19), the absolute difference 20 mL (95% CI, -13 to 35 mL). There were 6 cases of stroke or transient ischemic attack (4 in the fibrinogen group); 4 myocardial infarctions (3 in the fibrinogen group); 2 deaths (both in the fibrinogen group); 5 cases with renal insufficiency or failure (3 in the fibrinogen group); and 9 cases with reoperative thoracotomy (4 in the fibrinogen group)., Conclusions and Relevance: Among patients with intraoperative bleeding during high-risk cardiac surgery, administration of fibrinogen concentrate, compared with placebo, resulted in no significant difference in the amount of intraoperative blood loss., Trial Registration: clinicaltrials.gov Identifier: NCT01124981 and EudraCT No: 2009-018086-12.

The aim of this study was to investigate the impact of perioperative screening with modified transesophageal echocardiography (A-View method). We compared, in consecutive patients who underwent cardiac surgery between 2006 and 2014, 30-day mortality and in-hospital stroke incidence, operated either with perioperative modified TEE screening (intervention group) or only with conventional TEE screening (control group). Of the 8,605 study patients, modified TEE was applied in 1,391 patients (16.2%). Patients in the intervention group were on average older (71 versus 68 years, p < 0.001) and more often females (31.0% versus 28.0%, p < 0.001) and had a higher predicted mortality (EuroSCORE I: 5.9% versus 4.0%, p < 0.001). The observed 30-day mortality was 2.2% and 2.5% in both groups, respectively, with multivariable and propensity-score adjusted relative risks (RRs) of 0.70 (95% CI: 0.50-1.00, p = 0.05) and 0.67 (95% CI: 0.45-0.98, p = 0.04). In-hospital stroke was 2.9% and 2.1% in both groups, respectively, with adjusted RRs of 1.03 (95% CI: 0.73-1.45) and 1.01 (95% CI: 0.71-1.43). In patients undergoing cardiac surgery, use of perioperative screening for aortic atherosclerosis with modified TEE was associated with lower postoperative mortality, but not stroke, as compared to patients operated on without such screening.

In patients undergoing cardiac surgery, use of perioperative screening for aortic atherosclerosis with modified TEE (A-View method) was associated with lower postoperative mortality, but not stroke, as compared to patients operated on without such screening. At the time of clinical implementation and validation, we did not yet standardize the indications for modified TEE and the changes in patient management in the presence of aortic atherosclerosis. Therefore, we designed a protocol, which combined the diagnosis of atherosclerosis of thoracic aorta and the subsequent considerations with respect to the intraoperative management and provides a systematic approach to reduce the risk of cerebral complications.

Background: Post-traumatic stress disorder (PTSD) and depression are common after cardiac surgery. Lifetime stress exposure and personality traits may influence the development of these psychiatric conditions., Methods: Self-reported rates of PTSD and depression and potential determinants (i.e., trait anxiety and stress exposure) were established 1.5 to 4 years after cardiac surgery. Data was available for 1125 out of 1244 (90.4%) participants. Multivariable linear regressions were conducted to investigate mediating and/or moderating effects of trait anxiety on the relationship between stress exposure, and PTSD and depression. Pre-planned subgroup analyses were performed for both sexes., Results: PTSD and depression symptoms were present in 10.2% and 13.1% of the participants, respectively. Trait anxiety was a full mediator of the association between stress exposure and depression in both the total cohort and female and male subgroups. Moreover, trait anxiety partially mediated the relationship between stress exposure and PTSD in the full cohort and the male subgroup, whereas trait anxiety fully mediated this relationship in female patients. Trait anxiety did not play a moderating role in the total patient sample, nor after stratification on gender., Limitations: The unequal distribution of male (78%) and female patients (22%) might limit the generalizability of our findings. Furthermore, risk factors were investigated retrospectively and with variable follow-up time., Conclusions: In cardiac surgery patients, trait anxiety was found to be an important mediator of postoperative PTSD and depression. Prospective research is necessary to verify whether these factors are reliable screening measures of individuals' vulnerability for psychopathology development after cardiac surgery., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Background: Transesophageal echocardiography (TEE) is a key diagnostic modality in patients with acute aortic dissection, yet its sensitivity is limited by a "blind-spot" caused by air in the trachea. After placement of a fluid-filled balloon in the trachea visualization of the thoracic aorta becomes possible. This method, modified TEE, has been shown to be an accurate test for the diagnosis of upper aortic atherosclerosis. In this study we discuss how we use modified TEE for the diagnosis and management of patients with (suspected) acute aortic dissection., Novel Diagnostic Approach of the Dissected Aorta: Modified TEE provides the possibility to obtain a complete echocardiographic overview of the thoracic aorta and its branching vessels with anatomical and functional information. It is a bedside test, and can thus be applied in hemodynamic instable patients who cannot undergo computed tomography. Visualization of the aortic arch allows differentiation between Stanford type A and B dissections and visualization of the proximal cerebral vessels enables a timely identification of impaired cerebral perfusion. During surgery modified TEE can be applied to identify the true lumen for cannulation, and to assure that the true lumen is perfused. Also, the innominate- and carotid arteries can be assessed for structural integrity and adequate perfusion during multiple phases of the surgical repair., Conclusions: Modified TEE can reveal the "blind-spot" of conventional TEE. In patients with (suspected) aortic dissection it is thus possible to obtain a complete echocardiographic overview of the thoracic aorta and its branches. This is of specific merit in hemodynamically unstable patients who cannot undergo CT. Modified TEE can guide also guide the surgical management and monitor perfusion of the cerebral arteries.

