Critical Limb Ischemia Patients Research Articles

WIfI Classification Versus Angiosome Concept: A Change in the Infrapopliteal Angioplasties Paradigm

The objective of this study was to determine whether the angiosome concept and WIfI classification in patients undergoing endovascular treatment is associated with the limb salvage rate and wound healing rate in patients with critical limb ischemia(CLI). This was a retrospective, consecutive cohort study of CLI patients who underwent infrapopliteal angioplasty at the Vascular and Endovascular Surgery Service of the Hospital do Servidor Público Estadual, São Paulo, between January 2013 and January 2019. The primary outcome variable was the limb salvage rate and wound healing rate. The secondary outcome variables were patency, survival, time free from reintervention, and operative mortality rate. Overall, 95 infrapopliteal endovascular procedures were performed in 95 patients. The initial technical success rate was 100%. The mean±standard deviation outpatient follow-up time was 775±107.5days. The analyses were performed at 360days for wound healing rate and 720days for limb salvage rates, overall survival, and time freedom from reintervention. According to the angiosome concept, there were 54 patients (56.8%) classified in the direct group and 41 patients (43.2%) in the indirect group. Regarding the WIfI classification subanalysis, there were 22 patients WIfI 0-1 (23.2%) and 73 patients WIfI 2-3 (76.8%). Furthermore, the indirect group had a higher ulcer healing rate than the direct group; however, it was not statistically significant (82.9%; 66.7%%, respectively, P=0.059). However, the time to heal the ulcer was faster in the WIfI 0-1 groups than WIfI 2-3 groups (164.82days versus 251,48; P=0.017). The limb salvage rates at 720days were similar among indirect and direct Groups (92.6% and 85.4%, P=0.79). Likewise, the freedom from reintervention rates at 720days were also similar in Indirect and direct groups (74.6% and 64%, P=0.23). The survival rates at 720days were similar in both indirect and direct groups (86.8 and 85.6%, respectively; P=0.82). The amputation free survival rate at 720days by the Kaplan-Meier method was 91.3% in the indirect group and 85.9% in the direct group, but with no statistical significance between the groups (P=0.37) CONCLUSIONS: This study concluded that, in endovascular treatment, the angiosome concept is no longer important to limb salvage rates, nor ulcer/wound healing rates. Moreover, the WIfI classification 0-1 is associated with faster and higher wound/ulcer healing rates than WIfI classification 2-3.

CURRENT TRENDS IN CRITICAL LIMB ISCHEMIA - REVIEW

Critical limb ischemia (CLI) is considered the most severe clinical manifestation of peripheral artery disease (PAD). These patients carry high risk of amputation and mortality. CLI patientfaces may problems like restriction of movement, starvation of services and depression. Therapeutic goals in treating these patients include relieving ischemic pain, reducing cardiovascular risk factors, preventing major amputation, improving quality of life and increasing survival.Revascularization is the primary treatment strategy in critical limb ischemia patients. Many patients are not treatable by conventional techniques.This review article provides a comprehensive summary that includes current trends in the management of Critical limb ischemia like endovascular revascularization,gene and cell based therapies and drug eluting stents (DESs) etc.

Targeting QKI-7 in vivo restores endothelial cell function in diabetes

Vascular endothelial cell (EC) dysfunction plays a key role in diabetic complications. This study discovers significant upregulation of Quaking-7 (QKI-7) in iPS cell-derived ECs when exposed to hyperglycemia, and in human iPS-ECs from diabetic patients. QKI-7 is also highly expressed in human coronary arterial ECs from diabetic donors, and on blood vessels from diabetic critical limb ischemia patients undergoing a lower-limb amputation. QKI-7 expression is tightly controlled by RNA splicing factors CUG-BP and hnRNPM through direct binding. QKI-7 upregulation is correlated with disrupted cell barrier, compromised angiogenesis and enhanced monocyte adhesion. RNA immunoprecipitation (RIP) and mRNA-decay assays reveal that QKI-7 binds and promotes mRNA degradation of downstream targets CD144, Neuroligin 1 (NLGN1), and TNF-α-stimulated gene/protein 6 (TSG-6). When hindlimb ischemia is induced in diabetic mice and QKI-7 is knocked-down in vivo in ECs, reperfusion and blood flow recovery are markedly promoted. Manipulation of QKI-7 represents a promising strategy for the treatment of diabetic vascular complications.

