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Vascular papers


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Comparison of duplex imaging and arteriography in the evaluation of lower limb arteries. Aly S, Somerville K, Adiseshiah M, Raphael M, Coldridge Smith P D, Bishop C C R.  Br J Surg 1998; 85: 1099-1102.

Arteriography is regarded by most as the gold-standard investigation for the evaluation of peripheral vascular disease. It provides a good anatomical representation of the vascular tree but fails to give a functional assessment of stenotic lesions. Furthermore, arteriography has a significant morbidity and mortality. With recent technological advances, duplex ultrasound has been increasingly used in vascular assessments. It is non-invasive and has replaced arteriography as the investigation of choice in the assessment of carotid artery disease and in post-operative graft surveillance. The aim of this study was to assess the role of duplex ultrasound in the detection and assessment of severity of peripheral arterial disease and to evaluate the effect on clinical decision making. Some 177 legs were assessed in 90 patients (81 intermittent claudication, 8 rest pain, 1 ischaemic ulceration). Each patient underwent both angiography and ultrasound. Compared with angiography, duplex ultrasound had a sensitivity of 92%, specificity of 99%, positive predictive value 91% and negative predictive value of 100%. Ultrasound was reliable in assessing the length of vascular lesions. Both investigations had a similar influence on clinical decision making. It was concluded that duplex ultrasound is reliable in the assessment of peripheral arterial disease.

Mortality results for randomised controlled trial of early elective surgery or ultrasonographic surveillance for small abdominal aortic aneurysms. The UK Small Aneurysm Trial Participants.  Lancet 1998; 352: 1649-1655.

Abdominal aortic aneurysms often remain symptomless until they rupture ands are an important cause of sudden death. The mortality of elective aneurysm repair is about 5%. The risk of rupture increases with aneurysm diameter and it is general accepted that the potential benefits outweigh the risks for aneurysms greater than 6 cm. This study was designed to assess whether prophylactic surgery decreased the long-term mortality for small aneurysms. 1090 patients between 60 and 76 years with symptomless infrarenal AAA with a diameter of 4.0 to 5.5 cm were randomised to receive either early surgical repair (n=563) or ultrasound surveillance (n=527). Patients in this latter group underwent surgery if the aneurysms diameter increased to above 5.5 cm, increased at > 1 cm/year or become symptomatic. Patients were followed for a mean of 4.6 years. The primary end-point was overall mortality. Analysis was on an intention to treat basis. More than 60% of patients randomised to surveillance eventually underwent surgery. There were similar degrees of cardiovascular risk factors in both groups. Overall, 93% patients adhered to their assigned treatment group. A total of 309 patients died during the study period. The 30-day operative mortality was 5.8 %. The hazard ratio for all cause mortality of early treatment versus surveillance was 0.94 (95% CI 0.75-1.17. p=0.56). There was no difference in mortality between the two groups at 2, 4 and 6 years. It was concluded that early surgery produces no long-term survival advantages. This study does not support a policy of open surgical repair for AAA with a diameter of 4.0 to 5.5 cm.

The use of routine duplex scanning in the assessment of varicose veins. Wills V, Moylan D, Chambers J. Aust NZ J Surg 1998; 68: 41-44.

Varicose veins are a common condition affecting 10-15% of men and 20-25% of women in Western populations. They contribute to a considerable morbidity with a prevalence of chronic venous insufficiency of 2-7% and of venous ulceration of ~1%. Clinical assessment of venous insufficiency has been shown to compare poorly with the results of hand-held doppler examination or venography in the assessment of varicose veins. Although the use of duplex scanning has been described in the assessment of varicose vein there is little data comparing the combination of clinical and doppler assessment with duplex scanning. In this study 315 legs were assessed in 188 patients. After clinical and doppler assessment all patients underwent duplex scanning. The results were retrospectively compared with the clinical and doppler findings. Of the legs assessed 39% had recurrent varicose veins and 31% had trophic changes or skin ulceration. On duplex scanning 63% had sapheno-femoral incompetence, 19% sapheno-popliteal incompetence, 30% perforator incompetence and 8% deep venous insufficiency. The respective sensitivity of the combination of clinical and doppler assessment at these sites was 71, 36, 43 and 29% respectively. If the patients who were felt to have sole sapheno-femoral junction incompetence were treated by high ligation, strip and avulsions, 29% would have sites of reflux untreated. It was concluded that clinical and doppler assessment is unreliable. Routine duplex scanning is likely to reduce recurrence by identifying sites of reflux with greater accuracy.

Use of colour duplex imaging to diagnose and guide angioplasty of lower limb arterial lesions. London N J M, Nydahl S, Hartshorne T, Fishwick G. Br J Surg 1999; 86: 911-915.

Since its introduction in 1964, percutaneous transluminal angioplasty (PTA) has become widely used in vascular radiological practice. It has conventionally been guided by radiographic imaging with the small but none-the-less real risks associated with the use of ionising radiation and contrast media. High-resolution colour duplex imaging has recently been increasingly used in arterial assessment but with subsequent PTA guided radiographically. The aim of this study was to investigate whether colour duplex imaging alone could be safely and effectively used to diagnose lower limb arterial lesions and guide subsequent PTA. Patients with lower limb arterial lesions which could be visualised with colour duplex imaging were selected for duplex-guided PTA. No angiography was used at any stage. In total 55 arterial lesions in 50 legs of 45 patients were treated. The underlying clinical problems were claudication (44), critical limb ischaemia (3) and asymptomatic vein cuff stenosis (3). There were 53 stenoses and 2 occlusions. The lesions were in the iliac segment (4), superficial femoral artery (40) and popliteal artery (7). There were no complications and symptomatic improvement occurred in 46 of 47 legs. There was a significant increase in ABPI immediately following the procedure which was maintained at follow up. It was concluded that it was possible to diagnose and angioplasty lower limb arterial lesions using colour duplex imaging alone. Some may now consider that colour duplex imaging is now the 'gold standard' imaging method in the assessment of lower limb arterial disease.

Intermediate-term results of endoscopic transaxillary T2 sympathectomy for primary palmar hyperhidrosis. Chiou T S-M,  Chen S-C.  Br J Surg 1999;  86:  45-47.

Endoscopic transaxillary T2 sympathectomy is currently the preferred treatment for palmar hyperhidrosis.  With this technique the T2 ganglion and its associated fibres are diathermied along the upper border of the third rib.  It is a technique that has minimal post-operative morbidity and an early almost complete success rate.  The long-term efficacy remains unclear.  This paper studied the intermediate-term results of this operative procedure.  A retrospective review was performed of 91 consecutive patients treated between 1992 and 1996.  Patients were contacted by telephone or a post questionnaire to ascertain their satisfaction, late complications and morbidity.  In the early postoperative period no patient developed a Horner's syndrome.  One patient developed a haemothorax that did not require chest drainage.  Overall, 16% developed recurrent sweating but none required further surgery.  78% were satisfied with the outcome of their operation.  However, 13% were dissatisfied mainly due to compensatory hyperhidrosis which occurred in 97% of all patients within the first year.  It was concluded that the results of endoscopic sympathectomy deteriorated progressively from the immediate outcome and the compensatory hyperhidrosis was the principal reason for dissatisfaction.  

Clinical examination of varicose veins - a validation study. Kim J, Richards S,  Kent P J.  Ann R Coll Surg Eng 2000;  82:  171-175.

