Tamás Breuer

The Risks of Aprotinin and Tranexamic Acid in Cardiac Surgery: A One-year Follow-up of 1188 Consecutive Patients

BACKGROUND:Our aim was to investigate postoperative complications and mortality after administration of aprotinin compared to tranexamic acid in an unselected, consecutive cohort. METHODS:Perioperative data from consecutive cardiac surgery patients were prospectively collected between September 2005 and June 2006 in a university-affiliated clinic (n = 1188). During the first 5 mo, 596 patients received aprotinin (Group A); in the next 5 mo, 592 patients were treated with tranexamic acid (Group T). Except for antifibrinolytic therapy, the anesthetic and surgical protocols remained unchanged. RESULTS:The pre- and intraoperative variables were comparable between the treatment groups. Postoperatively, a significantly higher incidence of seizures was found in Group T (4.6% vs 1.2%, P < 0.001). This difference was also significant in the primary valve surgery and the high risk surgery subgroups (7.9% vs 1.2%, P = 0.003; 7.3% vs 2.4%, P = 0.035, respectively). Persistent atrial fibrillation (7.9% vs 2.3%, P = 0.020) and renal failure (9.7% vs 1.7%, P = 0.002) were also more common in Group T, in the primary valve surgery subgroup. On the contrary, among primary coronary artery bypass surgery patients, there were more acute myocardial infarctions and renal dysfunction in Group A (5.8% vs 2.0%, P = 0.027; 22.5% vs 15.2%, P = 0.036, respectively). The 1-yr mortality was significantly higher after aprotinin treatment in the high risk surgery group (17.7% vs 9.8%, P = 0.034). CONCLUSION:Both antifibrinolytic drugs bear the risk of adverse outcome depending on the type of cardiac surgery. Administration of aprotinin should be avoided in coronary artery bypass graft and high risk patients, whereas administration of tranexamic acid is not recommended in valve surgery.

Anxiety predicts mortality and morbidity after coronary artery and valve surgery--a 4-year follow-up study.

Objective: To explore the long-term effect of anxiety and depression on outcome after cardiac surgery. To date, the relationship between psychosocial factors and future cardiac events has been investigated mainly in population-based studies, in patients after cardiac catheterization or myocardial infarction. Methods: In total, 180 patients who underwent cardiac surgery using cardiopulmonary bypass were prospectively studied and followed up for 4 years. Anxiety (Spielberger State-Trait Anxiety Inventory, STAI-S/STAI-T), depression (Beck Depression Inventory, BDI), living alone, and education level along with clinical risk factors and perioperative characteristics were assessed. Psychological self-report questionnaires were completed preoperatively and 6, 12, 24, 36, and 48 months after discharge. Clinical end-points were mortality and cardiac events requiring hospitalization during follow-up. Results: Average preoperative STAI-T score was 44.6 ± 10. Kaplan-Meier analysis showed a significant effect of preoperative STAI-T >45 points (p = .008) on mortality. In multivariate models, postoperative congestive heart failure (OR: 10.8; 95% confidence interval [CI]:2.9–40.1; p = .009) and preoperative STAI-T (score OR: 1.07; 95% CI: 1.01–1.15; p = .05) were independently associated with mortality. The occurrence of cardiovascular hospitalization was independently associated with postoperative intensive care unit days (OR: 1.41; 95% CI: 1.01–1.96; p = .045) and post discharge 6th month STAI-T (OR: 1.06; 95% CI:1.01–1.13; p = .03). Conclusions: The results of the present study suggest that the assessment of psychosocial factors, particularly the ongoing assessment of anxiety, could help in risk stratification and identification of patients at risk of mortality and cardiovascular morbidity after cardiac surgery. BDI = Beck Depression Inventory; STAI-S = state anxiety subscale; STAI-T = trait anxiety subscale of Spielberger State-Trait Anxiety Inventory; CPB = cardiopulmonary bypass; CABG = coronary artery bypass grafting; CHF = congestive heart failure; CHD = coronary heart disease; ICU = intensive care unit; MI = myocardial infarction; PTSD = posttraumatic stress disorder.

