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Background: Postoperative bleeding requiring re-exploration is a serious complication that occurs in 2.8-4.6% of patients undergoing cardiac surgery. Re-exploration has previously been associated with a higher risk of short-term mortality. However, a comprehensive analysis of long-term outcomes after re-exploration for bleeding has not been published., Materials and Methods: The authors performed a systematic, three databases search to identify studies reporting long-term outcomes in patients who required re-exploration for bleeding after cardiac surgery compared to patients who did not, with at least 1-year of follow-up. Long-term survival was the primary outcome. Secondary outcomes were operative mortality, myocardial infarction, stroke, renal and respiratory complications, and hospital length of stay. Random-effects models was used. Individual patient survival data was extracted from available survival curves and reconstructed using restricted mean survival time., Results: Six studies totaling 135 456 patients were included. The average follow-up was 5.5 years. In the individual patient data, patients who required re-exploration had a significantly higher risk of death compared with patients who did not [hazard ratio (HR): 1.21; 95% CI: 1.14-1.27; P <0.001], which was confirmed by the study-level survival analysis (HR: 1.32; 95% CI: 1.12-1.56; P <0.01). Re-exploration was also associated with a higher risk of operative mortality [odds ratio (OR): 5.25, 95% CI: 4.74-5.82, P <0.0001], stroke (OR: 2.05, 95% CI: 1.72-2.43, P <0.0001), renal (OR: 4.13, 95% CI: 3.43-4.39 P <0.0001) respiratory complications (OR: 3.91, 95% CI: 2.96-5.17, P <0.0001), longer hospital length of stay (mean difference: 2.69, 95% CI: 1.68-3.69, P <0.0001), and myocardial infarction (OR: 1.85, 95% CI: 1.30-2.65, P =0.0007)., Conclusion: Postoperative bleeding requiring re-exploration is associated with lower long-term survival and increased risk of short-term adverse events including operative mortality, stroke, renal and respiratory complications, and longer hospital length of stay. To improve both short-term and long-term outcomes, strategies to prevent the need for re-exploration are necessary., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)

Objective: Risk factors for severe postoperative bleeding after cardiac surgery remain multiple and incompletely elucidated. We evaluated the impact of intraoperative blood product transfusions, intravenous fluid administration, and persistently low core body temperature (CBT) at intensive care unit arrival on risk of perioperative bleeding leading to reexploration., Methods: We retrospectively queried our tertiary care center's Society of Thoracic Surgeons Institutional Database for all index, on-pump, adult cardiac surgery patients between July 2016 and September 2022. Intraoperative fluid (crystalloid and colloid) and blood product administrations, as well as perioperative CBT data, were harvested from electronic medical records. Linear and nonlinear mixed models, treating surgeon as a random effect to account for inter-surgeon practice differences, were used to assess the association between above factors and reexploration for bleeding., Results: Of 4037 patients, 151 (3.7%) underwent reexploration for bleeding. Reexplored patients experienced remarkably greater postoperative morbidity (23% vs 6%, P < .001) and 30-day mortality (14% vs 2%, P < .001). In linear models, progressively increasing IV crystalloid administration (adjusted odds ratio, 1.11, 95% confidence interval, 1.03-1.19) and decreasing CBT on intensive care unit arrival (adjusted odds ratio, 1.20; 95% confidence interval, 1.05-1.37) were associated with greater risk of bleeding leading to reexploration. Nonlinear analysis revealed increasing risk after ∼6 L of crystalloid administration and a U-shaped relationship between CBT and reexploration risk. Intraoperative blood product transfusion of any kind was not associated with reexploration., Conclusions: We found evidence of both dilution- and hypothermia-related effects associated with perioperative bleeding leading to reexploration in cardiac surgery. Interventions targeting modification of such risk factors may decrease the rate this complication., Competing Interests: Conflict of Interest Statement The authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling or reviewing manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest., (Copyright © 2023 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: Bleeding as a complication is associated with poorer results in cardiac surgery. There is increasing evidence that the use of blood products is an independent factor of increased morbidity, mortality, and hospital costs. Dyke et al. established the universal definition of perioperative bleeding (UDPB). This classification is more precise defining mortality in relation to the degree of bleeding., Methods: A descriptive and analytical retrospective study of a database of patients underwent cardiac surgery from January 1, 2016, to December 31, 2017, was performed. The primary objective of the study was to look at mortality associated with the degree of bleeding using the UDPB., Results: A total of 918 patients who went to cardiac surgery were obtained. Most of the population was classified as insignificant bleeding class (n = 666, 72.9%), and for massive bleeding the lowest proportion (n = 25, 2.7%). For the primary outcome of 30-day mortality, a significant difference was found between the groups, observing that it increased to a higher degree of bleeding. This was corroborated by multivariate logistic regression analysis that was adjusted to EuroScore II and cardiopulmonary bypass (CPB) duration, finding an independent association of the bleeding class with 30-day mortality (OR, 95%, 5.82 [2.22-15.26], p = 0.0001)., Conclusions: We found that the higher the degree in UDPB was associated with higher mortality independently to EuroScore II and CPB duration for adult patients undergoing cardiac surgery., (Copyright: © 2020 Permanyer.)

Background: Although minimally invasive mitral valve surgery via a right minithoracotomy (MICS-mitral) is widely performed, no tool to evaluate its risk has been reported. We sought to establish MICS-mitral risk calculators using a national clinical database for selection of appropriate patients.Methods and Results:Between 2008 and 2015, 3,240 patients (mean age 59±14 years, males 1,950) underwent a MICS-mitral procedure in Japan and were registered in a national clinical database. We examined mortality and composite outcome (operative mortality, stroke, reoperation for bleeding) using multivariate analysis, then developed a risk calculator for each using stepwise analysis. Operative mortality was 1.1% and the composite outcome rate was 5%. In multivariate analysis, risk factors for operative mortality were shown to be age, respiratory dysfunction, thoracic aortic disease, myocardial infarction, body mass index >30, NYHA class IV, moderate or severe aortic regurgitation, mitral valve replacement, multiple valve surgery, and annual cases <10. ROC curve analysis of our prediction formulas for mortality and composite outcome revealed an area under the curve for operative mortality of 0.877 (95% confidence interval: 0.82-0.94, P<0.01) and for composite outcome of 0.665 (95% confidence interval: 0.62-0.71, P<0.01)., Conclusions: We developed risk calculator formulas using risk factors associated with both operative mortality and composite outcome. The present risk calculator formula is useful for patient selection and may influence future applications for this procedure.

Background: Bleeding is a significant complication in cardiac surgery and is associated with substantial morbidity and mortality. This study evaluated the impact of bleeding on length of stay (LOS) and critical care utilization in a nationwide sample of cardiac surgery patients treated at English hospitals., Methods: Retrospective, observational cohort study using linked English Hospital Episode Statistics (HES) and Clinical Practice Research Datalink (CPRD) records for a nationwide sample of patients aged ≥18 years who underwent coronary artery bypass graft (CABG), valve repair/replacement, or aortic operations from January 2010 through February 2016. The primary independent variables were in-hospital bleeding complications and reoperation for bleeding before discharge. Generalized linear models were used to quantify the adjusted mean incremental difference [MID] in post-procedure LOS and critical care days associated with bleeding complications, independent of measured baseline characteristics., Results: The study included 7774 cardiac surgery patients (3963 CABG; 2363 valve replacement/repair; 160 aortic procedures; 1288 multiple procedures, primarily CABG+valve). Mean LOS was 10.7d, including a mean of 4.2d in critical care. Incidences of in-hospital bleeding complications and reoperation for bleeding were 6.7 and 0.3%, respectively. Patients with bleeding had longer LOS (MID: 3.1d; p < 0.0001) and spent more days in critical care (MID: 2.4d; p < 0.0001). Reoperation for bleeding was associated with larger increases in LOS (MID = 4.0d; p = 0.002) and days in critical care (MID = 3.2d; p = 0.001)., Conclusions: Among English cardiac surgery patients, in-hospital bleeding complications were associated with substantial increases in healthcare utilization. Increased use of evidence-based strategies to prevent and manage bleeding may reduce the clinical and economic burden associated with bleeding complications in cardiac surgery.

Objectives: Rotational thromboelastometry (ROTEM)-guided transfusion algorithms in cardiac surgery have been proven to be successful in reducing blood loss in randomized controlled trials. Using an institutional hemostasis registry of patients in cardiac surgery (HEROES-CS), the authors hypothesized that the use of ROTEM-guided transfusion algorithms would save blood products and overall costs in cardiac surgery in every day practice., Design: Observational, prospective open cohort database., Setting: Single-center academic hospital., Participants: Cardiac surgery patients., Interventions: Implementation of ROTEM-guided bleeding management., Measurements and Main Results: A classical-guided algorithm and a ROTEM-guided algorithm were used for patient blood management in 2 cohorts. Primary outcome was the use and amount of blood products and hemostatic medication. Secondary outcomes were amount of rethoracotomies, length of stay, and 30-day mortality. Finally, costs and savings were calculated. The classical-guided cohort comprised 204 patients, and ROTEM-guided cohort comprised 151 patients. Baseline characteristics showed excellent similarities after propensity score matching of 202 patients. Blood loss was lower after ROTEM guidance (p < 0.001). Absolute risk reduction was 17% for red blood cells (p = 0.024), 12% for fresh frozen plasma (p = 0.019), and 4% for thrombocyte concentrates (p = 0.582). More tranexamic acid was given, but not more fibrinogen concentrate, while desmopressin was given less often. Hospital length of stay was reduced by an overall median of 2 and a mean of 4 days (p < 0.001). Mortality and rethoracotomy rates were not affected. Potential savings were about €4,800 ($5,630) per patient., Conclusions: Implementation of a ROTEM-guided transfusion algorithm in cardiac surgery patients reduced the use of blood products and hemostatic medication, hereby saving costs. Reductions in mortality and rethoracotomy rates could not be found., (Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.)

