Human fitting of pediatric and infant continuous-flow total artificial heart: visual and virtual assessment

Chihiro Miyagi; Munir Ahmad; Jamshid H Karimov; Anthony R Polakowski; Tara Karamlou; Malek Yaman; Kiyotaka Fukamachi; Hani K Najm

doi:10.3389/fcvm.2023.1193800

Human fitting of pediatric and infant continuous-flow total artificial heart: visual and virtual assessment

Front Cardiovasc Med. 2023 Jul 17:10:1193800. doi: 10.3389/fcvm.2023.1193800. eCollection 2023.

Authors

Chihiro Miyagi^#¹, Munir Ahmad^#², Jamshid H Karimov^{1

3}, Anthony R Polakowski¹, Tara Karamlou², Malek Yaman⁴, Kiyotaka Fukamachi^{1

3}, Hani K Najm²

Affiliations

¹ Department of Biomedical Engineering, Cleveland Clinic Lerner Research Institute, Cleveland, OH, United States.
² Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH, United States.
³ Department of Biomedical Engineering, Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland, OH, United States.
⁴ Department of Pediatric Cardiology, Cleveland Clinic Children's Hospital, Cleveland, OH, United States.

^# Contributed equally.

Abstract

Background: This study aimed to determine the fit of two small-sized (pediatric and infant) continuous-flow total artificial heart pumps (CFTAHs) in congenital heart surgery patients.

Methods: This study was approved by Cleveland Clinic Institutional Review Board. Pediatric cardiac surgery patients (n = 40) were evaluated for anatomical and virtual device fitting (3D-printed models of pediatric [P-CFTAH] and infant [I-CFTAH] models). The virtual sub-study consisted of analysis of preoperative thoracic radiographs and computed tomography (n = 3; 4.2, 5.3, and 10.2 kg) imaging data.

Results: P-CFTAH pump fit in 21 out of 40 patients (fit group, 52.5%) but did not fit in 19 patients (non-fit group, 47.5%). I-CFTAH pump fit all of the 33 patients evaluated. There were critical differences due to dimensional variation (p < 0.0001) for the P-CFTAH, such as body weight (BW), height (Ht), and body surface area (BSA). The cutoff values were: BW: 5.71 kg, Ht: 59.0 cm, BSA: 0.31 m². These cutoff values were additionally confirmed to be optimal by CT imaging.

Conclusions: This study demonstrated the range of proper fit for the P-CFTAH and I-CFTAH in congenital heart disease patients. These data suggest the feasibility of both devices for fit in the small-patient population.

Keywords: congenital heart disease; infant total artificial heart; mechanical circulatory support; pediatric heart failure; pediatric total artificial heart.

Grants and funding

This study was supported by funding from the National Heart, Lung, and Blood Institute, National Institutes of Health (NIH), (R01HL139984). (PI: Fukamachi).