Prevalence Of Critical Limb Ischemia Research Articles

Effects of chronic kidney disease on clinical outcomes in patients with peripheral artery disease undergoing endovascular treatment: Analysis from the K-VIS ELLA registry

ObjectivesChronic kidney disease (CKD) is a risk factor for peripheral artery disease (PAD), but the impact of CKD in PAD patients who received endovascular treatment (EVT) is not well studied. Aim of this study is to clarify the impact of CKD in patients with PAD in real EVT era. MethodsUsing the Korean Vascular Intervention Society (K-VIS) endovascular therapy in lower limb artery disease registry (ELLA) registry, we analyzed 3434 patients who underwent EVT. Baseline characteristics, in-hospital events, and overall- and major adverse limb events (MALE)-free survival were analyzed. Results2739 patients (3548 target limbs) were included. 272 patients featured CKD (9.9%). Limbs in CKD patients had higher Rutherford scores, higher prevalence of critical limb ischemia (CLI). There were no differences in technical success rates in non-CKD vs. CKD group comparison and non-severe CKD vs. severe CKD group comparison (p = 0.050, 0.581, respectively). In-hospital death (p < 0.001) and short-term unexpected amputation (p = 0.028) were more frequent in the CKD group. The short-term outcome differences between severe and non-severe CKD were insignificant. Kaplan–Meier curves favored overall and MALE-free survival in non-CKD patients compared with CKD patients, but there was no difference in overall- or MALE-free survival between non-severe CKD and severe CKD groups. ConclusionPAD patients with CKD showed worse short-term mortality, short-term unexpected amputation outcome, and overall- and MALE-free survival than those without CKD in real EVT era. These findings might provide additive prognostic information for PAD patients with CKD who will be treated with EVT.

Results of primary stent therapy for femoropopliteal peripheral arterial disease at 7 years

ObjectivePrimary stenting is a well-established treatment option for femoropopliteal arterial disease. However, there is a paucity of data concerning the performance of this modality at ≥5 years. This study evaluated the long-term clinical and radiologic outcomes of primary stent therapy in patients with femoropopliteal arterial disease. MethodsA prospective data collection and analysis was conducted in patients undergoing primary stent placement in femoropopliteal lesions between September 2006 and September 2007. The EverFlex (Medtronic/Covidien, Plymouth, Minn) bare-metal stent was used. The primary outcome of this study was the primary patency rate. Secondary outcomes were secondary patency rate, amputation-free-survival (AFS), and freedom from target lesion revascularization (TLR). A Cox regression analysis identified risk factors for the primary and the secondary measure outcomes. ResultsIncluded were 89 patients (102 stents). The prevalence of critical limb ischemia was 34% (n = 30). The initial angiography revealed a TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease C/D lesion in 31 patients (35%). Occlusions were present in 49 patients (55%), and the mean lesion length was 116 ± 33 mm. Popliteal artery disease was present in 39 treated limbs (35%). The primary patency rate at 1, 3, 5, and 7 years was 73%, 64%, 47%, and 33% respectively. At 7 years, secondary patency rate was 67%, freedom from TLR was 47%, and the AFS was 73%. Cox regression analysis revealed a decreased AFS among diabetic patients (hazard ratio [HR], 2.6; 95% confidence interval [CI], 1.08-6.28; P = .03), whereas secondary endovascular interventions showed a protective effect for AFS (HR, 0.14; 95% CI, 0.03-0.65; P = .01). Popliteal artery disease was identified as independent risk factor for secondary interventions (HR, 2.07; 95% CI, 1.05-4.06; P = .04) and TLR (HR, 1.99; 95% CI, 1.03-3.83; P = .04). Critical limb ischemia was associated with an increased incidence of surgical conversion owing to endovascular treatment failure (HR, 5.46; 95% CI, 2.44-12.17; P < .001). ConclusionsThis study found primary stenting was associated with acceptable clinical and radiologic long-term outcomes. Diabetes was associated with poor AFS, and popliteal artery involvement correlated with an increased need for reinterventions. AFS was better among patients undergoing secondary procedures.

Gender-Related Long-term Outcome of Primary Femoropopliteal Stent Placement for Peripheral Artery Disease

