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Arterial Ulcers - Overview

Arterial Ulcers - Overview

Arterial Ulcers - Overview


    This topic will be expanded to provide a list of Guidelines, Quality Measures and other resources on Arterial Ulcers. See topic "Arterial Ulcers - Introduction and Assessment" for a review and framework for assessment of arterial ulcers, including epidemiology, risk factors, etiology, pathophysiology, history, physical examination, diagnosis, differential diagnoses, documentation and ICD-10 coding. For clinical guidelines and quality measures, see "Arterial Ulcers - Overview" (coming soon).  For management of arterial ulcers see "Arterial Ulcers - Treatment", and "Arterial Ulcers - Surgical Treatment" (coming soon). For a patient education handout, see topic "Patient Education - Arterial Ulcer" (coming soon).


    RETIRED Local Coverage Determination for Hyperbaric Oxygen (HBO) Therapy (L35021), Association of cardiovascular risk factors with pattern of lower limb atherosclerosis in 2659 patients undergoing angioplasty., 2006 Jan
    Journal: European Journal of Vascular and Endovascular Surgery

    OBJECTIVES: Aim of this study is to correlate distribution pattern of lower limb atherosclerosis with cardiovascular risk factor profile of patients with peripheral arterial occlusive disease (PAD).

    PATIENTS AND METHODS: Analysis is based on a consecutive series of 2659 patients (1583 men, 1076 women, 70+/-11 years) with chronic PAD of atherosclerotic origin undergoing primary endovascular treatment of lower extremity arteries. Pattern of atherosclerosis was grouped into iliac (n=1166), femoropopliteal (n=2151) and infrageniculate (n=888) disease defined according to target lesions treated. A multivariable multinomial logistic regression analysis was performed to assess relation with age, gender and classical cardiovascular risk factors (diabetes mellitus, arterial hypertension, hypercholesterolemia, cigarette smoking) using femoropopliteal disease as reference.

    RESULTS: Iliac disease was associated with younger age (RRR 0.95 per year of age, 95%-CI 0.94-0.96, p< 0.001), male gender (RRR 1.32, 95%-CI 1.09-1.59, p=0.004) and cigarette smoking (RRR 2.02, 95%-CI 1.68-2.42, p< 0.001). Infrageniculate disease was associated with higher age (RRR 1.02, 95%-CI 1.01-1.02, p< 0.001), male gender (RRR 1.23, 95%-CI 1.06-1.41, p=0.005) and diabetes mellitus (RRR 1.68, 95%-CI 1.47-1.92, p< 0.001). Hypercholesterolemia was less prevalent in patients with lesions below the knee (RRR 0.82, 95%-CI 0.71-0.94, p=0.006), whereas no distinct pattern was apparent related to arterial hypertension.

    CONCLUSION: Clinical phenotype of peripheral atherosclerosis varies with prevalence of cardiovascular risk factors suggesting differences in mechanisms involved in iliac as compared with infrageniculate lesions. Identification of molecular mechanism might have influence on future therapeutic strategies in PAD patients.

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    Clinical assessment of peripheral arterial disease of the lower limbs., 2018 May 03
    Journal: The New England Journal of Medicine

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    Prosthetic fitting, use, and satisfaction following lower-limb amputation: a prospective study., 2012
    Journal: Journal of Rehabilitation Research and Development

    Providing a satisfactory, functional prosthesis following lower-limb amputation is a primary goal of rehabilitation. The objectives of this study were to describe the rate of successful prosthetic fitting over a 12 mo period; describe prosthetic use after amputation; and determine factors associated with greater prosthetic fitting, function, and satisfaction. The study design was a multicenter prospective cohort study of individuals undergoing their first major lower-limb amputation because of vascular disease and/or diabetes. At 4 mo, unsuccessful prosthetic fitting was significantly associated with depression, prior arterial reconstruction, diabetes, and pain in the residual limb. At 12 mo, 92% of all subjects were fit with a prosthetic limb and individuals with transfemoral amputation were significantly less likely to have a prosthesis fit. Age older than 55 yr, diagnosis of a major depressive episode, and history of renal dialysis were associated with fewer hours of prosthetic walking. Subjects who were older, had experienced a major depressive episode, and/or were diagnosed with chronic obstructive pulmonary disease had greater functional restriction. Thus, while most individuals achieve successful prosthetic fitting by 1 yr following a first major nontraumatic lower-limb amputation, a number of medical variables and psychosocial factors are associated with prosthetic fitting, utilization, and function.

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    The Impact of Restoring Flow in Order to Preserve Limbs | Today's Wound Clinic, Fighting Peripheral Arterial Disease One Leg at a Time | Today's Wound Clinic, Current Concepts of Non-Traumatic Foot Amputation: Indications and Aftercare | Today's Wound Clinic, Increased platelet aggregates in vascular and nonvascular illness: correlation with plasma fibrinogen and effect of ancrod., 1979 Mar
    Journal: Thrombosis Research

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    Cilostazol increases skin perfusion pressure in severely ischemic limbs., 2011 Jan
    Journal: Angiology

    Skin perfusion pressure (SPP) is a measure of peripheral circulation; low SPP (< 40 mm Hg) indicates poor wound healing. Cilostazol is used to alleviate symptoms and improve walking distance in patients with peripheral artery disease (PAD), but its effect on SPP is unknown. We enrolled patients whose symptoms were Rutherford class 3 or 4 and whose SPP was < 40 mm Hg. We analyzed patient symptoms, ankle-brachial index (ABI), and SPP before and 1 month after treatment with cilostazol. We analyzed 20 legs of 14 patients. Cilostazol improved symptoms in 12 legs. The average heart rate increased from 76 ± 16 to 84 ± 20 beats/min (P < .05). Cilostazol did not increase the ABI but caused a significant increase in the SPP from 24.5 ± 8.88 to 42.8 ± 21.0 mm Hg (P < .01). Cilostazol increases microvascular circulation in severely ischemic limbs and may be useful in critical limb ischemia.

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    Medical management of critical limb ischaemia: where do we stand today?, 2013 Oct
    Journal: Journal of Internal Medicine

    Critical limb ischaemia (CLI) is a severe form of peripheral arterial disease (PAD). CLI often causes disabling symptoms of pain and can lead to loss of the affected limb. It is also associated with increased risk of myocardial infarction, stroke and death from cardiovascular disease. The aims of management in patients with CLI are to relieve ischaemic pain, heal ulcers, prevent limb loss, improve function and quality of life and prolong survival. Here, current evidence regarding the medical management of CLI is reviewed. Cardiovascular risk factors should be assessed in all patients with CLI; smoking cessation and treatment of hypertension, hyperlipidaemia and diabetes all reduce the mortality rate in those with PAD. Antiplatelet agents (either aspirin or clopidogrel) are recommended to reduce both the incidence of cardiovascular events and risk of arterial occlusion. By contrast, routine use of anticoagulation (either warfarin or heparin) is not recommended. Treatment of the limbs themselves is often more challenging. Prostanoids may have some efficacy for treating rest pain and for ulcer healing, and iloprost shows favourable results in reducing the risk of major amputations, but long-term follow-up data regarding disease progression are lacking. There is insufficient evidence to support the use of naftidrofuryl or cilostazol, and pentoxifylline is not beneficial. Furthermore, there is no evidence of proven benefit of hyperbaric oxygen. A number of angiogenic growth factors have been studied in Phase I studies and randomized controlled trials (RCTs). They appear to be safe, but efficacy results have been mixed. Treatment with stem cells also shows some potential from early trials, but further larger RCTs are needed to demonstrate clear benefit. Thrombolysis may be an alternative for patients who develop acute limb ischaemia and are unsuitable for surgical intervention. However, newer endovascular techniques are likely to have a greater role in the future.

    © 2013 The Association for the Publication of the Journal of Internal Medicine.

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    Prostanoids for critical limb ischaemia., 2018 Jan 10
    Journal: Cochrane Database of Systematic Reviews

    BACKGROUND: Peripheral arterial occlusive disease (PAOD) is a common cause of morbidity and mortality due to cardiovascular disease in the general population. Although numerous treatments have been adopted for patients at different disease stages, no option other than amputation is available for patients presenting with critical limb ischaemia (CLI) unsuitable for rescue or reconstructive intervention. In this regard, prostanoids have been proposed as a therapeutic alternative, with the aim of increasing blood supply to the limb with occluded arteries through their vasodilatory, antithrombotic, and anti-inflammatory effects. This is an update of a review first published in 2010.

    OBJECTIVES: To determine the effectiveness and safety of prostanoids in patients with CLI unsuitable for rescue or reconstructive intervention.

    SEARCH METHODS: For this update, the Cochrane Vascular Information Specialist searched the Specialised Register (January 2017) and the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 1). In addition, we searched trials registries (January 2017) and contacted pharmaceutical manufacturers, in our efforts to identify unpublished data and ongoing trials.

    SELECTION CRITERIA: Randomised controlled trials describing the efficacy and safety of prostanoids compared with placebo or other pharmacological control treatments for patients presenting with CLI without chance of rescue or reconstructive intervention.

    DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials, assessed trials for eligibility and methodological quality, and extracted data. We resolved disagreements by consensus or by consultation with a third review author.

    MAIN RESULTS: For this update, 15 additional studies fulfilled selection criteria. We included in this review 33 randomised controlled trials with 4477 participants; 21 compared different prostanoids versus placebo, seven compared prostanoids versus other agents, and five conducted head-to-head comparisons using two different prostanoids.We found low-quality evidence that suggests no clear difference in the incidence of cardiovascular mortality between patients receiving prostanoids and those given placebo (risk ratio (RR) 0.81, 95% confidence interval (CI) 0.41 to 1.58). We found high-quality evidence showing that prostanoids have no effect on the incidence of total amputations when compared with placebo (RR 0.97, 95% CI 0.86 to 1.09). Adverse events were more frequent with prostanoids than with placebo (RR 2.11, 95% CI 1.79 to 2.50; moderate-quality evidence). The most commonly reported adverse events were headache, nausea, vomiting, diarrhoea, flushing, and hypotension. We found moderate-quality evidence showing that prostanoids reduced rest-pain (RR 1.30, 95% CI 1.06 to 1.59) and promoted ulcer healing (RR 1.24, 95% CI 1.04 to 1.48) when compared with placebo, although these small beneficial effects were diluted when we performed a sensitivity analysis that excluded studies at high risk of bias. Additionally, we found evidence of low to very low quality suggesting the effects of prostanoids versus other active agents or versus other prostanoids because studies conducting these comparisons were few and we judged them to be at high risk of bias. None of the included studies assessed quality of life.

    AUTHORS' CONCLUSIONS: We found high-quality evidence showing that prostanoids have no effect on the incidence of total amputations when compared against placebo. Moderate-quality evidence showed small beneficial effects of prostanoids for rest-pain relief and ulcer healing when compared with placebo. Additionally, moderate-quality evidence showed a greater incidence of adverse effects with the use of prostanoids, and low-quality evidence suggests that prostanoids have no effect on cardiovascular mortality when compared with placebo. None of the included studies reported quality of life measurements. The balance between benefits and harms associated with use of prostanoids in patients with critical limb ischaemia with no chance of reconstructive intervention is uncertain; therefore careful assessment of therapeutic alternatives should be considered. Main reasons for downgrading the quality of evidence were high risk of attrition bias and imprecision of effect estimates.

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    A systematic review of intermittent pneumatic compression for critical limb ischaemia., 2015 Feb
    Journal: Vascular Medicine

    Intermittent pneumatic compression (IPC) is designed to aid wound healing and limb salvage for patients with critical limb ischaemia who are not candidates for revascularisation. We conducted a systematic review of the literature to identify and critically appraise the evidence supporting its use in this population. A search was conducted in Embase, MEDLINE and clinical trial registries up to the end of March 2013. No date or language restrictions were applied. Quality assessment was performed by two people independently. Quality was assessed using the Cochrane risk of bias tool and the NICE case-series assessment tool. Two controlled before-and-after (CBA) studies and six case series were identified. One retrospective CBA study involving compression of the calf reported improved limb salvage and wound healing (OR 7.00, 95% CI 1.82 to 26.89, p< 0.01). One prospective CBA study involving sequential compression of the foot and calf reported statistically significant improvements in claudication distances and SF-36 quality of life scores. No difference in all-cause mortality was found. Complications included pain associated with compression, as well as skin abrasion and contact rash as a result of the cuff rubbing against the skin. All studies had a high risk of bias. In conclusion, the limited available results suggest that IPC may be associated with improved limb salvage, wound healing and pain management. However, in the absence of additional well-designed analytical studies examining the effect of IPC in critical limb ischaemia, this treatment remains unproven.

    © The Author(s) 2014.

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    Chapter IV: Treatment of critical limb ischaemia., 2011 Dec
    Journal: European Journal of Vascular and Endovascular Surgery

    Recommendations stated in the TASC II guidelines for the treatment of peripheral arterial disease (PAD) regard a heterogeneous group of patients ranging from claudicants to critical limb ischaemia (CLI) patients. However, specific considerations apply to CLI patients. An important problem regarding the majority of currently available literature that reports on revascularisation strategies for PAD is that it does not focus on CLI patients specifically and studies them as a minor part of the complete cohort. Besides the lack of data on CLI patients, studies use a variety of endpoints, and even similar endpoints are often differentially defined. These considerations result in the fact that most recommendations in this guideline are not of the highest recommendation grade. In the present chapter the treatment of CLI is not based on the TASC II classification of atherosclerotic lesions, since definitions of atherosclerotic lesions are changing along the fast development of endovascular techniques, and inter-individual differences in interpretation of the TASC classification are problematic. Therefore we propose a classification merely based on vascular area of the atherosclerotic disease and the lesion length, which is less complex and eases the interpretation. Lesions and their treatment are discussed from the aorta downwards to the infrapopliteal region. For a subset of lesions, surgical revascularisation is still the gold standard, such as in extensive aorto-iliac lesions, lesions of the common femoral artery and long lesions of the superficial femoral artery (>15 cm), especially when an applicable venous conduit is present, because of higher patency and limb salvage rates, even though the risk of complications is sometimes higher than for endovascular strategies. It is however more and more accepted that an endovascular first strategy is adapted in most iliac, superficial femoral, and in some infrapopliteal lesions. The newer endovascular techniques, i.e. drug-eluting stents and balloons, show promising results especially in infrapopliteal lesions. However, most of these results should still be confirmed in large RCTs focusing on CLI patients. At some point when there is no possibility of an endovascular nor a surgical procedure, some alternative non-reconstructive options have been proposed such as lumbar sympathectomy and spinal cord stimulation. But their effectiveness is limited especially when assessing the results on objective criteria. The additional value of cell-based therapies has still to be proven from large RCTs and should therefore still be confined to a research setting. Altogether this chapter summarises the best available evidence for the treatment of CLI, which is, from multiple perspectives, completely different from claudication. The latter also stresses the importance of well-designed RCTs focusing on CLI patients reporting standardised endpoints, both clinical as well as procedural.

    Copyright © 2011 European Society for Vascular and Endovascular Surgery Urology. Published by Elsevier Ltd. All rights reserved.

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    Spinal cord stimulation for non-reconstructable chronic critical leg ischaemia., 2013 Feb 28
    Journal: Cochrane Database of Systematic Reviews

    BACKGROUND: Patients suffering from inoperable chronic critical leg ischaemia (NR-CCLI) face amputation of the leg. Spinal cord stimulation (SCS) has been proposed as a helpful treatment in addition to standard conservative treatment.

    OBJECTIVES: To find evidence for an improvement on limb salvage, pain relief, and the clinical situation using SCS compared to conservative treatment alone.

    SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched January 2013) and CENTRAL (2012, Issue 12).

    SELECTION CRITERIA: Controlled studies comparing the addition of SCS with any form of conservative treatment to conservative treatment alone in patients with NR-CCLI.

