OBJECTIVE: The feasibility and efficacy of the pneumatic 'Berlin Heart'ventricular assist device (VAD) were evaluated in 14 pediatric patientswith profound cardiogenic shock refractory to conventional therapy.METHODS: There were two patient groups. Eleven patients, aged 2 weeks 15years and weighing 3.2-52 kg received a left ventricular assist device or abiventricular assist device as a bridge to cardiac transplantation (bridgegroup). Nine of them had liver, kidney, or lung dysfunction before deviceimplantation. Three patients were supported with a biventricular assistdevice for myocardial recovery (recovery group): a 6-month-old girl forpostcardiotomy shock, a 10-month-old girl for allograft failure aftercardiac transplantation, and a 4-year- old boy with acute myocarditis.RESULTS: In the bridge group, eight patients were transplanted after abridge duration of 6-98 days (mean, 32 days) with five long-term survivors.Organ functions were normalized during bridging in all of the transplantrecipients. In the recovery group, the first patient was removed fromsupport after 2 days because of irreversible brain damage. The secondpatient was weaned from biventricular support after 8 days, but sufferedfrom recurrent allograft failure. The third patient received biventricularsupport for 21 days followed by extracorporeal membrane oxygenation and wassubsequently discharged from the hospital. CONCLUSIONS: The 'Berlin Heart'VAD can keep selected infants and children with life-threatening heartfailure for weeks or months.