Carotid Artery Dissections from TCAR as Reported on the MAUDE Database

Transcarotid artery revascularization (TCAR) is hybrid procedure that allows carotid stenting using direct surgical access of the artery. It has shown lowest perioperative stroke rate when compared with any prospective trial transfemoral stenting. However, intraoperative injuries related to and its management are not well-characterized. We anticipate this analysis will add qualitative insight in further characterizing adverse outcomes novel technology. The Manufacturer User Facility Device Experience (MAUDE) Database was queried for all cases associated Silk Road Medical's ENROUTE Neuroprotection System from 2016 2020. Case narratives patient were individually analyzed determine type (carotid dissection [CD]) time injury (intraoperative, recovery, post-discharge follow-up). CD reporting procedural event at injury, number attempts repair, repair. Of 115 unique incidents database, there 58 CDs. Most identified intraoperatively (n = 55), whereas 3 incidentally postoperatively. Overall, sheath placement most common attributed 34). There adequate narrative information about repair 54 patients, where 52 them performed intraoperatively. total 28 endovascular 24 open repairs CDs TCAR (Table). significantly higher persistent failure engage true lumen two or more additional attempts. A four strokes CD. Two occurred during recovery admission one intervened per physician's discretion despite evidence procedure. other a fall hypotensive 7 hours after an One incident conversion endarterectomy as result 4 days which evaluation. reported on MAUDE database. placement. than dissections This should among vascular surgery community regarding procedure.TableCD characteristicsIntraoperative repairEndovascular n 28Open 24P valueCD without attempts25/5015/50.067CD required 2 attempts3/129/12.039CD, Carotid dissection. Open table new tab