Uncalibrated arterial waveform analysis enables dynamic preload assessment in a minimally invasive fashion. Evidence about the validity of the technique in patients with impaired left ventricular function is scarce, while adequate cardiac preload assessment would be of great value in these patients. The aim of this study was to investigate the diagnostic accuracy of stroke volume variation (SVV) measured with the FloTrac/Vigileo™ system in patients with impaired left ventricular function. In this prospective, observational study, 22 patients with a left ventricular ejection fraction of 40 % or less undergoing elective coronary artery bypass grafting were included. Patients were considered fluid responsive if cardiac output increased with 15 % or more after volume loading (7 ml kg(-1) ideal body weight). The following variables were calculated: area under the receiver operating characteristics (ROC) curve, ideal cut-off value for SVV, sensitivity, specificity, positive and negative predictive values, and overall accuracy. In addition, SVV cut-off points to obtain 90 % true positive and 90 % true negative predictions were determined. ROC analysis revealed an area under the curve of 0.70 [0.47; 0.92]. The ideal SVV cut-off value was 10 %, with a corresponding sensitivity and specificity of 56 and 69 % respectively. Overall accuracy was 64 %, positive and negative predictive values were 69 and 56 % respectively. SVV values to obtain more than 90 % true positive and negative predictions were 16 and 6 % respectively. The ability of uncalibrated arterial waveform analysis SVV to predict fluid responsiveness in patients with impaired LVF was low.

Background: In patients with symptomatic severe aortic stenosis, advanced age is often a reason for a transcatheter rather than surgical aortic valve replacement. In this pre-transcatheter cohort we had the unique opportunity to study outcomes after surgical aortic valve replacement for severe aortic stenosis in patients who might currently be triaged to a percutaneous approach., Methods: In a prospective single-center cohort study we compared the incidence of peri-operative complications, mortality, and health-related quality of life in octogenarians versus patients aged <80 years. The quality of life was measured using the SF-36 questionnaire and expressed as a physical and mental component score (PCS and MCS respectively); a score of 50 equals the average score in the age-matched general population. The association between age and the component scores at one-year follow-up was studied with the use of linear regression, corrected for a set of confounding variables., Results: We included 762 patients, of whom 21.4 % was aged >80 and 49.0 % underwent concomitant revascularization. In octogenarians, the incidence of post-operative delirium was 11.0 %, which was higher than in patients aged below 80 (6.2 %, p = 0.034); the operative mortality (1.9 % vs. 2.9 %; p = 0.59) and long-term survival were not different however (log-rank p = 0.75). In octogenarians, the quality of life was impaired 30-days after surgery (PCS 45.01, p < 0.001; MCS 48.21, p = 0.04), which improved towards or above normal values at one-year follow-up (PCS: 49.92, p = 0.67, MCS: 52.55, p < 0.001). After correction for confounding, age was not significantly associated with the one-year PCS (β 0.08 per year, p = 0.34) or MCS (β 0.08 per year, p = 0.32)., Conclusions: This pre-transcatheter study showed that surgical aortic valve replacement in octogenarians could be performed with very low mortality, and with a relevant and significant increase of the quality of life towards normal values. Also, age was not associated with a lower PCS or MCS one-year after surgery.

Objective: Cardiac surgery and postoperative admission to the ICU may lead to posttraumatic stress disorder and depression. Perioperatively administered corticosteroids potentially alter the risk of development of these psychiatric conditions, by affecting the hypothalamic-pituitary-adrenal axis. However, findings of previous studies are inconsistent. We aimed to assess the effect of a single dose of dexamethasone compared with placebo on symptoms of posttraumatic stress disorder and depression and health-related quality of life after cardiac surgery and ICU admission., Design: Follow-up study of a randomized clinical trial., Setting: Five Dutch heart centers., Patients: Cardiac surgery patients (n = 1,244) who participated in the Dexamethasone for Cardiac Surgery trial., Interventions: A single intraoperative IV dose of dexamethasone or placebo was administered in a randomized, double-blind way., Measurements and Main Results: Symptoms of posttraumatic stress disorder, depression, and health-related quality of life were assessed with validated questionnaires 1.5 years after randomization. Data were available for 1,125 patients (90.4%); of which 561 patients received dexamethasone and 564 patients received placebo. Overall, the prevalence of psychopathology was not influenced by dexamethasone. Posttraumatic stress disorder and depression were present in, respectively, 52 patients (9.3%) and 69 patients (12.3%) who received dexamethasone and in 66 patients (11.7%) and 78 patients (13.8%) who received placebo (posttraumatic stress disorder: odds ratio, 0.82; 95% CI, 0.55-1.20; p = 0.30; depression: odds ratio, 0.92; 95% CI, 0.64-1.31; p = 0.63). Subgroup analysis revealed a lower prevalence of posttraumatic stress disorder (odds ratio, 0.23; 95% CI, 0.07-0.72; p < 0.01) and depression (odds ratio, 0.29; 95% CI, 0.11-0.77; p < 0.01) in female patients after dexamethasone administration. Health-related quality of life did not differ between groups and was not associated with psychopathology., Conclusions: Overall, our findings suggest that exogenous administration of the glucocorticoid receptor agonist dexamethasone-compared with placebo-during cardiac surgery does not positively or negatively affect the prevalence of posttraumatic stress disorder and depression. However, in female patients, beneficial effects on the occurrence of posttraumatic stress disorder and depression may be present.

Background: Medical guidelines increasingly use risk stratification and implicitly assume that individuals classified in the same risk category form a homogeneous group, while individuals with similar, or even identical, predicted risks can still be very different. We evaluate a strategy to identify homogeneous subgroups typically comprising predicted risk categories to allow further tailoring of treatment allocation and illustrate this strategy empirically for cardiac surgery patients with high postoperative mortality risk., Methods: Using a dataset of cardiac surgery patients (n=6517) we applied cluster analysis to identify homogenous subgroups of patients comprising the high postoperative mortality risk group (EuroSCORE ≥ 15%). Cluster analyses were performed separately within younger (<75 years) and older (≥ 75 years) patients. Validity measures were calculated to evaluate quality and robustness of the identified subgroups., Results: Within younger patients two distinct and robust subgroups were identified, differing mainly in preoperative state and indication of recent myocardial infarction or unstable angina. In older patients, two distinct and robust subgroups were identified as well, differing mainly in preoperative state, presence of chronic pulmonary disease, previous cardiac surgery, neurological dysfunction disease and pulmonary hypertension., Conclusions: We illustrated a feasible method to identify homogeneous subgroups of individuals typically comprising risk categories. This allows a single treatment strategy--optimal only on average, across all individuals in a risk category--to be replaced by subgroup-specific treatment strategies, bringing us another step closer to individualized care. Discussions on allocation of cardiac surgery patients to different interventions may benefit from focusing on such specific subgroups., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

