FW-Ⅱ型轴流泵短期辅助生物功能性和血液相容性的实验研究
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摘要
目的：
FW-Ⅱ型轴流泵是经计算机流体力学优化设计的旋转叶轮连续性血流心室辅助装置。本研究拟利用大动物短期存活实验观察FW-Ⅱ轴流泵的循环辅助效果,并评价其对大动物的的血流动力学、肝肾功能的影响,为其后期的临床试验提供基础数据。方法：
9只小尾寒羊(60-75kg)分为轴流泵组(n=6)和假手术组(n=3),轴流泵组通过胸部左外侧切口,建立左心室-轴流泵-胸降主动脉心室辅助模型；假手术组在心尖部和胸降主动脉处切开后直接缝合,未安装轴流泵。术后3天内应用肝素抗凝,使全血激活凝固时间(ACT)维持至150-200秒,后期联合阿司匹林(100mg/d)和华法令(3mg/d)抗凝。应用Swan-Ganz导管监测手术前后、轴流泵不同转速下(7000-9000转/分)左心做功指数(LVSWI)、心指数(CI)、心肌加速度指数(ACI)、心率收缩压乘积(RPP)、肺毛细血管楔压(PCWP)和中心静脉压(CVP)等血流动力学指标；联合经食道超声心动图监测轴流泵不同转速下主动脉瓣开放关闭情况,分析不同转速和主动脉瓣开放、收缩压、舒张压、平均动脉压及脉压差之间相关性。在术前、术后第1、3、5、7、10及14天抽取两组动物静脉血检测肌酸激酶(CPK)、乳酸脱氢酶(LDH)、总蛋白、总胆红素、谷草转氨酶(AST)、谷丙转氨酶(ALT)、尿素氮(BUN)和肌酐(Cr)水平,评价肝肾功能。结果：
9只羊术后6-8小时拔除气管插管,其中FW-Ⅱ轴流泵辅助组5只羊辅助持续14至16天,轴流泵运转正常,1只羊因术后出血于第7天提前终止实验。在14天内,轴流泵的转速维持至7500-8500转/分,产生的血流量稳定在3.0±0.7L/min。同术前相比,术后随着转速的增加,LVSWI、CI、ACI和RPP显著降低(P<0.01)。在轴流泵转速设置范围内(7000-9000转/分),同主动脉瓣开放时相比较,主动脉瓣关闭时舒张压、平均压均显著增加(P<0.05),脉压差显著减少(P<0.05),收缩压无显著性差异(P>0.05)；同轴流泵低转速(7000rpm)相比,高转速(9000rpm)时主动脉瓣开放次数显著减少(22% vs 97%,P<0.001)；同低脉压差相比(<15mmHg),高脉压差时主动脉瓣开放次数显著增加(65% vs24%,P<0.001)。轴流泵组和假手术组CPK、LDH水平都在术后第三天达到峰值(673±26IU/L vs 642±22IU/L,357±13IU/L vs 302士14IU/L,P>0.05),10天后恢复至术前水平。两组总蛋白水平在术后第3天下降至最低(5.9±0.09g/dL vs6.1±0.12g/dL,P>0.05),术后10天恢复至正常范围；两组总胆红素水平术后第3天达峰值(0.5±0.04mg/dL vs 0.31±0.03mg/dL,P<0.05),术后7天恢复至术前水平。轴流泵组和假手术对照组AST及ALT均有升高,AST上升更为明显,术后第3天达到峰值(229.4±31.9IU/L vs 203.4±531.9IU/L,P>0.05),10天后逐渐下降至术前水平；两组的的ALT手术前后无显著性差异(12.9±53.1 vs15.6±6.1,P>0.05)。两组的BUN和Cr水平在14天内均保持稳定水平,最高峰值出现在第5天(14.5±2.5 vs13.2±2.1mmol/L；1.6±0.03 vs 1.5±0.03μmol/L),后逐渐降至正常范围。结论：
FW-Ⅱ型泵可安全短期辅助实验动物,左心辅助效果明显,血流动力学稳定,肝肾功能无损害。目的：
通过观察FW-Ⅱ型轴流泵短期辅助期间血液相容性表现,及白细胞-血小板聚集体生成水平在辅助循环过程与血栓形成的关系,为后期临床应用提供抗凝依据和监测手段。方法：