    DATA COLLECTION AND ANALYSIS: Both authors independently assessed the quality of the studies and extracted data.

    MAIN RESULTS: Six studies comprising nearly 450 patients were included. In general the quality of the studies was good. No study was blinded due to the type of intervention.Limb salvage after 12 months was significantly higher in the SCS group (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.56 to 0.90; risk difference (RD) -0.11, 95% CI -0.20 to -0.02). Significant pain relief occurred in both treatment groups, but was more prominent in the SCS group where the patients required significantly less analgesics. In the SCS group, significantly more patients reached Fontaine stage II than in the conservative group (RR 4.9, 95% CI 2.0 to 11.9; RD 0.33, 95% CI 0.19 to 0.47). Overall, no significantly different effect on ulcer healing was observed with the two treatments.Complications of SCS treatment consisted of implantation problems (9%, 95% CI 4 to 15%) and changes in stimulation requiring re-intervention (15%, 95% CI 10 to 20%). Infections of the lead or pulse generator pocket occurred less frequently (3%, 95% CI 0 to 6%). Overall risk of complications with additional SCS treatment was 17% (95% CI 12 to 22%), indicating a number needed to harm of 6 (95% CI 5 to 8).Average overall costs (one study) at two years were EUR 36,500 (SCS group) and EUR 28,600 (conservative group). The difference (EUR 7900) was significant (P < 0.009).

    AUTHORS' CONCLUSIONS: There is evidence to favour SCS over standard conservative treatment alone to improve limb salvage and clinical situations in patients with NR-CCLI. The benefits of SCS must be considered against the possible harm of relatively mild complications and the costs.

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    Treatment of ischemic wounds with noncontact, low-frequency ultrasound: the Mayo clinic experience, 2004-2006., 2007 Apr
    Journal: Advances in skin & wound care

    OBJECTIVE: To evaluate the clinical role of a novel, noncontact, low-intensity, low-frequency ultrasound therapy (MIST Therapy) in the treatment of nonhealing leg and foot ulcers associated with chronic critical limb ischemia.

    DESIGN: Prospective, parallel-group, randomized, controlled trial.

    SETTING: A multidisciplinary, vascular wound-healing clinic.

    PATIENTS: Thirty-five patients who received MIST Therapy plus the standard of wound care (treatment group) and 35 patients who received the standard of wound care alone (control group).

    INTERVENTIONS: Standard of wound care alone or standard of wound care plus MIST Therapy for 12 weeks or until fully healed. MIST Therapy was administered 3 times per week for 5 minutes per treatment.

    MAIN OUTCOME MEASURE: Percentage of patients with greater than 50% reduction in wound size from the index measurement after 12 weeks of treatment. The relationship of transcutaneous oximetry pressure in the supine and dependent position was evaluated as a factor in assessing the potential to heal ischemic ulcerations of the foot and leg.

    MAIN RESULTS: A significantly higher percentage of patients treated with the standard of care plus MIST Therapy achieved greater than 50% wound healing at 12 weeks than those treated with the standard of care alone (63% vs 29%; P < .001). Thus, failure to achieve the minimum wound healing requirement occurred in 37% of patients in the treatment group and 71% of patients in the control group. The predictive value of baseline transcutaneous oxygen pressure may benefit the clinician when assessing the potential to heal ischemic wounds.

    CONCLUSION: The rate of healing of cutaneous foot and leg ulcerations in patients with chronic critical limb ischemia improved significantly when MIST Therapy was combined with the standard of wound care.

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    2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteriesEndorsed by: the European Stroke Organization (ESO)The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS)., 2018 Mar 01
    Journal: European Heart Journal

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    Regional Wound Care: Clinicial Practice Guidelines: Venous, Arterial, and Mixed Lower leg Ulcers. , 2016 Management of peripheral arterial disease (PAD). TASC Working Group. TransAtlantic Inter-Society Consensus (TASC)., 2000 Jan
    Journal: Journal of Vascular Surgery

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    The harms of smoking and benefits of smoking cessation in women compared with men with type 2 diabetes: an observational analysis of the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron modified release Controlled Evaluation) trial., 2016 Jan 08
    Journal: BMJ Open

    OBJECTIVES: In general populations, the adverse effects of smoking on coronary risk have been demonstrated to be greater in women than in men; whether this is true for individuals with diabetes is unclear.

    DESIGN: Cohort study.

    SETTING: 20 countries worldwide participating in the ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron modified release Controlled Evaluation) trial.

    PARTICIPANTS: 11,140 patients with type 2 diabetes aged ≥ 55 years and in cardiovascular risk at the time of randomisation.

    PRIMARY AND SECONDARY OUTCOME MEASURES: Major cardiovascular events (death from cardiovascular disease, non-fatal stroke or non-fatal myocardial infarction (MI)), all cardiovascular events (major cardiovascular event or peripheral arterial disease or transient ischaemic attack), and all-cause mortality. Secondary outcome measures were major coronary events (fatal and non-fatal MI), major cerebrovascular events (fatal and non-fatal stroke), nephropathy (new or worsening renal disease), and all cancer.

    RESULTS: At baseline, 6466 (56% women) participants were never-smokers, 1550 (28% women) were daily smokers and 3124 (21% women) were former smokers. Median follow-up time was 5 years. In Cox regression models after multiple adjustments, compared with never smoking, daily smoking was associated with increased risk of all primary and secondary outcomes with the exception of major cerebrovascular disease. Only for major coronary events was there any evidence of a stronger effect in women than in men (ratio of the adjusted HRs women:men; 1.64 (0.83 to 3.26) p=0.08). For all other outcomes considered, the hazards of smoking were similar in men and women. Quitting smoking was associated with a 30% reduction in all-cause mortality (p=0.001) in both sexes.

    CONCLUSIONS: In individuals with diabetes, the effects of smoking on all major forms of cardiovascular disease are equally as hazardous in women and men with the possible exception of major coronary events where there was some evidence of a greater hazard in women.


    Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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    6. Glycemic Targets: Standards of Medical Care in Diabetes-2019., 2019
    Journal: Diabetes Care

    The American Diabetes Association (ADA) "Standards of Medical Care in Diabetes" includes ADA's current clinical practice recommendations and is intended to provide the components of diabetes care, general treatment goals and guidelines, and tools to evaluate quality of care. Members of the ADA Professional Practice Committee, a multidisciplinary expert committee, are responsible for updating the Standards of Care annually, or more frequently as warranted. For a detailed description of ADA standards, statements, and reports, as well as the evidence-grading system for ADA's clinical practice recommendations, please refer to the Standards of Care Introduction Readers who wish to comment on the Standards of Care are invited to do so at professional.diabetes.org/SOC.

    © 2018 by the American Diabetes Association.

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    Comparison of Clinical Outcomes and Adverse Events Associated With Glucose-Lowering Drugs in Patients With Type 2 Diabetes: A Meta-analysis., 2016 Jul 19
    Journal: The Journal of the American Medical Association

    IMPORTANCE: Numerous glucose-lowering drugs are used to treat type 2 diabetes.

    OBJECTIVE: To estimate the relative efficacy and safety associated with glucose-lowering drugs including insulin.

    DATA SOURCES: Cochrane Library Central Register of Controlled Trials, MEDLINE, and EMBASE databases through March 21, 2016.

    STUDY SELECTION: Randomized clinical trials of 24 weeks' or longer duration.

    DATA EXTRACTION AND SYNTHESIS: Random-effects network meta-analysis.

    MAIN OUTCOMES AND MEASURES: The primary outcome was cardiovascular mortality. Secondary outcomes included all-cause mortality, serious adverse events, myocardial infarction, stroke, hemoglobin A1c (HbA1C) level, treatment failure (rescue treatment or lack of efficacy), hypoglycemia, and body weight.

    RESULTS: A total of 301 clinical trials (1,417,367 patient-months) were included; 177 trials (56,598 patients) of drugs given as monotherapy; 109 trials (53,030 patients) of drugs added to metformin (dual therapy); and 29 trials (10,598 patients) of drugs added to metformin and sulfonylurea (triple therapy). There were no significant differences in associations between any drug class as monotherapy, dual therapy, or triple therapy with odds of cardiovascular or all-cause mortality. Compared with metformin, sulfonylurea (standardized mean difference [SMD], 0.18 [95% CI, 0.01 to 0.34]), thiazolidinedione (SMD, 0.16 [95% CI, 0.00 to 0.31]), DPP-4 inhibitor (SMD, 0.33 [95% CI, 0.13 to 0.52]), and α-glucosidase inhibitor (SMD, 0.35 [95% CI, 0.12 to 0.58]) monotherapy were associated with higher HbA1C levels. Sulfonylurea (odds ratio [OR], 3.13 [95% CI, 2.39 to 4.12]; risk difference [RD], 10% [95% CI, 7% to 13%]) and basal insulin (OR, 17.9 [95% CI, 1.97 to 162]; RD, 10% [95% CI, 0.08% to 20%]) were associated with greatest odds of hypoglycemia. When added to metformin, drugs were associated with similar HbA1C levels, while SGLT-2 inhibitors offered the lowest odds of hypoglycemia (OR, 0.12 [95% CI, 0.08 to 0.18]; RD, -22% [-27% to -18%]). When added to metformin and sulfonylurea, GLP-1 receptor agonists were associated with the lowest odds of hypoglycemia (OR, 0.60 [95% CI, 0.39 to 0.94]; RD, -10% [95% CI, -18% to -2%]).

    CONCLUSIONS AND RELEVANCE: Among adults with type 2 diabetes, there were no significant differences in the associations between any of 9 available classes of glucose-lowering drugs (alone or in combination) and the risk of cardiovascular or all-cause mortality. Metformin was associated with lower or no significant difference in HbA1C levels compared with any other drug classes. All drugs were estimated to be effective when added to metformin. These findings are consistent with American Diabetes Association recommendations for using metformin monotherapy as initial treatment for patients with type 2 diabetes and selection of additional therapies based on patient-specific considerations.

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    Cigarette Smoking: Health Risks and How to Quit (PDQ®): Health Professional Version, 2020

    This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the prevention and cessation of cigarette smoking and the control of tobacco use. It is intended as a resource to inform and assist clinicians who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions. This summary is reviewed regularly and updated as necessary by the PDQ Screening and Prevention Editorial Board, which is editorially independent of the National Cancer Institute (NCI). The summary reflects an independent review of the literature and does not represent a policy statement of NCI or the National Institutes of Health (NIH).

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    Evidence base and strategies for successful smoking cessation., 2010 Jun
    Journal: Journal of Vascular Surgery

    The burden of tobacco dependence can be measured in premature deaths due to accelerated atherosclerotic disease and cancer, and economic costs of lost productivity and intensified medical care. Smoking cessation efforts have benefited from continued pharmacologic developments, increased public awareness of stop-smoking programs, aggressive counter-campaigns to illustrate the toll of cigarette smoking, and recognition of the many primary and secondary effects of smoking exposure on the general public. Vascular surgeons and interventionalists, as well as vascular medicine specialists, are uniquely positioned to engage and educate the patient to promote cessation, monitor for continued abstinence, and assist in efforts to avoid relapses. This article reviews the effects of tobacco dependence on peripheral arterial disease, perioperative considerations in smokers, as well as common clinical interventions such as counseling and pharmacotherapy to encourage tobacco cessation.

    Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

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    Systematic literature review of randomized trials comparing antithrombotic therapy following revascularization procedures in patients with peripheral artery disease., 2020 Jul 08
    Journal: Angiology

    A systematic literature review was conducted to identify and summarize the clinical efficacy and safety of available antithrombotic therapies after peripheral endovascular or surgical revascularization in patients with peripheral artery disease (PAD). Five databases were searched using free-text and Emtree/Mesh terms for PAD, randomized controlled trials (RCTs), and antithrombotic therapies of interest (ie, single antiplatelet therapy, dual antiplatelet therapy, and vitamin K antagonists). Randomized controlled trials were eligible for inclusion if they assessed the risk of thrombotic events (ie, myocardial infarction, ischemic stroke, cardiovascular death, limb ischemia, or limb amputation) or safety profile (ie, minor, moderate, major, or fatal bleeding events) after revascularization. In total, 16 RCTs were identified. Only a few studies reported on treatment effects of the investigated therapies. Myocardial infarction, ischemic stroke, cardiovascular death, and amputation were reported in up to 2.3%, 2.3%, 5.6%, and 7.3% of patients, respectively. Bleeding events were observed in up to 8.4% (major) and 1.5% (fatal) of patients. Despite available treatments, patients with PAD undergoing revascularization remain at risk of thrombotic events. There is a need for new treatments that will help to optimize care for patients with symptomatic PAD undergoing revascularization.

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    A systematic literature review of quality of life in lower limb amputees., 2011
    Journal: Disability and rehabilitation

    PURPOSE: To systematically review studies on quality of life (QoL) in lower limb amputees.

    METHOD: Computerised literature search of MEDLINE, CINAHL, PUBMED and PsycINFO databases was performed using the keywords, amputee, leg, knee, foot, amputation, QoL, prosthesis, orthopaedic equipment, ADL, phantom, mobility, rehabilitation, psychosocial, psychology and social. Eligible studies published from database inception through March 2009 were selected. The study was included if (1) the study population comprised of adolescent and adult lower-limb amputees as a group or a sub-group, and had ten or more subjects; (2) the study involved subjective assessment of QoL or self-appraisal of life or satisfaction with life; (3) the study was an empirical research study and (4) at least one of the study outcomes was QoL or self-appreciation of life, and QoL results were presented. The selected articles were assessed for study quality based on a standardised set of 19 criteria. The criteria list was pilot-tested for applicability and operationalisation by the authors. Objectives, study population description, QoL instruments used and study outcomes were summarised for the included studies.

    RESULTS: Twenty-six articles met the inclusion criteria. Fifteen studies were cross-sectional, four prospective, six retrospective and one mixed study-design. The studies were found to be heterogeneous with respect to the study objectives and instruments used to assess QoL. The summary quality score was 50% or more for ten studies, with the maximum being 81%.

    CONCLUSIONS: Lacunas were found in the methodological and study population characteristics of most of the studies. Prospective longitudinal studies are envisaged to systematically study the events following amputation, and the change in QoL over time. To enable this, amputee specific standardised and validated QoL instruments are needed to capture the multitude of facets influencing QoL in amputees, and thereby, facilitating direct comparison across studies.

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    The Edinburgh Claudication Questionnaire: an improved version of the WHO/Rose Questionnaire for use in epidemiological surveys., 1992 Oct
    Journal: Journal of Clinical Epidemiology

    The WHO/Rose Questionnaire on intermittent claudication was developed in 1962 for use in epidemiological surveys, and has been widely used. Several population studies have shown, however, that it is only moderately sensitive (60-68%), although highly specific (90-100%). In this study, reasons for the poor sensitivity and good specificity were determined following its application to 586 claudicants and to 61 subjects with other causes of leg pain. The results showed two important findings: firstly, that over half of the false negatives were produced by one question alone; and secondly that only three questions were required to maintain the specificity of the questionnaire. This knowledge, in conjunction with the pre-testing of additional questions, enabled a new questionnaire to be constructed: the "Edinburgh Claudication Questionnaire". This questionnaire was tested on 300 subjects aged over 55 years attending their general practitioner, and found to be 91.3% (95% CI 88.1-94.5%) sensitive and 99.3% (95% CI 98.9-100%) specific in comparison to the diagnosis of intermittent claudication made by a physician. The repeatability of the questionnaire after 6 months was excellent (kappa = 0.76, p < 0.001). These results suggest that this revised version of the WHO/Rose Questionnaire should be adopted for use in future epidemiological surveys of peripheral vascular disease.