Many aspects of clinical physical examinations have not been prospectively evaluated and are of questionable accuracy.  Several tests have been described in the assessment of varicose veins. More recently hand-held doppler ultrasound has become available to supplement the clinical evaluation.  The aim of this study was to determine the accuracy of clinical tests and hand-held doppler ultrasound in the evaluation of varicose veins by performing a comparison with colour duplex scanning as the 'gold' standard investigation.  In total, 70 limbs with primary, previously untreated varicose veins in 44 consecutive patients were clinically assessed.  The following clinical tests were performed as described in standard surgical texts - cough test, tap test, Brodie-Trendelenberg test, Perthe's test.  Hand-held doppler and duplex scanning were then performed.  The sensitivity, specificity, positive and negative predictive values were calculated for each test.  Reflux was detected on duplex scanning at the sapheno-femoral junction in 54% and sapheno-popliteal junction in 13% of limbs.  The cough test had a low sensitivity (0.59) and specificity (0.67).  The tap test had a low sensitivity (0.18) and high specificity (0.92).  The Trendelenberg test had a high sensitivity (0.97) but low specificity (0.20).  Hand-held doppler at the sapheno-femoral and sapheno-popliteal junctions had a high sensitivity (0.97, 0.80) and high specificity (0.73, 0.90) of detecting reflux.  It was concluded that clinical tests in the evaluation of varicose veins are inaccurate.  Hand-held doppler ultrasound is more accurate and its use should be taught as part of the routine assessment of varicose veins.     

Population screening reduces mortality rate from aortic aneurysm rupture in men.  Heather B P, Poskitt K R, Earnshaw J J et alBr J Surg 2000;  87:  750-753.

Rupture of an abdominal aortic aneurysm (AAA) is a major cause of death in men over the age of 65 years.  It accounts for over 1% of all deaths in this age group and over 6,000 deaths annually in England and Wales.  Mortality from elective and emergency surgery has been reported to be less than 5% and over 80% respectively.  This vast difference in mortality rate has has lead to the conclusion that the best way of reducing the number of deaths from ruptured AAA is to screen for asymptomatic aneurysms and to increase the number of patients offered elective surgery. The value of screening for AAA is as yet unproven.  Screening of 65 year old men for the presence of asymptomatic AAA has been performed in one English county since 1990.  Men were offered screening by abdominal ultrasound examination via their general practice surgeries at their 65th birthday.  The aim of this study was to assess the impact of this programme on overall community mortality rate from all aneurysm-related causes in men offered screening.  The total number of deaths from all aortic aneurysm-related causes in the county's population was calculated from hospital records (hospital admission records, operating theatre logs and intensive care unit records) and death certificate records held on a computerised database.  This study showed that the overall number of aneurysm-related deaths in men aged 65-73 years has been progressively reduced by the screening programme when compared with that for men of all other ages.  During the study period the total number of aneurysm-related deaths decreased progressively year by year.  No changes were observed in the unscreened part of the population.  It was concluded that screening for asymptomatic AAA results in a significant reduction in the number of deaths from all aneurysm-related causes in the screened portion of the male population. 

Safety of a single duplex scan to exclude deep venous thrombosis.  Wolf B,  Nichols D M,  Duncan J L.  Br J Surg 2000;  87:  1525-1528.

Despite the widespread use of thromboprophylaxis, venous thromboembolism remains a common and often preventable cause of morbidity and mortality in surgical patients. The clinical diagnosis of deep venous thrombosis (DVT) is unreliable and needs to be confirmed by the appropriate use of investigations.  Venography is regarded by many as the gold standard, but it has been replaced in recent years by ultrasonography as the routine imaging modality in many centres. Recently published guidelines have recommended that a negative ultrasound scan should be followed by venography or a repeat scan after seven days so as to detect proximal extension of calf vein thrombosis.  This study aimed to evaluate whether anticoagulation can be safely withheld on the basis of a single negative duplex scan in patients presenting with suspected deep venous thrombosis.  Duplex scan reports, case notes and questionnaires returned by general practioners of patients with suspected DVT were analysed retrospectively.  The main outcome measure was occurrence of an adverse thromboembolic event (a symptomatic DVT or pulmonary embolus) within 3 months after a negative duplex scan. In a 12 month period 537 patients had 706 legs assessed because of leg symptoms or indirect evidence of a pulmonary embolus. Among the 352 who had negative scans only four possible adverse events were identified.  The rate of adverse events was 1.1% of patients and 0.9% of legs assessed.  It was concluded that withholding anticoagulation in patients who have a single complete negative duplex scan is safe and that a repeat scan should only be performed if there is ongoing high clinical suspicion or the calf veins were not visualised on the initial investigation.

Outcome of femoropopliteal angioplasty. Golledge J, Ferguson K, Sabharwal T et al. Ann Surg 1999; 229: 146-153.

Percutaneous transluminal angioplasty can be used to treat symptomatic femoropopliteal stenoses or occlusions but the long term success of this procedure is not as good as in the aorto-iliac segment. The aim of this study was to prospectively assess the outcome of femoropopliteal angioplasty and investigate prognostic indicators of success. In total, 72 consecutive patients treated by femoropopliteal angioplasty were studied. The indications for the procedure were intermittent claudication (43), rest pain (4) and tissue loss (27). Patients were followed up clinically and by assessment of ABPI and duplex monitoring of velocity gradient at the angioplasty site. Univariate comparisons, life table analysis and regression analysis were used to investigate factors predicting the symptomatic and haemodynamic outcome. Technical success was achieved in 61 (91%) of patients. At one year, successful symptomatic improvement was achieved in 35 (51%) patents with haemodynamic success in 41 (58%) patients. ABPI at 24 hours after angioplasty was the most significant variable that predicted symptomatic outcome. It was concluded that only half of the patients treated by femoropopliteal angioplasty had symptomatic improvement at one year. Restoration of the ABPI to > 0.9 was predictive of a favourable outcome.

In-hospital mortality from abdominal aortic surgery in Great Britain and Ireland:  Vascular Anaesthesia Society audit.  Bayly P J M,  Mathews J N S,  Dobson P M,  Price M L,  Thomas D G.  Br J Surg 2001;  88:  687-692.

Studies looking at mortality and factors predictive for an adverse outcome following abdominal aortic surgery have often been retrospective or performed over an extended period, making the findings less applicable to to current practice.  These studies have suggested a mortality rate for elective infrarenal aortic surgery of between 4 and 7%, a figure which has changed little over the past 20 years.  Factors associated with increasing mortality include age, chronic renal impairment, hypertension and a low case load.  In an attempt to obtain current information on the mortality of patients undergoing elective infrarenal aortic surgery the audit committee of the Vascular Anaesthesia Society of Great Britain and Ireland undertook a multicentre study from February to May 1999 inclusive.  Overall, 177 hospitals provided data.  Questionnaires were completed on all patients undergoing surgery for infrarenal abdominal aortic aneurysms and aorto-iliac occlusive disease.  There were 933 patients recruited into the audit with an overall mortality of 7.3%.  Factors increasing the risk of death by up to five-fold were age over 74 years, urgent surgery, surgery for occlusive disease, limited exercise capacity, history of angina or cardiac failure, the presence of  ventricular ectopics and abnormalities on the ECG suggestive of ischaemic heart disease.  It was concluded that although the in-hospital mortality rate was similar to previously published figures, the rate increased considerably when commonly encountered risk factors were present.

A single normal ultrasonographic scan at age 65 years rules out significant aneurysm disease for life in men. Crow P, Shaw E, Earnshaw J J, Poskitt K R, Whyman M R, Heather B P. Br J Surg 2001; 88: 941-944.

Ruptured abdominal aortic aneurysm (AAA) is a major cause of death in men over 65-years of age accounting for an estimated 6,000 deaths annually in England and Wales. Screening for AAA has been taking place in Gloucestershire since 1990 with men being offered an ultrasound scan at the age of 65 years. Subjects with an aortic anteroposterior diameter of greater than 26 mm are considered at risk of further aortic growth and offered annual re-imaging. Men with an aortic diameter of over 40 mm are referred to the surgical clinic where they are reviewed biannually. Surgery is offered when the aortic diameter exceeds 55 mm. The screening project has reduced the mortality from ruptured AAA within the screened portion of the population. An unanswered question is whether any further follow-up is necessary in men with a 'normal' aorta at the age of 65 years. A cohort study was performed on 223 65-year-old men who had an aortic diameter of less than 26 mm in 1988. These men had repeat ultrasound scans in both 1993 and 2000. The causes of death in men who died during the interval were investigated. Overall, 8 men were lost to follow-up. As far as it was possible to ascertain, none of the 86 men who died over the 12-year interval did so from a ruptured AAA. There was no clinically significant increase in mean aortic diameter in the remaining 129 who had three serial ultrasound scans. It was concluded that a single 'normal' ultrasound scan at 65 years effectively rules out the risk of clinically significant aneurysm disease for life in men.