Risks and Predictors of Blood Transfusion in Pediatric Patients Undergoing Open Heart Operations

BACKGROUND Blood transfusion in adults is associated with increased mortality and morbidity after cardiac operations. The aim of this study was to identify the main predictors of blood transfusion and explore the relationship between blood transfusion and adverse outcomes in a pediatric population. METHODS We retrospectively analyzed a prospectively collected database (January 2002 to December 2003) of 657 consecutive pediatric patients undergoing open heart procedures in a tertiary pediatric cardiac center. Risk models were calculated for each blood product and for the total amount of blood transfused during the operation and in the first 24 hours. Postoperative adverse events were investigated after propensity score adjustment. RESULTS During the postoperative period, 30 patients (4.6%) died, 80 (12.2%) sustained nonvascular pulmonary complications, and 113 (17.2%) had infection. The risk model for the total amount of blood transfusion included weight, preoperative creatinine clearance, preoperative mechanical ventilation, duration of operation and cross-clamp, surgeon, delayed chest closure, inotropic dose, and nitric oxide administration. Univariate analyses demonstrated significant associations between blood transfusion and occurrence of every complication except of neurologic events. After adjustment for propensity score and disease severity, the total amount of blood transfusion was independently associated with an increased risk for infections (odds ratio, 1.01; 95% confidence interval, 1.002 to 1.02; p = 0.01). Transfusion of platelets was associated with lower incidence of nonvascular pulmonary complications (odds ratio, 0.89; 95% confidence interval, 0.79 to 0.99; p = 0.049). CONCLUSIONS The amount of blood transfusion is independently associated with infections but not with mortality.

The blood sparing effect and the safety of aprotinin compared to tranexamic acid in paediatric cardiac surgery.

OBJECTIVE Recently, the safety of aprotinin administration during open-heart surgery has been debated. The aim of the study was to compare the blood sparing effect and the side effects of aprotinin and tranexamic acid in paediatric cardiac surgery patients. METHODS Perioperative data of 199 consecutive patients weighing less than 20kg undergoing open-heart cardiac surgery were prospectively collected between September 2005 and June 2006. During the first 5 months, 85 patients received aprotinin (group A); in the next 5 months, 114 patients were treated with tranexamic acid (group T). Except for antifibrinolytic therapy, the anaesthesiological and surgical protocols remained unchanged. Postoperative complications and in-hospital and 1-year mortality were considered as outcome parameters. RESULTS The descriptive parameters and the intraoperative parameters were well comparable in the two groups. The blood loss was significantly lower in group A compared to group T at 6h [55 (35-82.5) vs 70 (45-100)ml, p=0.031], but not at 12 and 24h after operation. The incidence [9 (11%) vs 25 (22%), p=0.035] and the amount of red blood cell transfusion during the first 24h after surgery were also significantly lower in group A (0.1+/-0.4 vs 0.3+/-0.6 unit, p=0.036). There were significantly less rethoracotomies in group A [2 (2.4%) vs 11 (9.6%), p=0.039]. We found no difference in the incidence of the postoperative complications and in-hospital and 1-year mortality. There was a tendency for a higher incidence of seizures in group T [4 (3.5%) vs 0 (0%), p=0.14]. CONCLUSIONS Aprotinin administration bears no additional risks compared to tranexamic acid and it has a stronger blood sparing effect in paediatric cardiac surgery. There were fewer rethoracotomies and less postoperative red blood cell transfusion in patients who received aprotinin.

Seizures after open heart surgery: comparison of ε-aminocaproic acid and tranexamic acid.

OBJECTIVE Although the lysine analogs tranexamic acid (TXA) and aminocaproic acid (EACA) are used widely for antifibrinolytic therapy in cardiac surgery, relatively little research has been performed on their safety profiles, especially in the setting of cardiac surgery. Two antifibrinolytic protocols using either TXA or aminocaproic acid were compared according to postoperative outcome. DESIGN A retrospective analysis. SETTING A university-affiliated hospital. PARTICIPANTS Six hundred four patients undergoing cardiac surgery. INTERVENTIONS One cohort of 275 consecutive patients received TXA; a second cohort of 329 consecutive patients was treated with EACA. Except for antifibrinolytic therapy, the anesthetic and surgical teams and their protocols remained unchanged. MEASUREMENTS AND MAIN RESULTS Besides major outcome criteria, namely postoperative bleeding, the need for allogeneic transfusions, operative revision because of bleeding, postoperative renal dysfunction, neurologic events, heart failure, and in-hospital mortality, the authors specifically sought differences between the groups concerning seizures. The 2 cohorts were comparable over a range of perioperative factors. Postoperative seizures occurred significantly more frequently in TXA patients (7.6% v 3.3%, p = 0.019), whereas EACA patients had a higher incidence of postoperative renal dysfunction (20.0% v 30.1%, p = 0.005). There were no differences in all other measured major outcome factors. CONCLUSION Both lysine analogs are associated with significant side effects, which must be taken into account when performing risk-benefit analyses of their use. Their use should be restricted to patients at high risk for bleeding; routine use on low-risk patients undergoing standard surgeries should face renewed critical reappraisal.

Acute kidney injury is associated with higher morbidity and resource utilization in pediatric patients undergoing heart surgery.

