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Incor左心室辅助装置的首次临床经验。

First clinical experience with the Incor left ventricular assist device.

作者信息

Schmid Christof, Tjan Tonny D T, Etz Christian, Schmidt Christoph, Wenzelburger Frauke, Wilhelm Markus, Rothenburger Markus, Drees Gabi, Scheld Hans H

机构信息

Department of Thoracic and Cardiovascular Surgery, University Hospital, Muenster, Germany.

出版信息

J Heart Lung Transplant. 2005 Sep;24(9):1188-94. doi: 10.1016/j.healun.2004.08.024.

DOI:10.1016/j.healun.2004.08.024
PMID:16143232
Abstract

BACKGROUND

The Incor (Berlin Heart AG, Germany) is a small (200 g), implantable, magnetically accentuated axial flow pump (non-pulsatile flow) designed to support the left ventricle for extended periods of time. We report on the first single-center clinical experience with this device.

METHODS

The Incor was studied in 15 consecutive patients (10 men, 5 women), 24 to 59 years of age. Underlying heart disease was end-stage ischemic heart disease (n = 5), acute myocardial infarction (n = 4), dilated cardiomyopathy (n = 3), acute myocarditis (n = 2) and Chagas disease (n = 1). All patients were in New York Heart Association (NYHA) Class IV heart failure. Four patients had prior open heart surgery. Implantation via cannulation of the left ventricular apex and the ascending aorta was elective in 6 patients and on an emergency basis in 9.

RESULTS

No early bleeding complications were seen, but late bleeding occurred in 4 patients. Minor cerebral thromboembolic events with transient neurologic symptoms occurred in 3 patients; severe stroke had to be treated in 1 patient. Systemic emboli were seen in 2 patients. Thrombus-related pump dysfunction was suspected in 3 patients, and managed by intensifying anti-coagulation. Five patients were successfully transplanted after a support interval of 90 to 156 days; 1 patient could be weaned from the system after 171 days. Six patients died during support, 9 to 63 days after device implantation. The remaining 3 patients are still under support, with excellent quality of life.

CONCLUSIONS

The Incor is a left ventricular assist device (LVAD) with transplant and adverse event rates comparable to those of other modern ventricular support devices. Its advantages include the small pump chamber, the virtual absence of device-related infections, and the extraordinary convenience during implantation and explantation.

摘要

背景

Incor(德国柏林心脏公司)是一款小型(200克)、可植入的、磁增强轴流泵(非搏动性血流),设计用于长时间支持左心室。我们报告了使用该设备的首例单中心临床经验。

方法

对15例连续患者(10例男性,5例女性)进行了Incor研究,年龄在24至59岁之间。基础心脏病为终末期缺血性心脏病(n = 5)、急性心肌梗死(n = 4)、扩张型心肌病(n = 3)、急性心肌炎(n = 2)和恰加斯病(n = 1)。所有患者均为纽约心脏协会(NYHA)IV级心力衰竭。4例患者曾接受过心脏直视手术。6例患者通过左心室尖部和升主动脉插管进行选择性植入,9例为急诊植入。

结果

未见早期出血并发症,但4例患者出现晚期出血。3例患者发生伴有短暂神经症状的轻微脑栓塞事件;1例患者不得不接受严重中风治疗。2例患者出现全身性栓塞。3例患者怀疑发生血栓相关的泵功能障碍,通过加强抗凝治疗。5例患者在90至156天的支持期后成功接受移植;1例患者在171天后脱离该系统。6例患者在支持期间死亡,在设备植入后9至63天。其余3例患者仍在接受支持,生活质量良好。

结论

Incor是一种左心室辅助装置(LVAD),其移植率和不良事件发生率与其他现代心室支持装置相当。其优点包括泵腔小、几乎不存在与设备相关的感染,以及植入和取出过程非常方便。

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