Miyagi Chihiro, Ahmad Munir, Karimov Jamshid H, Polakowski Anthony R, Karamlou Tara, Yaman Malek, Fukamachi Kiyotaka, Najm Hani K
Department of Biomedical Engineering, Cleveland Clinic Lerner Research Institute, Cleveland, OH, United States.
Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, OH, United States.
Front Cardiovasc Med. 2023 Jul 17;10:1193800. doi: 10.3389/fcvm.2023.1193800. eCollection 2023.
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.
This study was approved by Cleveland Clinic Institutional Review Board. Pediatric cardiac surgery patients ( = 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 ( = 3; 4.2, 5.3, and 10.2 kg) imaging data.
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 ( < 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 m. These cutoff values were additionally confirmed to be optimal by CT imaging.
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.
本研究旨在确定两款小型（儿科和婴儿型）连续流全人工心脏泵（CFTAH）在先天性心脏病手术患者中的适配情况。
本研究经克利夫兰诊所机构审查委员会批准。对儿科心脏手术患者（n = 40）进行了解剖学和虚拟设备适配评估（儿科[P-CFTAH]和婴儿型[I-CFTAH]模型的3D打印模型）。虚拟子研究包括对术前胸部X线片和计算机断层扫描（n = 3；体重分别为4.2、5.3和10.2 kg）成像数据的分析。
P-CFTAH泵在40例患者中的21例适配（适配组，52.5%），但在19例患者中不适配（非适配组，47.5%）。I-CFTAH泵在所有评估的33例患者中均适配。P-CFTAH在体重（BW）、身高（Ht）和体表面积（BSA）等维度变化方面存在显著差异（P < 0.0001）。截断值分别为：BW：5.71 kg，Ht：59.0 cm，BSA：0.31 m²。这些截断值经CT成像进一步证实为最佳值。
本研究证明了P-CFTAH和I-CFTAH在先天性心脏病患者中的适配范围。这些数据表明这两种设备在小患者群体中适配的可行性。
