Vogel Patrick Michael, Parise Carol
Sutter Institute for Medical Research, Sutter Hospital, Sacramento, California, USA.
J Vasc Interv Radiol. 2005 Dec;16(12):1619-26. doi: 10.1097/01.RVI.0000179792.23867.01.
To compare the SMART (shape memory alloy recoverable technology) stent with percutaneous transluminal angioplasty (PTA) alone in hemodialysis access venous stenoses.
A prospective, nonrandomized study was undertaken in 60 patients with dysfunctional polytetrafluoroethylene dialysis grafts. Indications for stent placement were acute PTA failure, rapid restenosis, and vessel perforation. The primary endpoint was improved graft patency in patients treated with stents compared with that in patients whose disease responded to PTA alone. The secondary endpoints were lower postprocedural midgraft pressures and similar complication rates compared with PTA alone.
The key venous stenosis was at the graft-to-vein anastomosis in all but two patients. Thirty-five patients showed a response to PTA alone. Sixteen patients received stents for stenoses greater than 30% after angioplasty, six for rapidly recurrent stenosis, and three for venous rupture. Nine patients received stents across the level of the elbow joint. Stenosis after intervention was significantly less frequent in the stent group (7% vs 16%; P = .001), but the midgraft systolic pressure ratios did not significantly differ. The clinical success rates were 100% after stent implantation and 97% after PTA alone. Except for venous rupture, there were no procedure-related complications, and, excluding early graft thrombosis, there were no complications at 30 days. A single stent fracture was found on follow-up. The mean primary graft patency times were 5.6 months after PTA and 8.2 months after stent treatment (P = .050). When stents were placed across the level of the elbow joint, the mean primary graft patency time was 8.9 months.
Implantation of the SMART stent is safe and effective for the treatment of residual or rapidly recurrent dialysis access venous stenoses and is associated with better patency than PTA alone.
比较SMART(形状记忆合金可回收技术)支架与单纯经皮腔内血管成形术(PTA)治疗血液透析通路静脉狭窄的效果。
对60例聚四氟乙烯透析移植物功能障碍患者进行了一项前瞻性、非随机研究。支架置入的指征为急性PTA失败、快速再狭窄和血管穿孔。主要终点是与单纯PTA治疗有效的患者相比,支架治疗患者的移植物通畅性改善情况。次要终点是与单纯PTA相比,术后移植物中段压力更低且并发症发生率相似。
除2例患者外,所有患者的关键静脉狭窄均位于移植物与静脉的吻合处。35例患者对单纯PTA有反应。16例患者因血管成形术后狭窄大于30%接受支架治疗,6例因快速复发性狭窄接受支架治疗,3例因静脉破裂接受支架治疗。9例患者在肘关节水平置入支架。支架组干预后狭窄的发生率显著更低(7%对16%;P = 0.001),但移植物中段收缩压比值无显著差异。支架植入术后临床成功率为100%,单纯PTA术后为97%。除静脉破裂外,无手术相关并发症,且排除早期移植物血栓形成后,30天内无并发症。随访时发现1例支架断裂。PTA术后移植物的平均初次通畅时间为5.6个月,支架治疗后为8.2个月(P = 0.050)。当在肘关节水平置入支架时,移植物的平均初次通畅时间为8.9个月。
植入SMART支架治疗残余或快速复发性透析通路静脉狭窄安全有效,且与单纯PTA相比,移植物通畅性更好。