Key result
In children supported by the Berlin Heart EXCOR device, mortality rates ranged from 6.3% to 38.9% and transplantation rates ranged from 37.0% to 72.5%.
Why the study?
To evaluate the current state of clinical outcomes in children after paediatric ventricular assist device support with the Berlin Heart EXCOR device.
What are the clinical outcomes and adverse event rates in pediatric patients supported by the Berlin Heart EXCOR VAD as a bridge to transplantation?
Systematic Review
What are the clinical outcomes and adverse event rates in pediatric patients supported by the Berlin Heart EXCOR VAD as a bridge to transplantation?
Despite a high incidence of adverse events such as stroke, the Berlin Heart EXCOR VAD serves as a viable bridge to transplantation for pediatric patients with end-stage heart failure.
Supports considering BH EXCOR as bridge-to-transplant in pediatric end-stage HF despite high adverse events; leaves open optimal timing and anticoagulation.
Ventricular assist devices (VADs) are widely accepted as therapy to bridge children to heart transplantation. We provide a systematic review of the current state of clinical outcomes in children after paediatric VAD support by the Berlin Heart EXCOR (BH EXCOR) device. A systematic literature search was performed in April 2018. Studies reporting clinical outcomes in at least 15 children supported by a BH EXCOR VAD were included. Additionally, we focused on outcomes in small children and compared outcomes of children supported by a left ventricular assist device (LVAD) versus children supported by a biventricular assist device (BiVAD). Eighteen publications fulfilled the inclusion criteria and were included in this systematic review. Mortality rates ranged from 6.3% [confidence interval (CI) 0.0-18.1%] to 38.9% (2.8-75.0%) while transplantation rates ranged from 37.0% (CI 18.8-55.2%) to 72.5% (CI 63.9-81.2%) and successful weaning rates from 0.0% to 20.7% (CI 6.0-35.5%). In children under 1 year of age, mortality rates ranged from 20.0% to 55.5% and transplantation rates ranged from 0.0% to 62.5%. BiVAD support seemed to result in worse clinical outcomes than LVAD support. Incidence of stroke ranged from 5.0% to 47.0% in all children supported with the BH EXCOR. Although a high incidence of adverse events such as stroke and pump thrombosis is reported, VAD support should be considered in children with end-stage heart failure awaiting heart transplantation. Further research is warranted, especially on optimal timing of device implantation and anticoagulation regimens.
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Rohde et al. (2019) conducted a systematic review in end-stage heart failure. Berlin Heart EXCOR (BH EXCOR) device was evaluated on clinical outcomes (mortality, transplantation, and successful weaning rates). In children supported by the Berlin Heart EXCOR device, mortality rates ranged from 6.3% to 38.9% and transplantation rates ranged from 37.0% to 72.5%.
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