Objectives: Uncalibrated arterial waveform analysis provides minimally invasive and continuous measurement of cardiac output (CO). This technique could be of great value in patients with impaired left ventricular function, but the validity in these patients is not well established. The aim of this study was to investigate the accuracy, precision, and trending ability of uncalibrated arterial waveform analysis of cardiac output in patients with impaired left ventricular function., Design: Prospective, observational, method-comparison study., Setting: Nonuniversity teaching hospital, single center., Participants: The study included 22 patients with a left ventricular ejection fraction of 40% or less undergoing elective coronary artery bypass grafting., Interventions: In the period between induction of anesthesia and sternotomy, CO was measured using the FloTrac/Vigileo system (third-generation software) and intermittent pulmonary artery thermodilution before and after volume loading., Measurements and Main Results: Accuracy and precision as determined using Bland-Altman analysis revealed a bias of -0.7 L/min, limits of agreement of -2.9 to 1.5 L/min, and a mean error of 55% for pooled data. Proportional bias and spread were present, indicating that bias and limits of agreement were underestimated for high CO values. Trending ability was assessed using 4-quadrant analysis, which revealed a concordance of 86%. Concordance from a clinical perspective was 36%. Polar plot analysis showed an angular bias of 13° degrees, with radial limits of agreement of -55° to 51°. Polar concordance at±30° was 50%., Conclusions: Arterial waveform analysis of cardiac output and pulmonary artery thermodilution cardiac output were not interchangeable in patients with impaired left ventricular function., (Copyright © 2016 Elsevier Inc. All rights reserved.)

The most severe complications after cardiac surgery are neurological complications including stroke which is often caused by emboli merging from atherosclerosis in the ascending aorta to the brain. Information about the thoracic aorta is crucial in reducing the embolization risk for both surgical open and closed chest procedures such as transaortic heart valve implantation. Several techniques are available to screen the ascending aorta, for example, transesophageal echocardiography (TEE), epiaortic ultrasound, TEE A-view method, manual palpation, computed tomography, and magnetic resonance imaging. This paper provides a description of the advantages and disadvantages of these imaging techniques.

Administration of prophylactic glucocorticoids has been suggested as a strategy to reduce postoperative AKI and other adverse events after cardiac surgery requiring cardiopulmonary bypass. In this post hoc analysis of a large placebo-controlled randomized trial of dexamethasone in 4465 adult patients undergoing cardiac surgery, we examined severe AKI, defined as use of RRT, as a primary outcome. Secondary outcomes were doubling of serum creatinine level or AKI-RRT, as well as AKI-RRT or in-hospital mortality (RRT/death). The primary outcome occurred in ten patients (0.4%) in the dexamethasone group and in 23 patients (1.0%) in the placebo group (relative risk, 0.44; 95% confidence interval, 0.19 to 0.96). In stratified analyses, the strongest signal for potential benefit of dexamethasone was in patients with an eGFR<15 ml/min per 1.73 m(2). In conclusion, compared with placebo, intraoperative dexamethasone appeared to reduce the incidence of severe AKI after cardiac surgery in those with advanced CKD., (Copyright © 2015 by the American Society of Nephrology.)

Background: Cardiac surgery with the use of cardiopulmonary bypass is associated with a systemic inflammatory response. Intraoperative corticosteroids are administered to attenuate this inflammatory response. The recent Dexamethasone for Cardiac Surgery (DECS) trial could not demonstrate a beneficial effect of dexamethasone on major adverse events in cardiac surgical patients. Previous studies suggest that corticosteroids may affect postoperative coagulation and blood loss, and therefore could influence the risk of surgical reinterventions. We investigated the effects of prophylactic intraoperative dexamethasone treatment on the rate of rethoracotomy after cardiac surgery., Methods: We performed a post-hoc additional data collection and analysis in the DECS trial. A total of 4,494 adult patients undergoing cardiac surgery with cardiopulmonary bypass were randomly assigned to intravenous dexamethasone (1.0 mg/kg) or placebo. The primary endpoint for the present study was the incidence of any rethoracotomy within the first 30 postoperative days. Secondary endpoints included the reason for rethoracotomy and the incidence of perioperative transfusion of blood products., Results: In the dexamethasone group, 217 patients (9.7%) underwent a rethoracotomy, and in the placebo group, 165 patients did (7.3%; relative risk 1.32, 95% confidence interval: 1.09 to 1.61, p = 0.005). The most common reason for rethoracotomy was tamponade in both groups: 3.9% versus 2.1%, respectively (relative risk 1.84, 95% confidence interval: 1.30 to 2.61, p < 0.001)., Conclusions: Intraoperative high-dose dexamethasone administration in cardiac surgery was associated with an increased rethoracotomy risk., (Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Cardiac surgery can be complicated by postoperative cognitive decline (POCD), which is characterized by impaired memory function and intellectual ability. The systemic inflammatory response that is induced by major surgery and cardiopulmonary bypass may play an important role in the etiology of POCD. Prophylactic corticosteroids to attenuate the inflammatory response may therefore reduce the risk of POCD. The authors investigated the effect of intraoperative high-dose dexamethasone on the incidence of POCD at 1 month and 12 months after cardiac surgery., Methods: This multicenter, randomized, double-blind, placebo-controlled trial is a preplanned substudy of the DExamethasone for Cardiac Surgery trial. A total of 291 adult patients undergoing cardiac surgery with cardiopulmonary bypass were recruited in three hospitals and randomized to receive dexamethasone 1 mg/kg (n = 145) or placebo (n = 146). The main outcome measures were incidence of POCD at 1- and 12-month follow-up, defined as a decline in neuropsychological test performance beyond natural variability, as measured in a control group., Results: At 1-month follow-up, 19 of 140 patients in the dexamethasone group (13.6%) and 10 of 138 patients in the placebo group (7.2%) fulfilled the diagnostic criteria for POCD (relative risk, 1.87; 95% CI, 0.90 to 3.88; P = 0.09). At 12-month follow-up, 8 of 115 patients in the dexamethasone group (7.0%) and 4 of 114 patients (3.5%) in the placebo group had POCD (relative risk, 1.98; 95% CI, 0.61 to 6.40; P = 0.24)., Conclusion: Intraoperative high-dose dexamethasone did not reduce the risk of POCD after cardiac surgery.