Randomized clinical trial comparing the efficacy of two bandaging regimens in the treatment of venous leg ulcers. Meyer F J,  Burnand K G,  Lagattolla N R F,  Eastham D.  Br J Surg 2002; 89: 40-44.

Active leg ulceration has a prevalence in the UK population of approximately 0.2%.  About 70% of leg ulcers are caused by venous disease and compression bandaging is an established form of treatment.  Debate continues as to whether compression bandaging should be 'elastic' or 'inelastic' in nature. Also it has been suggested that bandages capable of producing greater compression enhance ulcer healing.  The aim of this study was to compare the efficacy of two different compression regimens.  Elastic compression was achieved using Tensopress and inelastic compression was achieved using Elastocrepe bandages.  Tensopress produces a greater degree of compression.  The study was performed as a prospective randomised trial.  Overall, 112 patients were studied and all were treated with zinc-impregnated paste applied directly to the ulcer.  The paste was covered by either Tensopress (n=57) or Elastocrepe (n=55) bandages.  Both groups had a tubular bandage applied over the compression bandage to keep it in place.  All ulcers were stratified and randomised within one of three size groups.  The venous aetiology of the ulcer was confirmed on completion by calf pump function tests.  By 26 weeks, 58% of the patients treated with Tensopress and 62% of those treated with Elastocrepe had achieved ulcer healing.  The median times to healing were 9 and 9.5 weeks in the two groups respectively.  Large ulcers healed significantly slower than small ulcers, irrespective of the treatment method.  It was concluded that there was no significant improvement in venous ulcer healing using higher compression elastic bandages.

Effect of chronic renal failure on mortality rate following arterial reconstruction.  Gerrard D J,  Ray S A,  Barrio E A et al.  Br J Surg 2002;  89:  70-73.

The majority of patients who undergo arterial reconstruction for peripheral vascular disease have atherosclerosis.  A complex interrelationship exists between atherosclerosis and chronic renal failure with increasing awareness that end-stage renal disease may be secondary to atherosclerotic renal artery stenosis.  Furthermore, patients with end-stage renal disease are more likely to develop accelerated atherosclerosis requiring vascular intervention.  Patients with chronic renal failure who undergo arterial surgery have an increased operative mortality and poor long-term survival.  The aim this study was to compare the hospital mortality rates in patients with chronic renal failure and patients with normal renal function undergoing arterial surgery.  Data describing a consecutive series of 1718 patients undergoing arterial reconstruction were entered prospectively into a computerised database.  Chronic renal failure was defined as a serum creatinine more than 400umol/l, or a patient on dialysis or after a successful renal transplant.  Mortality was assessed either in hospital or at 30 days.  There were 69 patients (4%) with chronic renal failure.  The mortality rate in this group was 23% compared with the 1649 patients without renal failure.  The mortality was highest in those undergoing urgent or emergency surgery and in those undergoing surgery for lower limb occlusive disease.  The main causes of death were related to the cardiovascular system.  It was concluded that patients with chronic renal failure undergoing arterial surgery had a poor outcome compared with those with normal renal function.

Autologous versus allogeneic transfusion in aortic surgery.  Wong J C L,  Torella F,  Haynes S L et al.  Ann Surg 2002;  235:  145-151.

The United Kingdom is well served by the National Transfusion Service with a low risk of transfusion-related incidents.  However, recent concerns have lead to costly changes in the preparation of blood products.  Nucleic acid testing for Hepatitis C is now required for all plasma components and leukodepletion is required for all cellular products.  The cost of allogeneic blood has risen dramatically making autologous transfusion more attractive for elective surgery.  The aim of this study was to evaluate the efficacy of acute normovolaemic haemodilution (ANH) and intraoperative cell salvage (ICS) in blood-conservation strategies for infrarenal aortic surgery. A multicentre prospective randomised trial was performed comparing standard transfusion practice with autologous transfusion combining ANH and ICS in 145 patients undergoing elective aortic surgery.  The primary outcome measures were the proportion of patients requiring allogeneic blood and the volume of blood transfused.  The secondary outcome measures were the frequency of complications and duration of hospital stay.  The combination of ANH and ICS reduced the volume of allogeneic blood transfusion form a median of 2 units to zero.  The proportion of patients transfused was 56% in the allogeneic and 43% in the autologous groups.  There was no significant difference in complications or the length of hospital stay.  It was concluded that ANH and ICS were safe and reduced the allogeneic blood requirement in patients undergoing elective infrarenal aortic surgery.

Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer.  Bergqvist D,  Agnelli G, Cohen A T et al.  N Eng J Med 2002;  346:  975-980.

The efficacy of low-molecular-weight heparin (LMWH) in preventing postoperative venous thromboembolism is well documented, but the optimal duration of prophylaxis has not been clearly defined.  Prophylaxis is usually limited to the duration of hospitalisation, but the risk of thromboembolism remains high for several weeks after major surgery.  Several randomised trials have shown that prophylaxis with LMWH for approximately one month after orthopaedic surgery reduces the risk of DVT as compared with LMWH given only during the first postoperative week.  The value of this approach in cancer surgery remains unclear. This study was a double-blind multicentre trial in patients undergoing planned curative open surgery for abdominal or pelvic cancer.  All patients received enoxaparin 40mg daily subcutaneously for 6 to 10 days and were then randomly allocated to receive either enoxaparin or placebo for a further 21 days.  Bilateral venography was performed between 25 or 31 days, or sooner if symptoms of venous thromboembolism occurred.  The primary endpoint with respect to efficacy was the incidence of venous thromboembolism.  The primary endpoint with respect to safety was bleeding during the three weeks after randomisation.  Patients were followed up for three months.  On an intention-to-treat analysis of the 332 included patients, the rate of DVT at the end of the double-blind phase was 12% in the placebo group and 5% in the enoxaparin group (p=0.02).  This difference persisted at three months.  Three patients in the enoxaparin group and six in the placebo group died within three months after surgery.  There was no significant difference in the rates of bleeding or other complications during the follow up period.  It was concluded that LMWH prophylaxis for four weeks after surgery for abdominal or pelvic cancer is safe and significantly reduces the incidence of venographically demonstrated thrombosis as compared with treatment for one week.

Immediate repair compared with surveillance of small abdominal aortic aneurysms. Lederle F A, Wilson S E, Johnson G R et al. N Eng J Med 2002;  346: 1437-1444.

Annually in the United States, 9000 deaths occur as result of rupture of an abdominal aortic aneurysm.  A further 33,000 patients undergo elective repair of asymptomatic aneurysms to prevent rupture which result in between 1400 and 2800 perioperative deaths.  Because most aneurysms never rupture, elective repair only needs to be undertaken when the risk of rupture his high.  The strongest known predictor for rupture is aortic diameter but the optimal diameter at which to recommend open surgery is unknown.  The aim of this study was compare early open surgery with surveillance in patients with small abdominal aortic aneurysms.  Patients between 50 and 79 years of age and an aortic diameter of 4.0 to 5.4 cm who did not have high surgical risk were randomised to undergo immediate open surgical repair or surveillance by means of ultrasound or CT scanning every six months.  Repair was reserved for those in the surveillance group with an aneurysm that became symptomatic or enlarged to 5.5 cm.  The primary outcome measure was rate of death from any cause.  Mean follow-up was 4.9 years.  Overall, 569 patients were randomised to immediate repair and 567 patients to surveillance.  By the end of the study period, aneurysm repair had been performed in 93% of patients in the immediate group and 62% in the surveillance group.  The rate of death was not significantly different between the two groups. (RR 1.21 95% CI 0.95-1.54).  Trends in survival did not favour immediate repair in any of the prespecified subgroups defined by age or aortic diameter. These findings were obtained despite a low total operative mortality of 2.7% in the immediate repair group. It was concluded that survival is not improved by elective repair of abdominal aortic aneurysms less than 5.5 cm in diameter, even when operative mortality is low.

