Congenital heart disease was the most common neonatal cardiac indication for ECLS, comprising more than 80% of cases (Table 6). Neonates with cardiomyopathy and myocarditis had longer support duration but higher survival compared to other indications. Among neonates with congenital heart disease, those with hypoplastic left heart syndrome (HLHS), left ventricular outflow obstruction, and cyanosis with increased pulmonary blood flow (transposition of the great arteries and truncus arteriosus) had lower survival relative to those with decreased pulmonary blood flow (including tetralogy of Fallot, double outlet right ventricle with restricted pulmonary blood flow, Ebstein’s anomaly).
Pediatric cardiac ECLS was also most often delivered to support children with congenital heart disease (52%). Among pediatric cardiac ECLS patients, those with myocarditis had the highest survival rate (76%), while those requiring ECLS for a cardiac arrest had the lowest survival rate (45%) (Table 7). Among nonneonatal children with congenital heart disease, patients with HLHS had the longest average duration of support and lowest survival (46%), while right-sided obstructive lesions were associated with shorter runs and highest survival (62%).
Mechanical malfunctions during ECLS were uncommon in this cohort, but patient survival to discharge after mechanical complications was reduced by 10%–16% compared to average survival (Table 8). Bleeding at the surgical site was common in both neonatal and pediatric patients (26% and 25%, respectively). Intracranial pathology, cerebral infarction, or intracranial hemorrhage was associated with reduced survival compared to average in both neonates (12%–17%) and children (21%–31%).
The use of ECPR is increasing in children. During the study period, 3,005 ECPR runs were reported to the Registry with overall survival to hospital discharge of 43%. The ECPR cohort included 887 neonates and 2,118 pediatric patients with similar survival to discharge rate of 43% and mean ECLS run duration of five days for both age groups. From 2009 to 2015, neonatal ECPR increased by 35% from 108 to 146 annual cases and pediatric ECPR increased by 67% from 221 to 369 cases per year.
The ELSO Registry created a data collection addendum on cardiopulmonary resuscitation techniques and management for ECPR patients in 2011. Selected data from the addendum are presented in Table 9. Nearly all cardiac arrests were witnessed and over 80% of cardiac arrests leading to ECPR cannulation occurred in highly monitored environments such as the intensive care unit, operating room, and emergency department. The majority of ECLS circuits used in ECPR patients were blood primed and therapeutic hypothermia was used in more than half of cases. Median duration of CPR before ECLS was 40 minutes (interquartile range [IQR] 25–61 minutes); the majority (73%) received CPR < 60 minutes before ECLS support. Therapeutic hypothermia was commonly used following ECPR.
ECLS complications occurred frequently in those requiring ECPR; selected complications are shown in Table 10. As might be expected, neurological injury was common in this cohort. Approximately 10% of pediatric ECPR patients met brain death criteria, but brain death was uncommonly reported in the neonatal ECPR population (2%). These rates are considerably higher than in respiratory and cardiac ECLS support.
Since 2009 we have continued to see growth in the utilization of ECLS both in the number of centers and in the number of patients reported to the ELSO Registry. ECLS survival and the distribution of ECLS support types have been stable. From 2009 to 2015, approximately 48% of ECLS delivered to children was respiratory and 52% was cardiac or ECPR. Respiratory ECLS continued to use venoarterial cannulations in 70% of neonatal cases and 40% of pediatric cases. Roller pumps continued to predominate in neonatal respiratory disease, but centrifugal pumps were most common in all other ECLS subgroups. Among oxygenators, polymethylpentene was the most common in all age groups and support types.
This is the first ELSO Registry report to summarize data collected as part of the ECPR addendum. The report offers new insights into pediatric ECPR. It describes the duration of chest compressions, the location of arrest and cannulation, and the proportion of patients receiving therapeutic hypothermia. Thirty percent of patients are cannulated less than 30 minutes after compressions are started and 81% of arrests leading to ECPR occur in resource intense areas such as the intensive care unit, operating room, and emergency department. Half of ECPR patients received therapeutic hypothermia in the ELSO Registry. The therapeutic hypothermia after in-hospital cardiac arrest in children (THAPCA) trial was conducted from 2009 to 2015 and found no benefit of therapeutic hypothermia.24 It will be interesting to observe whether the proportion of patients receiving therapeutic hypothermia declines in the future.
Among patient complications, brain death was much less common in neonates than in pediatric patients for each support type. We suspect that this difference is at least partially due to difficulty in diagnosis of brain death in neonates compared to nonneonatal children.
As of September 2016, the ELSO Registry began collecting ICD-10 diagnostic codes, severity of illness data, date and times for procedures and complications, and implemented logical limits to data entry. In addition, researchers have published pre-ECLS specific measures of severity of illness for adult respiratory, adult cardiac, pediatric respiratory, and neonatal respiratory ECLS using the ELSO Registry.25–30 Also, there are ongoing initiatives to update a formal database dictionary for all data fields, to validate data entry both through external validation and measures of inter-rater reliability of data abstraction. Finally, there is ongoing work in the ELSO Registry to update dynamic quality reporting of outcomes, processes, and structures in ECLS care.
The ELSO Registry has been and continues to be used by regulatory agencies and industry to evaluate technology. The Registry is regularly used by clinicians to inform and support the care of ECLS patients. The Registry has been used in research trials such as the prospective trial of a pediatric ventricular assist device31 as well as over 225 retrospective studies listed in PubMed (April 1, 2017). The ELSO Registry is also used to promote quality improvement through real-time benchmarking reports that compare an individual center’s survival and complication rates to those of peer institutions. These initiatives will continue to improve the world’s largest ECLS Registry so that future patients requiring ECLS will benefit from improved care and technology.
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