Background: Cardiac surgery is often complicated by excessive bleeding that is commonly treated with blood products. In the year 2009 a transfusion protocol was introduced specifically designed for cardiac surgery procedures. This study aims to evaluate the effect of this protocol on transfusion of blood products and the occurrence of clinical events., Study Design and Methods: This was a nonrandomized intervention study. The index group was transfused according to a tailor-made transfusion protocol (operation in 2009/2010) and the control group was transfused according to the Dutch national transfusion guideline (operation in 2007/2008). The primary outcome was mean number of units transfused and proportion of patients transfused. Secondary outcomes were in-hospital mortality, myocardial infarction, cerebrovascular accident or transient ischemic attack, renal injury or failure, rethoracotomy, and prolonged mechanical ventilation., Results: The control group comprised 2685 patients and the index group 2534 patients. The tailor-made transfusion protocol resulted in a decrease of patients transfused with red blood cells (RBCs) and fresh-frozen plasma (FFP) during surgery with odds ratio of 0.69 (95% confidence interval [CI], 0.55-0.86) and 0.63 (95% CI, 0.46-0.86), respectively. Fewer myocardial infarctions were observed in the index group with OR of 0.67 (95% CI, 0.47-0.96)., Conclusion: The cardiac surgery-specific transfusion protocol resulted in fewer patients transfused with RBCs and FFP and a lower incidence of myocardial infarction. This tailor-made protocol has led to a more judicious use of blood products and is a basis for further refinement of coagulation management during cardiac surgery procedures., (© 2013 Issala Klinieken Zwolle. Transfusion © 2013 American Association of Blood Banks.)

Background: A combination of general anaesthesia (GA) with thoracic epidural analgesia (TEA) may have a beneficial effect on clinical outcomes by reducing the risk of perioperative complications after cardiac surgery., Objectives: The objective of this review was to determine the impact of perioperative epidural analgesia in cardiac surgery on perioperative mortality and cardiac, pulmonary or neurological morbidity. We performed a meta-analysis to compare the risk of adverse events and mortality in patients undergoing cardiac surgery under general anaesthesia with and without epidural analgesia., Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2012, Issue 12) in The Cochrane Library; MEDLINE (PubMed) (1966 to November 2012); EMBASE (1989 to November 2012); CINHAL (1982 to November 2012) and the Science Citation Index (1988 to November 2012)., Selection Criteria: We included randomized controlled trials comparing outcomes in adult patients undergoing cardiac surgery with either GA alone or GA in combination with TEA., Data Collection and Analysis: All publications found during the search were manually and independently reviewed by the two authors. We identified 5035 titles, of which 4990 studies did not satisfy the selection criteria or were duplicate publications, that were retrieved from the five different databases. We performed a full review on 45 studies, of which 31 publications met all inclusion criteria. These 31 publications reported on a total of 3047 patients, 1578 patients with GA and 1469 patients with GA plus TEA., Main Results: Through our search (November 2012) we have identified 5035 titles, of which 31 publications met our inclusion criteria and reported on a total of 3047 patients. Compared with GA alone, the pooled risk ratio (RR) for patients receiving GA with TEA showed an odds ratio (OR) of 0.84 (95% CI 0.33 to 2.13, 31 studies) for mortality; 0.76 (95% CI 0.49 to 1.19, 17 studies) for myocardial infarction; and 0.50 (95% CI 0.21 to 1.18, 10 studies) for stroke. The relative risks (RR) for respiratory complications and supraventricular arrhythmias were 0.68 (95% CI 0.54 to 0.86, 14 studies) and 0.65 (95% CI 0.50 to 0.86, 15 studies) respectively., Authors' Conclusions: This meta-analysis of studies, identified to 2010, showed that the use of TEA in patients undergoing coronary artery bypass graft surgery may reduce the risk of postoperative supraventricular arrhythmias and respiratory complications. There were no effects of TEA with GA on the risk of mortality, myocardial infarction or neurological complications compared with GA alone.

Objectives: Fibrinogen concentrate increasingly is used to treat coagulopathic bleeding in cardiac surgery although its effectiveness and safety have not been shown. The authors conducted a cohort study to quantify the effects of fibrinogen concentrate on postoperative blood loss and transfusion and the occurrence of adverse clinical events in complex cardiac surgery patients., Design: A cohort analysis using prospectively collected data., Setting: A teaching hospital., Participants: One thousand seventy-five patients who underwent complex cardiac surgery in the years 2007 to 2010., Intervention: A nonrandomized intervention with fibrinogen concentrate during complex cardiac surgery., Measurements and Main Results: Of the 1,075 patients, 264 (25%) received fibrinogen concentrate during surgery (median dose = 2 g). In the adjusted analysis, the effect of fibrinogen concentrate on blood loss and transfusion in the intensive care unit showed a ratio of geometric means of 1.02 (0.91-1.14) and an odds ratio of 1.14 (0.83-1.56), respectively. For the risk of 30-day mortality, myocardial infarction, cerebrovascular accident/transient ischemic attack, renal insufficiency/failure, total infections, and prolonged mechanical ventilation the adjusted odds ratios were 0.96 (0.48-1.92), 1.10 (0.53-2.27), 1.16 (0.50-2.72), 0.62 (0.29-1.32), 1.18 (0.72-1.95), and 1.44 (0.83-2.49), respectively., Conclusions: Fibrinogen concentrate infusion during surgery did not reduce postoperative blood loss and transfusion, and no increased risk for clinical adverse events was measured. The lower doses and the relatively late intervention with fibrinogen concentrate might have attenuated its hemostatic effect. This study reports the initial clinical use of fibrinogen concentrate in complex cardiac surgery. A randomized clinical trial has been initiated to investigate the hemostatic role of fibrinogen concentrate in cardiac surgery., (Copyright © 2012 Elsevier Inc. All rights reserved.)

