Evidence Of Peripheral Arterial Disease Research Articles

THE IMPORTANCE OF ANATOMICAL CHARCOT RECONSTRUCTION UTILIZING STANDARDIZED OSTEOTOMIES TO IMPROVE SURGICAL OUTCOMES

IntroductionCharcot neuroarthropathy is a debilitating condition that frequently leads to skeletal instability, and has an increased risk of ulceration leading to infection and amputation. However, surgical reconstruction may offer limb salvage and restauration of an ulcer-free, plantigrade stable foot for functional weight-bearing. We report on our case series according to a prospective protocol and analyse factors leading to a favourable outcome.MethodsWe report a prospective follow-up of 62 patients undergoing Charcot reconstruction, May 2014- Jan 2022, by two surgeons. Peripheral vascular disease was routinely assessed using Duplex scan and major arterial disease was treated before reconstruction. Utilising 3D modelling, pre-operative planning and standardised osteotomies, we performed anatomical correction with radiological evidence. Definitive fixation was undertaken with internal fixation to stabilise the hindfoot. Multivariant analysis was performed to assess risk factors for failure (P>0.05 statistical significance).Results59 feet were included, 3 patients did not progress to definitive surgery and 3 patients had bilateral surgery. 62.7% patients were male with an average age of 56, 88.13% had Type 2 diabetes, 56% were hypertensive, 14% were on dialysis. Twenty (54.1%) single stage reconstructions had pre-operative ulceration, 3 pts had ischaemic heart disease and 36 pts had evidence of peripheral arterial disease. 81% of patients achieved normalisation of the 3 out of 4 anatomical angles (P<0.05). Two patients (3.1%) required metalwork removal for infection and limb salvage, 11 (18.6%) had delayed wound healing. Survivorship was 97% at 3yrs, and 94% at 6yrs, however if pre-existing vascular disease was present, it was 94% at 3yrs 85.3% at 6yrs. All patients were mobile at a 3 years mean follow up.ConclusionCareful patient selection, multidisciplinary team and anatomic reconstruction led to predictable outcomes and functional limb salvage. Pre-operative vascular compromise led to a slight reduction in survivorship, but no major amputation.

OP83 Diagnostic Accuracy And Cost Effectiveness Of Automated Ankle Brachial Pressure Index Measurement For Peripheral Arterial Disease In People With Leg Ulceration

IntroductionLeg ulcers are usually treated with compression therapy unless there is evidence of peripheral arterial disease (PAD). Compression may lead to vascular complications in people with PAD. Timely diagnosis and appropriate treatment are important to ensure the best patient outcomes. PAD is usually assessed using a manual ankle brachial pressure index (ABPI). Automated devices may reduce time to diagnosis and treatment of leg ulcers. This study investigated the diagnostic accuracy, clinical effectiveness, and cost effectiveness of automated ABPI measurement, compared with manual doppler testing, to detect PAD in people with leg ulcers.MethodsWe conducted a systematic review of studies of any design assessing automated devices in any population. Meta-analyses were conducted where possible. A decision tree and Markov model was used to capture lifetime costs, quality-adjusted life-years (QALYs), and cost effectiveness from a UK National Health Service perspective. Sensitivity analyses captured the uncertainty surrounding model assumptions and probabilistic sensitivity analyses described parameter uncertainty. Value of information analysis was conducted to identify future research priorities.ResultsA total of 22 studies provided diagnostic accuracy data for five automated devices, but there were no studies in people with leg ulcers. Meta-analysis of 12 studies demonstrated a pooled sensitivity of 64 percent (95% confidence interval [CI]: 57, 71) and a specificity of 96 percent (95% CI: 92, 98) for detecting PAD. Automated devices were cheaper to complete due to shorter test times, but the increased risk of inappropriate or delayed treatment due to inaccurate test results offset the cost savings and reduced the QALYs for automated devices.ConclusionsGiven the current limited evidence base, automated devices would only be cost effective if they can demonstrate substantial reductions in time to diagnosis in clinical practice. Value of information analysis identified the following research priorities: (i) to determine diagnostic accuracy in a population with leg ulcers; (ii) to determine the impact of test results on ulcer healing times, and (iii) to determine the risk of providing inappropriate treatment based on inaccurate test results.

Regional skeletal muscle perfusion distribution in diabetic feet may differentiate short-term healed foot ulcers from non-healed ulcers.

