1 Vascular Service, Department of Surgery, Changi General Hospital, Singapore.
2 Department of Surgery, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.
J Endovasc Ther. 2017 Oct;24(5):619-626. doi: 10.1177/1526602817719283. Epub 2017 Jul 12.
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.
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 (TcPO), clinical improvement at 6 months, and wound healing.
The primary safety endpoints were achieved in 100% of patients, with no deaths, above-the-ankle 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 TcPO 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 TcPO 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.
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.
通过建立动静脉瘘，报告经皮深静脉动脉化（PDVA）治疗严重肢体缺血（CLI）的初步临床经验。
在一项试点研究中，招募了 7 名（中位年龄 85 岁；5 名女性）CLI 且无传统血管内或手术血运重建选择（无选择 CLI）的患者，以确定 PDVA 的安全性。所有患者均为糖尿病患者；4 例存在 Rutherford 6 级缺血。根据血管外科学会（SVS）WIfI（伤口、缺血和足部感染）分类，6 例患者被归类为高截肢风险。次要目标包括基于包括热测量、经皮氧分压（TcPO2）在内的结局测量的临床疗效、6 个月时的临床改善以及伤口愈合。
所有患者均达到了 100%的主要安全性终点，在 30 天内无死亡、踝上截肢或重大再介入，无重大不良心血管事件。技术成功率为 100%。2 例心肌梗死发生在 30 天内，均有轻微临床后果。所有患者均表现出症状改善，形成肉芽组织，缓解静息痛或两者兼有。7 例患者中有 4 例和 7 例患者分别在 6 个月和 12 个月完全愈合，中位愈合时间为 4.6 个月（95%置信区间 84-192）。术后 61mmHg 的 TcPO2 峰值与术前 8mmHg 的水平相比（p=0.046）。在伤口愈合时，5 例患者中有 4 例 TcPO2 水平>40mmHg。有 2 例患者进行了大截肢，1 例是 PDVA 血栓形成后的膝上截肢，1 例是感染引起的膝下截肢。3 例患者分别在术后 6、7 和 8 个月因与手术或研究器械无关的原因死亡。12 个月时的肢体存活率为 71%。
PDVA 是治疗无选择 CLI 的一种创新方法，代表了“荒漠足”的一种替代选择，可能避免了大截肢。我们的结果表明了其安全性和可行性，在这一小队列中显示出了早期临床结果的良好前景。