Context: Prophylactic corticosteroids are often administered during cardiac surgery to attenuate the inflammatory response to cardiopulmonary bypass and surgical trauma; however, evidence that routine corticosteroid use can prevent major adverse events is lacking., Objective: To quantify the effect of intraoperative high-dose dexamethasone on the incidence of major adverse events in patients undergoing cardiac surgery., Design, Setting, and Participants: A multicenter, randomized, double-blind, placebo-controlled trial of 4494 patients aged 18 years or older undergoing cardiac surgery with cardiopulmonary bypass at 8 cardiac surgical centers in The Netherlands enrolled between April 13, 2006, and November 23, 2011., Intervention: Patients were randomly assigned to receive a single intraoperative dose of 1 mg/kg dexamethasone (n = 2239) or placebo (n = 2255)., Main Outcome Measures: A composite of death, myocardial infarction, stroke, renal failure, or respiratory failure, within 30 days of randomization., Results: Of the 4494 patients who underwent randomization, 4482 (99.7%) could be evaluated for the primary outcome. A total of 157 patients (7.0%) in the dexamethasone group and 191 patients (8.5%) in the placebo group reached the primary study end point (relative risk, 0.83; 95% CI, 0.67-1.01; absolute risk reduction, -1.5%; 95% CI, -3.0% to 0.1%; P = .07). Dexamethasone was associated with reductions in postoperative infection, duration of postoperative mechanical ventilation, and lengths of intensive care unit and hospital stays. In contrast, dexamethasone was associated with higher postoperative glucose levels., Conclusion: In our trial of adults undergoing cardiac surgery, the use of intraoperative dexamethasone did not reduce the 30-day incidence of major adverse events compared with placebo., Trial Registration: clinicaltrials.gov Identifier: NCT00293592.

Purpose: In cardiac surgery prediction models identifying patients at risk of prolonged stay at the Intensive Care Unit (ICU) are used to optimize treatment and use of ICU resources. A recent systematic validation study of 14 of these models identified three models with a good predictive performance across patients of all ages. It is however unclear how these models perform in older patients, who nowadays form a considerable part of this patient population. The current study specifically validates the performance of these three models in older cardiac surgery patients and quantifies how their performance changes with increasing age of patients., Methods: The Parsonnet model, the EuroSCORE, and a model by Huijskes and colleagues were validated using prospectively collected data of 11,395 cardiac surgery patients. Performance of the models was described by discrimination (area under the ROC curve, AUC) and calibration., Results: For the Parsonnet model, the EuroSCORE and the Huijskes model discrimination clearly decreased with increasing age (AUCs of 0.76, 0.71 and 0.72 for ages 70-75 and 0.72, 0.70 and 0.72, respectively, for ages 75-80 and 0.68, 0.64 and 0.69, respectively, above 80 years). The models showed poor calibration in patients aged >70 (p values for fit of the models <0.006)., Conclusions: To optimize treatment and ICU resources, risk prediction for prolonged ICU stay after cardiac surgery using the existing models should be done with great care for older patients.

Background: A combination of general anesthesia (GA) with thoracic epidural anesthesia (TEA) may have a beneficial effect on clinical outcomes after cardiac surgery. We have performed a meta-analysis to compare mortality and cardiac, respiratory, and neurologic complications in patients undergoing cardiac surgery with GA alone or a combination of GA with TEA., Methods: Randomized studies comparing outcomes in patients undergoing cardiac surgery with either GA alone or GA in combination with TEA were retrieved from PubMed, Science Citation index, EMBASE, CINHAL, and Central Cochrane Controlled Trial Register databases., Results: The search strategy yielded 1,390 studies; 28 studies that included 2,731 patients met the selection criteria. Compared with GA alone, the combined risk ratio for patients receiving GA with TEA was 0.81 (95% CI: 0.40-1.64) for mortality, 0.80 (95% CI: 0.52-1.24) for myocardial infarction, and 0.59 (95% CI: 0.24-1.46) for stroke. The risk ratios for the respiratory complications and supraventricular arrhythmias were 0.53 (95% CI: 0.40-0.69) and 0.68 (95% CI: 0.50-0.93), respectively., Conclusions: This meta-analysis showed that the use of TEA in patients undergoing cardiac surgery reduces the risk of postoperative supraventricular arrhythmias and respiratory complications. The sparsity of events precludes conclusions about mortality, myocardial infarction, and stroke, but the estimates suggest a reduced risk after TEA. The risk of side effects of TEA, including epidural hematoma, could not be assessed with the current dataset, and therefore TEA should be used with caution until its benefit-harm profile is further elucidated.

Background: The addition of thoracic epidural anesthesia (TEA) to general anesthesia (GA) during cardiac surgery may have a beneficial effect on clinical outcomes. TEA in cardiac surgery, however, is controversial because the insertion of an epidural catheter in patients requiring full heparinization for cardiopulmonary bypass may lead to an epidural hematoma. The clinical effects of fast-track GA plus TEA were compared with those of with fast-track GA alone., Methods: A randomized controlled trial was conducted in 654 elective cardiac surgical patients who were randomly assigned to combined GA and TEA versus GA alone. Follow-up was at 30 days and 1 yr after surgery. The primary endpoint was 30-day survival free from myocardial infarction, pulmonary complications, renal failure, and stroke., Results: Thirty-day survival free from myocardial infarction, pulmonary complications, renal failure, and stroke was 85.2% in the TEA group and 89.7% in the GA group (P = 0.23). At 1 yr follow-up, survival free from myocardial infarction, pulmonary complications, renal failure, and stroke was 84.6% in the TEA group and 87.2% in the GA group (P = 0.42). Postoperative pain scores were low in both groups., Conclusions: This study was unable to demonstrate a clinically relevant benefit of TEA on the frequency of major complications after elective cardiac surgery, compared with fast-track cardiac anesthesia without epidural anesthesia. Given the potentially devastating complications of an epidural hematoma after insertion of an epidural catheter, it is questionable whether this procedure should be applied routinely in cardiac surgical patients who require full heparinization.