What We Already Know About This Topic: WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: Research into major bleeding during cardiac surgery is challenging due to variability in how it is scored. Two consensus-based clinical scores for major bleeding: the Universal definition of perioperative bleeding and the European Coronary Artery Bypass Graft (E-CABG) bleeding severity grade, were compared in this substudy of the Transfusion Avoidance in Cardiac Surgery (TACS) trial., Methods: As part of TACS, 7,402 patients underwent cardiac surgery at 12 hospitals from 2014 to 2015. We examined content validity by comparing scored items, construct validity by examining associations with redo and complex procedures, and criterion validity by examining 28-day in-hospital mortality risk across bleeding severity categories. Hierarchical logistic regression models were constructed that incorporated important predictors and categories of bleeding., Results: E-CABG and Universal scores were correlated (Spearman ρ = 0.78, P < 0.0001), but E-CABG classified 910 (12.4%) patients as having more severe bleeding, whereas the Universal score classified 1,729 (23.8%) as more severe. Higher E-CABG and Universal scores were observed in redo and complex procedures. Increasing E-CABG and Universal scores were associated with increased mortality in unadjusted and adjusted analyses. Regression model discrimination based on predictors of perioperative mortality increased with additional inclusion of the Universal score (c-statistic increase from 0.83 to 0.91) or E-CABG (c-statistic increase from 0.83 to 0.92). When other major postoperative complications were added to these models, the association between Universal or E-CABG bleeding with mortality remained., Conclusions: Although each offers different advantages, both the Universal score and E-CABG performed well in the validity assessments, supporting their use as outcome measures in clinical trials.

Background: Re-exploration after cardiac surgery remains a relatively frequent complication associated with adverse effects on outcome. We aimed to identify risk factors for re-exploration., Methods: We retrospectively reviewed 2,403 patients having undergone cardiac surgical procedure between January 2013 and December 2014. Re-exploration was required in 114 patients (4.7%). Patients with oral anticoagulation, infective endocarditis, or a clearly identified bleeding source were excluded. Therefore, 42 patients remained for analysis. A matched cohort was selected for age, sex, ejection fraction, creatinine, and procedure out of the non-re-explored patients., Results: Demographic data were similar in both groups, except for a higher prevalence of diabetes (45 vs. 21%; p  = 0.036) in the non-re-explored patients. Surgery was elective in two-thirds and preoperative plasma fibrinogen concentration was lower in patients requiring re-exploration (2.8 ± 0.9 vs. 3.6 ± 0.9 g/L; p  = 0.002). During the initial operation, re-explored patients received more packed red blood cells (1.5 ± 3 vs. 0 ± 1 units; p  < 0.001), Postoperatively, re-explored patients had higher lactate levels (1.7 ± 1.4 vs. 1.3 ± 0.6 mmol/L, p  = 0.044), more chest tube drainage (1,245 ± 948 vs. 685 ± 413 mL; p  < 0.001), higher hospital mortality (19 vs. 7%; p  = 0.19), and longer intensive care unit (ICU) stays (8 ± 8 vs. 4 ± 7 days; p  = 0.010). In addition, more fibrinogen was administrated during the initial surgery. Plasma fibrinogen concentration upon arrival at the ICU was lower in patients requiring re-exploration (2 ± 0.6 vs. 2.7 ± 0.7 g; p  < 0.001). Multivariable linear regression analysis identified fibrinogen upon arrival at the ICU as an independent predictor of postoperative bleeding., Conclusion: Cardiac surgery patients with low perioperative plasma fibrinogen concentration appear to be more susceptible to bleeding and re-exploration. Re-exploration in this group of patients is associated with increased morbidity and mortality., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (Georg Thieme Verlag KG Stuttgart · New York.)

Background: Although bloodless cardiac surgery has been successfully performed for many years, studies with controls permitting transfusion are few and their results inconclusive. This study compares the outcome of cardiac surgery on Jehovah's Witnesses (JW) refusing transfusion, with that of controls permitting transfusion if required., Methods: Data from 172 operations in 162 JW were compared with 172 matched controls. Risk factors, preoperative, operative, 48 hour postoperative variables, outcome data and transfusions were recorded., Results: Preoperative and operative variables were similar in both groups except for more previous cardiac operations, and more frequent use of cell saver and aprotinin in JW, who bled less and had higher hemoglobin concentrations at all periods. Thirty-day mortality was higher in JW (9.9% vs. 3.5%; P=0.03) (Risk difference 6.4%; CI95%: 2.7-10.1). Nevertheless operative mortality was similar in both groups (9.9% vs. 7.6%; P=0.44). Mortality in low-risk subjects was higher in JW (8.9% vs. 1.0%; P=0.02) (Risk difference 7.9%; CI95%: 2.7-13.2). Moreover, death associated with hemorrhage and anemia tended to be more frequent in JW. Mortality of transfused controls (14.1%) and their matched JW (13.0%) was similar. In contrast, mortality of non-transfused controls was zero versus 6.3% in their matched JW (P=0.059)., Conclusions: Low-risk JW had significantly higher mortality than controls. Bleeding related deaths tended to be more frequent in JW. Blood-sparing maneuvers should be intensively implemented in both JW and patients permitting transfusion in order to reduce bleeding and the need for transfusion with its harmful effects.

Background: Perioperative bleeding is a common complication in pediatric patients undergoing cardiac operation. Although thromboelastography (TEG) has been used in patients undergoing adult cardiac operation, limited data are available in pediatric patients. We hypothesize that TEG variables may be associated with surrogate end points for postoperative bleeding in pediatric patients undergoing complex cardiac operation., Methods: In a retrospective study, TEG was obtained after protamine administration and on admission to the intensive care unit (ICU) in pediatric patients (≤18 years) undergoing cardiac operation that required cardiopulmonary bypass. A composite end point of extended blood product transfusion or surgical re-exploration for bleeding was used as a surrogate for perioperative bleeding. TEG variables were compared between patients who did or did not reach the composite end point., Results: The study included 511 pediatric patients undergoing complex cardiac operation. The composite end point was reached in 52% of patients with maximum amplitude (MA) less than 45 mm compared with 31% with MA of 45 mm or more (p < 0.001). With the use of multivariable regression analysis, MA less than 45 mm was independently associated with the composite end point (p < 0.001). Patients with MA less than 45 mm who received platelet transfusion in the operating room (OR) were less likely to reach the composite end point within the subsequent 24 hours (8%) compared with patients who did not receive intraoperative platelet transfusion (24%) (p = 0.02)., Conclusions: Intraoperative TEG MA less than 45 mm is associated with a surrogate end point for intraoperative bleeding in pediatric patients undergoing complex cardiac operation. In patients with MA less than 45 mm, prophylactic platelet transfusion in the OR may be associated with reduction in bleeding end points in the ICU., (Copyright © 2018 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Background: Reducing blood product utilization after cardiac surgery has become a focus of perioperative care as studies have suggested improved outcomes. The relative impact of preoperative anemia versus packed red blood cells (PRBC) transfusion on outcomes remains poorly understood, however. In this study, we investigated the relative association between preoperative hematocrit (Hct) level and PRBC transfusion on postoperative outcomes after coronary artery bypass grafting (CABG) surgery., Methods: Patient records for primary, isolated CABG operations performed between January 2007 and December 2017 at 19 cardiac surgery centers were evaluated. Hierarchical logistic regression modeling was used to estimate the relationship between baseline preoperative Hct level as well as PRBC transfusion and the likelihoods of postoperative mortality and morbidity, adjusted for baseline patient risk. Variable and model performance characteristics were compared to determine the relative strength of association between Hct level and PRBC transfusion and primary outcomes., Results: A total of 33,411 patients (median patient age, 65 years; interquartile range [IQR], 57-72 years; 26% females) were evaluated. The median preoperative Hct value was 39% (IQR, 36%-42%), and the mean Society of Thoracic Surgeons (STS) predicted risk of mortality was 1.8 ± 3.1%. Complications included PRBC transfusion in 31% of patients, renal failure in 2.8%, stroke in 1.3%, and operative mortality in 2.0%. A strong association was observed between preoperative Hct value and the likelihood of PRBC transfusion (P < .001). After risk adjustment, PRBC transfusion, but not Hct value, demonstrated stronger associations with postoperative mortality (odds ratio [OR], 4.3; P < .0001), renal failure (OR 6.3; P < .0001), and stroke (OR, 2.4; P < .0001). A 1-point increase in preoperative Hct was associated with decreased probabilities of mortality (OR, 0.97; P = .0001) and renal failure (OR, 0.94; P < .0001). The models with PRBC had superior predictive power, with a larger area under the curve, compared with Hct for all outcomes (all P < .01). Preoperative anemia was associated with up to a 4-fold increase in the probability of PRBC transfusion, a 3-fold increase in renal failure, and almost double the mortality., Conclusions: PRBC transfusion appears to be more closely associated with risk-adjusted morbidity and mortality compared with preoperative Hct level alone, supporting efforts to reduce unnecessary PRBC transfusions. Preoperative anemia independently increases the risk of postoperative morbidity and mortality. These data suggest that preoperative Hct should be included in the STS risk calculators. Finally, efforts to optimize preoperative hematocrit should be investigated as a potentially modifiable risk factor for mortality and morbidity., (Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: To evaluate the results of patients with chronic hepatitis C virus (HCV) following cardiac surgery in the TurcoSCORE (TrS) database., Methods: Sixty patients with HCV who underwent cardiac surgery between 2005 and 2016 in our clinic out of a total 8,018 patients from the TrS database were included in the study. The perioperative morbidity and mortality rates in these patients were compared with a matched cohort., Results: The mean follow-up time was 96.6 ± 12.3 months. Hospital mortality rates (HCV group 5% vs. control group 1.7%, p  = 0.61) were similar between the groups. No significant difference was found in the duration of cardiopulmonary bypass (HCV 79.1 ± 12.3 vs. control 82.6 ± 11.8, p  = 0.88) and cross clamps (HCV 33.4 ± 6.9 vs control 33.8 ± 7.2 p  = 0.76) between the two groups. The rate of patients who were revised due to postoperative hemorrhage was significantly higher in the HCV arm compared with the matched cohort (HCV 13.3% vs. control 1.7%, p  < 0.05). Although the measured prothrombin time (PT) and international normalized ratio (INR) in the postoperative 24th hour were in normal ranges in both arms, they were significantly higher in the HCV arm (HCV 11.2 ± 1.2 vs. control 10.5 ± 0.8, p  < 0.05; HCV 0.99 ± 0.06, vs. control 0.92 ± 0.03, p  < 0.0001)., Conclusion: The presence of HCV can be an important prognostic factor for morbidity in patients undergoing cardiac surgery. It can also play an important role in the risk models generated for cardiac surgery., Competing Interests: Disclosure The authors report no conflicts of interest in this work., (Georg Thieme Verlag KG Stuttgart · New York.)