The purpose of this study was to leverage a magnetic resonance imaging (MRI) approach to characterize foot perfusion distribution in patients with diabetes, with or without foot ulcers, and determine the ability of the regional perfusion measurements to identify ulcer-healing status. Three groups of participants (n = 15 / group) were recruited: controls (without diabetes), type II diabetes, and type II diabetes with foot ulcers. All participants underwent MRI evaluating foot perfusion in three muscle layers (from plantar to dorsal) at rest and during a standardized toe-flexion exercise. The exercise perfusion and perfusion reserve values were analyzed around and away from ulcers. Participants with foot ulcers were followed up 3months after the MRI exams to determine the foot healing status. Foot plantar muscle perfusion reserves were progressively lower from controls to diabetes, and to diabetes with foot ulcers (e.g., 2.58 ± 0.67, 1.48 ± 0.71, 1.12 ± 0.35, p < 0.001). In controls, the plantar layer had significantly higher perfusion reserve than the dorsal layer, whereas in either diabetes group, there was no significant difference in perfusion reserve among muscle layers. Using the ratio of total exercise perfusion around ulcers to that away from ulcers, the sensitivity and specificity to differentiate healing from non-healed ulcers were 100% and 86%, respectively. Our study reveals significantly different foot perfusion distribution among controls, diabetes, and diabetes with foot ulcers. The prognostic value of MRI regional perfusion assessments has the potential to monitor interventions to improve ulcer healing outcomes. • Contrast-free MRI permits quantitative assessment of regional foot muscle perfusion at rest and during isometric exercise. • Patients with diabetes and foot ulcers, without clinical evidence of peripheral arterial disease, had significantly impaired foot muscle perfusion and perfusion reserve. • Regional foot perfusion distribution may be used to predict the short-term healing status of foot ulcers in diabetes.

Acute limb ischemia in an adolescent with COVID-19 and systemic scleroderma: a case report

BackgroundJuvenile Scleroderma is a rare autoimmune disease of the connective tissue. Its concurrence with COVID-19 can lead to limb ischemia as both disease entities are pro-inflammatory and pro-thrombotic. To date, there is no case report describing the symptomatology and course of disease in patients with juvenile Scleroderma and COVID-19.Case presentationAn adolescent with acute limb ischemia presented with a history of generalized hypo-and-hyperpigmented skin lesions and mild, non-productive cough. She tested positive for SARS-CoV-2 on nasopharyngeal swab RT-PCR. Further work-up revealed elevated anti-phospholipid antibodies, anti-nuclear antibody, and D-dimer; low Protein S activity; and evidence of peripheral arterial disease on imaging studies. She was started on peripheral vasodilators, Methotrexate, and anticoagulation. Close monitoring of the affected limbs and other organs involved was done. Control of limb ischemia was achieved after 4 months of regular Cyclophosphamide infusion. Continued multi-disciplinary care was ensured for this patient.ConclusionThere is evolving knowledge about the interplay of COVID-19 hyperinflammatory state and rheumatologic disorders. COVID-19 is thought to exacerbate cutaneous manifestations of autoimmune disorders via antigen protein mimicry and cytokine imbalance. Moreover, COVID-19 is characterized by complex hematopathologic processes that put a patient in a hypercoagulable state. Elevated D-dimer can be seen in both COVID-19 and systemic sclerosis owing to their pro-thrombotic sequela. There is scarcity of data on the association of Protein S activity with COVID-19 and systemic sclerosis. More studies need to be carried out to ultimately arrive at a consensus on thrombosis prophylaxis for patients with Scleroderma and COVID-19.

Abstract 10465: Abnormal Post Exercise Skeletal Muscle Microvascular Response and Metabolism Correlate With Patient Reported Outcomes in Patients With Intermittent Claudication From Peripheral Artery Disease

Background and Aims: Intermittent claudication (IC) in patients with peripheral artery disease (PAD) is thought to be caused by reduced lower extremity macrovascular blood flow. However, the ankle-brachial index (ABI) (a macrovascular measure) does not correlate well with patient-reported outcome measures. We aimed to study microvascular and metabolic skeletal muscle responses to exercise in patients with IC using positron emission tomography (PET). Methods: We enrolled 19 patients with IC (ABI &amp;lt; 0.90 and imaging/angiographic evidence of PAD) and 12 healthy controls (HCs) (normal ABI). All subjects underwent rest perfusion imaging of the legs with 13 N-ammonia or 11 C-acetate PET followed by a graded treadmill test. Subjects exercised until limited by claudication or the end of the 20-minute protocol. Subjects then underwent immediately post-exercise PET imaging of the legs. Skeletal muscle blood flow (SMBF) was quantified in each leg at rest and immediately post-exercise. Skeletal muscle oxygen utilization (SMVO 2 ) normalized to SMBF was also quantified for patients who underwent imaging with 11 C-acetate. Peripheral artery questionnaire (PAQ) summary score was obtained for all subjects. Results: We found that SMBF was increased post-exercise in all subjects, and stress/rest SMBF was higher in the legs of subjects with PAD than in the legs of HCs ( Figure 1A ). We also found that stress SMVO 2 /SMBF was higher in legs of patients with PAD than in the legs of HCs ( Figure 1B ). There was a moderate, significant correlation between limb stress/rest SMBF and PAQ score ( Figure 1C ) and a strong, significant correlation between limb stress SMVO 2 /SMBF and PAQ score ( Figure 1D ). Conclusions: In conclusion, we found that SMBF increased in all subjects after treadmill exercise and paradoxically to the greatest degree in patients with IC. We also found that PET-derived markers of post-exercise microvascular perfusion and metabolism correlated with patient-reported outcomes.

