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Background: A strong association exists between diabetes mellitus and critical limb ischemia. Methods and Results: We performed endovascular therapy on 1060 limbs in 884 patients with below knee lesions only. The patients were divided into diabetes (DG) and nondiabetes groups (NDG). Limb salvage was poorer in the DG (79% vs 89%, P =.0061). No significant difference was observed in mortality, amputation-free survival (AFS), and target vessel revascularization (TVR). Multivariate analysis revealed diabetes status, infection, poor activity of daily living (ADL), younger age, and procedure failure as independent predictors of major amputation in DG. In the NDG, procedure failure was the predictor, and younger age and poor ADL showed tendency of major amputation. Conclusions: Mortality, AFS, and TVR showed no significant difference between the 2 groups, but major amputation was more frequent in DG. Not only revascularization but also infection and diabetes control were very important for limb salvage in DG. [ABSTRACT FROM AUTHOR]

Patients on hemodialysis (HD) have abnormalities of calcium-phosphate (CaP) homeostasis and high CaP product contributes to atherosclerosis pathogenesis and adverse events. Patients on HD with critical limb ischemia (CLI) are at risk for major amputation and death because of advanced systemic atherosclerotic disease. The aim of this study was to evaluate the relationship between CaP product and amputation-free survival (AFS) in CLI after endovascular treatment (EVT). We retrospectively analyzed 221 CLI patients on HD. In Kaplan–Meier analysis, AFS was significantly lower in patients with CaP product ⩾55 mg2/dL2 compared to those with CaP product <55 mg2/dL2 (54.3% vs 78.5%, p = 0.002). However, neither serum phosphate nor calcium levels were individually associated with AFS. In multivariate analysis, CaP product ⩾55 mg2/dL2 was an independent predictor for AFS in CLI patients on HD (hazard ratio, 3.03; 95% confidence interval, 1.78–5.15; p-value <0.001). We concluded abnormal CaP homeostasis was associated with lower AFS after EVT in CLI patients on HD, and can serve for their risk stratification. [ABSTRACT FROM AUTHOR]

Background: Although skin perfusion pressure (SPP) is widely used clinically to predict probability of wound healing, correlation between clinical outcomes and SPP has not been systematically studied. Methods: This subanalysis of the prospective multicenter OLIVE registry of patients who received infrainguinal endovascular therapy (EVT) for critical limb ischemia (CLI) assessed the association between clinical outcomes and postoperative SPP in 211 consecutive patients. Logistic regression analysis was performed, with amputation-free survival (AFS), modified major adverse limb events (MALEs), and complete wound healing as dependent variables and postprocedural SPP as independent variable. Result: Pre- and postprocedural SPP was 28 ± 11 and 46 ± 18 mm Hg, respectively. In logistic regression analysis, postprocedural SPP correlated with 1-year AFS (P = .018), modified MALEs (P < .001), and wound healing (P = .022). Conclusion: Postprocedural SPP correlates with clinical outcomes after EVT for patients with CLI. [ABSTRACT FROM AUTHOR]

