Gray Bruce H, Miller Ryan, Langan Eugene M, Joels Charles S, Yasin Yousef, Kalbaugh Corey A
Academic Department of Surgery-Vascular Medicine, Greenville Hospital System University Medical Center, Greenville, SC 29605, USA.
Ann Vasc Surg. 2009 May-Jun;23(3):341-4. doi: 10.1016/j.avsg.2008.07.009. Epub 2008 Sep 21.
The StarClose (Abbott Vascular, Redwood City, CA) arterial closure device utilizes an extraluminal nitinol clip to establish hemostasis. The purpose of this study was to determine the safety and efficacy of StarClose from a prospective peripheral arterial disease (PAD) registry. Over an 18-month time interval, 500 StarClose devices were used in 378 consecutive patients with symptomatic PAD after diagnostic and/or therapeutic endovascular cases. Patient demographics along with objective criteria including duplex ultrasound images, common femoral artery flow velocities, and ankle-brachial indexes (ABIs) were analyzed before and after StarClose placement. All outpatients received prophylactic antibiotic (one dose), periprocedural heparin (without protamine reversal), and antiplatelet therapy. Aspirin and clopidogrel (Plavix) was used for all patients undergoing therapeutic intervention. There were 378 patients who underwent procedures for aortoiliac or infrainguinal PAD, 99 of which were bilateral. Of the 500 arteriotomy closures, 296 were therapeutic interventions with sheath sizes of 6-8 F in the common femoral artery. The diagnostic studies (n = 204 arteriotomies) were performed with a 5F sheath. The technical success in achieving hemostasis was 97.2%; only 14 devices had a deployment problem requiring prolonged manual compression. Median length of stay was 157 min for patients done on an outpatient basis. Eleven of 260 (4.2%) on duplex follow-up had a doubling of the peak systolic velocity, only one of which was symptomatic. Late follow-up showed 42 of 360 (11.7%) with a drop in ABI >0.10. Nine major complications (2.0%) were identified in follow-up. The StarClose closure device has a low major complication rate and is safe and efficacious in patients with PAD, although stenosis at the arteriotomy site may occur. The device has achieved rapid hemostasis without need for anticoagulant reversal and requires significantly less time to ambulation than manual compression.
StarClose（雅培血管，加利福尼亚州红木城）动脉闭合装置采用管腔外镍钛合金夹来实现止血。本研究的目的是通过一项前瞻性外周动脉疾病（PAD）注册研究来确定StarClose的安全性和有效性。在18个月的时间间隔内，378例有症状的PAD患者在诊断性和/或治疗性血管内手术后连续使用了500个StarClose装置。在放置StarClose前后，分析了患者的人口统计学数据以及包括双功超声图像、股总动脉血流速度和踝臂指数（ABI）在内的客观标准。所有门诊患者均接受预防性抗生素（一剂）、围手术期肝素（未用鱼精蛋白中和）和抗血小板治疗。所有接受治疗性干预的患者均使用阿司匹林和氯吡格雷（波立维）。有378例患者接受了主髂动脉或股下PAD手术，其中99例为双侧手术。在500例动脉切开闭合术中，296例为治疗性干预，股总动脉鞘管尺寸为6-8F。诊断性研究（n = 204例动脉切开术）使用5F鞘管进行。实现止血的技术成功率为97.2%；只有14个装置出现部署问题，需要长时间手动压迫。门诊患者的中位住院时间为157分钟。260例患者中有11例（4.2%）在双功超声随访时收缩期峰值速度加倍，其中只有1例有症状。晚期随访显示，360例患者中有42例（11.7%）ABI下降>0.10。随访中发现9例主要并发症（2.0%）。StarClose闭合装置的主要并发症发生率较低，对PAD患者安全有效，尽管动脉切开部位可能会出现狭窄。该装置无需抗凝逆转即可快速止血，与手动压迫相比，患者下地行走所需时间显著缩短。
