Anatomical study of the Cleveland Clinic continuous-flow total artificial heart in adult and pediatric configurations
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The purpose of this study was to assess the smallest possible body sizes of patients in whom the Cleveland Clinic continuous-flow total artificial heart for adult (CFTAH) and pediatric configurations (P-CFTAH) can fit. One of the most critical dimensions is the vertebra-to-sternum distance at the junction of the right atrium to the inferior vena cava (V–S distance). Our previous CFTAH anatomical fitting study suggested that the CFTAH would fit patients of V–S distance ≥ 7.5 cm and the P-CFTAH of V–S distance ≥ 5.25 cm (70% of 7.5 cm). To confirm this, we assessed the relationship between body surface area (BSA) and V–S distance in 15 adult patients (BSA 1.86–2.62 m2) and 31 pediatric patients (BSA 0.17–1.80 m2) whose computed tomography scans were available. We found a highly significant correlation between BSA and V–S distance (p < 1.0 × 10−25). It appears that the CFTAH will fit in most patients with BSA ≥ 1.0 m2 (corresponding height of ≥ 130 cm and age of 9 years) and the P-CFTAH in patients with BSA ≥ 0.3 m2 (corresponding height of ≥ 55 cm and age of 1 month). Further anatomical fitting studies are needed to evaluate the two pump models inside human chests to determine the smallest patient size/critical dimensions and device port configurations.
KeywordsTotal artificial heart Anatomical fit Pediatric device Body surface area
This study was supported by Cleveland Clinic internal funding. All authors had freedom of investigation and full control of the design of the study, methods used, outcome parameters and results, analysis of data, and production of the written report.
KF: study design, data analysis, supervision, drafting the manuscript, and principal investigator. JHK, NB, GS, and TM: study design and data analysis. DJH: device inventor.
Compliance with ethical standards
Conflict of interest
David J. Horvath is an inventor of the adult continuous-flow total artificial heart. The technology was licensed to Cleveland Heart, Inc., a Cleveland Clinic spin-off company. If the total artificial heart is successful, the inventors and Cleveland Clinic may benefit. None of the other authors has a financial interest or other potential conflict of interest related to the subject matter or materials mentioned in the manuscript.
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