Objectives This study sought to investigate the 3-year follow-up results of OLIVE registry patients. Background Although favorable 12-month clinical outcomes after endovascular therapy (EVT) in OLIVE registry patients with critical limb ischemia (CLI) from infrainguinal disease have been reported, long-term results after EVT remain unknown. Methods This was a prospective multicenter registry study that consecutively enrolled patients who received infrainguinal EVT for CLI. The primary outcome was 3-year amputation-free survival (AFS), whereas secondary outcome measures were 3-year freedom from major adverse limb events (MALE), wound-free survival, and wound recurrence rate. Prognostic predictors for each outcome were also elucidated by Cox proportional hazard regression analysis or the log-rank test. Results The completion rate of 3-year follow-up was 95%. Three-year AFS, freedom from MALE, and wound-free survival rates were 55.2%, 84.0%, and 49.6%, respectively. Wound recurrence out to 3 years was 43.9%. After multivariable analysis, age (hazard ratio [HR]: 1.43, p = 0.001), body mass index ≤18.5 (HR: 2.17, p = 0.001), dialysis (HR: 2.91, p < 0.001), and Rutherford 6 (HR: 1.64, p = 0.047) were identified as predictors of 3-year major amputation or death. Statin use (HR: 0.28, p = 0.02), Rutherford 6 (HR: 2.40, p = 0.02), straight-line flow to the foot (HR: 0.27, p = 0.001), and heart failure (HR: 1.96, p = 0.04) were identified as 3-year MALE predictors. Finally, CLI due to isolated below-the-knee lesion was a wound recurrence predictor (HR: 4.28, p ≤ 0.001). Three-year survival, freedom from major amputation, and reintervention rates were 63.0%, 87.9%, and 43.2%. Conclusions In CLI patients with infrainguinal lesions, 3-year clinical results of EVT were reasonable despite high reintervention and moderate ulcer recurrence rate. (A Prospective, Multi-Center, Three-Year Follow-Up Study on Endovascular Treatment for Infra-Inguinal Vessel in Patients With Critical Limb Ischemia [OLIVE 3-Year Follow-Up Study]; UMIN000014759 ) [ABSTRACT FROM AUTHOR]

Although limb salvage rate has improved in critical limb ischemia (CLI), an improvement in CLI prognosis has been scarcely reported. Multidisciplinary therapy (MT) including revascularization, wound bed preparation, treatment of comorbidity, and education of patients with CLI may improve prognosis. The aim of this study was to investigate the effectiveness of MT in prognostic improvement. We retrospectively analyzed 72 patients with CLI and assessed whether MT improved prognosis. The incidence of amputation-free survival (freedom from major amputation [MA] and death) was significantly different between the MT and conventional groups at 2 years (0% vs 33%; P = .024). After multivariate analysis, transfusion (hazard ratio [HR] 5.778; 95% confidence interval [CI], 2.372-14.073; P < .001), multivessel coronary disease (HR 3.353; 95% CI, 1.309-8.590; P = .012), and C-reactive protein >5 mg/dL (HR 3.958; 95% CI, 1.359-11.531; P = .012) were independent predictors for MA or death. We concluded that MT was effective in improved mortality and limb salvage rate. [ABSTRACT FROM AUTHOR]

Objectives This study sought to estimate the 2-year life expectancy (2YLE) (estimated survival rate >50% at 2 years) in patients with critical limb ischemia (CLI) using the risk score based on predictors of all-cause mortality within 2 years. Background It has been reported that 2YLE is one of the important factors in the decision making of the revascularization strategy. However, little is known about the probability and the prognostic factors of a 2YLE. Method This study was performed as a multicenter retrospective analysis. Between March 2004 and December 2011, 995 CLI patients with follow-up period >730 days undergoing endovascular therapy (EVT) were identified and analyzed. Results Within 2 years, 412 patients (41%) died, and a cardiovascular cause accounted for 47% of deaths. On multivariate analysis, the independent prognostic factors were age 65 to 79 years (odds ratio [OR]: 1.9), 80 years of age or older (OR: 3.7), body mass index (BMI) 18.0 to 19.9 kg/m 2 (OR: 1.5), BMI <18.0 kg/m 2 (OR: 2.9), nonambulatory status (OR: 2.4), hemodialysis (OR: 2.1), cerebrovascular disease (OR: 1.6), left ventricular ejection fraction (LVEF) of 40% to 49% (OR: 1.8), LVEF <40% (OR: 2.6), Rutherford class 5 (OR: 1.9), and Rutherford class 6 (OR: 3.4). The 2-year survival rate in each risk score was calculated based on each OR (full score: 15 points). After that, 2YLE was estimated based on the survival rate in each risk score, the probability of a 2YLE of ≥8 points indicated a <50% probability of 2-year survival. Conclusions The independent prognostic factors for the 2YLE were age, BMI, nonambulatory status, hemodialysis, cerebrovascular disease, LVEF, and tissue loss. A 2YLE score of ≥8 points indicated a <50% probability of 2-year survival. This score seemed to be helpful for identifying CLI patients with a poor prognosis. [ABSTRACT FROM AUTHOR]

