K.A.L. Darvall

Ultrasound-guided foam sclerotherapy is a safe and clinically effective treatment for superficial venous reflux

OBJECTIVE To test the hypothesis that ultrasound-guided foam sclerotherapy (UGFS) is a safe and durable treatment for superficial venous reflux (SVR) associated with CEAP clinical grade 2-6 disease. METHODS This was an interrogation of a prospectively gathered computerized database. RESULTS Between March 23, 2004 and December 31, 2009, 977 patients (1252 legs) underwent UGFS for unilateral (702 legs) or bilateral (550 legs) SVR in association with CEAP clinical grade 2-3 (n = 868), 4 (n = 232), or 5/6 (n = 152) disease. The following reflux in 1417 venous segments was treated: primary great saphenous vein (GSV) (n = 745); recurrent GSV (n = 286), primary small saphenous vein (SSV) (n = 189), recurrent SSV (n = 50); primary anterior accessory saphenous vein (AASV) (n = 93); recurrent AASV (n = 46); vein of the popliteal fossa (VOPF) (n = 5), and Giacomini vein (GV) (n = 3). Three hundred forty-eight legs (27.8%) had undergone previous surgery. Three patients suffered post-UGFS deep vein thrombosis (DVT) and one a pulmonary embolus (PE), all within the first month (0.4% venous thrombo-embolic complication rate). Five patients (0.5%) had transient visual disturbance at the time of, or shortly after, treatment. No other neurologic or serious complications were reported. During a mean (range) follow-up of 28 (<1 to 68) months, 161 (12.9%) legs underwent a further session of UGFS for truncal VV at a mean (range) of 17 (<1 to 63) months following the first treatment. In 52 legs, retreatment was due to the development of new SVR and in 109 legs was for true recurrence (8.7% complete or partial recanalization rate leading to treatment). There was no significant difference in retreatment rates between UGFS for GSV and SSV reflux or between UGFS for primary or recurrent disease. CONCLUSION UGFS for CEAP 2-6 SVR is associated with a low complication and retreatment rate. However, as patients are at risk of developing recurrent and new SVR they should be kept under review. Further UGFS for new or recurrent disease is simple, safe, and effective.

Healing and Recurrence Rates Following Ultrasound-guided Foam Sclerotherapy of Superficial Venous Reflux in Patients with Chronic Venous Ulceration

OBJECTIVES To determine healing and recurrence rates following ultrasound-guided foam sclerotherapy (UGFS) of superficial venous reflux (SVR) in patients with healed (clinical, etiologic, anatomic and pathophysiologic (CEAP) classification, C5) and open (C6) chronic venous ulceration (CVU). METHODS Between 1 March 2005 and 31 December 2009, 130 consecutive patients (132 limbs, 49 CEAP C5, 83 C6) of median age 70 (interquartile range (IQR) 56-76) years underwent UGFS as part of their treatment for CVU. RESULTS The median (IQR) follow-up time was 16 (12-32) months. One C6 patient moved abroad 1 week after UGFS and was lost to follow-up. Healing was observed in 67/82 (82%) remaining C6 patients at a median (IQR) of 1 (1-2) month following their first UGFS treatment. In 49 limbs originally treated for C5 disease, and in 67 limbs treated for C6 that healed following UGFS, there were five recurrent ulcers during the follow-up period, giving a 4.9% Kaplan-Meier estimate of recurrence at 2 years. In legs treated for C6 and C5 disease, the median (IQR) ulcer-free periods were 22 (IQR 9-32) and 14 (IQR 8-36) months, respectively. DISCUSSION Healing rates following UGFS for CVU are comparable to those reported after surgery but recurrence may be lower. UGFS is a safe, clinically effective and, thus, highly attractive minimally invasive alternative to surgery in patients with C5 and C6 disease.

Duplex Ultrasound Outcomes Following Ultrasound-Guided Foam Sclerotherapy of Symptomatic Primary Great Saphenous Varicose Veins