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    Self-administration of a questionnaire on chest pain and intermittent claudication., 1977 Mar 01
    Journal: Journal of Epidemiology & Community Health

    A total of 18 403 men aged between 40 and 64 years took part in a screening examination which included a self-administered version of the London School of Hygiene questionnaire on chest pain and intermittent claudication. The yield of positives for "angina" and "history of possible infarction" was about twice as high as with interviewers, but the positive groups obtained by the two techniques differed little in their association with electrocardiographic findings or in their ability to predict five-year coronary mortality risk. This risk ranged from 0-9% in men negative to questionnaire and electrocardiograms (ECG), to 4-3% for those with positive ECG but no symptoms, 4-5% for those with angina and negative ECG, up to 16% for those with angina and positive ECG. The self-administered version of this questionnaire provides a simple and convenient means of identifying individuals with a high risk of major coronary heart disease.

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    Wound vs. Ulcer: Selecting the Correct Diagnosis Code, 2019 Aug 01 Diagnostic performance of computed tomography angiography in peripheral arterial disease: a systematic review and meta-analysis., 2009 Jan 28
    Journal: The Journal of the American Medical Association

    CONTEXT: Computed tomography angiography (CTA) is an increasingly attractive imaging modality for assessing lower extremity peripheral arterial disease (PAD).

    OBJECTIVE: To determine the accuracy of CTA compared with intra-arterial digital subtraction angiography (DSA) in differentiating extent of disease in patients with PAD.

    DATA SOURCES AND STUDY SELECTION: Search of MEDLINE (January 1966-August 2008), EMBASE (January 1980-August 2008), and the Database of Abstracts of Reviews of Effectiveness for studies comparing CTA with intra-arterial DSA for PAD. Eligible studies compared multidetector CTA with intra-arterial DSA, included at least 10 patients with intermittent claudication or critical limb ischemia, aimed to detect more than 50% stenosis or arterial occlusion, and presented either 2 x 2 or 3 x 3 contingency tables (< or = 50% stenosis vs > 50% stenosis or occlusion), or provided data allowing their construction.

    DATA EXTRACTION: Two reviewers screened potential studies for inclusion and independently extracted study data. Methodological quality was assessed by using the QUADAS instrument.

    DATA SYNTHESIS: Of 909 studies identified, 20 (2.2%) met the inclusion criteria. These 20 studies had a median sample size of 33 (range, 16-279) and included 957 patients, predominantly with intermittent claudication (68%). Methodological quality was moderate. Overall, the sensitivity of CTA for detecting more than 50% stenosis or occlusion was 95% (95% confidence interval [CI], 92%-97%) and specificity was 96% (95% CI, 93%-97%). Computed tomography angiography correctly identified occlusions in 94% of segments, the presence of more than 50% stenosis in 87% of segments, and absence of significant stenosis in 96% of segments. Overstaging occurred in 8% of segments and understaging in 15%.

    CONCLUSION: Computed tomography angiography is an accurate modality to assess presence and extent of PAD in patients with intermittent claudication; however, methodological weaknesses of examined studies prevent definitive conclusions from these data.

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    A comparison of magnetic resonance angiography, contrast arteriography, and duplex arteriography for patients undergoing lower extremity revascularization., 2004 May
    Journal: Annals of Vascular Surgery

    The objective of this study was to compare magnetic resonance angiography (MRA), contrast arteriography (CA), and duplex arteriography (DA) for defining anatomic features relevant to performing lower extremity revascularizations. From March 1, 2001 to August 1, 2001, 33 consecutive inpatients with chronic lower extremity ischemia underwent CA, MRA, and DA before undergoing lower extremity revascularization procedures. The reports of these tests were compared prospectively and the differences in the aortoiliac segment, femoral-popliteal, and infrapopliteal segments were noted. The vessels were classified as mild disease (< 50%), moderate disease (50-70%), severe disease (71-99%), and occluded. These studies and treatment plans based on these data were compared. During this time period, 11 patients were not able to undergo MRA and therefore were excluded from the study. Thirty-three patients were included in this study. These patients underwent 35 procedures, as 2 patients underwent bilateral procedures. The mean age of the 33 patients was 76+/-10 years (SD). Indications for the procedures included gangrene (20), ischemic ulcer (8), rest pain (4), and severe claudication (1). Patients' medical history included diabetes mellitus (25), hypertension (20), and end-stage renal disease (5). No differences were noted between intraoperative findings and CA in this series. Two of the three differences between DA and CA were felt to be clinically significant whereas 9 of the 12 differences between MRA and CA were felt to be clinically significant. On the basis of these data in this series, MRA does not yet seem to be able to obtain adequate data on infrapopliteal segments, at least not for this highly selected population. When severe tibial calcification or very low flow states are identified, CA may be necessary for patients undergoing DA.

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    Duplex ultrasound scanning defines operative strategies for patients with limb-threatening ischemia., 1998 Sep
    Journal: Journal of Vascular Surgery

    PURPOSE: To characterize the accuracy of color-flow duplex ultrasound (DUS) in planning lower extremity revascularization procedures, we prospectively compared operations predicted by means of DUS arterial scanning (DUSAS) and operations predicted by means of conventional angiography (CA) with actual operations performed in 36 patients undergoing 40 vascular reconstructions for critical (grade II/III) lower extremity ischemia.

    METHODS: All patients were examined with lower extremity DUSAS followed by CA. DUSAS was performed from the aorta to the pedal vessels of the affected extremity. Adequacy of inflow was assessed, and the best distal target vessel with continuous, unobstructed flow was defined. An operative prediction was made and recorded based upon the DUSAS findings, and in a blinded fashion, based upon subsequent CA. The McNemar test for comparing correlated proportions was applied to test for the statistical significance of the difference (P < .05) between correct operations predicted by DUSAS and CA.

    RESULTS: Of the actual operations performed, 83% were correctly predicted by means of DUSAS (95% CI; range, 77% to 89%). Seven operations were incorrectly predicted with DUSAS. Of the actual operations performed, 90% were correctly predicted by means of CA (95% CI; range, 81% to 99%). Four operations were incorrectly predicted with CA. The McNemar test determined that the difference between correct operations predicted by means of DUSAS and correct operations predicted by means of CA was not statistically significant (P = .50).

    CONCLUSIONS: With few exceptions, DUSAS can be used to reliably predict infrainguinal reconstruction strategies. Vessels defined as adequate with DUSAS are rarely unfit for bypass. Prospective investigation of lower extremity revascularization based solely upon DUSAS is warranted.

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    Comparison of ankle pressure, systolic toe pressure, and transcutaneous oxygen pressure to predict major amputation after 1 year in the COPART cohort., 2019
    Journal: Angiology

    The hemodynamic definition of critical limb ischemia (CLI) has evolved over time but remains controversial. We compared the prediction of major amputation by 3 hemodynamic methods. Patients were selected from the Cohorte des Patients ARTériopathes cohort of patients hospitalized for peripheral arterial disease. Patients with CLI were enrolled according to the Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease II definition and followed up for at least 1 year. We compared the major amputation rate according to initial ankle pressure (AP), systolic toe pressure (STP), and forefoot transcutaneous oxygen pressure (TcPO2); 556 patients were included and divided into surgical (264) and medical (292) groups. The AP failed to identify 42% of patients with CLI. After 1 year, 27% of medical and 17% of surgical patients had undergone major amputation. The TP < 30 mm Hg predicted major amputation in the whole sample and in the medical group (odds ratio [OR] 3.5 [1.7-7.1] and OR 5 [2-12.4], respectively), but AP did not. The TcPO2 < 10 mm Hg also predicted major amputation (OR 2.3 [1.5-3.5] and OR 3.8 [2.1-6.8]). The best predictive thresholds to predict major amputation were STP < 30 mm Hg and TcPO2 < 10 mm Hg. None of these methods performed before surgery was able to predict outcome in the revascularized patients.

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    The association between elevated ankle systolic pressures and peripheral occlusive arterial disease in diabetic and nondiabetic subjects., 2008 Nov
    Journal: Journal of Vascular Surgery

    OBJECTIVE: The presence of a high ankle-brachial index (ABI) is related to stiff ankle arteries due to medial calcification. Recently, this condition has attracted new interest after reports of a worse cardiovascular prognosis, similar to a low ABI. We sought to compare risk factors contributing to a low (< or =0.90) and high (> or =1.40) ABI. Additionally, we hypothesized that in instances of high ABI, occlusive PAD may coexist.

    METHOD: This cross-sectional study was conducted at vascular laboratories in a university medical center. The subjects were 510 ambulatory patients (37% had diabetes) previously examined at our vascular laboratories and who responded positively to our invitation. We collected data on smoking, diabetes, hypertension, dyslipidemia, and cardiovascular disease history. The noninvasive assessment of lower limb arteries consisted of the measurement of ABI, toe-brachial index (TBI), and posterior tibial artery peak flow velocity (Pk-PT). A TBI >0.7 and a Pk-PT >10 cm/s were considered normal.

    RESULTS: High- and low-ABI were detected, respectively, in 2.1% and 57.8% of limbs. For a low ABI, age (odds ratio [OR], 1.29/10 y), pack-years (OR, 1.08/10 units), and hypertension (OR, 1.90) were independent significant (P < .001) factors. A strong association was found between diabetes and high ABI (OR, 16.0; P < .001). When ABI ranges were compared with TBI and Pk-PT results, those with ABI < or =0.90 and ABI > or =1.40 presented similar patterns of abnormalities. Pk-PT or TBI, or both, was abnormal in more than 80% of cases in both ABI < or =0.90 and > or =1.40 groups. The ABI vs TBI relationship appeared linear in nondiabetic patients, but had an inverted J-shape in diabetic patients, suggesting high ABI masked leg ischemia.

    CONCLUSIONS: Diabetes is the dominant risk factor for a high (> or =1.40) ABI. Occlusive PAD is highly prevalent in subjects with high ABI, and these subjects should be considered as PAD-equivalent.

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    The vascular territories (angiosomes) of the body: experimental study and clinical applications., 1987 Mar
    Journal: British journal of plastic surgery

    The blood supply to the skin and underlying tissues was investigated by ink injection studies, dissection, perforator mapping and radiographic analysis of fresh cadavers and isolated limbs. The results were correlated with previous regional studies done in this department. The blood supply is shown to be a continuous three-dimensional network of vessels not only in the skin but in all tissue layers. The anatomical territory of a source artery in the skin and deep tissues was found to correspond in most cases, giving rise to the angiosome concept. Arteries follow closely the connective tissue framework of the body. The primary supply to the skin is by direct cutaneous arteries which vary in calibre, length and density in different regions. This primary supply is reinforced by numerous small indirect vessels, which are "spent" terminal branches of arteries supplying the deep tissues. An average of 374 major perforators was plotted in each subject, revealing that there are still many more potential skin flaps. Our arterial roadmap of the body provides the basis for the logical planning of incisions and flaps. The angiosomes defined the tissues available for composite transfer.

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    Angiosomes of the foot and ankle and clinical implications for limb salvage: reconstruction, incisions, and revascularization., 2006 Jun
    Journal: Plastic and Reconstructive Surgery

    BACKGROUND: Ian Taylor introduced the angiosome concept, separating the body into distinct three-dimensional blocks of tissue fed by source arteries. Understanding the angiosomes of the foot and ankle and the interaction among their source arteries is clinically useful in surgery of the foot and ankle, especially in the presence of peripheral vascular disease.

    METHODS: In 50 cadaver dissections of the lower extremity, arteries were injected with methyl methacrylate in different colors and dissected. Preoperatively, each reconstructive patient's vascular anatomy was routinely analyzed using a Doppler instrument and the results were evaluated.

    RESULTS: There are six angiosomes of the foot and ankle originating from the three main arteries and their branches to the foot and ankle. The three branches of the posterior tibial artery each supply distinct portions of the plantar foot. The two branches of the peroneal artery supply the anterolateral portion of the ankle and rear foot. The anterior tibial artery supplies the anterior ankle, and its continuation, the dorsalis pedis artery, supplies the dorsum of the foot. Blood flow to the foot and ankle is redundant, because the three major arteries feeding the foot have multiple arterial-arterial connections. By selectively performing a Doppler examination of these connections, it is possible to quickly map the existing vascular tree and the direction of flow.

    CONCLUSIONS: Detailed knowledge of the vascular anatomy of the foot and ankle allows the plastic surgeon to plan vascularly sound reconstructions, the foot and ankle surgeon to design safe exposures of the underlying skeleton, and the vascular surgeon to choose the most effective revascularization for a given wound.

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    Angiosome theory: fact or fiction?, 2012
    Journal: Scandinavian journal of surgery : SJS : official organ for the Finnish Surgical Society and the Scandinavian Surgical Society

    The angiosome concept delineates the human body into three-dimensional blocks of tissue fed by specific arterial and venous sources named "angiosomes." Adjacent angiosomes are connected by a vast compensatory collateral web, or "choke vessels." This concept may provide new information applicable to improving targeted revascularization of ischemic tissue lesions. A few dedicated studies available seem to favor this strategy, as encouraging ulcer healing and limb preservation are reported in connection with both bypass and endovascular techniques based on these principles. The theory on the angiosome model of revascularization (AMV) may help the clinician to better refine vessel selection, vascular access, and specific strategies in the revascularization of critically ischemic legs with tissue lesions. Specific applications of angiosome-guided revascularization were recently suggested for patients with diabetes or renal insufficiency, with ischemic tissue lesions of the lower limb, and extended large- and medium-size collateral network decay. For these cases, the concept may allow deliberate arterial reconstruction following individual wound topographies in specific ischemic areas, although deprived from "rescue-vessel" supply. The AMV theory may contribute to a shift in common reperfusion options. However, the data available is suggestive and does not provide strong evidence as factors such as case mix and the severity of ischemia are unsatisfactorily controlled. At present, the evidence is scarce as to the effect of the severity of the arterial disease. In all comparisons, the groups treated are likely to be dissimilar and mismatched. The angiosome concept is postulated to be valid especially in diabetics, whose ischemic lesions tend to heal worse than those of non-diabetics.

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    Practice guidelines for the diagnosis and management of skin and soft tissue infections: 2014 update by the infectious diseases society of America., 2014 Jul 15
    Journal: Clinical Infectious Diseases

    A panel of national experts was convened by the Infectious Diseases Society of America (IDSA) to update the 2005 guidelines for the treatment of skin and soft tissue infections (SSTIs). The panel's recommendations were developed to be concordant with the recently published IDSA guidelines for the treatment of methicillin-resistant Staphylococcus aureus infections. The focus of this guideline is the diagnosis and appropriate treatment of diverse SSTIs ranging from minor superficial infections to life-threatening infections such as necrotizing fasciitis. In addition, because of an increasing number of immunocompromised hosts worldwide, the guideline addresses the wide array of SSTIs that occur in this population. These guidelines emphasize the importance of clinical skills in promptly diagnosing SSTIs, identifying the pathogen, and administering effective treatments in a timely fashion.

    © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

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    The diagnosis of osteomyelitis in diabetes using erythrocyte sedimentation rate: a pilot study., 2001 Oct
    Journal: Journal of the American Podiatric Medical Association

    Osteomyelitis secondary to diabetic foot infections can lead to proximal amputation if not diagnosed in a timely and accurate manner. The authors have found no studies to date that correlate a specific erythrocyte sedimentation rate with osteomyelitis. A retrospective chart review of 29 diabetic patients admitted to the hospital with diagnoses of osteomyelitis or cellulitis of the foot during a 1-year period was performed. Of the various lab values and demographic factors compared, erythrocyte sedimentation rate was the only measure that differed significantly between the two groups. A receiver operating characteristic curve was used to obtain the optimal cutoff value of 70 mm/h, a level above which osteomyelitis was present with the highest sensitivity (89.5%) and highest specificity (100%), along with a positive predictive value of 100% and a negative predictive value of 83%. This study shows that in combination with clinical suspicion in diabetic foot infections, the erythrocyte sedimentation rate is highly predictive of osteomyelitis, and that the value of 70 mm/h is the optimal cutoff to predict accurately the presence or absence of bone infection.

