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Low-frequency avoidable errors during transcarotid artery revascularization.

Authors
  • Teter, Katherine1
  • Lamparello, Patrick J1
  • Barfield, Michael1
  • Rockman, Caron B1
  • Macdonald, Sumaira2
  • Maldonado, Thomas S3
  • 1 Department of Vascular Surgery, NYU Langone Health, New York, NY.
  • 2 Silk Road Medical, Inc., Sunnyvale, Calif.
  • 3 Department of Vascular Surgery, NYU Langone Health, New York, NY. Electronic address: [email protected]
Type
Published Article
Journal
Journal of vascular surgery
Publication Date
May 01, 2021
Volume
73
Issue
5
Pages
1658–1664
Identifiers
DOI: 10.1016/j.jvs.2020.09.023
PMID: 33065241
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Transcarotid artery revascularization (TCAR) seems 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 decrease in periprocedural 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. The U.S. 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 820.198). Silk Road Medical, Inc (Sunnyvale, Calif), has established a process by which all feedback, including complaints that may not meet FDA criteria, is captured and stored in a database for detailed analysis. More than 13,300 cases have been performed; submitted complaints were reviewed for incidents of serious injury and periprocedural complications, above and beyond the device-related events that must be reported to the FDA. 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 (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 three reported pneumothoraces and one reported chylothorax. Many of these errors can be recognized and prevented with careful attention to detail. 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. Although significant, these events can be avoided through a review of the collective experience to date and recognition of potential pitfalls, as we have described. Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

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