Department of Radiology, University of Bonn, Bonn, Germany.
Institute for Medical Biometry, Informatics and Epidemiology, University of Bonn, Bonn, Germany.
Eur J Vasc Endovasc Surg. 2014 Nov;48(5):585-91. doi: 10.1016/j.ejvs.2014.08.006. Epub 2014 Sep 8.
To retrospectively evaluate the efficacy and time-to-hemostasis of antegrade femoral access closure using the ExoSeal vascular closure device (VCD).
Retrospective, single-center analysis.
Between September 2010 and February 2013, 148 ExoSeal VCD closures (5-7F) of antegrade femoral accesses were performed in 119 patients (70 males, mean age 71.6 years, range 40-97 years). In all cases initial diagnostic angiography was performed via an 18G/3.8F retrograde femoral access, which was left in place during intervention (in-house standard) and was used to obtain control angiography after successful closure of the antegrade access to determine hemostasis. Technical device success was defined as ExoSeal closure without major VCD-related complications; procedural success as hemostasis within 5 minutes. Statistical analysis was performed using a logistic regression model and correlation analyses.
145/148 (98.0%) ExoSeal closures were technically successful (5F: n = 76; 6F: n = 65; 7F: n = 7). Angiographic control showed closure after 2 minutes in 130/145 cases. In a further 14 cases hemostasis was achieved after an additional 3 minutes MC, so that closure was successful within 5 minutes in 144/148 cases (97.3%). No major complication occurred. One minor complication was recorded in a 6F access case. Pre-interventional activated partial thromboplastin time (aPTT) was the only statistically significant predictor of necessary manual compression (MC) > 2 minutes (p = .01), but with an odds-ratio of only 1.038. The INR showed an odds-ratio of 2.455 for need for 5 minutes MC (NS). Significant correlations were found between the need for 5 minutes MC and medication with acetylsalicylic acid (p = .01), clopidogrel (p < .01), and abciximab (p < .001).
ExoSeal vascular closure of antegrade femoral punctures is safe and effective with a low complication rate. Two minutes of MC are sufficient to achieve hemostasis in the majority of cases. However, in patients on antiplatelet therapy, especially after abciximab, the authors advocate prolonging MC to 5 minutes.
回顾性评估使用 ExoSeal 血管闭合装置（VCD）经顺行股动脉入路进行血管闭合的疗效和止血时间。
回顾性、单中心分析。
2010 年 9 月至 2013 年 2 月，对 119 例患者（70 例男性，平均年龄 71.6 岁，范围 40-97 岁）的 148 例经顺行股动脉入路的 ExoSeal VCD 闭合（5-7F）进行回顾性分析。所有患者均通过 18G/3.8F 逆行股动脉入路进行初始诊断性血管造影，该入路在介入过程中保持在位（内部标准），并在成功闭合顺行入路后用于获得控制血管造影，以确定止血情况。技术设备成功定义为 ExoSeal 闭合无重大 VCD 相关并发症；手术成功定义为 5 分钟内止血。使用逻辑回归模型和相关分析进行统计分析。
148 例 ExoSeal 闭合中，145 例（98.0%）技术上成功（5F：n=76；6F：n=65；7F：n=7）。130/145 例在血管造影控制 2 分钟后显示闭合。在另外 14 例中，在进行了额外的 3 分钟手动压迫（MC）后，止血成功，因此在 144/148 例（97.3%）中，在 5 分钟内成功闭合。无重大并发症发生。在 6F 入路的病例中记录到 1 例小并发症。介入前的部分凝血活酶时间（aPTT）是唯一具有统计学意义的需要手动压迫（MC）>2 分钟的预测因子（p=0.01），但比值比仅为 1.038。INR 显示需要 5 分钟 MC 的比值比为 2.455（NS）。需要 5 分钟 MC 与服用乙酰水杨酸（p=0.01）、氯吡格雷（p<0.01）和阿昔单抗（p<0.001）之间存在显著相关性。
使用 ExoSeal 血管闭合装置经顺行股动脉穿刺闭合安全有效，并发症发生率低。大多数情况下，2 分钟的 MC 即可达到止血效果。然而，对于接受抗血小板治疗的患者，特别是在使用阿昔单抗后，作者主张将 MC 延长至 5 分钟。