OBJECTIVES To describe duplex ultrasound (DUS) outcomes 12 months following ultrasound-guided foam sclerotherapy (UGFS) of primary great saphenous varicose veins (GSVV). METHODS A consecutive series of UK National Health Service patients underwent serial DUS examinations following UGFS with 3% sodium tetradecyl sulphate for symptomatic primary GSVV. RESULTS 344 treated legs (CEAP C(2/3) 237, C(4) 72, C(5) 14, C(6) 21) belonging to 278 patients (103 male) of median age 57 (range 21-89) years were enrolled between November 2004 and May 2007. The median volume of foam used was 10 (range 2-16) ml. Above-knee (AK) and below-knee (BK) GSV reflux was present in 333 (96.8%) and 308 (89.5%) legs respectively prior to treatment. AK and BK-GSV reflux was completely eradicated by a single session of UGFS in 323 (97.0%) and 294 (95.5%) legs respectively; and by two sessions of UGFS in 329 (98.8%) and 304 (98.7%) legs respectively. In those legs where GSV reflux had been eradicated, recanalisation occurred in 18/286 (6.3%) AK and 23/259 (8.9%) BK-GSV segments after 12 months follow-up. CONCLUSIONS A single session of UGFS can eradicate reflux in the AK and BK-GSV in over 95% of patients with symptomatic primary GSVV. Recanalisation at 12 months is superior to that reported after surgery and similar to that observed following other minimally invasive techniques.

Higher prevalence of thrombophilia in patients with varicose veins and venous ulcers than controls.

BACKGROUND Uncontrolled studies suggest that patients with chronic venous ulceration (CVU) have an increased prevalence of thrombophilia, similar to that observed in patients with deep vein thrombosis. This study compared the nature and prevalence of thrombophilia in patients with varicose veins (VV, CEAP clinical [C] grade C(2) to C(3)) and patients with CVU (C(5) to C(6)) with an age- and sex-matched population without clinical or duplex ultrasound evidence of venous disease. METHODS Twenty-seven patients with VV, 27 patients with CVU, and 54 age- and sex-matched case controls with no clinical or duplex evidence of lower limb venous disease, underwent testing for factor V Leiden and prothrombin 20210A mutations, antithrombin deficiencies, and levels of antiphospholipid antibodies, homocysteine, protein C and S, and factor VIII, IX, and XI. RESULTS The overall prevalences of single and multiple thrombophilias were significantly higher in cases than in controls. Specifically, in VV patients, the prevalences of no, single, and multiple thrombophilias were 33%, 52%, and 15%, respectively, compared with 63%, 26%, and 11% in VV controls. In CVU patients, the prevalences of no, single, and multiple thrombophilias was 26%, 30%, and 44%, respectively, compared with 66%, 22%, and 11% in CVU controls. Compared with controls, only factor XI levels were significantly higher in VV patients, and homocysteine and factor VIII, IX, and XI levels were all significantly higher in CVU patients. CONCLUSION Patients with VV, and particularly CVU, have significantly higher prevalences of single and multiple thrombophilias than age- and sex-matched controls without clinical or duplex evidence of lower limb venous disease. These data support the hypothesis that thrombophilia predisposes to the development of superficial and deep lower limb venous reflux, and so VV and CVU, through the increased occurrence of clinical and subclinical thrombosis.

Changes in health-related quality of life after ultrasound-guided foam sclerotherapy for great and small saphenous varicose veins

BACKGROUND Health-related quality of life (HRQOL) improves after superficial venous surgery for varicose veins, but the effect of ultrasound-guided foam sclerotherapy on HRQOL is unknown. The aim of this study was to determine changes in HRQOL after ultrasound-guided foam sclerotherapy for varicose veins. METHODS Consecutive patients undergoing ultrasound-guided foam sclerotherapy for varicose veins were sent the Short Form 12 (SF-12) questionnaire, a generic measure of HRQOL, and the Aberdeen Varicose Vein Symptom Score (AVSS) questionnaire, a disease-specific measure of HRQOL, 1 week before treatment and 1, 6, and 12 months after treatment. RESULTS The study enrolled 296 patients (34% male; 395 treated legs) with a median age of 57 years (range, 22-89 years). Of these, 24% had had previous superficial venous surgery, and 66% were CEAP C(2-3) (uncomplicated varicose veins). Questionnaire completion rates were 82%, 73%, and 69% at 1, 6, and 12 months after treatment. The median Physical Component Summary score of the SF-12 (higher score indicates better HRQOL) improved from 47.6 pretreatment to 49.4 at 1 month (P < .008, Wilcoxon signed rank test), to 51.9 at 6 months (P < .0005), and to 52.9 at 12 months (P < .0005). The median AVSS (lower score indicates better HRQOL) improved from 19.0 pretreatment to 16.5 at 1 month (P < .0005), to 8.7 at 6 months (P < .0005), and to 8.6 at 12 months (P < .0005). CONCLUSIONS Ultrasound-guided foam sclerotherapy for great and small saphenous varicose veins leads to significant improvements in generic and disease-specific HRQOL for at least 12 months after treatment.