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    Arterial ulcer checklist., 2010 Sep
    Journal: Advances in skin & wound care

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    An absent pulse is not sensitive for the early detection of peripheral arterial disease., 2006 Jan
    Journal: Family Medicine

    BACKGROUND: This study's objective was to determine the test characteristics of pedal pulse palpation in the diagnosis of peripheral arterial disease (PAD) when compared to the more widely recommended screening tool, the ankle-brachial index (ABI).

    METHODS: We screened patients > 50 years of age for PAD within primary care clinics in Houston. PAD was diagnosed by an ABI of < 0.9. At each visit, pedal pulse palpation was performed for each leg. Of the patients who screened positive for PAD by ABI, we determined the sensitivity, specificity, and positive predictive value of pulse palpation.

    RESULTS: We enrolled 403 patients with a mean age of 63.8 +/- .36 years. The prevalence of PAD was 16.6% (67 patients total). Of the 45 patients with disease involving their left leg, 37 (82.2%) had a palpable pulse. Of the 37 patients with disease involving their right leg, 25 (67.6%) had a palpable pulse. The sensitivity of a non-detectable pulse for the diagnosis of PAD was 17.8% and 32.4% for the left leg and the right leg, respectively. The specificity of pulse palpation for the detection of PAD was 98.7% and 97.8% for the left leg and the right leg, respectively.

    CONCLUSIONS: Pulse palpation is not sensitive for the detection of PAD compared to ABI. More than two thirds of the patients within our cohort with PAD of either the left or right leg had a detectable pulse.

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    Update and validation of the Society for Vascular Surgery wound, ischemia, and foot infection threatened limb classification system., 2014 Mar
    Journal: Seminars in vascular surgery

    The diagnosis of critical limb ischemia, first defined in 1982, was intended to delineate a patient cohort with a threatened limb and at risk for amputation due to severe peripheral arterial disease. The influence of diabetes and its associated neuropathy on the pathogenesis-threatened limb was an excluded comorbidity, despite its known contribution to amputation risk. The Fontaine and Rutherford classifications of limb ischemia severity have also been used to predict amputation risk and the likelihood of tissue healing. The dramatic increase in the prevalence of diabetes mellitus and the expanding techniques of arterial revascularization has prompted modification of peripheral arterial disease classification schemes to improve outcomes analysis for patients with threatened limbs. The diabetic patient with foot ulceration and infection is at risk for limb loss, with abnormal arterial perfusion as only one determinant of outcome. The wound extent and severity of infection also impact the likelihood of limb loss. To better predict amputation risk, the Society for Vascular Surgery Lower Extremity Guidelines Committee developed a classification of the threatened lower extremity that reflects these important clinical considerations. Risk stratification is based on three major factors that impact amputation risk and clinical management: wound, ischemia, and foot infection. This classification scheme is relevant to the patient with critical limb ischemia because many are also diabetic. Implementation of the wound, ischemia, and foot infection classification system in critical limb ischemia patients is recommended and should assist the clinician in more meaningful analysis of outcomes for various forms of wound and arterial revascularizations procedures required in this challenging, patient population.

    Copyright © 2014 Elsevier Inc. All rights reserved.

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    Validation of the Wound, Ischemia, foot Infection (WIfI) classification system in nondiabetic patients treated by endovascular means for critical limb ischemia., 2016 Jul
    Journal: Journal of Vascular Surgery

    BACKGROUND: The Society for Vascular Surgery Lower Extremity Guidelines Committee developed the Wound, Ischemia, foot Infection (WIfI) a classification system to predict the amputation risk in patients with critical limb ischemia (CLI). A number of published studies have already evaluated its prognostic value. However, most of the included patients were diabetic, and the validation was done independent of the revascularization procedure. This single-center study evaluated the prognostic value of WIfI stages in nondiabetic patients treated by endovascular means.

    METHODS: A retrospective analysis was performed of prospectively collected data of nondiabetic patients treated by endovascular means between January 2013 and September 2014. All patients were classified according to their wound status, ischemia index, and extent of foot infection to four classes: very low risk, low risk, moderate risk, and high risk. Comorbidities and vascular lesions for each group were analyzed. The prognostic value of WIfI was analyzed based on the amputation-free survival, overall survival rate, and freedom from amputation at 12 months.

    RESULTS: Data from 302 CLI patients treated in the study period were reviewed. A total of 219 patients (73%) underwent an endovascular intervention, and among them, 126 nondiabetic patients (58%) were enrolled in this study. Most patients were classified as low risk (33%), and the prevalence of very low-risk, moderate-risk, and very high-risk patients was 23%, 23%, and 21%, respectively. The modified Edifoligide for the Prevention of Infrainguinal Vein Graft Failure (PREVENT III) score was statistically significantly higher in the high-risk group (5.2 ± 2.4) than in the very low-risk, low-risk, and moderate-risk groups (4.3 ± 2.5, 3.5 ± 2.3, 4.5 ± 2.2, respectively; P = .048). One major amputation (1%) was performed during the hospital stay in a high-risk patient. Mean follow-up was 14 ± 8 months. The amputation-free survival at 12 months was 87%, 81%, 81%, and 62%, in the very low-risk, low-risk, moderate risk, and very high-risk groups, respectively (P = .106). The difference was statistically significant between the very low-risk and high-risk groups (hazard ratio, 3.4; 95% confidence interval, 1.1-10.3; P = .029). A similar trend was also observed for 1-year survival between the very low-risk and the high-risk groups (87%, 84%, 81%, 65%; P = .166). The amputation rate during the follow-up time was 0%, 2% (n = 6), 3% (n = 5), and 12% (n = 9) for the very low-risk, low-risk, moderate-risk, and very high-risk groups, respectively (P = .033).

    CONCLUSIONS: The WIfI classification system predicted the amputation risk and survival in this highly selected group of nondiabetic CLI patients treated by endovascular means, with a statistically significant difference between very low-risk and high-risk patients already at 1 year.

    Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

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    The Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification system predicts wound healing better than direct angiosome perfusion in diabetic foot wounds., 2018 May 24
    Journal: Journal of Vascular Surgery

    OBJECTIVE: Previous studies show conflicting results in wound healing outcomes based on angiosome direct perfusion (DP), but few have adjusted for wound characteristics in their analyses. We have previously shown that the Society for Vascular Surgery Wound, Ischemia, and foot Infection (WIfI) classification correlates with wound healing in diabetic foot ulcers (DFUs) treated by a multidisciplinary team. The aim of this study was to compare WIfI classification vs DP and pedal arch patency as predictors of wound healing in patients presenting with DFU and peripheral arterial disease.

    METHODS: We performed a retrospective review of a prospectively maintained database of all patients with peripheral arterial disease presenting to our multidisciplinary DFU clinic who underwent angiography. An angiosome was considered directly perfused if the artery feeding the angiosome was revascularized or was completely patent. Wound healing time at 1 year was compared on the basis of DP vs indirect perfusion, Rutherford pedal arch grade, and WIfI classification using univariable statistics and Cox proportional hazards models.

    RESULTS: Angiography was performed on 225 wounds in 99 patients (mean age, 63.3 ± 1.2 years; 62.6% male; 53.5% black) during the entire study period. There were 33 WIfI stage 1, 33 stage 2, 51 stage 3, and 108 stage 4 wounds. DP was achieved in 154 wounds (68.4%) and indirect perfusion in 71 wounds (31.6%). On univariable analysis, WIfI classification was significantly associated with improved wound healing (57.2% for WIfI 3/4 vs 77.3% for WIfI 1/2; P = .02), whereas DP and pedal arch patency were not (both, P ≥ .08). After adjusting for baseline patient and wound characteristics, WIfI stage remained independently predictive of wound healing (WIfI 3/4: hazard ratio [HR], 0.77; 95% confidence interval [CI], 0.67-0.88), whereas DP (HR, 0.82; 95% CI, 0.55-1.21) and pedal arch grade (HR, 0.85; 95% CI, 0.70-1.03) were not.

    CONCLUSIONS: In our population of patients treated by a multidisciplinary diabetic foot service, the Society for Vascular Surgery WIfI classification system was a stronger predictor of diabetic foot wound healing than DP or pedal arch patency. Our results suggest that a measure of wound severity should be included in all future studies assessing wound healing as an outcome, as differences in patients' wound characteristics may be a strong contributor to the variation of angiosome-directed perfusion results previously observed.

    Copyright © 2018 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

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    Peripheral artery disease in the lower limbs: The importance of secondary risk prevention for improved long-term prognosis., 2020
    Journal: Australian journal of general practice

    BACKGROUND: Patients with lower limb peripheral artery disease (PAD) are at high risk of cardiovascular mortality and morbidity along with limb loss. PAD is underdiagnosed in the community and presents a missed opportunity to prescribe evidence-based secondary prevention therapy.

    OBJECTIVE: The aim of this article is to summarise key updates in the management of patients with PAD, with particular reference to newly published guidelines.

    DISCUSSION: PAD continues to be a major contributor to the mortality and morbidity of patients with atherosclerosis in Australia. For patients with chronic limb-threatening ischaemia, revascularisation remains the mainstay of limb salvage, and expedited access to vascular surgery assessment is necessary. Both prescription of, and adherence to, evidence-based secondary prevention therapy is low. A greater emphasis on cardiovascular risk factor modification for all patients with PAD is required to improve long-term outcomes. General practitioners and vascular surgeons can work collaboratively to provide patient-centred, effective care to patients with PAD.

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    Vascular regeneration in peripheral artery disease., 2020 May 21
    Journal: Arteriosclerosis, Thrombosis, and Vascular Biology

    Peripheral artery disease is a common disorder and a major cause of morbidity and mortality worldwide. Therapy is directed at reducing the risk of major adverse cardiovascular events and at ameliorating symptoms. Medical therapy is effective at reducing the incidence of myocardial infarction and stroke to which these patients are prone but is inadequate in relieving limb-related symptoms, such as intermittent claudication, rest pain, and ischemic ulceration. Limb-related morbidity is best addressed with surgical and endovascular interventions that restore perfusion. Current medical therapies have only modest effects on limb blood flow. Accordingly, there is an opportunity to develop medical approaches to restore limb perfusion. Vascular regeneration to enhance limb blood flow includes methods to enhance angiogenesis, arteriogenesis, and vasculogenesis using angiogenic cytokines and cell therapies. We review the molecular mechanisms of these processes; briefly discuss what we have learned from the clinical trials of angiogenic and cell therapies; and conclude with an overview of a potential new approach based upon transdifferentiation to enhance vascular regeneration in peripheral artery disease.

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    Platelet-rich fibrin and concentrated growth factors as novel platelet concentrates for chronic hard-to-heal skin ulcers: A systematic review and meta-analysis of randomized controlled trials., 2020 May 22
    Journal: The Journal of Dermatological Treatment

    Background: This study aimed to determine superior outcomes of platelet-rich fibrin and concentrated growth factors dressings in chronic hard-to-heal skin ulcers.Methods: A search in PubMed, EMBASE, Cochrane Library and CINAHL(EBSCO) was performed for randomized controlled trials comparing platelet-rich fibrin or concentrated growth factors dressings to standard wound care in chronic hard-to-heal skin ulcers. Primary outcome was the number of ulcers completely healed. Secondary outcomes were percentage of ulcers area reduction and complications. Dichotomous and continuous results were pooled in risk difference and mean difference respectively, with a 95% confidence interval (CI).Results: Eight studies with 578 patients were included. The number of ulcers completely healed in platelet-rich fibrin was significantly higher than in control group, during the fourth week of follow-up (risk difference, 0.48; 95% CI, 0.31 - 0.66; p <  0.00001) and at the end of follow-up (risk difference, 0.17; 95% CI, 0.08 - 0.26; p = 0.0003). The pooled result between concentrated growth factors and control group was inconclusive due to two few studies included.Conclusions: Platelet-rich fibrin is safe and promising to promote healing of chronic hard-to-heal skin ulcers versus standard wound care. Further studies are warranted to evaluate the roles of concentrated growth factors.

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    Negative pressure wound therapy: Regulating blood flow perfusion and microvessel maturation through microvascular pericytes., 2017 Nov
    Journal: International Journal of Molecular Medicine

    Negative pressure wound therapy (NPWT) has been demonstrated to accelerate wound healing by promoting angiogenesis. However, whether blood flow perfusion is regulated by microvessel maturation and pericytes following NPWT remains unclear, as well as the exact association between pericytes and collagen type IV. The aim of this study was to investigate the relevant association between blood flow perfusion and microvessel maturation and pericytes following NPWT, and to further explore the underlying molecular mechanisms. We also aimed to investigate the association between pericytes and collagen type IV. For this purpose, we created a rat model of diabetic wounds and microvascular blood flow perfusion was detected using a laser Doppler blood perfusion imager. The expression levels of angiogenin-1, tyrosine phosphorylation of tyrosine kinase receptor-2 (Tie-2), α-smooth muscle actin (α-SMA) and collagen type IV were detected and analyzed through immunohistochemistry, immunofluorescence, RT-qPCR and western blot analysis. The results revealed that NPWT promoted the overexpression of angiogenin-1, Tie-2, α-SMA and collagen type IV, and significantly increased blood flow perfusion coupled with microvessel maturation in the NPWT group at the later stages (7-10 days) of wound healing. Our results suggested that NPWT can preferentially enhance vessel maturation and increase the number of pericytes, thus regulating blood flow perfusion. On the other hand, pericytes and collagen type IV had a mutual interaction, promoting microvessel maturation.

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    Application of low-pressure negative pressure wound therapy to ischaemic wounds., 2012 Mar
    Journal: Journal of Plastic, Reconstructive & Aesthetic Surgery

    Negative pressure wound therapy (NPWT) is a useful wound dressing that can be applied to a wide variety of wounds. Patients with ischaemic wounds, however, may experience further necrosis with NPWT at the commonly recommended pressure of -125 mm Hg. We hypothesized that with a suction pressure of -125 mm Hg, tissue pressure will likely occlude most of the capillaries adjacent to the wound edge. Therefore, we treated three patients with ischaemic wounds using low-pressure NPWT at -50 mm Hg. All wounds healed successfully without further necrosis at the wound edge.

    Crown Copyright © 2011. Published by Elsevier Ltd. All rights reserved.

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    Changing pattern of surgical revascularization for critical limb ischemia over 12 years: endovascular vs. open bypass surgery., 2006 Aug
    Journal: Journal of Vascular Surgery

    OBJECTIVE: This study is a review and evaluation of our 12-year experience of revascularization for critical limb ischemia (CLI) with angioplasty/stenting and bypass surgery to identify specific trends of procedure volume and outcomes in this particular group.

    METHODS: Endovascular and open bypass procedures done for CLI by a single surgeon between 1993 and 2004 were evaluated retrospectively. Thrombolysis and thrombectomy procedures done as the only revascularization procedure were excluded from analysis. The data were divided into three groups by time periods: the first period, 1993 to 1996; the second period, 1997 to 2000; and the third period, 2001 to 2004. Outcomes were defined according to the reporting standards of the Society for Vascular Surgery/International Society for Cardiovascular Surgery. The study included 416 procedures done in 237 limbs in 192 patients. The mean follow-up was 23 months (range, 1 to 122 months).