Background: Epiaortic ultrasound scanning (EUS) is regarded as the reference standard for detecting atherosclerosis in the ascending aorta (AA). Combined with appropriate surgical modifications, EUS use can significantly reduce the incidence of postoperative stroke when detecting severe AA atherosclerosis. A recently introduced modification of conventional transoesophageal echocardiography (TOE), known as the A-View method, has proven capable of inspecting the distal AA. The objective of this study was to quantify the diagnostic accuracy of modified TOE in assessing atherosclerosis of the distal AA., Methods: After approval by the institutional medical ethical committee and after obtaining written informed consent, 465 consecutive patients above 65 yr old, undergoing elective cardiac surgery with a median sternotomy, were included. The study followed a cross-sectional diagnostic design. All consecutive patients underwent modified TOE followed by EUS (reference standard) to assess the severity of distal AA atherosclerosis. We constructed contingency tables to compare the presence (and severity) of atherosclerosis, detected by the two techniques., Results: The positive predictive value of modified TOE for the detection of clinically significant atherosclerosis was 67%, and the negative predictive value was 97%. The sensitivity was 95% and the specificity was 79%. One patient suffered a pulmonary haemorrhage, although he recovered without further sequelae. We did not observe any clinical significant haemodynamic or ventilatory effects., Conclusions: The high negative predictive value and sensitivity show that modified TOE yields adequate diagnostic accuracy for excluding clinically relevant aorta atherosclerosis without significant cardiopulmonary side-effects, provided that the A-View catheter is introduced carefully.

Background: Fast-track cardiac anesthesia (FTCA) has been widely implemented but its safety has not been evaluated in sufficiently powered studies., Methods: We compared outcomes of patients undergoing FTCA with a historical control group undergoing conventional high-dose opioid cardiac anesthesia (CCA). The primary outcome measure was the incidence of in-hospital mortality. Secondary outcome measures were the incidence of in-hospital acute myocardial infarction, renal failure, and stroke. We also compared duration of mechanical ventilation and length of hospitalization in the intensive care unit and postoperative ward., Results: The CCA group comprised 4020 patients and the FTCA Group 3969 patients. The patients in the FTCA group were slightly older, had more comorbidities, and were more likely to undergo valve surgery than the CCA group. The incidence of in-hospital mortality was 1.9% in the CCA group and 2.3% in the FTCA group. Compared with the CCA group, the crude odds ratio for mortality in the FTCA group was 1.20 (95% confidence interval 0.88-1.64, P = 0.25) and the adjusted odds ratio was 0.92 (95% confidence interval, 0.65-1.32, P = 0.66). The incidence of myocardial infarction and stroke in the CCA and FTCA groups were 5.2% and 5.5% (P = 0.61), and 0.9% and 1.3%, (P = 0.06), respectively, whereas the incidence of acute renal failure was similar in both groups (0.8%, P = 0.84). The duration of mechanical ventilation was shorter in the FTCA patients compared with the CCA group (6 vs 12 h, P < or = 0.001), but their median intensive care stay was 1 h longer (23 vs 22 h, P < or = 0.001). Although the median duration of hospitalization was 6.0 days in both groups, the 90th percentile of the hospitalization time was 13 days in the CCA group and 18 days in the FTCA group (P < or = 0.001)., Conclusions: These data from 7989 cardiac surgical patients showed no evidence of an increased risk of adverse outcomes in patients undergoing FTCA.

Background: Our objective was to evaluate the accuracy and safety of a real-time (RT) continuous glucose monitoring system (CGMS) in patients before and after cardiothoracic surgery and to investigate whether activation of the alarm function of the RT-CGMS had an effect on glucose control., Methods: Patients scheduled for elective cardiothoracic procedures, without a history of insulin-requiring diabetes, were perioperatively monitored with RT-CGMS for 72 h and were randomized into two groups: with or without the alarm function (set at 4 and 10 mmol/L) of the device activated. Sensor values were compared with capillary, arterial, and venous blood glucose values. Percentages of time spent in various glucose ranges were compared between groups., Results: There were no adverse effects of the RT-CGMS. Of the 1,001 sensor value comparisons with capillary or arterial measurements, 96.6% fell within Clarke Error Grid zones A and B, with relative absolute differences ranging from 15% (preoperative period) to 12% (intensive care unit period) to 14% (postoperative period on the ward). Seventeen (7.9%) arterial and 16 (2.0%) capillary comparisons fell within zone D or E. Whether or not the alarm function, as used in this pilot study, was activated did not affect time spent in different glucose ranges., Conclusions: Although the RT-CGMS is safe and accurate according to accepted standards, there are still small aberrations, which in our opinion preclude unlimited use in its present form in a clinical setting. The effect of the alarm function at different glucose levels remains to be investigated.

Background: Stroke after cardiac surgery may be caused by emboli emerging from an atherosclerotic ascending aorta (AA). Epiaortic ultrasound scanning (EUS), the current 'gold' standard for detecting AA atherosclerosis, has not gained widespread use because there is a lack of optimized ultrasound devices, it lengthens the procedure, it endangers sterility, and there is a false belief by many surgeons that palpation is as sensitive as EUS. Furthermore there is no clear evidence proving that the use of epiaortic scanning changes outcome in cardiac surgery. Various researchers investigated the ability of transesophageal echocardiography (TEE) to discriminate between the presence and absence of AA atherosclerosis. It is acknowledged that TEE has limited value in this, but it has never been supported by a meta-analysis estimating the true diagnostic accuracy of TEE based on all quantitative evidence. We aimed to do this using state-of-the-art methodology of diagnostic meta-analyses., Methods: We searched multiple databases for studies comparing TEE vs. EUS for detection of atherosclerosis. A random-effects bivariate meta-regression model was used to obtain summary estimates of sensitivity and specificity, incorporating the correlation between sensitivity and specificity as well as covariates to explore heterogeneity across studies., Results: We extracted six studies with a total of 346 patients, of whom 419 aortic segments were analyzed, including 100 segments with atherosclerosis [median prevalence 25% (range 17-62%)]. Summary estimates of sensitivity and specificity were 21% (95% CI 13-32%) and 99% (96-99%), respectively., Conclusions: Because of the low sensitivity of TEE for the detection of AA atherosclerosis, a negative test result requires verification by additional testing using epiaortic scanning. In case of a positive test result, AA atherosclerosis can be considered as present, and less manipulative strategies might be indicated.