Duration of prophylaxis against venous thromboembolism with enoxaparin after surgery for cancer.  Bergqvist D,  Agnelli G,  Cohen A T et al.  N Eng J Med 2002;  346:  975-980.

The efficacy of Low-Molecular-Weight Heparin (LMWH) in preventing postoperative venous thromboembolism is well document, but the optimal duration of prophylaxis after surgery for cancer has not been clearly defined.  Prophylaxis is usually limited to the duration of hospitalisation but the risk of thromboembolism remains high for several weeks after major surgery.  Several randomised, double-blind trials have shown that prophylaxis with LMWH for approximately one month after orthopaedic surgery significantly reduces the frequency of deep-vein thrombosis as compared with prophylaxis only give for one week.  This paper reports a double-blind multicentre trial in which patients undergoing planned curative open surgery for abdominal or pelvic cancer received enoxaparin daily for 6 to 10 days and were then randomly assigned to either enoxaparin or placebo for a further 21 days.  Bilateral venography was performed between days 25 and 30 or sooner if symptoms of venous thromboembolism occurred.  The primary end-point with respect to efficacy was the incidence of venous thromboembolism between 25 and 31 days.  The primary safety end-point was bleeding during the three-week period after randomisation.  The patients were followed up for three months.  Overall 332 patients were included in the study.  On an intention-to treat analysis, the rates of venous thromboembolism at the end of the double-blind phase were 12% in the placebo group and 5% in the enoxaparin group (p=0.02).  The significant difference persisted at three months.  Three patients in the enoxaparin group and six in the placebo group died within three months of surgery.  There was no significant differences in the rates of bleeding or other complications during the double-blind or follow-up periods.  It was concluded that enoxaparin prophylaxis for four weeks after surgery for abdominal or pelvic cancer is safe and significantly reduces the incidence of venographically demonstrated thrombosis as compared with enoxaparin prophylaxis for one week.

The Multicentre Aneurysm Screening Study (MASS) into the effect of abdominal aortic aneurysm screening on mortality in men:  a randomised controlled trial.  The Multicentre Aneurysm Screening Study Group.  Lancet 2002;  360:  1531-1539.  

Ultrasound can reliably visualise the aorta in 99% of people thus providing the possibility of detection of abdominal aortic aneurysm (AAA) at a size when rupture is unlikely to occur.  Intervention at this stage could reduce the frequency of rupture and so reduce mortality.  Elective surgery for AAA is however also associated with a mortality risk of between 2 and 6%.  Thus opposing views have been published on the importance of ultrasound screening for AAA.  The Multicentre Aneurysm Screening Study was designed to asses whether or not such screening is beneficial.  A population-based sample of men (n=67,800) aged 65-74 years was enrolled and each individual was randomly allocated to either receive an invitation for an abdominal ultrasound scan (invited group, n=22,839) or not (control group, n=33, 961).  Men in whom a AAA (>3 cm diameter) were detected were followed up with repeat ultrasound scans for a mean of 4.1 years.  Surgery was considered on specific criteria (diameter >5.5 cm, expansion > 1 cm per year, symptoms).  Mortality data was obtained from the Office of National Statistics and an intention-to-treat analysis was based on cause of death.  Quality of life was assessed with four standardised scales.  The primary outcome measure was mortality related to AAA.  27,146 of 33,839 (80%) men invited for screening accepted the invitation and 1333 aneurysms were detected.  There were 65 aneurysm-related deaths (absolute risk 0.19%) in the invited group and 113 (0.33%) in the control group (risk reduction 42%,  95% CI 22-58;  p=0.0002) with a 53% reduction in those who attended screening.  30-day mortality was 6% (24 of 414) after elective surgery for AAA and 37% (30 of 81) after emergency surgery.  It was concluded that there is reliable evidence to support screening for AAA.

Randomized clinical trial and economic analysis of four-layer compression bandaging for venous ulcers.  O'Brien J F,  Grace P A,  Perry I J et al.  Br J Surg 2003;  90:  794-798.  

Compression in the form of four-layer bandaging is the recommended treatment for venous ulceration, but the efficacy of this therapy remains unclear.  Early studies lacked valid controls.  Three-month healing rates of between 69 and 74% have been reported in patients treated with four-layer bandaging in specialised clinics.  These rates compared with about 20% in patients receiving traditional care.  The aim of this study was to compare the cost-effectiveness of four-layer bandaging with that of alternative dressings available for venous ulcers.  In a randomised controlled trial, 200 patients with venous ulceration were randomised to either to four-layer bandaging (intervention group;  n=100) or to continue their usual system of care (control group;  n=100).  The follow-up for each patient was 12 weeks.  Analysis was by intention-to-treat.  The main outcome measures were time to healing and cost to the health board per leg healed.  Baseline characteristics were well matched in the two groups.  The Kaplan-Meier estimate of the healing rate at 3 months was 54% with four-layer compression bandaging and 34% in the control group.  Throughout the 3 months, four-layer bandaging healed leg ulcers significantly earlier (p=0.006).  There was a significant reduction in the median cost per leg healed with four-layer bandaging.  It was concluded that four-layer bandaging is currently the most effective method of treating venous leg ulcers in a community setting.

Prevention of disabling and fatal strokes by successful carotid endarterectomy in patients without recent neurological symptoms:  randomised controlled trial.  MRC Asymptomatic Carotid Surgery Trial (ACST) Collaborative Group.  Lancet 2004;  363:  1491-1502.

Patients with substantial carotid artery narrowing are at increased risk of suffering a disabling or fatal ischaemic stroke.  The hazard i greater if they are already symptomatic.  In those patients without recent neurological symptoms, the balance of surgical risks and long-term benefits from carotid endarterectomy (CEA) are unclear.  Between 1993 and 2003, 3120 asymptomatic patients with substantial carotid narrowing (60-99%) were randomised equally between immediate CEA (50% got CEA by one month and 88% by one year) and indefinite deferral of CEA (only 4% per year got CEA) and were followed up for 5 years.  Kaplan-Meier analyses of 5-year risks were performed by allocated treatment.  The risk of stroke within 30 days of CEA was 3.1% (95% CI 2.3-4.1).  Comparing all patients allocated immediate CEA versus all allocated deferral, but excluding such perioperative events, the 5-year stroke rate was 3.8 vs. 11% (gain 7.2%.  95% CI 5.0-9.4).  The gain chiefly involved carotid territory ischaemic strokes of which half were disabling or fatal.  Combining the perioperative events and the non-perioperative strokes, the net 5-year risks were 6.4% vs. 11.8% for all strokes (gain 5.4%.  95% CI 3.0-7.8).  Subgroup-specific analyses found no significant heterogeneity in the perioperative hazards or in the long-term postoperative benefits.  It was concluded that in asymptomatic patients younger then 75 years of age with carotid diameter reduction about 70% or more on ultrasound (many of whom were on asprin, antihypertensives and in recent years, statin therapy) immediate CEA halved the net 5-year stroke risk form about 12% to 6% (including the 3% perioperative hazard).  Half this 5-year benefit involved disabling or fatal strokes.  Outside clinical trials, inappropriate selection of patients or poor surgery could obviate such benefits. 

Randomised clinical trial of distal anastomotic interposition vein cuff in infrainguinal polytetrafluoroethylene bypass grafting.  Griffiths G D,  Nagy J,  Black D et al.  Br J Surg 2004;  91:  560-562.

