Abstract
Background: The pediatric continuous-flow total artificial heart (P-CFTAH) is a novel mechanical circulatory support system intended for pediatric population with end-stage heart failure. P-CFTAH has been evaluated in animal models and additional design modifications or adjustments from multiple perspectives are ongoing. Herein, we report a thorough summary and update on the P-CFTAH development. Methods: A working prototype of the P-CFTAH was fabricated at the scale of 0.70 of adult CFTAH, and human intraoperative fitting study was performed to determine the range of appropriate anatomical fit for this device. In vivo studies (n=2) with healthy lambs (20.5 and 22.4 kg) were performed through a full median sternotomy. As a parallel effort, computational fluid dynamics (CFD) analyses were performed to guide and evaluate the pump’s flow path design. Results: From the fitting study, we analyzed and concluded that the P-CFTAH could be implanted in children over 5.7 kg of body weight and 0.31 m2 of body surface area. In vivo animal experiments, the anatomical and surgical fit of the P-CFTAH was optimal. All implantations were uncomplicated, and the P-CFTAH ran as expected during the experiment over a wide range of ratios of systemic/pulmonary vascular resistance (0.1 to 37.4). The CFD results were used to select the nominal bearing radial clearance, visualize the flow field throughout the pump, and identify potential flow-related improvements for a next generation design. Conclusion: The P-CFTAH has demonstrated optimal anatomical fitting in small-size models and reasonable selfregulation in various test configurations.
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