Low Frequency Avoidable Errors During TCAR

Abstract: Objective TransCarotid Artery Revascularization (TCAR) appears to be a safe and effective alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). The TCAR system represents a paradigm shift in the management of carotid artery stenosis with potential for a significant reduction in peri-procedural morbidity. However, as with CEA or TF-CAS, TCAR is associated with infrequent complications related to user technical error, most of which are preventable. Our goal is to describe these low frequency events, and to provide guidelines for avoiding them. Methods The Food and Drug Administration (FDA) requires that all medical device manufacturers create a system for receiving, reviewing, and evaluating complaints (Code 21 of Federal Regulations (CFR) 820.198). Silk Road Medical Inc. (Sunnyvale, CA) has established a process by which all feedback, including complaints which may not meet FDA criteria, is captured and stored in a database for detailed analysis. Over 13,300 cases have been performed; submitted complaints were reviewed for incidents of serious injury and peri-procedural complications, above and beyond the device-related events which must be reported to the FDA. Results A total of 13,334 patients have undergone TCAR worldwide between early 2011 and December 2019 using the SilkRoad device. Reported complications included 173 dissections (1.4% overall rate) of the common carotid artery at the access point, of which 22.5% were managed without intervention or with medical therapy alone and 24.3% were converted to CEA (considered failing safely). Errors in the location of stent deployment occurred in 16 cases (0.13%), with the most common site being the external carotid artery (ECA) (75%). One wrong side carotid artery stent was placed in a patient with a high midline pattern of the bovine arch. Cranial nerve injury was reported in 11 cases (0.08%), only one of which persisted beyond 3 months. There have been 3 reported pneumothoraces and 1 reported chylothorax. Many of these errors can be recognized and prevented with careful attention to detail. Conclusions In high-risk patients requiring treatment for carotid artery stenosis, TCAR has been proven as an alternative to TF-CAS with an excellent safety profile. As with CEA or TF-CAS, this procedure has the potential for infrequent complications, often as a result of user technical error. While significant, these can be avoided through a review of the collective experience to date and recognition of potential pitfalls, as we have described.