An interposition vein cuff (Miller cuff) may be used to augment the distal anastomosis of a prosthetic infrainguinal bypass.  The aim of this study was to examine the effect of a Miller cuff at the distal anastomosis on the medium to long-term patency and limb salvage rates of femoral to above-knee and femoral to below-knee popliteal artery polytetrafluoroethylene (PTFE) bypasses.  Outcome measures were bypass graft patency and limb salvage.  Overall, 261 bypass operations were randomised.  Full data was available on 235 patients (120 with a Miller Cuff, 115 without).  The cumulative 5-year patency rate for above-knee bypasses with a Miller cuff was 40%, compared with 42% for non-cuffed bypasses (p=0.702).  The cumulative 3-year patency rate for below knee bypasses with a Miller cuff was 45%, compared with 19% for non-cuffed bypasses (p=0.018).  A Miller cuff had no significant effect on limb salvage for above-knee or below-knee bypasses.  It was concluded that 3-year patency rates of femoral to below-knee popliteal PTFE bypasses were improved with a Miller cuff.  Miller cuffs had no effect on patency rates for femoral to above-knee popliteal bypasses at 5 years and did not improve limb salvage in either group.

Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study):  randomised controlled trial.  Barwell J R,  Davies C E,  Deacon J et al.  Lancet 2004;  363:  1854-1859. 

Chronic venous ulceration affects 1-2% of the population and usually has a protracted course of healing and often recurs many times.  The disorder accounts for about 1% of the total health costs of developed countries.  It can be managed by compression therapy, elevation of the leg and exercise.  The addition of ablative superficial venous surgery to this strategy has not been shown to affect ulcer healing.  The aim of this study was to assess healing and recurrence rates after treatment with compression with and without surgery in patients with leg ulceration.  Venous duplex imaging of ulcerated or recently healed legs was obtained in 500 consecutive patients from three centres.  Patients with isolated superficial venous reflux and mixed superficial and deep reflux were randomly allocated to either compression treatment alone or in combination with superficial venous surgery.  Compression consisted of multilayer compression bandaging every week until ulcer healing then class 2 below knee stockings.  Primary endpoints were 24-week healing rates and 12-month recurrence rates.  Analysis was on an intention to treat basis.  Overall, 40 patients were lost to follow up and were censored.  The 24-week healing rates were similar in the compression and surgery and compression alone groups (65% vs. 65%,  HR = 0.84.  95% CI 0.77 to 1.24.  p = 0.85).   However, the 12-month recurrence rates were significantly reduced in the compression plus surgery group  (12% vs. 28%.  HR = -2.76.  95% CI -1.78 to -4.27.  p < 0.0001).  Adverse events were minimal and about equal in each group.  It was concluded that surgical correction of superficial venous reflux reduces 12-month ulcer recurrence.  Most patients with chronic venous ulceration will benefit from the addition of simple venous surgery.

Randomized clinical trial of low molecular weight heparin with thigh-length or knee-length antiembolism stockings for patients undergoing surgery.  Howard A,  Zaccagnini D,  Ellis M et al.  Br J Surg 2004;  91:  842-847. 

Currently the most appropriate means of preventing deep vein thrombosis (DVT) in surgical patients are subcutaneous heparin and antiembolism stockings, which offer increased benefit when used in combination.  Other pharmacological and physical prophylactic measures exist but are less effective, less safe or impractical.  The aim of this study was to determine the optimal length of stocking for use in a safe single 'blanket' protocol to prevent postoperative DVT for all patients undergoing any surgical procedure.  Of 426 patients interviewed, 376 agreed to be randomised to receive one of three types of antiembolism stockings.  Two were thigh-length and one was a knee-length stocking.  All patients received low molecular weight heparin (LMWH) thromboprophylaxis.  Duplex ultrasonography was used to assess the incidence of postoperative DVT.  No postoperative DVT occurred in 85 patients at low or moderate risk.  Nineteen DVTs occurred, all in the 291 high-risk patients.  Eight DVTs occurred in those with thigh-length stockings and 11 with knee-length stockings.  No patients developed a pulmonary embolus.  The different stocking groups were similar for age, sex, thromboembolic risk, type of operation and compliance.  One significant bleeding complication occurred.  It was concluded that a single protocol comprising LMWH and thigh-length stockings abolished DVT in low and moderate-risk patients and reduced the rate of DVT to 2% in high risk patients.

Endovascular aortic aneurysm repair in the octogenarian.  Minor M E,  Ellozy S,  Carroccio A et al.  Arch Surg 2004;  139:  308-314. 

During the past decade, endovascular stent graft repair (EVSG) of abdominal aortic aneurysms has emerged as a less invasive and less morbid alternative yo open surgical repair.  This study looked at whether EVSG may become the treatment of choice among patients older then 80 years old.  The study was a retrospective case series in am major academic medical centre with extensive experience in endovascular and open aortic aneurysm surgery.  During a 5-year period, EVSG was performed in 595 patients at this institution.  Amongst this group 150 (25%) were older than 80 years.  A prospectively acquired database was reviewed with respect to demographic, intraoperative and outcome data of this elderly population.  The main outcome measures were technical and clinical success, aneurysm-related events (aneurysm-related death, type I or type III endoleaks, aneurysm expansion or aneurysm rupture) and secondary interventions.  There were 119 men (79%) and 32 women (21%).  The mean age was 85 years.  Mean aneurysm diameter was 6.7 cm.  Comorbidities including chronic obstructive pulmonary disease, coronary artery disease, chronic renal insufficiency, peripheral vascular disease, hypertension and hypercholesterolaemia were common with an average of 2.9 comorbid conditions in each patient.  Mean follow-up was 17 months.  Overall, 146 patients (97%) received only regional anaesthesia and the average intraoperative blood loss was 370ml.  Average hospital stay was 2.5 days.  There were 5 aborted procedures and 4 conversions to open aortic repair (2.6%).  In addition these aborted procedures there were 2 additional technical failures resulting ain a technical success rate of 95%.  Endoleaks were common including 9 type I, 35 type II and 1 type III.  The majority resolved either spontaneously or with minimally invasive secondary intervention.  There were 5 perioperative deaths (3%).  Forty late deaths occurred which were unrelated to the EVSG procedure.  It was concluded that EVSG repair of abdominal aortic aneurysms can be performed safely and successfully in the majority of octogenarians with relatively low complications rates.  Improved EVSG devices and operator experience may make this procedure the treatment method of choice for patients in this age group who meet specific anatomical criteria.

Randomised clinical trial of intraoperative autotransfusion in surgery for abdominal aortic aneurysm.  Mercer K G,  Spark J I,  Berridge D C et al.  Br J Surg 2004;  91:  1443-1448.

Over 3500 patients undergo elective repair of an abdominal aortic aneurysm (AAA) each year in the United Kingdom.  An average blood transfusion requirement of 3.5 units amounts to a demand for more than 12 000 units of blood per annum for these elective procedures.  Homologous blood transfusion (HBT) is associated with a risk of transfusion reaction, disease transmission and metabolic changes relating to the composition of stored blood.  It has also been suggested that HBT may impair immunological function.  Intraoperative autologous transfusion (IAT) is a method for blood conservation that has been shown to be effective in reducing the requirement for blood transfusion.  The aim of this study was to investigate the benefits of IAT in reducing the incidence of systemic inflammatory response syndrome (SIRS) in a prospective randomised clinical trial using requirement for HBT and postoperative infection as secondary outcome measures.  Overall, 40 patients were randomised to IAT and 41 underwent surgery with HBT only.  Patients in both groups received HBT to maintain a haemoglobin level above 8 g/dl.  Transfusion requirements and incidence of SIRS and infection were compared.  Significantly fewer patients in the IAT group required HBT (21 vs. 31;  p=0.038) and the median blood requirement per patient was 2 units lower (p=0.012).  There was a higher incidence of chest infection (12 vs.4 patients; p=0.049) and SIRS (20 vs. 9 patients; p=0.020) in the HBT group.  Risk of SIRS was related to aortic cross-clamp time in the IAT group only.  It was concluded that use of autotransfusion reduced the need for HBT and was associated with a reduced incidence of postoperative SIRS and infective complications in patients undergoing elective AAA surgery.