Microbiology of diabetic foot osteomyelitis – Is it geographically variable?

IntroductionDiabetic foot osteomyelitis (DFO) is a dreaded complication as both diagnosis and treatment of the condition is laborious. However, for proper decision on antibiotics in medical management of DFO, accurate determination of microbes is necessary to narrow the spectrum of coverage and to reduce adverse effects of long-term administration of antibiotics. With differing pattern of use of antimicrobials and their resistance pattern in different countries, it is empirical to determine the microbiological characteristics of bone cultures in DFO from a referral institute in South India. Materials and MethodsThis study was a retrospective chart review of all cases of proven DFO who had consented for debridement and bone culture or those who underwent amputation. Both deep soft tissue (DST) and bone cultures were obtained for aerobic bacteria. Clinical characteristics and site(s) of DFO were recorded. Investigations for peripheral artery disease were performed if clinically indicated. ResultsIn all, 105 patients with DFO were reviewed. Mean age was 62 years and 70% were men. Of those who were screened, 57% had evidence of peripheral arterial disease by arterial doppler. 46% of bone culture samples were sterile. Gram- negative organisms were more common (58%). Following staphylococcus, pseudomonas was the second common isolate. Of total staphylococcal isolates 37% were MRSA and 33% of klebsiella isolates were ESBL producing. Concordance rate between DST and bone cultures was 66%. 90% were mono-bacterial isolates. The commonest site of involvement of DFO was terminal phalanges of toes rather than base of 1st metatarsal. ConclusionWidespread use of antibiotics, tropical climate and route of entry of organisms causing DFO differed in our cohort of patients. Further studies from different regions of world would shed light onto different pattern of microbes causing DFO.

The Prevalence and Risk Factors for Peripheral Arterial Disease in Adults Living With Human Immunodeficiency Virus.

Adult patients with human immunodeficiency virus (HIV) appear to be at high risk of cardiovascular disease (CVD). Peripheral arterial disease (PAD) is particularly concerning as it is associated with myocardial infarction and stroke. Nevertheless, the incidence of PAD is still unknown. The authors prospectively recruited HIV-infected patients from the outpatient clinic of the Department of Internal Medicine in our center. We assessed ankle-brachial index (ABI) using the VaSera system™ (Fukuda Denshi Co., Ltd). Patients were grouped into 3 ABI levels: an ABI ≤0.90 was considered abnormal and evidence of PAD, an ABI 1.0 to 1.40 was considered normal, and 0.91 to 0.99 was considered borderline. Cardiovascular risk factors were compared across all 3 levels of ABI and were analyzed using multivariate ordinal logistic regression. Eight hundred ninety-two patients were recruited. The mean age was 42.9 ± 10.0 years and 458 (51.4%) were males. There were 704, 149, and 39 patients in the normal, borderline, and abnormal ABI groups, respectively. The latter group of 39 patients was considered to have PAD, yielding a prevalence of 4.37% (95% confidence interval [CI] 3.21-5.93). Sex ratio, age, education levels, smoking rate, body mass index (BMI), blood pressure, prevalence of comorbidities with hypertension and coronary heart disease, median triglyceride level, reduced kidney function and HIV-1 RNA undetectable ratio, duration of HIV diagnosis, and duration on antiretroviral treatment were significantly different among 3 ABI subgroups. Independent risk factors associated with PAD were being female (odds ratio [OR]: 2.86; 95% CI: 1.94-4.22), being <30 years of age (OR: 4.66; 95% CI: 2.78-7.81), being overweight (BMI 25-25.9; OR: 0.39; 95% CI: 0.20-0.76), being obese (BMI: 30; OR: 3.53; 95% CI: 1.51-8.22), having a diastolic blood pressure ≥80 mmHg (OR: 0.50; 95% CI: 0.35-0.71), and having detectable HIV-1 RNA ≥20 copies/mL (OR: 1.85; 95% CI: 1.13-3.03). In conclusion, the prevalence of PAD in HIV-infected Thais was 4.37% in infected patients on therapy attending outpatient clinics. For this population, PAD appears to be relatively poorly correlated with traditional risk factors of CVD.