Purpose: To evaluate gender-related long-term outcomes in patients undergoing stent treatment of femoropopliteal peripheral artery disease. Methods: Between September 2006 and August 2010, all 517 patients (333 men and 184 women; mean age 70.6 years) undergoing primary stent placement in femoropopliteal atherosclerotic lesions at 2 European vascular centers were prospectively enrolled in the study. The main study outcome was primary stent patency. Secondary outcomes included secondary patency, limb salvage, and all-cause mortality. Results: Women had a higher incidence of critical limb ischemia (32.1% vs. 16.9%, p<0.001). Lesion characteristics according to the TransAtlantic Inter-Society Consensus (TASC) classification were comparable in both genders (p=0.52), although total occlusions and popliteal involvement were observed more frequently in female patients (p=0.043 and p=0.001, respectively). Both genders showed similar 5-year primary patency rates (64.3% men vs. 58.1% women, p=0.11). A statistically significant difference was observed concerning the secondary patency rates in favor of men (71.9% vs. 66.8% at 5 years, p=0.005). Limb salvage rates did not vary between the groups (p=0.83). Survival rates were comparable at 5 years (83.3% and 82.6% for men and women, respectively; p=0.63), although female patients were older at their presentation (68.5 vs. 74.3 years, p<0.001). Female gender was an independent risk factor for restenosis for TASC C/D lesions (primary patency rate 39.8% in women vs. 62.0% in men; p=0.002). Finally, critical limb ischemia was an independent risk factor for restenosis in women (odds ratio 1.5). Conclusion: Female gender was associated with a higher prevalence of critical limb ischemia, poorer secondary patency, and more frequent restenosis in TASC C/D lesions. Endovascular treatment of femoropopliteal lesions provides equal results between genders in terms of primary stent patency in the long term.

Pooled Analysis of the CONFIRM Registries

Purpose: To compare the acute procedure and angiographic outcomes of peripheral artery disease (PAD) patients treated with orbital atherectomy stratified by gender. Methods: The CONFIRM I, II, and III registries are US multicenter, nonrandomized, all-comers registries of PAD patients who were treated with orbital atherectomy. All patients with gender specified in the registry database were included in the current analysis, which compared the final residual stenosis achieved after atherectomy and the rate of acute complications in female and male patients. The 3 registries included 3131 patients with 4761 lesions: 1261 women (mean age 73.2±10.7 years) with 1874 lesions and 1870 men (mean age 70.4±10.2) with 2887 lesions. Results: The women were older (p<0.001) and had a higher but nonsignificant prevalence of critical limb ischemia (p=0.075). After treatment, the final residual stenosis in women vs. men was 9%±11% vs. 11%±11%, respectively (p<0.001). Women had a higher rate of all types of dissection (13.3% vs. 9.9%, p<0.001). However, both genders had similar rates of flow-limiting dissections (1.6% vs. 1.4%, p=0.61), perforation, slow flow, vessel closure, spasm, embolism, and thrombus formation. Conclusion: The gender analysis of the CONFIRM registries revealed that there was successful lesion modification with orbital atherectomy in both men and women; however, women had a higher rate of dissection (all types). This difference is likely because of the older age and higher percentage of critical limb ischemia in women in this cohort. These results, however, suggest that additional studies should be completed to further understand the increased risks for women vs. men during endovascular procedures.

Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population

Critical limb ischemia (CLI) represents the most severe clinical manifestation of peripheral arterial disease (PAD) and is the major cause of ischemic amputation in the United States. Risk factors and the associated incidence and prevalence of CLI have not been well described in the general population. This study describes the risk factors for PAD progression to CLI and estimates the annual incidence and prevalence of CLI in a representative United States patient cohort. This was a retrospective cohort analysis of adults with commercial, Medicare supplemental, or Medicaid health insurance who had at least one PAD or CLI health care claim from January 1, 2003, through December 31, 2008, and 12 months of continuous coverage. Two subgroups of CLI presentation were identified: primary CLI (patients without any prior PAD or subsequent PAD diagnostic code >30 days after CLI diagnostic code) and secondary CLI (patients with prior PAD or subsequent PAD diagnostic codes ≤30 days of a CLI diagnostic code). Patterns of presentation, annual incidence, and prevalence of CLI were stratified by health care plan. Risk factors for progression to CLI were compared by presentation type. From 2003 to 2008, the mean annual incidence of PAD was 2.35% (95% confidence interval [CI], 2.34%-2.36%) and the incidence of CLI was 0.35% (95% CI, 0.34%-0.35%) of the eligible study population, with primary and secondary presentations occurring at similar rates. The mean annualized prevalence of PAD was 10.69% (95% CI, 10.67%10.70%) and the mean annualized prevalence of CLI was 1.33% (95% CI, 1.32%-1.34%) of the eligible study population, and two-thirds of the cases presented as secondary CLI. CLI developed in 11.08% (95% CI, 11.30%-11.13%) of patients with PAD. A multivariable model demonstrated that diabetes, heart failure, stroke, and renal failure were stronger predictors of primary rather than secondary CLI presentation. These data establish new national estimates of the incidence and prevalence of CLI and define key risk factors that contribute to primary or secondary presentations of CLI within a very large contemporary insured population cohort in the United States.

