Methylprednisolone for Heart Surgery in Infants - A Randomized, Controlled Trial.

BACKGROUND: Although perioperative prophylactic glucocorticoids have been used for decades, whether they improve outcomes in infants after heart surgery with cardiopulmonary bypass is unknown. METHODS: We conducted a multicenter, prospective, randomized, placebo-controlled, registry-based trial involving infants (<1 year of age) undergoing heart surgery with cardiopulmonary bypass at 24 sites participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database. Registry data were used in the evaluation of outcomes. The infants were randomly assigned to receive prophylactic methylprednisolone (30 mg per kilogram of body weight) or placebo, which was administered into the cardiopulmonary-bypass pump-priming fluid. The primary end point was a ranked composite of death, heart transplantation, or any of 13 major complications. Patients without any of these events were assigned a ranked outcome based on postoperative length of stay. In the primary analysis, the ranked outcomes were compared between the trial groups with the use of odds ratios adjusted for prespecified risk factors. Secondary analyses included an unadjusted odds ratio, a win ratio, and safety outcomes. RESULTS: A total of 1263 infants underwent randomization, of whom 1200 received either methylprednisolone (599 infants) or placebo (601 infants). The likelihood of a worse outcome did not differ significantly between the methylprednisolone group and the placebo group (adjusted odds ratio, 0.86; 95% confidence interval [CI], 0.71 to 1.05; P = 0.14). Secondary analyses (unadjusted for risk factors) showed an odds ratio for a worse outcome of 0.82 (95% CI, 0.67 to 1.00) and a win ratio of 1.15 (95% CI, 1.00 to 1.32) in the methylprednisolone group as compared with the placebo group, findings suggestive of a benefit with methylprednisolone; however, patients in the methylprednisolone group were more likely than those in the placebo group to receive postoperative insulin for hyperglycemia (19.0% vs. 6.7%, P<0.001). CONCLUSIONS: Among infants undergoing surgery with cardiopulmonary bypass, prophylactic use of methylprednisolone did not significantly reduce the likelihood of a worse outcome in an adjusted analysis and was associated with postoperative development of hyperglycemia warranting insulin in a higher percentage of infants than placebo. (Funded by the National Center for Advancing Translational Sciences and others; STRESS ClinicalTrials.gov number, NCT03229538.).

Retrospective Comparison of Recombinant Activated Factor VII Versus 4-Factor Prothrombin Complex Concentrate in Cardiac Surgical Patients.

OBJECTIVES: To compare the incidences of postoperative thrombotic complications, transfusion of blood products, and chest tube output in congenital cardiac surgical patients who received either recombinant activated factor VII (rFVIIa) or 4-factor prothrombin complex concentrate (4F-PCC). DESIGN: We performed a retrospective study. SETTING: Patients who underwent surgery at a tertiary academic hospital. PARTICIPANTS: Pediatric patients who underwent cardiac surgery. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Data were obtained from the Society of Thoracic Surgeons and the Pediatric Cardiac Critical Care Consortium databases, as well as from manual chart review. Adjusted p values were obtained from multivariate regression using age (days), surgeon (number), cardiopulmonary bypass time (minutes), and need for deep hypothermic circulatory arrest (yes/no). A total of 55 patients were included in the 4F-PCC group, and 89 in the rFVIIa group. The median dose of rFVIIa was 77 mcg/kg (46-88), and the median dose of 4F-PCC was 31 IU/kg (24-43). The incidences of thrombotic complications were 8% in the 4F-PCC group and 30% in the rFVIIa group (adjusted p = 0.023). No difference was reported between the groups regarding chest tube output on days 1 and 2 or transfusion of blood products. Using a sensitivity analysis with propensity matching, the incidence of thrombosis was 10% in the 4F-PCC group (n = 38), and 31% in the rFVIIa group (n = 39) (p = 0.036). No difference was reported in terms of bleeding or transfusion. CONCLUSIONS: This retrospective study suggested that the administration of rFVIIa was associated with a higher risk of thrombotic complications when compared to 4F-PCC, without benefits in terms of bleeding and transfusions.

Transfusion therapy of neonatal and paediatric patients: They are not just little adults.

Patient blood management (PBM) strategies are needed in the neonate and paediatric population, given that haemoglobin thresholds used are often higher than recommended by evidence, with exposure of children to potential complications without meaningful benefit. A literature review was performed on the following topics: evidence-based transfusions of blood components and pharmaceutical agents. Other topics reviewed included perioperative coagulation assessment and perioperative PBM. The Transfusion and Anaemia Expertise Initiative (TAXI) consortium published a consensus statement addressing haemoglobin (Hb) transfusion threshold in multiple subsets of patients. A multicentre trial (PlaNeT-2) reported a higher risk of bleeding and death or serious new bleeding among infants who received platelet transfusion at a higher (50 000/µl) compared to a lower (25 000/µl) threshold. Recent data support the use of a restrictive transfusion threshold of 25 000/µl for prophylactic platelet transfusions in preterm neonates. The TAXI-CAB consortium mentioned that in critically ill paediatric patients undergoing invasive procedures outside of the operating room, platelet transfusion might be considered when the platelet count is less than or equal to 20 000/µl and there is no benefit of platelet transfusion when the platelet count is more than 50 000/µl. There are limited controlled studies in paediatric and neonatal population regarding plasma transfusion. Blood conservation strategies to minimise allogenic blood exposure are essential to positive patient outcomes neonatal and paediatric transfusion practices have changed significantly in recent years since randomised controlled trials were published to guide practice. Additional studies are needed in order to provide practice change recommendations.