Objective: To derive and validate an objective definition of postoperative bleeding in neonates and infants undergoing cardiac surgery with cardiopulmonary bypass., Methods: Using a retrospective cohort of 124 infants and neonates, we included published bleeding definitions and cumulative chest tube output over different postoperative periods (eg, 2, 12, or 24 hours after intensive care unit admission) in a classification and regression tree model to determine chest tube output volumes that were associated with red blood cell transfusions and surgical re-exploration for bleeding in the first 24 hours after intensive care unit admission. After the definition of excessive bleeding was determined, it was validated via a prospective cohort of 77 infants and neonates., Results: Excessive bleeding was defined as ≥7 mL/kg/h for ≥2 consecutive hours in the first 12 postoperative hours and/or ≥84 mL/kg total for the first 24 postoperative hours and/or surgical re-exploration for bleeding or cardiac tamponade physiology in the first 24 postoperative hours. Excessive bleeding was associated with longer length of hospital stay, increased 30-day readmission rate, and increased transfusions in the postoperative period., Conclusions: The proposed standard definition of excessive bleeding is based on readily obtained objective data and relates to important early clinical outcomes. Application and validation by other institutions will help determine the extent to which our specialty should consider this definition for both clinical investigation and quality improvement initiatives., (Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Objective: To determine the effectiveness and safety of aprotinin use in adult patients undergoing thoracic aortic surgery., Design: Single-center, retrospective study., Setting: All cases performed at a single university hospital., Participants: Between January 2004 and December 2014, 846 adult patients underwent thoracic aortic surgery. Due to missing or duplicated data on primary outcomes, 314 patients were excluded. The final sample of 532 patients underwent surgery on the thoracic aorta., Interventions: The patients were divided in the following 2 groups: 107 patients (20.1%) received aprotinin during the surgery, which represented the study group, whereas the remaining 425 patients (79.9%) underwent surgery without the use of aprotinin., Measurements and Main Results: To adjust for patient selection and preoperative characteristics, a propensity score-matched analysis was conducted. Mean total blood loss at 12 hours after surgery was similar between the 2 groups. The blood product transfusion rates did not differ in the 2 groups, except for the rate of fresh frozen plasma transfusion being significantly higher in the aprotinin group. Re-exploration for bleeding and the incidence of a major postoperative bleeding event were similar between the groups. Rates of in-hospital mortality, renal failure, and cerebrovascular accidents did not show any statistically significant difference. Aprotinin did not represent a risk factor for mortality over the long term (hazard ratio 1.14, 95% confidence interval 0.62-2.08, p = 0.66)., Conclusions: The use of aprotinin demonstrated a limited effect in reducing postoperative bleeding and prevention of major bleeding events. Aprotinin did not adversely affect early outcomes and long-term survival., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Postoperative re-exploration for bleeding (RB) is a frequent complication following cardiac surgery. We aim to assess incidence, risk factors, and prognostic significance of RB in a large cohort of cardiac patients., Materials and Methods: We reviewed prospectively collected data for all patients who underwent cardiac surgery at our institution from 2007 to 2015. Logistic regression analysis was used to identify independent predictors of RB and specific outcomes. Propensity matching using a 1:1-ratio compared outcomes of patients who had RB with patients who did not., Results: During the study period, 7381 patients underwent cardiac operations. Of them, 189 (2.6%) underwent RB. RB was an independent predictor of in-hospital mortality (Odds Ratio (OR):2.62 Confidence Interval (CI):1.38-4.96; p = 0.003), major adverse events (OR:3.94, CI:2.79-5.62; p < 0.001), gastrointestinal events (OR:3.54 CI:1.73-7.24), renal failure (OR:2.44, CI:1.23-4.82), prolonged ventilation (OR:3.83, CI:2.60-5.62, p < 0.001), and sepsis (OR:2.50, CI:1.03-6.04, p = 0.043). Preoperative shock (OR:3.68, CI:1.66-8.13; p = 0.001), congestive heart failure (OR:1.70 CI:1.24-2.32; p = 0.001), and urgent and emergent status (OR:2.27, CI:1.65-3.12 and OR:3.57, CI:1.89-6.75; p < 0.001 for both) were predictors of RB operative mortality. Operative mortality, incidence of major adverse events, gastrointestinal events, and respiratory failure were all significantly higher in the propensity matched RB group (p = 0.050, p < 0.001, p = 0.046, and p < 0.001 respectively)., Conclusions: RB significantly increases in-hospital mortality and morbidity after cardiac surgery., (Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.)

Objective: To determine the incidence of gastrointestinal (GI) bleeding in patients after cardiac surgery, assess the perioperative risk factors, and determine the type of GI tract pathology associated with bleeding events., Methods: At a tertiary referral hospital, all cardiac surgery patients having a postoperative GI bleed from April 2002 to March 2012 were identified. To determine bleeding etiology, only patients requiring endoscopy were included in the analysis. By retrospective review of 3 prospectively maintained databases, the incidence and independent predictors of GI bleeding, as well as endoscopic findings, were determined., Results: Ninety-one GI bleeding events that required endoscopy were identified in 9017 patients. Those that bled were aged 71 ± 12 years, and 76% were men. Sixty-three percent of these patients had valve surgery and 37% had an isolated coronary artery bypass grafting. The overall incidence of GI bleeding was 1.01%, with an upper GI source accounting for 78%. Endoscopy data found a duodenal ulcer as the bleeding source in 71%, whereas stress gastritis accounted for 8%. Preoperative risk factors for bleeding included age ≥70 years, ejection fraction <35%, congestive heart failure, cerebrovascular disease, chronic kidney disease, and gastrointestinal disease. A preoperative history of atrial fibrillation and anticoagulation with Coumadin also was associated with bleeding. Patients that bled had a 30-day mortality rate of 8.8%, which was significantly greater than patients who did not bleed (4.3%; P = .03)., Conclusions: Clinical variables can be used to identify patients at high risk for GI bleeding after cardiac surgery. When GI bleeding occurs, the most common cause is duodenal ulceration, which has an association with Helicobacter pylori infection. These findings may provide an opportunity to initiate preoperative preventative strategies., (Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Aim: To define the risk factors of complications which are followed by re-operations in patients with cardiac and pericardial wounds and to prevent these complications., Material and Methods: Retrospective and prospective analysis of 1072 victims with cardiac and pericardial injuries for 35 years was performed. Overall mortality was 17.2%. 98 patients died during surgery. Postoperative bleeding was observed in 38 (3.9%) cases., Results: In 28 cases re-operations were performed for bleeding-related complications. Indications for re-thoracotomy were one-time drainage from pleural cavity over 500 ml or bleeding rate over 100 ml per hour for 4 hours. Prevention of postoperative bleeding in case of cardiac and pericardial wounds was developed on basis of analysis of these observations., Conclusion: Risk factors of complications requiring re-operation are cardiomyopathy of different etiology, technical and tactical errors during primary intervention and hypocoagulation with massive blood loss. Prevention of these complications includes careful heart wound closure, comprehensive intraoperative control, correction of hemostatic system.

