Neuromuscular Electrical Stimulation for Intermittent Claudication (NESIC): multicentre, randomized controlled trial.

METHODS: This was an open, multicentre, randomized controlled trial. Patients with intermittent claudication attending vascular surgery outpatient clinics were randomized (1:1) to receive either neuromuscular electrical stimulation (NMES) or not in addition to local standard care available at study centres (best medical therapy alone or plus supervised exercise therapy (SET)). The objective of this trial was to investigate the clinical efficacy of an NMES device in addition to local standard care in improving walking distances in patients with claudication. The primary outcome was change in absolute walking distance, measured by a standardized treadmill test at 3 months. Secondary outcomes included intermittent claudication (IC) distance, adherence, quality of life, and haemodynamic changes. RESULTS: Of 200 participants randomized, 160 were included in the primary analysis (intention to treat, Tobit regression model). The square root of absolute walking distance was analysed (due to a right-skewed distribution) and, although adjunctive NMES improved it at 3 months, no statistically significant effect was observed. SET as local standard care seemed to improve distance compared to best medical therapy at 3 months (3.29 units; 95 per cent c.i., 1.77 to 4.82; P < 0.001). Adjunctive NMES improved distance in mild claudication (2.88 units; 95 per cent c.i., 0.51 to 5.25; P = 0.02) compared to local standard care at 3 months. No serious adverse events relating to the device were reported. CONCLUSION: Supervised exercise therapy is effective and NMES may provide further benefit in mild IC.This trial was supported by a grant from the Efficacy and Mechanism Evaluation Program, a Medical Research Council and National Institute for Health and Care Research partnership. Trial registration: ISRCTN18242823.

Patients with intermittent claudication experience pain in their legs during walking or exercise which ends with rest. This severely impairs physical activity and quality of life. Treatment for such patients typically involves best medical therapy, which includes exercise advice. This study aimed to determine whether a neuromuscular electrical stimulation device improved the walking distance of patients with intermittent claudication compared to local standard care available (which may include supervised exercise therapy) in a trial. Supervised exercise improved walking distances but there was no difference in those that received a device in this patient group.

A cross-sectional audit of the risk of burnout among senior medical staff in a UK district general hospital.

OBJECTIVE: The objective was to assess burnout in senior hospital doctors (consultants and staff grade, associate specialist and specialty (SAS) doctors) within a UK-based NHS district general hospital (DGH). METHOD: A web-based survey was created using the validated abbreviated Maslach Burnout Inventory (aMBI) with consultants and SAS doctors in a DGH. PRIMARY AND SECONDARY OUTCOME MEASURES: We measured scores on aMBI subscales: depersonalisation, emotional exhaustion, personal accomplishment and efficacy. RESULTS: One-hundred and seventy-eight senior clinicians (60% of consultant and SAS doctors) completed the survey with 85% of these being substantive consultants. Forty-nine per cent of senior clinicians were found to be at high risk of burnout using metrics from the aMBI. CONCLUSIONS: Burnout is prevalent among senior clinicians at this DGH.

A multicenter randomized controlled study to evaluate whether neuromuscular electrical stimulation improves the absolute walking distance in patients with intermittent claudication compared with best available treatment.

OBJECTIVE: To assess the clinical efficacy of a neuromuscular electrical stimulation (NMES) device to improve the absolute walking distance in patients with intermittent claudication as an adjunct to the local standard care available at the study sites compared with local standard care alone. METHODS: This open, multicenter, randomized controlled trial included eight participating centers in England. Sites are equally distributed between those that provide supervised exercise therapy programs and those that do not. Patients with intermittent claudication meeting the eligibility criteria and providing consent will be randomized, depending on the center type, to either NMES and locally available standard care or standard care alone. The primary end point is change in absolute walking distance at 3 months (the end of the intervention period) by treadmill testing. Secondary outcomes include quality of life, compliance with the interventions, economic evaluation of the NMES device, and lower limb hemodynamic measures to further the understanding of underlying mechanisms. Recruitment commenced in March 2018 and will continue for a total of 15 months. The Neuromuscular Electrical Stimulation Improves the Absolute Walking Distance in Patients with Intermittent Claudication trial is funded by the UK Efficacy and Mechanism Evaluation Programme, Medical Research Council, and National Institute for Health Research partnership.

