Initial Fitting Study of a Pediatric Continuous-Flow Total Artificial Heart

• Published in: The Journal of heart and lung transplantation Vol. 40; no. 4; p. S174
• Main Authors: Miyagi, C., Karimov, J.H., Kado, Y., Ray, D., Polakowski, T., Ahmad, M., Karamlow, T., Najm, H.K., Fukamachi, K.
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 01.04.2021
• ISSN: 1053-2498; 1557-3117
• DOI: 10.1016/j.healun.2021.01.511

End-stage heart failure is frequently encountered in complex congenital heart disease. Currently, we are developing a pediatric continuous flow total artificial heart (P-CFTAH). Due to the variations in congenital heart anomalies, the device should be suitable for multiple inflow and outflow structures. The purpose of this study is to evaluate the fitness of a replica of the prototype of P-CFTAH in different ages, weights and morphologies. The P-CFTAH pump was derived from the adult CFTAH configuration by downsizing it with a scale factor of 0.70 (1/3 of total volume, Fig. 1a). The 3D-printed models of the pump were evaluated for anatomical fit during open-heart surgery for a variety of congenital heart anatomies. A total of 23 patients were enrolled so far (3.2-30 kg) and divided into 2 groups after the fitting study: fit or non-fit group. The pre-op thoracic size (mm), heart size (mm), cardio thoracic ratio (CTR) were measured using their pre-op chest X-rays and the differences between the 2 groups were statistically analyzed. Among the 23 patients, 13 patients were assigned to the fit group, and 10 patients assigned to the non-fit group after the intraoperative visual assessment. There were significant differences (p < 0.0001) between fit/non-fit groups for body weight (BW), height (Ht), body surface area (BSA), thoracic and heart size (A, B, C, D in Fig. 1b). The cutoff values of each are, BW: 5.71 kg, Ht: 66.5 cm, BSA: 0.31 m2, A: 148.0 mm, B: 84.0 mm, C: 57.0 mm, D: 76.0 mm, and the area under curve of all of the parameters were >0.94. The CTR (B/A in Fig.1b) showed no significant differences among groups. This study revealed suitability of the P-CFTAH for wide range of pediatric patients, and the range of proper fit was evident. Further studies including the evaluation of the pump performance in vivo and the development of even smaller pumps for the patients below the cutoff line.