Dual antiplatelet therapy (DAPT) with acetylsalicylic acid and a P2Y12 inhibitor (clopidogrel, ticagrelor, or prasugrel) reduces thrombotic events in patients with acute coronary syndrome (ACS), but it is also associated with an increased risk of bleeding complications. Excessive bleeding in cardiac surgery patients is associated with increased morbidity and mortality and high costs. In this review, different aspects of platelet inhibition in cardiac surgery patients will be discussed, including direct effects on bleeding and transfusion requirements, discontinuation and reinstitution of antiplatelet drugs before and after surgery, and the use of perioperative platelet function testing.

Objectives: Evacuation of shed blood from around the heart and lungs is a critical requirement for patients in early recovery after cardiac surgery. Incomplete evacuation of shed blood can result in retained blood, which may require subsequent reinterventions to facilitate recovery. The purpose of this study was to determine the incidence of retained blood requiring reintervention and examine the impact on outcomes., Methods: We performed a cross-sectional, observational study of all adult patients undergoing cardiac surgery between 2006 and 2013. Subjects who required an intervention to remove blood, blood clot, or bloodily fluid were attributed to the retained blood group. These patients were compared with those not presenting with any of the defined criteria for retained blood. Multivariate regression was performed to account for confounders., Results: Of 6909 adult patients who underwent cardiac surgery, 1316 (19%) presented with a retained blood-related condition. Retained blood was associated with increased in-hospital mortality (odds ratio [OR], 4.041; 95% confidence interval [CI], 2.589-6.351, P < .001) and a length of stay more than 13 days in the hospital (OR, 3.853; 95% CI, 2.882-5.206; P < .001) and 5 days in the intensive care unit (OR, 4.602; 95% CI, 3.449-6.183; P < .001). The OR for a time of ventilation greater than 23 hours was 3.596 (95% CI, 2.690-4.851; P < .001) and for incidence of renal replacement therapy was 4.449 (95% CI, 3.188-6.226; P < .001)., Conclusions: Postoperative retained blood is a common outcome and associated with higher in-hospital mortality, longer intensive care unit and hospital stay, and higher incidence of renal replacement therapy. Further research is needed to validate these results and explore interventions to reduce these complications., (Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

Background: There is currently no accepted standard for reporting outcomes following cardiac surgery. The objective of this paper was to systematically review the literature to evaluate the current use and definition of perioperative outcomes reported in cardiac surgery trials., Methods and Results: We reviewed 5 prominent medical and surgical journals on Medline from January 1, 2010, to June 30, 2014, for randomized controlled trials involving coronary artery bypass grafting and/or valve surgery. We identified 34 trials meeting inclusion criteria. Sample sizes ranged from 57 to 4752 participants (median 351). Composite end points were used as a primary outcome in 56% (n=19) of the randomized controlled trials and as a secondary outcome in 12% (n=4). There were 14 different composite end points. Mortality at any time (all-cause and/or cardiovascular) was reported as an individual end point or as part of a combined end point in 82% (n=28), myocardial infarction was reported in 68% (n=23), and bleeding was reported in 24% (n=8). Patient-centered outcomes, such as quality of life and functional classification, were reported in 29% (n=10). Definition of clinical events such as myocardial infarction, stroke, renal failure, and bleeding varied considerably among trials, particularly for postoperative myocardial infarction and bleeding, for which 8 different definitions were used for each., Conclusions: Outcome reporting in the cardiac surgery literature is heterogeneous, and efforts should be made to standardize the outcomes reported and the definitions used to ascertain them. The development of standardizing outcome reporting is an essential step toward strengthening the process of evidence-based care in cardiac surgery., (© 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Our objectives were to study risk factors and post-operative outcomes associated with excessive post-operative bleeding in pediatric cardiac surgeries performed using cardiopulmonary bypass (CPB) support. A retrospective observational study was undertaken, and all consecutive pediatric heart surgeries over 1 year period were studied. Excessive post-operative bleeding was defined as 10 ml/kg/h of chest tube output for 1 h or 5 ml/kg/h for three consecutive hours in the first 12 h of pediatric cardiac intensive care unit (PCICU) stay. Risk factors including demographics, complexity of cardiac defect, CPB parameters, hematological studies, and post-operative morbidity and mortality were evaluated for excessive bleeding. 253 patients were studied, and 107 (42 %) met the criteria for excessive bleeding. Bayesian model averaging revealed that greater volume of blood products transfusion during CPB was significantly associated with excessive bleeding. Multiple logistic regression analysis of blood products transfusion revealed that increased volume of packed red blood cells (PRBCs) administration for CPB prime and during CPB was significantly associated with excessive bleeding (p = 0.028 and p = 0.0012, respectively). Proportional odds logistic regression revealed that excessive bleeding was associated with greater time to achieve negative fluid balance, prolonged mechanical ventilation, and duration of PCICU stay (p < 0.001) after adjusting for multiple parameters. A greater volume of blood products administration, especially PRBCs transfusion for CPB prime, and during the CPB period is associated with excessive post-operative bleeding. Excessive bleeding is associated with worse post-operative outcomes.

Objective: Postcardiopulmonary bypass hemorrhage remains a serious complication of cardiac surgery. Given concerns regarding adverse effects of blood product transfusion and limited efficacy of current antifibrinolytics, procoagulant medications, including recombinant factor VIIa (rFVIIa) and factor eight inhibitor bypass activity (FEIBA), increasingly have been used in managing refractory bleeding. While effective, these medications are associated with thromboembolic complications. This study compared the efficacy and risk of adverse events of rFVIIa and FEIBA in cardiac surgical patients with refractory bleeding., Design: This retrospective study evaluated 168 patients who underwent cardiac surgery and received either FEIBA or rFVIIa to manage postbypass hemorrhage. Demographic, clinical, and outcomes data were collected and statistical analysis performed to compare thromboembolic event rates, relative efficacy, and 30-day mortality following administration of these medications., Setting: Single university hospital., Participants: Patients undergoing cardiac surgery., Interventions: None., Measurements and Main Result: Sixty-one patients received rFVIIa, and 107 received FEIBA. Demographics, surgical procedures, and preoperative anticoagulation were similar between the cohorts; however, the rFVIIa cohort had longer durations of cardiopulmonary bypass (305.1 v 243.8 min, p<0.01). There were no significant differences in the number of thromboembolic events, 30-day mortality, or rates of revision surgery. Neither group demonstrated a clear relationship between dosage and occurrence of thromboembolic events. The rFVIIa cohort received more platelets than the FEIBA cohort (3.13 v 1.67 units, p = 0.01), but transfusion rates of other blood products were similar., Conclusions: This study suggests that rFVIIa and FEIBA have similar efficacy and adverse event profiles in managing intractable postbypass hemorrhage in cardiac surgical patients. Further prospective studies are required., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: Infants undergoing cardiac surgery often have postoperative bleeding contributing to the occurrence of adverse events. A quantitative evaluation of postoperative bleeding has not been well described., Methods: We identified 1071 infants who had undergone cardiopulmonary bypass from August 1, 2008 to December 31, 2011. The volume of postoperative bleeding and its effect on mortality were reviewed., Results: Postoperative bleeding during the first 12 hours postoperatively was stratified by quartiles. Bleeding was significantly associated with increased mortality (odds ratio [OR], 1.15; 95% confidence interval [CI] 1.10-1.21; P < .001). Other risk factors significantly associated with mortality included greater Risk Adjustment for Congenital Heart Surgery score (OR, 1.5; 95% CI, 1.22-1.85; P < .001), single ventricle anatomy (OR, 3.09; 95% CI, 1.68-5.67; P < .001), younger age (OR, 0.99; 95% CI, 0.98-0.99; P < .001), and longer perfusion time (OR, 1.01; 95% CI, 1.01-1.02; P < .001). Subjects with greater bleeding volumes experienced a longer postoperative mechanical ventilation and intensive care unit stay. The overall hospital mortality was 4.1%. On multivariate analysis, adjusting for age, single ventricle anatomy, Risk Adjustment for Congenital Heart Surgery score, and perfusion time, an increasing bleeding volume was independently associated with increased mortality. Packed red blood cell transfusion was independently associated with an increased duration of mechanical ventilation (P = .01) and intensive care unit length of stay (P = .003)., Conclusions: Early postoperative hemorrhage was independently associated with an increased mortality in infants after cardiac surgery. The longer interval from surgery to death suggests that other factors, aside from the bleeding itself, including the transfusion volume, might contribute to mortality. Initiatives to limit postoperative bleeding and to critically appraise packed red blood cell transfusion practices are warranted., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: Fibrinogen supplementation is increasingly recommended with the use of rotational thromboelastometry (ROTEM). However, data regarding the paediatric population are sparse., Objective: We aimed to assess the relationship between plasma fibrinogen concentration and postoperative blood loss in children undergoing cardiac surgery., Design: Retrospective analysis., Setting: Data prospectively recorded in our departmental database between September 2010 and January 2012., Patients: Data from 156 children scheduled for congenital heart surgery with ROTEM performed at the end of cardiopulmonary bypass (CPB) were analysed., Intervention: None., Main Outcome Measures: Abnormal bleeding was defined as blood loss that exceeded 10% of total blood volume within the first 6 postoperative hours. Logistic regression analyses were used to determine variables associated with bleeding. Correlation analyses and receiver operating characteristic (ROC) curves were designed to evaluate the relationship between blood loss and plasma fibrinogen concentration or ROTEM variables, if relevant., Results: Thirty-six children were considered as 'bleeders' and 120 as 'nonbleeders'. Univariate and multivariate logistic regression analysis revealed time for wound closure, clot formation time, maximal clot firmness (MCF) and plasma fibrinogen concentration as variables independently associated with postoperative bleeding. MCF was best correlated with plasma fibrinogen concentration. ROC curves for blood loss versus fibrinogen concentration and MCF showed that a plasma fibrinogen concentration of 1.5 g l and a MCF value 3 mm or less could be used to predict blood loss., Conclusion: Post-CPB plasma fibrinogen concentration significantly influences blood loss in children undergoing cardiac surgery. A fibrinogen concentration of at least 1.5 g l or a MCF of at least 3 mm should accurately predict excessive blood loss in cardiac surgery children. Further prospective trials are needed to assess the effect of fibrinogen supplementation on postoperative blood loss in this population.