Background: Atherosclerosis of the ascending aorta (AA) and stroke after cardiac surgery are related. Knowledge of the location of AA-atherosclerosis pre-sternotomy allows changes in surgical strategy to avoid manipulation of the AA. The gold-standard for assessment of AA-atherosclerosis is intraoperative epiaortic ultrasound scanning (EUS). Transoesophageal echocardiography (TOE) is unable to detect atherosclerosis in the distal AA due to the 'blind spot'. A new method [A-View (Aortic-view) method] using a fluid-filled catheter may enhance the assessment of distal AA-atherosclerosis. The aim of this study was to evaluate whether the A-View method indeed visualizes the distal AA and to assess the safety of this technology., Methods: In a cross-sectional diagnostic study, 41 patients undergoing cardiac surgery including sternotomy underwent the same work-up including TOE, the A-View method, EUS, and routine operative monitoring., Results: With the A-View method, the distal AA was visible in all (100%) patients. There were no clinical important side-effects associated with the use of the A-View catheter; however, in one patient the endotracheal tube was accidentally dislocated leading to a decrease in Sa(O2). Severity of atherosclerosis visualized with the A-View method compared with EUS results showed good agreement between the two methods [Kappa of 0.69 (0.50-0.88)]. The Bland-Altman analysis showed poor agreement in plaque-size measurements (bias 0.05 cm2, limits of agreement - 0.63 to 0.74 cm2)., Conclusions: The A-View method offers a minimally invasive and safe approach to preoperatively resolving the blind spot of TOE. Compared with EUS, the A-View method yielded satisfactory results in the detection of AA-atherosclerosis. The A-View method seems a promising tool for patients undergoing cardiac surgery to direct surgical management.

High shear forces can induce structural changes in the shape of the von Willebrand factor (VWF) molecule, making it more sensitive for ADAMTS-13, a specific VWF protease. This leads to proteolysis of the highest-molecular-weight multimers, which are the most effective in platelet-mediated hemostasis under conditions of high shear stress. The use of cardiopulmonary bypass (CPB) is accompanied with high shear forces and could therefore lead to diminished VWF activity. Therefore, we studied VWF activity in patients undergoing myocardial revascularization. We enrolled 60 patients undergoing coronary artery bypass graft (CABG) surgery with and without CPB (30 in each group). ADAMTS-13 activity, VWF antigen (VWF:Ag) and propeptide levels were measured directly before and after the procedure. VWF activity was determined using both the ristocetin cofactor activity (VWF:Rcof) and collagen binding (VWF:CB) assays. VWF:Rcof and VWF:CB, both corrected for VWF:Ag, were significantly increased after the procedure in the off-pump group (p < 0.001 and p = 0.05, respectively), but not in the CPB group. Postoperative VWF:Ag and VWF-propeptide levels significantly increased in both groups. ADAMTS-13 activity increased after both types of surgery after correction for hemodilution. Postoperative VWF:Rcof levels correlated with postoperative D-dimer levels (p = 0.025) and were associated with early cognitive decline in the off-pump group (p = 0.025). Our data indicate that VWF activity is increased after off-pump CABG, but not after CABG with CPB. Since release of VWF is comparable in both groups, shear stress-induced proteolysis due to the use of CPB may be responsible for the decreased VWF activity.

In the Octopus Study, 281 coronary artery bypass surgery patients were randomized to surgery with or without cardiopulmonary bypass. The primary objective was to compare cognitive outcome between off-pump and on-pump coronary artery bypass surgery. Before and after surgery, psychologists administered a battery of 10 neuropsychological tests to the patients. Cognitive decline was defined as a decrease in an individual's performance of at least 20% from baseline, in at least 20% of the main variables. According to this definition, cognitive decline was present in 21% in the off-pump group and 29% in the on-pump group, 3 months after the procedure (P = .15). At 12 months, cognitive decline was present in 31% in the off-pump group and 34% in the on-pump group (P = .69). These results indicated that patients undergoing coronary artery bypass surgery without cardiopulmonary bypass had improved cognitive outcomes 3 months after the procedure, but the effects were limited and became negligible at 12 months. The same definition of cognitive decline was also applied to 112 volunteers not undergoing surgery. The definition labeled 28% of the control subjects as suffering from cognitive decline, 3 months after their first assessment. This suggests that the natural fluctuations in performance during repeated neuropsychological testing should be included in the statistical analysis of cognitive decline. Using an alternative definition of cognitive decline that takes these natural fluctuations in performance into account, the proportions of coronary artery bypass surgery patients displaying cognitive decline were substantially lower. This indicates that the incidence of cognitive decline after coronary artery bypass surgery has been overestimated.

