Recanalisation and ulcer recurrence rates following ultrasound-guided foam sclerotherapy.

OBJECTIVES: The aim was to assess vein recanalisation and ulcer recurrence in patients with chronic venous ulceration following ultrasound-guided foam sclerotherapy. METHOD: Open (CEAP 6) or recently healed (CEAP 5) chronic venous leg ulcers were treated with foam sclerotherapy between July 2010 and August 2012. Venous duplex scans were performed two weeks and one and two years post treatment, recording recanalisation and reflux. One- and two-year ulcer recurrence rates were calculated using Kaplan-Meier survival analysis. RESULTS: A total of 100 legs were treated in 92 patients; 86 were CEAP 5 and 14 were CEAP 6. At two weeks complete or short segment occlusion was demonstrated in 99/100 legs. Complete follow-up was 93% at one year and 88% at two years. Complete and segmental recanalisation with new reflux was recorded in 11/93 (12%) legs and 25/93 (27%) legs, respectively (overall 36/93; 39%) at one year; and 6/88 (7%) legs and 15/88 (17%) legs, respectively (overall 21/88; 24%) at two years. Kaplan-Meier survival analysis shows 64% ulcers healed at 24 weeks and 86% at one year. Ulcer recurrence rate at one and two years was 2.3% and 5.1%. CONCLUSIONS: Over one-third of superficial veins treated with foam sclerotherapy recanalised at one year and just under a quarter of superficial veins recanalised at two years. Despite this, ulcer recurrence rates were low, and recanalisation failed to predict recurrence.

The incidence and characterization of deep vein thrombosis following ultrasound-guided foam sclerotherapy in 1000 legs with superficial venous reflux.

OBJECTIVE: The incidence of deep vein thrombosis (DVT) following ultrasound-guided foam sclerotherapy (UGFS) ranges from 0% to 5.7%. The aim of this study was to assess the incidence of DVT following UGFS in a single vascular center. METHODS: Patients undergoing UGFS between December 2005 and September 2011 underwent quality control duplex imaging within 2 weeks of treatment. This was performed by an independent senior vascular technologist, and data were entered on a prospectively maintained database. Deep venous segments assessed included common femoral vein, femoral vein, above- and below-knee popliteal veins, gastrocnemius, and tibial veins. DVT when present was labeled as endovenous foam-induced thrombosis (EFIT) type 1 when thrombus was lining <25% of the lumen of the deep vein; type 2 when thrombus extension was 25% to 50%; type 3 when thrombus extension was 50% to 99%; and type 4 when the deep vein was occluded. RESULTS: A total of 1166 UGFS treatments were performed in 1000 legs (776 patients). Complete occlusion of the treated veins was seen in 84.5% of the legs after one session of treatment. Overall, 17 DVTs were detected (1.5%) with no DVTs detected in legs undergoing multiple treatments. Of the 17 episodes of DVT, 16 legs had DVT following treatment for truncal reflux (658 legs; 2.43%). Seven DVTs were EFIT type 1, two were type 2, two were type 3, and five were type 4. One DVT was seen in the gastrocnemius vein alone. Two of 1166 treatments (0.2%) resulted in a symptomatic DVT, both of which were EFIT type 4. On regression analysis, there was an increase in the risk of DVT when ≥10 mL of foam was injected (odds ratio, 4.63; 95% confidence interval, 1.44-14.9; P = .01). CONCLUSIONS: The incidence of duplex-detected DVT following foam sclerotherapy is low and may be associated with the injection of ≥10 mL of foam.

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.

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 [controlled-trials.com].

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.