Objectives: Perioperative bleeding is common among patients undergoing cardiac surgery; however, the definition of perioperative bleeding is variable and lacks standardization. We propose a universal definition for perioperative bleeding (UDPB) in adult cardiac surgery in an attempt to precisely describe and quantify bleeding and to facilitate future investigation into this difficult clinical problem., Methods: The multidisciplinary International Initiative on Haemostasis Management in Cardiac Surgery identified a common definition of perioperative bleeding as an unmet need. The functionality and usefulness of the UDPB for clinical research was then tested using a large single-center, nonselected, cardiac surgical database., Results: A multistaged definition for perioperative bleeding was created based on easily measured clinical end points, including total blood loss from chest tubes within 12 hours, allogeneic blood products transfused, surgical reexploration including cardiac tamponade, delayed sternal closure, and the need for salvage treatment. Depending on these components, bleeding is graded as insignificant, mild, moderate, severe, or massive. When applied to an established cardiac surgery dataset, the UDPB provided insight into the incidence and outcome of bleeding after cardiac surgery., Conclusions: The proposed UDPB in adult cardiac surgery provides a precise classification of bleeding that is useful in everyday practice as well as in clinical research. Once fully validated, the UDPB may be useful as an institutional quality measure and serve as an important end point in future cardiac surgical research., (Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Background: During on-pump cardiac surgery, hemorrhagic complications occur frequently. Fresh-frozen plasma (FFP) is widely transfused to provide coagulation factors. Yet, no randomized clinical trial has demonstrated its benefits on mortality. We assessed the relationship between therapeutic transfusion of FFP and 30-day mortality in cardiac surgery patients suffering from excessive bleeding in a prospective cohort study., Study Design and Methods: Adult patients who underwent on-pump cardiac surgery and experienced excessive bleeding during the 48-hour perioperative period were recruited from 15 French centers between February 2004 and January 2006. Patients who received a preventive FFP transfusion were excluded. The association between FFP transfusion and all cause 30-day mortality was estimated using a Cox proportional hazards model, adjusted for confounding. A propensity score (PS) sensitivity analysis was also performed., Results: Among 967 patients included in this study, 58.1% received FFP. The median dose was 11.3 mL/kg (interquartile range, 7.6-19.5). The cumulative 30-day mortality rate was 11.3% (95% confidence interval [CI], 9.5-13.5). FFP transfusion was associated with a higher 30-day mortality (hazard ratio [HR], 3.2; 95% CI, 1.7-6.1) in univariate analysis; however, after adjusting for prognostic factors, there was no longer any association (HR, 1.5; 95% CI, 0.8-3.0, p = 0.20). The results of the PS analysis were consistent with the adjusted analysis., Conclusion: Among on-pump cardiac surgery patients experiencing excessive perioperative bleeding, there is no evidence of a beneficial impact of FFP transfusion on mortality., (© 2013 American Association of Blood Banks.)

Background: The widespread off-label use of recombinant activated factor VII for the control of refractory postoperative hemorrhage continues despite a warning from the Food and Drug Administration. Although effective in reducing the need for transfusion of blood and blood products, safety concerns still prevail., Objective: To compare the dosing and efficacy of recombinant activated factor VII between pediatric and adult patients, and in the operating room and intensive care unit., Methods: The records of 69 patients (33 children and 36 adults) who underwent cardiovascular surgery and received recombinant activated factor VII were reviewed retrospectively. The dose of recombinant activated factor VII, mediastinal drainage, use of blood and blood products, incidence of thrombosis, and 28-day mortality were studied., Results: the efficacy of recombinant activated factor VII was comparable in adults and children, despite the lower dose in adults. Prophylactic use of recombinant activated factor VII decreased the incidence of mediastinal exploration and the duration of intensive care unit stay. A 4.3% incidence of thrombotic complications was observed in this study., Conclusion: The efficacious dose of recombinant activated factor VII is much less in adults compared to children. Prophylactic use of recombinant activated factor VII decreases the dose required, the incidence of mediastinal exploration, and intensive care unit stay, with no survival benefit.

Excessive bleeding after cardiopulmonary bypass (CPB) is risk factor for adverse outcomes after elective cardiac surgery (ECS). Differentiating between patients who bleed due to surgical issues and those whose excessive chest tube output (CTO) is due to coagulopathy, remains challenging. Bedside suitable tests to identify hemostatic disturbances and predict excessive bleeding are desirable. The study sought to evaluate prediction of excessive bleeding after ECS using two bedside suitable devices for platelet function and viscoelastic blood clot properties assessment. We enrolled 148 patients (105 male and 43 female) undergoing ECS in a prospective observational study. Patients were characterized as bleeders if their 24 h CTO exceeded the 75th percentile of distribution. Multiple electrode aggregometry (MEA, with ASPI, ADP and the TRAP test) and rotational thromboelastometry (TEM, with ExTEM, HepTEM and FibTEM test), were performed at three time points: preoperatively (T1), during CPB (T2), and after protamine administration (T3). The primary endpoint was CTO and the secondary endpoint was administration of blood products, 30-day and 1 year mortality. The best predictors of increased bleeding tendency were the tests performed after protamine administration (T3). At T3, patients characterized as bleeders had significantly lower MEA ASPI (median, 14 vs. 27 AUC, p = 0.004) and ADP test values (median, 22 vs. 41 AUC, p = 0.002) as well as TEM values expressed in maximum clot firmness after 30 min (MCF 30) for ExTEM (53 vs. 56 mm, p = 0.005), HepTEM (48 vs. 52 mm, p = 0.003) and FibTEM (8 vs. 11 mm, p < 0.001) test. 24 h CTO inversely correlated with both the MEA (ASPI test: r = -0.236, p = 0.004; ADP test: r = -0.299, p < 0.001), and TEM MCF 30 (ExTEM: r = -0.295, p < 0.001; HepTEM: -0.329, p < 0.001; FibTEM: -0.377, p < 0.001) test values. Our study showed that MEA and TEM are useful methods for prediction of excessive bleeding after ECS. In order to prevent excessive postoperative CTO, hemostatic interventions with timely and targeted blood component therapy according to MEA and TEM results should be considered.

Objective: Recently we suggested a comprehensive blood-sparing approach in pediatric cardiac surgery that resulted in no transfusion in 71 infants (25%), postoperative transfusion only in 68 (24%), and intraoperative transfusion in 149 (52%). We analyzed the effects of transfusion on postoperative morbidity and mortality in the same cohort of patients., Methods: The effect of transfusion on the length of mechanical ventilation and intensive care unit stay was assessed using Kaplan-Meier curves. To assess whether transfusion independently determined the length of mechanical ventilation and length of intensive care unit stay, a multivariate model was applied. Additionally, in the subgroup of transfused infants, the effect of the applied volume of packed red blood cells was assessed., Results: The median length of mechanical ventilation was 11 hours (interquartile range, 9-18 hours), 33 hours (interquartile range, 18-80 hours), and 93 hours (interquartile range, 34-161 hours) in the no transfusion, postoperative transfusion only, and intraoperative transfusion groups, respectively (P < .00001). The corresponding median lengths of intensive care unit stay were 1 day (interquartile range, 1-2 days), 3.5 days (interquartile range, 2-5 days), and 8 days (interquartile range, 3-9 days; P < .00001). The multivariate hazard ratio for early extubation was 0.24 (95% confidence interval, 0.16-0.35) and 0.37 (95% confidence interval, 0.25-0.55) for the intraoperative transfusion and postoperative transfusion only groups, respectively (P < .00001). In addition, the cardiopulmonary time, body weight, need for reoperation, and hemoglobin during cardiopulmonary bypass affected the length of mechanical ventilation. Similar results were obtained for the length of intensive care unit stay. In the subgroup of transfused infants, the volume of packed red blood cells also independently affected both the length of mechanical ventilation and the length of intensive care unit stay., Conclusions: The incidence and volume of blood transfusion markedly affects postoperative morbidity in pediatric cardiac surgery. These results, although obtained by retrospective analysis, might stimulate attending physicians to establish stringent blood-sparing approaches in their institutions., (Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objectives: Prior studies have found that cardiac surgery patients receiving blood transfusions are at risk for increased mortality and morbidity following surgery. It is not clear whether this increased risk occurs across all haematocrit (HCT) levels. The goal of this study was to compare operative mortality in propensity-matched cardiac surgery patients based on stratification of the preoperative HCT levels., Methods: Between 1 August 2004 and 30 June 2011, 3516 patients had cardiac surgery. One thousand nine hundred and twenty-two (54.5%) required blood transfusion during or after surgery. A propensity score for transfusion was developed based on 22 baseline variables. One thousand seven hundred and fourteen patients were matched: 857 in the transfusion group (TG) and 857 in the non-transfused control group (CG). Univariate analyses demonstrated that, after propensity matching, the groups did not differ on any baseline factors included in the propensity model. Operative mortality was defined as death within 30 days of surgery. Preoperative HCT was stratified into four groups: <36, 36-39, 40-42 and ≥ 43., Results: For HCT <36%, 30-day mortality was higher in the TG than that in the CG (3.0 vs 0.0%). For HCT 36-39, operative mortality was similar between TG (1.1%, N = 180) and CG (0.8%, N = 361; P = 0.748). For HCT 40-42, operative mortality was significantly higher in the TG compared with that in the CG (1.9 vs 0%, N = 108 and 218, respectively; P = 0.044). For HCT of ≥ 43, there was a trend towards higher operative mortality in the TG vs the CG (2.0 vs 0%, N = 102 and 152, respectively; P = 0.083). Other surgical complications followed the same pattern with higher rates found in the transfused group at higher presurgery HCT levels. HCT at discharge for the eight groups were similar, with an average of 29.1 ± 1.1% (P = 0.117)., Conclusions: Our study indicates that a broad application of blood products shows no discernible benefits. Furthermore, patients who receive blood at all HCT levels may be placed at an increased risk of operative mortality and/or other surgical complications. Paradoxically, even though patients with low HCTs theoretically should benefit the most, transfusion was still associated with a higher complication and mortality rate in these patients. Our results indicate that blood transfusion should be used judiciously in cardiac surgery patients.