分别于轴流泵组和假手术组术前、术后第1、3、5、7、10、14天采集中心静脉血液标本,检测常规血液学指标包括：红细胞、白细胞、血小板计数、血浆游离血红蛋白(PFH)、凝血酶原时间(PT)、国际标准化比值(INR)、部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(Fg),检测血清中白介素-6(IL-6)、肿瘤坏死因子-α(TNF-a)、补体C3a和C5a含量。通过流式细胞仪检测上述时间点血小板激活和白细胞-血小板聚集体；在术后第10天,不同转速下(7000、7500、8000、8500和9000转/分),分别采集静脉血检测白细胞-血小板聚集体。于术前、术后、血小板数恢复正常后、口服阿司匹林后和口服华法令后分别抽取静脉血,通过PFA-100分析仪检测花生四烯酸(AA)和二磷酸腺苷(ADP)诱导的血小板聚集率；通过血栓弹力描记图(TEG)检测反应时间(R值)、凝固时间(K值)、血栓最大幅度值(Ma)、凝固角(a)、凝血指数(CI),监测凝血功能状态。实验结束后,拆分轴流泵观察各组成部分有无血栓形成,取材观察心、肺、脾、肾、脑大体和镜下病理表现。结果：
轴流泵组和假手术组术后红细胞计数均下降,术后第3天最低(2.4×1012/Lvs 3.2×1012/L),两组分别于术后10天和14天恢复至术前水平。轴流泵组术后血浆游离血红蛋白水平第三天达到最高值(170±20mg/L),1周内维持在50mg/L以上,10天后逐渐降低；假手术组后第1天略有增高,2天后降至术前水平。两组动物白细胞计数术后第5天达到高峰(13.28±0.24×109/L vs 11.74±0.96×109/L),随后逐渐下降；与假手术组相比,轴流泵组术后14天内白细胞计数维持在较高水平。两组血小板计数均于术后3天内均有不同程度下降,随后逐渐增加,14天内血小板数变化无显著性差异(P>0.05)。与术前相比较,植入轴流泵后外周血中循环血小板激活和白细胞-血小板聚集体形成,术后第2天达到高峰(42±6%,40±5%,P<0.01),7天内维持较高状态,后逐渐降低,但术后14天仍高于术前水平(17±4%,20±6%,P>0.05)；第三只实验羊的白细胞-血小板聚集体活化数显著高于另外4只。在第10天,调节轴流泵转速从7000增加到9000转/分,血小板活化和白细胞-血小板聚集体数变化呈现V字形变化,在8000转/分时最低(15±3%,16±4%),而在7000转/分和9000转/分时达到高值(33±3%,31±5%)。血小板激活和白细胞-血小板聚集体在术后早期持续高水平状态,口服阿司匹林后,血小板活化数减少(P<0.01),而白细胞-血小板聚集体数无减少。与术前相比较,血小板聚集率在术后早期下降,血小板计数恢复后显著增加(P<0.05),口服阿司匹林治疗后显著降低(P<0.01),而在口服华法令治疗后无显著改变。与术前相比,R值和K值术后无显著变化；凝固角和MA在血小板计数恢复后显著增加(P<0.01),抗血小板治疗后无显著改变；凝血指数在血小板计数恢复后增加(P<0.05),在抗血小板治疗后下降。实验结束后拆分FW-Ⅱ轴流泵,轴流泵轴两端根部有少量血栓形成(重0.008±0.004g),除第三次实验泵流入管处有少量血栓形成(重0.14g),所有泵的前、后导叶、叶轮及泵管均无血栓形成,心脑脾肾等主要脏器大体和镜下观察均无血栓形成及缺血梗死表现。结论：
FW-Ⅱ型泵抗血栓性能良好,可用于短期循环辅助。8000转/分血小板活化和白细胞-血小板聚集体值达到最低。
Objective:
FW-Ⅱaxial blood pump is rotary impeller continuous blood ventricular assist device with design optimization of computational fluid dynamics. In this study, we observed assistance effect of FW-II axial blood pump, and evaluated its impact on hemodynamics, liver and renal function by large animal survival experiment.