Background: Activation of the complement system after coronary artery bypass graft surgery involves C-reactive protein (CRP). This inflammatory response is related to baseline CRP levels and associated with postoperative arrhythmia, in particular atrial fibrillation (AF). We investigated whether baseline CRP levels are a risk indicator for the occurrence of AF and whether this phenomenon is cardiopulmonary bypass dependent., Methods: C-reactive protein was measured in perioperative blood samples of patients of the Octopus Study (coronary artery bypass graft surgery with [n = 73] or without cardiopulmonary bypass [n = 79]). Baseline CRP was dichotomized into a low and a high baseline group, using a cutoff value of 3.0 mg/L., Results: After coronary artery bypass graft surgery with cardiopulmonary bypass 11 of 53 patients (21%) with low preoperative CRP levels had AF versus 11 of 20 patients (55%) with high baseline CRP levels (p = 0.01). In the off-pump group AF occurred in 4 of 52 patients (8%) who had low baseline CRP levels, versus 8 of 27 patients (30%) with high preoperative CRP levels (p = 0.002). After adjusting for age, the odds ratio (95% confidence interval) was 4.6 (1.4 to 15.3) with cardiopulmonary bypass, 3.7 (0.93 to 14.7) in the off-pump group, and 3.3 (1.4 to 7.6) for both groups together. Continuous baseline CRP was an independent predictor for AF in a multivariate logistic regression model (p = 0.02)., Conclusions: Patients with high baseline CRP levels are at higher risk of having postoperative AF in both on-pump and off-pump surgery.

Activation of coagulation, fibrinolysis, and the vascular endothelium occurs after heart surgery with cardiopulmonary bypass (CPB), but the effects of eliminating CPB in patients undergoing coronary artery bypass grafting (CABG) are unknown. Therefore, we compared the hemostatic profiles of off-pump and on-pump CABG patients. Two groups of consecutive patients participating in a larger trial (the Octopus Trial) were randomly allocated to undergo CABG with (n = 20) or without (n = 20) CPB. Platelet numbers and plasma concentrations of P-selectin, prothrombin fragment 1.2 (F1.2), soluble fibrin, d-dimers, and von Willebrand factor (as a marker of endothelial cell activation) were measured and corrected for hemodilution. Compared with the on-pump CABG group, F1.2 and d-dimer levels were significantly lower (P = 0.004 and P = 0.03, respectively) in patients having CABG surgery performed off-pump. In the CPB group, F1.2 (median [interquartile range], 450% of baseline [233%-847%]) and d-dimer (538% [318%-1192%]) peaked in the immediate postoperative period and remained increased until Day 4, whereas in the off-pump group, F1.2 and d-dimer levels increased more gradually and peaked on Day 4 (342% [248%-515%] and 555% [387%-882%], respectively). In both groups, von Willebrand factor concentrations were increased until Day 4 (CPB, 308% [228%-405%]; off-pump, 288% [167%-334%]). Despite heparinization, CABG surgery with CPB was associated with excessive thrombin generation and fibrinolytic activity immediately after surgery. The off-pump group demonstrated a delayed postoperative response that became equal in magnitude to the CPB in the later (20-96 h) postoperative period.

Context: Coronary artery bypass graft (CABG) surgery is associated with a decline in cognitive function, which has largely been attributed to the use of cardiopulmonary bypass (on-pump procedures). Cardiac stabilizers facilitate CABG surgery without use of cardiopulmonary bypass (off-pump procedures) and should reduce the cognitive decline associated with on-pump procedures., Objective: To compare the effect of CABG surgery with (on-pump) and without (off-pump) cardiopulmonary bypass on cognitive outcome., Design and Setting: Randomized controlled trial conducted in the Netherlands of CABG surgery patients enrolled from March 1998 through August 2000, with 3- and 12-month follow-up., Participants and Intervention: Patients scheduled for their first CABG surgery (mean age, 61 years; n = 281) were randomly assigned to off-pump surgery (n = 142) or on-pump surgery (n = 139)., Main Outcome Measures: Cognitive outcome at 3 and 12 months, which was determined by psychologists (blinded for randomization) who administered 10 neuropsychological tests before and after surgery. Quality of life, stroke rate, and all-cause mortality at 3 and 12 months were secondary outcome measures., Results: Cognitive outcome could be determined at 3 months in 248 patients. Cognitive decline occurred in 21% in the off-pump group and 29% in the on-pump group (relative risk [RR], 0.65; 95% confidence interval [CI], 0.36-1.16; P =.15). The overall standardized change score (ie, improvement of cognitive performance) was 0.19 in the off-pump vs 0.13 in the on-pump group (P =.03). At 12 months, cognitive decline occurred in 30.8% in the off-pump group and 33.6% in the on-pump group (RR, 0.88; 95% CI, 0.52-1.49; P =.69). The overall standardized change score was 0.19 in the off-pump vs 0.12 in the on-pump group (P =.09). No statistically significant differences were observed between the on-pump and off-pump groups in quality of life, stroke rate, or all-cause mortality at 3 and 12 months., Conclusion: Patients who received their first CABG surgery without cardiopulmonary bypass had improved cognitive outcomes 3 months after the procedure, but the effects were limited and became negligible at 12 months.

Background: The use of cardiopulmonary bypass during coronary artery bypass surgery (CABG) has been associated with substantial morbidity. The recent introduction of cardiac stabilizers facilitates CABG without cardiopulmonary bypass (off-pump CABG), but it is unknown whether cardiac outcome after off-pump surgery is similar to that for the on-pump procedure., Methods and Results: In a multicenter trial, 281 patients (mean age 61 years, SD 9 years) were randomly assigned to off-pump or on-pump CABG. In-hospital results and cardiac outcome and quality of life after 1 month are presented. Cardiac outcome was defined as survival free of stroke, myocardial infarction, and coronary reintervention. The mean numbers of distal anastomoses per patient were 2.4 (SD 1.0) and 2.6 (SD 1.1) in the off-pump and on-pump groups, respectively. Completeness of revascularization was similar in both groups. Blood products were needed during 3% of the off-pump procedures and 13% of the on-pump procedures (P<0.01). Release of creatine kinase muscle-brain isoenzyme was 41% less in the off-pump group (P<0.01). Otherwise, no differences in complications were found postoperatively. Off-pump patients were discharged 1 day earlier. At 1 month, operative mortality was zero in both groups, and quality of life had improved similarly. In both groups, 4% of the patients had recurrent angina. The proportions of patients surviving free of cardiovascular events were 93.0% in the off-pump group and 94.2% in the on-pump group (P=0.66)., Conclusions: In selected patients, off-pump CABG is safe and yields a short-term cardiac outcome comparable to that of on-pump CABG.