Rodriguez Ariel, Katz Steven G
Keck-USC School of Medicine, Los Angeles, CA, USA.
Vasc Endovascular Surg. 2011 Oct;45(7):627-30. doi: 10.1177/1538574411410327. Epub 2011 Jun 5.
Following percutaneous intervention, obtaining femoral artery hemostasis quickly and reliably with few complications is of considerable importance. While the StarClose device has been studied in patients undergoing cardiac catheterization, its use in patients undergoing treatment for peripheral vascular disease has rarely been reported. It is the purpose of this report to determine whether the Starclose is able to deliver safe and effective femoral artery closure in this group of patients.
The records of all patients undergoing StarClose closure of the femoral artery by or under the supervision of a single vascular surgeon were reviewed. Indication, type of intervention, and size of the vascular sheath employed were noted. Times to mobilization and discharge were tabulated. Complications including hemorrhage, pseudoaneurysm, infection, and vessel occlusion were recorded.
Between February 2006 and September 2009, 603 StarClose nitinol clip closure devices were deployed in 478 patients. In all, 97 procedures were diagnostic and 506 included therapeutic interventions. A total of 97 5F sheaths, 465 6F sheaths, and 41 7F sheaths were employed. Time to ambulation and discharge was 44.2 ± 13.2 minutes and 119.3 ± 22.6 minutes in patients in whom a 5F sheath was used, 112.5 ± 13.5 minutes and 157.5 ± 20.6 minutes when a 6F sheath was used, and 121.9+/-38.8 minutes and 160.2+/-43.2 minutes when a 7F sheath was employed. The clip could not be successfully deployed in 21 arteries (3.5%) and manual compression was successful in achieving hemostasis in 17 patients without complication. Three patients (0.5%) developed major hematomas requiring transfusion; 1 patient developed a pseudoaneurysm (0.17%) requiring thrombin injection. A single patient (0.17%) occluded his common femoral artery following StarClose deployment and 1 patient (0.17%) developed a femoral artery stenosis requiring balloon dilatation. No patient developed a groin infection.
The StarClose provides a safe and reliable method of achieving femoral artery closure following percutaneous intervention for peripheral arterial disease. When successfully deployed, it allows for early ambulation and discharge. Since it remains entirely extraluminal, it offers advantages over other closure devices and can be safely used in the vast majority of patients with peripheral vascular disease.
经皮介入治疗后，快速、可靠地实现股动脉止血且并发症少具有重要意义。虽然StarClose装置已在接受心脏导管插入术的患者中进行了研究，但其在接受外周血管疾病治疗的患者中的应用鲜有报道。本报告旨在确定StarClose能否在这类患者中实现安全有效的股动脉闭合。
回顾了由一位血管外科医生或在其监督下对股动脉进行StarClose闭合的所有患者的记录。记录适应症、干预类型和所用血管鞘的尺寸。将活动时间和出院时间制成表格。记录包括出血、假性动脉瘤、感染和血管闭塞在内的并发症。
2006年2月至2009年9月期间，478例患者使用了603个StarClose镍钛合金夹闭合装置。其中，97例为诊断性操作，506例包括治疗性干预。总共使用了97个5F鞘、465个6F鞘和41个7F鞘。使用5F鞘的患者的下床活动时间和出院时间分别为44.2±13.2分钟和119.3±22.6分钟，使用6F鞘时分别为112.5±13.5分钟和157.5±20.6分钟，使用7F鞘时分别为121.9±38.8分钟和160.2±43.2分钟。21条动脉（3.5%）未能成功部署夹子，17例患者通过手动压迫成功止血且无并发症。3例患者（0.5%）出现需要输血的大出血；1例患者出现假性动脉瘤（0.17%），需要注射凝血酶。1例患者（0.17%）在部署StarClose后出现股总动脉闭塞，1例患者（0.17%）出现需要球囊扩张的股动脉狭窄。没有患者发生腹股沟感染。
StarClose为外周动脉疾病经皮介入治疗后实现股动脉闭合提供了一种安全可靠的方法。成功部署后，它允许早期下床活动和出院。由于它完全位于管腔外，与其他闭合装置相比具有优势，可安全用于绝大多数外周血管疾病患者。
