Department of Surgery, University of South Carolina, Columbia, SC.
Advanced Cardiac and Vascular Amputation Prevention Centers, Grand Rapids, Mich.
J Vasc Surg. 2021 Nov;74(5):1626-1635. doi: 10.1016/j.jvs.2021.04.057. Epub 2021 May 18.
We report the 6- and 12-month outcomes of the PROMISE I early feasibility study after treatment of no-option chronic limb-threatening ischemia (CLTI) with percutaneous deep vein arterialization (pDVA) using the LimFlow System.
Thirty-two patients with no-option CLTI, previously offered major amputation, were enrolled in this single-arm early feasibility study of the LimFlow pDVA System. No-option CLTI was defined as being ineligible for surgical or endovascular arterial revascularization. Patients were assessed for clinical status, pain, wound healing, and duplex ultrasound at 30 days, 6 months, and 12 months post-treatment. Primary endpoint analysis was amputation-free survival (AFS) at 30 days and 6 and 12 months. AFS was defined as freedom from above-ankle amputation of the index limb and freedom from all-cause mortality. Secondary endpoints evaluated included technical success of the procedure, and wound healing at 6 and 12 months.
Of 32 enrolled patients, 31 (97%) were successfully treated with the LimFlow System at the time of the procedure, and two (6.3%) were lost to follow-up. The 30-day, 6-month, and 12-month AFS rates were 91%, 74%, and 70% respectively. The wound healing status of fully healed or healing was 67% at 6 months, and 75% at 12 months. Reintervention was performed in 16 patients (52%) with 14 (88%) of the maintenance reinterventions occurring within the first 3 months. The majority of reinterventions (n = 12; 75%), involved the arterial inflow tract proximal to the stented LimFlow circuit, and no in-stent stenoses were determined to have been the cause of reintervention.
The LimFlow pDVA System was utilized in treating patients with no-option CLTI. A high technical success rate was observed, with a significant percentage of patients surviving free of major amputation at 12 months. These results suggest early safety and provide an initial assessment of the efficacy of the LimFlow pDVA System that supports the expansion of carefully executed studies to determine whether this is a viable option that can be used in this critically disadvantaged and growing patient population.
我们报告了使用 LimFlow 系统对无选择慢性肢体威胁性缺血 (CLTI) 进行经皮深静脉动脉化 (pDVA) 治疗后的 PROMISE I 早期可行性研究的 6 个月和 12 个月结果。
这项 LimFlow pDVA 系统的单臂早期可行性研究纳入了 32 例先前被建议进行大截肢的无选择 CLTI 患者。无选择 CLTI 的定义是不符合手术或血管内动脉血运重建适应证。在治疗后 30 天、6 个月和 12 个月时，对患者的临床状况、疼痛、伤口愈合和双功超声进行评估。主要终点分析是 30 天、6 个月和 12 个月时的免于截肢生存率 (AFS)。AFS 定义为指数肢体免于踝上截肢和免于全因死亡率。次要终点评估包括手术的技术成功率和 6 个月和 12 个月时的伤口愈合情况。
在 32 例入组患者中，31 例 (97%) 在 LimFlow 系统治疗时手术成功，2 例 (6.3%) 失访。30 天、6 个月和 12 个月的 AFS 率分别为 91%、74%和 70%。6 个月时完全愈合或愈合的伤口愈合状态为 67%，12 个月时为 75%。16 例患者 (52%) 进行了再介入治疗，其中 14 例 (88%) 的维持性再介入治疗发生在第 3 个月内。大多数再介入治疗 (n=12; 75%) 涉及动脉流入道近端到支架置入的 LimFlow 导管，并且没有发现支架内狭窄是再介入治疗的原因。
LimFlow pDVA 系统用于治疗无选择 CLTI 患者。观察到高的技术成功率，有相当比例的患者在 12 个月时免于主要截肢。这些结果表明早期安全性，并提供了对 LimFlow pDVA 系统疗效的初步评估，支持精心执行的研究的扩展，以确定这是否是一种可行的选择，可以用于这个处于严重不利地位且不断增长的患者群体。