Ultrasound-Guided Foam Sclerotherapy for the Treatment of Chronic Venous Ulceration: A Preliminary Study

OBJECTIVES When compared to compression therapy alone, surgical correction of superficial venous reflux (SVR) reduces recurrence but does not appear to increase healing of chronic venous ulceration (CVU). The role of ultrasound-guided foam sclerotherapy (UGFS) of SVR as part of the treatment of CVU remains uncertain. The aim of this study is to describe CVU healing and recurrence rates after UGFS and to relate these outcomes to patterns of pre- and post-intervention venous reflux. METHODS A prospective study of 27 consecutive patients (28 legs) of median age 69 (interquartile range 54-79) years undergoing UGFS for SVR in addition to compression for treatment of CVU of median duration 12 (IQR 6-23) months. Prior to and 1, 6, and 12 months after treatment patients underwent clinical and duplex assessment. RESULTS 8 limbs (29%) had deep and superficial venous reflux, and 20 limbs had SVR alone. There was a history of DVT in 4 limbs, and 4 patients were on warfarin. No limbs had significant arterial disease and all received post-UGFS compression. Median volume of (3% STD) foam used was 8 (range 2-14) ml. 1, 3 and 6 months after UGFS, 22 (79%), 27 (96%) and 27 (96%) CVU had healed. At 12 months, 25 ulcers remained healed, 2 ulcers had recurred; one patient had died from carcinomatosis. DISCUSSION Following UGFS as an adjunct to compression, 96% of CVU healed within 3 months and only 2 healed ulcers (7%) had recurred at 12 months. UGFS appears to be an attractive minimally-invasive alternative to surgery to treat SVR in patients with CVU, especially the elderly and frail.

Generic Health-related Quality of Life is Significantly Worse in Varicose Vein Patients with Lower Limb Symptoms Independent of Ceap Clinical Grade

OBJECTIVES To determine the relationship between lower limb symptoms and generic health-related quality of life (HRQL) in patients with varicose veins (VV). METHODS 284 patients on the waiting list for VV treatment completed the Short Form-12 (SF12) and a questionnaire asking about the presence of lower limb symptoms commonly attributed to venous disease (pain or ache, itching, tingling, cramp, restless legs, a feeling of swelling, and heaviness). RESULTS Median age was 57 years (interquartile range 45-67); 100 (35%) were male, and 182 (64%) had CEAP clinical grade 2 or 3 disease. Jonckheere-Terpstra test for trend revealed that both physical (P < .0005) and mental (P = .001) HRQL worsened as the reported number of symptoms increased. Patients reporting tingling (P = .016, Mann-Whitney U test), cramp (P = .001), restless legs (P < .0005), swelling (P < .0005), and heaviness (P < .0005) had a significantly worse physical HRQL than those who did not. Mental HRQL was also significantly worse in patients with tingling (P = .010), cramp (P = .008), restless legs (P = .040), swelling (P = .001), and heaviness (P = .035). These significant relationships remained, and pain was also correlated with worse physical HRQL (P = .011), when linear regression was performed to control for CEAP clinical grade, age and sex. CONCLUSIONS Physical and mental HRQL is significantly worse in VV patients with lower limb symptoms irrespective of the clinical stage of disease. This observation confirms that VV are not primarily a cosmetic problem and that NHS rationing of treatment to those with CEAP C4-6 disease excludes many patients who would benefit from intervention in terms of HRQL. Generic HRQL instruments also allow comparison with interventions for other chronic conditions.

Recovery after ultrasound-guided foam sclerotherapy compared with conventional surgery for varicose veins

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 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.

Medium-term results of ultrasound-guided foam sclerotherapy for small saphenous varicose veins

The results of surgery for small saphenous varicose vein (SSV) varicosities may be suboptimal in terms of recurrence and complications. The role of minimally invasive alternatives remains incompletely defined. The aim was to review the medium‐term outcomes of ultrasound‐guided foam sclerotherapy (UGFS) for SSV.

Patient‐reported outcomes 5–8 years after ultrasound‐guided foam sclerotherapy for varicose veins

The aim was to determine the long‐term (5–8 years) outcomes of ultrasound‐guided foam sclerotherapy (UGFS) for varicose veins using health‐related quality of life (HRQL), patient‐reported outcomes (PROMs), patient satisfaction and retreatment rates.