Systematic Review and Meta-analysis of Clinical Trials Examining the Benefit of Exercise Programmes Using Nordic Walking in Patients With Peripheral Artery Disease.

OBJECTIVES: An exercise programme is part of the initial management of peripheral artery disease (PAD). Nordic walking uses poles and a core-focused walking technique to reduce the load on the legs, which may have advantages as an exercise programme for PAD. This systematic review examined the benefit of a Nordic walking programme for treating PAD compared with other programmes. METHODS: A systematic approach was used to identify clinical trials comparing Nordic walking and control programmes in PAD patients. For inclusion, studies had to report maximum walking distance (MWD) measured with a treadmill test or corridor walking test both at entry and follow up. Study quality was appraised using the Cochrane collaboration tool for assessing risk of bias. An inverse variance weighted meta-analysis was performed to compare improvements in MWD. RESULTS: Five independent trials involving 294 patients were identified. In three trials, supervised Nordic walking programmes were compared with supervised standard walking. One trial compared a home based Nordic walking programme with a similar standard walking programme. One trial compared a partly supervised Nordic walking programme with best medical management. Meta-analysis of all data suggested that MWD improvements were similar for patients treated by Nordic and standard walking programmes (standardised mean difference, SMD = 1.31, 95% CI -1.28 to 3.91; p = .322). Findings for completely supervised programmes were similar to the primary analysis (SMD = -0.79, 95% CI -2.81 to 1.24; p = .446) while those from partially supervised or home based programmes favoured Nordic walking (SMD = 4.46, 95% CI 3.39, 5.53; p < .001), mainly due to results from one home based trial. CONCLUSIONS: This systematic review suggests no benefit of Nordic over standard walking as supervised exercise for PAD. Favourable results were reported for one home based Nordic walking programme. A larger trial is needed to assess whether this finding can be replicated or not.

Long-term outcomes after stenting versus endarterectomy for treatment of symptomatic carotid stenosis: the International Carotid Stenting Study (ICSS) randomised trial.

BACKGROUND: Stenting is an alternative to endarterectomy for treatment of carotid artery stenosis, but long-term efficacy is uncertain. We report long-term data from the randomised International Carotid Stenting Study comparison of these treatments. METHODS: Patients with symptomatic carotid stenosis were randomly assigned 1:1 to open treatment with stenting or endarterectomy at 50 centres worldwide. Randomisation was computer generated centrally and allocated by telephone call or fax. Major outcomes were assessed by an independent endpoint committee unaware of treatment assignment. The primary endpoint was fatal or disabling stroke in any territory after randomisation to the end of follow-up. Analysis was by intention to treat ([ITT] all patients) and per protocol from 31 days after treatment (all patients in whom assigned treatment was completed). Functional ability was rated with the modified Rankin scale. This study is registered, number ISRCTN25337470. FINDINGS: 1713 patients were assigned to stenting (n=855) or endarterectomy (n=858) and followed up for a median of 4·2 years (IQR 3·0-5·2, maximum 10·0). Three patients withdrew immediately and, therefore, the ITT population comprised 1710 patients. The number of fatal or disabling strokes (52 vs 49) and cumulative 5-year risk did not differ significantly between the stenting and endarterectomy groups (6·4% vs 6·5%; hazard ratio [HR] 1·06, 95% CI 0·72-1·57, p=0·77). Any stroke was more frequent in the stenting group than in the endarterectomy group (119 vs 72 events; ITT population, 5-year cumulative risk 15·2% vs 9·4%, HR 1·71, 95% CI 1·28-2·30, p<0·001; per-protocol population, 5-year cumulative risk 8·9% vs 5·8%, 1·53, 1·02-2·31, p=0·04), but were mainly non-disabling strokes. The distribution of modified Rankin scale scores at 1 year, 5 years, or final follow-up did not differ significantly between treatment groups. INTERPRETATION: Long-term functional outcome and risk of fatal or disabling stroke are similar for stenting and endarterectomy for symptomatic carotid stenosis. FUNDING: Medical Research Council, Stroke Association, Sanofi-Synthélabo, European Union.