Methods:
9 small tail sheep were divided into axial blood pump group(n=6) and sham group(n=3):for pump group, left ventricular-axial blood pump-descending aorta model was established by the left lateral thorocotomy; for sham group, incise and suture cardiac apex and descending aorta without implanting pump. All sheep were used heparin to maintain 150-200 seconds of ACT, and then received oral aspirin(100mg/day) and warfarin(3mg/day). We used Swan-Ganz to monitor indices of hemodynamics perioperatively:left ventricular stroke work index(LVSWI), cardiac index(CI), acceleration index(ACI), rate-pressure-product(RPP), pulmonary Capillary wedge pressure(PCWP); Aortic valve opening and closing was observed by transesophageal echocardiography under different rotational speed, the relation between different pump speed and mean arterial pressure, pulse pressure, and aortic valve opening was analyzed. Serum creatine kinase (CPK), lactate dehydrogenase (LDH), total protein, total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN) and creatinine (Cr) level were detected in the preoperative,1,3,5,7,10 and 14 days to assess the function of liver and kidney.
Results:
All sheep were extubated 6-8 hours postoperatively. For pump group,5 sheep were assisted for 14-16 days without pump dysfunction, one sheep died of hemorrhage at 7 days. Within 14 days, the pump was maintained 7500-8500 rounds per minute(RPM), and produce stable blood flow(3.0±0.7L/min). Compared with the preoperative value, LVSWI, CI, ACI, and RPP were significantly lower (P<0.01). within the range of pump speed setting, compared with aortic valve opening, pump speed, diastolic pressure, mean arterial pressure significantly increased (P<0.05), pulse pressure significantly reduced (P<0.05), systolic blood pressure insignificantly changed (P> 0.05) when aortic valve closed. compared to high speed (9000rpm), the number of aortic valve opening reduced significantly with low-speed (7000rpm) (22% vs 97%, P<0.001). Compared with low pulse pressure (<15mmHg), the number of aortic valve opening with high pulse pressure(>15mmHg) increased significantly (65% vs 24%, P<0.001). CPK and LDH levels of two groups peaked in day 3(673±26 vs 642±22 IU/L,357±13IU/L vs 302±14IU/L, P>0.05), gradually recovered to preoperative level at day 10. Total protein levels in two groups were the lowest at day 3(5.9±0.09g/dL vs 6.1±0.12g/dL, P> 0.05), returned to normal level at day10; total bilirubin of two groups peaked at day 3 (0.5±0.04mg/dL vs 0.31±0.03mg/dL, P <0.05), decreased to preoperative level at day 5. AST level of two groups increased significantly, peaked at day 3 (229.4±31.9 vs 203.4±31.9 IU/L, P> 0.05), declined to preoperative level at day 10; there was no significant difference between pre and post operative ALT level of two groups (12.9±3.1 vs 15.6±6.1, P> 0.05). within 14 days, BUN and Cr levels in both groups remained stable, peaked at day 5 (14.5±2.5 vs13.2±2.1mmol/L; 1.6±0.03 vs 1.5±0.03μmol/L).
Conclusions:
FW-Ⅱaxial blood pump can safely assist animals, unload left ventricular obviously, present stable hemodynamics, and has little effect on liver and kidney function.
Blood Compatibility Study of FW-II Axial Blood Pump for Short-Term Assistance
Objective:
To provide anticoagulation evidence and monitoring methods for future clinical use, we observed blood compatibility of FW-II axial blood pump and the relation between leukocyte-platelet aggregation and thrombosis for short-term assistance.
Methods:
At preoperative and postoperative day 1,3,5,7,10,14, venous samples of pump and sham group were collected to detect hematologic indices:red blood cells, white blood cells, platelets count, plasma free hemoglobin and coagulation parameters. serum interleukin-6(IL-6), tumor necrosis factor (TNF-α), C3a and C5a content were also detected by enzyme-linked immunosorbent assay(ELISA). Platelet activation and leukocyte-platelet aggregation were detected by flow cytometry. At day 10, venous samples of different speed(7000-9000 round per minute) were collected to detect leukocyte-platelet aggregation. At the day of preoperative, postoperative, platelet count normalization, aspirin, and warfarin, venous samples were collected, platelet aggregation induced by arachidonic acid (AA) and adenosine diphosphate (ADP) was detected through PFA-100 analyzer. Thrombelastography(TEG) was used to monitor coagulation status:R time (R value), K time (K), maximum amplitude(Ma), (a), coagulation index (CI). FW-II axial blood pumps were explanted and each part was inspected to find any thrombus formation. Macroscopic and histological examination were checked on heart, brain, kidney and spleen respectively for thrombosis.