    RESULTS: Primary revascularization procedures for CLI were angioplasty in 153 limbs (65%) and bypass surgery in 84 (35%). Subsequent procedures were angioplasty in 102 limbs (57%) and open surgery (bypass and/or patch angioplasty) in 77 limbs (43%). The rates for technical and clinical success and complications in the entire group were 99%, 95%, and 4%, respectively. One patient died perioperatively (0.5%). Among the three periods, TransAtlantic Inter-Society Consensus lesion types were significantly more severe in patients in the first period (P < .05). Additionally, the complication rate was significantly higher and the mean hospital stay was significantly longer in the first period compared with the second and third periods (P < .05). Furthermore, between the first and third periods, the number of endovascular revascularization procedures done as primary and secondary procedures significantly increased from 15 to 84 (+460%) and from 13 to 57 (+340%), whereas the number of open surgical procedures done as primary and secondary procedures decreased from 39 to 20 (-49%) and from 35 to 18 (-49%), respectively (P < .0001). The assisted primary patency rates in the third period were significantly higher than those in the first and second periods (P = .012); otherwise, the long-term outcomes among the three periods were not statistically different. Multivariate analysis revealed that, while controlling for other factors, the third period showed improvement in the primary patency (P = .032) and assisted primary patency (P = .051), and the bypass group showed improvement in the primary patency (P = .008).

    CONCLUSIONS: In our experience, open surgical procedures for the treatment of CLI have been largely replaced by angioplasty procedures without compromising outcomes. Angioplasty is a feasible, safe, and effective procedure and can be the procedure of choice for the primary and secondary treatment of CLI. Open surgical procedures can be reserved for lesions technically unsuitable for endovascular procedures and patients who do not demonstrate clinical improvement after angioplasty.

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    Is There an Important Role for Anxiety and Depression in the Elderly Patients with Critical Limb Ischemia, Especially After Major Amputation?, 2019 Jul
    Journal: Annals of Vascular Surgery

    BACKGROUND: In patients with critical limb ischemia, an association is assumed between depression and worse outcome for morbidity, such as major limb amputation. After major amputation, anxiety and depression are common. We aimed to determine the association of depressive and anxiety symptoms in the elderly with critical limb ischemia, especially after major limb amputation.

    METHODS: Patients with critical limb ischemia aged ≥70 years were included in this prospective observational cohort study between January 2012 and February 2016 in 2 Dutch hospitals. After a multidisciplinary vascular conference, patients were divided into 4 treatment groups: endovascular revascularization, surgical revascularization, conservative therapy, and primary major amputation. In a 1-year follow-up period, depression and anxiety were measured 4 times using the Dutch versions of the Center for Epidemiological Studies Depression Scale and the State-Trait Anxiety Inventory.

    RESULTS: One Hundred eighty-seven patients were included. Within 1 year, 44 patients underwent a major limb amputation. Lower amputation-free survival did not differ significantly for patients with versus without greater anxiety (X2 [1] = 0.689, P = 0.407) and also not for patients with versus without more depressive symptoms (X2 [1] = 0.614, P = 0.433). For both groups, there were no significant changes in anxiety scores over time. After a median follow-up time of 336.5 days and 365 days, depressive symptoms significantly decreased in amputees, respectively, 8.5 vs. 4.5 (95% CI 1.76-7.48, P = 0.002) and 8.5 vs. 4.3 (95% CI 0.61-9.82, P = 0.027) when compared to the baseline measurement. Similarly, nonamputees had significantly lower overall score for depressive symptoms after a median follow-up time of 365 days (10.1 vs. 4.1, 95% CI 4.49 to 6.90, P <  0.001).

    CONCLUSIONS: In the opinion of the medical health care provider, amputation is a severe and unwanted end phase of critical limb ischemia. However, depressive symptoms seem to decrease over time and anxiety symptoms do not seem to be affected in patients after major limb amputation. In addition, patients with greater trait anxiety or more depressive symptoms at baseline did not have significantly higher amputation rates. These findings are similar to the course of depressive and anxiety symptoms for the elderly patients without major limb amputation.

    Copyright © 2019 Elsevier Inc. All rights reserved.

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    Insulated Offloading Provides Offloading Protection and Enhanced Skin Perfusion | Wounds Research, Lower Extremity Ulcer or Problem Wound, Characteristics and long-term follow-up of participants with peripheral arterial disease during ALLHAT., 2014 Nov
    Journal: Journal of General Internal Medicine

    BACKGROUND: Hypertension is a major risk factor for peripheral artery disease (PAD). Little is known about relative efficacy of antihypertensive treatments for preventing PAD.

    OBJECTIVES: To compare, by randomized treatment groups, hospitalized or revascularized PAD rates and subsequent morbidity and mortality among participants in the Antihypertensive and Lipid-Lower Treatment to Prevent Heart Attack Trial (ALLHAT).

    DESIGN: Randomized, double-blind, active-control trial in high-risk hypertensive participants.

    PARTICIPANTS: Eight hundred thirty participants with specified secondary outcome of lower extremity PAD events during the randomized phase of ALLHAT.

    INTERVENTIONS/EVENTS: In-trial PAD events were reported during ALLHAT (1994-2002). Post-trial mortality data through 2006 were obtained from administrative databases. Mean follow-up was 8.8 years.

    MAIN MEASURES: Baseline characteristics and intermediate outcomes in three treatment groups, using the Kaplan-Meier method to calculate cumulative event rates and post-PAD mortality rates, Cox proportional hazards regression model for hazard ratios and 95 % confidence intervals, and multivariate Cox regression models to examine risk differences among treatment groups.

    KEY RESULTS: Following adjustment for baseline characteristics, neither participants assigned to the calcium-channel antagonist amlodipine nor to the ACE-inhibitor lisinopril showed a difference in risk of clinically advanced PAD compared with those in the chlorthalidone arm (HR, 0.86; 95 % CI, 0.72-1.03 and HR, 0.98; 95 % CI, 0.83-1.17, respectively). Of the 830 participants with in-trial PAD events, 63 % died compared to 34 % of those without PAD; there were no significant treatment group differences for subsequent nonfatal myocardial infarction, coronary revascularizations, strokes, heart failure, or mortality.

    CONCLUSIONS: Neither amlodipine nor lisinopril showed superiority over chlorthalidone in reducing clinically advanced PAD risk. These findings reinforce the compelling need for comparative outcome trials examining treatment of PAD in high-risk hypertensive patients. Once PAD develops, cardiovascular event and mortality risk is high, regardless of type of antihypertensive treatment.

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    High-Intensity Statin Therapy Is Associated With Improved Survival in Patients With Peripheral Artery Disease., 2017 Jul 15
    Journal: Journal of the American Heart Association

    BACKGROUND: The relative benefit of higher statin dosing in patients with peripheral artery disease has not been reported previously. We compared the effectiveness of low- or moderate-intensity (LMI) versus high-intensity (HI) statin dose on clinical outcomes in patients with peripheral artery disease.

    METHODS AND RESULTS: We reviewed patients with symptomatic peripheral artery disease who underwent peripheral angiography and/or endovascular intervention from 2006 to 2013 who were not taking other lipid-lowering medications. HI statin use was defined as atorvastatin 40-80 mg or rosuvastatin 20-40 mg. Baseline demographics, procedural data, and outcomes were retrospectively analyzed. Among 909 patients, 629 (69%) were prescribed statins, and 124 (13.6%) were treated with HI statin therapy. Mean low-density lipoprotein level was similar in patients on LMI versus HI (80±30 versus 87±44 mg/dL, P=0.14). Demographics including age (68±12 versus 67±10 years, P=0.25), smoking history (76% versus 80%, P=0.42), diabetes mellitus (54% versus 48%, P=0.17), and hypertension (88% versus 89%, P=0.78) were similar between groups (LMI versus HI). There was a higher prevalence of coronary artery disease (56% versus 75%, P=0.0001) among patients on HI statin (versus LMI). After propensity weighting, HI statin therapy was associated with improved survival (hazard ratio for mortality: 0.52; 95% confidence interval, 0.33-0.81; P=0.004) and decreased major adverse cardiovascular events (hazard ratio: 0.58; 95% confidence interval 0.37-0.92, P=0.02).

    CONCLUSIONS: In patients with peripheral artery disease who were referred for peripheral angiography or endovascular intervention, HI statin therapy was associated with improved survival and fewer major adverse cardiovascular events compared with LMI statin therapy.

    © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

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    2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APHA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines., 2019 Jun 25
    Journal: Journal of the American College of Cardiology

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    Comparative Efficacy and Safety of Different Antiplatelet Agents for Prevention of Major Cardiovascular Events and Leg Amputations in Patients with Peripheral Arterial Disease: A Systematic Review and Network Meta-Analysis., 2015 Aug 14
    Journal: Plos One

    There is a lack of consensus regarding which type of antiplatelet agent should be used in patients with peripheral arterial disease (PAD) and little is known on the advantages and disadvantages of dual antiplatelet therapy. We conducted a systematic review and network meta-analysis of available randomized controlled trials (RCT) comparing different antiplatelet drugs (Aspirin, Ticlopidine, Clopidogrel, Ticagrelor, Cilostazol, Picotamide and Vorapaxar as monotherapies or in combination with aspirin) in PAD patients (PROSPERO public database; CRD42014010299).We collated evidence from previous relevant meta-analyses and searched online databases. Primary efficacy endpoints were: (1) the composite rate of major adverse cardiovascular events (MACE; including vascular deaths, non-fatal myocardial infarction and non-fatal stroke), and (2) the rate of major leg amputations. The primary safety endpoint was the rate of severe bleeding events. Bayesian models were employed for multiple treatment comparisons and risk-stratified hierarchies of comparative efficacy were produced to aid medical decision making. Number-Needed-to-Treat (NNT) and Number-Needed-to-Harm (NNH) are reported in case of significant results. We analyzed 49 RCTs comprising 34,518 patients with 88,358 person-years of follow-up with placebo as reference treatment. Aspirin, Cilostazol, Vorapaxar and Picotamide were ineffective in reducing MACE. A significant MACE reduction was noted with Ticagrelor plus aspirin (RR: 0.67; 95%CrI: 0.46-0.96, NNT = 66), Clopidogrel (RR: 0.72; 95%CrI: 0.58-0.91, NNT = 80), Ticlopidine (RR: 0.75; 95%CrI: 0.58-0.96, NNT = 87), and Clopidogrel plus aspirin (RR: 0.78; 95%CrI: 0.61-0.99, NNT = 98). Dual antiplatelet therapy with Clopidogrel plus aspirin significantly reduced major amputations following leg revascularization (RR: 0.68; 95%CrI: 0.46-0.99 compared to aspirin, NNT = 94). The risk of severe bleeding was significantly higher with Ticlopidine (RR: 5.03; 95%CrI: 1.23-39.6, NNH = 25), Vorapaxar (RR: 1.80; 95%CrI: 1.22-2.69, NNH = 130), and Clopidogrel plus aspirin (RR: 1.48; 95%CrI: 1.05-2.10, NNH = 215). Clopidogrel monotherapy showed the most favourable benefit-harm profile (79% cumulative rank probability best and 77% cumulative rank probability safest). In conclusion, Clopidogrel should be the indicated antiplatelet agent in PAD patients. Dual antiplatelet therapy with aspirin and Clopidogrel can reduce the rate of major leg amputations following revascularization, but carries a slightly higher risk of severe bleeding.

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    A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee., 1996 Nov 16
    Journal: The Lancet

    BACKGROUND: Many clinical trials have evaluated the benefit of long-term use of antiplatelet drugs in reducing the risk of clinical thrombotic events. Aspirin and ticlopidine have been shown to be effective, but both have potentially serious adverse effects. Clopidogrel, a new thienopyridine derivative similar to ticlopidine, is an inhibitor of platelet aggregation induced by adenosine diphosphate.

    METHODS: CAPRIE was a randomised, blinded, international trial designed to assess the relative efficacy of clopidogrel (75 mg once daily) and aspirin (325 mg once daily) in reducing the risk of a composite outcome cluster of ischaemic stroke, myocardial infarction, or vascular death; their relative safety was also assessed. The population studied comprised subgroups of patients with atherosclerotic vascular disease manifested as either recent ischaemic stroke, recent myocardial infarction, or symptomatic peripheral arterial disease. Patients were followed for 1 to 3 years.

    FINDINGS: 19,185 patients, with more than 6300 in each of the clinical subgroups, were recruited over 3 years, with a mean follow-up of 1.91 years. There were 1960 first events included in the outcome cluster on which an intention-to-treat analysis showed that patients treated with clopidogrel had an annual 5.32% risk of ischaemic stroke, myocardial infarction, or vascular death compared with 5.83% with aspirin. These rates reflect a statistically significant (p = 0.043) relative-risk reduction of 8.7% in favour of clopidogrel (95% Cl 0.3-16.5). Corresponding on-treatment analysis yielded a relative-risk reduction of 9.4%. There were no major differences in terms of safety. Reported adverse experiences in the clopidogrel and aspirin groups judged to be severe included rash (0.26% vs 0.10%), diarrhoea (0.23% vs 0.11%), upper gastrointestinal discomfort (0.97% vs 1.22%), intracranial haemorrhage (0.33% vs 0.47%), and gastrointestinal haemorrhage (0.52% vs 0.72%), respectively. There were ten (0.10%) patients in the clopidogrel group with significant reductions in neutrophils (< 1.2 x 10(9)/L) and 16 (0.17%) in the aspirin group.

    INTERPRETATION: Long-term administration of clopidogrel to patients with atherosclerotic vascular disease is more effective than aspirin in reducing the combined risk of ischaemic stroke, myocardial infarction, or vascular death. The overall safety profile of clopidogrel is at least as good as that of medium-dose aspirin.

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    Wounds in advanced illness: a prevalence and incidence study based on a prospective case series., 2008 Jun
    Journal: International wound journal

    A prospective observational sequential case series was studied in order to ascertain an accurate inventory of the various wound types, their point prevalence and incidence rates and their anatomic locations in patients with advanced illness. Five hundred and ninety-three patients were serially assessed until their deaths. Forty-three individual wound types were identified and grouped into nine distinct classes. Data were stratified between patients suffering from malignant and non malignant disorders. One thousand and thirty-six individual wounds (average 1.8 wounds per patient) were identified at baseline. Eight hundred and ninety-one individual wounds (average 1.5 wounds per patient) were identified between baseline and their date of death. Pressure ulcers constituted the most commonly occurring wound class affecting more than 50% of all patients. Malignant wounds were observed only in cancer patients. Baseline point prevalence for pressure ulcers, traumatic wounds, venous ulcers and arterial ulcers in non cancer patients exceeded that in cancer patients. At baseline, iatrogenic wounds were more prevalent in cancer patients than in non cancer patients. Incidence rates for pressure ulcers, traumatic wounds, diabetic ulcers, arterial ulcers and ostomies in non cancer patients exceeded those in cancer patients. The broad range of wounds along with high rates of prevalence and incidence, identified in this study, reflects that wounds represent a significant management issue for patients with advanced illness. Therefore, there exists a need for advancement in modalities and measures aimed at risk assessment, prevention and appropriate goal-oriented management.

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    Psoriasis and vascular disease-risk factors and outcomes: a systematic review of the literature., 2011 Sep
    Journal: Journal of General Internal Medicine

    BACKGROUND: Psoriasis afflicts 2-3% of the world's population. Affected patients commonly have risk factors for cardiovascular disease (CVD). In addition, psoriasis is independently associated with CVD and mortality.

    PURPOSE: To determine which CVD risk factors are associated with psoriasis independent of confounders, whether psoriasis is associated with CVD independent of CVD risk factors, and whether there is increased mortality among patients with psoriasis.

    DATA SOURCES: MEDLINE, Embase, and Cochrane Collaborations from inception through October 2009. We reviewed bibliographies of retrieved articles for additional references.

    STUDY SELECTION: Cross-sectional, cohort-based, case-control, and randomized controlled trials which involved patients with psoriasis.

    DATA EXTRACTION: Two investigators independently reviewed studies and resolved any discrepancies by consensus.

    DATA SYNTHESIS: Of the 2,303 articles identified by literature search, 90 studies met inclusion criteria for this review; 15 were cohort-based studies, 45 were case-control, and 30 were cross-sectional.

    LIMITATIONS: The quality of evidence was limited by study heterogeneity and lack of large scale prospective studies with long-term follow-up.