Which is the best revascularization for critical limb ischemia: Endovascular or open surgery?

This review considers the roles of endovascular and open surgery for critical lower limb ischemia. The TransAtlantic Inter-Society Consensus document offers sensible guidelines for the treatment of both suprainguinal and infrainguinal disease. For bilateral/diffuse suprainguinal disease, aortobifemoral bypass remains the best option, but great care should be taken in this new era of hospital-acquired infection. Unilateral iliac occlusions should be treated by primary stenting, but an iliofemoral or femorofemoral bypass may be the best option when the disease extends down into the common femoral artery. Stents may reduce the risk of embolization in iliac stenoses but probably confer no benefit in long-term patency. Iliac stenoses should be treated by angioplasty, with stents reserved for flow-limiting complications. Although infrainguinal bypass surgery is in decline, probably due to better medical treatment and more endovascular intervention, bypass using autologous saphenous vein remains the gold standard. In the absence of leg veins, arm vein should be considered. Prosthetic grafts should be used as a last resort, and only with a venous cuff. The long-term results of the Bypass Versus Angioplasty in Severe Ischemia of the Leg (BASIL) trial favor surgery rather than angioplasty if there is a good vein and the patient is fit. Further randomized studies of infrainguinal stenting vs bypass are required. Some patients with critical lower limb ischemia are best treated by analgesia or primary amputation.

Developing assessments of surgical skills for the GMC Performance Procedures.

INTRODUCTION: The objectives were to: (i) establish how 'typical' consultant surgeons perform on 'generic' (non-specialist) surgical simulations before their use in the General Medical Council's Performance Procedures (PPs); (ii) measure any differences in performance between specialties; and (iii) compare the performance of group of surgeons in the PPs with the 'typical' group. VOLUNTEERS AND METHODS: Seventy-four consultant volunteers in gastrointestinal surgery (n=21), vascular surgery (n=11), urology (n=10), orthopaedics (n=15), cardiothoracic surgery (n=10) and plastic surgery (n=7), plus 9 surgeons undertaking phase 2 of the PPs undertook 7 simple simulations in the skills laboratory. The scores of the volunteers were analysed by simulation and specialty using ANOVA. The scores of the volunteers were then compared with the scores of the surgeons in the PPs. RESULTS: There were significant differences between simulations, but most volunteers achieved scores of 75-100%. There was a significant simulation by specialty interaction indicating that the scores of some specialties differed on some simulations. The scores of the group of surgeons in the PPs were significantly lower than the reference group for most simulations. CONCLUSIONS: Simple simulations can be used to assess the basic technical skills of consultant surgeons. The simulation by specialty interaction suggests that whilst some skills may be generic, others are not. The lower scores of the surgeons in the PPs suggest that these tests possess criterion validity, i.e. they may help to determine when poor performance is due to lack of technical competence.

Problem-based learning for surgical trainees.

Problem-based learning (PBL) represents an educational technique that many medical schools have adopted for their undergraduate curricula. This article discusses the application of PBL for surgical trainees.

Carotid artery stenting: it's all about appropriate patient selection and keeping to the indications.

With increasing carotid artery stenting (CAS) expertise and improved CAS equipment, recent trials have demonstrated better results for CAS compared with earlier studies. As a result, it may be argued that CAS is currently non-inferior to carotid endarterectomy (CEA), at least in some patient subgroups. Consequently, there have been recent calls for extending CAS indications to include average surgical risk patients with symptomatic or asymptomatic carotid stenosis. However, CAS remains a less cost-effective option than CEA. Opening the floodgates to unrestricted CAS for both symptomatic and asymptomatic carotid patients would have considerable cost implications for any health system. Appropriate patient selection and keeping to the indications are crucial to optimize CAS outcomes.