The Nitric Oxide System in Peripheral Artery Disease: Connection with Oxidative Stress and Biopterins.

Peripheral artery disease (PAD) pathophysiology extends beyond hemodynamics to include other operating mechanisms, including endothelial dysfunction. Oxidative stress may be linked to endothelial dysfunction by reducing nitric oxide (NO) bioavailability. We aimed to investigate whether the NO system and its regulators are altered in the setting of PAD and to assess the relationship between NO bioavailability and oxidative stress. Sera from 35 patients with intermittent claudication (IC), 26 patients with critical limb ischemia (CLI), and 35 non-PAD controls were analyzed to determine levels of tetrahydrobiopterin (BH4), dihydrobiopterin (BH2), nitrate/nitrite (nitric oxides, or NOx), arginine, citrulline, asymmetric dimethylarginine (ADMA), symmetric dimethylarginine (SDMA), and the oxidative stress markers 8-Oxo-2′-deoxyguanosine (8-OHdG), 4-hydroxynonenal (4-HNE), advanced glycation end products (AGEs), and protein carbonyls. NOx was significantly lower in IC and CLI patients compared to controls in association with elevated oxidative stress, with the greatest NOx reductions observed in CLI. Compared with controls, IC and CLI patients had reduced BH4, elevated BH2, and a reduced BH4/BH2 ratio. SDMA, the arginine/SDMA ratio, and the arginine/ADMA ratio were significantly higher in CLI patients. The NO system and its regulators are significantly compromised in PAD. This dysregulation appears to be driven by increased oxidative stress and worsens as the disease progresses from claudication to CLI.

Herbal therapy treatment in thromboangiitis obliterans: a retrospective clinical study.

Critical limb ischemia in patients with thromboangiitis obliterans (TAO, Buerger's disease) is associated with refractory rest pain, gangrene, and increased rates of amputation. Tuoju lotion was prepared by the Pharmacy Department of Dongfang Hospital. The focus of the study is to elicit the efficacy of the addition of Herbal therapy treatment to conventional treatment in TAO patients with severe extremity pain and to assess any statistically significant benefits in patient's pain control at rest. We fund that the addition of herbal therapy treatment can augment conventional treatments in TAO patients by improving or eliminating intermittent claudication symptoms, prolonging claudication distance, and reducing total blood viscosity. At the same time, Tuoju lotion can improve microcirculation status in the short term. The purpose of this study was to investigate the effect of topical Herbal therapy treatment on patient outcomes in patients with TAO. Seventy patients with TAO treated between January 2009 and July 2019 were included in a retrospective analysis of a single university hospital vascular center. Forty patients received topical herbal treatment in addition to conventional therapy and were compared to a control group who received standard treatment alone (n=30). Patients in both, the experimental and control group, were matched according to age and gender. There was no significant difference in course of disease and past medical history between the two groups. The mean ankle brachial index (ABI), toe pressure, and blood viscosity were also similar in both groups. Rest pain score (baseline VAS 4.76±2.87, post-treatment 3.32±1.29) and walking distance (baseline 169.7±23.6 m, post-treatment 284.5±32.3 m) significantly improved in the herbal treatment group. ABI values improved and total blood viscosity decreased in both groups with no significant difference between the herbal and conservative treatment arms. However, the arterial blood pressure ratio in the lower extremity stage showed no difference between the superficial femoral artery and the popliteal artery. The addition of Herbal therapy treatment to conventional treatment in TAO patients with severe extremity pain was associated with a reduction of rest pain and intermittent claudication.

Limb Salvage in Patients With Severe Critical Limb Ischemia (CLI) After Referral for a Second Opinion to a Dedicated CLI Center.

