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A Device for Proximal Anastomosis of Autologous Coronary Vein Grafts: Report from the Meeting of the Circulatory System Devices Panel of the Food and Drug Administration Center for Devices and Radiologic Health

The Food and Drug Administration (FDA) Circulatory System Devices Advisory Panel was asked to make recommendations on the PAS-Port Proximal Anastomosis System (Cardica, Inc), a device intended to create an end-to-side anastomosis between the aorta and autologous vein graft during coronary artery bypass graft surgery. Advisory panels make nonbinding recommendations to the FDA.

Classically, coronary artery bypass graft surgery (CABG) has been performed with hypothermic cardiac arrest, aortic cross-clamping, and extracorporeal circulatory support to provide the “clean” field demanded by the challenge of suturing small vessels. These factors may contribute to the neurocognitive decline, strokes, and other adverse patient outcomes often observed after CABG. “Off-pump” and “beating-heart” bypass procedures have been developed in an effort to minimize the untoward effects of circulatory support and to permit faster postoperative recovery.

Facilitation of vascular anastomoses may permit faster and less invasive CABG. Anastomotic devices may not only simplify the procedural mechanics for the operator but also potentially obviate the need for many of the factors that contribute to poor patient outcomes, including extracorporeal circulatory support, induced hypothermic cardiac arrest, and aortic cross-clamping. Ultimately, these devices may simplify beating-heart surgery and reduce complications, although this remains to be proved.

In 2001, the Symmetry Bypass Aortic Connector (St Jude Medical, Inc) became the first automated vascular anastomotic device cleared for marketing in the United States by the Food and Drug Administration (FDA). After device clearance and marketing, and after tens of thousands of implantations in patients worldwide, a number of apparently device-related adverse events were reported to FDA. More than 180 injuries and 20 deaths were observed, apparently as a result of occlusion, thrombus, or stenosis at the connector site, aortic dissection associated with device deployment, graft kinking, and postoperative device detachment resulting in hemorrhagic shock and/or death. Ultimately, the Symmetry device was voluntarily …