Early or late fresh frozen plasma administration in newborns and small infants undergoing cardiac surgery: the APPEAR randomized trial.

BACKGROUND: In newborns and small infants undergoing cardiac surgery with cardiopulmonary bypass (CPB) and blood priming, it is unclear whether there is reduced blood loss if fresh frozen plasma (FFP) is added to the CPB priming volume. This single-centre, randomized trial tested the hypothesis that the administration of FFP after CPB (late FFP group) is superior to FFP priming (early FFP group) in terms of postoperative bleeding and overall red blood cell (RBC) transfusion. METHODS: Seventy-three infants weighing <10 kg were randomly allocated to receive FFP to supplement RBCs in the CPB priming solution ( n =36) or immediately after CPB ( n =37). The primary endpoint was a difference in postoperative blood loss; secondary endpoints included the amount of RBCs and FFP transfused through the first 48 postoperative hours. RESULTS: All patients were included in the analysis. Patients in the late FFP arm had greater postoperative mean blood loss than patients in the early FFP arm [33.1 ( sd 20.6) vs 24.1 (12.9) ml kg -1 ; P =0.028], but no differences in transfusions were found. The subgroup of cyanotic heart disease patients had comparable results, but with greater use of RBCs in the late FFP group. CONCLUSIONS: In infants undergoing cardiac surgery, FFP in the priming solution appears slightly superior to late administration in terms of postoperative bleeding. CLINICAL TRIAL REGISTRATION: www.ClinicalTrials.gov , NCT02738190.

Effects of priming volume reduction on allogeneic red blood cell transfusions and renal outcome after heart surgery.

INTRODUCTION: Excessive hemodilution during cardiopulmonary bypass (CPB) is associated with an increased rate of red blood cell (RBC) transfusion and acute kidney injury (AKI). Minimization of the oxygenator priming volume is a measure to contain hemodilution. In this study, we evaluated the new oxygenator, Sorin Inspire 6™, with respect to its ability to limit hemodilution, RBC transfusion rate and postoperative AKI rate. METHODS: A retrospective study on a consecutive series of 1,724 adult patients receiving heart surgery with CPB. Patients treated with the Inspire 6™ were assigned to the low priming volume oxygenator (LPVO) group (N=383) and patients treated with conventional oxygenators to the conventional group (N=1,341). Dynamic priming volume, time course of the hematocrit, RBC transfusions and AKI rate were compared between the groups. RESULTS: Priming volume was significantly (p=0.001) lower in the LPVO group (624±113 mL) vs. the conventional group (775±150 mL), with higher values of hematocrit during and after CPB. After correction for other confounders, patients in the LPVO group had a significantly lower RBC transfusion rate (odds ratio 0.68, 95% confidence interval 0.52-0.90, p=0.006) and AKI rate (odds ratio 0.55, 95% confidence interval 0.32-0.93, p=0.032). CONCLUSION: The Inspire 6™ oxygenator allows a significant containment of hemodilution during CPB, reducing the risk of RBC transfusions and postoperative AKI.

Percentage hematocrit variation (PHEVAR) index as a quality indicator of patient blood management in cardiac surgery.

BACKGROUND: Severe hemodilution and perioperative bleeding are determinants of hematocrit (HCT) variations in cardiac surgery patients. These variations may be direct determinants of bad outcomes, and may trigger allogeneic blood product transfusions, which are associated with morbidity and mortality. The present study introduces the Percentage HEmatocrit VARiation (PHEVAR) index as a tool to assess the quality of patient blood management (PBM) and to possibly guide specific interventions. METHODS: Seven-hundred-thirteen adult cardiac surgery patients were included in a retrospective analysis. The PHEVAR index was assessed based on the HCT determination at six points in time, being represented by the area under the curve of the percentage HCT variation from baseline. The PHEVAR index was explored for association with operative mortality and other outcome measurements. RESULTS: The PHEVAR index was an independent predictor of operative mortality (odds ratio 1.015, 95% confidence interval 1.005-1.026), postoperative bleeding, length of mechanical ventilation; significantly higher values of PHEVAR were detected in patients with acute kidney injury, low cardiac output, and ventricular arrhythmias. Acute kidney injury was associated with a larger HCT variation during surgery; low cardiac output with a larger postoperative HCT variation; and ventricular arrhythmias with a larger preoperative HCT variation. CONCLUSION: The PHEVAR index reflects HCT variations during 7 days of hospital stay in cardiac surgery patients, is associated with mortality and morbidity, and may be used as a quality index for PBM.