A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysm.  Prinssen M,  Verhoeven E L G,  Buth J et al.  N Engl J Med 2004;  351:  1607-1618

Elective surgical repair is indicated in patients with a large abdominal aortic aneurysm.  The threshold for surgery is still a subject of debate but varies between 5.0 and 5.5 cm in diameter.  Endovascular repair is a less invasive alternative to conventional open repair and as a result has been used in patients for whom open repair poses a high risk.  Although the initial results of endovascular repair of abdominal aortic aneurysm were promising, current evidence from controlled studies does not convincingly show a reduction in 30-day mortality relative to that achieved with open repair.  The aim of this study was to perform multicentre, randomised trial comparing open and endovascular abdominal aortic aneurysm repair.  Overall, 345 patients with an aortic aneurysm less than 5cm in diameter and considered fit for either open or endovascular repair, were recruited. The outcome events analysed were operative (30-day) mortality and two composite endpoints of operative mortality and severe complications and operative mortality and moderate or severe complications.  The operative mortality rate was 4.6% in the open-repair group (8 of 174, 95% CI 2.0-8.9%) and 1.2% in the endovascular-repair group (2 0f 171, 95%CI 0.1-4.2%) resulting in risk ratio of 3.9 (95% CI 0.9-32.9).  The combined rate of operative mortality and severe complications was 9.8% in the open-repair and 4.7% in the endovascular group resulting in risk ratio of 2.1.  It was concluded that on the basis of the overall results of this trial, endovascular repair is preferable to open repair in patients who have an abdominal aortic aneurysm that is at least 5 cm in diameter.  Long-term follow-up is needed to determine whether the advantage is sustained.

Protected carotid artery stenting versus endarterectomy in high-risk patients.  Yadav J S,  Wholey M H,  Kuntz R E et al.  N Engl J Med 2004;  351:  1493-1501.

Several trials have shown carotid endarterectomy to be superior to medical management for the prevention of stroke in patients with symptomatic and asymptomatic carotid-artery stenosis.  During the past decade carotid angioplasty with stenting has been used to treat patients at high surgical risk but its use has been limited by the risks of compression of the stent and embolisation of plaque debris.  Nickel-titanium crush resistant stents and emboli-protection devices have been developed to address these problems.  This study was a randomised trial comparing carotid artery stenting with the use of an emboli-protection device to endarterectomy in 334 patients with coexisting conditions that potentially increased the risk posed by endarterectomy and who had either a symptomatic carotid artery stenosis of at least 50% of the luminal diameter or an asymptomatic stenosis of at least 80%.  The primary endpoint of the study was the cumulative incidence of a major cardiovascular event at one year - a composite of death, stroke or myocardial infraction within 30 days after the intervention or death or ipsilateral stroke between 31 days and one year.  The study was designed to test the hypothesis that the less invasive strategy, stenting, was not inferior to endarterectomy.  The primary end point occurred in 20 patients randomly assigned to undergo carotid artery stenting (cumulative incidence 12.2%) and in 32 patients assigned to undergo endarterectomy (cumulative incidence 20.1%; p=0.004). At the on year, carotid revascularisation was repeated in fewer patients who had received stents than in those who had undergone endarterectomy (0.6% vs. 4.3%; p=0.04).  It was concluded that among patients with severe carotid artery stenosis and coexisting conditions, carotid stenting with the use of an emboli-protection devise is not inferior to carotid endarterectomy.

Randomised clinical trial of four-layer and short-stretch compression bandages for venous leg ulcers.  Nelson E A,  Iglesias C P, Cullum N et al.  Br J Surg 2004;  91:  1292-1299.

Leg ulceration affects 15-18 per 1000 adults in developed countries and is associated with pain and a lower quality of life.  The majority of leg ulcers are secondary to venous insufficiency and it has been estimated that the management of venous ulcers in the UK costs 100-300 million per year.  Systematic reviews have found that compression therapy heals more ulcers than dressings alone and that high-level compression systems are more effective than low compression systems.  The aim of this study was to determine the relative effectiveness of four layer and short-stretch bandaging for venous ulceration.  A total of 387 adults with venous ulcers, who were receiving leg ulcer treatment either in primary care or as a hospital patient were recruited to this parallel group open study and were randomised to either four-layer or short-stretch bandages.  Follow-up continued until the patient's reference leg was ulcer free or for a minimum of 12 months.  The primary endpoint was time to complete healing of all ulcers on the reference leg.  Secondary outcomes included proportion of ulcers healed, health-related quality of life, withdrawals and adverse events.  Analysis was by intention to treat.  Unadjusted analysis identified no statistically significant difference in median time to healing:  92 days for four-layer compression and 126 days for short-stretch bandages,  However, when prognostic factors were included in a Cox proportional hazard regression model, ulcers treated with short-stretch bandage had a lower probability of healing than those treated with four-layer bandage (HR 0.72; 95% CI 0.57-0.91).  More adverse events and withdrawals were reported with the short-stretch bandage.  It was concluded that venous leg ulcers treated with a four-layer bandage healed more quickly than those treated with a short-stretch bandage.

Critical appraisal of femorofemoral crossover grafts.  Pursell R,  Sideso E,  Magee T R et al.  Br J Surg 2005;  92:  565-569.

Femorofemoral crossover grafts have gained popularity for unilateral iliac artery occlusion.  It can also be used following aorto uni-iliac endovascular abdominal aortic aneurysm repair.  The operation is generally well tolerated with low 30-day morbidity and mortality rates.  However, long-term patency of femorofemoral crossover grafts is lower than that of aortofemoral bypass grafts and is similar to that of iliofemoral bypass grafts.  Success of any bypass graft is based on patency, limb salvage and long-term survival.  An ideal result is further defined by an uncomplicated operation with primary wound healing, relief of symptoms without recurrence and no need for further intervention.  The aim of this study was to determine how often femorofemoral crossover grafting for critical limb ischaemia or intermittent claudication give an ideal result.  All patients undergoing primary femorofemoral crossover grafting between January 1988 and December 2003 were studied.  Some 144 operations were analysed.  Overall, 51 patients had critical ischaemia and 93 patients had claudication.  There was one postoperative death (0.7%).  Complications occurred within 30 days in 32 patients (22%) including graft occlusion in three (2%).  Six patients (4%) required early reoperation.  Primary patency for patients with critical ischaemia was 88, 82 and 74% at one , 3 and 5 years respectively.  Respective figures for those who presented with claudication were 92, 92 and 90%.  Late symptoms included graft occlusion (20 patients), disease progression (25 patients), ongoing ulceration (6 patients), graft infection (9 patients), false aneurysm formation (2 patients) and late donor site stenosis (2 patients).  It was concluded that when obtaining informed consent, simply describing patency and limb salvage rates does not provide an accurate picture of the outcome of femorofemoral grafting.

Randomized clinical trial of routine preoperative duplex imaging before varicose vein surgery.  Blomgren L,  Johansson G,  Bergqvist D.  Br J Surg 2006;  92:  688-694

Surgery for varicose veins is associated with high recurrence rates and frequent reoperations, even when performed by experienced surgeons.  Residual varices, progression of disease and neovascularisation are all causes that have been discussed in recent studies.  Another important and potentially preventable factor is inaccurate preoperative diagnosis with respect to the source of the venous hypertension.  Duplex imaging is used increasingly for the preoperative evaluation of varicose veins, but its value in terms of long-term results of surgery is unclear.  Patients with primary varicose veins were randomised to operation with or without preoperative duplex imaging.  Reoperation rates, clinical and duplex findings were compared at 2 months and 2 years after surgery.  Overall, 293 patients (343 legs) had varicose vein surgery after duplex imaging (Group 1, n=166 legs) or no imaging (Group 2, n=177 legs).  In 44 legs (27%) duplex imaging suggested a different surgical procedure than had been considered on clinical grounds.  The procedure was changed accordingly for 29 legs.  At 2 months, incompetence was detected at the saphenofemoral or sapheno-popliteal junction (or both) in 14 legs (9%) in Group 1 and 44 legs (26%) in Group 2 (p<0.001).  At 2 years, two legs (1.4%) had undergone or were awaiting reoperation in Group 1 and 14 legs (9.5%) in Group 2 (p=0.002).  In the remainder, major incompetence was found in 19 legs (15%) in Group 1 and 53 (41%) in Group 2 (p<0.001).  It was conclude that routine preoperative duplex examination led to improvement in results 2 years after surgery for patients with primary varicose veins. 

