Outcomes after endovascular intervention for chronic critical limb ischemia

Abstract

This study evaluated outcomes after endovascular intervention (EVI) for chronic critical limb ischemia (CLI) by Rutherford category (RC) 4, rest pain; and 5, tissue loss. The medical records of all EVI performed for RC-4 to RC-5 by vascular surgeons at a single institution during a 3-year period were reviewed for sustained clinical success (SCS), defined as Rutherford improvement score (RIS) 2(+), without target extremity revascularization (TER). The RC-5 group was evaluated for patency until healing and healing ≤4 months without recurrence or new ulceration. Secondary sustained clinical success (SSCS) was a RIS of 2(+) with TER. The RC-5 group was evaluated for patency until healing and healing at any time during follow-up, without recurrent or new ulceration. Significance was established at the 0.05 level. Of 106 EVI performed for CLI, 78 (74%) were RC-5. There were 39 (37%) men. Mean age was 73 ± 12 years. Mean follow-up was 19 months (range, 1-44 months). RC-5 patients were significantly more likely than RC-4 to be diabetic (58% vs 32%; P = .020), dialysis dependent (14% vs 0%; P = .036), and to require distal EVI (53% vs 29%; P = .029). RC-4 patients were more likely to be current smokers (57% vs 32%; P = .023). At 24 months, survival was comparable, with RC-4 at 84% ± 8% vs RC-5 at 62% ± 7% (P = .09), but limb salvage was significantly better for RC-4 (100%) vs RC-5 (83% ± 4%; P = .026), as was SCS (48% vs 21%; P = .006) and SSCS (85% vs 39%; P < .001). Independent predictors of failed SSCS were diabetes (odds ratio [OR], 2.83; 95% confidence interval [CI], 1.07-7.46; P = .036), congestive heart failure (CHF; OR, 3.62; 95% CI, 1.19-10.99; P = .023), and RC-5 (OR, 5.5; 95% CI, 2.4-30.3; P = .001). SSCS was 94% in RC-4 patients without diabetes mellitus (DM) or CHF and 10% in RC-5 with DM or CHF (P < .001) but improved to 67% in RC-5 when neither CHF nor DM were present (P = .004). RC-4 have fewer comorbidities, less advanced ischemia, and better outcome than RC-5. These groups should be evaluated individually. Limb salvage was acceptable, yet early wound healing without TER (SCS) occurred in only 21%. RC-5, DM, and CHF were predictors of poor SSCS. Careful selection of patients should improve outcome.