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Use of Two Intracorporeal Ventricular Assist Devices As a Total Artificial Heart
Published on: May 11, 2018
Human fitting of pediatric and infant continuous-flow total artificial heart: visual and virtual assessment
Chihiro Miyagi1, Munir Ahmad2, Jamshid H Karimov1,3
1Department of Biomedical Engineering, Cleveland Clinic Lerner Research Institute, Cleveland, OH, United States.
Insights
This study assessed continuous-flow total artificial heart pumps (CFTAHs) for pediatric and infant congenital heart surgery patients. The infant CFTAH fit all patients, while the pediatric CFTAH fit 52.5%, identifying key fitting parameters.
Area of Science:
- Biomedical Engineering
- Pediatric Cardiology
- Thoracic Surgery
Background:
- Congenital heart disease necessitates advanced circulatory support in pediatric patients.
- Small-sized continuous-flow total artificial heart pumps (CFTAHs) are being developed for pediatric and infant populations.
- Assessing device fit is crucial for the efficacy of artificial heart implantation.
Purpose of the Study:
- To determine the anatomical and virtual fit of pediatric (P-CFTAH) and infant (I-CFTAH) continuous-flow total artificial heart pumps.
- To identify critical patient parameters influencing the fit of the P-CFTAH in congenital heart surgery patients.
- To evaluate the feasibility of CFTAHs for small-patient populations.
Main Methods:
- Utilized 3D-printed models of P-CFTAH and I-CFTAH for virtual fitting in 40 pediatric cardiac surgery patients.
- Analyzed preoperative thoracic radiographs and computed tomography (CT) imaging data from three infants (4.2, 5.3, 10.2 kg).
- Determined critical cutoff values for body weight, height, and body surface area for P-CFTAH fit.
Main Results:
- The I-CFTAH demonstrated a suitable fit in all 33 evaluated patients.
- The P-CFTAH fit in 21 out of 40 patients (52.5%), with 19 patients (47.5%) showing a non-fit.
- Significant dimensional variations (p < 0.0001) impacting P-CFTAH fit included body weight (<5.71 kg), height (<59.0 cm), and body surface area (<0.31 m²).
Conclusions:
- Established the range of proper fit for P-CFTAH and I-CFTAH in congenital heart disease patients.
- The study suggests the feasibility of both pediatric and infant CFTAH devices for small-patient populations.
- Identified specific anthropometric criteria crucial for successful P-CFTAH implantation.
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.