Randomized clinical trial of the effects of methylprednisolone on renal function after major vascular surgery.  Turner S,  Derham C,  Orsi N M et al.  Br J Surg 2008;  95:  50-56.

Up to 25% of patients with abdominal aortic aneurysm (AAA) have chronic renal failure and those who undergo elective repair have a risk of acute renal failure.  Vascular surgical patients are particularly venerable to excess morbidity and mortality from postoperative increases in serum creatinine concentrations.  Perioperative renal dysfunction following AAA repair is multifactorial and may involve hypotension, hypoxia and ischaemia-reperfusion injury.  Studies of hepatic and cardiac transplant patients have demonstrated beneficial effects on renal function of high-dose methylprednisolone administered before surgery.  The aim of this study was to test the hypothesis that in the setting of elective open AAA repair, methylprednisolone give before the onset of ischaemia and subsequent reperfusion might attenuate sub-clinical renal dysfunction.  Twenty patients undergoing elective open AAA repair were randomised to receive either methylprednisolone 10mg/kg or dextrose before induction of anaesthesia.  Blood was analysed for a panel of cytokine representatives of T helper type 1 and 2 subsets.  Data was analysed from 18 patients.  Both groups demonstrated glomerular and proximal tubular dysfunction that was unaffected by steroid treatment.  Steroid administration increased serum levels of urea and creatinine (both p<0.001).  The steroid group had increased levels of interleukin 10 levels (p=0.005).  There was no difference between groups in overall surgical complications, length of ICU stay, or 30-day mortality.  It was concluded that methylprednisolone alter the cytokine profile favourably but adversely affected postoperative renal function

Randomized clinical trial comparing endovenous laser ablation with surgery for the treatment of primary great saphenous varicose veins.  Darwood R J,  Theivacumar N,  Dellagrammaticas D et al.  Br J Surg 2008;  95:  294-301.

Varicose veins affect up to 32% of women and 40% of men.  The majority are due to saphenofemoral and great saphenous vein (GSV) incompetence.  Conventional surgery involves saphenofemoral ligation,  GSV stripping and phlebectomy of residual varicosities.  This is usually performed as a day case procedure under general anaesthesia. Recently, minimally invasive endovenous techniques have been developed as alternatives to conventional surgery.  The potential advantages of these include a reduction in postoperative morbidity and a shorter recovery period.  Endovenous laser ablation (EVLA) is usually performed on an outpatient basis using local anaesthesia  ad results in thermal ablation of the GSV.  Although previous series report GSV occlusion rates of 95-98% with EVLA only one randomised clinical trial has compared the outcome with surgery.  The aim of this study was to compare EVLA with surgery for the treatment of varicose veins associated with saphenofemoral and GSV incompetence.  Consecutive patients with symptomatic varicose veins were randomised to EVLA or surgery.  Principle outcome measures were abolition of GSV reflux and improvement in Aberdeen Varicose Vein Symptom Score (AVVSS) 3 months after treatment.  GSV was abolished in 41 of 42 legs treated with EVLA and 28 of 32 after surgery (p=0.227).  The median AVVSS improvements were similar between the two groups.  Return to normal activity was quicker after EVLA. It was concluded that abolition of reflux and improvement in disease-specific quality of life was comparable following both EVLA and surgery.  The earlier return to normal activity following EVLA may confer important socioeconomic advantages. 

Long-term results of carotid stenting versus endarterectomy in high-risk patients.  Gurm H S,  Yadav J S,  Fayad P F et al.  N Engl J Med 2008;  358:  1572-1579.

There is a direct relationship between the degree of carotid artery stenosis and the risk of ipsilateral stroke.  Carotid revascularisation by means of carotid endarterectomy has proved highly successful in reducing the incidence of stroke among patients with moderate to severe symptomatic carotid stenosis, as well as those with severe asymptomatic carotid stenosis.  Although carotid endarterectomy has been considered the gold standard for the treatment of carotid stenosis, carotid artery stenting has emerged as emerged as an alternative treatment for this common disorder.  The Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) study randomised high surgical risk patients to undergo protected carotid arterial stenting or endarterectomy.    Early results showed that stenting was not inferior to surgery.  This paper publishes the 3 year follow-up results.  The trial evaluated carotid artery stenting with the use of an emboli-protection devise as compared endarterectomy in 334 patients at increased risk for complications from endarterectomy who had either symptomatic stenosis of at lease 50% of the luminal diameter or an asymptomatic stenosis of at lease 80%.  The prespecified major secondary endpoint at 3 years was a composite of death, stroke, or myocardial infarction within 30 days of the procedure or death or ipsilateral stroke between 31 days and 3 years.  At 3 years data was available for 260 patients (78%) including 85% of patients in the stenting groups and 70% of those in the endarterectomy group.  The prespecified secondary endpoint occurred in 41 patients in the stenting group (cumulative incidence 24%, Kaplan-Meier estimate 26%) and 45 patients in the endarterectomy group (cumulative incidence 27%, Kaplan-Meier estimate 30%).  The absolute difference in the cumulative incidence for stenting was -2.3% (95% CI -11.8 to 7.0).  There were 15 strokes in each group.  It was concluded that in patients with severe carotid stenosis and increased surgical risk, there was no difference in long-term outcome between patients undergoing carotid artery stenting and those undergoing endarterectomy

General anaesthesia versus local anaesthesia for carotid surgery (GALA): a multicentre, randomised controlled trial.  GALA Trial Collaborative Group.  Lancet 2008;  372:  2132-2142. 

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. The aim of this study was to compare 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. A parallel group, multicentre, randomised controlled trial of 3526 patients with symptomatic or asymptomatic carotid stenosis from 95 centres in 24 countries was undertaken. 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.  A primary outcome occurred in 84 (48%) patients assigned to surgery under general anaesthesia and 80 (45%) 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] 094 [95% CI 070 to 127]). 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. It was concluded that there was no 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.

Recovery after ultrasound-guided foam sclerotherapy compared with conventional surgery for varicose veins.  Darvall K A L, Bate G R, Adam D J et alBr J Surg 2009;  96:  1262-1267. 

The advantages of minimally invasive alternatives such as ultrasound-guided foam sclerotherapy (UGFS) over conventional surgery for the treatment of varicose veins include lower morbidity and faster recovery times. The aim of this study was to compare morbidity, analgesia use, and time to return to driving and work following UGFS with those reported after conventional surgery for varicose veins. Patients who had UGFS or surgery for varicose veins were sent a questionnaire 4 weeks after treatment. A total of 332 (849 per cent) of 391 patients who had UGFS and 53 (56 per cent) of 94 who had surgery returned a questionnaire. The groups were similar in terms of age, sex, and the proportion who had treatment of bilateral or recurrent veins. Patients who had surgery were more likely to have significant bruising (44 versus 72 per cent; P < 0001) and pain (17 versus 55 per cent; P = 0001). After UGFS, 432 per cent of patients returned to work within 24 hours compared with none who had surgery (P < 0001). Patients who had UGFS were more likely to return to driving within 4 days (P = 0014).It was concluded that UGFS was associated with less pain and analgesia requirement, time off work and quicker return to driving.

Outcomes following endovascular vs. open repair of abdominal aortic aneurysm.  A randomized trial.  Lederle F A,  Freischlag J A,  Kyriakides J A et al.  JAMA 2009;  302:  1535-1542.

