M. R. Whyman

Comparison of surgery and compression with compression alone in chronic venous ulceration (ESCHAR study): randomised controlled trial

BACKGROUND Chronic venous leg ulceration can be managed by compression treatment, elevation of the leg, and exercise. The addition of ablative superficial venous surgery to this strategy has not been shown to affect ulcer healing, but does reduce ulcer recurrence. We aimed to assess healing and recurrence rates after treatment with compression with or without surgery in people with leg ulceration. METHODS We did venous duplex imaging of ulcerated or recently healed legs in 500 consecutive patients from three centres. We randomly allocated those with isolated superficial venous reflux and mixed superficial and deep reflux either compression treatment alone or in combination with superficial venous surgery. Compression consisted of multilayer compression bandaging every week until healing then class 2 below-knee stockings. Primary endpoints were 24-week healing rates and 12-month recurrence rates. Analysis was by intention to treat. FINDINGS 40 patients were lost to follow-up and were censored. Overall 24-week healing rates were similar in the compression and surgery and compression alone groups (65% vs 65%, hazard 0.84 [95% CI 0.77 to 1.24]; p=0.85) but 12-month ulcer recurrence rates were significantly reduced in the compression and surgery group (12% vs 28%, hazard -2.76 [95% CI -1.78 to -4.27]; p<0.0001). Adverse events were minimal and about equal in each group. INTERPRETATION 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.

Long term results of compression therapy alone versus compression plus surgery in chronic venous ulceration (ESCHAR): randomised controlled trial

Objective To determine whether recurrence of leg ulcers may be prevented by surgical correction of superficial venous reflux in addition to compression. Design Randomised controlled trial. Setting Specialist nurse led leg ulcer clinics in three UK vascular centres. Participants 500 patients (500 legs) with open or recently healed leg ulcers and superficial venous reflux. Interventions Compression alone or compression plus saphenous surgery. Main outcome measures Primary outcomes were ulcer healing and ulcer recurrence. The secondary outcome was ulcer free time. Results Ulcer healing rates at three years were 89% for the compression group and 93% for the compression plus surgery group (P=0.73, log rank test). Rates of ulcer recurrence at four years were 56% for the compression group and 31% for the compression plus surgery group (P<0.01). For patients with isolated superficial reflux, recurrence rates at four years were 51% for the compression group and 27% for the compress plus surgery group (P<0.01). For patients who had superficial with segmental deep reflux, recurrence rates at three years were 52% for the compression group and 24% for the compression plus surgery group (P=0.04). For patients with superficial and total deep reflux, recurrence rates at three years were 46% for the compression group and 32% for the compression plus surgery group (P=0.33). Patients in the compression plus surgery group experienced a greater proportion of ulcer free time after three years compared with patients in the compression group (78% v 71%; P=0.007, Mann-Whitney U test). Conclusion Surgical correction of superficial venous reflux in addition to compression bandaging does not improve ulcer healing but reduces the recurrence of ulcers at four years and results in a greater proportion of ulcer free time. Trial registration Current Controlled Trials ISRCTN07549334.

Is intermittent claudication improved by percutaneous transluminal angioplasty? A randomized controlled trial☆☆☆★★★♢