At Odense University Hospital (OUH), 5-9% of all unselected cardiac surgical patients undergo reoperation due to excessive bleeding. The reoperated patients have an approximately three times greater mortality than non-reoperated. To reduce the rate of reoperations and mortality due to postoperative bleeding, we aim to identify risk factors that predict reoperation. A total of 1452 consecutive patients undergoing cardiac surgery using extracorporeal circulation (ECC) between November 2005 and December 2008 at OUH were analysed. Statistical tests were used to identify risk factors for reoperation. We performed a case-note review on propensity-matched patients to assess the outcome of reoperation for bleeding regarding morbidity and mortality. In total, 101 patients (7.0%) underwent surgical re-exploration due to excessive postoperative bleeding. Significant risk factors for reoperation for bleeding after cardiac surgery was low ejection fraction, high EuroSCORE, procedures other than isolated CABG, elongated time on ECC, low body mass index, diabetes mellitus and preoperatively elevated s-creatinine. Reoperated patients significantly had a greater increase in postoperative s-creatinine and higher mortality. Surviving reoperated patients significantly had a lower EuroSCORE and a shorter time on ECC compared with non-survivors. The average time to re-exploration was 155 min longer for non-survivors when compared with survivors.

The aim of this study was to determine the outcome of patients who had a chest resternotomy and to identify risk factors for higher in-hospital mortality after re-exploration for bleeding and/or tamponade after cardiac operations. We present our experience of an acceptably low re-exploration rate after cardiac surgery, and the outcomes of those re-explored. This was a retrospective analysis of medical records of all patients who had a chest re-exploration for the control of bleeding and cardiac tamponade over a 7-year period (2000-06), at the Cardiothoracic Centre of the Hospital České Budějovice, Czech Republic. Between 2000 and 2006, 152 patients (3.4% of the total heart operations) underwent re-exploration after heart surgery. One hundred and seven (70.4%) were re-explored for bleeding, 36 (23.7%) for possible tamponade and nine (5.9%) for both. An identifiable source of bleeding was found in 72.4% patients. Risk factors associated with higher in-hospital mortality after re-exploration for bleeding and tamponade include delayed resternotomy, higher levels of lactate and lower levels of haematocrit before revision and other well-known risk factors such as older age, more complex cardiac procedures, redo operations, longer cardiopulmonary bypass, renal failure and diabetes mellitus. Patients who need re-exploration are at a higher risk of complications, morbidity and mortality if the time until re-exploration is prolonged.

Objective: Ecallantide is a recombinant peptide in the same class as aprotinin that inhibits plasma kallikrein, a major component of the contact coagulation and inflammatory cascades. Therefore, ecallantide was expected to reduce blood loss associated with cardiac surgery requiring cardiopulmonary bypass., Methods: This prospective multinational, randomized, double-blind trial enrolled patients undergoing cardiac surgery using cardiopulmonary bypass for procedures associated with a high risk of bleeding. Patients were randomly assigned to ecallantide (n = 109) or tranexamic acid (high dose, n = 24; low dose, n = 85). Efficacy was assessed from the volume of packed red blood cells administered within the first 12 hours after surgery., Results: The study was terminated early after the independent data safety and monitoring board observed a statistically significantly higher 30-day mortality in the ecallantide group (12%) than in the tranexamic acid groups (4%, P = .041). Patients receiving ecallantide received more packed red blood cells within 12 hours of surgery than tranexamic acid-treated patients: median = 900 mL (95% confidence interval, 600-1070) versus 300 mL (95% confidence interval, 0-523) (P < .001). Similar differences were seen at 24 hours and at discharge. Patients treated with the higher tranexamic acid dose received less packed red blood cells, 0 mL (95% confidence interval, 280-600), than the group treated with the lower dose, 400 mL (95% confidence interval, 0-400) (P = .008). No deaths occurred in the higher dose tranexamic acid group., Conclusions: Ecallantide was less effective at reducing perioperative blood loss than tranexamic acid. High-dose tranexamic acid was more effective than the low dose in reducing blood loss., (Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Objective: Factors contributing to postoperative complications include blood loss and a heightened inflammatory response. The objective of this study was to test the hypothesis that aprotinin would decrease perioperative blood product use, reduce biomarkers of inflammation, and result in improved clinical outcome parameters in neonates undergoing cardiac operations., Methods: This was a secondary retrospective analysis of a clinical trial whereby neonates undergoing cardiac surgery received either aprotinin (n = 34; before May 2008) or tranexamic acid (n = 42; after May 2008). Perioperative blood product use, clinical course, and measurements of cytokines were compared., Results: Use of perioperative red blood cells, cryoprecipitate, and platelets was reduced in neonates receiving aprotinin compared with tranexamic acid (P < .05). Recombinant activated factor VII use (2/34 [6%] vs 18/42 [43%]; P < .001), delayed sternal closure (12/34 [35%] vs 26/42 [62%]; P = .02), and inotropic requirements at 24 and 36 hours (P < .05) were also reduced in the aprotinin group. Median duration of mechanical ventilation was reduced compared with tranexamic acid: 2.9 days (interquartile range: 1.7-5.1 days) versus 4.2 days (2.9-5.2 days), P = .04. Production of tumor necrosis factor and interleukin-2 activation were attenuated in the aprotinin group at 24 hours postoperatively. No differential effects on renal function were seen between agents., Conclusions: Aprotinin, compared with tranexamic acid, was associated with reduced perioperative blood product use, improved early indices of postoperative recovery, and attenuated indices of cytokine activation, without early adverse effects. These findings suggest that aprotinin may have unique effects in the context of neonatal cardiac surgery and challenge contentions that antifibrinolytics are equivalent with respect to early postoperative outcomes., (Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

Antifibrinolytic agents such as aprotinin and epsilon aminocaproic acid limit postoperative bleeding and blood transfusion in patients undergoing cardiac operations using cardiopulmonary bypass (CPB). Recent evidence suggests that these agents have adverse side effects that influence operative mortality and morbidity. We studied postoperative bleeding, transfusion rates, and operative outcomes in our patients in order to assess the efficacy of these agents during cardiac operations requiring CPB. We reviewed records of 520 patients undergoing a variety of cardiac operations between January 2005 and May 2009. We measured multiple variables including pre-operative risk factors, antifibrinolytic agent used, and outcomes of operation, such as measures of bleeding and blood transfusion, as well as serious operative morbidity and mortality. Postoperative bleeding rates varied significantly between patients receiving aprotinin and those receiving aminocaproic acid (P < 0.05). There was an associated 12% decrease in operative site bleeding in aprotinin-treated patients compared with aminocaproic acid. There was no significant difference in the transfusion rates of packed red blood cells between patients receiving aminocaproic acid or aprotinin (P > 0.05), though individuals in the aprotinin group did receive FFP more frequently than patients in the aminocaproic acid group (P < 0.05). There was no significant difference in morbidity and mortality rates between patients in either drug group (P > 0.05). Our study shows that aprotinin is more effective at controlling operative site bleeding than aminocaproic acid. Reduced operative site bleeding did not portend better outcome or differences in transfusion requirements. Aminocaproic acid remains a safe and cost-effective option for antifibrinolytic prophylaxis because of unavailability of aprotinin.