Lack of Iliac Engagement Correlates With Iliac Limb Complications Following Standard EVAR.

OBJECTIVE: An adequate distal sealing zone is a prerequisite for successful endovascular aneurysm repair (EVAR). Poor engagement of iliac limbs within the common iliac artery potentially increases the risk of limb-related complications. The aim of this study was to investigate the proportion of common iliac artery used for distal sealing as a predictor of iliac limb complications following standard EVAR. METHODS: This was a retrospective case controlled study where an iliac complication group was compared to a larger control group from the unit database. Core analysis of postoperative computed tomography scans was used to ascertain the percentage engagement of the iliac limb of the stent graft within the native iliac artery in both groups. RESULTS: There were 240 limbs in the control group and 33 limbs in the complications group. Complications included 10 endoleaks, 1 iliac limb dislocation, 2 insufficient engagement, 4 occlusions, and 16 kinks. The proportion of common iliac artery engagement was significantly higher in the control group compared with the complications group (75.3:68.6%, P = .003). CONCLUSIONS: Increased engagement in the common iliac artery following standard EVAR reduces the risks of limb complications. A clinical guide utilization of more than 70% of the total length of common iliac artery could be used as this was associated with a significantly lower rate of iliac limb complications following standard EVAR.

The impact of endovascular aneurysm repair on aortoiliac tortuosity and its use as a predictor of iliac limb complications.

OBJECTIVE: Aortoiliac tortuosity is often cited subjectively as a causative factor in iliac limb complications after endovascular aneurysm repair (EVAR); however, evidence on this subject is poor. The aim of this study was to investigate the impact of stent grafting on aortoiliac tortuosity and to explore the role of the tortuosity index (TI) as a predictor of iliac limb complications after EVAR. METHODS: A retrospective case-control study was performed comparing an iliac limb complication group with a control group. Reconstructed computed tomography angiography images were analyzed to calculate TI of the aortoiliac segments. RESULTS: This study included 153 patients, 120 in the control groups (40 Zenith flex [Cook Medical, Bloomington, Ind], 40 Endurant II [Medtronic, Minneapolis, Minn], and 40 Excluder [W. L. Gore and Associates, Flagstaff, Ariz] stent grafts) and 33 in the complications group (13 Zenith flex, 14 Endurant II, 4 Excluder, and 2 Aorfix [Lombard Medical, Oxfordshire, UK] stent grafts). There was a significant reduction in aortic and iliac TI after EVAR. This was greatest with the Zenith Flex compared with Endurant, with the least change in TI seen after Gore Excluder implantation. Iliac limb complications included 10 type Ib endoleaks, one iliac limb modular dislocation, two limbs with insufficient engagement, four occlusions, and 16 iliac limb kinks. There was no significant difference in complication rates between the three stent grafts (Zenith flex, 1.4%; Endurant, 2.9%; Excluder, 1.9%; P = .115). The median time to iliac complication was 14 months (range, 1-90 months). The iliac limb complication group was found to have a significantly increased aortoiliac TI on both preoperative and postoperative computed tomography imaging. CONCLUSIONS: EVAR has a significant effect on aortoiliac tortuosity. Despite the reduction of aortoiliac tortuosity after the insertion of a stent graft, TI may serve as a predictor of iliac limb complications after EVAR.

The effects of laparoscopic adjustable gastric banding on idiopathic intracranial hypertension.

The purpose of this study was to determine whether laparoscopic adjustable gastric banding has a role in the treatment of idiopathic intracranial hypertension. This pilot study was undertaken in a single, tertiary referral centre. Data on all patients with idiopathic intracranial hypertension that have undergone laparoscopic adjustable gastric banding in our unit were collected from our prospectively maintained bariatric database. Additional information was obtained via telephone questionnaires and review of medical records. Four female patient with a mean age of 32 years (range 29-39 years) and mean pre-operative body mass index of 46.1 kg/m(2) (range 38.2-54.0 kg/m(2)) underwent laparoscopic adjustable gastric banding between June 2006 and July 2009. At a mean follow-up of 19.8 months all four patients reported either total resolution of headache or significant improvement in headache, with a mean improvement in pain score of 76.3/100 (range 55-95) on a analogue pain score. Mean excess weight loss at follow-up was 64.1% (range 50.1-88.2%). There were no complications or mortality in this cohort. This study suggests that laparoscopic adjustable gastric banding represents an effective and safe treatment for idiopathic intracranial hypertension associated with morbid obesity. We have shown good results both in terms of symptom resolution and weight loss, whilst avoiding alimentary tract diversion procedures in these young female patients. A randomized, controlled trial can be justified on the basis of this initial pilot study.

