Preoperative intra-aortic balloon pump in patients with ST-elevation myocardial infarction undergoing urgent cardiac bypass surgery.

BACKGROUND: In patients with ST-elevation myocardial infarction (STEMI), either with or without cardiogenic shock, mechanical circulatory support with an intra-aortic balloon pump (IABP) is not associated with lower mortality. However, in STEMI patients undergoing urgent coronary artery bypass grafting (CABG), preoperative insertion of an IABP has been suggested to reduce mortality. In this study, the effect of preoperative IABP use on mortality in STEMI patients undergoing urgent CABG was investigated. METHODS: All consecutive STEMI patients undergoing urgent CABG in a single centre between 2000 and 2018 were studied. The primary outcome, 30-day mortality, was compared between patients with and without a preoperative IABP. Subgroup analysis and multivariable analysis using a propensity score and inverse probability treatment weighting were performed to adjust for potential confounders. RESULTS: A total of 246 patients were included, of whom 171 (69.5%) received a preoperative IABP (pIABP group) and 75 (30.5%) did not (non-pIABP group). In the pIABP group, more patients suffered from cardiogenic shock, persistent ischaemia and reduced left ventricular function. Unadjusted 30-day mortality was comparable between the pIABP and the non-pIABP group (13.3% vs 12.3%, p = 0.82). However, after correction for confounders and inverse probability treatment weighting preoperative IABP was associated with reduced 30-day mortality (relative risk 0.52, 95% confidence interval 0.30-0.88). CONCLUSION: In patients with STEMI undergoing urgent CABG, preoperative insertion of an IABP is associated with reduced mortality.

Preoperative anaemia and outcome after elective cardiac surgery: a Dutch national registry analysis.

BACKGROUND: Previous studies have shown that preoperative anaemia in patients undergoing cardiac surgery is associated with adverse outcomes. However, most of these studies were retrospective, had a relatively small sample size, and were from a single centre. The aim of this study was to analyse the relationship between the severity of preoperative anaemia and short- and long-term mortality and morbidity in a large multicentre national cohort of patients undergoing cardiac surgery. METHODS: A nationwide, prospective, multicentre registry (Netherlands Heart Registration) of patients undergoing elective cardiac surgery between January 2013 and January 2019 was used for this observational study. Anaemia was defined according to the WHO criteria, and the main study endpoint was 120-day mortality. The association was investigated using multivariable logistic regression analysis. RESULTS: In total, 35 484 patients were studied, of whom 6802 (19.2%) were anaemic. Preoperative anaemia was associated with an increased risk of 120-day mortality (adjusted odds ratio [aOR] 1.7; 95% confidence interval [CI]: 1.4-1.9; P<0.001). The risk of 120-day mortality increased with anaemia severity (mild anaemia aOR 1.6; 95% CI: 1.3-1.9; P<0.001; and moderate-to-severe anaemia aOR 1.8; 95% CI: 1.4-2.4; P<0.001). Preoperative anaemia was associated with red blood cell transfusion and postoperative morbidity, the causes of which included renal failure, pneumonia, and myocardial infarction. CONCLUSIONS: Preoperative anaemia was associated with mortality and morbidity after cardiac surgery. The risk of adverse outcomes increased with anaemia severity. Preoperative anaemia is a potential target for treatment to improve postoperative outcomes.

Mortality Reduction After a Preincision Safety Check Before Cardiac Surgery: Is It the Aorta?

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.

Effect of Fibrinogen Concentrate on Intraoperative Blood Loss Among Patients With Intraoperative Bleeding During High-Risk Cardiac Surgery: A Randomized Clinical Trial.

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.

Effectiveness of a cardiac surgery-specific transfusion protocol.

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.

Fibrinogen concentrate therapy in complex cardiac surgery.

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.

Implementation of a specific safety check is associated with lower postoperative mortality in cardiac surgery.

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.

Targeting cefuroxime plasma concentrations during coronary artery bypass graft surgery with cardiopulmonary bypass.