Outcomes of Arterial Conduits in Vascular Reconstruction After Oncologic Resection of Locally Advanced Pancreatic Malignancies

To determine early and midterm outcomes of various conduit types for visceral artery reconstruction after resection of locally advanced pancreatic malignancies. Retrospective review of all patients who underwent resection for pancreatic malignancy with visceral reconstruction using superficial femoral artery (SFA), great saphenous vein (GSV), splenic artery (SA), cryopreserved allograft, or prosthetic graft (PG) between 2000 and 2019. The SFA donor limbs were revascularized with expanded polytetrafluoroethylene interposition grafts. End points for visceral and donor limb arterial reconstructions are primary and secondary patency, vascular complications, and mortality. Visceral reconstruction for oncologic resection was performed in 57 patients. Reconstructed arteries included proper hepatic (n = 24), common hepatic (n = 17), superior mesenteric (n = 22), right hepatic (n = 5), and left hepatic (n = 2) with multivessel reconstructions performed in 13 patients. Of 57 visceral reconstructions, 30 were performed with autogenous SFA; 27 had no preoperative evidence of peripheral arterial disease. Median follow-up for all patients was 9 months. The 30-day visceral reconstruction complications included pseudoaneurysms in one SFA conduit (requiring gastroduodenal artery coiling and covered stent placement) and one GSV conduit (requiring covered stent placement), thrombosis in one PG conduit and one GSV conduit (both requiring open thrombectomy), and anastomotic bleed from one SA conduit (requiring operative repair). The 30-day SFA harvest donor limb complications included one hematoma, one lymphocele, and one symptomatic edema. Early mortality occurred in three patients including one SA conduit with multiorgan failure, one GSV conduit pseudoaneurysm rupture secondary to pancreatic leak and one SFA conduit of unknown cause. Midterm visceral reconstruction complications included pseudoaneurysm in 6 patients (3 SFA conduits with 2 treated, 3 GSV conduits with all treated), and graft occlusion in 10 patients (3 SFA, 4 GSV, 1 cryopreserved allograft and 2 PG). One patient underwent percutaneous angioplasty for high-grade stenosis of a SA graft. This gave a primary and secondary patency for all visceral arterial reconstructions of 81% and 84%, respectively. Midterm SFA donor limb patency was 100% with median follow-up of 8 months. Late mortality occurred in 19 patients (33%) with 11 cancer-related deaths and 5 of unknown cause or unrelated to the primary cancer. Three late mortalities occurred secondary to mycotic graft pseudoaneurysm ruptures in the setting of bile and pancreatic leaks (1 GSV, 1 PG secondary reconstruction in SFA conduit patient and 1 SFA conduit). This preliminary study suggests that superficial femoral artery can be considered feasible conduit in oncologic reconstructions with low morbidity of the donor limb. Long-term follow-up is needed to identify oncologic and patency-related outcomes.TablePrimary end points by conduit choiceConduitNo. of patientsPrimary patencySecondary patencyMajor early visceral graft complicationsAll-cause mortality, % (vascular-related, %)Median follow-up, months (range)Superficial femoral artery3090%90%n = 1 pseudoaneurysm30 (7)8 (2-39)Cryopreserved allograft988%88%n = 00 (0)4 (1-23)Great saphenous vein838%38%n = 2 (1 pseudoaneurysm, 1 thrombosis)75 (25)11 (0-25)Prosthetic graft667%83%n = 1 thrombosis67 (0)12 (1-107)Splenic artery450%50%n = 1 anastomotic bleed50 (0)26 (1-52) Open table in a new tab

Association of 4-limb systolic blood pressure heterogeneity with peripheral artery disease and left ventricular mass index.

A large interarm and interleg systolic blood pressure (SBP) difference and ankle-brachial index (ABI) <0.9 were associated with peripheral artery disease and left ventricular hypertrophy. These 3 parameters were derived from 4-limb SBP data. However, there is no study to assess clinical significance of SBP heterogeneity in 4 limbs. The aim of this study was to evaluate the association of 4-limb SBP standard deviation (SD) with peripheral vascular parameters and echocardiographic data in patients with or without clinical findings of peripheral artery disease.A total of 1240 patients were included, of whom 1020 had no clinical evidence of overt peripheral artery disease. The 4-limb blood pressures, brachial-ankle pulse wave velocity, and ABI were measured simultaneously by an ABI-form device.In the multivariable linear regression analysis, increased left ventricular mass index (LVMI), ABI < 0.9, interarm SBP difference >10 mm Hg, and interleg SBP difference >15 mm Hg (P ≤ .030) were associated with increased 4-limb SBP SD. Additionally, a subgroup multivariable linear regression analysis in 1020 patients without ABI < 0.9, interarm SBP difference >10 mm Hg, and interleg SBP difference >15 mm Hg found 4-limb SBP SD still had a positive correlation with LVMI (P < .001).In addition to significant association with ABI < 0.9, interarm SBP difference >10 mm Hg, and interleg SBP difference >15 mm Hg, 4-limb SBP SD was positively correlated with LVMI in the multivariable linear regression analysis in all study patients. Furthermore, in the subgroup of patients without clinical evidence of peripheral artery disease, 4-limb SBP SD still had a positive correlation with LVMI. Hence, assessment of 4-limb SBP heterogeneity is useful in identification of high-risk group of peripheral artery disease and/or increased LVMI, irrespective of the presence of overt peripheral artery disease.

