Chiu Albert Ho Yuen, Vander Wal Ross, Tee Kenneth, Knight Roslyn, Coles Simon Richard, Nadkarni Sanjay
Department of Radiology, Sir Charles Gairdner Hospital, Perth, Australia.
J Endovasc Ther. 2008 Jun;15(3):315-21. doi: 10.1583/07-2190.1.
To compare the efficacy, primary failure rates, and complications for the Angio-Seal and Perclose closure devices in antegrade and retrograde common femoral artery (CFA) punctures during peripheral angioplasty procedures.
A retrospective single-center analysis was conducted between April 2002 and June 2006 of all patients who had a CFA puncture and no other intervention planned during the same admission. Patients undergoing thrombolysis were excluded. Of 215 punctures in 191 patients, 123 closures in 97 patients (82 men; mean age 69.5 +/-10.4 years, range 41-93) were eligible for analysis. Of these, 49 punctures were antegrade and 74 were retrograde. An Angio-Seal device was used in 40 closures, while 83 punctures were closed with a Perclose device. Deployment outcomes and complications were compared between devices for each puncture direction and between antegrade and retrograde punctures.
Seventy-eight (63.4%) of the 123 closures reached the primary endpoint of complication-free progress to discharge, comprising 30 (61.2%) of the 49 antegrade closures and 48 (64.9%) of the 74 retrograde closures. There was no significant difference between the devices for the primary endpoint. Twenty-two (17.9%) attempted closures failed. Forty-one (33.3%) closures had a complication after the procedure, but none required further intervention. In antegrade closures, Angio-Seal had a significantly lower rate of primary failure (11.1% versus 38.7% for Perclose, p = 0.038). Antegrade closures had a higher rate of primary failure (p<0.01); however, this did not translate into any significant differences in postprocedural complications. No significant differences in primary failure or complication rates were found between the devices when used in retrograde punctures.
Angio-Seal had a lower rate of primary failure than Perclose in antegrade puncture closures. We believe this reinforces the need for larger studies to compare closure devices in antegrade punctures.
比较血管封堵器（Angio-Seal）和缝合器（Perclose）在周围血管成形术顺行和逆行股总动脉（CFA）穿刺中的疗效、初次失败率及并发症。
对2002年4月至2006年6月期间所有在同一住院期间进行CFA穿刺且无其他干预计划的患者进行回顾性单中心分析。排除接受溶栓治疗的患者。191例患者共215次穿刺，其中97例患者的123次封堵（82名男性；平均年龄69.5±10.4岁，范围41 - 93岁）符合分析条件。其中，49次为顺行穿刺，74次为逆行穿刺。40次封堵使用血管封堵器，83次穿刺使用缝合器进行封堵。比较每种穿刺方向的两种器械之间以及顺行和逆行穿刺之间的封堵效果和并发症情况。
123次封堵中有78次（63.4%）达到无并发症直至出院的主要终点，包括49次顺行封堵中的30次（61.2%）和74次逆行封堵中的48次（64.9%）。两种器械在主要终点方面无显著差异。22次（17.9%）封堵尝试失败。41次（33.3%）封堵术后出现并发症，但均无需进一步干预。在顺行封堵中，血管封堵器的初次失败率显著较低（血管封堵器为11.1%，缝合器为38.7%，p = 0.038）。顺行封堵的初次失败率较高（p<0.01）；然而，这并未转化为术后并发症的任何显著差异。在逆行穿刺中使用这两种器械时，初次失败率或并发症发生率均无显著差异。
在顺行穿刺封堵中，血管封堵器的初次失败率低于缝合器。我们认为这进一步表明需要进行更大规模的研究来比较顺行穿刺中的封堵器械。
