Abstract：
OBJECTIVE: In some patients, revascularization is not possible or is not effective. For these, percutaneous deep vein arterialization (p-DVA) could be considered an alternative treatment. The aim of this study is to evaluate the long-term results of an intravascular ultrasound (IVUS)-guided technique that has only one percutaneous access.
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.
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.
摘要：
目标：在一些患者中，血运重建是不可能的或无效的。对于这些，经皮深静脉动脉化(p-DVA)可被视为替代治疗.这项研究的目的是评估仅具有一个经皮通道的血管内超声（IVUS）引导技术的长期结果。
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。
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。