Purpose: To investigate the impact of angiosome-oriented revascularization on clinical outcomes in critical limb ischemia (CLI) patients excluding those with both diabetes and wound infection. Methods: Using a retrospective multicenter database, a propensity score matching analysis was performed of 539 consecutive CLI patients (375 men; mean age 71 ± 11 years) without concurrent wound infection and diabetes who underwent balloon angioplasty of isolated infrapopliteal lesions. Propensity score matching produced 2 groups of 182 patients each who underwent angiosome-oriented direct revascularization (123 men; mean age 72 ± 11 years) or indirect revascularization (125 men; mean age 72 ± 11 years). The groups were compared for wound healing rate, freedom from major adverse limb events (MALE), and amputation-free survival (AFS). Results: In the overall population, indirect revascularization was performed in 36.6% (n=197). In the propensity matching analysis, the complete wound healing rate at 12 months was higher in the direct group than the indirect revascularization patients (75% vs. 64%, p=0.01), while freedom from MALE (p=0.99) and AFS (p=0.17) were not significantly different at up to 24 months. In multivariate analysis, indirect revascularization had an independent negative impact on wound healing (adjusted hazard ratio 0.7, p=0.008). Conclusion: After propensity matching analysis for CLI patients other than those with both diabetes and wound infection, the wound healing rate was higher after direct revascularization than after indirect revascularization, whereas MALE and AFS were not significantly different. [ABSTRACT FROM AUTHOR]

The article discusses a study which evaluated clinical outcomes of Japanese critical limb ischemia patients with infrainguinal arterial lesions who underwent endovascular treatment (EVT). Data show the amputation-free survival (AFS) rate and adverse limb event-free rate. Findings revealed the association of body mass index, heart failure and wound infection with poor prognosis for AFS, and hemodialysis, heart failure and Rutherford classification with poor prognosis for adverse limb events.

Purpose: To evaluate the long-term clinical results after isolated infrapopliteal balloon angioplasty for critical limb ischemia (CLI) in end-stage renal disease patients on hemodialysis. Methods: Between April 2004 and October 2010, 406 CLI consecutive patients (275 men; mean age 71±11 years) who underwent balloon angioplasty for primary treatment of isolated infrapopliteal artery lesions in 465 limbs were enrolled in a multicenter, nonrandomized registry. The patients were classified into 2 groups, those on hemodialysis (242 patients with 283 limbs) and those not (164 patients with 182 limbs), for a retrospective comparative study of clinical outcomes [target extremity revascularization (TER), major amputation (MA), and survival] at an average 3.4±1.9 years. Results: Freedom from TER at 5 years was lower in the hemodialysis patients (48.3% vs. 65.4% in non-hemodialysis patients, p<0.001); 9.9% of hemodialysis patients had undergone bypass surgery in contrast to 3.8% of non-hemodialysis patients (p=0.011). Freedom from MA was 77.1% in hemodialysis patients and 85.1% in non-hemodialysis patients at 5 years (p=0.058). Hemodialysis patients had significantly poorer survival (24.3% vs. 48.0%, p<0.001) and MA-free survival (20.8% vs. 42.9%, p<0.001) than non-hemodialysis patients at 5 years. Multivariate predictors of MA or all-cause death were non-ambulatory status (p<0.001), gangrene (p=0.036), and higher C-reactive protein levels (p=0.048). Conclusion: Although hemodialysis patients have a higher TER rate compared to the general population, the long-term limb salvage rate after balloon angioplasty for isolated infrapopliteal lesions is acceptable; nevertheless, the MA-free survival rate is very low. [ABSTRACT FROM AUTHOR]