Long-Term Prognosis of Diabetic Patients With Critical Limb Ischemia

Faglia, Ezio; Clerici, Giacomo; Clerissi, J; Gabrielli, L.; Losa, Sergio; Mantero, Manuela; Caminiti, Maurizio; Curci, Vincenzo; Quarantiello, Antonella; Luppattelli, T.; Morabito, Alberto

doi:10.2337/dc08-1223

Cited by 188 publications

(175 citation statements)

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“…ABI <0.9 approximately doubles the risk of mortality and the risk is four-fold higher in patients with ABI values <0.6 [Ankle Brachial Index Collaboration, 2008]. The highest mortality rates were reported in patients in whom revascularization was not possible [Faglia et al 2009]. MAC is indicative of excess cardiovascular mortality [Allison et al 2008].…”

Section: Discussionmentioning

confidence: 99%

Improving major amputation rates in the multicomplex diabetic foot patient: focus on the severity of peripheral arterial disease

Brechow¹,

Slesaczeck²,

Münch³

et al. 2013

Therapeutic Advances in Endocrinology

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Objective: Peripheral arterial disease (PAD), as well as diabetic neuropathy, is a risk factor for the development of diabetic foot ulcers. The aim of this study was to evaluate differences and predictors of outcome parameters in patients with diabetic foot by stratifying these subjects according to the severity of PAD. Research design and methods: In a prospective study, patients with new diabetic foot ulcers have been treated and investigated by structured healthcare. Subjects were recruited between 1 January 2000 and 31 December 2007. All study participants underwent a 2-year follow-up observation period. The patients underwent a standardized examination and classification of their foot ulcers according to a modification of the University of Texas Wound Classification System. The severity of PAD was estimated by measurement of the ankle brachial index (ABI) and the continuous wave Doppler flow curve into undisturbed perfusion (0.9 < ABI < 1.3), compensated perfusion (0.5 < ABI < 0.9), decompensated perfusion (ABI < 0.5) and medial arterial calcification. Results: A total of 678 patients with diabetic foot were consecutively included into the study (69% male, mean age 66.3 ± 11.0 years, mean diabetes duration 15.8 ± 10.2 years). Major amputations (above the ankle) were performed in 4.7% of the patients. 22.1% of these subjects had decompensated PAD. These subjects had delayed ulcer healing, higher risk for major amputation [odds ratio (OR) 7.7, 95% confidence interval (CI) 2.8-21.2, p < 0.001] and mortality (OR 4.9, 95 % CI 1.1-22.1, p < 0.05).Conclusion: This prospective study shows that the severity of PAD significantly influences the outcome of diabetic foot ulcers regarding to wound healing, major amputation and mortality.

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Section: Discussionmentioning

confidence: 99%

Improving major amputation rates in the multicomplex diabetic foot patient: focus on the severity of peripheral arterial disease

Brechow¹,

Slesaczeck²,

Münch³

et al. 2013

Therapeutic Advances in Endocrinology

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“…end points of minor amputation and healing because vessel patency alone is considered necessary but not sufficient to guarantee amputation-free survival. 2,8,21 However, post hoc analysis revealed that DEBs are likely to provide significant improvement in the rate of complete index ulcer healing at 12 months. The possibility that treatment with DEB might result in significant clinical benefit is further compounded by the more favorable distribution of Rutherford classes at follow-up and faster index ulcer healing in the DEB group.…”

Section: Discussionmentioning

confidence: 99%

Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation (DEBATE-BTK)

et al. 2013

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Background-The 1-year restenosis rate after balloon angioplasty of long lesions in below-the-knee arteries may be as high as 70%. Our aim was to investigate the efficacy of a paclitaxel drug-eluting balloons versus conventional percutaneous transluminal angioplasty (PTA) for the reduction of restenosis in diabetic patients with critical limb ischemia undergoing endovascular intervention of below-the-knee arteries. Methods and Results-The Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation(DEBATE-BTK) is a randomized, open-label, single-center study comparing drug-eluting balloons and PTA. Inclusion criteria were diabetes mellitus, critical limb ischemia (Rutherford class 4 or higher), significant stenosis or occlusion >40 mm of at least 1 below-the-knee vessel with distal runoff, and life expectancy >1 year. Binary in-segment restenosis at a 1-year angiographic or ultrasonographic follow-up was the primary end point. Clinically driven target lesion revascularization, major amputation, and target vessel occlusion were the secondary end points. One hundred thirty-two patients with 158 infrapopliteal atherosclerotic lesions were enrolled. Mean length of the treated segments was 129±83 mm in the drugeluting balloon group compared with 131±79 mm in the PTA group (P=0.7). Binary restenosis, assessed by angiography in >90% of patients, occurred in 20 of 74 lesions (27%) in the drug-eluting balloon group compared with 55 of 74 lesions (74%) in the PTA group (P<0.001); target lesion revascularization, in 12 (18%) versus 29 (43%; P=0.002); and target vessel occlusion, in 12 (17%) versus 41 (55%; P<0.001). Only 1 major amputation occurred, in the PTA group (P=0.9). Conclusions-Drug-eluting balloons compared with PTA strikingly reduce 1-year restenosis, target lesion revascularization, and target vessel occlusion in the treatment of below-the-knee lesions in diabetic patients with critical limb ischemia. Clinical Trial Registration-URL: http://ClinicalTrials.gov. Unique identifier: NCT01558505. Received February 6, 2013; accepted June 12, 2013. From the Cardiovascular and Neurological Department (F.L., I.P., P.A., S.G., K.D., G.F., G.V., F.T., G.B., L.B.) and Diabetes Unit (L.R.), San Donato Hospital, Arezzo, Italy; and Department of Cardiovascular Diseases, University of Siena, Le Scotte Hospital, Siena, Italy (S.G.).Correspondence to Francesco Liistro, MD, Cardiovascular and Neurological Department, San Donato Hospital, Via Pietro Nenni 20, 52100, Arezzo, Italy. E-mail francescoliistro@hotmail.com We designed a prospective, randomized trial to compare the performance of a novel DEB (IN.PACT Amphirion, Medtronic, Santa Rosa, CA) with conventional PTA in diabetics with de novo, long atherosclerotic lesions of the BTK area using 1-year binary restenosis rate as the primary end point. Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation (DEBATE-BTK) A Randomized Trial in Diabetic Patients With Critical Limb Ischemia Methods Study DesignThe Drug-Eluting...

