Papers reviewed in February 2016February 18, 2016
Davies H et al
A review of randomised controlled trials comparing ultrasound-guided foam sclerotherapy with endothermal ablation for the treatment of great saphenous varicose veins.
Phlebology. 2015 Jul 9. [Epub ahead of print]
Objective: The last 10 years have seen the introduction into everyday clinical practice of a wide range of novel nonsurgical treatments for varicose veins. In July 2013, the UK National Institute for Health and Care Excellence recommended the following treatment hierarchy for varicose veins: endothermal ablation, ultrasound-guided foam sclerotherapy, surgery and compression hosiery. The aim of this paper is to review the randomised controlled trials that have compared endothermal ablation and ultrasound-guided foam sclerotherapy to determine if the level 1 evidence base still supports an ‘‘endothermal ablation first’’ strategy for the treatment of varicose veins.
Methods: A PubMed and OVID literature search (until 31 January 2015) was performed and randomised controlled trials comparing endothermal ablation and ultrasound-guided foam sclerotherapy were obtained.
Results: Although anatomical success appeared higher with endothermal ablation than ultrasound-guided foam sclerotherapy, clinical success and patient-reported outcomes measures were similar. Morbidity and complication rates were very low and not significantly different between endothermal ablation and ultrasound-guided foam sclerotherapy. Ultrasound-guided foam sclerotherapy was consistently less expensive that endothermal ablation.
Conclusions: All endovenous modalities appear to be successful and have a role in modern day practice. Although further work is required to optimise ultrasound-guided foam sclerotherapy technique to maximise anatomical success and minimise retreatment, the present level 1 evidence base shows there is no significant difference in clinical important outcomes between ultrasound-guided foam sclerotherapy and endothermal ablation. As ultrasound-guided foam sclerotherapy is less expensive, it is likely to be a more cost-effective option in most patients in most healthcare settings. Strict adherence to the treatment hierarchy recommended by National Institute for Health and Care Excellence seems unjustified.
Davies H et al
The impact of 2013 UK NICE guidelines on the management of varicose veins at the Heart of England NHS Foundation Trust, Birmingham, UK.
Phlebology. 2015 Oct 8. [Epub ahead of print]
Objective: Although varicose veins are a common cause of morbidity, the UK National Health Service and private medical insurers have previously sought to ration their treatment in a non-evidence based manner in order to limit health-care expenditure and reimbursement. In July 2013, the UK National Institute for Health and Care Excellence published new national Clinical Guidelines (CG168) to promote evidence-based commissioning and management of varicose veins. The aim of this study was to evaluate the impact of CG168 on the referral and management of varicose veins at the Heart of England NHS Foundation Trust, Birmingham, UK.
Methods: Interrogation of a prospectively gathered database, provided by the Heart of England NHS Foundation Trust Performance Unit, of patients undergoing interventions for varicose veins since 1 January 2012. Patients treated before (group 1) and after (group 2) publication of CG168 were compared.
Results: There were 253 patients, 286 legs (48% male, mean (range) age 54 (20–91) years) treated in group 1, and 417 patients, 452 legs, (46% male, mean (range) age 54 (14–90) years) treated in group 2, an increase of 65%. CG168 was associated with a significant reduction in the use of surgery (131 patients (52%) group 1 vs. 127 patients (30%) group 2, p=0.0003, x2), no change in endothermal ablation (30 patients (12%) group 1 vs. 45 patients (11%) group 2), a significant increase in ultrasound-guided foam sclerotherapy (92 patients (36%) group 1 and 245 patients (59%) group 2, p=0.0001, x2) and an increase in treatment for C2/3 disease (53% group 1 and 65.2% group 2, p=0.0022, x2).
Conclusions: Publication of National Institute for Health and Care Excellence CG168 has been associated with a significant increase (65%) in the number of patients treated, referral at an earlier (CEAP C) stage and increased use of endovenous treatment. CG 168 has been highly effective in improving access to, and quality of care, for varicose veins at Heart of England NHS Foundation Trust.
Grover et al (Plymouth)
Chronic venous leg ulcers: Effects of foam sclerotherapy on healing and recurrence.
Phlebology. 2014 Oct 28. [Epub ahead of print]
Introduction: Ultrasound-guided foam sclerotherapy is a minimally invasive treatment option used for ablation of axial and perforator reflux for chronic venous ulceration. Active ulceration presents a significant health burden in both the primary and secondary care setting. The objective of this study is to determine ulcer healing rates at 24 weeks and 12 months, and ulcer recurrence rates at one year for chronic venous ulcers after ultrasound-guided foam sclerotherapy.
Methods: Between 2007 and 2012, 54 patients underwent ultrasound-guided foam sclerotherapy for clinical, aetiological, anatomical and pathological C6 ulcers. All patients were followed up clinically, and venous duplex was performed on all legs before and after treatment. A prospectively maintained database was analysed to determine venous truncal occlusion rates, 24-week and 12-month healing and recurrence rates (using Kaplan–Meier survival analysis).
Results: Fifty-seven ulcerated legs, 39 primary and 18 with recurrent superficial venous reflux were analysed. Median time of active ulceration at presentation was 15.2 months (range 5 months to 17 years). At a median follow-up of 2.7 months, 90% (51 legs) achieved full truncal occlusion after one session, 4% (2) short segment occlusion and 5% (3) failed to occlude and one patient died and was lost to follow-up; 13/57 (23%) required a second session of treatment for completion of treatment, recanalisations and to treat perforator disease, 88% (50/57) ulcers healed at a median of 5.3 months (interquartile range 2.9–8.4 months) following their first ultrasound-guided foam sclerotherapy treatment. The
24-week and 12-month estimated healing rates were 53% and 72%, respectively. The estimated 12-month recurrence rate was 9.2%. There were no reported incidences of deep venous thrombosis or neurological symptoms.
Conclusion: This study affirms the role of ultrasound-guided foam sclerotherapy as a safe and effective option for abolition of superficial reflux.
Garcarek et al
A new option for endovascular treatment of leg ulcers caused by venous insufficiency with fluoroscopically guided sclerotherapy
Wideochir Inne Tech Maloinwazyjne. 2015 Sep;10(3):423-9.
Introduction: Ulcers of lower legs are the most bothersome complication of chronic venous insufficiency (CVI).
Aim: To assess the effectiveness of endovascular fluoroscopically guided sclerotherapy for the treatment of venous ulcers.
Material and methods: Thirty-eight limbs in 35 patients with crural venous ulcers were treated with guided sclerotherapy under the control of fluoroscopy. Patients with non-healing ulcers in the course of chronic venous insufficiency, with and without features of past deep vein thrombosis, were qualified for the study. Doppler ultrasound and dynamic venography with mapping of venous flow were performed. Ambulatory venous pressure measurements, leg circumference and varicography were performed just before and following the procedure.
Results: In 84% of cases, ulcers were treated successfully and healed. Patients with post-thrombotic syndrome (n = 17) healed in 13 (76.5%) cases, whereas patients without post-thrombotic syndrome (n = 21) healed in 19 (90.5%) cases. The mean time of healing of an ulcer for all patients was 83 days (in the first group it was 121 days and in the second group 67 days). Recurrence of an ulcer was observed in 10 limbs: 6 cases in the first group and 4 cases in the second group. Occurrence of deep vein thrombosis associated with the procedure was not observed. Temporary complications were reported but none giving a serious clinical outcome.
Conclusions: Endovascular fluoroscopically guided sclerotherapy can be an alternative method of treatment of venous ulcers, especially in situations when surgical procedures or other options of treatment are impossible.