Baim D S, Knopf W D, Hinohara T, Schwarten D E, Schatz R A, Pinkerton C A, Cutlip D E, Fitzpatrick M, Ho K K, Kuntz R E
Beth Israel-Deaconess Medical Center and the Cardiovascular Data Analysis Center, Boston, Massachusetts 02215, USA.
Am J Cardiol. 2000 Apr 1;85(7):864-9. doi: 10.1016/s0002-9149(99)00882-6.
Despite advances in other aspects of cardiac catheterization, manual or mechanical compression followed by 4 to 8 hours of bed rest remains the mainstay of postprocedural femoral access site management. Suture-mediated closure may prove to be an effective alternative, offering earlier sheath removal and ambulation, and potentially a reduction in hemorrhagic complications. The Suture To Ambulate aNd Discharge trial (STAND I) evaluated the 6Fr Techstar device in 200 patients undergoing diagnostic procedures, with successful hemostasis achieved in 99% of patients (94% with suture closure only) in a median of 13 minutes, and 1% major complications. STAND II randomized 515 patients undergoing diagnostic or interventional procedures to use of the 8Fr or 10Fr Prostar-Plus device versus traditional compression. Successful suture-mediated hemostasis was achieved in 97.6% of patients (91.2% by the device alone) compared with 98.9% of patients with compression (p = NS). Major complication rates were 2.4% and 1.1%, and met the Blackwelder's test for equivalency (p <0.05). Median time to hemostasis (19 vs 243 minutes, p <0.01) and time to ambulation (3.9 vs 14.8 hours, p <0.01) were significantly shorter for suture-mediated closure. Suture-mediated closure of the arterial puncture site thus affords reliable immediate hemostasis and shortens the time to ambulation without significantly increasing the risk of local complications.
尽管心脏导管插入术的其他方面有所进展，但手动或机械压迫并随后卧床休息4至8小时仍是术后股动脉穿刺部位管理的主要方法。缝合介导的闭合术可能是一种有效的替代方法，它能使鞘管更早拔除并允许患者更早活动，还可能减少出血并发症。“缝合介导以实现活动和出院”试验（STAND I）在200例接受诊断性操作的患者中评估了6Fr的Techstar装置，99%的患者实现了成功止血（仅缝合闭合的患者为94%），中位止血时间为13分钟，主要并发症发生率为1%。STAND II将515例接受诊断性或介入性操作的患者随机分为使用8Fr或10Fr的Prostar-Plus装置组和传统压迫组。与压迫止血组98.9%的患者相比，缝合介导止血组97.6%的患者实现了成功止血（仅使用该装置的患者为91.2%，p = 无显著差异）。主要并发症发生率分别为2.4%和1.1%，满足等效性的布莱克韦尔德检验（p <0.05）。缝合介导闭合的中位止血时间（19分钟对243分钟，p <0.01）和活动时间（3.9小时对14.8小时，p <0.01）明显更短。因此，动脉穿刺部位的缝合介导闭合可实现可靠的即时止血，并缩短活动时间，且不会显著增加局部并发症的风险。
