Outcome for Endovascular and Open Procedures in Infrapopliteal Lesions for Critical Limb Ischemia: Registry Based Single Center Study

WHAT THIS PAPER ADDS There is a lack of robust contemporary data from randomized controlled trials regarding differences in the outcome of patients with below knee critical limb ischemia treated by endovascular or open repair. This large, single center series of 549 patients shows a similar risk factor profile, distribution of concomitant diseases, and outcome between the two treatment groups, even if wound complications were more common in the open, group. This single center, real world experience in a large number of patients encourages the continued search for refined measures to select the best treatment modality for each patient. Objective/Background: To describe the risk factor distribution and outcome for patients with critical limb ischemia (CLI) due to infrapopliteal arterial lesions treated by endovascular or open procedures, with special consideration of diabetic patients. Methods: Data were collected from the Swedish Vascular Registry, Swedvasc, covering all procedures performed on 549 consecutive patients between May 2008 and January 2014 at the Karolinska University Hospital. Diagnosis of ischemic rest pain and/or tissue loss and treatment of infrapopliteal arterial occlusive disease were considered. Analysis was performed on the first procedure during the observation period, "endo" or "open". Amputation rate and death from any cause were recorded as the primary outcome measures. Subgroup analysis was performed on diabetic patients. Results: Patient demographics did not differ between the endo (n = 430) and open (n = 114) cohorts. Wound complications requiring treatment within 30 days were more common in patients treated with open procedures (32% vs. 1% for endo; p <.001), as well as stroke and myocardial infarction. Amputation rates were higher at 30 days in the open group (7% vs. 2%; p =.012) but similar at 1 year (10% vs. 7%; p =.206). Mortality was similar at 30 days (p =.400) and 1 year (p =.860). Median survival at the end of the observation period was 43 months for endo and 56 months for open patients (p =.055). Patients with diabetes treated with open procedures had more complications at 30 days and a higher rate of transfemoral amputations at 1 year compared with non-diabetic patients. Conclusion: This non-randomized registry based study shows similar outcomes regarding amputation and survival rate in a large group of patients treated for infrapopliteal CLI with endovascular or open procedures, although more post-operative complications were reported in the open group. These findings support the continued use of both treatments while stressing the importance of minimizing surgical trauma to reduce wound complications. (C) 2016 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.