Outcomes in small children on Berlin Heart EXCOR support: age and body surface area as clinical predictive factors

Abstract

Introduction The Berlin Heart EXCOR offers circulatory support across all paediatric ages. Clinically, the necessary care as well as outcomes differ in various age groups. The EUROMACS database was used to study age and size-related outcomes for this specific device. Methods All patients <19 years of age from the EUROMACS database supported with a Berlin Heart EXCOR between 2000 and November 2021 were included. Maximally Selected Rank statistics were used to determine BSA cut-off values. Multivariable Cox Proportional-Hazard Regression using ridge penalization was performed to identify factors associated with outcomes. Results In total, 303 patients were included (mean age: 2.0 years (interquartile range: 0.6–8.0, males: 48.5%)). Age and BSA were not significantly associated with mortality (n = 74, p = 0.684, p = 0.679). Factors associated with transplantation (n = 175) were age (HR 1.07, p = 0.006) and aetiology other than congenital heart disease (HR 1.46, p = 0.020). Recovery rates (n = 42) were highest in patients with a BSA <0.53 m2 (21.8% vs 4.3–7.6% at 1 year, p = 0.00534). Patients with a BSA ≥0.73 m2 had a lower risk of early pump thrombosis, but a higher risk of early bleedings compared to children with a BSA <0.73 m2. Conclusions Mortality rates in Berlin Heart supported patients cannot be predicted by age or BSA. Recovery rates are remarkably high in the smallest patient category (BSA <0.53 m2). This underscores that the Berlin Heart EXCOR is a viable therapeutic option, even for the smallest and youngest patients.

Myocardial recovery in children supported with a durable ventricular assist device—a systematic review

“…Furthermore, age and body surface area are associated with myocardial recovery. A previous report from our group showed significantly higher recovery rates in BHE-supported children with a body surface area < 0.53 m 2 compared to children with a higher body surface area (21.8% vs 4.3–7.6% at 1 year, P = 0.00534) [ 26 ]. Similarly, Miera et al [ 7 ] showed a more than fivefold increased recovery rate for children under 2 years of age (OR 5.64, 95% CI 2.0–16.6).…”

“…Myocarditis was associated with higher myocardial recovery [odds ratio (OR) 17.56, 95% confidence interval (CI) 4.6–67.4) in a study from Miera et al that included almost 150 patients [ 7 ]. However, our group performed a multivariable Cox regression analysis using the paediatric European Registry for Patients with Mechanical Circulatory Support (EUROMACS) on 303 BHE-supported children and found no significant association between primary diagnoses and recovery (non-CHD versus CHD: hazard ratio 0.919, 95% CI 0.525–1.611, P = 0.771) [ 26 ]. This review also showed that myocarditis and post-cardiotomy failure are not the only diagnoses associated with successful VAD explantation due to recovery.…”

“…On the other hand, in the included study with the highest recovery rate (38.1%), 60% of the children were classified as INTERMACS I and one-third were supported by ECMO prior to VAD support [ 13 ]. INTERMACS classification, previous ECMO or previous intubation was not significantly associated with multivariable analyses in BHE-supported children [ 26 ].…”