Background Ventricular Assist Devices (VADs) have come into increasing use in recent years for children. One year survival rates are now above 80% in multiple reports. This report describes adverse events experienced by children with durable ventricular assist devices, using a national-level registry (Pedimacs, a component of Intermacs) Methods Pedimacs is a national registry that contains clinical data on patients who are less than 19 years of age at the time of implantation with a VAD. Data collection concludes at the time of VAD explantation. All FDA-approved devices are included. Pedimacs was launched on September 1, 2012 and this report includes all data from launch until August 2014. Adverse events were coded with a uniform, pre-specified set of definitions. Results This report comprises data from 200 patients, with median age of 11 years (range 11 days-18 years), and total follow-up of 783 patient-months. The diagnoses were cardiomyopathy (n=146, 73%), myocarditis (17, 9%), congenital heart disease (35, 18%), and other (2, 1%). Pulsatile flow devices were used in 91 patients (45%), and continuous flow devices in 109 (55%). Actuarial survival was 86% at 6 months. There were 418 adverse events reported. The most frequent events were device malfunction (n=79), infection (78), neurological dysfunction (52), and bleeding (68). Together, these accounted for 277 events, 66% of the total. Although 38% of patients had no reported adverse event, 16% of patients had 5 or more adverse events. Adverse events occurred at all times following implantation but were most likely to occur in the first 30 days. For continuous flow devices, there were broad similarities in adverse event rates between this cohort, and historical rates from the Intermacs population. Conclusions In this cohort, the overall rate of early adverse events (within 90 days of implantation) was 86.3 events per 100 patient months, and of late adverse events, 20.4 events per 100 patient months. The most common adverse events in recipients of pulsatile VADs were device malfunction, neurological dysfunction, bleeding and infection. For continuous flow VADs, the most common adverse events were infection, bleeding, cardiac arrhythmia, neurological dysfunction and respiratory failure. Compared to an adult Intermacs cohort, the overall rate and distribution of adverse events appears similar.

Objectives: The objective of this study was to determine the prevalence of ICU delirium in children less than 18 years old that underwent cardiac surgery within the last 30 days. The secondary aim of the study was to identify risk factors associated with ICU delirium in postoperative pediatric cardiac surgical patients. Design: A 1-day, multicenter point-prevalence study of delirium in pediatric postoperative cardiac surgery patients. Setting: Twenty-seven pediatric cardiac and general critical care units caring for postoperative pediatric cardiac surgery patients in North America. Patients: All children less than 18 years old hospitalized in the cardiac critical care units at 06:00 on a randomly selected, study day. Interventions: Eligible children were screened for delirium using the Cornell Assessment of Pediatric Delirium by the study team in collaboration with the bedside nurse. Measurement and Main Results: Overall, 181 patients were enrolled and 40% (n = 73) screened positive for delirium. There were no statistically significant differences in patient demographic information, severity of defect or surgical procedure, past medical history, or postoperative day between patients screening positive or negative for delirium. Our bivariate analysis found those patients screening positive had a longer duration of mechanical ventilation (12.8 vs 5.1 d; p = 0.02); required more vasoactive support (55% vs 26%; p = 0.0009); and had a higher number of invasive catheters (4 vs 3 catheters; p = 0.001). Delirium-positive patients received more total opioid exposure (1.80 vs 0.36 mg/kg/d of morphine equivalents; p < 0.001), did not have an ambulation or physical therapy schedule (p = 0.02), had not been out of bed in the previous 24 hours (p < 0.0002), and parents were not at the bedside at time of data collection (p = 0.008). In the mixed-effects logistic regression analysis of modifiable risk factors, the following variables were associated with a positive delirium screen: 1) pain score, per point increase (odds ratio, 1.3; 1.06–1.60); 2) total opioid exposure, per mg/kg/d increase (odds ratio, 1.35; 1.06–1.73); 3) SBS less than 0 (odds ratio, 4.01; 1.21–13.27); 4) pain medication or sedative administered in the previous 4 hours (odds ratio, 3.49; 1.32–9.28); 5) no progressive physical therapy or ambulation schedule in their medical record (odds ratio, 4.40; 1.41–13.68); and 6) parents not at bedside at time of data collection (odds ratio, 2.31; 1.01–5.31). Conclusions: We found delirium to be a common problem after cardiac surgery with several important modifiable risk factors.

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BACKGROUND: This initiative sought to improve nutrition delivery in critically ill children with heart disease admitted to the cardiac ICU (CICU) and neonates undergoing stage 1 palliation (S1P) for single-ventricle physiology through interdisciplinary team interventions. Specific goals were increased caloric and protein delivery for all patients and a more nourished state for infants with single ventricles at the time of discharge.