Departments of Bioengineering & Surgery, Cardiovascular Innovation Institute, University of Louisville, 302 East Muhammad Ali Blvd, Louisville, KY 40202, USA.
Artif Organs. 2012 Aug;36(8):677-82. doi: 10.1111/j.1525-1594.2012.01514.x.
Mechanical circulatory assist devices that provide temporary support in heart failure patients are needed to enable recovery or provide a bridge to decision. Minimizing risk of blood damage (i.e., hemolysis) with these devices is critical, especially if the length of support needs to be extended. Hematologic responses of the RotaFlow (Maquet) and CentriMag (Thoratec) temporary support devices were characterized in an in vitro feasibility study. Paired static mock flow loops primed with fresh bovine blood (700 mL, hematocrit [Hct] = 25 ± 3%, heparin titrated for activated clotting time >300 s) pooled from a single-source donor were used to test hematologic responses to RotaFlow (n = 2) and CentriMag (n = 2) simultaneously. Pump differential pressures, temperature, and flow were maintained at 250 ± 10 mm Hg, 25 ± 2°C, and 4.2 ± 0.25 L/min, respectively. Blood samples (3 mL) were collected at 0, 60, 120, 180, 240, 300, and 360 min after starting pumps in accordance with recommended Food and Drug Administration and American Society for Testing and Materials guidelines. The CentriMag operated at a higher average pump speed (3425 rpm) than the RotaFlow (3000 rpm) while maintaining similar constant flow rates (4.2 L/min). Hematologic indicators of blood trauma (hemoglobin, Hct, platelet count, plasma free hemoglobin, and white blood cell) for all measured time points as well as normalized and modified indices of hemolysis were similar (RotaFlow: normalized index of hemolysis [NIH] = 0.021 ± 0.003 g/100 L, modified index of hemolysis [MIH] = 3.28 ± 0.52 mg/mg compared to CentriMag: NIH = 0.041 ± 0.010 g/100 L, MIH = 6.08 ± 1.45 mg/mg). In this feasibility study, the blood trauma performance of the RotaFlow was similar or better than the CentriMag device under clinically equivalent, worst-case test conditions. The RotaFlow device may be a more cost-effective alternative to the CentriMag.
在体外可行性研究中，表征了 RotaFlow（美敦力）和 CentriMag（Thoratec）临时支持设备的血液反应。使用来自单个供体的新鲜牛血（700 毫升，Hct = 25 ± 3%，肝素滴定至激活凝血时间> 300 秒）预充的配对静态模拟流回路，同时测试 RotaFlow（n = 2）和 CentriMag（n = 2）的血液反应。泵压差、温度和流量分别维持在 250 ± 10 毫米汞柱、25 ± 2°C 和 4.2 ± 0.25 升/分钟。根据推荐的食品和药物管理局和美国测试材料协会指南，在启动泵后 0、60、120、180、240、300 和 360 分钟时收集 3 毫升血液样本。CentriMag 的平均泵速（3425 rpm）高于 RotaFlow（3000 rpm），但保持相似的恒定流量（4.2 L/min）。所有测量时间点的血液创伤指标（血红蛋白、Hct、血小板计数、血浆游离血红蛋白和白细胞）以及归一化和改良的溶血指标均相似（RotaFlow：归一化溶血指数 [NIH] = 0.021 ± 0.003 g/100 L，改良溶血指数 [MIH] = 3.28 ± 0.52 mg/mg，相比之下，CentriMag：NIH = 0.041 ± 0.010 g/100 L，MIH = 6.08 ± 1.45 mg/mg）。在这项可行性研究中，在临床等效的最坏情况下，RotaFlow 的血液创伤性能与 CentriMag 设备相似或更好。RotaFlow 装置可能是 CentriMag 的更具成本效益的替代方案。