PURPOSE Percutaneous transluminal angioplasty (PTA) is an increasingly popular invasive treatment for peripheral arterial disease, but there have been very few controlled trials to justify its use. This randomized controlled clinical trial was performed to determine in patients with mild and moderate intermittent claudication differences in outcome between PTA and conventional medical treatment after 2 years. METHODS Six hundred patients with claudication were screened at the Peripheral Vascular Clinic, Royal Infirmary of Edinburgh. Sixty-two patients with short femoral artery stenoses or occlusions (47 patients) and iliac stenoses (15 patients) were randomized to either PTA plus medical treatment (PTA group, 30 patients) or to medical treatment alone (control group, 32 patients). Medical treatment consisted of daily low-dose aspirin and advice on smoking and exercise. Outcome measures studied were patient-reported maximum walking distance, exercise treadmill distance until onset of claudication, treadmill maximum walking distance, ankle-brachial pressure index (ABPI), quality of life (Nottingham Health Profile), and duplex ultrasound-measured extent of occlusive disease. RESULTS At 2 years of follow-up, the PTA group and control subjects did not differ significantly in patient-reported maximum walking, treadmill onset to claudication, treadmill maximum walking distances, or ABPI (p > 0.05). However, the PTA group had significantly fewer occluded arteries (p = 0.003) and a lesser degree of stenosis (expressed in terms of the velocity ratio; p = 0.004) in patent arteries. Quality of life was not demonstrably different between the two groups (p > 0.05). CONCLUSIONS Two years after PTA, patients had less extensive disease than medically treated patients, but this did not translate into a significant advantage in terms of improved walking or quality of life. There are important implications for patient management and future clinical research.

Recommendations for screening intervals for small aortic aneurysms

The aim was to determine the optimum rescreening interval for small abdominal aortic aneurysms (AAAs).

Twenty-year review of abdominal aortic aneurysm screening in men in the county of Gloucestershire, United Kingdom

OBJECTIVE An ultrasound screening program for abdominal aortic aneurysms (AAAs) in men began in Gloucestershire in 1990 and has been running for 20 years. This report examines the workload and results. METHODS We reviewed the screening database for attendance and outcome records from AAA surgery in Gloucestershire and postmortem and death certificate results looking for men who died from ruptured AAAs in the screening cohort. The setting was an AAA screening program in the county of Gloucestershire, UK. Men aged 65 were invited by year of birth to attend for an ultrasound screening for AAAs. Men with an aorta <2.6 cm were reassured and discharged; men with an aorta between 2.6 cm and 5.4 cm were offered follow-up surveillance; men with an aorta >5.4 cm were considered for intervention. We analyzed attendance rates, screening and surveillance outcomes, and intervention rates and outcomes over the 20 years of the study. RESULTS Some 61,982 men were invited, and 52,690 attended for screening (85% attendance). At first scan, 50,130 men (95.14%) had an aortic diameter <2.6 cm in diameter and were reassured and discharged; 148 men (0.28%) had an AAA >5.4 cm in diameter and were referred for possible treatment; 2412 (4.57%) had an aortic diameter between 2.6 and 5.4 cm and entered a program of ultrasound surveillance. The overall mean aortic diameter on initial scan fell from 2.1 cm to 1.7 cm during the study (reduction 0.015 cm/y, 95% confidence interval [CI], 0.0144-0.0156 cm/y; P < .0001). Some 631 patients with AAAs had intervention treatment with a perioperative mortality rate of 3.9%; during the same interval, 372 AAAs detected incidentally were treated, with a mortality rate of 6.7%. The number of ruptured AAAs treated annually in Gloucestershire fell during the study (χ(2) for trend = 18.31, df = 1; P < .0001). CONCLUSIONS Screening reduced the number of ruptured AAAs in Gloucestershire during the 20 years of the program. There has been a significant reduction of men with an abnormal aorta, as the mean aortic diameter of the 65-year-old male has reduced over 20 years.

Management of mixed arterial and venous leg ulcers

The aim was to assess healing in patients with mixed arterial and venous leg ulcers after protocol‐driven treatment in a specialist leg ulcer clinic.

Randomized clinical trial of compression plus surgery versus compression alone in chronic venous ulceration (ESCHAR study)—haemodynamic and anatomical changes

The aim of this study was to evaluate the anatomical and haemodynamic effects of superficial venous surgery and compression on legs with chronic venous ulceration.

