Objective: Shunting during carotid endarterectomy (CEA) preserves intraoperative cerebral perfusion. The Food and Drug Administratione directed post-market clinical follow-up study evaluated the safety and efficacy of the Sundt (Integra LifeSciences, Billerica, Mass) carotid shunt. Methods:The Sundt carotid shunt is constructed from soft, durable silastic that is radially reinforced with a stainless steel spring to minimize kinking and occlusion of the cannula lumen. The shunt is available in a range of sizes in 10-cm (indwelling shunt) and 30-cm (external) lengths. The present nonrandomized, multicenter, single-arm, all-comers, retrospective study collected data from 100 consecutive patients (age, 69 6 7 years; 37 women) at three participating sites: Mount Sinai Medical Center (New York), Deaconess Heart Group (Indiana), and Hackensack University Medical Center (New Jersey). The shunts were used as a temporary conduit during CEA to maintain antegrade perfusion to the ipsilateral cerebral hemisphere. The bulbous ends of the Sundt carotid shunt facilitate fixation using carotid shunt clamps in the vessel during temporary carotid artery bypass. The parameters of shunt effectiveness and safety, including clamping method and duration, and any evidence of device-related damage to the vessel, reduced flow within the shunt, excessive bleeding, vessel injury from shunt removal, arteriotomy closure complication due to shunt, any other devicerelated complications, and postoperative cerebral ischemia or injury were measured and recorded using case-report forms.Results: The performance analysis showed that surgery delay for preparation of the shunt occurred in one case (1%). No device-related damage to the artery during insertion, reduced flow within the shunt, excessive bleeding around shunt after initial placement, vessel injury from removal of the shunt, complications related to closure, or any other complications caused by the shunt were recorded. The occurrence of cerebral ischemia and 60% stenosis at the distal edge of the endarterectomy within 60 days postoperatively was 2% and 1%, respectively. No neck hematoma, cranial nerve injury, stroke or transient ischemic attack, wound complication, or death had occurred by 60 days after surgery.Conclusions: The Sundt shunt has been demonstrated to be safe and effective for use in preserving ipsilateral cerebral perfusion during CEA with a high degree of reliability and ease of use.

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