Recombinant activated factor VII in neonatal cardiac surgery.

OBJECTIVES: The aim of this study is to determine whether recombinant activated factor VII (rVIIa) was associated with thrombus formation in neonates undergoing cardiac surgery. METHODS: This is a retrospective study of neonates undergoing surgical repair of congenital cardiac lesions during a 9-year period. RESULTS: In our study, 416 cardiac operations requiring cardiopulmonary bypass (CPB) were performed on 414 neonates. The overall intravascular thrombus (thrombus) frequency for all operations was 45 of 416 (11%). A thrombus developed in 17 of 287 (6%) operations when rVIIa was not given. rVIIa was administered in 129 of 416 (31%) operations. Thrombus formation occurred in 28 of 129 (22%) operations when rVIIa was administered. There was an association between rVIIa use and thrombus formation [odds ratio (OR) 4.4, 95% confidence interval (CI) 2.3-8.4; P < 0.0001]. Patients with thrombus formation had an increased length of stay compared to those without thrombus. Neonates who underwent the Norwood procedures and received rVIIa and developed thrombus were more likely to be supported with extracorporeal membrane oxygenation (ECMO) and had a higher mortality compared to Norwood patients without thrombus. Logistic analysis adjusted for the paediatric index of mortality 2 score, the risk adjustment for congenital heart surgery and the use of ECMO demonstrated a strong association between rVIIa administration and thrombus formation (OR 3.5, 95% CI 1.7-6.9; P = 0.0004). However, there was no effect of the risk adjustment for congenital heart surgery-1 category or the paediatric index of mortality 2 score on thrombus formation. CONCLUSIONS: In neonates who underwent CPB surgery, administration of rVIIa was associated with an increased occurrence of intravascular thrombus formation compared to neonates not given rVIIa. In the Norwood population, thrombus formation was associated with a higher mortality.

Identifying incidents of suboptimal care during paediatric emergencies-an observational study utilising in situ and simulation centre scenarios.

AIM: Life threatening paediatric emergencies are relatively uncommon events. When they do occur staff caring for these children must have the ability to recognise the deterioration, evaluate and simultaneously treat these patients. The aim of this study was to identify suboptimal care during standardised simulated scenarios and to identify the potential causation factors. METHODS: Participants were emergency department and operating theatre staff in Sydney, Australia. Incidents of suboptimal care were identified during scenarios and were analysed by thematic qualitative assessment methods. Potential causation factors were elicited both during and immediately after the scenarios and during facilitated debriefings. Causation factors were attributed to any of seven pre-defined categories. RESULTS: Seventy-three simulations occurred over 9 month period in 2011. 270 doctors, 235 nurses and 11 students participated. 194 incidents of suboptimal care were observed and attributed to 325 causation factors. There were 76 knowledge deficits, 39 clinical skill deficits, 36 leadership problems, 84 communication failures, 20 poor resource utilisations, 23 preparation and planning failures and 47 incidents of a loss of situational awareness. Clinically important themes were: paediatric life support, drug choice and doses, advanced airway and ventilation, intravenous fluids and recognition of the deteriorating patient. Recurring incidents included the failure to recognise a cardiac arrest, inadequate fluid resuscitation and incorrect medication dose administration. CONCLUSIONS: During standardised paediatric simulations multiple incidents of suboptimal care have been identified and multiple causation factors attributed to these. Educators should use this information to adapt current training programs to encompass these factors.