    CONCLUSIONS: Patients with psoriasis demonstrate a higher prevalence of cardiovascular risk factors and appear to be at increased risk for ischemic heart disease, cerebrovascular disease, and peripheral arterial disease. This increase in vascular disease may be independent of shared risk factors and may contribute to the increase in all-cause mortality. Future research should aim to more confidently distinguish between a true causal relationship or merely an association resulting from multiple shared risk factors. Physicians should screen for and aggressively treat modifiable risk factors for CVD in patients with psoriasis.

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    Clinical characteristics of coronavirus disease 2019 in China., 2020 Feb 28
    Journal: The New England Journal of Medicine

    BACKGROUND: Since December 2019, when coronavirus disease 2019 (Covid-19) emerged in Wuhan city and rapidly spread throughout China, data have been needed on the clinical characteristics of the affected patients.

    METHODS: We extracted data regarding 1099 patients with laboratory-confirmed Covid-19 from 552 hospitals in 30 provinces, autonomous regions, and municipalities in China through January 29, 2020. The primary composite end point was admission to an intensive care unit (ICU), the use of mechanical ventilation, or death.

    RESULTS: The median age of the patients was 47 years; 41.9% of the patients were female. The primary composite end point occurred in 67 patients (6.1%), including 5.0% who were admitted to the ICU, 2.3% who underwent invasive mechanical ventilation, and 1.4% who died. Only 1.9% of the patients had a history of direct contact with wildlife. Among nonresidents of Wuhan, 72.3% had contact with residents of Wuhan, including 31.3% who had visited the city. The most common symptoms were fever (43.8% on admission and 88.7% during hospitalization) and cough (67.8%). Diarrhea was uncommon (3.8%). The median incubation period was 4 days (interquartile range, 2 to 7). On admission, ground-glass opacity was the most common radiologic finding on chest computed tomography (CT) (56.4%). No radiographic or CT abnormality was found in 157 of 877 patients (17.9%) with nonsevere disease and in 5 of 173 patients (2.9%) with severe disease. Lymphocytopenia was present in 83.2% of the patients on admission.

    CONCLUSIONS: During the first 2 months of the current outbreak, Covid-19 spread rapidly throughout China and caused varying degrees of illness. Patients often presented without fever, and many did not have abnormal radiologic findings. (Funded by the National Health Commission of China and others.).

    Copyright © 2020 Massachusetts Medical Society.

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    Factors that impair wound healing., 2012 Dec
    Journal: The journal of the American College of Clinical Wound Specialists

    The body's response to tissue injury in a healthy individual is an intricate, sequential physiologic process that results in timely healing with full re-epithelialization, resolution of drainage, and return of function to the affected tissue. Chronic wounds, however, do not follow this sequence of events and can challenge the most experienced clinician if the underlying factors that are impairing wound healing are not identified. The purpose of this article is to present recent information about factors that impair wound healing with the underlying pathophysiological mechanism that interferes with the response to tissue injury. These factors include co-morbidities (diabetes, obesity, protein energy malnutrition), medications (steroids, non-steroidal anti-inflammatory drugs or NSAIDs, anti-rejection medications), oncology interventions (radiation, chemotherapy), and life style habits (smoking, alcohol abuse). Successful treatment of any chronic wound depends upon identification and management of the factors for each individual.

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    Secondhand smoking is associated with vascular inflammation., 2015 Jul
    Journal: Chest

    BACKGROUND: The relative risk for cardiovascular diseases in passive smokers is similar to that of active smokers despite almost a 100-fold lower dose of inhaled cigarette smoke. However, the mechanisms underlying the surprising susceptibility of the vascular tissue to the toxins in secondhand smoke (SHS) have not been directly investigated. The aim of this study was to investigate directly vascular endothelial cell function in passive smokers.

    METHODS: Using a minimally invasive method of endothelial biopsy, we investigated directly the vascular endothelium in 23 healthy passive smokers, 25 healthy active smokers, and 23 healthy control subjects who had never smoked and had no regular exposure to SHS. Endothelial nitric oxide synthase (eNOS) function (expression of basal eNOS and activated eNOS [phosphorylated eNOS at serine1177 (P-eNOS)]) and expression of markers of inflammation (nuclear factor-κB [NF-κB]) and oxidative stress (nitrotyrosine) were assessed in freshly harvested venous endothelial cells by quantitative immunofluorescence.

    RESULTS: Expression of eNOS and P-eNOS was similarly reduced and expression of NF-κB was similarly increased in passive and active smokers compared with control subjects. Expression of nitrotyrosine was greater in active smokers than control subjects and similar in passive and active smokers. Brachial artery flow-mediated dilation was similarly reduced in passive and active smokers compared with control subjects, consistent with reduced endothelial NO bioavailability.

    CONCLUSIONS: Secondhand smoking increases vascular endothelial inflammation and reduces active eNOS to a similar extent as active cigarette smoking, indicating direct toxic effects of SHS on the vasculature.

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    Patient-reported outcome measures in patients with peripheral arterial disease: a systematic review of psychometric properties., 2016 Nov 24
    Journal: Health and Quality of Life Outcomes

    BACKGROUND: Peripheral arterial disease (PAD) is generally associated with considerable morbidity and reduced quality of life. Patient-reported outcome measures (PROMs) provide important information about the burden of disease and impact of treatment in affected patients.

    OBJECTIVES: The objective of the review was to identify and appraise studies reporting the psychometric evaluation of PROMs administered to a specified population of patients with PAD with a view to recommending suitable PROMs.

    METHODS: A systematic review of peer-reviewed English language articles was undertaken to identify primary studies reporting psychometric properties of PROMs in English-speaking patients with various stages of PAD. Comprehensive searches were completed up until January 2015. Study selection, data extraction and quality assessment were undertaken independently by at least two researchers. Findings were presented as tabular and narrative summaries based on accepted guidance.

    RESULTS: Psychometric evaluation of 6 generic and 7 condition-specific PROMs reported in 14 studies contributed data to the review. The frequently reported measure was the SF-36 (n = 11 studies); others included the Walking Impairment Questionnaire (n = 8 studies), EQ-5D (n = 5 studies) and the Vascular Quality of Life Questionnaire (n = 3 studies). Studies included a diverse PAD population and varied in methodology, including approach to validation of PROMs.

    CONCLUSIONS: Various PROMs have been validated in patients with PAD but no study provided evidence of a full psychometric evaluation in the patient population. Careful selection is required to identify reliable and valid PROMs to use in clinical and research settings.

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    Nutritional considerations for peripheral arterial disease: A narrative review., 2019 May 29
    Journal: Nutrients

    Those with peripheral arterial disease (PAD) require important considerations with respect to food and nutrition, owing to advanced age, poor diet behaviours and immobility associated with the disease process and co-morbid state. These considerations, coupled with the economic effectiveness of medical nutrition therapy, mandate that dietetic care plays a vital role in the management of PAD. Despite this, optimising dietetic care in PAD remains poorly understood. This narrative review considers the role of medical nutrition therapy in every stage of the PAD process, ranging from the onset and initiation of disease to well established and advanced disease. In each case, the potential benefits of traditional and novel medical nutrition therapy are discussed.

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    The genetic basis of peripheral arterial disease: current knowledge, challenges, and future directions., 2015 Apr 24
    Journal: Circulation Research

    Several risk factors for atherosclerotic peripheral arterial disease (PAD), such as dyslipidemia, diabetes mellitus, and hypertension, are heritable. However, predisposition to PAD may be influenced by genetic variants acting independently of these risk factors. Identification of such genetic variants will provide insights into underlying pathophysiologic mechanisms and facilitate the development of novel diagnostic and therapeutic approaches. In contrast to coronary heart disease, relatively few genetic variants that influence susceptibility to PAD have been discovered. This may be, in part, because of greater clinical and genetic heterogeneity in PAD. In this review, we (1) provide an update on the current state of knowledge about the genetic basis of PAD, including results of family studies and candidate gene, linkage as well as genome-wide association studies; (2) highlight the challenges in investigating the genetic basis of PAD and possible strategies to overcome these challenges; and (3) discuss the potential of genome sequencing, RNA sequencing, differential gene expression, epigenetic profiling, and systems biology in increasing our understanding of the molecular genetics of PAD.

    © 2015 American Heart Association, Inc.

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    Hypothyroidism and the risk of lower extremity arterial disease., 2010 Oct 21
    Journal: Vascular health and risk management

    BACKGROUND: Although an independent association between hypothyroidism and coronary artery disease has been demonstrated, few studies have examined the association between hypothyroidism and peripheral arterial disease. In the current study, we test the hypothesis that there is an independent association between hypothyroidism and lower extremity arterial disease.

    METHODS: We retrospectively compared the prevalence of hypothyroidism in patients who had infra-inguinal arterial bypass surgery over a 6-year period with that of a control group of surgical patients who had pure cardiac valve surgery during the same time period. Both unadjusted and adjusted odds ratios were calculated to estimate the association between hypothyroidism and lower extremity arterial disease.

    RESULTS: A total of 614 cases and 529 control subjects had surgery during the study period. When comparing all subjects, there was no association between hypothyroidism and lower extremity arterial disease (unadjusted odds ratio 0.88; 95% confidence intervals [CI]: 0.61-1.28). However, gender was found to be a significant effect modifier (P < 0.001), and gender-stratified analyses were subsequently performed. In men, there was a positive independent association between hypothyroidism and lower extremity arterial disease (adjusted odds ratio 2.65; 95% CI: 1.19-5.89), whereas in women there was a negative independent association (adjusted odds ratio 0.22; 95% CI: 0.11-0.46).

    CONCLUSIONS: Gender is a significant effect modifier for the association between hypothyroidism and lower extremity arterial disease. The association is positive in men and negative in women. Future prospective studies that evaluate hypothyroidism as a risk factor for peripheral arterial disease should consider gender stratification in order to corroborate this finding.

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    Warfarin-Induced Skin Necrosis in Patients With Low Protein C Levels., 2016 Aug
    Journal: Acta medica Iranica

    Warfarin-induced skin necrosis (WISN) is a rare complication of anticoagulant therapy associated with a high incidence of  morbidity and mortality requiring immediate drug cessation. At particular risk are those with various thrombophilic abnormalities, especially when warfarinisation is undertaken rapidly with large loading doses of warfarin. Cutaneous findings include petechiae that progress to ecchymosis and hemorrhagic bullae. With the increasing number of patients anticoagulated as out-patients for thromboprophylaxis, we are concerned that the incidence of skin necrosis may increase. We present a case of WISN with low protein C level. He was a 50-year-old male who came to our department because of acute infarction in irrigation area of the superior cerebellar artery. He had intermittent atrial fibrillation and was started on anticoagulant therapy.  After few day of therapy, he developed skin necrosis, and his level of protein C was low. Warfarin-induced skin necrosis is a rare but serious complication that can be prevented by routine screening for protein C, protein S or antithrombin deficiencies or for the presence of antiphospholipid antibodies before beginning warfarin therapy.

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    Warfarin-induced skin necrosis., 2014 Feb 17
    Journal: Annals of dermatology

    Warfarin-induced skin necrosis is an infrequent complication occurring in individuals under warfarin treatment who have a thrombophilic history or after administration of large loading doses of warfarin particularly without simultaneous initial use of heparin. A 62-year-old lady developed skin necrosis 4 days after initiating warfarin therapy of 5 mg daily without initial co-administration of heparin. The patient had a normal clotting profile. Skin necrosis progressed to eschar formation after cessation of warfarin and heparinization stopped expanding. Warfarin was reintroduced at 2 mg daily, initially together with low molecular weight heparin. Autolytic debridement of the necrotic tissue was followed by healing of the cutaneous deficit by secondary intention. Prompt diagnosis and discontinuation of warfarin are crucial for the prognosis.

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    Heparin-induced thrombocytopenia., 2014 Jul
    Journal: Clinical Toxicology

    Abstract A summary of heparin-induced thrombocytopenia (HIT) is presented. HIT is an adverse drug reaction characterized by thrombocytopenia and a high risk for venous or arterial thrombosis. The frequency of HIT ranges from 1 to 5% of patients receiving heparin with exact frequencies ranging between specific agents. Interestingly, this immune-mediated syndrome is ironically associated with thrombosis, not bleeding, with thrombin formation playing a major role. It is caused by heparin-dependent, platelet-activating antibodies that identifies a self-protein, PF4, bound to heparin that results in an antibody formation. The resulting platelet activation is associated with increased thrombin generation. Typically, the platelet count fall begins 5-10 days after starting heparin, although a rapid platelet count fall can occur in a patient who has antibodies from recent heparin use. Typical causes of HIT as well as the best diagnostic studies and treatment are discussed in this review. HIT was reviewed using a pubmed™ search; google scholar™ using key words: "Heparin-induced thrombocytopenia"; "heparin", and "drug AND thrombocytopenia."

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    Drug-induced thrombosis: an update., 2013 Aug
    Journal: Drug Safety

    Drugs may play an important role in development of thrombosis, and in recent years there has been increased attention to the importance of this issue. Although drug-induced thrombosis usually causes venous thrombotic events, arterial events are also noted due to drug administration. Here we review the different mechanisms through which drugs can exert thrombosis. Drugs can cause direct endothelial damage and expose the underlying subendothelium thus leading to platelet adherence and subsequent thrombus formation. Such an effect is seen by contrast media and chemotherapeutic cytotoxic drugs. Drugs may also attenuate the secretion of pro- and anticoagulation mediators by the endothelial cells and may have prothrombotic effects on platelets by increasing adhesion and aggregation, as for example seen after heparin administration in an immune-mediated mechanism. Red and white cells can also be affected by drugs, by increasing their aggregation or adhesion to the endothelial wall. Some drugs, such as oral contraceptive pills, may promote thrombosis by altering the balance between the different coagulation factors, and many drugs can lead to decreased blood flow by increasing blood viscosity, as seen for example after intravenous immunoglobulin administration. Better understanding of the mechanisms through which drugs exert thrombosis may facilitate their safe use in patients. Additionally, awareness of the drugs that are known to induce thrombosis is important in order to stop their administration in case of a thrombotic event. This review further emphasizes the fact that drug administration is a risk factor that should always be considered together with additional known thromboembolic risk factors such as genetic predisposition or cancer.

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    Non-atherosclerotic Arterial Disorders of the Lower Extremities, 2013 Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA Guideline Recommendations): a report of the American C... - PubMed - NCBI, Association between advanced age and vascular disease in different arterial territories: a population database of over 3.6 million subjects., 2013 Apr 23
    Journal: Journal of the American College of Cardiology

    OBJECTIVES: This study sought to determine the relationship between vascular disease in different arterial territories and advanced age.

    BACKGROUND: Vascular disease in the peripheral circulation is associated with significant morbidity and mortality. There is little data to assess the prevalence of different phenotypes of vascular disease in the very elderly.

    METHODS: Over 3.6 million self-referred participants from 2003 to 2008 who completed a medical and lifestyle questionnaire in the United States were evaluated by screening ankle brachial indices < 0.9 for peripheral artery disease (PAD), and ultrasound imaging for carotid artery stenosis (CAS) >50% and abdominal aortic aneurysm (AAA) >3 cm. Participants were stratified by decade of life. Multivariate logistic regression analysis was used to estimate odds of disease in different age categories.

    RESULTS: Overall, the prevalence of PAD, CAS, and AAA, was 3.7%, 3.9%, and 0.9%, respectively. Prevalence of any vascular disease increased with age (40 to 50 years: 2%, 51 to 60 years: 3.5%, 61 to 70 years: 7.1%, 71 to 80 years: 13.0%, 81 to 90 years: 22.3%, 91 to 100 years: 32.5%; p < 0.0001). Prevalence of disease in each vascular territory increased with age. After adjustment for sex, race/ethnicity, body mass index, family history of cardiovascular disease, smoking, diabetes, hypertension, hypercholesterolemia, and exercise, the odds of PAD (odds ratio [OR]: 2.14; 95% confidence interval [CI]: 2.12 to 2.15), CAS (OR: 1.80; 95% CI: 1.79 to 1.81), and AAA (OR: 2.33; 95% CI: 2.30 to 2.36) increased with every decade of life.

