In Vitro and In Vivo Performance Evaluation of the Second Developmental Version of the PediaFlow Pediatric Ventricular Assist Device

摘要: Ventricular assist devices (VADs) have significantly impacted the treatment of adult cardiac failure, but few options exist for pediatric patients. This has motivated our group to develop an implantable magnetically levitated rotodynamic VAD (PediaFlow®) 3–20 kg The second prototype design PediaFlow (PF2) is 56% smaller than earlier prototypes, and achieves 0.5–1.5 L/min blood flow rates. In vitro hemodynamic performance hemolysis testing were performed with analog whole ovine blood, respectively. vivo evaluation was in model evaluate hemocompatibility end-organ function. normalized index 0.05–0.14 g/L over specified operating range. satisfactory two three implanted animals. A mechanical defect caused early termination at 17 days first study, subsequent implants proceeded without complication electively terminated 30 70 days. Serum chemistries plasma free hemoglobin within normal limits. Gross necropsy revealed small, subclinical infarctions kidneys day animals (confirmed by histopathology). results these experiments, particularly biocompatibility demonstrated encourage further development a miniature population. Ongoing work including reduction size will lead freeze preparation clinical trials.