Carotid artery dissections from transcarotid artery revascularization as reported by the Food and Drug Administration

作者：Dongjin Suh, Yuchi Ma, Daniel H. Newton, Michael Amendola, Kedar S. Lavingia · 发表于：Vascular · 年份：2023 · DOI：10.1177/17085381231194410 · 被引用次数：6 · 研究领域：Cerebrovascular and Carotid Artery Diseases、Intracranial Aneurysms: Treatment and Complications、Aortic Disease and Treatment Approaches

Objectives Transcarotid artery revascularization (TCAR) is a hybrid procedure that allows reversal of blood flow away from the brain while placing a stent through direct surgical access of the common carotid artery. It has been shown to have a lower risk of perioperative stroke compared with any prospective trial of transfemoral carotid artery stenting. However, intraoperative injuries related to the procedure and its management are not well characterized. One of the intraoperative complications seen in TCAR is iatrogenic carotid artery dissection (CD). We aim to add qualitative insight in further characterizing CDs and its management in this emerging technology. Methods The Food and Drug Administration (FDA) maintains the Manufacturer and User Facility Device Experience (MAUDE) database for surveillance of all medical devices approved for use. This database was queried for all cases associated with Silk Road Medical’s ENROUTE Transcarotid Neuroprotection System from September 2016 to October 2020. Case narratives related to CD were individually analyzed to determine time of injury (intraoperative, recovery, and post-discharge follow-up). CD reporting was further analyzed for the associated procedural event at the time of injury, number of access attempts to CD repair, and type of CD repair. Reports associated with CD repair were further categorized into endovascular repair and open surgical repair. Results Of the 115 unique adverse events in the database, there were 58 CDs. ...