Accuracy of Peripheral Arterial Disease Registers in UK General Practice: Case-Control Study.

Background:Approximately 20% of the UK population aged 55 to 75 years have evidence of peripheral arterial disease (PAD). PAD affects quality of life and life expectancy if not appropriately diagnosed and managed. At risk patients require accurate diagnosis to ensure optimal treatment to slow disease progression and minimize adverse outcomes.Aim:To assess the accuracy of general practice (GP) registration of the diagnosis of peripheral arterial disease (PAD).Design and Setting:An observational analytic case-control study. As part of a National Institute for Health Research–funded (ISRCTN13301188) project assessing novel diagnostic methods set in GP practice.Methods:A total of 125 patients registered as having PAD and 125 age- and sex-matched controls were recruited from 15 general practices across North East England. The register was then assessed for accuracy of diagnosis. Duplex vascular ultrasound scanning (DUS) undertaken by vascular scientists was used as the gold standard reference for PAD.Results:The PAD register had a sensitivity of 86% (95% CI 77%-92%) and specificity of 74% (95% CI 67%-81%) when compared with DUS. The positive predictive value, however, was 69.6% (95% CI 63%-75%) and negative predictive value 88.8% (95% CI 82%-92%). The overall diagnostic effectiveness of the PAD register was 79.2% (95% CI 73%-84%).Conclusion:This analysis indicates that while PAD is detected with reasonable sensitivity in primary care, many patients registered with a diagnosis of PAD lacked DUS-proven disease. Improved approaches to the objective diagnosis of PAD may improve diagnosis and management of PAD in primary care.

Assessment of the Utility of a Vascular Early Warning System Device in the Assessment of Peripheral Arterial Disease in Patients with Diabetes and Incompressible Vessels

The objective of this study was to assess the ability of a novel, automated Conformité Européenne marked vascular early warning system (VEWS) device to detect peripheral arterial disease in patients with incompressible ankle arteries and non-measurable ankle brachial pressure index (ABPI) secondary to diabetes. Recruited patients had diabetes, recent magnetic resonance angiography evidence of peripheral arterial disease (PAD), and incompressible vessels on ABPI. VEWS indices of each leg were automatically calculated by using optical infrared and red sensors applied to the foot, with readings obtained with the subject's leg both flat and elevated. Indices <1.03 and ≤0.94 were considered upper and lower diagnostic cutoff limits for PAD. Bollinger scores were calculated from the magnetic resonance angiography. A Best Bollinger Score (BBS) of <4 was defined as no significant PAD. All patients had tissue loss. Per protocol analysis of 28 limbs in 14 patients: VEWS had a sensitivity of 94% and specificity 20% for the detection of PAD at <1.03 cutoff and sensitivity 89% and specificity 80% at ≤0.94 cutoff. There was a good correlation between the VEWS index and BBS (-0.637; P=0.0003). VEWS is a safe, simple-to-use, promising tool to assist in the diagnosis of PAD in patients with incompressible vessels due to diabetes.

Improvement of the Quality of Evidence of Peripheral Artery Disease in Diabetic Foot Ulceration: Small Step for a Doctor, Giant Leap for Mankind?

Improvement of the Quality of Evidence of Peripheral Artery Disease in Diabetic Foot Ulceration: Small Step for a Doctor, Giant Leap for Mankind?

Mitochondrial complex I defect resulting from exercise-induced lower limb ischemia in patients with peripheral arterial disease.

