Patient-reported outcomes 5-8 years after ultrasound-guided foam sclerotherapy for varicose veins.

BACKGROUND: 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. METHODS: Consecutive patients undergoing UGFS between April 2004 and May 2007 were invited for review at least 5 years after treatment. Patients completed generic (Short Form 12) and disease-specific (Aberdeen Varicose Vein Symptom Severity Score, AVSS) HRQL instruments, and questionnaires enquiring about lower limb symptoms, lifestyle factors and satisfaction with treatment. Data on retreatments were recorded prospectively. RESULTS: A total of 391 limbs in 285 patients were included (81·2 per cent response rate) at a median of 71 (i.q.r. 67-78) months following first UGFS treatment. Originally 72·1 per cent had symptomatic, uncomplicated varicose veins, 21·9 per cent had undergone surgery previously, 87·2 per cent had treatment of great saphenous veins and 19·9 per cent treatment of short saphenous veins. Disease-specific HRQL scores improved significantly at long-term follow-up, with 88·5 per cent having an improved AVSS compared with baseline. Regarding lower limb symptoms and lifestyle improvement, 62·7-93·8 per cent of patients had their pretreatment expectations met or exceeded. Overall, 82·0 per cent were very satisfied with their treatment and only 3·3 per cent were dissatisfied; 91·0 per cent would recommend the treatment to others. Some 15·3 per cent of limbs required retreatment by 5 years (Kaplan-Meier analysis). CONCLUSION: UGFS has durable results as reported by PROMs to at least 5 years. Only 15·3 per cent of limbs required retreatment for recurrence during follow-up.

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.

Duplex ultrasound outcomes following ultrasound-guided foam sclerotherapy of symptomatic recurrent great saphenous varicose veins.

OBJECTIVES: To describe duplex ultrasound (DUS) outcomes 12 months following ultrasound-guided foam sclerotherapy (UGFS) of recurrent 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 recurrent GSVV. RESULTS: 91 treated legs (CEAP C(2/3) 58, C(4) 21, C(5) 8, C(6) 4) belonging to 73 patients (24 male) of median age 58 (range 32-86) years were enrolled between November 2004 and May 2007. The median volume of foam used was 8 (range 4-14) ml. Above-knee (AK) and below-knee (BK) GSV reflux was present in 88 (97%) and 80 (88%) legs respectively prior to treatment. AK and BK-GSV reflux was completely eradicated by a single session of UGFS in 86 (98%) and 74 (93%) legs respectively; and by two sessions of UGFS in 88 (100%) and 77 (97%) legs respectively. In those legs where GSV reflux had been eradicated, recanalisation occurred in 7/78 (9%) AK and 8/68 (12%) BK-GSV segments after 12 months follow-up. Retreatment, where undertaken, with a single UGFS session effectively eradicated all GSV reflux in all cases of recanalisation. DISCUSSION: A single session of UGFS can eradicate reflux in the AK and BK-GSV in over 93% of patients with symptomatic recurrent GSVV. Re-recurrence at 12 months is superior to that reported after redo GSV surgery, similar to that observed following other minimally-invasive techniques and, when it occurs, is effectively and simply treated by a single further session of UGFS.

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.

Photoplethysmographic venous refilling times following ultrasound guided foam sclerotherapy for symptomatic superficial venous reflux: relationship with clinical outcomes.

INTRODUCTION: Digital photoplethysmography (PPG) provides an inexpensive, reproducible, quantitative, non-invasive assessment of lower limb venous function. AIM: To examine the relationship between venous refilling time (VRT) and severity of venous disease, and also between changes in VRT and symptomatic improvement after ultrasound guided foam sclerotherapy (UGFS) for symptomatic superficial venous reflux (SVR). METHODS: Prior to and 6 months after UGFS, 246 patients (317 limbs) completed a symptom questionnaire, underwent duplex ultrasonography and clinical assessment, and VRT measurement by digital PPG. Health related quality of life (HRQL) questionnaires were also completed. RESULTS: Median VRT improved from 11 to 31 s (P < 0.0005, Wilcoxon Signed Ranks). Abnormal VRT (<20 s) correlated well with the presence of SVR on duplex (sensitivity 75%, specificity 94%). Pre-treatment there was a significant relationship between reducing VRT and increasing CEAP clinical grade (P < 0.0005, chi(2)), extent of SVR on duplex (P < 0.0005) and a non-significant relationship with overall increasing symptom severity (P = 0.097). Relief of all symptoms was more likely when there was normalisation of VRT after treatment (80% vs. 65%, P < 0.0005, chi(2)). Pre-treatment VRT correlated with both generic physical (r = 0.428, P = 0.002) and disease-specific (r = -0.413, P = 0.003, Spearman's rank) HRQL. CONCLUSIONS: UGFS for SVR improves VRT measured by digital PPG and that improvement correlates with symptom relief.

