Department of Biomedical Engineering, Cleveland Clinic Lerner Research Institute, Cleveland, Ohio, USA.
Biological Resources Unit, Cleveland Clinic, Cleveland, Ohio, USA.
Artif Organs. 2022 Aug;46(8):1555-1563. doi: 10.1111/aor.14237. Epub 2022 Mar 31.
The evaluation of pulsatile flow created by the new Cleveland Clinic continuous-flow total artificial heart (CFTAH100), which has a re-designed right impeller and motor, had not been tested in vivo. The purpose of this study was to evaluate the feasibility of pulsatility with the CFTAH100 during the application of pump speed modulation protocols in a chronic animal model.
A 30-day chronic animal experiment was conducted with a calf. Five pulsatile studies were performed on the alert animal. The mean pump speed was set at 2800 rpm, and modulated sinusoidally within a range of 0 to ± 35% of mean speed, in increments of 5% at 80 beats per minute (bpm). The pressures and pump flow were collected and a pulsatility index (PI) was calculated.
The calf was supported with the CFTAH100 without any major complications. The maximum and minimum pump flows changed significantly from baseline in all conditions, while the mean pump flow did not change. All flow pulsatility (FP) readings in all conditions significantly increased from baseline, and the percent modulation (%S) and FP had a strong positive correlation (r = 0.99, p < 0.01). The PI also increased significantly in all conditions (maximum at %S of 35%, 2.2 ± 0.05, p < 0.01), and a positive correlation between %S and PI (r = 0.99, p < 0.01) was observed.
The CFTAH100 showed the feasibility of creating pulsatile circulation with sinusoidal pump speed modulation.
新克利夫兰诊所连续流全人工心脏(CFTAH100)的脉动流评估,其重新设计了右叶轮和电机,尚未在体内进行测试。本研究的目的是在慢性动物模型中应用泵速调节方案评估 CFTAH100 的脉动性可行性。
对小牛进行了 30 天的慢性动物实验。在清醒动物上进行了 5 次脉动研究。平均泵速设定为 2800 rpm,并以平均速度的±35%的范围内以 80 次/分钟(bpm)的 5%递增幅度进行正弦调制。收集压力和泵流量,并计算脉动指数(PI)。
小牛在没有任何重大并发症的情况下使用 CFTAH100 得到支持。在所有条件下,最大和最小泵流量与基线相比均发生显著变化,而平均泵流量没有变化。所有条件下的所有流量脉动(FP)读数均与基线相比显著增加,而调制百分比(%S)和 FP 之间存在很强的正相关(r=0.99,p<0.01)。在所有条件下,PI 也显著增加(最大在%S 为 35%时,2.2±0.05,p<0.01),且%S 和 PI 之间存在正相关(r=0.99,p<0.01)。
CFTAH100 表明了通过正弦泵速调节创建脉动循环的可行性。