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新一代体外膜肺氧合采用 MedTech Mag-Lev,一种一次性使用的、磁悬浮、离心式血泵:小牛的临床前评估。

New generation extracorporeal membrane oxygenation with MedTech Mag-Lev, a single-use, magnetically levitated, centrifugal blood pump: preclinical evaluation in calves.

机构信息

Department of Cardiovascular Surgery, Tokyo Medical and Dental University, Bunkyo-ku, Tokyo, Japan.

出版信息

Artif Organs. 2013 May;37(5):447-56. doi: 10.1111/aor.12006. Epub 2013 Mar 13.

Abstract

We have evaluated the feasibility of a newly developed single-use, magnetically levitated centrifugal blood pump, MedTech Mag-Lev, in a 3-week extracorporeal membrane oxygenation (ECMO) study in calves against a Medtronic Bio-Pump BPX-80. A heparin- and silicone-coated polypropylene membrane oxygenator MERA NHP Excelung NSH-R was employed as an oxygenator. Six healthy male Holstein calves with body weights of about 100 kg were divided into two groups, four in the MedTech group and two in the Bio-Pump group. Under general anesthesia, the blood pump and oxygenator were inserted extracorporeally between the main pulmonary artery and the descending aorta via a fifth left thoracotomy. Postoperatively, both the pump and oxygen flow rates were controlled at 3 L/min. Heparin was continuously infused to maintain the activated clotting time at 200-240 s. All the MedTech ECMO calves completed the study duration. However, the Bio-Pump ECMO calves were terminated on postoperative days 7 and 10 because of severe hemolysis and thrombus formation. At the start of the MedTech ECMO, the pressure drop across the oxygenator was about 25 mm Hg with the pump operated at 2800 rpm and delivering 3 L/min flow. The PO2 of the oxygenator outlet was higher than 400 mm Hg with the PCO2 below 45 mm Hg. Hemolysis and thrombus were not seen in the MedTech ECMO circuits (plasma-free hemoglobin [PFH] < 5 mg/dL), while severe hemolysis (PFH > 20 mg/dL) and large thrombus were observed in the Bio-Pump ECMO circuits. Plasma leakage from the oxygenator did not occur in any ECMO circuits. Three-week cardiopulmonary support was performed successfully with the MedTech ECMO without circuit exchanges. The MedTech Mag-Lev could help extend the durability of ECMO circuits by the improved biocompatible performances.

摘要

我们评估了一种新开发的一次性、磁悬浮离心式血液泵 MedTech Mag-Lev 在小牛体外膜肺氧合(ECMO)研究中的可行性,与 Medtronic Bio-Pump BPX-80 进行了比较。肝素和硅涂层的聚丙烯膜式氧合器 MERA NHP Excelung NSH-R 用作氧合器。六头体重约 100 公斤的健康雄性荷斯坦小牛分为两组,四头在 MedTech 组,两头在 Bio-Pump 组。在全身麻醉下,通过第五次左开胸术将血液泵和氧合器插入体外主肺动脉和降主动脉之间。手术后,将泵和氧气流量都控制在 3 L/min。持续输注肝素以将激活凝血时间维持在 200-240 s。所有 MedTech ECMO 小牛均完成了研究。然而,由于严重的溶血和血栓形成,Bio-Pump ECMO 小牛在手术后第 7 天和第 10 天终止。在 MedTech ECMO 开始时,当泵以 2800 rpm 运行并输送 3 L/min 的流量时,氧合器上的压降约为 25 mm Hg。氧合器出口处的 PO2 高于 400 mm Hg,PCO2 低于 45 mm Hg。在 MedTech ECMO 回路中未观察到溶血和血栓形成(血浆游离血红蛋白[PFH] < 5 mg/dL),而在 Bio-Pump ECMO 回路中观察到严重的溶血(PFH > 20 mg/dL)和大血栓。在任何 ECMO 回路中均未发生氧合器的血浆泄漏。使用 MedTech ECMO 成功地进行了 3 周的心肺支持,而无需更换回路。Mag-Lev 可以通过改善的生物相容性来帮助延长 ECMO 回路的耐久性。

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