Duffin D C, Muhlestein J B, Allisson S B, Horne B D, Fowles R E, Sorensen S G, Revenaugh J R, Bair T L, Lappe D L
Division of Cardiology, LDS Hospital, 8th Avenue and C Street, Salt Lake City, Utah 84143, USA.
J Invasive Cardiol. 2001 May;13(5):354-62.
Vascular access site management is crucial to safe, efficient and comfortable diagnostic or interventional transfemoral percutaneous coronary procedures. Two new femoral access site closure devices, Perclose and Angio-Seal , have been proposed as alternative methods to manual compression (MC). We compared these two devices and tested them in reference to standard MC for safety, effectiveness and patient preference.
Prospective demographic, peri-procedural, and late follow-up data for 1,500 patients undergoing percutaneous coronary procedures were collected from patients receiving femoral artery closure by MC (n = 469), Perclose (n = 492), or Angio-Seal (n = 539). Peri-procedural, post-procedural, and post-hospitalization endpoints were: 1) safety of closure method; 2) efficacy of closure method; and 3) patient satisfaction.
Patients treated with Angio-Seal experienced shorter times to hemostasis (p < 0.0001, diagnostic and interventional) and ambulation (diagnostic, p = 0.05; interventional, p < 0.0001) than those treated with Perclose. Those treated with Perclose experienced greater access site complications (Perclose vs. Angio-Seal, p = 0.008; Perclose vs. MC, p = 0.06). Patients treated with Angio-Seal reported greater overall satisfaction, better wound healing and lower discomfort (each vs. Perclose or vs. MC, all p < or = 0.0001). For diagnostic cath only, median post-procedural length of stay was reduced by Angio-Seal (Angio-Seal vs. MC, p < 0.0001; Angio-Seal vs. Perclose, p = 0.009). No difference was seen in length of stay for interventional cases.
Overall, Angio-Seal performed better than Perclose or MC in reducing time to ambulation and length of stay among patients undergoing diagnostic procedures. There was a higher rate of successful deployment and shorter time to hemostasis for Angio-Seal, and this was accomplished with no increase in bleeding complications throughout the follow-up. Additionally, Angio-Seal performed better than Perclose in exhibiting a superior 30-day patient satisfaction and patient assessment of wound healing with less discomfort.
血管穿刺部位管理对于安全、高效且舒适的经股动脉诊断或介入性经皮冠状动脉手术至关重要。两种新型股动脉穿刺部位闭合装置，即Perclose和Angio-Seal，已被提议作为手动压迫（MC）的替代方法。我们比较了这两种装置，并参照标准手动压迫对它们的安全性、有效性及患者偏好进行了测试。
收集了1500例行经皮冠状动脉手术患者的前瞻性人口统计学、围手术期及后期随访数据，这些患者分别接受了手动压迫（n = 469）、Perclose（n = 492）或Angio-Seal（n = 539）股动脉闭合术。围手术期、术后及出院后终点指标包括：1）闭合方法的安全性；2）闭合方法的有效性；3）患者满意度。
与接受Perclose治疗的患者相比，接受Angio-Seal治疗的患者止血时间（诊断性和介入性手术，p < 0.0001）和下床活动时间（诊断性手术，p = 0.05；介入性手术，p < 0.0001）更短。接受Perclose治疗的患者穿刺部位并发症更多（Perclose与Angio-Seal相比，p = 0.008；Perclose与MC相比，p = 0.06）。接受Angio-Seal治疗的患者总体满意度更高、伤口愈合更好且不适感更低（与Perclose或MC相比，所有p < 或 = 0.0001）。仅对于诊断性导管插入术，Angio-Seal缩短了术后住院时间中位数（Angio-Seal与MC相比，p < 0.0001；Angio-Seal与Perclose相比，p = 0.009）。介入性手术的住院时间无差异。
总体而言，在缩短诊断性手术患者的下床活动时间和住院时间方面，Angio-Seal比Perclose或MC表现更好。Angio-Seal的成功置入率更高且止血时间更短，并且在整个随访期间出血并发症并未增加。此外，在30天患者满意度以及患者对伤口愈合的评估方面，Angio-Seal比Perclose表现更好，不适感更低。
