Rickli Hans, Unterweger Martin, Sütsch Gabor, Brunner-La Rocca Hans Peter, Sagmeister Markus, Ammann Peter, Amann Franz W
Department of Clinical Medicine, Division of Cardiology, Kantonsspital, St. Gallen, Switzerland.
Catheter Cardiovasc Interv. 2002 Nov;57(3):297-302. doi: 10.1002/ccd.10294.
The aim of this study was to assess costs and safety of immediate femoral sheath removal and closure with a suture-mediated closure device (Perclose, Menlo Park, CA) in patients undergoing elective (PCI). A total of 193 patients was prospectively randomized to immediate arterial sheath removal and access site closure with a suture-mediated closure device (SMC; n = 96) or sheath removal 4 hr after PCI followed by manual compression (MC; n = 97). In the SMC group, patients were ambulated 4 hr after elective PCI if hemostasis was achieved. In the MC group, patients were ambulated the day after the procedure. In addition to safety, total direct costs including physician and nursing time, infrastructure, and the device were assessed in both groups. Total direct costs were significantly (all P < 0.001) lower in the SMC group. Successful hemostasis without major complication was achieved in all patients. The time to achieve hemostasis was significantly shorter in the SMC group (7.1 +/- 3.4 vs. 22.9 +/- 14.0 min; P < 0.01) and 85% of SMC patients were ambulated on the day of intervention. Suture-mediated closure allows a reduction in hospitalization time, leading to significant cost savings due to decreased personnel and infrastructural demands. In addition, the use of SMC is safe and convenient to the patients.
本研究的目的是评估在接受择期经皮冠状动脉介入治疗（PCI）的患者中，使用缝线介导闭合装置（Perclose，位于加利福尼亚州门洛帕克）立即拔除股动脉鞘并闭合穿刺部位的成本和安全性。总共193例患者被前瞻性随机分为两组，一组使用缝线介导闭合装置（SMC；n = 96）立即拔除动脉鞘并闭合穿刺部位，另一组在PCI术后4小时拔除鞘管，随后进行手工压迫（MC；n = 97）。在SMC组中，如果实现止血，择期PCI术后4小时让患者下床活动。在MC组中，患者在术后第二天下床活动。除了安全性评估外，还对两组包括医生和护理时间、基础设施以及装置在内的总直接成本进行了评估。SMC组的总直接成本显著更低（所有P < 0.001）。所有患者均成功止血且无 major complication。SMC组实现止血的时间显著更短（7.1 +/- 3.4分钟 vs. 22.9 +/- 14.0分钟；P < 0.01），85%的SMC组患者在干预当天即可下床活动。缝线介导闭合可缩短住院时间，由于人员和基础设施需求减少而显著节省成本。此外，使用SMC对患者来说安全且方便。
