Shah Sumedh S, Perez Giancarlo, Snelling Brian M, Haussen Diogo C, Sur Samir, Sharma Ishna, Yavagal Dileep R, Elhammady Mohamed Samy, Peterson Eric C
Department of Neurosurgery, University of Miami Miller School of Medicine, Miami, Florida, USA.
Department of Neurology, Emory University School of Medicine, Atlanta, Georgia, USA.
J Neurointerv Surg. 2017 Oct;9(10):982-985. doi: 10.1136/neurintsurg-2016-012592. Epub 2016 Sep 27.
Angioseal, an arteriotomy closure device (ACD), functions as a collagen plug that physically closes arteriotomy sites and can simultaneously induce platelet activation and aggregation. When used 'on-label', the safety and efficacy profile of Angioseal is superior compared with those of other ACDs. However, Angioseal is sometimes deployed in less than ideal situations. Therefore, we sought to assess the safety and efficacy of 'off-label' Angioseal use in patients undergoing femoral arteriotomies.
We performed a retrospective review of all femoral arterial angiograms executed at our institution between 2008 and 2014. Patients whose femoral punctures did not fit the criteria for on-label Angioseal use were included, and were dichotomized based on vascular closure (off-label Angioseal vs manual compression).
Of the 521 patients (1023 angiograms) reviewed, 303 (58.2%) patients had off-label Angioseal groin punctures. Mean patient age was 46.2±14.0 years, and 113 were men. 234 patients (77%) had off-label Angioseal deployment while 69 (22%) individuals received manual pressure, serving as controls. Demographic and procedural variables were nearly identical between the two groups but the Angioseal group comprised mostly patients that underwent neurointerventional procedures and thus received intraprocedural heparinization (41%) more often than the manual compression group (19%). The overall rate of major complications associated with off-label Angioseal deployment was low (<0.85%), and clinical complications were not independently associated with Angioseal use (OR 0.76 (95% CI 0.06 to 8.86); p=0.69).
Off-label use of Angioseal was found to be safe and was not associated with an increased complication rate in our cohort.
血管封堵器Angioseal是一种动脉切开闭合装置（ACD），其作用是形成一个胶原塞，从物理上封闭动脉切开部位，同时可诱导血小板活化和聚集。当按照说明书使用时，Angioseal的安全性和有效性优于其他动脉切开闭合装置。然而，Angioseal有时会在不太理想的情况下使用。因此，我们试图评估在接受股动脉切开术的患者中“超说明书”使用Angioseal的安全性和有效性。
我们对2008年至2014年在本机构进行的所有股动脉血管造影进行了回顾性研究。纳入股动脉穿刺不符合Angioseal说明书使用标准的患者，并根据血管闭合方式（超说明书使用Angioseal与手动压迫）将其分为两组。
在纳入研究的521例患者（1023次血管造影）中，303例（58.2%）患者进行了超说明书的腹股沟穿刺。患者平均年龄为46.2±14.0岁，男性113例。234例患者（77%）接受了超说明书的Angioseal植入，69例（22%）患者接受手动压迫作为对照。两组的人口统计学和操作变量几乎相同，但Angioseal组主要是接受神经介入手术的患者，因此术中接受肝素化治疗的比例（41%）高于手动压迫组（19%）。与超说明书使用Angioseal相关的主要并发症总体发生率较低（<0.85%），临床并发症与使用Angioseal无独立相关性（比值比0.76（95%置信区间0.06至8.86）；p = 0.69）。
在我们的队列中，发现超说明书使用Angioseal是安全的，且与并发症发生率增加无关。