Length of carotid stenosis predicts peri-procedural stroke or death and restenosis in patients randomized to endovascular treatment or endarterectomy.

BACKGROUND: The anatomy of carotid stenosis may influence the outcome of endovascular treatment or carotid endarterectomy. Whether anatomy favors one treatment over the other in terms of safety or efficacy has not been investigated in randomized trials. METHODS: In 414 patients with mostly symptomatic carotid stenosis randomized to endovascular treatment (angioplasty or stenting; n = 213) or carotid endarterectomy (n = 211) in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS), the degree and length of stenosis and plaque surface irregularity were assessed on baseline intraarterial angiography. Outcome measures were stroke or death occurring between randomization and 30 days after treatment, and ipsilateral stroke and restenosis ≥50% during follow-up. RESULTS: Carotid stenosis longer than 0.65 times the common carotid artery diameter was associated with increased risk of peri-procedural stroke or death after both endovascular treatment [odds ratio 2.79 (1.17-6.65), P = 0.02] and carotid endarterectomy [2.43 (1.03-5.73), P = 0.04], and with increased long-term risk of restenosis in endovascular treatment [hazard ratio 1.68 (1.12-2.53), P = 0.01]. The excess in restenosis after endovascular treatment compared with carotid endarterectomy was significantly greater in patients with long stenosis than with short stenosis at baseline (interaction P = 0.003). Results remained significant after multivariate adjustment. No associations were found for degree of stenosis and plaque surface. CONCLUSIONS: Increasing stenosis length is an independent risk factor for peri-procedural stroke or death in endovascular treatment and carotid endarterectomy, without favoring one treatment over the other. However, the excess restenosis rate after endovascular treatment compared with carotid endarterectomy increases with longer stenosis at baseline. Stenosis length merits further investigation in carotid revascularisation trials.

Endovascular treatment of isolated internal iliac artery aneurysms.

The aim of the paper is to evaluate the outcome of endovascular treatments for isolated internal iliac artery aneurysms. A systematic review of the literature using public domain databases was undertaken. All studies reporting on endovascular treatment of isolated hypogastric artery aneurysms were considered. Experience from our institution was involved in the data analysis. The primary outcome measures were technical success, perioperative, and overall mortality and morbidity. Data were extracted from 30 articles fulfilling the selection criteria, and the study cohort consisted of 55 patients having undergone treatment of 59 internal iliac artery aneurysms. Ten patients (18%) were treated on an urgent or emergency basis for a ruptured aneurysm. Technical success was achieved in 71% of the cases. The most common reason for technical failure was incomplete exclusion of the aneurysm sac. Thirty-day mortality occurred in one patient (2%). The 30-day morbidity rate was 20%, and was mostly associated with insufficiency of the pelvic circulation. One aneurysm-related death occurred during a mean follow-up period of 13 months (range 0.5-56 months). Open surgical intervention for aneurysm-related complications was required in five patients. In conclusion, endovascular treatment of isolated internal iliac artery aneurysms is an effective alternative option, with satisfactory early and mid-term results.

Endovascular treatment with angioplasty or stenting versus endarterectomy in patients with carotid artery stenosis in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial.