This study aims to compare the structural and mitochondrial alterations between muscle segments affected by exercise-induced ischemia and segments of the same muscle without ischemia, in the same subject. In a prospective analysis, 34 patients presenting either peripheral arterial disease or chronic coronary syndrome without any evidence of peripheral arterial disease were eligible for inclusion based on findings indicating a need for either a femoro-popliteal bypass or a saphenous harvesting for coronary bypass. Before surgery, we assessed the level of exercise-induced ischemia in proximal and distal sections of the thigh by the measurement of transcutaneous oxygen pressure during an exercise treadmill test. Distal and proximal biopsies of the sartorius muscle were procured during vascular surgical procedures to assess mitochondrial function and morphometric parameters of the sartorius myofibers. Comparisons were made between the distal and proximal biopsies, with respect to these parameters. Thirteen of the study patients that initially presented with peripheral arterial disease had evidence of an isolated distal thigh exercise-induced ischemia, associated with a 35% decrease in the mitochondrial complex I enzymatic activity in the distal muscle biopsy. This defect was also associated with a decreased expression of the manganese superoxide dismutase enzyme and with alterations of the shapes of the myofibers. No functional or structural alterations were observed in the patients with coronary syndrome. We validated a specific model ischemia in peripheral arterial disease characterized by muscular alterations. This "Distal-Proximal-Sartorius Model" would be promising to explore the physiopathological consequences specific to chronic ischemia. NEW & NOTEWORTHY We compared proximal versus distal biopsies of the sartorius muscle in patients with superficial femoral artery stenosis or occlusion and proof of, distal only, regional blood flow impairment with exercise oximetry. We identified a decrease in the mitochondrial complex I enzymatic activity and antioxidant system impairment at the distal level only. We validate a model to explore the physiopathological consequences of chronic muscle ischemia.

Rivaroxaban with or without aspirin in patients with stable peripheral or carotid artery disease: an international, randomised, double-blind, placebo-controlled trial

Patients with peripheral artery disease have an increased risk of cardiovascular morbidity and mortality. Antiplatelet agents are widely used to reduce these complications. This was a multicentre, double-blind, randomised placebo-controlled trial for which patients were recruited at 602 hospitals, clinics, or community practices from 33 countries across six continents. Eligible patients had a history of peripheral artery disease of the lower extremities (previous peripheral bypass surgery or angioplasty, limb or foot amputation, intermittent claudication with objective evidence of peripheral artery disease), of the carotid arteries (previous carotid artery revascularisation or asymptomatic carotid artery stenosis of at least 50%), or coronary artery disease with an ankle-brachial index of less than 0·90. After a 30-day run-in period, patients were randomly assigned (1:1:1) to receive oral rivaroxaban (2·5 mg twice a day) plus aspirin (100 mg once a day), rivaroxaban twice a day (5 mg with aspirin placebo once a day), or to aspirin once a day (100 mg and rivaroxaban placebo twice a day). Randomisation was computer generated. Each treatment group was double dummy, and the patient, investigators, and central study staff were masked to treatment allocation. The primary outcome was cardiovascular death, myocardial infarction or stroke; the primary peripheral artery disease outcome was major adverse limb events including major amputation. This trial is registered with ClinicalTrials.gov, number NCT01776424, and is closed to new participants. Between March 12, 2013, and May 10, 2016, we enrolled 7470 patients with peripheral artery disease from 558 centres. The combination of rivaroxaban plus aspirin compared with aspirin alone reduced the composite endpoint of cardiovascular death, myocardial infarction, or stroke (126 [5%] of 2492 vs 174 [7%] of 2504; hazard ratio [HR] 0·72, 95% CI 0·57-0·90, p=0·0047), and major adverse limb events including major amputation (32 [1%] vs 60 [2%]; HR 0·54 95% CI 0·35-0·82, p=0·0037). Rivaroxaban 5 mg twice a day compared with aspirin alone did not significantly reduce the composite endpoint (149 [6%] of 2474 vs 174 [7%] of 2504; HR 0·86, 95% CI 0·69-1·08, p=0·19), but reduced major adverse limb events including major amputation (40 [2%] vs 60 [2%]; HR 0·67, 95% CI 0·45-1·00, p=0·05). The median duration of treatment was 21 months. The use of the rivaroxaban plus aspirin combination increased major bleeding compared with the aspirin alone group (77 [3%] of 2492 vs 48 [2%] of 2504; HR 1·61, 95% CI 1·12-2·31, p=0·0089), which was mainly gastrointestinal. Similarly, major bleeding occurred in 79 (3%) of 2474 patients with rivaroxaban 5 mg, and in 48 (2%) of 2504 in the aspirin alone group (HR 1·68, 95% CI 1·17-2·40; p=0·0043). Low-dose rivaroxaban taken twice a day plus aspirin once a day reduced major adverse cardiovascular and limb events when compared with aspirin alone. Although major bleeding was increased, fatal or critical organ bleeding was not. This combination therapy represents an important advance in the management of patients with peripheral artery disease. Rivaroxaban alone did not significantly reduce major adverse cardiovascular events compared with asprin alone, but reduced major adverse limb events and increased major bleeding. Bayer AG.

