Clinical evaluation of a new dispersive aortic cannula

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.

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.

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.

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.