BACKGROUND The RIFLE (risk, injury, failure, loss, and end-stage renal disease) classification system was developed to standardize the definition of acute kidney injury (AKI) in adults. We hypothesized that AKI was associated with increased mortality and morbidity. METHODS Acute kidney injury was defined as a decrease in the amount of estimated creatinine clearance based on pediatric-modified RIFLE (pRIFLE) criteria. Using propensity score analysis, 325 patients who had AKI were matched to 325 patients who did not have AKI from a database of 1,510 consecutive pediatric patients who underwent cardiac surgery between January 2004 and December 2008 at a single center. The association between AKI and outcome was analyzed after propensity score matching of perioperative variables. RESULTS Four hundred eighty-one patients (31.9%) had AKI according to the RIFLE categories. Of those 1,510, 173 (11.5%) reached pRIFLE criteria for risk; 26 (1.7%) reached the criteria for injury; and 282 (18.7%) reached the criteria for failure. Fifty-five patients (3.6%) died. The 2 matched groups were well balanced in terms of measured perioperative variables. Mortality rate was 5.2% in the AKI and 2.5% in the matched control group (p=0.09). Occurrence of low cardiac output syndrome (p=0.002), need for dialysis (p<0.001), and infection (p=0.03) were significantly higher, and duration of mechanical ventilation (p<0.001) and length of intensive care unit stay (p<0.001) were significantly longer compared with the matched control group. CONCLUSIONS Acute kidney injury was independently associated with an increased occurrence of postoperative complications but not with mortality after pediatric cardiac surgery.

Tranexamic acid versus ɛ-aminocaproic acid: efficacy and safety in paediatric cardiac surgery

OBJECTIVE Tranexamic acid (TXA) and ɛ-aminocaproic acid (EACA) are used for antifibrinolytic therapy in cardiac surgery, although data directly comparing their blood sparing effect and their side effects, especially in paediatric cardiac surgical patients, are still missing. METHODS We analysed perioperative data of 234 paediatric patients weighing less than 20 kg undergoing cardiac surgery. In a 5-month period, all patients (n=114) received TXA (group TXA). During a second 5-month period, all patients (n=120) were treated with EACA (group EACA). Primary outcome was blood loss at 24h postoperatively; secondary outcome criteria were transfusion requirement, rate of revision for bleeding, postoperative complications and in-hospital mortality. RESULTS All descriptive and intra-operative parameters were well comparable. There was no evidence for a difference in blood loss at 24h postoperatively (TXA 21 ml kg(-1) (14-38) (median (interquartile range)) vs EACA 29 ml kg(-1) (14-40), p=0.242), rate of re-operation for bleeding (TXA 9.6% vs EACA 8.3%, p=0.725) and transfusion of blood products. The incidence of postoperative complications such as seizures (TXA 3.5% vs EACA 0.8%, p=0.203) and other neurological complications (TXA 2.6% vs EACA 1.7%, p=0.677), renal injury (TXA 9.6% vs EACA 13.3%, p=0.378), renal failure (TXA 1.8% vs EACA 4.2%, p=0.447), low cardiac output syndrome (TXA 12.3% vs EACA 10.8%, p=0.729), and vascular thrombosis (TXA 4.4% vs EACA 5.0%, p=0.824), as well as the in-hospital mortality (TXA 2.6% vs EACA 3.3%, p>0.999) did not show any statistically significant difference. CONCLUSIONS TXA and EACA are well comparable in their effect on perioperative blood loss as well as in major clinical outcome criteria. Although the fourfold risk for seizures using TXA was not significant, we currently use EACA in paediatric cardiac surgery.

Aprotinin and renal dysfunction after pediatric cardiac surgery

Background:  Aprotinin is a potent antifibrinolytic drug, which reduces postoperative bleeding and transfusion requirements. Recently, two observational studies reported increased incidence of renal dysfunction after aprotinin use in adults. Therefore, the aim of the study was to investigate the safety of aprotinin use in pediatric cardiac surgery patients.

Impact of blood glucose values in patients with and without insulin treatment following paediatric cardiac surgery

Abstract Objective: To investigate the associations of blood glucose (BG) parameters and postoperative complications following paediatric cardiac surgery in the presence and absence of insulin treatment. Methods: Prospectively collected perioperative data on 810 consecutive patients who underwent surgery for congenital heart disease were retrospectively analysed. A combined outcome of death and multiple organ dysfunction (any two of the followings: infectious, cardiac, pulmonary, renal or neurological complications) was considered as the endpoint. Results: In total, 110 patients developed the combined endpoint and 32 of these patients died during the perioperative period. Patients treated with insulin were younger, smaller and underwent more complex procedures. They had higher peak BG levels and higher daily BG fluctuation, however, BG parameters were not associated with adverse outcome. In patients without insulin treatment, peak BG values higher than 250 mg/dl (OR, 7.65; 95% CI, 1.06–55.17; p=0.043) and...