Michael J. Gough

General anaesthesia versus local anaesthesia for carotid surgery (GALA): a multicentre, randomised controlled trial

BACKGROUND The effect of carotid endarterectomy in lowering the risk of stroke ipsilateral to severe atherosclerotic carotid-artery stenosis is offset by complications during or soon after surgery. We compared surgery under general anaesthesia with that under local anaesthesia because prediction and avoidance of perioperative strokes might be easier under local anaesthesia than under general anaesthesia. METHODS We undertook a parallel group, multicentre, randomised controlled trial of 3526 patients with symptomatic or asymptomatic carotid stenosis from 95 centres in 24 countries. Participants were randomly assigned to surgery under general (n=1753) or local (n=1773) anaesthesia between June, 1999 and October, 2007. The primary outcome was the proportion of patients with stroke (including retinal infarction), myocardial infarction, or death between randomisation and 30 days after surgery. Analysis was by intention to treat. The trial is registered with Current Control Trials number ISRCTN00525237. FINDINGS A primary outcome occurred in 84 (4.8%) patients assigned to surgery under general anaesthesia and 80 (4.5%) of those assigned to surgery under local anaesthesia; three events per 1000 treated were prevented with local anaesthesia (95% CI -11 to 17; risk ratio [RR] 0.94 [95% CI 0.70 to 1.27]). The two groups did not significantly differ for quality of life, length of hospital stay, or the primary outcome in the prespecified subgroups of age, contralateral carotid occlusion, and baseline surgical risk. INTERPRETATION We have not shown a definite difference in outcomes between general and local anaesthesia for carotid surgery. The anaesthetist and surgeon, in consultation with the patient, should decide which anaesthetic technique to use on an individual basis. FUNDING The Health Foundation (UK) and European Society of Vascular Surgery.

Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins

Endovenous laser ablation (EVLA) is a minimally invasive technique for treating varicose veins due to truncal vein incompetence. This randomized trial compared EVLA with conventional surgery in patients with primary saphenofemoral and great saphenous vein (GSV) reflux.

Minimally invasive treatment for varicose veins: a review of endovenous laser treatment and radiofrequency ablation.

Varicose veins are a common problem, conventionally treated by an operation. Within the last few years, minimally invasive techniques have been developed as alternatives to surgery in an attempt to reduce morbidity and improve recovery time. Radiofrequency ablation and endovenous laser ablation are the most promising of these new techniques. This review article looks at the evidence for these techniques and the clinical experience to date and discusses their role in the future treatment of varicose veins.

Endovenous laser ablation: Does standard above-knee great saphenous vein ablation provide optimum results in patients with both above- and below-knee reflux? A randomized controlled trial

BACKGROUND Following above-knee (AK) great saphenous vein (GSV) endovenous laser ablation (EVLA) 40% to 50% patients have residual varicosities. This randomized controlled trial (RCT) assesses whether more extensive GSV ablation enhances their resolution and influences symptom improvement. METHOD Sixty-eight limbs (65 patients) with varicosities and above and below-knee GSV reflux were randomized to Group A: AK-EVLA (n = 23); Group B: EVLA mid-calf to groin (n = 23); and Group C: AK-EVLA, concomitant below-knee GSV foam sclerotherapy (n = 22). Primary outcomes were residual varicosities requiring sclerotherapy (6 weeks), improvement in Aberdeen varicose vein severity scores (AVVSS, 12 weeks), patient satisfaction, and complication rates. RESULTS EVLA ablated the treated GSV in all limbs. Sclerotherapy requirements were Group A: 14/23 (61%); Group B: 4/23 (17%); and Group C: 8/22 (36%); chi2 = 9.3 (2 df) P = .01 with P(A-B) = 0.006; P(B-C) = 0.19; P(A-C) = 0.14. AVVSS scores improved in all groups as follows: A: 14.8 (9.3-22.6) to 6.4 (3.2-9.1), (P < .001); B: 15.8 (10.2-24.5) to 2.5 (1.1-3.7), (P < .001); and C: 15.1 (9.0-23.1) to 4.1 (2.3-6.8), (P < .001) and P(A-B) = 0.011, P(A -C) = 0.042. Patient satisfaction was highest in Group B. BK-EVLA was not associated with saphenous nerve injury. CONCLUSIONS Extended EVLA is safe, increases spontaneous resolution of varicosities, and has a greater impact on symptom reduction. Similar benefits occurred after concomitant BK-GSV foam sclerotherapy.

Fate and clinical significance of saphenofemoral junction tributaries following endovenous laser ablation of great saphenous vein

Unlike surgery, endovenous laser ablation (EVLA) abolishes great saphenous vein (GSV) reflux but does not specifically interrupt the GSV tributaries at the groin. The fate and clinical significance of these tributaries were assessed in a prospective study.

Cost-effectiveness analysis of general anaesthesia versus local anaesthesia for carotid surgery (GALA Trial).

Health outcomes and costs are both important when deciding whether general (GA) or local (LA) anaesthesia should be used during carotid endarterectomy. The aim of this study was to assess the cost‐effectiveness of carotid endarterectomy under LA or GA in patients with symptomatic or asymptomatic carotid stenosis for whom surgery was advised.