Selected 2021 Highlights in Congenital Cardiac Anesthesia.

This article is a review of the highlights of pertinent literature of interest to the congenital cardiac anesthesiologist and was published in 2021. After a search of the United States National Library of Medicine PubMed database, several topics emerged where significant contributions were made in 2021. The authors of this manuscript considered the following topics noteworthy to be included in this review: risk stratification in adult congenital heart disease surgery, physician burnout in pediatric cardiac anesthesia, transfusion practice in pediatric congenital heart surgery, and racial disparity and outcomes in pediatric patients with congenital heart disease.

Selected 2019 Highlights in Congenital Cardiac Anesthesia.

This article is a review of the highlights of pertinent literature published in 2019, which is of interest to the pediatric cardiac anesthesiologist. After a search of the United States National Library of Medicine PubMed database, several topics emerged in which significant contributions were made in 2019. The authors of this manuscript considered the following topics noteworthy and were included in this review: advances in pediatric heart transplantation, blood management in pediatric cardiac surgery, the impact of nutrition on outcomes in congenital heart surgery, and the use of vasopressin in patients after Fontan palliation.

Cardiac Arrest With or Without Need for Extracorporeal Life Support After Congenital Cardiac Surgery.

BACKGROUND: Postoperative cardiac arrest (CA) with or without need for extracorporeal cardiopulmonary resuscitation (ECPR) is one of the most significant complications in the early postoperative period after pediatric cardiac operation. The objective of this study was to develop and to validate a predictive model of postoperative CA with or without ECPR. METHODS: In this retrospective cohort study, we reviewed data from patients who underwent cardiac surgery with cardiopulmonary bypass (CPB) between July 20, 2020, and December 31, 2021. Variables included demographic data, presence of preoperative risk factors, The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery mortality categories, perioperative data, residual lesion score (RLS), and vasoactive-inotropic score (VIS). We used multivariable logistic regression analysis to develop a predictive model. RESULTS: The incidence of CA with or without ECPR was 4.4% (n = 24/544). Patients who experienced postoperative CA with or without ECPR were younger (age, 130 [54-816.5] days vs 626 [127.5-2497.5] days; P < .050) and required longer CPB (253 [154-332.5] minutes vs 130 [87-186] minutes; P < .010) and cross-clamp (116.5 [75.5-143.5] minutes vs 64 [30-111] minutes; P < .020) times; 37.5% of patients with an outcome had at least 1 preoperative risk factor (vs 16.9%; P < .010). Our multivariable logistic regression determined that the presence of at least 1 preoperative risk factor (P = .005), CPB duration (P = .003), intraoperative residual lesion score (P = .009), and postsurgery vasoactive-inotropic score (P = .010) were predictors of the incidence of CA with or without ECPR. CONCLUSIONS: We developed a predictive model of postoperative CA with or without ECPR after congenital cardiac operation. Our model performed better than the individual scores and risk factors.

The use of bumetanide for oliguric acute renal failure in preterm infants.

OBJECTIVE: To determine the effects of bumetanide in preterm infants with oliguric acute renal failure (OARF). STUDY DESIGN: Retrospective data review and multivariate analysis of urine output and serum creatinine, blood urea nitrogen, Na, K, Cl, and Ca levels before, during, and after bumetanide therapy in preterm infants with OARF whose conditions did not respond to furosemide therapy. RESULTS: A total of 35 infants received bumetanide for OARF after an initial trial of furosemide. Their birth weight, gestational age at birth, and postconceptional age at OARF were 811 ± 326 g, 26 ± 2.75 wks, and 29.2 ± 2.7 wks, respectively. Twenty-nine of the 35 infants (83%) responded to bumetanide. Seventeen of the 35 infants subsequently died in the hospital due to multiorgan dysfunction. For the survivors (n = 18) and 11 of 17 of nonsurvivors, urine output increased from 0.6 ± 0.6 mL/kg/hr to 3.0 ± 2.1 mL/kg/hr during bumetanide therapy (p < .0005). Serum creatinine levels increased from 2.13 ± 0.83 mg/dL to 2.3 ± 0.92 mg/dL (p = .04) during bumetanide treatment, whereas blood urea nitrogen levels decreased after bumetanide therapy from 38 ± 19 mg/dL to 31.67 ± 21.6 mg/dL (p = .049). No significant changes were noted in serum sodium, chloride, or calcium concentration. CONCLUSIONS: Bumetanide therapy significantly increased urine output within 24-48 hrs, but its use was associated with a transient increase in serum creatinine level. Bumetanide can be used in preterm infants to reverse oliguria when therapy with furosemide fails. Prospective, randomized, controlled trials with long-term follow-up in preterm infants are necessary to establish the usefulness of bumetanide for OARF.