Mustapha J A, Saab Fadi A, Clair Daniel, Schneider Peter
Advanced Cardiac and Vascular Amputation Prevention Centers, 1525 E. Beltline Ave. NE, Suite 101, Grand Rapids, MI 49525 USA.
J Invasive Cardiol. 2019 Mar;31(3):57-63. doi: 10.25270/jic/18.00340.
To investigate the feasibility, safety, and effectiveness of the LimFlow stent-graft system in performing percutaneous deep vein arterialization (pDVA) for treatment of critical limb ischemia (CLI) patients ineligible for conventional endovascular or surgical revascularization procedures.
Ten no-option CLI patients (mean age, 67 ± 11 years; 30% women) were enrolled. All patients were classified as Rutherford class 5 or 6 and were deemed by a committee of experts to be ineligible for endovascular or surgical procedures to restore blood flow. Eighty percent were categorized as stage 4 (high risk of amputation) based on Society for Vascular Surgery wound, ischemia, and foot infection (SVS WIfI) scoring index. The primary safety endpoint was amputation-free survival (AFS) at 30 days. A secondary safety endpoint evaluated AFS at 6 months. Other secondary endpoints included primary patency, wound healing, and technical success.
Amputation-free survival was achieved in 100% of patients, with no deaths or index limb above-ankle amputations observed at 30 days and 6 months. Technical success rate was 100%. No procedural complications were reported. Primary patency rates at 1 month and 6 months were 90% and 40%, respectively, with reintervention performed in 30% of patients. By 6 months, 30% of patients experienced complete (100%) wound healing, half of patients had 84%-93% wound healing, and 20% of patients experienced 60% healing.
pDVA using the LimFlow system is a novel approach for treating patients with no-option CLI and may reduce amputation in this population for whom it would otherwise be considered inevitable. Initial findings from this early feasibility trial are promising and additional study is warranted.
探讨LimFlow支架移植物系统用于为不符合传统血管内或外科血运重建手术条件的严重肢体缺血（CLI）患者进行经皮深静脉动脉化（pDVA）的可行性、安全性和有效性。
纳入10例无其他选择的CLI患者（平均年龄67±11岁；30%为女性）。所有患者均被归类为卢瑟福分级5级或6级，专家委员会认为其不符合进行恢复血流的血管内或外科手术条件。根据血管外科学会伤口、缺血和足部感染（SVS WIfI）评分指数，80%的患者被归类为4期（截肢高风险）。主要安全终点是30天时的无截肢生存期（AFS）。次要安全终点评估6个月时的AFS。其他次要终点包括初始通畅率、伤口愈合和技术成功率。
100%的患者实现了无截肢生存，在30天和6个月时未观察到死亡或指数肢体踝关节以上截肢。技术成功率为100%。未报告手术并发症。1个月和6个月时的初始通畅率分别为90%和40%，30%的患者进行了再次干预。到6个月时，30%的患者实现了完全（100%）伤口愈合，一半患者的伤口愈合率为84%-93%，20%的患者伤口愈合率为60%。
使用LimFlow系统进行pDVA是治疗无其他选择的CLI患者的一种新方法，可能会减少该人群中原本被认为不可避免的截肢情况。这项早期可行性试验的初步结果很有前景，有必要进行进一步研究。