Results:
Postoperative red blood cell count of two groups decreased, reached the lowest level at day 3 (2.4×1012/Lvs3.2×1012/L), and returned to preoperative level respectively at day 10 and 14. Plasma free hemoglobin of pump group peaked at day 3(170mg±20mg/L), maintained 50mg/L within 7 days, and gradually decreased from day 10. White blood cell count of two groups peaked at day 5(13.28±0.24×109/L vs 11.74±0.96×109/L), and then gradually decreased. Compared to sham group, WBC count of pump group had been a high level. Platelet count of two groups decreased within 3 days, and gradually returned to preoperative level. Compared with preoperative baseline, the number of platelet activation and leukocyte-platelet aggregates reached the peak at postoperative day 2(42±6%,40±5%,P<0.01), retained a high level within 7 days, then gradually decreased, but were still higher than preoperative level at day 14 (17±4%,20±6%, P>0.05). According to rotating speed, the number of platelet activation and platelet-leukocyte aggregates were lowest at the speed of 8000 round per minute (15±3%,16±4%). Platelet-leukocyte aggregates of the third sheep were significantly higher than other four sheep. Compared with preoperative baseline, platelet aggregates significantly increased after platelet count recover to normal level. Compared with preoperative baseline, there was no significant change for R and K value, aangle and MA significantly increased after platelet count recovered to normal level, coagulation index increased after postoperatively platelet count normalization, reduce significantly after oral aspirin. Minus thrombus were found in front and rear hub of pump rotor(0.008±0.004g). except round thrombus of inflow housing in the third pump, no thrombus at other components (flow straighter, impeller, pump housing) was found. There was not any ischemia and infarction evidence in macroscopic and histological examination of heart, brain, kidney and spleen.
Conclusion:
FW-Ⅱaxial blood pump can be used to assist left ventricular circulation for 2 weeks with a satisfactory antithrombosis ability. The level of platelet activation and leukocyte-platelet aggregation can be reduced to bottom at a optimized pump speed.
FW-Ⅱ型轴流泵是经计算机流体力学优化设计的旋转叶轮连续性血流心室辅助装置。本研究拟利用大动物短期存活实验观察FW-Ⅱ轴流泵的循环辅助效果,并评价其对大动物的的血流动力学、肝肾功能的影响,为其后期的临床试验提供基础数据。方法：
9只小尾寒羊(60-75kg)分为轴流泵组(n=6)和假手术组(n=3),轴流泵组通过胸部左外侧切口,建立左心室-轴流泵-胸降主动脉心室辅助模型；假手术组在心尖部和胸降主动脉处切开后直接缝合,未安装轴流泵。术后3天内应用肝素抗凝,使全血激活凝固时间(ACT)维持至150-200秒,后期联合阿司匹林(100mg/d)和华法令(3mg/d)抗凝。应用Swan-Ganz导管监测手术前后、轴流泵不同转速下(7000-9000转/分)左心做功指数(LVSWI)、心指数(CI)、心肌加速度指数(ACI)、心率收缩压乘积(RPP)、肺毛细血管楔压(PCWP)和中心静脉压(CVP)等血流动力学指标；联合经食道超声心动图监测轴流泵不同转速下主动脉瓣开放关闭情况,分析不同转速和主动脉瓣开放、收缩压、舒张压、平均动脉压及脉压差之间相关性。在术前、术后第1、3、5、7、10及14天抽取两组动物静脉血检测肌酸激酶(CPK)、乳酸脱氢酶(LDH)、总蛋白、总胆红素、谷草转氨酶(AST)、谷丙转氨酶(ALT)、尿素氮(BUN)和肌酐(Cr)水平,评价肝肾功能。结果：
