Darling Jeremy D, Li Siling, Lee Andy, Liang Patric, Wyers Mark C, Schermerhorn Marc L, Secemsky Eric A, Stangenberg Lars
Department of Surgery, Division of Vascular and Endovascular Surgery, Beth Israel Deaconess Medical Center, Boston, MA.
Richard A. and Susan F. Smith Center for Outcomes Research, Division of Cardiovascular Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
J Vasc Surg. 2025 Sep;82(3):1007-1013. doi: 10.1016/j.jvs.2025.04.003. Epub 2025 Apr 11.
Despite advances in the management of chronic limb-threatening ischemia (CLTI), a large proportion of these patients are not candidates for traditional revascularization and may be destined for major amputation. Given this medically complex and no-option patient population, deep venous arterialization (DVA) has been recently revitalized as a limb salvage technique, whereby an arteriovenous fistula in the lower leg is created to supply more oxygenated blood via the venous system to the foot. Recently, PROMISE II (Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia) demonstrated a 6-month amputation-free survival (AFS) rate of 66% after DVA. With this trial in mind, our study aimed to evaluate the real-world outcomes of this procedure.
The study population included all patients undergoing a DVA from January 1, 2021, through December 31, 2023 among fee-for-service beneficiaries identified in the Medicare Fee-for-Service Carrier Claims file. DVA procedures were identified using Current Procedural Terminology code 0620T. Outcomes included limb salvage, freedom from major adverse limb events (defined as major amputation or ipsilateral reintervention), survival, and AFS. Cumulative incidences for outcomes that include death were estimated from traditional Kaplan-Meier methods; for non-death end points, outcomes were estimated from the cumulative incidence function, accounting for the competing risk of death.
Between 2021 and 2023, 134 patients underwent a DVA for CLTI. Among these, the median age was 70 years and the majority of patients were male (66%), White (63%), and had tissue loss (72%), hypertension (99%), hyperlipidemia (96%), chronic kidney disease (89%), and diabetes (83%). After a DVA for CLTI, the 6-month and 1-year AFS incidences were 42% and 33%, respectively. One-year incidences of limb salvage, freedom from major adverse limb events, and survival were 53%, 36%, and 65%, respectively.
Among patients with no traditional options for revascularization, our data demonstrate that DVA is a procedure that is, by its nature, performed on high-risk individuals who continue to have a high risk of limb loss and mortality. Importantly, AFS in our analysis was notably worse than that reported in PROMISE II and, as such, raises questions about the generalizability of this procedure in real world practice. Further investigation is needed regarding patient selection criteria for and the clinical usefulness of the DVA procedure.
尽管在慢性肢体威胁性缺血（CLTI）的治疗方面取得了进展，但很大一部分此类患者不适合进行传统的血运重建，可能注定要接受大截肢手术。鉴于这一医学情况复杂且别无选择的患者群体，深静脉动脉化（DVA）最近作为一种肢体挽救技术得以复兴，即通过在小腿建立动静脉瘘，经静脉系统向足部供应更多含氧血液。最近，PROMISE II（经皮深静脉动脉化治疗晚期慢性肢体威胁性缺血）试验表明，DVA术后6个月无截肢生存率（AFS）为66%。考虑到该试验，我们的研究旨在评估这一手术的实际效果。
研究人群包括2021年1月1日至2023年12月31日期间在医疗保险服务收费承运人索赔文件中确定的按服务收费受益人中所有接受DVA的患者。使用当前手术操作术语代码0620T识别DVA手术。结果包括肢体挽救、无严重肢体不良事件（定义为大截肢或同侧再次干预）、生存率和AFS。包括死亡在内的结局累积发生率采用传统的Kaplan-Meier方法估计；对于非死亡终点，结局采用累积发生率函数估计，并考虑死亡的竞争风险。
2021年至2023年期间，134例患者因CLTI接受了DVA。其中，年龄中位数为70岁，大多数患者为男性（66%）、白人（63%），有组织缺损（72%）、高血压（99%）、高脂血症（96%）、慢性肾病（89%）和糖尿病（83%）。CLTI患者接受DVA后，6个月和1年的AFS发生率分别为42%和33%。1年的肢体挽救、无严重肢体不良事件和生存率分别为53%、36%和65%。
在没有传统血运重建选择的患者中，我们的数据表明，DVA手术本质上是针对肢体丧失和死亡风险仍然很高的高危个体进行的。重要的是，我们分析中的AFS明显低于PROMISE II报告的结果，因此，这一手术在实际临床应用中的可推广性存在疑问。需要进一步研究DVA手术的患者选择标准及其临床实用性。