Carotid Artery Imaging for Secondary Stroke Prevention Both Imaging Modality and Rapid Access to Imaging Are Important

Background and Purpose— Patients with transient ischemic attack require carotid imaging to diagnose carotid stenosis. The differing sensitivity/specificity and availability of carotid imaging methods have created uncertainty over which noninvasive method is best and whether intra-arterial angiography is still required. We evaluated the influence of carotid imaging methods on secondary stroke prevention. Methods— We modeled the effect of different carotid imaging strategies and timing on endarterectomy workload, stroke, and death at 1 and 5 years. We used all available data on stroke prevention after transient ischemic attack from systematic reviews (carotid imaging, medical and surgical interventions), population-based transient ischemic attack/stroke studies, government statistics, and stroke prevention clinics. Results— Choice of imaging strategy affected speed of assessment, strokes prevented, and endarterectomy workload. The number of strokes prevented at 5 years varied by up to 22 per 1000 patients between imaging strategies for a given time to assessment. Delaying endarterectomy from 14 to approximately 30 days would fail to prevent up to 11 strokes per 1000 patients depending on the imaging strategy. Sensitive fast imaging (eg, ultrasound) was best for patients seen early; specific imaging (eg, CT angiography or contrast-enhanced MR angiography) was best for patients seen late after transient ischemic attack. Intra-arterial angiography conferred no advantage over noninvasive imaging. Conclusions— Rapid access to sensitive noninvasive carotid imaging prevents most strokes. However, imaging strategies differ in their effect on stroke prevention by as much as 22 per 1000 patients and optimal imaging varies with time after transient ischemic attack TIA. Routine intra-arterial angiography should be avoided.

Macrophage accumulation within the cap of carotid atherosclerotic plaques is associated with the onset of cerebral ischemic events

PURPOSE Macrophage accumulation is associated with aortic and coronary plaque instability. The macrophage content of carotid plaques removed at carotid endarterectomy (CE) was assessed, and the relevance to the onset of ipsilateral cerebral ischemic events (CIE) was examined. METHODS Carotid plaques from patients undergoing CE were examined (group I, symptomatic stenoses, n = 28; group II, high-grade asymptomatic stenosis, n = 7). The plaques were stained with monoclonal antimacrophage antibody (HAM56), and the interval since the last CIE was recorded. The percentage area of the cap, shoulder, and entire sclerotic region was quantified by computerized planimetry. RESULTS The macrophage content of the cap, shoulder, and sclerotic region in all 35 plaques was 1.14% (interquartile range, 0.56 to 3.86), 1.03% (0.51 to 2.15), and 0.49% (0.27 to 0.63), respectively (cap vs sclerotic, P <.01; shoulder vs sclerotic, P <. 01; cap vs shoulder, P =.23). In 18 plaques that were removed less than 180 days after the last CIE, the macrophage content of the cap, shoulder, and entire sclerotic region was 2.41% (0.95 to 4.81), 0. 83% (0.40 to 2.52), and 0.53% (0.38 to 0.71), respectively (cap vs sclerotic, P =.01; cap vs shoulder, P =.01). The content in the cap of these plaques was greater than in plaques removed more than 180 days after symptoms, or asymptomatic plaques (n = 17; 0.62% [0.44 to 1.25], P =.01). The cap macrophage content was inversely related to the time since the last CIE (r = -0.414, P =.029). CONCLUSION In patients requiring CE, macrophage accumulation was maximal within the cap of carotid plaques and greatest in plaques removed less than 180 days after the last CIE. These findings and the inverse relationship between macrophage content and the interval since symptoms support the hypothesis that macrophage accumulation is associated with plaque instability.

A late complication of internal carotid artery stenting

Carotid angioplasty and stenting is gaining in popularity as an alternative to carotid endarterectomy for the treatment of symptomatic critical stenoses of the internal carotid artery. However, the durability of this technique and the incidence of recurrent stenoses has not yet been fully evaluated. It has been reported that mechanical factors may cause deformity of a Palmaz stent, negating the initial benefits of the procedure. We describe successful carotid endarterectomy after distortion of a Strecker balloon-expandable stent.

GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery

BackgroundPatients who have severe narrowing at or near the origin of the internal carotid artery as a result of atherosclerosis have a high risk of ischaemic stroke ipsilateral to the arterial lesion. Previous trials have shown that carotid endarterectomy improves long-term outcomes, particularly when performed soon after a prior transient ischaemic attack or mild ischaemic stroke. However, complications may occur during or soon after surgery, the most serious of which is stroke, which can be fatal. It has been suggested that performing the operation under local anaesthesia, rather than general anaesthesia, may be safer. Therefore, a prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy was proposed to determine whether type of anaesthesia influences peri-operative morbidity and mortality, quality of life and longer term outcome in terms of stroke-free survival.Methods/designA two-arm, parallel group, multicentre randomised controlled trial with a recruitment target of 5000 patients. For entry into the study, in the opinion of the responsible clinician, the patient requiring an endarterectomy must be suitable for either local or general anaesthesia, and have no clear indication for either type. All patients with symptomatic or asymptomatic internal carotid stenosis for whom open surgery is advised are eligible. There is no upper age limit. Exclusion criteria are: no informed consent; definite preference for local or general anaesthetic by the clinician or patient; patient unlikely to be able to co-operate with awake testing during local anaesthesia; patient requiring simultaneous bilateral carotid endarterectomy; carotid endarterectomy combined with another operation such as coronary bypass surgery; and, the patient has been randomised into the trial previously. Patients are randomised to local or general anaesthesia by the central trial office. The primary outcome is the proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction 30 days post-surgery. Secondary outcomes include the proportion of patients alive and stroke free at one year; health related quality of life at 30 days; surgical adverse events, re-operation and re-admission rates; the relative cost of the two methods of anaesthesia; length of stay and intensive and high dependency bed occupancy.Trial registrationCurrent Controlled Trials ISRCTN00525237