Angioplasty versus stenting for superficial femoral artery lesions.

BACKGROUND: Lower limb peripheral arterial disease (PAD) is a common, important manifestation of systemic atherosclerosis. Stenoses or occlusions in the superficial femoral artery may result in intermittent claudication as an early consequence, which may be treated by balloon angioplasty with or without stenting. OBJECTIVES: The objective was to determine the effect of percutaneous transluminal angioplasty (PTA) when compared with PTA with stenting for lesions of the superficial femoral artery, for people with intermittent claudication or critical limb ischaemia. SEARCH STRATEGY: The Cochrane Peripheral Vascular Diseases (PVD) Group searched their trials register (last searched February 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2009, Issue 1) for publications describing randomised controlled trials (RCTs) of percutaneous angioplasty with or without stenting. SELECTION CRITERIA: Randomised trials of angioplasty alone versus angioplasty with stenting for the treatment of superficial femoral artery stenoses. DATA COLLECTION AND ANALYSIS: Two authors (CT, JC) independently selected suitable trials,assessed trial quality and extracted data. A third author (AS) ranked the concealment of allocation and checked the final manuscript. The fourth author (DM) cross checked all stages of the review process. MAIN RESULTS: Eight trials with 968 participants were included. The average age was 67 and all trials included men and women. Participants were followed for up to two years.There was a small but statistically significant improvement in primary angiographic and duplex patency at six months in patients treated with PTA plus stent over lesions treated with PTA alone (three trials and four trials, respectively). However, primary angiographic patency was non-significant 12 months (five trials, P = 0.23) and 24 months (two trials, P = 0.45). A similar but lesser effect was seen for ankle brachial pressure index (ABPI), while a more pronounced improvement in treadmill walking distance in patients with PTA plus stent insertion was observed at six and 12 (P < 0.0001), but not 24 months (P = 0.81). Only one trial reported quality of life, which showed no significant difference between patients treated with PTA alone or PTA with stent insertion at any time interval. Antiplatelet therapy protocols and inclusion criteria between trials showed marked heterogenicity. AUTHORS' CONCLUSIONS: There is limited benefit to stenting lesions of the superficial femoral artery in addition to angioplasty, however this cannot be recommended routinely based on the results of this analysis.

Bony lesions in BCG-vaccinated children: consider BCG osteitis.

This instructive case describes a 31-day-old female infant presenting with left elbow swelling. Radiographs were initially consistent with non-accidental injury, and she was investigated accordingly. After Paediatric Orthopaedic review, BCG osteitis was considered as a differential diagnosis. By this time it was too late to investigate for this uncommon condition. With the increasing incidence of tuberculosis in the Western world, BCG vaccination at birth will become more common. This case illustrates the need for multidisciplinary management of bony lesions in infants and children, involving paediatricians, orthopaedic surgeons and paediatric radiologists.

Cholesterol granuloma of the superior mediastinum.

Cholesterol granuloma develops as a response to cholesterol acting as an irritant and causing giant cell formation. This more commonly affects the sinuses with no previous report in the mediastinal region. We describe such a case in a cardiac surgical patient with an incidental finding of testicular lumps.

A quadricuspid aortic valve in a patient with neurofibromatosis type 1.

Quadricuspid aortic valve is a rare cardiovascular abnormality. Herein is described the case of a male patient with neurofibromatosis type 1 (NF1) who was found to have a quadricuspid aortic valve causing severe aortic regurgitation. Although congenital cardiac malformations have been described in patients with NF1, to the best of the present authors' knowledge this is the first time that a quadricuspid valve in a patient with neurofibromatosis has been described.