The prevalence of peripheral artery disease by using ankle brachial index in hypertensive patients

Introduction: Hypertension is one of the leading causes of global burden of disease. In a study, prevalence of hypertension in India was quoted 13.1% and only 16.7% of the person had achieved BP control of 140/90mm Hg. Peripheral vascular disease (PVD) is a slow and progressive circulation disorder which is characterized by narrowing of the vessels that carry blood to the leg and arm muscles. It is estimated that PAD affects 2 billion people worldwide. It is also estimated that of all the hypertensives at presentation, 2-5% have claudication. Similarly 50-92% of patients with PAD have hypertension. The Ankle-brachial Index (ABI) is the ratio of the systolic blood pressures between the dorsalis pedis and the posterior tibial artery to the higher of the systolic blood pressures in the two brachial arteries. The ABI’s sensitivity is 90% and its specificity is 98%. Normal ABI range of 1.00 to 1.40.The patient is diagnosed with PAD when the ABI is ? 0.90, ABI Acts as an independent predictor of coronary and cardiovascular morbidity and mortality.Materials and methods: In this study 100 patients were registered who were suffering from hypertension, which include both indoor and outdoor patients, were studied. These patients were between the age group 45-75 years. In this study 82 were males and 18 were females. .Patients with history of Diabetes, Smoking, Hyperlipidemia, and with other risk factors excluding hypertension were excluded from the study. Ankle Brachial Index (ABI) was measured for the patients. A Doppler ultrasound blood flow detector and a sphygmomanometer (blood pressure cuff) was used to measure ABI. The patient is diagnosed with PAD when the ABI is ? 0.90Observation: Total number of patients 100. Prevalence rate of peripheral arterial disease in hypertensive patients with age group (45-75) was 7%. The highest prevalence rate was seen in patients in age group 65-75 years. Males had slightly higher prevalence of peripheral arterial disease than females. Prevalence of ECG abnormalities suggesting cardiovascular disease was higher in patients with peripheral arterial disease than patients without peripheral arterial disease. Abnormal ABI (&lt;0.9) was found in significantly higher proportion of patients with clinical evidence of peripheral arterial disease (86%) than in patients without clinical evidence of peripheral arterial disease (1.1%).Conclusion: The present study shows that ABI is a valuable method for the diagnosis of peripheral arterial disease in patients of Hypertension and should be applied in routine practices which may improve cardiovascular risk predictionBangladesh Journal of Medical Science Vol.15(4) 2016 p.556-564

Decreased bone cortical density at the forearm in subjects with subclinical peripheral arterial disease.

The association between peripheral arterial disease (PAD) and low bone mass is controversial. In our study, peripheral quantitative computed tomography shows a reduction of cortical but not trabecular, bone mineral density (BMD) at the forearm, in patients with subclinical PAD. Some controversy exists regarding the association between peripheral arterial disease (PAD) and low bone mass. Previous studies have evaluated bone mineral density (BMD) in patients with subclinical PAD, with mixed results. Inconsistency of data may depend on the fact that most studies measured areal bone mineral density (aBMD) by Dual-energy-x ray absorptiometry (DXA). Because DXA cannot distinguish between cortical and trabecular compartments, we reasoned that a study aimed to establish whether these compartments were differentially affected by PAD status could give more information on the nature of this association. In this cross-sectional study, we used peripheral quantitative computed tomography (pQCT) to examine volumetric cortical and trabecular mineral density at the radius (vBMD) in a cohort of subjects with subclinical PAD as defined by ABI ≤0.90 and compared them with healthy subjects with no evidence of PAD. Patients with subclinical PAD had significantly reduced cortical density (1101.0 ± 45.4 vs 1156.2 ± 51.3 mg/cm(3), p < 0.001) and cortical area (75.0 ± 20.9 vs 99.9 ± 18.2 mm(2), p < 0.001) than healthy subjects. Trabecular density (178.1 ± 47.9 vs 165.8 ± 29.6 mg/cm(3)) was not significantly different in the two groups. Subclinical PAD induces a selective bone loss at the radius compartment, not identified by standard DXA, which seems to occur primarily at the cortical level.

Epidemiology, risk factors and impact on long-term pancreatic function of infection following pancreas-kidney transplantation