The complexity of critical limb ischemia (CLI) requires dedicated multidisciplinary teams of different care providers, who will supervise the full cycle of CLI care. Until CLI treatment is fully centralized, such dedicated teams may work as second-opinion tools before major amputation is undertaken in CLI patients. The aim of the study is to assess the effectiveness of a well-timed referral to a dedicated CLI-center of patients scheduled to major amputation elsewhere. A retrospective analysis of all CLI-patients treated in our department between January 2019 and March 2020 was conducted. Only patients scheduled for a major amputation elsewhere and referred to our clinic were included. Primary endpoint was amputation-free survival, whereas technical success, limb salvage, minor amputation rate, re-admission at 30 days, and frequency of medication change from other disciplines were the secondary endpoints. Sixteen patients with 19 treated limbs were identified and included in this analysis. The WIfI (wound, infection and foot ischemia) clinical stage on admission was 2 in 4 limbs (21%), 3 in 5 limbs (26%), and 4 in 10 limbs (53%). All patients underwent advanced endovascular revascularization. Minor amputation was performed in 8 patients (42%). Amputation-free survival at 6 months was 93% with limb salvage rate of 100%. Technical success and re-admission rates at 30 days was 95% and 6%, respectively. There was a medication adjustment from other specialties in 13 (81%) patients. Patients in severe stages of CLI scheduled to major amputation reached high limb salvage and survival rate, since they are referred for a second opinion to a dedicated multidisciplinary CLI team.

Organizational problems and possible ways of its resolve when providing emergency surgical care to patients with comorbid status in a highly specialized medical institution

Purpose of the study. To demonstrate the difficulties of objective interpretation of providing medical care to patients with critical limb ischemia.Materials and methods. The results of treatment of more than 29 thousand patients of one of the highly specialized medical organizations of St. Petersburg were studied, in which the main activity of the staff is the examination of patients with surgical infection of soft tissues (particularly, the critical limb ischemia).Results. It has been ascertained that, despite the unconditional success of providing medical care to patients with critical limb ischemia, a high frequency of unsatisfactory treatment results for this category of patients remains (in 2017, among 685 patients of the specialized department of the highly specialized medical organization, the proportion of cases of performing high amputations of limbs and mortality, respectively, was 11,7% (80) and 2,6% (18)). It has been demonstrated on clinical examples that the pronounced comorbidity of critical limb ischemia patients and the severity of their general condition (combined with organizational difficulties in providing them with providing medical care in conditions of highly specialized medical organization) contribute to the formation of complications (up to lethal outcomes) of not only the underlying, but also concomitant diseases. Difficulties in providing medical care of adequate quality in life-threatening conditions for patients of highly specialized medical organization in cases of critical limb ischemia necessitate a wider interaction between specialists in narrow and multidisciplinary hospitals as part of the emergency surgery service.Conclusion. When creating specialized medical centers outside of multidisciplinary medical institutions, the possibilities should be provided for the regulated involvement of highly professional consultants with a reasonable algorithm for routing patients in cases of the need for their emergency re-hospitalization to other medical institutions.

The Value of Using a Dedicated Vascular Lab in Managing and Treating Diabetic Critical Limb Ischemia Patients

Critical limb ischemia (CLI) is a debilitating end stage of advanced peripheral vascular disease. Treating CLI, particularly in the diabetic patient, is a multifaceted process that requires an experienced team of providers. The CLI model employs practitioners from interventional cardiology, vascular surgery, wound care, endocrinology, nephrology, internal medicine, and podiatry. The main treatment goal is to improve quality of life and reduce the number of limb amputations and the subsequent complications. Often, multiple endovascular procedures are needed to restore perfusion to the lower leg and foot to prevent limb loss. The overall health care savings are significant if limb loss is avoided despite requiring multiple procedures. The number of patients, particularly diabetics, who will need this advanced level of care is only expected to rise.