Nutritional status in the healthy longeval population from Sardinia (Italy).

OBJECTIVES: The aim of this study was to evaluate sex- and age-related variations of the nutritional status in the aged population of central Sardinia, a geographical area with a high frequency of long-lived people, particularly men. DESIGN: The sample consisted of 200 subjects over 70 years of age (men: N= 100, age= 81.0 +/- 7.0 years; women: N= 100, age= 81.5 +/- 7.3 years). SETTING: Orroli (central Sardinia, Italy). MEASUREMENTS: Mini nutritional assessment (MNA) and bioelectrical impedance vector analysis (BIVA) were used to evaluate nutritional status and body composition. RESULTS: The indicators revealed a generally good nutritional status. The MNA results (men: 24.6 +/- 2.2; women: 23.4 +/- 2.5) showed that 64.1% of the subjects had a normal nutritional status and only a small proportion (1.2%) could be classified as malnourished. BIVA showed that most subjects (74.2%) were normal, while the prevalence of low body cell mass was 10.7% and that of dehydration 11.2%. According to the MNA, the nutritional status was significantly better in the men. Almost three-quarters of the men (73.1%) were well nourished vs. half of the women (50.6%). A worsening of the nutritional status with age was observed. The proportion of malnourished individuals, as assessed by MNA, increased from 0% to 9.1% from 70-79 to > 90 years. CONCLUSIONS: With respect to their contemporaries from other regions, the elderly of Orroli presented a better nutritional status, a similar worsening with age and generally higher sexual dimorphism.

Closed, phosphorylcholine-coated circuit and reduction of systemic heparinization for cardiopulmonary bypass: the intraoperative ECMO concept.

Cardiopulmonary bypass with heparin-bonded circuits reduces systemic heparinization which is associated to a better clinical outcome in cardiac operations. In the present study, a novel biocompatible treatment, based on a phosphorylcholine coating without heparin, has been used to reduce systemic heparinization during cardiopulmonary bypass. Sixty patients underwent coronary revascularization with a fully phosphorylcholine-coated circuit. The circuit was entirely closed; suctions from the field were separated during the cardiopulmonary bypass time. A low systemic heparinization protocol based on half the loading dose of heparin (150 IU/kg) and a target activated clotting time of 320 seconds was applied. No thrombus formation inside the extracorporeal circulation circuit occurred; in-hospital mortality was absent. One patient (1.6%) had a postoperative myocardial infarction and 2 (3.3%) were surgically revised due to bleeding. Homologous blood transfusion rate was 11.6%, postoperative bleeding was 310 +/- 136 ml. If compared to patients treated with heparin-coated circuits and low systemic heparinization, these patients have better platelet count preservation and lower postoperative bleeding. The low thrombogenicity of phosphorylcholine-treated surfaces, despite the absence of surface-immobilized heparin, allows a safe reduction of systemic heparinization in the setting of an ECMO-like intraoperative cardiopulmonary - bypass. This intraoperative ECMO approach offers promising results in terms of clinical outcome after coronary revascularization operations.

Gabexate mesilate and antithrombin III for intraoperative anticoagulation in heparin pretreated patients.

Thirty patients scheduled for elective myocardial revascularization and having undergone preoperative heparin treatment have been admitted to this prospective, randomized study. The aim of the study was to test two different strategies for preserving circulating antithrombin III (AT-III) during cardiopulmonary bypass. Patients in the control group (group C, n = 10) were treated with a standard heparinization (300 IU/kg). Patients in group A (n = 10) received the same management plus two doses of purified antithrombin III (1000 IU each). Patients in group GA received 200 IU/kg heparin and a continuous infusion of heparin (100 IU/kg/h) and gabexate mesilate (2 mg/kg/h) plus the same dose of antithrombin III as group A. Both group A and group GA demonstrated a preservation of circulating AT-III when compared to group C; this effect was more pronounced in group GA. The total heparin dosage was less in group GA than in groups A and C. Purified AT-III administration is recommended in heparin pretreated patients; the addition of gabexate mesilate to this protocol decreases the heparin requirement and increases the AT-III preservation.