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

BACKGROUND: 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. METHODS: Eighty-six patients (92 legs) undergoing UGFS for SSV were assessed before, and 1, 6 and 12 months after treatment. Outcome measures were occlusion of, and abolition of reflux in, the SSV (technical success), absence of visible varicose veins (clinical success) and improvement in disease-specific health-related quality of life (HRQL) following treatment (Aberdeen Varicose Vein Symptom Severity Score (AVSS)). RESULTS: The technical and clinical success rates at 12 months were 91 and 93 per cent respectively; only three patients required a second treatment. After treatment of isolated SSV varicosities there was a significant improvement in AVSS, from a median of 19.0 (interquartile range 13.4-26.8) before treatment to 10.2 (4.0-18.3) and 9.7 (3.5-19.1) at 6 and 12 months respectively. The only complication was a popliteal vein thrombosis that required anticoagulation. CONCLUSION: UGFS was an effective treatment for SSV, with abolition of reflux and visible varicose veins, and improvement in HRQL for at least 12 months.

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

BACKGROUND: 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. METHODS: Patients who had UGFS or surgery for varicose veins were sent a questionnaire 4 weeks after treatment. RESULTS: A total of 332 (84.9 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 7.2 per cent; P < 0.001) and pain (17 versus 5.5 per cent; P = 0.001). After UGFS, 43.2 per cent of patients returned to work within 24 h compared with none who had surgery (P < 0.001). Patients who had UGFS were more likely to return to driving within 4 days (P = 0.014). CONCLUSION: UGFS was associated with less pain and analgesia requirement, time off work and quicker return to driving.

Patients' expectations before and satisfaction after ultrasound guided foam sclerotherapy for varicose veins.

OBJECTIVES: Ultrasound guided foam sclerotherapy (UGFS) is a minimally invasive treatment for varicose veins (VV) whose clinical and cost-effectiveness remains incompletely defined. The aim of the current study was to examine patients' expectations before and satisfaction after UGFS for VV in terms of relief of lower limb symptoms, improvement in appearance, and beneficial effect on life-style. METHODS: A consecutive series of 351 patients (464 limbs) undergoing UGFS for VV completed questionnaires one week prior to and six months after treatment. RESULTS: Pre and post-treatment response rates were 80%; 60% returned both questionnaires. Virtually all patients were expecting improvement in lower limb symptoms; these were exceeded in a third. Most patients expected cosmetic improvement and these were largely met. Two-thirds of patients expected significant life-style (clothes, work, social) benefits and outcomes were slightly less than expected. A quarter expected improvement in their interpersonal relationships. This benefit was greater than expected occurring in one-third of patients. Overall, a quarter of patients had their expectations exceeded and 10% (appearance and relationships) to 25% (clothing, work and social and leisure activities) were left with unmet expectations. DISCUSSION: When specifically asked most patients admit to having a wide range of expectations in relation to their VV treatment, many of them probably unanticipated by the clinician. However, present data indicate that UGFS is usually able to meet, and often exceeds, these physical and psychosocial needs and expectations. UGFS is, therefore, a highly effective treatment for VV from the patients' perspective.

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.

Measurement of arterial stiffness in subjects with vascular disease: Are vessel wall changes more sensitive than increase in intima-media thickness?

BACKGROUND AND AIMS: It is widely accepted that subjects with vascular disease have increased arterial stiffness and intima-media thickness (IMT) when compared with healthy controls. The aim of this study was to investigate indices of arterial stiffness and IMT in the common carotid arteries (CCAs) of subjects with and without peripheral arterial disease (PAD), in order to look for evidence of change in wall quality and quantity to explain increased stiffness that has been found in the arteries of subjects with vascular disease. METHODS AND RESULTS: The arterial distension waveform (ADW), IMT, diameter and brachial blood pressure were measured to calculate Young's Modulus (E) and elastic modulus (Ep) in the common carotid arteries of subjects with and without PAD. 38 subjects with confirmed PAD were compared with 43 normal controls matched for age, sex, smoking and hypertension. The mean diameter (8.35mm [95% CI 7.93-8.77] vs. 6.93mm [6.65-7.20] P<0.001, increase 20%), IMT (0.99mm [0.92-1.07] vs. 0.88mm [0.82-0.93] P=0.020, increase 12.5%), Ep (315kPa [185-444] vs. 190kPa [164-216] P=0.034, increase 66%) and E (1383kPa [836-1930] vs. 744kPa [641-846] P=0.006, increase 86%) were all significantly higher in subjects with PAD. CONCLUSIONS: This study suggests that increased stiffness observed in subjects with peripheral vascular disease is a result of change in both quantity and quality of the arterial wall. Changes in indices of arterial stiffness were much higher than changes in IMT and diameter. These preliminary observations may be an indication that indices of arterial stiffness are a sensitive early marker of atherosclerosis.