9只羊术后6-8小时拔除气管插管,其中FW-Ⅱ轴流泵辅助组5只羊辅助持续14至16天,轴流泵运转正常,1只羊因术后出血于第7天提前终止实验。在14天内,轴流泵的转速维持至7500-8500转/分,产生的血流量稳定在3.0±0.7L/min。同术前相比,术后随着转速的增加,LVSWI、CI、ACI和RPP显著降低(P<0.01)。在轴流泵转速设置范围内(7000-9000转/分),同主动脉瓣开放时相比较,主动脉瓣关闭时舒张压、平均压均显著增加(P<0.05),脉压差显著减少(P<0.05),收缩压无显著性差异(P>0.05)；同轴流泵低转速(7000rpm)相比,高转速(9000rpm)时主动脉瓣开放次数显著减少(22% vs 97%,P<0.001)；同低脉压差相比(<15mmHg),高脉压差时主动脉瓣开放次数显著增加(65% vs24%,P<0.001)。轴流泵组和假手术组CPK、LDH水平都在术后第三天达到峰值(673±26IU/L vs 642±22IU/L,357±13IU/L vs 302士14IU/L,P>0.05),10天后恢复至术前水平。两组总蛋白水平在术后第3天下降至最低(5.9±0.09g/dL vs6.1±0.12g/dL,P>0.05),术后10天恢复至正常范围；两组总胆红素水平术后第3天达峰值(0.5±0.04mg/dL vs 0.31±0.03mg/dL,P<0.05),术后7天恢复至术前水平。轴流泵组和假手术对照组AST及ALT均有升高,AST上升更为明显,术后第3天达到峰值(229.4±31.9IU/L vs 203.4±531.9IU/L,P>0.05),10天后逐渐下降至术前水平；两组的的ALT手术前后无显著性差异(12.9±53.1 vs15.6±6.1,P>0.05)。两组的BUN和Cr水平在14天内均保持稳定水平,最高峰值出现在第5天(14.5±2.5 vs13.2±2.1mmol/L；1.6±0.03 vs 1.5±0.03μmol/L),后逐渐降至正常范围。结论：
FW-Ⅱ型泵可安全短期辅助实验动物,左心辅助效果明显,血流动力学稳定,肝肾功能无损害。目的：
通过观察FW-Ⅱ型轴流泵短期辅助期间血液相容性表现,及白细胞-血小板聚集体生成水平在辅助循环过程与血栓形成的关系,为后期临床应用提供抗凝依据和监测手段。方法：
分别于轴流泵组和假手术组术前、术后第1、3、5、7、10、14天采集中心静脉血液标本,检测常规血液学指标包括：红细胞、白细胞、血小板计数、血浆游离血红蛋白(PFH)、凝血酶原时间(PT)、国际标准化比值(INR)、部分凝血活酶时间(APTT)、凝血酶时间(TT)、纤维蛋白原(Fg),检测血清中白介素-6(IL-6)、肿瘤坏死因子-α(TNF-a)、补体C3a和C5a含量。通过流式细胞仪检测上述时间点血小板激活和白细胞-血小板聚集体；在术后第10天,不同转速下(7000、7500、8000、8500和9000转/分),分别采集静脉血检测白细胞-血小板聚集体。于术前、术后、血小板数恢复正常后、口服阿司匹林后和口服华法令后分别抽取静脉血,通过PFA-100分析仪检测花生四烯酸(AA)和二磷酸腺苷(ADP)诱导的血小板聚集率；通过血栓弹力描记图(TEG)检测反应时间(R值)、凝固时间(K值)、血栓最大幅度值(Ma)、凝固角(a)、凝血指数(CI),监测凝血功能状态。实验结束后,拆分轴流泵观察各组成部分有无血栓形成,取材观察心、肺、脾、肾、脑大体和镜下病理表现。结果：
轴流泵组和假手术组术后红细胞计数均下降,术后第3天最低(2.4×1012/Lvs 3.2×1012/L),两组分别于术后10天和14天恢复至术前水平。轴流泵组术后血浆游离血红蛋白水平第三天达到最高值(170±20mg/L),1周内维持在50mg/L以上,10天后逐渐降低；假手术组后第1天略有增高,2天后降至术前水平。两组动物白细胞计数术后第5天达到高峰(13.28±0.24×109/L vs 11.74±0.96×109/L),随后逐渐下降；与假手术组相比,轴流泵组术后14天内白细胞计数维持在较高水平。两组血小板计数均于术后3天内均有不同程度下降,随后逐渐增加,14天内血小板数变化无显著性差异(P>0.05)。与术前相比较,植入轴流泵后外周血中循环血小板激活和白细胞-血小板聚集体形成,术后第2天达到高峰(42±6%,40±5%,P<0.01),7天内维持较高状态,后逐渐降低,但术后14天仍高于术前水平(17±4%,20±6%,P>0.05)；第三只实验羊的白细胞-血小板聚集体活化数显著高于另外4只。在第10天,调节轴流泵转速从7000增加到9000转/分,血小板活化和白细胞-血小板聚集体数变化呈现V字形变化,在8000转/分时最低(15±3%,16±4%),而在7000转/分和9000转/分时达到高值(33±3%,31±5%)。血小板激活和白细胞-血小板聚集体在术后早期持续高水平状态,口服阿司匹林后,血小板活化数减少(P<0.01),而白细胞-血小板聚集体数无减少。与术前相比较,血小板聚集率在术后早期下降,血小板计数恢复后显著增加(P<0.05),口服阿司匹林治疗后显著降低(P<0.01),而在口服华法令治疗后无显著改变。与术前相比,R值和K值术后无显著变化；凝固角和MA在血小板计数恢复后显著增加(P<0.01),抗血小板治疗后无显著改变；凝血指数在血小板计数恢复后增加(P<0.05),在抗血小板治疗后下降。实验结束后拆分FW-Ⅱ轴流泵,轴流泵轴两端根部有少量血栓形成(重0.008±0.004g),除第三次实验泵流入管处有少量血栓形成(重0.14g),所有泵的前、后导叶、叶轮及泵管均无血栓形成,心脑脾肾等主要脏器大体和镜下观察均无血栓形成及缺血梗死表现。结论：
FW-Ⅱ型泵抗血栓性能良好,可用于短期循环辅助。8000转/分血小板活化和白细胞-血小板聚集体值达到最低。
Objective:
FW-Ⅱaxial blood pump is rotary impeller continuous blood ventricular assist device with design optimization of computational fluid dynamics. In this study, we observed assistance effect of FW-II axial blood pump, and evaluated its impact on hemodynamics, liver and renal function by large animal survival experiment.
Methods:
