• Mehdi H Shishehbor, Richard J Powell, Miguel F Montero-Baker, Anahita Dua, Jorge L Martínez-Trabal, Matthew C Bunte, Arthur C Lee, Andrew S Mugglin, Joseph L Mills, Alik Farber, Daniel G Clair, and PROMISE II Investigators.
• 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): 117111801171-1180.

BackgroundApproximately 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.MethodsWe 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.ResultsWe 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.ConclusionsWe 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.).Copyright © 2023 Massachusetts Medical Society.

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