Introduction:

Cerebral injury is a serious complication in open-heart surgery. Once it occurs, it causes significant disability and death. We developed a novel dispersive aortic cannula named the Stealth Flow cannula and used it as a standard aortic cannula in cardiopulmonary bypass. The aim of this study was to evaluate the efficiency of this aortic cannula.

Methods:

A total of 182 consecutive patients undergoing cardiac surgery using cardiopulmonary bypass were studied. The patients were divided into two groups: the Soft-Flow cannula group (n = 89) and the Stealth Flow cannula group (n = 93). Patients with a shaggy aortic arch were excluded from this study because the cannulae were inserted at the ascending aorta with a cannula tip directed toward the aortic root in these cases. Patients with multiple arterial perfusion sites were also excluded. Complications including early mortality, perioperative stroke, and intraoperative aortic injury were compared between the two groups.

Results:

Age, operative procedure, cardiopulmonary bypass time, and the Japan SCORE were not significantly different between the groups. In comparisons between the Stealth Flow and Soft-Flow groups, the incidences of early mortality, perioperative stroke, intraoperative aortic dissection, and all complications were 1.08% versus 1.12% (p = 0.98), 1.1% versus 2.2% (p = 0.53), 0% versus 1.1% (p = 0.33), and 1.1% versus 3.4% (p = 0.29), respectively. The incidence of major cardiovascular events, including early death, perioperative stroke, and aortic dissection, was not different.

Conclusions:

The Stealth Flow cannula, which was designed based on our previous experimental study, contributed to reducing cerebral and aortic events as much as the Soft-Flow cannula in the present clinical study.

中文翻译：

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新型分散式主动脉插管的临床评价。

介绍：

脑损伤是心脏直视手术的严重并发症。一旦发生，就会导致严重的残疾和死亡。我们开发了一种名为 Stealth Flow 插管的新型分散式主动脉插管，并将其用作体外循环中的标准主动脉插管。本研究的目的是评估该主动脉插管的效率。

方法：

共研究了 182 名连续使用体外循环进行心脏手术的患者。患者分为两组：Soft-Flow 插管组（n = 89）和 Stealth Flow 插管组（n = 93）。主动脉弓毛茸茸的患者被排除在本研究之外，因为在这些情况下，插管插入升主动脉，插管尖端指向主动脉根部。具有多个动脉灌注部位的患者也被排除在外。比较两组的早期死亡率、围手术期卒中和术中主动脉损伤等并发症。

结果：

年龄、手术程序、体外循环时间和日本评分在各组之间没有显着差异。在 Stealth Flow 和 Soft-Flow 组之间的比较中，早期死亡率、围手术期卒中、术中主动脉夹层和所有并发症的发生率分别为 1.08% 与 1.12% (p = 0.98)、1.1% 与 2.2% (p = 0.53) ，分别为 0% 与 1.1% (p = 0.33) 和 1.1% 与 3.4% (p = 0.29)。主要心血管事件的发生率，包括早期死亡、围手术期卒中和主动脉夹层，没有什么不同。

结论：

Stealth Flow 插管是根据我们之前的实验研究设计的，在本临床研究中与 Soft-Flow 插管一样有助于减少大脑和主动脉事件。