Improving the management of varicose veins.
ABSTRACT Up to 30% of the UK population are affected by varicose veins. They are a manifestation of increased venous pressure in the lower limb caused by impaired venous return. Primary varicosities result from poor drainage from the superficial to the deep venous system. Secondary varicosities arise as a result of underlying pathology impeding venous drainage, such as deep venous thrombosis or increased intra-abdominal pressure caused by a mass, pregnancy or obesity. Patients with bleeding varicose veins should be referred to a vascular service immediately. Referral is also indicated in the following cases: symptomatic primary or recurrent varicose veins; lower limb skin changes thought to be caused by chronic venous insufficiency; superficial vein thrombosis and suspected venous incompetence; a venous leg ulcer or healed venous leg ulcer. Imaging is crucial in the assessment of the superficial and deep venous system to enable assessment of venous competence. The gold standard imaging technique is colour duplex ultrasonography. Duplex ultrasound should be used to confirm the diagnosis of varicose veins and the extent of truncal reflux, and to plan treatment for patients with suspected primary or recurrent varicose veins. Superficial vein ligation, phlebectomy and stripping have been the mainstay of treatment. In recent years, new techniques have been developed that are minimally invasive, enabling treatment of superficial venous incompetence with reduced morbidity. NICE recommends that endothermal ablation, in the form of radiofrequency or laser treatment, should be offered as treatment for patients with confirmed varicose veins and truncal reflux.
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ABSTRACT: Whereas thermal ablation of incompetent saphenous veins is highly effective, all heat-based ablation techniques require the use of perivenous subfascial tumescent anesthesia, involving multiple needle punctures along the course of the target vein. Preliminary evidence suggests that cyanoacrylate embolization (CAE) may be effective in the treatment of incompetent great saphenous veins (GSVs). We report herein early results of a randomized trial of CAE vs radiofrequency ablation (RFA) for the treatment of symptomatic incompetent GSVs. Two hundred twenty-two subjects with symptomatic GSV incompetence were randomly assigned to receive either CAE (n = 108) with the VenaSeal Sapheon Closure System (Sapheon, Inc, Morrisville, NC) or RFA (n = 114) with the ClosureFast system (Covidien, Mansfield, Mass). After discharge, subjects returned to the clinic on day 3 and again at months 1 and 3. The study's primary end point was closure of the target vein at month 3 as assessed by duplex ultrasound and adjudicated by an independent vascular ultrasound core laboratory. Statistical testing focused on showing noninferiority with a 10% delta conditionally followed by superiority testing. No adjunctive procedures were allowed until after the month 3 visit, and missing month 3 data were imputed by various methods. Secondary end points included patient-reported pain during vein treatment and extent of ecchymosis at day 3. Additional assessments included general and disease-specific quality of life surveys and adverse event rates. All subjects received the assigned intervention. By use of the predictive method for imputing missing data, 3-month closure rates were 99% for CAE and 96% for RFA. All primary end point analyses, which used various methods to account for the missing data rate (14%), showed evidence to support the study's noninferiority hypothesis (all P < .01); some of these analyses supported a trend toward superiority (P = .07 in the predictive model). Pain experienced during the procedure was mild and similar between treatment groups (2.2 and 2.4 for CAE and RFA, respectively, on a 10-point scale; P = .11). At day 3, less ecchymosis in the treated region was present after CAE compared with RFA (P < .01). Other adverse events occurred at a similar rate between groups and were generally mild and well tolerated. CAE was proven to be noninferior to RFA for the treatment of incompetent GSVs at month 3 after the procedure. Both treatment methods showed good safety profiles. CAE does not require tumescent anesthesia and is associated with less postprocedure ecchymosis. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.Journal of Vascular Surgery 01/2015; 61(4). DOI:10.1016/j.jvs.2014.11.071 · 2.98 Impact Factor