BACKGROUND: Endovascular treatment (angioplasty with or without stenting) is an alternative to carotid endarterectomy for carotid artery stenosis but there are scarce long-term efficacy data showing that it prevents stroke. We therefore report the long-term results of the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS). METHODS: Between March, 1992, and July, 1997, patients who presented at a participating centre with a confirmed stenosis of the internal carotid artery that was deemed equally suitable for either carotid endarterectomy or endovascular treatment were randomly assigned to either treatment in equal proportions by telephone or fax from the randomisation service at the Oxford Clinical Trials Unit, UK. Patients were seen by an independent neurologist at 1 and 6 months after treatment and then every year after randomisation for as long as possible, up to a maximum of 11 years. Major outcome events were transient ischaemic attack, non-disabling, disabling, and fatal stroke, myocardial infarction, and death from any other cause. Outcomes were adjudicated on by investigators who were masked to treatment. Analysis was by intention to treat. This study is registered, number ISRCTN 01425573. FINDINGS: 504 patients with stenosis of the carotid artery (90% symptomatic) were randomly assigned to endovascular treatment (n=251) or surgery (n=253). Within 30 days of treatment, there were more minor strokes that lasted less than 7 days in the endovascular group (8 vs 1) but the number of other strokes in any territory or death was the same (25 vs 25). There were more cranial nerve palsies (22 vs 0) in the endarterectomy group than in the endovascular group. Median length of follow up in both groups was 5 years (IQR 2-6). By comparing endovascular treatment with endarterectomy after the 30-day post-treatment period, the 8-year incidence and hazard ratio (HR) at the end of follow-up for ipsilateral non-perioperative stroke was 11.3% versus 8.6% (HR 1.22, 95% CI 0.59-2.54); for ipsilateral non-perioperative stroke or TIA was 19.3% versus 17.2% (1.29, 0.78-2.14); and for any non-perioperative stroke was 21.1% versus 15.4% (1.66, 0.99-2.80). INTERPRETATION: More patients had stroke during follow-up in the endovascular group than in the surgical group, but the rate of ipsilateral non-perioperative stroke was low in both groups and none of the differences in the stroke outcome measures was significant. However, the study was underpowered and the confidence intervals were wide. More long-term data are needed from the on going stenting versus endarterectomy trials. FUNDING: British Heart Foundation; UK National Health Service Management Executive; UK Stroke Association.

Long-term risk of carotid restenosis in patients randomly assigned to endovascular treatment or endarterectomy in the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS): long-term follow-up of a randomised trial.

BACKGROUND: In the Carotid and Vertebral Artery Transluminal Angioplasty Study (CAVATAS), early recurrent carotid stenosis was more common in patients assigned to endovascular treatment than it was in patients assigned to endarterectomy (CEA), raising concerns about the long-term effectiveness of endovascular treatment. We aimed to investigate the long-term risks of restenosis in patients included in CAVATAS. METHODS: 413 patients who were randomly assigned in CAVATAS and completed treatment for carotid stenosis (200 patients had endovascular treatment and 213 patients had endarterectomy) had prospective clinical follow-up at a median of 5 years and carotid duplex ultrasound at a median of 4 years. We investigated the cumulative long-term incidence of carotid restenosis after endovascular treatment and endarterectomy, the effect of the use of stents on restenosis after endovascular treatment, risk factors for the development of restenosis, and the effect of carotid restenosis on the risk of recurrent cerebrovascular events. Analysis was by intention to treat. This study is registered, number ISRCTN01425573. FINDINGS: Severe carotid restenosis (>or=70%) or occlusion occurred significantly more often in patients in the endovascular arm than in patients in the endarterectomy arm (adjusted hazard ratio [HR] 3.17, 95% CI 1.89-5.32; p<0.0001). The estimated 5-year incidence of restenosis was 30.7% in the endovascular arm and 10.5% in the endarterectomy arm. Patients in the endovascular arm who were treated with a stent (n=50) had a significantly lower risk of developing restenosis of 70% or greater compared with those treated with balloon angioplasty alone (n=145; HR 0.43, 0.19-0.97; p=0.04). Current smoking or a history of smoking was a predictor of restenosis of 70% or more (2.32, 1.19-4.54; p=0.01) and the early finding of moderate stenosis (50-69%) up to 60 days after treatment was associated with the risk of progression to restenosis of 70% or more (3.76, 1.88-7.52; p=0.0002). The composite endpoint of ipsilateral non-perioperative stroke or transient ischaemic attack occurred more often in patients in whom restenosis of 70% or more was diagnosed in the first year after treatment compared with patients without restenosis of 70% or more (5-year incidence 23%vs 11%; HR 2.18, 1.04-4.54; p=0.04), but the increase in ipsilateral stroke alone was not significant (10%vs 5%; 1.67, 0.54-5.11). INTERPRETATION: Restenosis is about three times more common after endovascular treatment than after endarterectomy and is associated with recurrent ipsilateral cerebrovascular symptoms; however, the risk of recurrent ipsilateral stroke is low. Further data are required from on-going trials of stenting versus endarterectomy to ascertain whether long-term ultrasound follow-up is necessary after carotid revascularisation. FUNDING: British Heart Foundation; UK National Health Service Management Executive; UK Stroke Association.