Background: Aprotinin has been associated with significant morbidity and mortality in adults, leading to its withdrawal from the market and clinical substitution with the lysine analogs, tranexamic acid and ε-aminocaproic acid. Neonates undergoing cardiopulmonary bypass are especially at risk for perioperative bleeding, yet little data exist comparing lysine analogs with aprotinin., Methods: Neonates undergoing cardiopulmonary bypass (January 2006 to December 2009) were included in this single-institution, retrospective cohort study. Preoperative, intraoperative, and postoperative data were analyzed. The relationship between demographic, surgical risk data, and outcomes were analyzed. Markers of effectiveness included transfusion requirement, duration of operation, duration of ventilation, and intensive care unit length of stay. Markers of safety included reexploration, renal dysfunction, neurologic complications, and death., Results: Of 423 included neonates, 271 (64%) received aprotinin and 152 (36%) a lysine analog. Infants who received aprotinin had a higher baseline creatinine and lower weight and gestational age. The aprotinin group experienced shorter time to surgical closure, lower blood product use, and lower rates of reexploration and postoperative renal dysfunction compared with the lysine-analog group. There was no difference in duration of ventilation or intensive care unit stay, neurologic outcomes, or death., Conclusions: Neonates who received aprotinin had significantly lower intraoperative transfusion requirements and shorter surgical closure times. The aprotinin group was less likely to require surgical reexploration and had a lower rate of renal injury. These data illustrate the need for further research regarding safety and efficacy of aprotinin in a larger sample of children undergoing cardiac operations., (Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.)

Objective: Negative pressure wound therapy is the first-line treatment modality for poststernotomy mediastinitis in many heart centers. The aim of this study was to analyze major complications and possible preventive methods during negative pressure wound therapy in patients with deep sternal wound infections., Methods: We retrospectively analyzed 69 consecutive patients treated with negative pressure wound therapy for poststernotomy mediastinitis between June 2006 and September 2009., Results: Five (7.2%) patients sustained major complications during negative pressure wound therapy. Bleeding from coronary artery venous bypass grafts was observed in 4 patients and fulminant bleeding from an infected homograft of the ascending aorta was observed in 1 patient during routine dressing changes of the negative pressure wound therapy system., Conclusions: Bleeding is the major complication during negative pressure wound therapy for poststernotomy mediastinitis. Covering the heart with several layers of paraffin gauze is a necessary protective maneuver but cannot completely prevent major complications during negative pressure wound therapy. All operative procedures, including dressing changes, should be performed in the operating room under optimal hygienic and monitoring conditions to increase the salvage rate and to guarantee optimal surgical and anesthesiologic conditions in case of negative pressure wound therapy-related complications., (Copyright © 2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.)

We analyzed cases of re-exploration for bleeding after 19,680 open heart operations performed between January 1995 and January 2009 to determine the risk factors for mortality and morbidity. Half of the 282 patients reexplored had nonsurgical causes of bleeding. The patients were grouped according to the timing of reoperation, early re-exploration being on the day of the operation. Mortality, total morbidity, and the need for transfusion of any blood product were compared between the early and late re-exploration groups. Most patients (77.7%) were reexplored early. Overall mortality was 8.5% (24 patients). Mortality, total morbidity, renal, gastrointestinal, neurologic and infectious complications, and low cardiac output differed significantly between the 2 groups. Significant predictors of mortality were old age, female sex, left ventricular dysfunction, noncoronary operations, and delayed reoperation. Predictors of morbidity were old age, preoperative dialysis, tobacco use, chronic lung disease, and delayed reoperation. No factors were found to be associated with the need for transfusion.

Objective: To determine the incidence, short term survival and safety of delayed sternal closure following open-heart operation due to myocardial edema, non-surgical bleeding and malignant arrhythmia., Methods: We retrospectively reviewed our medical records to identify the patients who underwent delayed sternal closure following open-heart operation and recorded morbidity, mortality postoperative complications of these patients. Among 2698 patients who underwent on- pump cardiac surgery, the sternum was left open in 46 (1.7%) patients, 31 men and 15 women, ranging in age from 2 to 73 years (mean 57.0+/-7.6 years). In 39 patients sternum was left opened following the initial operation and in 7 patients sternum was re-opened due to bleeding or hemodynamic instability after initial surgery. Statistical analysis was accomplished using Chi-square test, Mann Whitney U test and analysis of variances for repeated measurements., Results: The operative procedures were classified as elective in 24 (52.8%), emergency in 10 (22%), urgent in 7 (15.4%), and redo cardiac operations in 5 patients (11%). Bleeding (n=21), hemodynamic instability (n=16), arrest (n=5), and arrhythmia (n=4) were the reasons of delayed sternal closure. The patients had an open sternum for 3.48+/-0.35 days. Time to discharge was 21.5+/-1.6 days after operation and 17.6+/-1.6 days after sternal closure. Mortality within 30 days was 23.9% (7 patients died before closure and the remaining 4 after closure). Complications were mediastinitis (n=2), minor wound infection (n=3) and renal failure (n=5)., Conclusion: Delayed sternal closure is a safe and simple method for treating bleeding, arrhythmia and myocardial edema following on pump cardiac surgery. It is anticipated that as cardiac surgeons become more familiar with the technique of delayed sternal closure, the frequency of its use following on pump cardiac surgery may increase.

Introduction: Postoperative bleeding is a common and potentially fatal complication following open heart surgery, studies reporting a reoperation rate for bleeding in the range of 2-6%. Surgical outcome after such reoperations has not been previously studied in Iceland., Material and Methods: In this retrospective study were included all adults that underwent open heart surgery in Iceland during a 6 year period, between January 1, 2000 and December 31, 2005., Results: There were 103 reoperations (mean age 68 years, 76% males), but throughout the same 6 year period a total of 1295 open heart procedures were performed, the reoperation-rate being 8%. One third of all patients were on aspirin and 8% on clopidogrel less than 5 days before surgery. The bleeding in the primary operation averaged 1523 ml (range 300-4780) and 3942 ml for the first 24 hours postoperatively. Half of the patients were reoperated on within 2 h and 97% within 24 hours. The patients received on average 16.5 units of packed cells, 15.6 units of plasma and 2.3 sets of thrombocytes. The most common postoperative complication was atrial fibrillation (58.3%), pleural effusion that needed chest tube drainage (24.3%), myocardial infarction (23.3%) and sternal wound infection (11.7%). Median length of stay was 14 days (range 6-85), including 2 days (range 1-38) in ICU. Operative mortality was 15.5% and 1 year crude survival 79.6%., Conclusion: Reoperation-rate for bleeding was 8%, which is higher compared to other studies. Bleeding is a serious complication following open heart surgery with high morbidity and significant mortality.

The aim of this case series is to review the effect of recombinant activated factor VIIa (rFVIIa) on refractory haemorrhage, despite aggressive treatment with conventional blood products and medications at our institution. All patients undergoing cardiac surgery who received rFVIIa as rescue therapy for persistent uncontrollable haemorrhage were studied. We examined coagulation immediately before and after rFVIIa was given; international normalized ratio (INR), activated partial thromboplastin (APTT) fibrinogen and platelet levels, in addition to the use of red cell and non-red cell blood products, morbidity and mortality. Thirty patients (0.6%) received 31 doses of rFVIIa for bleeding refractory to conventional treatment. Twenty received rFVIIa in theatre after primary surgery, three after re-exploration and eight in the intensive care unit (ICU). Hospital mortality was 6.5% (2/30) and there were no documented thromboembolic phenomena. There was significant reduction in red blood cell and product transfusion before and after rFVIIa administration (P<0.001). There was significant correction in coagulation parameters after rFVIIa. Recombinant FVIIa appears to be safe, and is effective in reducing red blood cell and product transfusion requirements and may impact on early and late outcomes in this small complex subgroup of patients.

Background: Surgical reexploration due to postoperative bleeding occurs in 2% to 6% of cardiac surgical patients and is accompanied by increased morbidity and mortality. In this study, we addressed the postoperative course of patients needing surgical reexploration, with specific respect to the timing of reexploration and the transfusional needs as determinants of morbidity and mortality., Methods: This was a retrospective study of 232 patients having undergone surgical reexploration owing to postoperative bleeding after cardiac operations, compared with a control, propensity-matched group., Results: Patients in the surgical reexploration group had greater morbidity (low cardiac output, acute renal failure, sepsis) and longer mechanical ventilation time and intensive care unit stay than did control patients, and a significantly higher mortality rate (14.2% versus 3.4%, p = 0.001). The timing of surgical reexploration was not associated with morbidity or mortality. The amount of packed red cells transfused was significantly associated with increased morbidity (acute renal failure, low cardiac output syndrome, sepsis), with mechanical ventilation time and intensive care unit stay, and with the mortality rate (0.25% increase for each unit transfused)., Conclusions: The main determinant of morbidity and mortality for patients requiring a surgical reexploration after cardiac operations is the amount of packed red cells transfused. Delaying the timing of reexploration may represent a risk factor only when the delay creates the need for an excessive use of allogeneic blood products, or in the presence of clinical signs of cardiac tamponade.

Background: Refractory postoperative bleeding complicates a significant number of cardiac surgical procedures and results in both morbidity and mortality. Conventional strategies to effect hemostasis include surgical reexploration and administration of blood products. In some cases, bleeding remains intractable despite these methods, and alternatives are needed. Herein, we report our experience with the use of factor eight inhibitor bypassing activity (FEIBA), a coagulation factor concentrate, for refractory postoperative bleeding., Methods: A retrospective review of the experience with FEIBA at a university-affiliated cardiac surgery program between February 2004 and January 2007 was performed., Results: Sixteen patients received FEIBA for refractory postoperative bleeding. The majority (69%) received a single dose, either intraoperatively or postoperatively. The recipients of multiple doses were more likely to undergo operative reexploration. Blood product utilization and hourly chest tube output were decreased significantly following administration of FEIBA. Three deaths occurred (19%), two from multisystem organ failure and one from respiratory failure. Thrombotic events included the development of a clotted hemothorax in one patient and distal extremity ischemia in another., Conclusions: FEIBA administration is associated with decreased blood product utilization and chest tube output in patients with refractory postoperative bleeding.

