Abstract
ABSTRACTObjective: To describe the characteristics, the management and the outcome of a consecutive series of patients with diabetic foot lesions (DF) and no-option critical limb ischemia (CLI) treated with a multidimensional, interdisciplinary approach in a dedicated center.Research Design and Methods: The prospective database of the Diabetic Foot Unit of the Maria Cecilia Hospital (Cotignola, Italy) collects medical history, risk factors, chemistry values, angiographic data, characteristic of foot lesions, medical and surgical therapies of all patients admitted with a diagnosis of DF and CLI. All patients were followed-up for at least 1 year and/or total recovery. The primary endpoint was 1-year amputation-free survival (AFS), secondary endpoints were limb salvage and survival.Results: Between October 2014 and October 2017, 1024 patients with DF and CLI were admitted to the center. Eighty-four of them (8.2%) fulfilled the criteria for no-option CLI. At 1 year, AFS, limb salvage, and survival rates were 34%, 34%, and 83%, respectively. Lesions located proximal to the Lisfranc joint were associated with major amputation (HR 2.1 [1.2–3.6]). One-year survival of patients treated with minor procedures was significantly higher compared to patients treated with major amputation (96% vs 76%, log-rank p = 0.019). Major amputation was independently associated with mortality (HR 7.83 [1.02–59.89]).Conclusions: The application of dedicated and standardized strategies permitted limb salvage in one-third of patients with no-option CLI. Patients with stable lesions limited to the forefoot and without ischaemic pain had a greater probability to successfully receive conservative treatments. Limb salvage was associated with subsequent higher one-year survival.
Highlights
After a discussion in the multidisciplinary ‘foot team’, those patients were judged affected by diabetic foot lesions (DF) with no-option critical limb ischemia (CLI) and represent the study population of the current investigation
The rate of limb salvage reported in clinical trials is higher, but the most critical cases were often excluded, as well as patients on dialysis [16–19]
Even the definition of no-option CLI adopted in these trials are variable and subjective [13]
Summary
AFS rate had significantly increased in patients with baseline foot lesions located distal to Lisfranc joint compared to patients with lesions proximal to it, both at 1-year (42% vs 19%, log-rank p = 0.006) (Figure 1) and during the overall follow-up (40% vs 7%, log-rank p < 0.001). Variables associated with major amputation or death at one-year were foot lesion location (proximal vs distal to Lisfranc joint, HR 2.080 [1.221–3.545]), total cholesterol (HR 0.991 [0.983–0.999]), C-reactive protein (HR 1.043 [1.009–1.079]) and hemoglobin (HR 0.780 [0.611–0.995]). One year after the diagnosis of no-option CLI, 55 (66%) patients received a major amputation of the index limb, corresponding to a limb salvage rate of 34%.
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