Chamberlin J R, Lardi A B, McKeever L S, Wang M H, Ramadurai G, Grunenwald P, Towne W P, Grassman E D, Leya F S, Lewis B E, Stein L H
Division of Cardiology, Loyola University Medical Center, Maywood, Illinois, USA.
Catheter Cardiovasc Interv. 1999 Jun;47(2):143-7; discussion 148. doi: 10.1002/(SICI)1522-726X(199906)47:2<143::AID-CCD1>3.0.CO;2-M.
Transcatheter coronary interventions requiring abciximab (ReoPro) are associated with vascular access site complications. Several devices have been developed to aid in the closure of the femoral arteriotomy, including collagen plug devices (VasoSeal, AngioSeal), percutaneous suture closure (Perclose), and aids to manual compression (Femostop). In 185 patients who received abciximab plus aspirin and heparin for transcatheter coronary interventions, we compared femoral arteriotomy closure by three different methods: VasoSeal, Perclose, and Femostop. A composite endpoint of late complications defined as an access site-related bleed or hematoma that required blood transfusion or an extended hospital stay, pseudoaneurysm, arteriovenous fistula, arterial or venous thrombosis was compared. VasoSeal was initially successful in 41/52 patients (78.8%). The 11 patients who failed to have adequate hemostasis with VasoSeal required manual compression aided by Femostop, but had no late complications. There was one access site infection and one fatal retroperitoneal hematoma unrelated to the vascular access site (surgically explored). There were no late complications. Perclose was successful in 48/56 patients (85.7%). One Perclose failure required surgical repair for an extensive arteriotomy. The other Perclose failure required manual compression aided by Femostop, but had no late complications. There were no access site infections requiring intravenous antibiotics. There was one retroperitoneal bleed that extended the patient's hospital stay and for which a blood transfusion was required. Femostop was successful in 77/77 patients (100%). There were no infections. Late complications occurred in four patients. These included three episodes of bleeding or hematomas requiring blood transfusion, and one pseudoaneurysm.
In patients receiving abciximab in addition to aspirin and heparin, VasoSeal and Perclose are at least as safe as Femostop when used to achieve homeostasis after sheath removal. VasoSeal and Perclose have a significantly lower initial rate of successful hemostasis than Femostop. The numbers of late complications between the VasoSeal, Perclose, and Femostop groups were not significantly different. In those patients in whom VasoSeal or Perclose failed, no late complications occurred. Access site infections were no different between VasoSeal, Perclose, and Femostop.
需要使用阿昔单抗(ReoPro)的经导管冠状动脉介入治疗与血管穿刺部位并发症相关。已研发出多种器械来辅助闭合股动脉切开处,包括胶原塞装置(VasoSeal、AngioSeal)、经皮缝合闭合装置(Perclose)以及手动压迫辅助装置(Femostop)。在185例接受阿昔单抗加阿司匹林和肝素进行经导管冠状动脉介入治疗的患者中,我们比较了三种不同方法闭合股动脉切开处的效果:VasoSeal、Perclose和Femostop。比较了一个综合终点,即定义为需要输血或延长住院时间的与穿刺部位相关的出血或血肿、假性动脉瘤、动静脉瘘、动脉或静脉血栓形成的晚期并发症。VasoSeal在52例患者中的41例(78.8%)初次使用成功。11例使用VasoSeal未能实现充分止血的患者需要在Femostop辅助下进行手动压迫,但无晚期并发症。有1例穿刺部位感染和1例与血管穿刺部位无关的致命性腹膜后血肿(经手术探查)。无晚期并发症。Perclose在56例患者中的48例(85.7%)使用成功。1例Perclose使用失败的患者因广泛的动脉切开需要手术修复。另1例Perclose使用失败的患者需要在Femostop辅助下进行手动压迫,但无晚期并发症。无需要静脉使用抗生素治疗的穿刺部位感染。有1例腹膜后出血延长了患者的住院时间且需要输血。Femostop在77例患者中的77例(100%)使用成功。无感染发生。4例患者出现晚期并发症。其中包括3次需要输血的出血或血肿发作,以及1例假性动脉瘤。
在除阿司匹林和肝素外还接受阿昔单抗治疗的患者中,VasoSeal和Perclose在拔除鞘管后用于实现止血时至少与Femostop一样安全。VasoSeal和Perclose的初次止血成功率显著低于Femostop。VasoSeal、Perclose和Femostop组之间的晚期并发症数量无显著差异。在VasoSeal或Perclose使用失败的患者中,无晚期并发症发生。VasoSeal、Perclose和Femostop之间的穿刺部位感染情况无差异。