AbstractLimited information exists about epidemiology and risk factors of infection following pancreas-kidney transplantation and its impact on long-term pancreatic graft function. A retrospective chart review of episodes of severe infection in consecutive pancreas-kidney transplantations in a single institution was performed to assess the epidemiology, risk factors for infection and their impact on the development of pancreatic graft dysfunction. Ninety-four (81%) of 116 recipients (median follow-up of 1492 days; mean 1594) developed 248 episodes of severe infection. Bacterial infections were present in 208 episodes, with 12% of the isolates resistant to antibiotics used in prophylaxis. There were 40 episodes of fungal infection in 32 patients (28%) (mostly Candida spp), and CMV disease appeared in 20 patients (17%), of which 50% appeared after the third month following surgery. The multivariate analysis identified that surgical re-intervention and the use of steroid pulses were independently associated with the development of any infection. Additionally, pre-transplant evidence of peripheral artery disease, a longer cold ischaemia time and high transfusional requirements were associated with fungal infections. Cytomegalovirus (CMV) mismatch was independently related to CMV disease and female sex, and bladder drainage of the exocrine pancreas was associated with urinary tract infection. At the end of follow-up, 29 patients (25%) had developed severe pancreatic graft dysfunction, and fungal infection was independently associated with it. Our study identifies a subset of pancreas-kidney transplant recipients at a higher risk of developing severe infection. Fungal infection is an independent risk factor for the development of severe pancreatic graft dysfunction.

Cardiovascular morbidity–mortality associated to ankle-brachial index in the general population

Background and objectivesAbnormal ankle-brachial index (ABI) is associated with a high risk of cardiovascular disease. This study has aimed to investigate the association between low ABI and risk of cardiovascular death in a general population attended in a primary care center. Patients and methodsA total of 1361 volunteers aged between 60 and 79 years without any evidence of peripheral artery disease who attended a primary care center participated in the study. They underwent a complete physical examination, together with standard blood tests and ABI was determined. The participants were contacted by telephone 4 years later and asked about any cardiovascular problems for that period. Causes of death and hospitalization were confirmed in the medical records in the primary care center and/or hospital. ResultsInformation was obtained about the clinical evolution of 1300 participants (mean age 69.9 years, 38.2% men). Mean follow-up was 49.8 months. There were 13 cardiovascular death and 49 major cardiovascular events. Low ABI (<0.9) was associated with a significant higher risk of cardiovascular death (adjusted relative risk 6.83; 95% confidence interval 1.36–34.30, P=0.020), and with a higher risk of major cardiovascular events (adjusted relative risk 2.42; 95% confidence interval 0.99–5.91, P=0.051). High or uncompressible ABI was not associated with higher cardiovascular risk. ConclusionsA low ABI was associated with higher risk of cardiovascular death in the general population followed up in a primary care center.

Morbimortalidad cardiovascular asociada al índice tobillo-brazo en la población general

Background and objectivesAbnormal ankle-brachial index (ABI) is associated with a high risk of cardiovascular disease. This study has aimed to investigate the association between low ABI and risk of cardiovascular death in a general population attended in a primary care center. Patients and methodsA total of 1,361 volunteers aged between 60 and 79 years without any evidence of peripheral artery disease who attended a primary care center participated in the study. They underwent a complete physical examination, together with standard blood tests and ABI was determined. The participants were contacted by telephone 4 years later and asked about any cardiovascular problems for that period. Causes of death and hospitalization were confirmed in the medical records in the primary care center and/or hospital. ResultsInformation was obtained about the clinical evolution of 1,300 participants (mean age 69.9 years, 38.2% men). Mean follow-up was 49.8 months. There were 13 cardiovascular death and 49 major cardiovascular events. Low ABI (<0.9) was associated with a significant higher risk of cardiovascular death (adjusted relative risk 6.83; 95% confidence interval 1.36-34.30, P=.020), and with a higher risk of major cardiovascular events (adjusted relative risk 2.42; 95% confidence interval 0.99-5.91, P=.051). High or uncompressible ABI was not associated with higher cardiovascular risk. ConclusionsA low ABI was associated with higher risk of cardiovascular death in the general population followed-up in a primary care center.

Differences in the ankle-brachial index in the general population after 4 years of follow-up

Variation in the ankle-brachial index (ABI) is related to the progression of atherosclerosis in the lower extremities and is associated with mid-term cardiovascular morbidity and mortality. The aim of this study was to investigate the changes in ABI after four years of follow-up of individuals in the general population, and the factors associated with relevant variations observed. The study was performed in 750 volunteers (mean age 69.9 years) men without any evidence of peripheral artery disease, who attended a primary care centre. A complete physical examination, together with standard blood tests and ABI were performed. Four years later a new clinical evaluation was done. Variations in ABI values were considered relevant if > 10 %. Mean ABI in the second visit was 1.07 ± 0.15, which represented 0.02 ± 0.12 points lower than in the first visit (P < 0.001). Of these subjects, 157 (21.6 %) had an ABI decrease > 10 %. Multivariate analysis showed that the change was associated with male gender, cardiovascular history, no intake of blockers of the renin-angiotensin system, and the presence of atherogenic dyslipidaemia. A relevant increase in ABI was observed in 117 subjects (16.1 %), but was not associated with any of the studied factors. ABI values tend to decrease in the general population, although one sixth of the studied subjects had a relevant increase in this parameter.