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使用微创体外循环系统(MiECC)进行冠状动脉血运重建的前瞻性、随机、非盲三臂对照研究:生物相容性的替代参数分析

Prospective, Randomized Un-Blinded Three Arm Controlled Study in Coronary Artery Revascularization with Minimal Invasive Extracorporeal Circulation Systems (MiECC): Surrogate Parameter Analysis of Biocompatibility.

作者信息

Kiessling Arndt H, Keller Harald, Moritz Anton

机构信息

Department of Clinical Research, Medical School Berlin, Berlin, Germany.

University Hospital, Department of Thoracic and Cardiovascular Surgery, Frankfurt/Main, Germany.

出版信息

Heart Surg Forum. 2018 May 16;21(3):E179-E186. doi: 10.1532/hsf.1946.

DOI:10.1532/hsf.1946
PMID:29893677
Abstract

OBJECTIVES

Minimal extracorporeal circulation techniques and systems (MiECC) may reduce the negative side effects of conventional extracorporeal circulation (ECC). However, it is still unclear as to what this is caused by, the reduced priming volume and hemodilution, or the avoidance of blood-air contact and dispersion of mediastinal debris into the systemic circulation. The aim of the trial was the comparison of MiECC to an open ECC setup (openECC) or a system with reduced blood air and debris interaction (closeECC). Methods: In a prospective randomized trial, 72 patients (73 ± 5.3 years; 83% male) referred for coronary artery bypass graft (CABG) were randomly assigned either to MiECC (priming volume 550mL), closeECC, or openECC (priming volume 1250mL). The laboratory surrogate endpoints (renal function, inflammatory response, ischemia, coagulation, and hemolysis) and clinical data were measured at six different time points (T1-6). Results: Patients were comparable for all preoperative variables. The operation times (MiECC 261 ± 79min; openECC 264 ± 75min; closeECC 231 ± 68min) and perfusion times (MiECC 115 ± 49min; openECC353 107 ± 37min; closeECC 99 ± 22min) revealed a trend of faster performance in the closeECC group (P < .05). Pro-inflammatory cytokines, ischemia, and coagulation markers were significantly elevated postoperatively in all cardiopulmonary bypass types, and decreased to pre-baseline levels at discharge (T5) without identifiable statistical differences between the three study groups. Free-hemoglobin was not significantly increased by centrifugal pump or cell saver procedures. Significant intraoperative hemodilution effects due to the different priming volumes were demonstrated only at the end of operation (T2) (MiECC Hb 9.6 ± 1.1g/dL; openECC Hb 9.0 ± 0.8g/dL; closeECC Hb 8.7 ± 1g/dL; P =. 01).

CONCLUSION

Neither the hemodilution, suction technique (MiECC), nor blood-air interface (closeECC) could show sustainable benefits in this underpowered study, compared to conventional ECC systems (openECC) in a high volume series of surrogate parameters.

摘要

目的

微创体外循环技术与系统(MiECC)可能会减少传统体外循环(ECC)的负面副作用。然而,其原因仍不明确,是由于预充量减少和血液稀释,还是避免了血液与空气接触以及纵隔碎屑进入体循环。该试验的目的是比较MiECC与开放体外循环设置(openECC)或血液与空气及碎屑相互作用减少的系统(closeECC)。方法:在一项前瞻性随机试验中,72例因冠状动脉旁路移植术(CABG)就诊的患者(73±5.3岁;83%为男性)被随机分配至MiECC组(预充量550mL)、closeECC组或openECC组(预充量1250mL)。在六个不同时间点(T1 - 6)测量实验室替代终点指标(肾功能、炎症反应、缺血、凝血和溶血)及临床数据。结果:所有术前变量在患者中具有可比性。手术时间(MiECC组261±79分钟;openECC组264±75分钟;closeECC组231±68分钟)和灌注时间(MiECC组115±49分钟;openECC组107±37分钟;closeECC组99±22分钟)显示closeECC组有更快完成手术的趋势(P < 0.05)。在所有体外循环类型中,促炎细胞因子、缺血和凝血标志物术后均显著升高,并在出院时(T5)降至基线前水平,三个研究组之间无明显统计学差异。离心泵或细胞回收程序未使游离血红蛋白显著增加。仅在手术结束时(T2)显示出因不同预充量导致的显著术中血液稀释效应(MiECC组血红蛋白9.6±1.1g/dL;openECC组血红蛋白9.0±0.8g/dL;closeECC组血红蛋白8.7±1g/dL;P = 0.01)。结论:在这项样本量不足的研究中,与传统ECC系统(openECC)相比,无论是血液稀释、抽吸技术(MiECC)还是血液 - 空气界面(closeECC),在大量替代参数方面均未显示出可持续的益处。

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