9 small tail sheep were divided into axial blood pump group(n=6) and sham group(n=3):for pump group, left ventricular-axial blood pump-descending aorta model was established by the left lateral thorocotomy; for sham group, incise and suture cardiac apex and descending aorta without implanting pump. All sheep were used heparin to maintain 150-200 seconds of ACT, and then received oral aspirin(100mg/day) and warfarin(3mg/day). We used Swan-Ganz to monitor indices of hemodynamics perioperatively:left ventricular stroke work index(LVSWI), cardiac index(CI), acceleration index(ACI), rate-pressure-product(RPP), pulmonary Capillary wedge pressure(PCWP); Aortic valve opening and closing was observed by transesophageal echocardiography under different rotational speed, the relation between different pump speed and mean arterial pressure, pulse pressure, and aortic valve opening was analyzed. Serum creatine kinase (CPK), lactate dehydrogenase (LDH), total protein, total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), blood urea nitrogen (BUN) and creatinine (Cr) level were detected in the preoperative,1,3,5,7,10 and 14 days to assess the function of liver and kidney.
Results:
All sheep were extubated 6-8 hours postoperatively. For pump group,5 sheep were assisted for 14-16 days without pump dysfunction, one sheep died of hemorrhage at 7 days. Within 14 days, the pump was maintained 7500-8500 rounds per minute(RPM), and produce stable blood flow(3.0±0.7L/min). Compared with the preoperative value, LVSWI, CI, ACI, and RPP were significantly lower (P<0.01). within the range of pump speed setting, compared with aortic valve opening, pump speed, diastolic pressure, mean arterial pressure significantly increased (P<0.05), pulse pressure significantly reduced (P<0.05), systolic blood pressure insignificantly changed (P> 0.05) when aortic valve closed. compared to high speed (9000rpm), the number of aortic valve opening reduced significantly with low-speed (7000rpm) (22% vs 97%, P<0.001). Compared with low pulse pressure (<15mmHg), the number of aortic valve opening with high pulse pressure(>15mmHg) increased significantly (65% vs 24%, P<0.001). CPK and LDH levels of two groups peaked in day 3(673±26 vs 642±22 IU/L,357±13IU/L vs 302±14IU/L, P>0.05), gradually recovered to preoperative level at day 10. Total protein levels in two groups were the lowest at day 3(5.9±0.09g/dL vs 6.1±0.12g/dL, P> 0.05), returned to normal level at day10; total bilirubin of two groups peaked at day 3 (0.5±0.04mg/dL vs 0.31±0.03mg/dL, P <0.05), decreased to preoperative level at day 5. AST level of two groups increased significantly, peaked at day 3 (229.4±31.9 vs 203.4±31.9 IU/L, P> 0.05), declined to preoperative level at day 10; there was no significant difference between pre and post operative ALT level of two groups (12.9±3.1 vs 15.6±6.1, P> 0.05). within 14 days, BUN and Cr levels in both groups remained stable, peaked at day 5 (14.5±2.5 vs13.2±2.1mmol/L; 1.6±0.03 vs 1.5±0.03μmol/L).