BACKGOUND: Patients are at risk for severe postoperative infections after coronary artery bypass graft (CABG) surgery. Clinical laboratory data showed that unbound plasma concentrations of cefuroxime were not always adequate, therefore we developed a new dosing regimen. OBJECTIVE: The aim of this prospective study is to evaluate the new dosing strategy by monitoring patients for unbound cefuroxime plasma concentrations during CABG surgery with cardiopulmonary bypass (CPB). SETTING: A Dutch teaching hospital. METHODS: In this prospective trial, patients scheduled for CABG surgery with CPB were included. A starting dose of 1500 mg cefuroxime was given with anesthesia induction, followed by 750 mg cefuroxime every hour until wound closure. In case of renal failure the dosing regimen was adapted. Serial blood samples were collected before, during and after the CPB process. Pharmacokinetic modelling was performed by using an 'iterative two-stage Bayesian population procedure'. MAIN OUTCOME MEASURE: Unbound plasma concentrations of cefuroxime. RESULTS: 22 patients were included, data could be evaluated of 21 patients. In 24 % of the patients the unbound cefuroxime plasma concentration was below the target range during surgery before CPB started. Patients with a bodyweight above 100 kg or age <60 years were more likely to have unbound plasma concentrations below the target range (P = 0.030 and P = 0.008). During CPB, the half-life of unbound cefuroxime increased by 17 % and the clearance decreased by 11 % compared to before CPB (P = 0.033 and P = 0.014). The mean pharmacokinetic parameters before, during and after CPB were as follows: elimination half-life 72, 84 and 76 min; clearance of unbound cefuroxime (Clu) 14.2, 12.7, 13.8 l/h and volume of distribution (Vu) 0.280, 0.284 and 0.290 l/kg respectively. Variations in unbound fractions before, during and after CPB were below 2 %, implicating the unbound fraction of cefuroxime is not influenced by CPB. CONCLUSION: Our results show that CPB during CABG surgery does not lead to inadequate unbound cefuroxime concentrations. Age, renal function and possibly also weight are more important factors that can result in unbound plasma cefuroxime concentrations below the target value.

Blood concentrations of cefuroxime in cardiopulmonary bypass surgery.

OBJECTIVES: Patients with coronary artery bypass graft (CABG) surgery are at risk for severe postoperative infections. Prophylactic cefuroxime may help to reduce this risk, however sufficient concentrations, i.e. above the breakpoint (32 mg/L), are mandatory. The aim of this study is to evaluate the blood concentrations of cefuroxime during and after CABG surgery with cardiopulmonary bypass (CPB) and hypothermia, to determine the concentration of cefuroxime in sternum fluid and to evaluate possible factors of influence. METHODS: Seventeen patients were enrolled in this study, given 1.5 g cefuroxime at anaesthesia induction and an additional 1.5 g at start CPB. Blood samples were collected at skin incision, start CPB, every 30 min on CPB, end CPB, at wound closure and 1 h after surgery. Cefuroxime concentrations were determined by high performance liquid chromatography. RESULTS: In 47 % of the patients the cefuroxime concentration was below the breakpoint at some point during the operation and in 59 % of the patients 1 h after surgery. A statistically significant inverse correlation between estimated glomerular filtration rate and plasma cefuroxime concentrations was found (P = 0.034). Cefuroxime levels in the sternum are not significantly different from blood levels from the radial artery catheter, taken at approximately the same time (P = 0.30). CONCLUSIONS: The current antibiotic regimen used did not maintain cefuroxime concentrations above the breakpoint throughout the operation, suggesting insufficient antibiotic prophylaxis. Further research to other antibiotic regimes is therefore necessary.

Results of a consensus meeting on the use of argatroban in patients with heparin-induced thrombocytopenia requiring antithrombotic therapy - a European Perspective.

Argatroban has been introduced as an alternative parenteral anticoagulant for HIT-patients in several European countries in 2005. In 2009 a panel of experts discussed their clinical experience with argatroban balancing risks and benefits of argatroban treatment in managing the highly procoagulant status of HIT-patients. This article summarizes the main conclusions of this round table discussion. An ongoing issue is the appropriate dosing of argatroban in special patient groups. Therefore, dosing recommendations for different HIT-patient groups (ICU patients; non-ICU patients, paediatric patients, and for patients undergoing renal replacement therapies) are summarized in this consensus statement. Because of the strong correlation between argatroban dosing requirements and scores used to characterize the severity of illness (APACHE; SAPS, SOFA) suitable dosing nomograms are given. This consensus statement contributes to clinically relevant information on the appropriate use and monitoring of argatroban based on the current literature, and provides additional information from clinical experience. As the two other approved drugs for HIT, danaparoid and lepirudin are either currently not available due to manufacturing problems (danaparoid) or will be withdrawn from the market in 2012 (lepirudin), this report should guide physicians who have limited experience with argatroban how to use this drug safely in patients with HIT.