The Value of Using a Dedicated Vascular Lab in Managing and Treating Diabetic Critical Limb Ischemia Patients Test 0.5 CME

The Value of Using a Dedicated Vascular Lab in Managing and Treating Diabetic Critical Limb Ischemia Patients Test 0.5 CME

Digital Subtraction Angiography Prior to an Amputation for Critical Limb Ischemia (CLI): An Expert Recommendation Statement From the CLI Global Society to Optimize Limb Salvage

Despite recent guideline updates on peripheral artery disease (PAD) and critical limb ischemia (CLI) treatment, the optimal treatment for CLI is still being debated. As a result, care is inconsistent, with many CLI patients undergoing an amputation prior to what many consider to be mandatory: consultation with an interdisciplinary specialty care team and a comprehensive imaging assessment. More importantly, quality imaging is critical in CLI patients with below-the-knee disease. Therefore, the CLI Global Society has put forth an interdisciplinary expert recommendation for superselective digital subtraction angiography (DSA) that includes the ankle and foot in properly indicated CLI patients to optimize limb salvage. A recommended imaging algorithm for CLI patients is included.

Supera Stent for Management of Occlusive Popliteal Artery Disease: an Indian Experience

IntroductionPopliteal artery occlusion is common in elderly, smokers, and patients with diabetes, with globally rising incidence. Angioplasty and stenting are common treatment options available to manage lower limb occlusive diseases. As popliteal artery experiences high biomechanical stress, Supera stent is designed to reduce the risk of stent fractures and for better patency across the knee joint.Aim & ObjectivesThe aim of this study is to evaluate the Supera stent in the management of popliteal artery occlusive disease. The objectives of this study are (1) to evaluate the efficacy of Supera stent in the management of popliteal artery occlusive disease and (2) to prove it as a relatively safe to use option.Material & MethodsPatients who underwent stent implantation in popliteal artery were analyzed with regular/serial follow-up. Critical limb ischemia and intermittent claudication patients were included. Medical records, radiographs, and procedural data were examined. The patients were classified according to Trans-Atlantic Inter Society Consensus II criteria. The femoropopliteal lesions which were classified into TASC B and C categories were included in the study. Stents of 5 mm and 5.5 mm diameter and with various lengths were used to treat all the patients.ResultsA total number of patients with tissue loss and rest pain analyzed were eighty-six and all of them were treated by implanting stents in popliteal artery. In 71.4% of cases, the lesions were found in the proximal segment of the artery. In nearly 95% of cases, technical success was achieved with the use of single stent. The primary and assisted primary patency rates at 24 months were found to be 86.04% and 95.34%, respectively. Notwithstanding the stent placement at a region of high biomechanical stress, there was no case of stent fracture. The limb salvage rate was 100%. The patients who died due to unrelated causes within 90 days of procedure were two.ConclusionThe present study demonstrated that Supera stent is a safe and effective procedure for treating claudication and limb ischemia due to popliteal artery disease.

Evaluation of the proliferative potential of skin keratinocytes and fibroblasts isolated from critical limb ischemia patients.

Impaired wound healing in critical limb ischemia (CLI) results from multiple factors that affect many cell types and their behavior. Epidermal keratinocytes and dermal fibroblasts play crucial roles in wound healing. However, it remains unclear whether these cell types irreversibly convert into a non-proliferative phenotype and are involved in impaired wound healing in CLI. Here, we demonstrate that skin keratinocytes and fibroblasts isolated from CLI patients maintain their proliferative potentials. Epidermal keratinocytes and dermal fibroblasts were isolated from the surrounding skin of foot wounds in CLI patients with diabetic nephropathy on hemodialysis, and their growth potentials were evaluated. It was found that keratinocytes from lower limbs and trunk of patients can give rise to proliferative growing colonies and can be serially passaged. Fibroblasts can also form colonies with a proliferative phenotype. These results indicate that skin keratinocytes and fibroblasts maintain their proliferative capacity even in diabetic and ischemic microenvironments and can be reactivated under appropriate conditions. This study provides strong evidence that the improvement of the cellular microenvironments is a promising therapeutic approach for CLI and these cells can also be used for potential sources of skin reconstruction.

