METHODS: This is a prospective monocentric study on 18 no-option CLTI limbs treated with an IVUS-guided p-DVA. The primary outcome measures are: the freedom from major adverse events (MAEs) and survival at 30 days; limb salvage and amputation free survival (AFS) at 30 days, 6 months, 12 months and 24 months. The secondary outcome measures are: procedural success, survival, patency and wound healing.
RESULTS: We treated 14 patients with no-option CLTI, carrying out 18 p-DVA. Median age was 74,4 years (60-87). All these patients had a previous failed angioplasty of the tibial and foot arteries. Procedural success rate, defined as the establishment of arterial flow into the venous system of the foot, was 100%. No deaths and MAEs recorded at 30 days. Survival was 100%, 83.4% and 77.8%; limb salvage was 88.9%, 77.8% and 77.8%; AFS was 88.9%, 61.1% and 55.6% at 6, 12 and 24 months. Complete wound healing was 18.7% at 6 months, 80.0% at 12 months and 100% at 24 months.
CONCLUSIONS: Based on these results, the IVUS-guided p-DVA seems to be safe and effective for no-option CLTI patients, with no mortality related to the intervention, an acceptable limb salvage rate and amputation free survival.
方法:这是一项前瞻性单中心研究,研究对象为18条非选择性CLTI肢体,采用IVUS引导的p-DVA治疗。主要结局指标是:无重大不良事件(MAE)和30天的生存率;30天的保肢和无截肢生存率(AFS)。6个月,12个月和24个月。次要结果指标是:程序成功,生存,通畅和伤口愈合。
结果:我们用无选择的CLTI治疗了14例患者,进行18p-DVA。中位年龄为74,4岁(60-87岁)。所有这些患者先前的胫骨和足动脉血管成形术失败。程序性成功率,定义为建立进入脚静脉系统的动脉血流,是100%。30天时无死亡和MAE记录。存活率是100%,83.4%和77.8%;保肢率88.9%,77.8%和77.8%;AFS为88.9%,6、12和24个月分别为61.1%和55.6%。6个月时伤口完全愈合为18.7%,12个月时为80.0%,24个月时为100%。
结论:基于这些结果,IVUS引导的p-DVA对于无选择的CLTI患者似乎是安全有效的,没有与干预相关的死亡率,可接受的保肢率和无截肢生存率。