Introduction: We evaluated the efficacy of activated recombinant factor VIIa (rFVIIa) administration for critical bleeding during cardiothoracic surgery in Iceland., Materials and Methods: Over a 33 month period, 10 consecutive patients with major life-threatening bleeding during or right after open cardiac surgery that received rFVIIa in 11 operations. Clinical information was retrospectively collected from hospital charts., Results: The 10 patients were on average 66 year old, ranging 36-82 yrs. All patients were NYHA-class III or IV, there of three underwent emergency surgery. Complicated AVR+/-CABG was the most common type of operation (n=5), with average operation time 673 min. (range 475-932) and perfusion time 287 min. (range 198-615). After the administration of rFVIIa, haemostasis was acquired in 8 of 11 operations, with a significant improvement in coagulation parameters. Three patiens needed reoperation for bleeding. Transfusion of packed red cell (p=0.002) and plasma (p<0.02) decreased significantly after administration of rFVIIa and prothrombin time was shortened (p<0.004). Five patients succumbed, one of them with a cerebral infarction and pulmonary embolus, the latter confirmed at autopsy. Other causes of death were intractable bleeding, myocardial infarction, multiorgan failure and disseminated intravascular coagulopathy., Conclusions: rFVIIa can be used effectively to stop intractable bleedings in open heart surgery, with 8 out of 11 patients in this small series achieving hemostasis after its administration. Mortality in this group of patients was high (50%), however, in all cases rFVIIa was used as an end-of-the-line treatment where other therapy had failed. One patient died from pulmonary embolism and cerebral infarct, raising the question of hypercoagulation. Further studies on the side effects and indications of rFVIIa treatment are necessary.

Objective: The antifibrinolytic drug aprotinin has been the most widely used agent to reduce bleeding and its complications in cardiac surgery. Several randomized trials and meta-analyses have demonstrated it to be effective and safe. However, 2 recent reports from a single database have implicated the use of aprotinin as a risk for postoperative complications and reduced long-term survival., Methods: In this single-institution observational study involving 7836 consecutive patients (1998-2006), we assessed the safety of using aprotinin in risk reduction strategy for postoperative bleeding., Results: Aprotinin was used in 44% of patients. Multivariate analysis identified aprotinin use in risk reduction for reoperation for bleeding (odds ratio, 0.51; 95% confidence interval, 0.36-0.72; P = .001) and need for blood transfusion postoperatively (odds ratio, 0.67; 95% confidence interval, 0.57-0.79; P = .0002). The use of aprotinin did not affect in-hospital mortality (odds ratio, 1.03; 95% confidence interval, 0.71-1.49; P = 0.73), intermediate-term survival (median follow-up, 3.4 years; range, 0-8.9 years; hazard ratio, 1.09; 95% confidence interval, 0.93-1.28; P = .30), incidence of postoperative hemodialysis (odds ratio, 1.16; 95% confidence interval, 0.73-1.85; P = .49), and incidence of postoperative renal dysfunction (odds ratio, 0.78; 95% confidence interval, 0.59-1.03; P = .07)., Conclusion: This study demonstrates that aprotinin is effective in reducing bleeding after cardiac surgery, is safe, and does not affect short- or medium-term survival.

We reviewed the outcome following use of recombinant activated factor VII (rVIIa) in patients with major bleeding post cardiothoracic surgery in our unit between January 2002 and July 2004. The unit consists of 16 cardiothoracic intensive care beds in a public metropolitan teaching hospital which serves as a referral centre for heart and lung transplant surgery. Patients with refractory bleeding following cardiothoracic surgical procedures who were treated with rVIIa were identified. A total of 12 episodes of rVIIa use were recorded in ten patients, including three episodes with ventricular assist devices, and 5 heart and/or lung transplants. The median dose used was 85 microg/kg. Chest tube drainage decreased in all patients following administration of rVlIIa; median chest tube drainage decreased from 445 ml/h to 171 ml/h (P = 0.03). Despite cessation of bleeding, mortality was high when rVIIa was used after more than 24 hours. In six episodes, despite early rVIIa use (within six hours), continued bleeding necessitated return to theatre, where a surgical source of bleeding was found. In this small retrospective study, rVIIa significantly reduced bleeding that was refractory to standard blood product transfusion. In this series of patients, those that did not respond to rVIIa early in the postoperative phase were found to have a surgical source of bleeding.

Unlabelled: According to the data from different cardiac surgery centers, the incidence of urgent repetitive resternotomy for bleeding after cardiac on-pump operations varies from 2 to 5%. The aim of the study was to determinate the risk factors influencing resternotomy after cardiac surgery, features of early postoperative period, and outcomes., Material and Methods: Altogether, 37 consecutive patients undergoing urgent resternotomy due to bleeding early after cardiac surgery were analyzed retrospectively. Urgent resternotomies made up 4.3% of all cardiac on-pump surgeries performed on 856 patients at the Clinic of Cardiac Surgery of Kaunas University of Medicine Hospital during 2004. The mean age of patients was 64.9+/-12.9 years; 29.7% of patients were women and 70.3% were men., Results: During analysis of preoperative clinical data factors that could influence coagulation status were determined. Twenty patients (54.1%) had moderate hypertension, three patients (8.1%) had severe insulin-dependent diabetes mellitus, and five patients (13.5%) had chronic renal insufficiency treated with dialysis. Assessing other risk factors it was observed that many patients were on peroral anticoagulation therapy before surgery. The most frequently administered drugs preoperatively were aspirin (16 cases, 43.2%) and direct-acting anticoagulants (17 cases, 45.9%)., Conclusions: The use of antiaggregants and anticoagulants before surgery increases the incidence of resternotomies in the early postoperative period. Postoperative infections that require more expensive treatment with antibiotics are detected much more frequently in patients after resternotomies comparing to the remaining postoperative cardiac patients (15/37 and 69/819, respectively). However, longer hospitalization length (15.8 and 58.0 days, respectively) and higher mortality rate (4.5 and 10.8%, respectively) were observed in patients after resternotomy.

Objective: Analysis of safety and efficacy of recombinant activated factor VII (rFVIIa) used as the last resort for refractory bleeding after cardiac surgery., Design: Retrospective cohort analysis and matched pairs analysis with historic controls were performed. In the rFVIIa group, which also received conventional hemostatic therapy, data were collected for a median of 14 hrs from admission to the intensive care unit (ICU) to the administration of rFVIIa and for the following 24 hrs. In the control group, which received only conventional hemostatic therapy, data were collected for 14 and then for 24 hrs after admission to the ICU., Setting: University hospital., Patients: Twenty-four patients matched with historic controls., Interventions: None., Measurements and Main Results: No thromboembolic complications were observed in the rFVIIa group. Blood loss and transfusion requirements were significantly reduced in the period after the administration of rFVIIa. However, in the 24-hr period after rFVIIa administration, blood loss (p = .140) and transfusion of packed red blood cells (p = .442) and fresh frozen plasma (p = .063) were not different between the rFVIIa and control groups. Platelet concentrates (p = .004) were transfused less in the control group. Mortality and 6-month survival rates were not different between the groups., Conclusions: When used as a last resort, rFVIIa was safe but not incrementally efficacious over conventional hemostatic therapy.

Objectives: This study was undertaken to determine the incidence and outcome of major bleeding complicating deep sternal infection after cardiac surgery, to identify predisposing factors and means of prevention, and to clarify management options., Methods: This was a retrospective study of 10,863 consecutive patients, of whom 213 (2.18%) acquired deep sternal infection. With 43 additional referrals, the total number of patients with deep sternal infection was 280. Deep sternal infection was managed by a two-stage scheme. Major bleeding was considered to be bleeding that occurred during or after operation for deep sternal infection from the heart, great vessels, or grafts, or bleeding requiring urgent exploration., Results: Fifteen patients (5.36%) had major bleeding. The incidences of deep sternal infection and bleeding were highest among patients undergoing coronary artery bypass grafting. Thirteen patients had underlying diseases (type 2 diabetes in 9 cases). Deep sternal infection was diagnosed a median of 15 days after reoperation. Bleeding originated from the right ventricle in 9 patients. In 4 patients bleeding was iatrogenic during surgery for wire removal (n = 2) or reconstruction (n = 2). In 11 it occurred 15 minutes to 15 days (median 2 days) after wire removal, as a result of shearing forces in 7 cases and of infection only in 4 cases. Three patients died immediately. The other 12 were operated on, 6 with complete cardiopulmonary bypass, 2 with femoral cannulation, and 4 without cardiopulmonary bypass. The immediate mortality was 26.7%; the overall mortality was 53.3%. The median length of hospitalization of surviving patients was 38 days., Conclusions: The probability of development of major bleeding in patients with deep sternal infection was unrelated to the primary operation. The mortality associated with this complication was high. Meticulous technique during wire removal may decrease the risk of major bleeding. The impacts of cardiopulmonary bypass and of the technique and timing of sternal reconstruction remain undetermined.