Abstract
The study aimed to evaluate clinical and vascular characteristics, as well as outcomes, for diabetic persons with foot ulceration and no-option critical limb ischemia (CLI). The study group included a sample of patients admitted to our diabetic foot unit because of a new diabetic foot ulcer and CLI. All subjects were managed using a limb salvage protocol which includes lower-limb revascularization. According to whether or not the revascularization procedure was a success, patients were respectively divided into two groups: successfully treated CLI patients (ST-CLI) and no-option CLI patients (NO-CLI). Failed revascularization was considered in the case of technical recanalization failure of occluded vessels (inability to overcome the obstruction) and/or absence of arterial flow to the foot. Limb salvage, major amputation, and death after 1 year of follow-up were evaluated and compared between the two groups. Overall, 239 patients were included, 74.9% belonging to ST-CLI and 25.1% to NO-CLI. NO-CLI patients reported more cases of ischemic heart disease (80 vs. 62.1, p = 0.008), heart failure (63.3 vs. 32.4%, p < 0.0001), and end-stage renal disease (ESRD) (60 vs. 25.7%) than ST-CLI patients. In addition, more vessels were affected in the NO-CLI group (5.2 ± 1.6 vs. 4 ± 1.5, p < 0.0001), and there was more involvement of tibio-peroneal trunk (50 vs. 30.2%, p = 0.006), anterior tibial (93.3 vs. 82.7, p = 0.03), posterior tibial (93.3 vs. 73.7%, p = 0.0005), peroneal (70 vs. 48%, p = 0.002), and below-the-ankle arteries (73.3 vs. 39.1%, p < 0.0001) than ST-CLI. The 1 year outcomes for the whole population were 69.9% limb salvage, 10.9% major amputation, and 19.2% death. The outcomes for NO-CLI and ST-CLI were, respectively, as follows: limb salvage (13.8 vs. 73.4%, p < 0.0001), amputation (30 vs. 4.5%, p = 0.0001), and mortality (50 vs. 8.9%, p < 0.0001). NO-CLI patients showed a more severe pattern of peripheral arterial disease (PAD) with distal arterial lesions and worse outcomes than ST-CLI.
Highlights
A specific limb salvage protocol including lower-limb revascularization for managing ischemic diabetic foot ulcers (DFUs) is well established [1].In recent years, several studies appeared to demonstrate improved rates of limb salvage associated with revascularization in comparison to the medical treatment in patients with peripheral arterial disease (PAD) and DFUs [2].in clinical practice, several cases of technical revascularization failure, defined as the inability to overcome vessel obstruction and/or absence of blood flow to the foot, are still reported [3,4]
Patients with untreatable critical limb ischemia (CLI), termed no-option critical limb ischemia (NO-CLI), are currently a clinical challenge for all clinicians involved in the management of ischemic DFUs, due to the fact that failed or missing revascularization is a predictor of nonhealing, amputation, and mortality [5]
The study group was composed of 239 patients: 179 (74.9%) belonging to the successfully treated CLI patients (ST-CLI) cohort and 60 (25.1%) to the no-option CLI patients (NO-CLI) cohort
Summary
A specific limb salvage protocol including lower-limb revascularization for managing ischemic diabetic foot ulcers (DFUs) is well established [1]. In clinical practice, several cases of technical revascularization failure, defined as the inability to overcome vessel obstruction and/or absence of blood flow to the foot, are still reported [3,4]. Patients with untreatable critical limb ischemia (CLI), termed no-option critical limb ischemia (NO-CLI), are currently a clinical challenge for all clinicians involved in the management of ischemic DFUs, due to the fact that failed or missing revascularization is a predictor of nonhealing, amputation, and mortality [5]. Even though the needs of patients with NO-CLI remain unmet clinically, there is limited data about specific vascular and clinical features. It would be very useful to know the characteristics of NO-CLI patients, in order to evaluate future therapeutic options and their outcomes
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