Characteristics of Peripheral Arterial Disease and Its Relevance to the Diabetic Population

Peripheral arterial disease (PAD) is very frequent in diabetics, and it increases with age. Foot examination contributes poorly to diagnosis of PAD. The ankle-brachial index (ABI) measurement is considered the most accurate noninvasive diagnostic method when evaluating PAD: ABI evaluation is recommended in all diabetics aged >50 years. Many diabetic patients with PAD have a concomitant sensitive neuropathy: as a consequence, perception of ischemic pain is remarkably reduced or completely blocked. The result is that the prevalence of claudication in the diabetic population with PAD is lower than the prevalence of critical limb ischemia (CLI) in this population. CLI is a major risk factor for lower extremity amputation without revascularization. Ankle and toe pressures and oxygen tension at the foot are the noninvasive diagnostic parameters of CLI though the medial artery calcification inhibits accurate determination of the ankle and toe pressures, especially when a forefoot ulcer is present. In diabetics, the anatomical localization is mainly distal; arterial wall calcification is frequently observed and occlusion occurs more frequently than stenosis. Such anatomical features, along with the difficulties in the diagnostic approach, account for the fundamental role of CLI as the main prognostic indicator for major amputation. PAD is an expression of systemic atherosclerotic disease. Prognosis of patients with PAD is related to the presence and extent of underlying coronary artery disease (CAD) but also to the severity of PAD: in particular, patients in whom revascularization is not feasible have the highest mortality rate.

Abstract 6053: Long-Term Outcome of Percutaneous Transluminal Angioplasty in Chronic Hemodialysis Patients with Peripheral Arterial Disease

Chronic hemodialysis (HD) patients are at an increased risk for peripheral artery disease (PAD). Although percutaneous transluminal angioplasty (PTA) has become a widely used therapeutic intervention for PAD, its outcome in HD patients remains poorly understood. The aim of this study was to clarify the long-term outcome after PTA in HD patients with PAD. Consecutive 241 HD patients with 418 lesions and 152 non-HD patients with 201 lesions who underwent successful PTA as a first-choice therapeutic option for PAD were enrolled. They were followed for 8 years. Outcome measures included target lesion revascularization (TLR), major amputation, and all-cause mortality. Mean age was younger and prevalence of coronary artery disease and femoropopliteal lesion were significantly more frequent in HD patients (66±10years vs. 71±10years, p=0.0001, 52% vs. 41%, p=0.035 and 71% vs. 52%, p=0.0002, respectively). Prevalence of critical limb ischemia and TASC C+D lesion types were comparable in both groups (45% vs. 34% and 37% vs. 38%, respectively). During 46±38months, the 8-year freedom from TLR (64% vs. 76%, p=0.0057) limb salvage (82% vs. 97%, p=0.0001) and survival rates (52% vs. 87%, p&lt;0.0001) were significantly lower in HD patients, respectively. On Cox multivariate analysis, HD status was strongly predictive of major amputation (HR 4.69, 95%CI 1.34 –16.39, p=0.015) and all-cause death (HR 5.13, 95%CI 2.14 –12.35, p=0.0002) but not of TLR (HR 1.54, 95%CI 0.85–2.78, p=0.15). In HD patients, ulceration/gangrene were independent predictors for all outcome (HR 2.50, 95%CI 1.22–5.09, p=0.0003 for TLR, HR 6.71, 95%CI 2.78 –16.13, p&lt;0.0001 for amputation, and HR 1.95, 95%CI 1.11– 4.20, p=0.017 for all-cause death, respectively). Additional stenting was an independent predictor to reduce TLR in HD patients (HR 0.51, 95%CI 0.28 – 0.94, p=0.031). The long-term outcome after PTA was still poorer in HD patients compared with non-HD patients, but it might be acceptable in HD patients. Ulceration/gangrene was deeply associated with any outcome, thus, the detection at the earlier stage of PAD is important in this population who are at the highest risk for arteriosclerosis. Additional stenting was useful to reduce TLR.

Women and peripheral arterial disease: same disease, different issues

Atherosclerosis is a multifactorial disease and, thus, its clinical manifestations are likely to present gender-specific differences with respect to their development, course, symptom complexes and prognosis. The present study aimed to examine sex differences in peripheral arterial disease (PAD) and its clinical correlates. PAD severity, quality of life (assessed by ST-22), cardiovascular risk factors, inflammatory profile and comorbidity were assessed in 163 men and 68 women who were consecutively diagnosed with PAD at three Italian University vascular centres. Compared to men, women showed a higher prevalence of critical limb ischemia (P = 0.018), but had a less impaired quality of life (assessed by ST-22), and were less likely to have a history of lower extremity revascularization. Furthermore, women tended to be older (P = 0.058), and more likely to present hypercholesterolemia (P = 0.053), diabetes mellitus (P = 0.001), body mass index > or = 30 kg/m2 (P = 0.003) and metabolic syndrome (P = 0.001). Conversely, C-reactive protein plasma levels were similar in the two groups. No gender-specific difference was observed in cardiovascular comorbidity; however, the condition showing the strongest association with coronary artery disease was diabetes mellitus in women (odds ratio = 4.96, P = 0.021), and smoking in men (odds ratio = 2.66, P = 0.008). In PAD, there are several sex differences in baseline characteristics, especially with respect to the weight and significance of cardiovascular risk factors. Knowledge of these differences may help achieve optimal gender-specific cardiovascular risk prevention.