Assessment of surgical skills of trainees in the UK.

Surgical training and assessment in the UK has been criticised in the past for lacking transparency, reliability and validity. The new Intercollegiate Surgical Curriculum Programme (ISCP) has a well-defined, competence-based syllabus and a system of workplace-based assessments and examinations that map to the syllabus. The main aims of workplace-based assessment are to aid learning through objective feedback and to provide evidence that the competencies required to progress to the next level of training have been achieved. Reduction in surgical experience means that more training will need to be undertaken on simulations, although experience and assessment in the operating room must remains the 'gold-standard'. Simulation training will require the provision of properly resourced surgical skills facilities in every hospital. The key to reliable assessment and constructive feedback is well-trained trainers. Training is a skill that must be learned, and assessment and feedback techniques form part of this. In surgery, it has been assumed that all consultants are trainers but this is clearly not the case. Surgeons will need to follow the example of primary care, where trainers are selected from experienced general practitioners who demonstrate enthusiasm and ability. The reward for the trainer should be protected time for training. The reward for the National Health Service will be better trained surgeons.

Endofibrosis of iliac arteries in high-performance athletes: diagnostic approach and minimally invasive endovascular treatment.

The aim of this article is to report our experience in the diagnosis of two cases of iliac artery endofibrosis or arteriopathy, a rare entity occurring in high-performance athletes, presenting with intermittent claudication (right-sided in both) after maximal exercise. External iliac artery endofibrosis or arteriopathy is a likely diagnosis in competitive athletes free of cardiovascular risk factors who present with leg claudication. Arteriography and a papaverine-assisted mean pressure gradient across the iliac arteries of more than 10 mmHg is a useful diagnostic approach. Moreover, balloon angioplasty of the iliac artery in that patient, in whom a pressure gradient was detected, resulted in symptomatic relief for 2 months followed by mild symptom recurrence. Thus, although balloon angioplasty is feasible and safe, it might not be adequate to treat this entity and, thus, its value remains undefined.

Assessing the performance of doctors in teams and systems.

INTRODUCTION: Increasing attention is being directed towards finding ways of assessing how well doctors perform in clinical practice. Current approaches rely on strategies directed at individuals only, but, in real life, doctors' work is characterised by multiple complex professional interactions. These interactions involve different kinds of teams and are embedded within the overall context and systems of care. In addition to individual factors, therefore, we propose that the performance of doctors in health care teams and systems will also impact on the overall quality of patient care. Assessing these dimensions, however, poses a number of challenges. STRATEGIES: Taking a profile of a National Health Service, UK surgeon as an example, the team structures to which he or she may relate are illustrated. These include formal teams such as those found in the operating theatre, and those formed through various professional and collegial partnerships. The authors then propose a model for assessing doctors' performances in teams and systems, which incorporates the educational principles of continuous feedback to enhance future performance. DISCUSSION: To implement the proposed model, a wide range of professional, educational and regulatory bodies must collaborate. This raises a number of important implications for the future roles and relationships of these bodies, which are discussed. A strong and constructive partnership will be essential if the full potential of a more inclusive and representative assessment approach is to be realised.