Limited data are available to assess whether endovascular repair of abdominal aortic aneurysm (AAA) improves short-term outcomes compared with traditional open repair. The aim of this study was to compare postoperative outcomes up to 2 years after endovascular or open repair of AAA in a planned interim report of a 9-year trial. A randomized, multicentre clinical trial of 881 veterans (aged 49 years) from 42 Veterans Affairs Medical Centres with eligible AAA who were candidates for both elective endovascular repair and open repair of AAA. The trial is ongoing and this report described the period between October 2002, and October 2008. Patients were randomised to either elective endovascular (n = 444) or open (n = 437) repair of AAA. The main outcome measures were procedure failure, secondary therapeutic procedures, length of stay, quality of life, erectile dysfunction, major morbidity, and mortality. The mean follow-up was 1.8 years. Perioperative mortality (30 days or inpatient) was lower for endovascular repair (0.5% vs. 3.0%; p = 0.004), but there was no significant difference in mortality at 2 years (7.0% vs. 9.8%, p = 0.13). Patients in the endovascular repair group had reduced median procedure time (2.9 vs. 3.7 hours), blood loss (200 vs. 1000 mL), transfusion requirement (0 vs. 1.0 units), duration of mechanical ventilation (3.6 vs. 5.0 hours), hospital stay (3 vs. 7 days), and intensive care unit stay (1 vs 4 days), but required substantial exposure to fluoroscopy and contrast. There were no differences between the 2 groups in major morbidity, procedure failure, secondary therapeutic procedures, aneurysm-related hospitalizations, health-related quality of life, or erectile function. It was concluded that the short-term outcomes after elective AAA repair, perioperative mortality was low for both procedures and lower for endovascular than open repair. The early advantage of endovascular repair was not offset by increased morbidity or mortality in the first 2 years after repair. Longer-term outcome data are needed to fully assess the relative merits of the 2 procedures.

Carotid artery stenting compared with endarterectomy in patients with symptomatic carotid stenosis (International Carotid Stenting Study).  International Carotid Stenting Investigators.  Lancet 2010;  375:  985-997.

Stents are an alternative treatment to carotid endarterectomy for symptomatic carotid stenosis, but previous trials have not established equivalent safety and efficacy. The aim of this study was to compare the safety of carotid artery stenting with that of carotid endarterectomy. The International Carotid Stenting Study (ICSS) is a multicentre, international, randomised controlled trial with blinded adjudication of outcomes. Patients with recently symptomatic carotid artery stenosis were randomly assigned in a 1:1 ratio to receive carotid artery stenting or carotid endarterectomy. Randomisation was by telephone call or fax to a central computerised service and was stratified by centre with minimisation for sex, age, contralateral occlusion, and side of the randomised artery. Patients and investigators were not masked to treatment assignment. Patients were followed up by independent clinicians not directly involved in delivering the randomised treatment. The primary outcome measure of the trial is the 3-year rate of fatal or disabling stroke in any territory, which has not been analysed yet. The main outcome measure for this interim safety analysis was the 120-day rate of stroke, death, or procedural myocardial infarction. Analysis was by intention to treat (ITT). The trial enrolled 1713 patients (stenting group, n=855; endarterectomy group, n=858). Two patients in the stenting group and one in the endarterectomy group withdrew immediately after randomisation, and were not included in the ITT analysis. Between randomisation and 120 days, there were 34 (Kaplan-Meier estimate 40%) events of disabling stroke or death in the stenting group compared with 27 (32%) events in the endarterectomy group (hazard ratio [HR] 128, 95% CI 077211). The incidence of stroke, death, or procedural myocardial infarction was 85% in the stenting group compared with 52% in the endarterectomy group (72 vs 44 events; HR 169, 116245, p=0006). Risks of any stroke (65 vs 35 events; HR 192, 127289) and all-cause death (19 vs seven events; HR 276, 116656) were higher in the stenting group than in the endarterectomy group. Three procedural myocardial infarctions were recorded in the stenting group, all of which were fatal, compared with four, all non-fatal, in the endarterectomy group. There was one event of cranial nerve palsy in the stenting group compared with 45 in the endarterectomy group. There were also fewer haematomas of any severity in the stenting group than in the endarterectomy group (31 vs 50 events; p=00197). It was concluded that completion of long-term follow-up is needed to establish the efficacy of carotid artery stenting compared with endarterectomy. In the meantime, carotid endarterectomy should remain the treatment of choice for patients suitable for surgery.

10-year stroke prevention after successful carotid endarterectomy for asymptomatic stenosis (ACST-1): a multicentre randomised trial.  Halliday A,  Harrison M,  Hayter E et al.  Lancet 2010;  376:  1074-1084.

If carotid artery narrowing remains asymptomatic (i.e., has caused no recent stroke or other neurological symptoms), successful carotid endarterectomy (CEA) reduces stroke incidence for some years. The aim of this study was to asses the long-term effects of successful CEA in stroke prevention. Between 1993 and 2003, 3120 asymptomatic patients from 126 centres in 30 countries were allocated equally, by blinded minimised randomisation, to immediate CEA (median delay 1 month, IQR 0325) or to indefinite deferral of any carotid procedure, and were followed up until death or for a median among survivors of 9 years (IQR 611). The primary outcomes were perioperative mortality and morbidity (death or stroke within 30 days) and non-perioperative stroke. Kaplan-Meier percentages and log rank p values are from intention-to-treat analyses. Overall, 1560 patients were allocated immediate CEA versus 1560 allocated deferral of any carotid procedure. The proportions operated on while still asymptomatic were 897% versus 48% at 1 year (and 921% vs 165% at 5 years). Perioperative risk of stroke or death within 30 days was 30% (95% CI 2439; 26 non-disabling strokes plus 34 disabling or fatal perioperative events in 1979 CEAs). Excluding perioperative events and non-stroke mortality, stroke risks (immediate vs deferred CEA) were 41% versus 100% at 5 years (gain 59%, 95% CI 4078) and 108% versus 169% at 10 years (gain 61%, 2794); ratio of stroke incidence rates 054, 95% CI 043068, p<00001. 62 versus 104 had a disabling or fatal stroke, and 37 versus 84 others had a non-disabling stroke. Combining perioperative events and strokes, net risks were 69% versus 109% at 5 years (gain 41%, 2062) and 134% versus 179% at 10 years (gain 46%, 1279). Medication was similar in both groups; throughout the study, most were on anti-thrombotic and antihypertensive therapy. Net benefits were significant both for those on lipid-lowering therapy and for those not, and both for men and for women up to 75 years of age at entry (although not for older patients). It was concluded that successful CEA for asymptomatic patients younger than 75 years of age reduces 10-year stroke risks. Half this reduction is in disabling or fatal strokes. Net benefit in future patients will depend on their risks from non-operated carotid lesions (which will be reduced by medication), on future surgical risks (which might differ from those in trials), and on whether life expectancy exceeds 10 years.

 Randomized clinical trial of ultrasound‐guided foam sclerotherapy versus surgery for the incompetent great saphenous vein.  Shadid N,  Ceulen R,  Nelemans P et al.  Br J Surg 2012;  99:  1062-1070. 

New minimally invasive treatment modalities, such as ultrasound‐guided foam sclerotherapy (UGFS), are becoming more popular in the management of varicose veins. In a multicentre randomized controlled non-inferiority trial, the effectiveness and costs of UGFS and surgery for treatment of the incompetent great saphenous vein (GSV) were compared. Patients with primary great saphenous varicose veins were assigned randomly to either UGFS or surgical stripping with high ligation. Recurrence, defined as reflux combined with venous symptoms, was determined on colour duplex scans at baseline, 3 months, 1 year and 2 years after initial treatment. Secondary outcomes were presence of recurrent reflux (irrespective of symptoms), reduction of symptoms, health-related quality of life, adverse events and direct hospital costs. Two hundred and thirty patients were treated by UGFS and 200 underwent GSV stripping. The two -year probability of recurrence was similar in the UGFS and surgery groups: 113 per cent (24 of 213) and 90 per cent (16 of 177) respectively (P = 0407). At two years, reflux irrespective of venous symptoms was significantly more frequent in the UGFS group (350 per cent) than in the surgery group (210 per cent) (P = 0003). At two-year follow-up, UGFS was not inferior to surgery when reflux associated with venous symptoms was the clinical outcome of interest. UGFS has the potential to be a cost-effective approach to a common health problem.


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