Current and Past Obesity in Japanese Patients with Critical Limb Ischemia Undergoing Revascularization.

Aim: Recent studies suggested that past history of obesity or maximum body mass index (BMI) in the past was a strong prognostic predictor in a general population. The current study aimed to survey the distribution of current and maximum BMIs and to investigate their prognostic impact in patients with critical limb ischemia (CLI), whose prognosis was poor even after revascularization.Methods: We analyzed a database of a prospective, multicenter registry in Japan, including 499 CLI patients undergoing revascularization. Their current and maximum BMIs were surveyed at registration. The distribution and the impact on the prognosis were explored.Results: The estimated means (95% confidence intervals) of current and maximum BMIs were respectively 22.0 (21.7 to 22.3) and 25.3 (24.8 to 25.8) kg/m2; the difference was 3.3 (2.9 to 3.7) kg/m2. The prevalence of current obesity (BMI ≥ 25 kg/m2) was 18% (15% to 22%), whereas 48% (43% to 53%) had ever been obese (maximum BMI ≥ 25 kg/m2). Past obesity was not rare even in currently lean subjects (BMI < 18.5 kg/m2), with the prevalence of 18% (7% to 29%). Current BMI, but not maximum BMI, was associated with the mortality risk; the adjusted hazard ratios per 5 kg/m2 increase were 0.61 [0.46, 0.81] (P = 0.001) and 1.07 [0.87, 1.31] (P = 0.55), respectively.Conclusion: The prevalence of current obesity was as low as 18% (15% to 22%) in Japanese CLI patients undergoing revascularization, whereas about a half were formerly obese. Maximum BMI was not independently associated with the mortality risk in the population.

ACTIVE SMOKING IS ASSOCIATED WITH DECREASED RATES OF WOUND HEALING AFTER ENDOVASCULAR TREATMENT OF CRITICAL LIMB ISCHEMIA

Previous studies have shown that smoking cessation is associated with improved wound healing in diabetic ulcers, but there are few data for the association between active smoking and wound healing in critical limb ischemia (CLI). CLI patients who underwent endovascular interventions were included.

DIFFERENCES BETWEEN PATIENTS WITH INTERMITTENT CLAUDICATION AND CRITICAL LIMB ISCHEMIA UNDERGOING ENDOVASCULAR INTERVENTION

PAD is a spectrum of disease ranging from intermittent claudication (IC) to critical limb ischemia (CLI). Recent data suggest that the underlying pathophysiology of these two diseases may differ. We sought to characterize patient and lesion level differences between IC and CLI patients undergoing

Mitochondrial Structure and Function in the Metabolic Myopathy Accompanying Patients with Critical Limb Ischemia.

Mitochondrial dysfunction has been implicated as a central mechanism in the metabolic myopathy accompanying critical limb ischemia (CLI). However, whether mitochondrial dysfunction is directly related to lower extremity ischemia and the structural and molecular mechanisms underpinning mitochondrial dysfunction in CLI patients is not understood. Here, we aimed to study whether mitochondrial dysfunction is a distinctive characteristic of CLI myopathy by assessing mitochondrial respiration in gastrocnemius muscle from 14 CLI patients (65.3 ± 7.8 y) and 15 matched control patients (CON) with a similar comorbidity risk profile and medication regimen but without peripheral ischemia (67.4 ± 7.4 y). Furthermore, we studied potential structural and molecular mechanisms of mitochondrial dysfunction by measuring total, sub-population, and fiber-type-specific mitochondrial volumetric content and cristae density with transmission electron microscopy and by assessing mitophagy and fission/fusion-related protein expression. Finally, we asked whether commonly used biomarkers of mitochondrial content are valid in patients with cardiovascular disease. CLI patients exhibited inferior mitochondrial respiration compared to CON. This respiratory deficit was not related to lower whole-muscle mitochondrial content or cristae density. However, stratification for fiber types revealed ultrastructural mitochondrial alterations in CLI patients compared to CON. CLI patients exhibited an altered expression of mitophagy-related proteins but not fission/fusion-related proteins compared to CON. Citrate synthase, cytochrome c oxidase subunit IV (COXIV), and 3-hydroxyacyl-CoA dehydrogenase (β-HAD) could not predict mitochondrial content. Mitochondrial dysfunction is a distinctive characteristic of CLI myopathy and is not related to altered organelle content or cristae density. Our results link this intrinsic mitochondrial deficit to dysregulation of the mitochondrial quality control system, which has implications for the development of therapeutic strategies.

