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Berlin Heart EXCOR use in patients with congenital heart disease
David L S Morales1, Farhan Zafar1, Christopher S Almond2
1The Heart Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Insights
Management of mechanical circulatory support with the Berlin Heart EXCOR in pediatric congenital heart disease (CHD) patients is challenging. Outcomes are poorer in CHD patients, especially neonates and infants, and depend on end-organ function and prior interventions.
Area of Science:
- Pediatric Cardiology
- Mechanical Circulatory Support
- Congenital Heart Disease
Background:
- Mechanical circulatory support (MCS) in children with congenital heart disease (CHD) presents unique challenges due to physiological variations and anatomical constraints.
- The Berlin Heart EXCOR is a ventricular assist device used in pediatric patients, but its efficacy in CHD populations requires further investigation.
Purpose of the Study:
- To examine the utilization and outcomes of the Berlin Heart EXCOR device in pediatric patients with congenital heart disease (CHD).
- To compare the success rates and adverse events between CHD and non-CHD patients receiving EXCOR support.
- To identify predictors of poor outcomes in CHD patients supported by the EXCOR device.
Main Methods:
- Analysis of the EXCOR Pediatric Study data set (2007-2010) to identify patients with CHD.
- Comparison of mortality and serious adverse events between CHD and non-CHD cohorts.
- Identification of factors associated with adverse outcomes in the CHD cohort.
Main Results:
- Congenital heart disease (CHD) was present in 29% of all EXCOR patients. Successful bridging to transplant or wean was significantly lower in CHD patients (48%) compared to non-CHD patients (80%).
- Survival rates varied by age in CHD patients: 0% for neonates, 25% for infants, and 65% for children over one year. Prior congenital heart surgery (CHS) and extracorporeal membrane oxygenation (ECMO) on the same admission were associated with significantly lower survival (8%) compared to those without (61%).
- Independent predictors of mortality included smaller pump size, pre-implant bilirubin levels >1.2 mg/dL, and renal dysfunction.
Conclusions:
- End-organ function at the time of implant is a critical predictor of adverse outcomes in pediatric MCS patients.
- The use of the Berlin Heart EXCOR in neonates and infants with CHD should be approached with extreme caution due to poor survival rates.
- While challenging, successful outcomes with EXCOR support in older children with CHD are achievable with careful patient selection, particularly avoiding those with extensive pre-implant interventions like CHS and ECMO.
Background:
Management of mechanical circulatory support in children with congenital heart disease (CHD) is challenging due to physiologic variations and anatomic limitations to device placement. In this study we examine the use of Berlin Heart EXCOR in CHD patients.
Methods:
CHD patients were identified from the EXCOR Pediatric Study data set (2007 to 2010). Mortality and serious adverse events were compared between CHD and non-CHD cohorts, and predictors of poor outcomes in the CHD cohort were identified.
Results:
CHD was present in 29% (n = 59, 18 with 1-ventricle physiology) of all EXCOR patients (N = 204). Successful bridge (transplant or wean) was less likely in CHD patients compared with non-CHD patients (48% vs 80%; p < 0.01). Among CHD patients, no neonates, 25% of infants (30 days to 1 year) and 65% of children (>1 year) were successfully bridged. Pre-implant congenital heart surgery (CHS) and extracorporeal membrane oxygenation (ECMO) on the same admission occurred in 60% of children ≤1 year of age (83% of neonates, 50% of infants), with 8% survival. Regardless of age, patients who did not have CHS and ECMO had 61% survival. Smaller pump, pre-implant bilirubin >1.2 mg/dl and renal dysfunction were independently associated with mortality.
Conclusions:
End-organ function at implant reliably predicts adverse outcomes and should be considered when making implant decisions. EXCOR use in neonates and infants with CHD should be approached cautiously. If patients have undergone pre-implant CHS and ECMO, EXCOR support may not provide any survival benefit. EXCOR support in non-infants with CHD is challenging but can be consistently successful with appropriate patient selection.
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