White Rodney, Krajcer Zvonimir, Johnson Matthew, Williams David, Bacharach Michael, O'Malley Ellen
University of Los Angeles Medical Center, Harbor, Los Angeles, California, and Texas Heart Institute, Houston, Texas, USA.
J Trauma. 2006 Jun;60(6):1189-95; discussion 1195-6. doi: 10.1097/01.ta.0000220372.85575.e2.
The safety and efficacy of endovascular treatment of arterial trauma using the Wallgraft Endoprosthesis was evaluated in a subgroup analysis of a prospective, multicenter, nonrandomized registry trial with a historical control to surgical management. Endpoints were exclusion success at procedure and at 12-months, primary patency and freedom-from-bypass at 12-months, and major adverse events.
Sixty-two patients were treated for arterial trauma from October 1997 to June 2003. The anatomic locations of the injuries were: iliac (33), subclavian (18), and femoral (11) arteries. Indication for treatment was perforation/rupture (33), acute pseudoaneurysm (10), AV fistula (16), and dissection (3). Exclusion and patency were assessed using arteriography, duplex ultrasound, CT, or MRA at postprocedure and 12-months. Major adverse event and mortality rates were compared with surgical intervention of arterial trauma using literature based objective performance criteria.
The Wallgraft Endoprosthesis achieved postprocedure exclusion in 58 of 62 cases (93.5%). One-year exclusion rates were 91.3% iliac, 90.0% subclavian, and 62.3% femoral. One-year primary patency rates were 76.4% iliac, 85.7% subclavian, and 85.7% femoral. Freedom-from-bypass was achieved in 74.3% iliac and 100% femoral and subclavian injuries. The most common adverse events were stenosis (4.8%) and occlusion (6.5% early, 1.6% late). There were no device- or procedure-related deaths. Analysis of the literature revealed the rates and severity of complications are less than those associated with surgical repair.
The Wallgraft Endoprosthesis for the treatment of traumatic arterial injuries offers a promising alternative to conventional operative repair with comparable patency and less major morbidity and mortality.
在一项前瞻性、多中心、非随机登记试验的亚组分析中，采用Wallgraft血管内支架对动脉创伤进行血管内治疗，并与手术治疗进行历史对照，评估其安全性和有效性。观察终点包括手术时及术后12个月的封堵成功率、术后12个月的一期通畅率和无需旁路移植率，以及主要不良事件。
1997年10月至2003年6月期间，62例患者接受了动脉创伤治疗。损伤的解剖部位包括：髂动脉（33例）、锁骨下动脉（18例）和股动脉（11例）。治疗指征为穿孔/破裂（33例）、急性假性动脉瘤（10例）、动静脉瘘（16例）和夹层（3例）。术后及术后12个月时，采用动脉造影、双功超声、CT或MRA评估封堵情况和通畅情况。采用基于文献的客观性能标准，将主要不良事件和死亡率与动脉创伤的手术干预进行比较。
62例患者中，58例（93.5%）使用Wallgraft血管内支架术后实现封堵。髂动脉1年封堵率为91.3%，锁骨下动脉为90.0%，股动脉为62.3%。髂动脉1年一期通畅率为76.4%，锁骨下动脉为85.7%，股动脉为85.7%。髂动脉损伤患者74.3%无需旁路移植，股动脉和锁骨下动脉损伤患者100%无需旁路移植。最常见的不良事件为狭窄（4.8%）和闭塞（早期6.5%，晚期1.6%）。未发生与器械或手术相关的死亡。文献分析显示，与手术修复相比，该治疗并发症的发生率和严重程度更低。
Wallgraft血管内支架治疗创伤性动脉损伤为传统手术修复提供了一种有前景的替代方法，其通畅率相当，且主要发病率和死亡率更低。