    CONCLUSIONS: There is a dramatic increase in the prevalence of PAD, CAS, and AAA with advanced age. More than 20% and 30% of octogenarians and nonagenarians, respectively, have vascular disease in at least 1 arterial territory.

    Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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    Associations between conventional cardiovascular risk factors and risk of peripheral artery disease in men., 2012 Oct 24
    Journal: The Journal of the American Medical Association

    CONTEXT: Previous studies have examined the associations of individual clinical risk factors with risk of peripheral artery disease (PAD), but the combined effects of these risk factors are largely unknown.

    OBJECTIVE: To estimate the degree to which the 4 conventional cardiovascular risk factors of smoking, hypertension, hypercholesterolemia, and type 2 diabetes are associated with the risk of PAD among men.

    DESIGN, SETTING, AND PARTICIPANTS: Prospective study of 44,985 men in the United States without a history of cardiovascular disease at baseline in 1986; participants in the Health Professionals Follow-up Study were followed up for 25 years until January 2011. The presence of risk factors was updated biennially during follow-up.

    MAIN OUTCOME MEASURE: Clinically significant PAD defined as limb amputation or revascularization, angiogram reporting vascular obstruction of 50% or greater, ankle-brachial index of less than 0.90, or physician-diagnosed PAD.

    RESULTS: During a median follow-up of 24.2 years (interquartile range, 20.8-24.7 years), there were 537 cases of incident PAD. Each risk factor was significantly and independently associated with a higher risk of PAD after adjustment for the other 3 risk factors and confounders. The age-adjusted incidence rates were 9 (95% CI, 6-14) cases/100,000 person-years (n = 19 incident cases) for 0 risk factors, 23 (95% CI, 18-28) cases/100,000 person-years (n = 99 incident cases) for 1 risk factor, 47 (95% CI, 39-56) cases/100,000 person-years (n = 176 incident cases) for 2 risk factors, 92 (95% CI, 76-111) cases/100,000 person-years (n = 180 incident cases) for 3 risk factors, and 186 (95% CI, 141-246) cases/100,000 person-years (n = 63 incident cases) for 4 risk factors. The multivariable-adjusted hazard ratio for each additional risk factor was 2.06 (95% CI, 1.88-2.26). Men without any of the 4 risk factors had a hazard ratio of PAD of 0.23 (95% CI, 0.14-0.36) compared with all other men in the cohort. In 96% of PAD cases (95% CI, 94%-98%), at least 1 of the 4 risk factors was present at the time of PAD diagnosis. The population-attributable risk associated with these 4 risk factors was 75% (95% CI, 64%-87%). The absolute incidence of PAD among men with all 4 risk factors was 3.5/1000 person-years.

    CONCLUSION: Among men in this cohort, smoking, hypertension, hypercholesterolemia, and type 2 diabetes account for the majority of risk associated with development of clinically significant PAD.

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    Pathophysiology, clinical assessment, and investigations involving leg ulcers., 2014 Oct
    Journal: Indian dermatology online journal

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    Guidelines on diagnosis, prognosis, and management of peripheral artery disease in patients with foot ulcers and diabetes (IWGDF 2019 update)., 2020 Jan 20
    Journal: Diabetes/Metabolism Research and Reviews

    The International Working Group on the Diabetic Foot (IWGDF) has published evidence-based guidelines on the prevention and management of diabetic foot disease since 1999. This guideline is on the diagnosis, prognosis, and management of peripheral artery disease (PAD) in patients with foot ulcers and diabetes and updates the previous IWGDF Guideline. Up to 50% of patients with diabetes and foot ulceration have concurrent PAD, which confers a significantly elevated risk of adverse limb events and cardiovascular disease. We know that the diagnosis, prognosis, and treatment of these patients are markedly different to patients with diabetes who do not have PAD and yet there are few good quality studies addressing this important subset of patients. We followed the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to devise clinical questions and critically important outcomes in the patient-intervention-comparison-outcome (PICO) format, to conduct a systematic review of the medical-scientific literature, and to write recommendations and their rationale. The recommendations are based on the quality of evidence found in the systematic review, expert opinion where evidence was not available, and a weighing of the benefits and harms, patient preferences, feasibility and applicability, and costs related to the intervention. We here present the updated 2019 guidelines on diagnosis, prognosis, and management of PAD in patients with a foot ulcer and diabetes, and we suggest some key future topics of particular research interest.

    © 2020 John Wiley & Sons Ltd.

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    Determinants of Long-Term Outcomes and Costs in the Management of Critical Limb Ischemia: A Population-Based Cohort Study., 2018 Aug 21
    Journal: Journal of the American Heart Association

    Background The optimal treatment for critical limb ischemia remains controversial owing to conflicting conclusions from previous studies. Methods and Results We obtained administrative claims on Medicare beneficiaries with initial critical limb ischemia diagnosis in 2011. Clinical outcomes and healthcare costs over 4 years were estimated among all patients and by first treatment (endovascular revascularization, surgical revascularization, or major amputation) in unmatched and propensity-score-matched samples. Among 72 199 patients with initial primary critical limb ischemia diagnosis in 2011, survival was 46% (median survival, 3.5 years) and freedom from major amputation was 87%. Among 9942 propensity-score-matched patients (8% rest pain, 26% ulcer, and 66% gangrene), survival was 38% with endovascular revascularization (median survival, 2.7 years), 40% with surgical revascularization (median survival, 2.9 years), and 23% with major amputation (median survival, 1.3 years; P< 0.001 for each revascularization procedure versus major amputation). Corresponding major amputation rates were 6.5%, 9.6%, and 10.6%, respectively ( P< 0.001 for all pair-wise comparisons). The cost per patient year during follow-up was $49 700, $49 200, and $55 700, respectively ( P< 0.001 for each revascularization procedure versus major amputation). Conclusions Long-term survival and cost in critical limb ischemia management is comparable between revascularization techniques, with lower major amputation rates following endovascular revascularization. Primary major amputation results in shorter survival, higher risk of subsequent major amputation, and higher healthcare costs versus revascularization. Results from this observational research may be susceptible to bias because of the influence of unmeasured confounders.

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    Heart Disease and Stroke Statistics-2019 Update: A Report From the American Heart Association., 2019 Mar 05
    Journal: Circulation

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    ESVM Guideline on peripheral arterial disease., 2019
    Journal: Vasa. Zeitschrift fur Gefasskrankheiten. Journal for Vascular Diseases

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    Noninvasive physiologic vascular studies: A guide to diagnosing peripheral arterial disease., 2017 Feb
    Journal: Radiographics

    Noninvasive physiologic vascular studies play an important role in the diagnosis and characterization in peripheral arterial disease (PAD) of the lower extremity. These studies evaluate the physiologic parameters of blood flow through segmental arterial pressures, Doppler waveforms, and pulse volume recordings. Collectively, they comprise a powerful toolset for defining the functionality of the arterial system, localizing the site of disease, and providing prognostic data. This technology has been widely adopted by diverse medical specialty practitioners, including radiologists, surgeons, cardiologists, and primary care providers. The use of these studies increased substantially between 2000 and 2010. Although they do not employ imaging, they remain a critical component for a comprehensive radiologic vascular laboratory. A strong presence of radiology in the diagnosis of PAD adds value in that radiologists have shifted to noninvasive alternatives to diagnostic catheter angiography (DCA), such as computed tomography (CT) and magnetic resonance (MR) angiography, which provide a more efficient, less-expensive, and lower-risk alternative. Other specialties have increased the use of DCA during the same period. The authors provide a review of the relevant anatomy and physiology of PAD as well as the associated clinical implications. In addition, guidelines for interpreting the ankle-brachial index, segmental pressures, Doppler waveforms, and pulse volume recordings are reviewed as well as potential limitations of these studies. Noninvasive physiologic vascular studies are provided here for review with associated correlating angiographic, CT, and/or MR findings covering the segmental distribution of PAD as well as select nonatherosclerotic diagnoses. ©RSNA, 2016.

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    2016 AHA/ACC Guideline on the Management of Patients with Lower Extremity Peripheral Artery Disease: Executive Summary., 2017
    Journal: Vascular Medicine

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    Statement for Doppler waveforms analysis., 2017 Aug
    Journal: Vasa. Zeitschrift fur Gefasskrankheiten. Journal for Vascular Diseases

    Peripheral artery disease of the lower limbs (PAD) is a common disease. Evaluation of PAD is primarily based on non-invasive examinations with analysis of the arterial Doppler signal being a key element. However, the description of arterial Doppler waveforms morphologies varies considerably across medical schools and from country to country. In order to overcome this issue, the French College of Teachers for Vascular Medicine (Collège des Enseignants de Médecine Vasculaire; CEMV) has summarised the published data on Doppler waveforms analysis and proposes a new "Saint-Bonnet" classification system to describe Doppler waveforms morphologies. The simplified Saint-Bonnet classification comprises eight types and allows taking into account if the Doppler signal does not revert to baseline. This classification, which is based on previous classifications, could improve the descriptions of both physiological and pathological waveforms, recorded in lower limb arteries. According to the reviewed literature, recommendations about the use of Doppler waveforms are proposed. This statement is a preamble to reach an international consensus on the subject, which would standardize the description of arterial waveforms and improve the management of PAD patients.

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    2016 american college of cardiology/american heart association guideline on the management of patients with lower extremity peripheral artery disease: perioperative implications., 2017 Apr 26
    Journal: Journal of Cardiothoracic and Vascular Anesthesia

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    Editor's Choice - 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS)., 2018
    Journal: European Journal of Vascular and Endovascular Surgery

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    Angiosome perfusion of the foot: An old theory or a new issue?, 2018 Dec 20
    Journal: Seminars in vascular surgery

    The angiosome concept of foot perfusion was conceived based on anatomical studies of arterial circulation and used for planning surgical procedures, tissue reconstruction, and amputation. Its application is relevant in diabetic patients with critical limb ischemia and nonhealing foot ulcer or amputation. An understanding of foot angiosome anatomy is useful for predicting healing and planning arterial revascularization. A review of the literature, including the most recent systematic reviews and meta-analyses, indicates improved wound healing is achieved when the angiosome concept is followed. The greatest value of angiosome-based revascularization is in patients with lesion(s) limited to a single angiosome, or to achieve optimal healing of amputation sites. Future research should focus on proper identification of (imaging) modalities to determine the hemodynamic and functional changes before and after revascularization, thus identifying the "real" angiosome and directing optimal therapy.

    Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

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    Noninvasive vascular assessment of lower extremity wounds in diabetics: are we able to predict perfusion deficits?, 2017 Oct 12
    Journal: Surgical Technology International

    Vascular assessment of the lower extremity is a critical step in any patient presenting with lower extremity chronic wounds to predict the likelihood of healing and risk of amputation. This concept is vital in patients with diabetes due to their complex vascular anatomy and disease distribution. Three arteries supply the six angiosomes of the lower extremity (i.e., three-dimensional blocks of tissue fed by a "source" artery in the foot and ankle). In diabetic patients, assessment of adequate blood flow to the lower extremities is complicated by the presence of arterial calcification, associated neuropathy, and inflammation. This review focuses on noninvasive vascular assessment methods to better understand perfusion and direct therapy to improve diabetic wound healing. Clinical examination of pulses and Ankle Brachial Index (ABI) can be supplemented by handheld Doppler assessment of direction of blood flow and pulse volume recordings to understand the site and extent of peripheral arterial disease. Duplex ultrasound has been used, but is operator dependent. CT angiogram has limitations in the presence of calcifications and renal insufficiency, prevalent in the diabetic population. Novel modalities, like hyperspectral imaging, ICG fluorescence angiography, and nuclear imaging are being studied for their potential to overcome some of these challenges, but the data is limited. At present, these newer modalities are not widely available, but once validated by robust data, they may supplant older, less reliable techniques and improve our ability to predict wound healing. This will help reduce healthcare costs and improve outcomes as wound care specialists will be able to more accurately direct patients to the best treatment plan to preserve mobility and reduce mortality.

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    Questions and Answers on Diagnosis and Management of Patients with Peripheral Arterial Diseases: A Companion Document of the 2017 ESC Guidelines for the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS)., 2018 Apr 06
    Journal: European Journal of Vascular and Endovascular Surgery

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    Screening for Peripheral Artery Disease Using the Ankle-Brachial Index: An Updated Systematic Review for the U.S. Preventive Services Task Force, 2018

    OBJECTIVE: We conducted this systematic review to support the U.S. Preventive Services Task Force (USPSTF) in updating its recommendation on screening for peripheral artery disease (PAD). Our review addressed five key questions: 1) Is screening for PAD in generally asymptomatic adults with the ankle-brachial index (ABI) effective in reducing cardiovascular disease (CVD) or PAD morbidity (e.g., impaired ambulation or amputation) or mortality? 2) What is the diagnostic accuracy of the ABI as a screening test for PAD in generally asymptomatic adults? 3) What are the harms of screening for PAD with the ABI? 4) Does treatment of screen-detected or generally asymptomatic adults with PAD or an abnormal ABI lead to improved patient health outcomes? 5) What are the harms of treatment of screen-detected or generally asymptomatic adults with PAD or an abnormal ABI?

    DATA SOURCES: We searched MEDLINE, PubMed publisher-supplied records, and the Cochrane Central Register of Controlled Trials (CENTRAL) for relevant English-language literature published between January 2012 and May 2, 2017. One ongoing screening trial was published after the search date and was formally evaluated for inclusion. Additionally, we re-evaluated all studies included in the 2013 review. We supplemented our searches with reference lists from relevant existing systematic reviews, suggestions from experts, and ClinicalTrials.gov to identify ongoing trials.

    STUDY SELECTION: Two researchers reviewed 4,194 titles and abstracts and 105 full-text articles applying prespecified inclusion criteria. Eligible studies included: randomized controlled or clinically controlled trials and systematic reviews on the effectiveness of PAD screening and early treatment of screen-detected PAD to prevent CVD and PAD morbidity and mortality and quality of life; observational diagnostic accuracy studies and systematic reviews on the accuracy of the ABI to diagnose PAD; and randomized or clinically controlled trials, cohort studies, observational studies, and case-control studies on the harms of screening and treatment.

    DATA ANALYSIS: One investigator abstracted data into an evidence table and a second investigator confirmed these data. Two investigators independently assessed study quality using methods developed by the USPSTF. We qualitatively synthesized the data for each key question.

    RESULTS: No population-based screening trials evaluated the direct benefits or harms of ABI screening alone. We identified a total of five trials (n=5,864 total) examining indirect evidence for the effectiveness and harms of screening and treatment of screen-detected PAD. A single diagnostic accuracy study in a screen-detected older population of adults (n=306) showed that the ABI has low sensitivity (confidence intervals ranging from 7 to 34% in individual limbs) and high specificity (96 to 100%) characteristics compared with MRA gold standard imaging; false negative rates were high (>80%). Overall, data are limited but suggest that the ABI may not be a sufficiently sensitive screening test to detect PAD in generally asymptomatic adults. Two adequately powered trials (n=4,626) in asymptomatic populations with a low ABI but not meeting typical PAD thresholds (≤0.95 or ≤0.99) with and without diabetes showed no statistically significant effect of aspirin 100 mg daily for composite CVD outcomes (adjusted HR 1.00 [95% CI, 0.81 to 1.23] and HR 0.98 [95% CI, 0.76 to 1.26]); there were no differences seen in individual CVD outcomes or all-cause mortality compared with placebo control after 6 to 8 years of followup. There is no compelling evidence to support a differential treatment effect by age, sex, or diabetes status. Limited evidence from one trial demonstrates a trend toward higher risk for major bleeding events with the use of aspirin; the same trial showed no effect on major GI bleeding. Two trials reported conflicting results on total or fatal hemorrhagic CVA risk with wide confidence intervals due to a rare event rate. Two exercise trials (n=932) in populations that were screen-detected or oversampled for no or atypical symptoms reported no differences in quality of life (QOL), the Walking Impairment Questionnaire (WIQ) walking distance, or symptoms at 12 and 52 weeks. No harms were reported in the exercise trials.

