J. R. Barwell

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.

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.

A Modern Leg Ulcer Service

Aim: To define the components and organization of a modern leg ulcer service that is acceptable to patients cost effective and produces high quality outcomes. Method: Analysis of data from published literature as well as experience from the organisation of a leg ulcer service in Gloucestershire. Synthesis: Assessment of leg ulcers requires the services of a vascular laboratory to assess the venous and arteria systems. Effective systems of compression must be employed. Staff and patients must be educated to understand the principals behind their use. For some patients pinch-grafting may be appropriate. Where arterial disease is present in the lower limb, reconstructive surgery should be used for the lower limb vessels The organisation of such a service must ensure good liaison between General Practitioners, community nurses and hospital specialists. Many patients may be managed in community leg ulcer clinics. In some cases, the advice of specialists such as rheumatologists and dermatologists may be required. Conclusions: A national framework for leg ulceir management is needed within which resources are made available in a way that satisfy local needs. Such a framework must be based on management protocols derived from evidence-based practices that have been developed through the experiences of modern leg ulcer services.

RESULTS COMPARING COMPRESSION ALONE VERSUS COMPRESSION AND SURGERY IN TREATING VENOUS ULCERATION

Publisher Summary This chapter discusses the results comparing compression alone versus compression and surgery in treating venous ulceration. Chronic venous ulceration is widely accepted as a common, debilitating, and expensive health problem. Although most patients have superficial venous incompetence potentially amenable to surgical correction, evidence to support operative intervention has been scarce. Other researches strongly suggest that superficial venous surgery reduces venous ulcer recurrence and should be considered for all patients with chronic venous ulceration. Patients deemed suitable for surgical treatment should undergo color duplex venous mapping in order to identify superficial venous incompetence potentially suitable for surgical correction. Although the advantage appears greatest for legs with isolated superficial reflux, surgery may also reduce ulcer recurrence for some patients with deep venous incompetence, and hemodynamic assessment may be a useful selection tool. Despite any proven clinical benefit, it must be acknowledged that elderly patients with leg ulcers may be unfit for surgical intervention or unwilling to accept it. Local anesthetic surgery was performed in a quarter of patients, but long-term effectiveness is unlikely to match general anesthetic procedures. Residual venous reflux after venous surgery was common, although this was not associated with reduced hemodynamic function or clinical outcomes.

Role of superficial venous surgery in the treatment of venous ulceration.

Letter 1 : J. Barwell, K. Poskitt, M. Whyman, Department of Vascular Surgery, Cheltenham General Hospital, Cheltenham GL53 7AN, UK