Low Frequency Avoidable Errors During TCAR: Lessons Learned
Thomas S. Maldonado, MD, Katherine Teter, MD, Patrick J. Lamparello, MD, Neal S. Cayne, MD, Caron B. Rockman, MD.
New York University Langone Health, New York, NY, USA.
Objective: TransCarotid Artery Revascularization (TCAR) is a safe and effective alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS). The TCAR system represents a paradigm shift in managing carotid artery stenosis with potential for significant reduction in peri-procedural morbidity. However, as with CEA or TF-CAS, TCAR is associated with its own unique but infrequent procedural adverse events, some of which may be related to preventable technical error. Our goal is to describe these low frequency events, and provide a roadmap to 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. has established a process by which all feedback, even complaints which may not meet FDA criteria, is captured and stored in a database for detailed analysis. Over 13,300 cases have been performed, and submitted complaints were reviewed for incidents of serious injury and peri-procedural complications, beyond the device-related events which must be reported to the FDA. Results: A total of 13,334 patients have undergone TCAR worldwide since 2011 using the SilkRoad device. Reported complications included 173 dissections (1.4% overall rate), of which 22.5% were managed without intervention or with medical therapy alone and 24.3% were converted to CEA (considered failing safely). Stent location errors 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 bovine arch. Cranial nerve injury was reported in 11 cases, only 1 of which persisted beyond 3 months. There has been 1 reported pneumothorax and 1 reported chylothorax. Each of these errors can be recognized and most often prevented with careful attention to detail during the procedure. 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 as a result of user technical error or procedural adverse events. While significant, these can be avoided through a review of the collective experience to date and recognition of potential pitfalls, as we have described.
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