    LIMITATIONS: Our search was limited to English-language literature. We excluded trials specifically recruiting participants from vascular laboratories for screening accuracy studies and treatment trials of symptomatic populations that would not be generalizable to screen-detected or generally asymptomatic populations. Our review protocol prioritized hard health outcomes (PAD and CVD morbidity and mortality; quality of life) and did not include changes in functional testing (e.g., 6-minute walk, lower-extremity strength), changes in the ABI, behavioral changes (e.g., physical activity levels, smoking cessation), or intermediate cardiovascular outcomes (e.g., blood pressure, lipid levels).

    CONCLUSIONS: The current evidence base for screening for PAD is limited, with no direct evidence examining the effectiveness of ABI screening alone. Indirect evidence is scant and includes a single diagnostic accuracy study of the ABI in an unselected population showing poor sensitivity; two aspirin trials in screen-detected populations (with and without diabetes) with a low ABI defined as ≤0.95 or ≤0.99 show no benefit for primary composite cardiovascular outcomes. Two underpowered exercise trials in screen-detected or atypical and asymptomatic populations show no statistically significant effect on hard health outcomes.

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    Clinical assessment of peripheral arterial disease in the office: what do the guidelines say?, 2018 Dec
    Journal: Seminars in interventional radiology

    Lower extremity peripheral arterial disease (PAD) is the manifestation of atherosclerotic disease within the lower extremities. The presentation of PAD is diverse ranging from asymptomatic disease to claudication or to debilitating rest pain, nonhealing ulcers, and gangrene. PAD is associated with significant morbidity, mortality, and healthcare costs. Proper diagnosis and management of PAD is important so as to maintain quality of life and reduce the risk of cardiovascular disease and adverse limb events such as amputation. This document provides a comprehensive outpatient approach to the clinical assessment of PAD that includes risk factors, diagnosis, treatment, and follow-up options.

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    Differentiating lower extremity wounds: arterial, venous, neurotrophic., 2018 Dec
    Journal: Seminars in interventional radiology

    Peripheral arterial disease (PAD) is a currently underdiagnosed and underrecognized vascular disease afflicting up to 200 million people worldwide, with at least 1 million of those suffering from critical limb ischemia (CLI). The 5-year mortality after major amputation for CLI (70%) is twice the average 5-year cancer mortality in the United States, and as many as 50% of CLI patients proceed directly to amputation without preceding vascular assessment or revascularization. Each year, twice as many breast augmentations are performed as leg revascularizations. Strong evidence in the literature supports markedly improved outcomes when multidisciplinary care teams across specialties are engaged to evaluate, treat, and manage patients with lower extremity wounds. This article assists the vascular specialist in differentiating the three most common lower extremity wound types.

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    Hospital Discharge Teaching for Patients with Peripheral Vascular Disease., 2019 Mar
    Journal: Critical care nursing clinics of North America

    Peripheral disease affects both arteries and veins and encompasses pathophysiologic conditions that affect arterial, venous, and lymphatic circulations. This article discusses disorders of peripheral vascular disease (PVD) that affect the lower extremity. PVD is an obstruction in the arteries known as arteriosclerosis obliterans, a condition that manifests from insufficient tissue perfusion that results in hardening of the arteries. Peripheral artery disease leads to an inflammatory condition called atherosclerosis. People at greatest risk include smokers, diabetics, those with high blood pressure, and those with elevated cholesterol levels.

    Copyright © 2018. Published by Elsevier Inc.

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    Lower extremity peripheral artery disease: diagnosis and treatment., 2019 Mar 15
    Journal: American Family Physician

    Lower extremity peripheral artery disease (PAD) affects 12% to 20% of Americans 60 years and older. The most significant risk factors for PAD are hyperlipidemia, hypertension, diabetes mellitus, chronic kidney disease, and smoking; the presence of three or more factors confers a 10-fold increase in PAD risk. Intermittent claudication is the hallmark of atherosclerotic lower extremity PAD, but only about 10% of patients with PAD experience intermittent claudication. A variety of leg symptoms that differ from classic claudication affects 50% of patients, and 40% have no leg symptoms at all. Current guidelines recommend resting ankle-brachial index (ABI) testing for patients with history or examination findings suggesting PAD. Patients with symptoms of PAD but a normal resting ABI can be further evaluated with exercise ABI testing. Routine ABI screening for those not at increased risk of PAD is not recommended. Treatment of PAD includes lifestyle modifications-including smoking cessation and supervised exercise therapy-plus secondary prevention medications, including antiplatelet therapy, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and statins. Surgical revascularization should be considered for patients with lifestyle-limiting claudication who have an inadequate response to the aforementioned therapies. Patients with acute or limb-threatening limb ischemia should be referred immediately to a vascular surgeon.

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    Lower extremity critical limb ischemia: A review of clinical features and management., 2019 Apr 15
    Journal: Trends in cardiovascular medicine

    Lower extremity critical limb ischemia (CLI) represents symptoms related to end-stage atherosclerotic peripheral arterial disease manifested by rest pain and tissue loss. It is associated with increased risk of limb amputation and cardiovascular-related mortality. The prevalence and cost of CLI are expected to increase with both the aging of the U.S. population and continued influence of smoking and diabetes. Treatments encompass measures to reduce cardiovascular risk and preserve limb viability. Despite increasing popularity of endovascular modalities, revascularization with either surgical bypass or endovascular intervention is the cornerstone of therapy. Adequate Level I data to guide decisions regarding optimal strategies to treat CLI, particularly in patients who are candidates for both open and percutaneous approaches, are currently lacking. Ongoing randomized controlled trials aim to resolve the clinical equipoise.

    Copyright © 2019. Published by Elsevier Inc.

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    Peripheral artery disease: past, present, and future., 2019 Oct
    Journal: The American Journal of Medicine

    Peripheral artery disease is a prevalent but underdiagnosed manifestation of atherosclerosis. There is insufficient awareness of its clinical manifestations, including intermittent claudication and critical limb ischemia and of its risk of adverse cardiovascular and limb outcomes. In addition, our inadequate knowledge of its pathophysiology has also limited the development of effective treatments, particularly in the presence of critical limb ischemia. This review aims to highlight essential elements of the epidemiology and pathophysiology of peripheral artery disease, bring attention to the often-atypical manifestations of occlusive arterial disease of the lower extremity, increase awareness of critical limb ischemia, briefly describe the diagnostic role of the ankle brachial index, and go over the contemporary management of peripheral artery disease. An emphasis is placed on evidence-based medical treatments to improve symptoms and quality of life and to reduce the risk of cardiovascular and limb events in these patients, including supervised exercise training, smoking cessation, antagonism of the renin-angiotensin system, lipid-lowering, antiplatelet, and antithrombotic therapies.

    Copyright © 2019 Elsevier Inc. All rights reserved.

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    Editor's Choice - European Society for Vascular Surgery (ESVS) 2020 Clinical Practice Guidelines on the Management of Acute Limb Ischaemia., 2020 Feb
    Journal: European Journal of Vascular and Endovascular Surgery

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    New vascular guidelines for treating acute and chronic limb-threatening ischaemia., 2020 Feb
    Journal: The British Journal of Surgery

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    Adherence to Guideline-Recommended Therapy-Including Supervised Exercise Therapy Referral-Across Peripheral Artery Disease Specialty Clinics: Insights From the International PORTRAIT Registry., 2020 Feb 04
    Journal: Journal of the American Heart Association

    Background Underuse of guideline-recommended therapy in peripheral artery disease (PAD) in administrative and procedural databases has been described, but reports on medically managed patients and referral to supervised exercise therapy (SET) in PAD are lacking. We aimed to document the use of PAD guideline-recommended therapy, including SET in patients with PAD symptoms consulting a specialty clinic across 3 countries. Methods and Results The 16-center PORTRAIT (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) registry enrolled 1275 patients with new or an exacerbation of PAD symptoms (2011-2015). We prospectively documented antiplatelet medications, statins, smoking cessation counseling and/or therapy, and referral to SET: "2 quality measures" referred to the use of both statin and antiplatelet medications; "4 quality measures" to receiving all 4 measures. Median odds ratios were calculated to quantify treatment variation across sites. A total of 89% patients were on antiplatelets, 83% on statins, and 23% had been referred to SET. Of 455 current smokers, 342 (72%) patients received smoking cessation therapy/counseling. Overall, 77.2% of patients received "2 quality measures" and 19.7% "4 quality measures." The median odds ratio for 2 quality measures was 2.13 (95% CI, 1.61-3.56; P< 0.001) and for 4 quality measures was 5.43 (95% CI, 2.84-17.91; P< 0.001). Variability in adherence was not explained by country, except for referral to SET. The odds for SET referral in The Netherlands (70% referral rate) was nearly 100 times greater than in US sites (2% referral rate). Conclusions Not all patients who have undergone a PAD workup at a specialty care facility are treated with evidence-based care, especially so for SET.

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    Evidence-Based Medical Management of Peripheral Artery Disease., 2020 Mar
    Journal: Arteriosclerosis, Thrombosis, and Vascular Biology

    Peripheral artery disease is an atherosclerotic disease of the lower extremities associated with high cardiovascular mortality. Management of this condition may include lifestyle modifications, medical management, endovascular repair, or surgery. The medical approach to peripheral artery disease is multifaceted and includes cholesterol reduction, antiplatelet therapy, anticoagulation, peripheral vasodilators, blood pressure management, exercise therapy, and smoking cessation. Adherence to this regimen can reduce limb-related complications like critical limb ischemia and amputation, as well as systemic complications of atherosclerosis like stroke and myocardial infarction. Relative to coronary artery disease, peripheral artery disease is an undertreated condition. In this article, we explore the evidence behind medical therapies for the management of peripheral artery disease.

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    Dressings and topical agents for arterial leg ulcers., 2020 Jan 20
    Journal: Cochrane Database of Systematic Reviews

    BACKGROUND: It is estimated that up to 1% of people in high-income countries suffer from a leg ulcer at some time in their life. The majority of leg ulcers are associated with circulation problems; poor blood return in the veins causes venous ulcers (around 70% of ulcers) and poor blood supply to the legs causes arterial ulcers (around 22% of ulcers). Treatment of arterial leg ulcers is directed towards correcting poor arterial blood supply, for example by correcting arterial blockages (either surgically or pharmaceutically). If the blood supply has been restored, these arterial ulcers can heal following principles of good wound-care. Dressings and topical agents make up a part of good wound-care for arterial ulcers, but there are many products available, and it is unclear what impact these have on ulcer healing. This is the third update of a review first published in 2003.

    OBJECTIVES: To determine whether topical agents and wound dressings affect healing in arterial ulcers. To compare healing rates and patient-centred outcomes between wound dressings and topical agents.

    SEARCH METHODS: The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials, MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature and Allied and Complementary Medicine databases, the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials register to 28 January 2019.

    SELECTION CRITERIA: Randomised controlled trials (RCTs), or controlled clinical trials (CCTs) evaluating dressings and topical agents in the treatment of arterial leg ulcers were eligible for inclusion. We included participants with arterial leg ulcers irrespective of method of diagnosis. Trials that included participants with mixed arterio-venous disease and diabetes were eligible for inclusion if they presented results separately for the different groups. All wound dressings and topical agents were eligible for inclusion in this review. We excluded trials which did not report on at least one of the primary outcomes (time to healing, proportion completely healed, or change in ulcer area).

    DATA COLLECTION AND ANALYSIS: Two review authors independently extracted information on the participants' characteristics, the interventions, and outcomes using a standardised data extraction form. Review authors resolved any disagreements through discussion. We presented the data narratively due to differences in the included trials. We used GRADE to assess the certainty of the evidence.

    MAIN RESULTS: Two trials met the inclusion criteria. One compared 2% ketanserin ointment in polyethylene glycol (PEG) with PEG alone, used twice a day by 40 participants with arterial leg ulcers, for eight weeks or until healing, whichever was sooner. One compared topical application of blood-derived concentrated growth factor (CGF) with standard dressing (polyurethane film or foam); both applied weekly for six weeks by 61 participants with non-healing ulcers (venous, diabetic arterial, neuropathic, traumatic, or vasculitic). Both trials were small, reported results inadequately, and were of low methodological quality. Short follow-up times (six and eight weeks) meant it would be difficult to capture sufficient healing events to allow us to make comparisons between treatments. One trial demonstrated accelerated wound healing in the ketanserin group compared with the control group. In the trial that compared CGF with standard dressings, the number of participants with diabetic arterial ulcers were only reported in the CGF group (9/31), and the number of participants with diabetic arterial ulcers and their data were not reported separately for the standard dressing group. In the CGF group, 66.6% (6/9) of diabetic arterial ulcers showed more than a 50% decrease in ulcer size compared to 6.7% (2/30) of non-healing ulcers treated with standard dressing. We assessed this as very-low certainty evidence due to the small number of studies and arterial ulcer participants, inadequate reporting of methodology and data, and short follow-up period. Only one trial reported side effects (complications), stating that no participant experienced these during follow-up (six weeks, low-certainty evidence). It should also be noted that ketanserin is not licensed in all countries for use in humans. Neither study reported time to ulcer healing, patient satisfaction or quality of life.

    AUTHORS' CONCLUSIONS: There is insufficient evidence to determine whether the choice of topical agent or dressing affects the healing of arterial leg ulcers.

    Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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    Trends in peripheral arterial disease incidence and mortality in EU15+ countries 1990-2017., 2020 Feb 03
    Journal: European journal of preventive cardiology

    AIMS: The aim was to assess trends in peripheral arterial disease (PAD) incidence and mortality rates in European Union(15+) countries between 1990 and 2017.

    METHODS AND RESULTS: This observational study used data obtained from the 2017 Global Burden of Disease study. Age-standardised mortality and incidence rates from PAD were extracted from the Global Health Data Exchange for EU15+ countries for the years 1990-2017. Trends were analysed using Joinpoint regression analysis. Between 1990 and 2017, the incidence of PAD decreased in all 19 EU15+ countries for females, and in 18 of 19 countries for males. Increasing PAD incidence was observed only for males in the United States (+1.4%). In 2017, the highest incidence rates were observed in Denmark and the United States for males (213.6 and 202.3 per 100,000, respectively) and in the United States and Canada for females (194.8 and 171.1 per 100,000, respectively). There was a concomitant overall trend for increasing age-standardised mortality rates in all EU15+ countries for females, and in 16 of 19 EU15+ countries for males between 1990 and 2017. Italy (-25.1%), Portugal (-1.9%) and Sweden (-0.6%) were the only countries with reducing PAD mortality rates in males. The largest increases in mortality rates were observed in the United Kingdom (males +140.4%, females +158.0%) and the United States (males +125.7%, females +131.2%).

    CONCLUSIONS: We identify shifting burden of PAD in EU15+ countries, with increasing mortality rates despite reducing incidence. Strong evidence supports goal-directed medical therapy in reducing PAD mortality - population-wide strategies to improve compliance to optimal goal-directed medical therapy are warranted.

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    Topic 761 Version 1.0


    ABSTRACT Placeholder, INTRODUCTION Overview Placeholder, Background Definitions:  Arterial or ischemic leg ulcers (AU) are leg ulcers that develop due to inadequate blood supply to the skin (arterial insufficiency). The decrease in blood supply may be caused by underlying peripheral arterial disease (PAD), which results from narrowing of the arteries to the legs