Evaluation of cyclosporin (CsA) profiles month 2 to 6 in an international phase III randomized, multicenter, double-blind study of everolimus in DE novo heart transplant recipients

Abstract

heart is not available. A large amount of experience exists with BTT in the adult population; relatively less information is available in the pediatric population with pulsatile devices. Ten pediatric patients are presented who underwent BTT or recovery with pneumatic paracorporeal systems. The Berlin Heart biventricular assist device was utilized in 1 patient (BVAD), the Medos VAD was utilized in four patients (1 LVAD, 3 BVAD); the Thoratec VAD in 5 patients (3 BVAD, 2 LVAD). The pediatric population consisted of 3 females and 7 males. Mean age of the population was 7.4 years (youngest 4 months), weight 25 kg, BSA 0.88 m. Etiologies for heart failure were: 4 viral, 3 congenital and 3 idiopathic cardiomyopathies. Prior to implant, all patients exhibited evidence of progressive cardiac failure despite inotropic support, 2 patients had been on ECMO for 1 week. Mean duration on the device was 34.3 (8 -107) days. Two patients suffered strokes and recovered without sequelae. Two patients died of ischemic strokes and 1 of sepsis. Seven patients survived (6 transplanted and 1 weaned) for a survival rate of 70% compared to survival for ECMO as BTT of 40–50%. All survivors experienced complications related to bleeding, thromboembolic events, and infections. The Thoratec VAD can be placed in small patients with large hearts that can accommodate the available cannulas. The Berlin Heart and the Medos VAD have a selection of ventricles with small stroke volumes. All 3 systems can be successfully used in the pediatric population as BTT with better survival than ECMO. Anticoagulation in children and selection criteria has to be better understood. Lack of potential donors may further accelerate the use of these devices.