Conclusions:
FW-Ⅱaxial blood pump can safely assist animals, unload left ventricular obviously, present stable hemodynamics, and has little effect on liver and kidney function.
Blood Compatibility Study of FW-II Axial Blood Pump for Short-Term Assistance
Objective:
To provide anticoagulation evidence and monitoring methods for future clinical use, we observed blood compatibility of FW-II axial blood pump and the relation between leukocyte-platelet aggregation and thrombosis for short-term assistance.
Methods:
At preoperative and postoperative day 1,3,5,7,10,14, venous samples of pump and sham group were collected to detect hematologic indices:red blood cells, white blood cells, platelets count, plasma free hemoglobin and coagulation parameters. serum interleukin-6(IL-6), tumor necrosis factor (TNF-α), C3a and C5a content were also detected by enzyme-linked immunosorbent assay(ELISA). Platelet activation and leukocyte-platelet aggregation were detected by flow cytometry. At day 10, venous samples of different speed(7000-9000 round per minute) were collected to detect leukocyte-platelet aggregation. At the day of preoperative, postoperative, platelet count normalization, aspirin, and warfarin, venous samples were collected, platelet aggregation induced by arachidonic acid (AA) and adenosine diphosphate (ADP) was detected through PFA-100 analyzer. Thrombelastography(TEG) was used to monitor coagulation status:R time (R value), K time (K), maximum amplitude(Ma), (a), coagulation index (CI). FW-II axial blood pumps were explanted and each part was inspected to find any thrombus formation. Macroscopic and histological examination were checked on heart, brain, kidney and spleen respectively for thrombosis.
Results:
Postoperative red blood cell count of two groups decreased, reached the lowest level at day 3 (2.4×1012/Lvs3.2×1012/L), and returned to preoperative level respectively at day 10 and 14. Plasma free hemoglobin of pump group peaked at day 3(170mg±20mg/L), maintained 50mg/L within 7 days, and gradually decreased from day 10. White blood cell count of two groups peaked at day 5(13.28±0.24×109/L vs 11.74±0.96×109/L), and then gradually decreased. Compared to sham group, WBC count of pump group had been a high level. Platelet count of two groups decreased within 3 days, and gradually returned to preoperative level. Compared with preoperative baseline, the number of platelet activation and leukocyte-platelet aggregates reached the peak at postoperative day 2(42±6%,40±5%,P<0.01), retained a high level within 7 days, then gradually decreased, but were still higher than preoperative level at day 14 (17±4%,20±6%, P>0.05). According to rotating speed, the number of platelet activation and platelet-leukocyte aggregates were lowest at the speed of 8000 round per minute (15±3%,16±4%). Platelet-leukocyte aggregates of the third sheep were significantly higher than other four sheep. Compared with preoperative baseline, platelet aggregates significantly increased after platelet count recover to normal level. Compared with preoperative baseline, there was no significant change for R and K value, aangle and MA significantly increased after platelet count recovered to normal level, coagulation index increased after postoperatively platelet count normalization, reduce significantly after oral aspirin. Minus thrombus were found in front and rear hub of pump rotor(0.008±0.004g). except round thrombus of inflow housing in the third pump, no thrombus at other components (flow straighter, impeller, pump housing) was found. There was not any ischemia and infarction evidence in macroscopic and histological examination of heart, brain, kidney and spleen.
Conclusion:
FW-Ⅱaxial blood pump can be used to assist left ventricular circulation for 2 weeks with a satisfactory antithrombosis ability. The level of platelet activation and leukocyte-platelet aggregation can be reduced to bottom at a optimized pump speed.
引文
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