High-fat diet pre-conditioning improves microvascular remodelling during regeneration of ischaemic mouse skeletal muscle.

Critical limb ischaemia (CLI) is characterized by inadequate angiogenesis, arteriolar remodelling and chronic myopathy, which are most severe in type 2 diabetic patients. Hypertriglyceridaemia, commonly observed in these patients, compromises macrovascular function. However, the effects of high-fat diet-induced increases in circulating lipids on microvascular remodelling are not established. Here, we investigated if high-fat diet would mimic the detrimental effect of type 2 diabetes on post-ischaemia vascular remodelling and muscle regeneration, using a mouse model of hindlimb ischaemia. Male C57Bl6/J mice were fed with normal or high-fat diets for 8weeks prior to unilateral femoral artery ligation. Laser doppler imaging was used to assess limb perfusion recovery. Vascular recovery, inflammation, myofibre regeneration and fibrosis were assessedat 4 or 14days post-ligation by histology and RNA analyses. Capillary-level haemodynamics were assessed by intravital microscopy of control and regenerating muscles 14days post-ligation. High-fat diet increased muscle succinate dehydrogenase activity and capillary-level oxygen supply. At 4days post-ligation, no diet differences were detected in muscle damage, inflammatory infiltration or capillary activation. At 14days post-ligation, high fat-fed mice displayed accelerated limb blood flow recovery, elevated capillary and arteriole densities as well as greater red blood cell supply rates and capillary-level oxygen supply. Regenerating muscles from high fat-fed mice displayed lower interstitial fat and collagen deposition. The muscle-level adaptations to high-fat diet improved multiple aspects of muscle recovery in response to ischaemia and did not recapitulate the worse outcomes seen in diabetic CLI patients.

3:45 PM Abstract No. 47 MicroStent: initial single-center experience at a vascular center of excellence

(1) Brief overview on the treatments used in critical limb ischemia (CLI) arteries below the knee (BTK) and the current treatment landscape limitations. (2) Guide the reader on the composition of the MicroStent (Micro Medical Solutions, Wilmington, MA) (MS), dedicated for below-the-knee vessels in CLI. (3) Discuss our single-center experience via retrospective analysis and case examples Based on the angiographosome concept, vascular specialists have aimed to revascularize BTK vessels to improve in line flow to aid wound healing and promote limb salvage in Rutherford class (RC) 4-6 patients. Traditional methods spanning from POBA and bare-metal stenting to newer paclitaxel impregnated devices and atherectomy have been the mainstay to restore vessel patency and flow. However, there has been no dedicated peripheral stent for vessels BTK prior to recent advancements. Off label use of coronary stents, such as the 4-mm Resolute Onyx (Medtronic, Dublin, Ireland) have been used to salvage perfusion BTK. MS aims to create an ‘instructions for use’ (IFU) BTK stent for CLI therapy. Here, we share our experience with MS, exploring parameters beyond initial feasibility trials. Single center retrospective analysis in RC 4-6 CLI patients revascularized with MS. The first phase of the study included 8 patients treated from April–November 2018. Ultrasound was obtained for primary patency and hemodynamically significant stenosis with standardized protocol performed by a single technician on prescheduled follow-up visits at 15 days, 30 days, 3 months, 6 months and 1 year. Our analysis examined (1) primary patency, (2) secondary patency (defined as 1 reintervention at target lesion), (3) change of 1 or more RC, (4) wound healing, (5) major amputation and cardiovascular events, and (6) death. The second phase of the study is under enrollment with further analysis to be performed with larger sample size prior to publication. Exploring the safety and efficacy of novel devices for tibiopedal disease is imperative to develop IFU and treatment algorithms in this complex disease. Here, we share our early experience with MS in BTK arteries and what impact it may have to further the fight against amputation and CLI mortality.