The relationship between cytokine concentrations and wound healing in chronic venous ulceration

OBJECTIVE The importance of wound cytokine function in chronic venous leg ulcers remains poorly understood. This study evaluated the relationship between local and systemic concentrations of wound cytokines and wound healing in patients with chronic venous ulceration. METHODS This prospective observational study was set in a community- and hospital-based leg ulcer clinic. Consecutive patients with chronic leg ulceration and ankle-brachial pressure index >0.85 were prospectively investigated. All patients were treated with multilayer compression bandaging. Wound fluid and venous blood samples were collected at recruitment and 5 weeks later. In the wound fluid and venous blood, cytokines and factors reflecting the processes of inflammation (interleukin 1beta, tumor necrosis factor-alpha), proteolysis (matrix metalloproteinases-2 and -9), angiogenesis (basic fibroblast growth factor [bFGF], vascular endothelial growth factor), and fibrosis (transforming growth factor-beta(1) [TGFbeta(1)]) were measured. Ulcer healing was assessed using digital planimetry at both assessments. RESULTS The study comprised 80 patients (43 men, 37 women). Median (range) ulcer size reduced from 4.4 (0.1-142.4) cm(2) to 2.2 (0-135.5) cm(2) after 5 weeks (P < .001; Wilcoxon signed rank), although 17 of 80 ulcers increased in size. The volume of wound fluid collected strongly correlated with ulcer size (Spearman rank = 0.801, P < .01). Initial wound fluid concentrations of bFGF correlated with ulcer size (Pearson coefficient = 0.641, P < .01), and changes in wound fluid TGFbeta(1) concentrations inversely correlated with changes in ulcer size (Spearman rank = -0.645, P = .032). There were no significant correlations between changes in other factors and ulcer healing. Wound fluid and serum cytokine concentrations correlated poorly. CONCLUSION Wound fluid collection volume correlates with ulcer size. Ulcer healing correlated with increased concentrations of TGFbeta(1), possibly reflecting increased fibrogenesis in the proliferating wound. Aside from this, there was a large variation in wound and serum cytokine levels that largely limits their usefulness as markers of healing.

Risk Factors for Healing and Recurrence of Chronic Venous Leg Ulcers

Objective: To identify independent risk factors for delayed healing and increased recurrence of chronic venous leg ulcers. Design: Prospective study. Setting: Community-based leg ulcer service. Patients: Six hundred and thirty-three limbs in 587 consecutive patients with an ankle-brachial pressure index (ABPI) ≥0.85. Method: Potential risk factors were initially assessed in a one-stop clinic incorporating clinical evaluation, ABPI and venous duplex imaging. Limbs were treated within a defined protocol. Twenty-four-week healing and 3-year ulcer recurrence rates were determined. Results: Of 12 potential risk factors age (p< 0.001), ulcer chronicity (p< 0.001) and popliteal vein reflux (p< 0.005) were independent risks for delayed healing. Of 13 potential risk factors rheumatoid arthritis (p<0.005) and healing time (p < 0.05) were independent risks for ulcer recurrence. Isolated superficial venous reflux treated by saphenous vein surgery predicted reduced ulcer recurrence (p< 0.005). Conclusion: Targeting in primary care of ulcer patients with specific characteristics might encourage earlier referral and appropriate resource management. Leg ulcer patients with superficial venous reflux might benefit from surgical correction.

Ankle Motility is a Risk Factor for Healing of Chronic Venous Leg Ulcers

Objective: To investigate the effect of ankle motility on chronic venous leg ulcer healing, and to relate this to calf pump function and muscle bulk. Methods: This was a prospective cohort study undertaken in a leg ulcer clinic. Ankle motility, calf-ankle circumference ratio and calf pump power (derived from digital photoplethysmography) were assessed as to their effect on ulcer healing rate. Thirty consecutive patients undergoing multi-layer compression bandaging for open chronic venous ulcers were included. Results: Ankle motility was an independent risk factor for ulcer healing (p = 0.001, hazard ratio 1.08, 95% CI 1.03–1.13). Ankle motility correlated with calf-ankle circumference ratio (r = 0.48, p<0.01). No relationship was found between photoplethysmography-derived calf pump power, ankle motility or ulcer healing rate. Conclusions Ulcers in legs with poor ankle motility are slower to heal and this may be related to reduced calf muscle bulk. Ankle exercises or physiotherapy could be considered in such patients.