Department of Vascular Surgery, NYU Langone Health, New York, NY.
Silk Road Medical, Inc., Sunnyvale, Calif.
J Vasc Surg. 2021 May;73(5):1658-1664. doi: 10.1016/j.jvs.2020.09.023. Epub 2020 Oct 14.
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.
经颈动脉血管重建术（TCAR）似乎是一种安全有效的颈动脉内膜切除术（CEA）和经股动脉颈动脉支架置入术（TF-CAS）替代方法。TCAR 系统代表了颈动脉狭窄管理的范式转变，有可能显著降低围手术期发病率。然而，与 CEA 或 TF-CAS 一样，TCAR 与用户技术错误相关的罕见并发症有关，其中大多数是可以预防的。我们的目标是描述这些低频事件，并提供避免它们的指南。
美国食品和药物管理局（FDA）要求所有医疗器械制造商建立一个接收、审查和评估投诉的系统（联邦法规 21 章第 820.198 条）。Silk Road Medical, Inc.（加利福尼亚州森尼韦尔）已经建立了一个流程，通过该流程，可以捕获和存储所有反馈，包括可能不符合 FDA 标准的投诉，并将其存储在数据库中进行详细分析。已经进行了超过 13300 例手术；对严重伤害和围手术期并发症的提交投诉进行了审查，这些并发症超出了必须向 FDA 报告的与设备相关的事件。
自 2011 年初至 2019 年 12 月，全球共有 13334 例患者使用 SilkRoad 装置进行了 TCAR。报告的并发症包括在进入点处的颈总动脉发生 173 次（总体发生率为 1.4%）夹层，其中 22.5%未经干预或仅接受药物治疗即可管理，24.3%转为 CEA（被认为安全失败）。支架放置位置的错误发生在 16 例（0.13%）中，最常见的部位是颈外动脉（75%）。在一位具有高中线牛弓模式的患者中，误将一侧颈动脉支架放置在错误的一侧。报告了 11 例（0.08%）颅神经损伤，只有 1 例持续超过 3 个月。有 3 例报告气胸和 1 例报告乳糜胸。通过仔细注意细节，可以识别和预防许多此类错误。
在需要治疗颈动脉狭窄的高危患者中，TCAR 已被证明是 TF-CAS 的替代方法，具有极好的安全性。与 CEA 或 TF-CAS 一样，该手术也有发生罕见并发症的潜力，通常是由于用户技术错误。尽管这些事件很重要，但可以通过回顾迄今为止的集体经验并认识到潜在的陷阱来避免，正如我们所描述的那样。
