Zhao Han-Jun, Yan Hong-Bing, Wang Jian, Song Li, Li Qing-Xiang, Li Shi-Ying, Chi Yun-Peng, Wu Zheng, Zhang Xiao-Jiang, Zhao Yong A, Zheng Bin
28th Division, Beijing Anzhen Hospital of Capital Medical University, Beijing 100029, China.
Chin Med J (Engl). 2009 Mar 20;122(6):648-54.
A growing volume of data suggests that simple manual thrombus aspiration followed by direct stenting improves myocardial reperfusion and clinical outcome compared with conventional primary PCI, but there is still limited data comparing the in vivo performance among different devices. This study aimed to compare the efficacy and operability of thrombus aspiration by the Diver CE (Invatec, Brescia, Italy) and ZEEK (Zeon Medical Inc., Tokyo, Japan) aspiration catheters in ST-segment elevation myocardial infarction (STEMI) and their impact on 3-month outcome.
From September 2004 to June 2008, 298 consecutive patients with STEMI who received manual thrombus aspiration were involved in a single center retrospective analysis. Of them, 229 and 69 were treated with Diver CE and ZEEK aspiration catheters, respectively. Primary endpoints were myocardial blush grade (MBG), thrombolysis in myocardial infarction (TIMI) flow grade, ST-segment elevation resolution (STR), device pushability and trackability as judged by the frequency of usage of dual guide wires and aspiration efficacy as indicated by size distribution of aspirated thrombi. Secondary endpoints were 3-month outcome including left ventricular end diastolic diameter (LVEDD), left ventricular ejection fraction (LVEF), as well as cardiac death, target lesion revascularization (TLR), re-infarction and their combination as major adverse cardiac events (MACE).
Baseline characteristics were not different between the two groups expect for a higher frequency of temporary cardiac pacing in the ZEEK group (ZEEK) than in the Diver CE group (Diver CE) (0.44% vs 5.8%, P = 0.002). Visible retrieved thrombi were achieved in 65.9% of the Diver CE and 68.1% of the ZEEK (P = 0.74). Aspirated thrombi were categorized as small thrombi (< 3.5 mm), moderate thrombi (3.5-7.0 mm) and large thrombi (> 7.0 mm). Small thrombi were more frequently seen in the Diver CE (61.6% vs 42.6%), whereas moderate and larger thrombi were more frequently found in the ZEEK (38.4% vs 57.4%) (P = 0.021). Rates of dual wire utilization were 1.7% of the Diver CE and 7.2% of the ZEEK (P = 0.052). There were no differences in MBG, STR and TIMI flow grade between the two groups. No differences were found in cardiac death, TLR, re-infarction, MACE, LVEDD and LVEF between the Diver CE and the ZEEK during 3-month follow-up.
Both Diver CE and ZEEK manual aspiration catheters are effective for thrombectomy in STEMI. In clinical practice, ZEEK presents a stronger aspiration capacity for moderate to large thrombi compared with Diver CE, but Diver CE displays a trend towards better pushability and trackability than ZEEK. Differences in aspiration capacity and operability between Diver CE and ZEEK in this setting do not influence myocardial reperfusion and 3-month outcome.
越来越多的数据表明，与传统的直接经皮冠状动脉介入治疗（PCI）相比，简单的手动血栓抽吸后直接支架置入可改善心肌再灌注和临床结局，但比较不同器械体内性能的数据仍然有限。本研究旨在比较Diver CE（意大利布雷西亚英维特公司）和ZEEK（日本东京泽恩医疗公司）抽吸导管在ST段抬高型心肌梗死（STEMI）中进行血栓抽吸的疗效和可操作性，以及它们对3个月结局的影响。
2004年9月至2008年6月，对298例接受手动血栓抽吸的STEMI连续患者进行单中心回顾性分析。其中，分别有229例和69例患者使用Diver CE和ZEEK抽吸导管进行治疗。主要终点为心肌 blush分级（MBG）、心肌梗死溶栓（TIMI）血流分级、ST段抬高消退（STR）、根据双导丝使用频率判断的器械推送性和可跟踪性，以及根据吸出血栓大小分布表示的抽吸效果。次要终点为3个月结局，包括左心室舒张末期内径（LVEDD）、左心室射血分数（LVEF），以及心脏死亡、靶病变血管重建（TLR）、再梗死及其组合作为主要不良心脏事件（MACE）。
两组的基线特征无差异，但ZEEK组（ZEEK）临时心脏起搏的频率高于Diver CE组（Diver CE）（0.44%对5.8%，P = 0.002）。Diver CE组65.9%和ZEEK组68.1%的患者成功吸出可见血栓（P = 0.74）。吸出的血栓分为小血栓（< 3.5 mm）、中等血栓（3.5 - 7.0 mm）和大血栓（> 7.0 mm）。小血栓在Diver CE组中更常见（61.6%对42.6%），而中等和大血栓在ZEEK组中更常见（38.4%对57.4%）（P = 0.021）。双导丝使用率在Diver CE组为1.7%，在ZEEK组为7.2%（P = 0.052）。两组之间的MBG、STR和TIMI血流分级无差异。在3个月的随访期间，Diver CE组和ZEEK组在心脏死亡、TLR、再梗死、MACE、LVEDD和LVEF方面均无差异。
Diver CE和ZEEK手动抽吸导管在STEMI血栓清除中均有效。在临床实践中，与Diver CE相比，ZEEK对中等至大血栓的抽吸能力更强，但Diver CE在推送性和可跟踪性方面比ZEEK有更好的趋势。在这种情况下，Diver CE和ZEEK在抽吸能力和可操作性上的差异不影响心肌再灌注和3个月结局。
