From University Hospitals Harrington Heart and Vascular Institute, Cleveland (M.H.S.); the Division of Vascular Surgery, Dartmouth-Hitchcock Medical Center, Lebanon, NH (R.J.P.); the Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston (M.F.M.-B., J.L.M.); the Division of Vascular Surgery, Massachusetts General Hospital, Harvard Medical School (A.D.), and the Division of Vascular and Endovascular Surgery, Boston Medical Center, Boston University School of Medicine (A.F.) - both in Boston; the Division of Vascular Surgery, Ponce Health Sciences University, St. Luke's Episcopal Hospital, Ponce, Puerto Rico (J.L.M.-T.); Saint Luke's Mid America Heart Institute, Kansas City, MO (M.C.B.); HCA Florida North Florida Hospital, the Cardiac and Vascular Institute, Gainesville (A.C.L.); Paradigm Biostatistics, Anoka, MN (A.S.M.); and the Department of Vascular Surgery, Vanderbilt School of Medicine, Nashville (D.G.C.).
N Engl J Med. 2023 Mar 30;388(13):1171-1180. doi: 10.1056/NEJMoa2212754.
Approximately 20% of patients with chronic limb-threatening ischemia have no revascularization options, leading to above-ankle amputation. Transcatheter arterialization of the deep veins is a percutaneous approach that creates an artery-to-vein connection for delivery of oxygenated blood by means of the venous system to the ischemic foot to prevent amputation.
We conducted a prospective, single-group, multicenter study to evaluate the effect of transcatheter arterialization of the deep veins in patients with nonhealing ulcers and no surgical or endovascular revascularization treatment options. The composite primary end point was amputation-free survival (defined as freedom from above-ankle amputation or death from any cause) at 6 months, as compared with a performance goal of 54%. Secondary end points included limb salvage, wound healing, and technical success of the procedure.
We enrolled 105 patients who had chronic limb-threatening ischemia and were of a median age of 70 years (interquartile range, 38 to 89). Of the patients enrolled, 33 (31.4%) were women and 45 (42.8%) were Black, Hispanic, or Latino. Transcatheter arterialization of the deep veins was performed successfully in 104 patients (99.0%). At 6 months, 66.1% of the patients had amputation-free survival. According to Bayesian analysis, the posterior probability that amputation-free survival at 6 months exceeded a performance goal of 54% was 0.993, which exceeded the prespecified threshold of 0.977. Limb salvage (avoidance of above-ankle amputation) was attained in 67 patients (76.0% by Kaplan-Meier analysis). Wounds were completely healed in 16 of 63 patients (25%) and were in the process of healing in 32 of 63 patients (51%). No unanticipated device-related adverse events were reported.
We found that transcatheter arterialization of the deep veins was safe and could be performed successfully in patients with chronic limb-threatening ischemia and no conventional surgical or endovascular revascularization treatment options. (Funded by LimFlow; PROMISE II study ClinicalTrials.gov number, NCT03970538.).
约 20%的慢性肢体威胁性缺血患者没有血管重建的选择，导致踝关节以上截肢。深静脉经皮动脉化是一种经皮方法，通过静脉系统将含氧血液输送到缺血足，以防止截肢，从而建立动脉-静脉连接。
我们进行了一项前瞻性、单组、多中心研究，以评估深静脉经皮动脉化在非愈合性溃疡且无手术或血管内血运重建治疗选择的患者中的效果。复合主要终点是 6 个月时免于截肢的存活率（定义为免于踝关节以上截肢或任何原因导致的死亡），与 54%的表现目标相比。次要终点包括肢体保存、伤口愈合和手术技术成功。
我们纳入了 105 名患有慢性肢体威胁性缺血且中位年龄为 70 岁（四分位距 38 至 89 岁）的患者。纳入的患者中，33 名（31.4%）为女性，45 名（42.8%）为黑种人、西班牙裔或拉丁裔。深静脉经皮动脉化在 104 名患者（99.0%）中成功完成。6 个月时，66.1%的患者免于截肢。根据贝叶斯分析，6 个月时免于截肢的生存概率超过 54%的表现目标的后验概率为 0.993，超过了预设的 0.977 阈值。通过 Kaplan-Meier 分析，67 名患者（76.0%）实现了肢体保存（避免踝关节以上截肢）。63 名患者中有 16 名（25%）的伤口完全愈合，32 名（51%）的伤口正在愈合。没有报告任何意外的器械相关不良事件。
我们发现，深静脉经皮动脉化在慢性肢体威胁性缺血且没有传统手术或血管内血运重建治疗选择的患者中是安全且可成功进行的。（由 LimFlow 资助；PROMISE II 研究 ClinicalTrials.gov 编号，NCT03970538）。
