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BACKGROUND: Transcarotid artery revascularization (TCAR) is hybrid procedure that allows carotid stenting using direct surgical access of the carotid artery to restore blood flow through the carotid artery. It has shown the lowest perioperative stroke rate when compared with any prospective trial of transfemoral carotid artery stenting. However, intraoperative injuries related to the procedure and its management are not well characterized. We anticipate that this analysis will add qualitative insight in further characterizing adverse outcomes of this novel technology.
METHODS: The FDA maintains a database called the MAUDE (Manufacturer and User Facility Device Experience) 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 patient injuries were individually analyzed to determine type (carotid artery dissection) and time of injury (intraoperative, recovery, post-discharge follow- up). Carotid artery dissection (CD) reporting was further analyzed for associated procedural event at the time of injury, number of access attempts to CD repair, and type of CD repair.
RESUTS: Of the 115 unique incidents in the database, there were 58 CDs. Most were identified intraoperatively (n=55), while 3 were incidentally identified postoperatively. Overall, sheath placement was the most common procedural event attributed to CD (n=34). There was adequate narrative information about CD repair in 54 patients where 52 of them were performed intraoperatively. There were total of 28 endovascular repair and 24 open surgical repairs of CDs from TCAR procedure.
There was no significant difference in rate of endovascular and open surgical repair of CDs that did not need additional access attempts. However, rate of open surgical repair was significantly higher in CDs with persistent failure to engage the true lumen in 2 or more additional access attempts.
Total of 4 strokes were associated with CD. Two occurred during recovery from TCAR admission where one was not intervened per physician’s discretion despite evidence of dissection during the procedure. The other was associated with a fall from a hypotensive event 7 hours after an endovascular CD repair. One incident of stroke occurred intraoperatively during a conversion to CEA as a result of CD. One incident of stroke occurred 4 days after TCAR procedure in which a CD was identified during the stroke evaluation
Conclusion: Carotid artery dissection is the most common injury related to TCAR as reported on MAUDE database. Most common procedural event associated CD was sheath placement. Rate of open surgical repair was significantly higher than endovascular repair in dissections with persistent failure to engage true lumen despite additional access attempts. This should add to qualitative insight among vascular surgery community regarding intraoperative management of carotid artery dissections from a TCAR procedure.
tcar, carotid artery stenosis, transcarotid artery revascularization, vascular surgery
Michael F. Amendola, Kedar S. Lavingia, Daniel H. Newton
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VCU Graduate Research Posters