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“…Most amputations are carried out on people with diabetes mellitus, who have rampant atherosclerosis and poor angiomyogenesis (2)(3)(4)(5).…”

Section: Introductionmentioning

confidence: 99%

Activation of the Pro-Oxidant PKCβII-p66Shc Signaling Pathway Contributes to Pericyte Dysfunction in Skeletal Muscles of Patients With Diabetes With Critical Limb Ischemia

et al. 2016

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General rightsThis document is made available in accordance with publisher policies. Please cite only the published version using the reference above. Full terms of use are available: http://www.bristol.ac.uk/pure/about/ebr-terms AbstractCritical limb ischemia (CLI), foot ulcers, former amputation and impaired regeneration are independent risk factors for limb amputation in diabetic subjects. The present work investigates whether and by which mechanism diabetes negatively impacts on functional properties of muscular pericytes (MPs), which are resident stem cells committed to reparative angiomyogenesis.We obtained muscle biopsies from diabetic patients undergoing major limb amputation and control subjects. Diabetic muscles collected at the rim of normal tissue surrounding the plane of dissection showed myofibres degeneration, fat deposition, and reduction of MPs vascular coverage. Diabetic MPs (D-MPs) display ultrastructural alterations, a differentiation bias towards adipogenesis at the detriment of myogenesis and an inhibitory activity on angiogenesis. Furthermore, they have an imbalanced redox state, with down-regulation of the anti-oxidant enzymes SOD-1 and catalase and activation of the pro- Myofibres Cross-Sectional AnalysisCryosections from diabetic and control muscle biopsies were stained with anti-laminin antibody and analyzed using an ImageJ macro. For each sample (n=3), the area of more than two thousand single fibres was measured. MP isolationHuman MPs were isolated following well-established procedures (12; 27). Briefly, muscle biopsies were finely minced and digested with collagenase II (100U/mL) for 45min at 37°C on shaking. The digestion mixture was centrifuged and re-suspended in growth medium (α-MEM supplemented with 20% FBS). The cell suspension was filtered through a 70μm cell strainer, dispensed in plastic dishes at clonal density (1000 cell/cm 2 ) and incubated at 37°Cand 5% CO2 in the growth medium. MPs were selected by plastic adherence in culture for at least 10 days when they form colonies positive for ALP, NG2 and CD146 (27). Transmission electron microscopy (TEM)For ultrastructural analysis, a pellet of MPs was fixed for 2h at 4°C in a mixture of 2% paraformaldehyde and 2% glutaraldehyde in 0.05mol/L pH7.3 cacodylate buffer, post-fixed in 1% osmium tetroxide, and embedded in Epon-Araldite. Thin sections were counterstained with uranyl acetate and lead citrate and examined with a Philips/FEI Morgagni electron microscope.7 Immuno-cytochemistryAfter fixation with 4% paraformaldehyde, cells were permeabilized with 0.3% Triton X-100 Microphotographs were acquired using the imaging software AxioVision Imaging System (Zeiss). When required for 3D image acquisition, an Olympus FV 1000 confocal laser scanning microscope with 60X oil immersion lens was used. MP flow cytometryMPs were stained for surface antigen expression using the following antibodies: CD44-APC, CD90-APC, and ALP-PerCP Cy5.5 (all from BD Biosciences). For Ser36-phospho-p66Shc quantification, cells were fixed and permeabilized...

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Long-Term Prognosis of Diabetic Patients With Critical Limb Ischemia

Cited by 188 publications

References 26 publications

Improving major amputation rates in the multicomplex diabetic foot patient: focus on the severity of peripheral arterial disease

Improving major amputation rates in the multicomplex diabetic foot patient: focus on the severity of peripheral arterial disease

Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation (DEBATE-BTK)

Activation of the Pro-Oxidant PKCβII-p66Shc Signaling Pathway Contributes to Pericyte Dysfunction in Skeletal Muscles of Patients With Diabetes With Critical Limb Ischemia

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