4:03 PM Abstract No. 49 Outcomes of below-the-ankle revascularization and impact of pedal arch patency in critical limb ischemia

Report outcomes of below-the-ankle (BTA) revascularization in critical limb ischemia (CLI) and investigate the association of pedal arch patency with limb salvage. A single-center review was conducted of CLI patients undergoing BTA revascularization (2009-2018). Records were reviewed for demographics, comorbidities, technical details and wound healing. Postintervention arteriograms were classified as demonstrating a complete (CPA), incomplete (IPA) or absent (APA) pedal arch. Clinical endpoints included overall survival (OS), minor (ankle preserving) amputation-free survival (AFS) and major (above-the-ankle) AFS at 6- and 12-months following initial BTA intervention. Sixty consecutive Rutherford Class 5 and 6 patients underwent BTA revascularization with concurrent tibial (100%) and femoropopliteal (55%) endovascular therapy. The mean age was 69 years with 58% male, 82% diabetic, 56% CKD and 48% smoker. Angioplasty of 81 BTA lesions (53 dorsalis pedis, 16 pedal arch, 12 lateral plantar) was performed including adjunctive orbital atherectomy in 3 cases. The pedal loop technique was used in 6 cases and retrograde pedal access technique in 18 cases. The 6- and 12-month OS was 95% and 95% with 3 mortalities attributed to cardiac arrest on postop day 32, 44 and 59. The 6- and 12-month minor AFS rate was 63% and 63%, respectively, with average amputation at 0.9 months. The 6- and 12-month major AFS rate was 65% and 58%, respectively, with average amputation at 2.5 months. Mean follow-up was 18.3 months with 43% achieving complete wound healing on average at 7.4 months and 42% censored due to major amputation or death. Postintervention, there were 25 (42%) complete pedal arches (CPA) and 35 (58%) incomplete pedal arches. Subgroup analyses showed no significant difference (P > 0.05) between pedal arch status and demographics, comorbidities, OS, major AFS or wound healing rates. However, the association between CPA and minor AFS was significant (P < 0.001). This study establishes a CPA as predictive of avoiding minor amputation in patients with CLI. Further study to stratify angiographic endpoints and patient selection for BTA intervention is needed.

Malnutrition and Clopidogrel Non-Use Worsen Prognosis of Critical Limb Ischemia Patients After Revascularization.

Background: Critical limb ischemia (CLI) patients have high risk for major adverse cerebrovascular and cardiovascular events. This study investigated the risk factors of cerebrovascular or cardiovascular death in CLI patients with concomitant coronary artery disease (CAD).Methods and Results: The association between baseline characteristics and cerebrovascular or cardiovascular death ≤2 years after revascularization for CLI was investigated in 137 CLI patients who previously underwent successful revascularization for CAD before treatment for CLI. Twenty-three patients (17%) died. Geriatric nutritional risk index (GNRI) in the deceased group (DG) was significantly lower than in the surviving group (SG). On Cox proportional hazard multivariate analysis, hemodialysis (HD) and malnutrition (defined as GNRI <92) were significantly associated with cerebrovascular or cardiovascular death. Also, on Kaplan-Meier analysis, survival rate was significantly lower in CLI patients with either malnutrition or HD compared with patients without either malnutrition or HD, respectively. Furthermore, clopidogrel was less used in the DG than in the SG. The use of clopidogrel was associated with cerebrovascular or cardiovascular death. Especially, non-use of clopidogrel in the malnutrition group further increased the correlation with cerebrovascular or cardiovascular death.Conclusions: Malnutrition is a crucial risk factor for cerebrovascular and cardiovascular death in CLI patients with CAD. Nutritional status intervention and use of clopidogrel may be an important strategy for CLI.