Department of Surgery, University of Iowa Hospitals and Clinics, Iowa, IA, USA.
Virginia Commonwealth University School of Medicine, Richmond, VA, USA.
Vascular. 2024 Dec;32(6):1291-1294. doi: 10.1177/17085381231194410. Epub 2023 Aug 8.
Transcarotid artery revascularization (TCAR) is a hybrid procedure that allows reversal of blood flow away from the brain while placing a stent through direct surgical access of the common carotid artery. It has been shown to have a lower risk of perioperative stroke compared with any prospective trial of transfemoral carotid artery stenting. However, intraoperative injuries related to the procedure and its management are not well characterized. One of the intraoperative complications seen in TCAR is iatrogenic carotid artery dissection (CD). We aim to add qualitative insight in further characterizing CDs and its management in this emerging technology.
The Food and Drug Administration (FDA) maintains the Manufacturer and User Facility Device Experience (MAUDE) database 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 CD were individually analyzed to determine time of injury (intraoperative, recovery, and post-discharge follow-up). CD reporting was further analyzed for the associated procedural event at the time of injury, number of access attempts to CD repair, and type of CD repair. Reports associated with CD repair were further categorized into endovascular repair and open surgical repair.
Of the 115 unique adverse events in the database, there were 58 CDs. Most were identified intraoperatively ( = 55), while three were incidentally found postoperatively. Overall, sheath placement was the most common procedural event attributed to CD ( = 34). There was adequate narrative information about CD repair in 54 patients. Intraoperative repair was performed in 52 cases and two were repaired after post-discharge follow-up imaging was performed.Among CDs that did not require additional access to engage the true lumen, the proportion of endovascular repair (62.5%) was significantly higher ( = .044) compared to the proportion of open surgical repair (37.5%). However, the proportion of open surgical repair (75%) was significantly higher than the proportion of endovascular repair (25%) in CDs with persistent failure to engage the true lumen despite ≥2 access attempts ( = .039).
CD is the most common injury related to TCAR as reported on MAUDE. The most commonly reported procedural event associated with CD was sheath placement. The rate of intraoperative endovascular and open surgical CD repair was associated with whether the access to the true lumen of the carotid artery required additional access attempts or not. This should add qualitative insight among the vascular surgery community regarding intraoperative management of CDs from a TCAR procedure.
经颈动脉血管重建术（TCAR）是一种混合手术，它允许在通过直接手术进入颈总动脉放置支架的同时将血流从大脑中反向引导。与任何前瞻性的股动脉颈动脉支架置入术相比，它具有较低的围手术期中风风险。然而，与该手术及其管理相关的术中损伤尚未得到很好的描述。TCAR 术中出现的一种并发症是医源性颈动脉夹层（CD）。我们的目的是在这一新兴技术中，通过定性的方法进一步描述 CD 及其处理方法。
食品和药物管理局（FDA）维护着制造商和用户设施设备体验（MAUDE）数据库，用于监测所有获得批准使用的医疗器械。对 2016 年 9 月至 2020 年 10 月期间与 Silk Road Medical 的 ENROUTE 经颈动脉神经保护系统相关的所有病例进行了 MAUDE 数据库查询。对与 CD 相关的个案叙述进行了单独分析，以确定损伤时间（术中、恢复中和出院后随访）。进一步分析 CD 报告中与损伤时相关的程序事件、修复 CD 的尝试次数和 CD 修复类型。与 CD 修复相关的报告进一步分为血管内修复和开放手术修复。
在数据库中的 115 个独特的不良事件中，有 58 个是 CD。大多数在术中发现（n=55），有 3 例是在术后意外发现的。总的来说，鞘的放置是与 CD 最相关的程序事件（n=34）。在 54 例患者中，有足够的 CD 修复叙述信息。52 例在术中进行了修复，2 例在出院后随访影像学检查后进行了修复。在不需要进一步进入真腔来修复 CD 的病例中，血管内修复（62.5%）的比例明显高于开放手术修复（37.5%）（p=0.044）。然而，在尽管尝试了≥2 次进入真腔但仍未能进入的 CD 病例中，开放手术修复（75%）的比例明显高于血管内修复（25%）（p=0.039）。
CD 是 MAUDE 报告中与 TCA 相关的最常见损伤。与 CD 最相关的程序事件是鞘的放置。是否需要进一步进入颈动脉真腔来修复 CD，与术中进行血管内和开放手术修复 CD 的比例有关。这应该为血管外科学领域提供关于 TCA 手术中 CD 术中管理的定性见解。
