Midterm Outcomes From a Pilot Study of Percutaneous Deep Vein Arterialization for the Treatment of No-Option Critical Limb Ischemia
Midterm Outcomes From a Pilot Study of Percutaneous Deep Vein Arterialization for the Treatment of No-Option Critical Limb Ischemia
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DOI：
10.1177/1526602817719283
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发表时间：
2017-10-01
影响因子：
2.6
通讯作者：
Mutirangura, Pramook
中科院分区：
文献类型：
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作者：
Kum, Steven;Tan, Yih Kai;Mutirangura, Pramook
目的：报告经皮深静脉动脉化(PDVA)通过建立动静脉瘘治疗严重肢体缺血(CLI)的初步临床经验。方法：选择7名CLI患者(中位年龄85岁；5名女性)，无传统的血管内或外科血管重建术(非选择性CLI)，进行初步研究，以确定PDVA的安全性。所有患者都是糖尿病患者；4名患者患有卢瑟福6类缺血。根据血管外科学会WiFi(创伤、缺血和足部感染)分类，有6人被归类为截肢高危人群。主要安全终点为30天内的主要不良肢体事件和主要不良冠状动脉事件，以及6个月内的严重不良事件。次要目标包括基于结果测量的临床疗效，包括体温测量、经皮氧分压(TcPO2)、6个月后的临床改善和伤口愈合。结果：100%的患者达到了主要的安全终点，在30天内没有死亡、踝关节以上截肢或主要的再干预。技术成功率为100%。在30天内发生了两次心肌梗死，每一次都有轻微的临床后果。所有患者都表现出症状改善，肉芽组织形成，休息疼痛缓解，或两者兼而有之。术后6个月和12个月分别有4例和5例创面完全愈合，中位愈合时间为4.6个月(95%可信区间84~192)。术后峰值TcPO2中位数为61 mm Hg，而术前为8 mm Hg(p=0.046)。在伤口愈合时，5名患者中有4名达到40毫米汞柱的TcPO2水平。有2例大腿截肢，1例因PDVA血栓形成，1例在膝关节以上，1例在膝关节以下，因感染。3例患者分别于术后6、7、8个月死于与手术或研究装置无关的原因。术后12个月肢体保留率为71%。结论：PDVA是治疗非选择性CLI的一种创新方法，是治疗“沙漠足”的另一种选择，有可能避免重大截肢。我们的结果证明了它的安全性和可行性，在这个小队列中有希望的早期临床结果。
Purpose: To report the initial clinical experience with percutaneous deep vein arterialization (PDVA) to treat critical limb ischemia (CLI) via the creation of an arteriovenous fistula. Methods: Seven patients (median age 85 years; 5 women) with CLI and no traditional endovascular or surgical revascularization options (no-option CLI) were recruited in a pilot study to determine the safety of PDVA. All patients were diabetic; 4 had Rutherford category 6 ischemia. Six were classified at high risk of amputation based on the Society for Vascular Surgery WIfI (wound, ischemia, and foot infection) classification. The primary safety endpoints were major adverse limb events and major adverse coronary events through 30 days and serious adverse events through 6 months. Secondary objectives included clinical efficacy based on outcome measures including thermal measurement, transcutaneous partial pressure of oxygen (TcPO2), clinical improvement at 6 months, and wound healing. Results: The primary safety endpoints were achieved in 100% of patients, with no deaths, above-theankle amputations, or major reinterventions at 30 days. The technical success rate was 100%. Two myocardial infarctions occurred within 30 days, each with minor clinical consequences. All patients demonstrated symptomatic improvement with formation of granulation tissue, resolution of rest pain, or both. Complete wound healing was achieved in 4 of 7 patients and 5 of 7 patients at 6 and 12 months, respectively, with a median healing time of 4.6 months (95% confidence interval 84-192). Median postprocedure peak TcPO2 was 61 mm Hg compared to a preprocedure level of 8 mm Hg (p=0.046). At the time of wound healing, 4 of 5 of patients achieved TcPO2 levels of >40 mm Hg. There were 2 major amputations, 1 above the knee after PDVA thrombosis and 1 below the knee for infection. Three patients died of causes unrelated to the procedure or study device at 6, 7, and 8 months, respectively. Limb salvage was 71% at 12 months. Conclusion: PDVA is an innovative approach for treating no-option CLI and represents an alternative option for the "desert foot," potentially avoiding major amputation. Our results demonstrate its safety and feasibility, with promising early clinical results in this small cohort.