目的:描述在西澳大利亚州的一个三级中心使用WRAPSODY细胞不透性内假体相关的临床结果。
方法:患者在其动静脉通路的静脉流出道中患有顽固性闭塞性疾病的患者接受WRAPSODY治疗。术后12个月对患者进行前瞻性随访。研究措施包括30天不良事件,技术上的成功,靶病变原发通畅,接入电路初级通畅,和辅助接入电路初级通畅。
结果:使用27台WRAPSODY装置治疗15例连续患者。技术成功率为100%。在随访期间没有观察到与设备相关的不良事件。两名患者未完成完整随访。通畅率在3-,6-,12个月的靶病变原发通畅率为100%(15/15),100%(15/15),100%(13/13),分别。接入电路初级通畅率为3-,6-,12个月为73.3%(11/15),46.7%(7/15),和46.2%(6/13),分别。在33.3%(5/15)的病例中观察到边缘狭窄,占8例患者中的5例,这些患者在血管造影中经历了一次通路通畅失败。在12个月时,主要辅助功能通畅率为100%。
结论:WRAPSODY可以安全使用,并且在现实世界中具有复杂解剖性肾通路狭窄病变的患者中具有持久的通畅性。与装置相关联的治疗益处可以鼓励在临床实践中更广泛地使用。
OBJECTIVE: To describe clinical outcomes associated with the use of the WRAPSODY Cell-Impermeable Endoprosthesis at a tertiary center in Western Australia.
METHODS: Patients with recalcitrant occlusive disease in the venous outflow of their arteriovenous access circuits were treated with WRAPSODY. Patients were prospectively followed up to 12-month post-procedure. Study measures included 30-day adverse events, technical success, target lesion primary patency, access circuit primary patency, and assisted access circuit primary patency.
RESULTS: Twenty-seven WRAPSODY devices were used to treat 15 consecutive patients. The technical success rate was 100%. No device-related adverse events were observed during the follow-up period. Two patients did not complete the full follow up. Patency rates at 3-, 6-, and 12 months for target lesion primary patency were 100% (15/15), 100% (15/15), and 100% (13/13), respectively. Rates for access circuit primary patency at 3-, 6-, and 12 months were 73.3% (11/15), 46.7 % (7/15), and 46.2% (6/13), respectively. Edge stenosis was observed in 33.3% (5/15) of cases and accounted for 5 of the 8 patients who experienced failed access circuit primary patency on angiogram. Primary assisted functional patency was 100% at 12 months.
CONCLUSIONS: WRAPSODY can be utilized safely and has durable patency in real-world patients with complex anatomical renal access stenotic lesions. The therapeutic benefits associated with the device may encourage broader use in clinical practice.