Background: The 21st century has witnessed a rise in the use of endovenous thermal ablation. Being highly clinically and cost-effective and improving the quality of life of patients, they are now considered to be the ''gold-standard'' treatment for varicose veins. Postintervention management, especially in terms of postoperative compression; however, remains unclear. As a result, a randomized study was undertaken to investigate the effects of wearing compression stockings after varicose vein treatment. Method: Patients with saphenous vein reflux undergoing treatment with endothermal ablation (with or without concurrent phlebectomies) were randomized to receive either 7 days of compression stockings or no stockings. The primary outcome measure for this study was the pain score over the first 10 postoperative days. The pain scores, clinical score, time to return to normal activities, and ecchymosis were assessed. Patients were followed-up at 2 weeks and 6 months post-ablation. Results: In total, 206 patients were randomized, 49% of them to the compression group. The mean age was 49.7 (AE16) years and approximately 51% of the population was male. The median pain score in the compression group using a visual analog scale was significantly lower on days 2-5, compared to the no compression group. Those having concurrent phlebectomies and compression stockings also had significantly better pain scores on days 1-3, day 5, and day 7. Improvement in the median venous clinical severity score was noted at 6-month follow-up, but this was not significant. No difference in the generic-or disease-specific quality of life was observed and the time to return to activities was similar. There were no differences in the degree of ecchymosis between the 2 groups and both groups had similar occlusion rates. Conclusions: These results indicate that wearing compression stockings after endothermal ablation is advantageous in the first few days after treatment and is especially beneficial for those having concurrent phlebectomies.
Abstract:Varicose veins are a very common condition and have been the subject of a recent proliferation of treatment modalities. The advent of the endovenous treatment era has led to a confusing array of different techniques which can be daunting when making the transition from traditional surgery. All modalities offer excellent results in the right situation and each has their own treatment profile. Thermal ablation techniques have matured and have a reassuring and reliable outcome, but the arrival of non-thermal techniques has delivered further options for both patient and surgeon. This article provides an overview of the different treatment devices and modalities available to the modern superficial vein surgeon and details the currently available evidence and summation analysis to help surgeons to make an appropriate treatment choice for their patients. Keywords:Endovenous ablation, varicose veins, venous disease, radiofrequency, sclerotherapy, cyanoacrylate Page 1 of 24 http://mc.manuscriptcentral.com/ang Angiology 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 IntroductionVaricose veins are a common condition affecting up to one-third of the population, with detrimental effects on the quality of life (QoL). 1-2Until the past decade, the traditional technique of saphenofemoral or saphenopopliteal ligation with or without vein stripping has been the gold standard treatment of truncal saphenous incompetence. This usually necessitates either general or regional anaesthesia. 3 Although surgery provides good outcomes, it is associated with ecchymosis, hematoma, tenderness, 4 infection, nerve injury, delayed return to normal activity 3-5 and routinely necessitates narcotic analgesia. 3In response to the need for less invasive treatment, endovenous treatments, namely radio-frequency ablation (RFA) and endovenous laser ablation (EVLA) have been developed. These have led to a reduction in morbidity compared with open surgery, 4-6 by reducing postoperative pain, providing faster recovery time, improving QoL and lowering complication rates. 7-8More recently, new non-thermal, non-tumescent (NTNTs) treatments have been developed to overcome the shortcomings associated with thermal ablation. Both thermal and non-thermal treatments are discussed in this review. Thermal-Tumescent Ablative ManagementSince 1999, endovenous thermal ablation, in the form of RFA and EVLA have been developed. More recently, endovenous microwave ablation (EMA) and steam vein sclerosis (SVS) have also been introduced. Their mechanism of action involves using heat to cause thermal damage to the venous wall. Radio-frequency ablation (RFA)The practice of RFA utilizes radio-frequency waves to produce thermal energy (85-120°C) resulting in endothelial damage and sealing of the incompetent vein ( Figure 1). In 1999, the U.S. Food and Drug Administration (FDA) approved RFA for...
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Background Ambulatory phlebectomies and foam sclerotherapy are two of the most common treatments for varicose vein tributaries. Many studies have been published on these treatments, but few comparative studies have attempted to determine their relative effectiveness. Methods/design This is a prospective single-centre randomised clinical trial. Patients with primary truncal vein incompetence and varicose vein tributaries requiring treatment will be assigned randomly to either ambulatory phlebectomies or foam sclerotherapy. The primary outcome measure is the re-intervention rate for the varicose vein tributaries during the study period. The secondary outcomes include the degree of pain during the first two post-operative weeks and the time to return to usual activities or work. Improvements in clinical scores, quality of life scores, occlusion rates and cost-effectiveness for each intervention are other secondary outcomes. The re-intervention rate will be considered from the third month. Discussion This study compares ambulatory phlebectomies and foam sclerotherapy in the treatment of varicose vein tributaries. The re-intervention rates, safety, patient experience and the cost-effectiveness of each intervention will be assessed. This study aims to recruit 160 patients and is expected to be completed by the end of 2019. Trial registration ClinicalTrials.gov, NCT03416413 . Registered on 31 January 2018. Electronic supplementary material The online version of this article (10.1186/s13063-019-3398-0) contains supplementary material, which is available to authorized users.
BackgroundThermal ablation techniques have become the first-line treatment of truncal veins in the management of chronic venous disease (CVD). Despite excellent outcomes, these methods are often associated with pain; generally due to their use of heat and the necessity of fluid infiltration around the vein. More recently, novel non-thermal techniques, such as mechanochemical ablation (MOCA) and cyanoacrylate adhesive (CAE) have been developed to overcome these unwelcome effects. So far, the novel techniques have been found to have similar efficacy to thermal methods, yet no direct comparisons between the non-thermal treatment techniques have been conducted to date, giving rise to this study.Methods/designThis is a prospective, multicentre, randomised clinical trial, recruiting patients with truncal saphenous incompetence. Patients will be randomised to undergo either MOCA or CAE truncal ablation, followed by treatment of any varicosities. All patients will be required to wear compression stockings for 4 days post intervention. The primary outcome measure is the pain score immediately following completion of truncal ablation, measured by a 100-mm Visual Analogue Scale (VAS). The secondary outcomes are entire treatment pain scores, clinical scores, quality of life scores, occlusion rates, time to return to usual activities/work at 2 weeks, 3, 6 and 12 months. Re-intervention rate will be considered from the third month. Cost-effectiveness will be assessed for each intervention at 12 months. The study is powered to detect a mean 10-mm difference in maximum pain score. Allowing for loss to follow-up, the total target recruitment is 180 patients.DiscussionThe study will be the first study to compare MOCA against CAE and is designed to determine which method causes less pain. Completion of this study is expected to be the end of 2019.Trial registrationClinicalTrials.gov, ID: NCT03392753. Registered on 17 November 2017.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2807-0) contains supplementary material, which is available to authorized users.
The American Venous Forum and the National Institute for Health and Care Excellence recommend endothermal ablation (ETA) techniques as the first line treatment for superficial venous incompetence. However, these techniques require the use of tumescent anaesthesia prior to energy delivery, which may be a source of discomfort for the patient and can prolong procedure time. Recently, nonthermal, nontumescent (NTNTs) techniques such as mechanochemical ablation (MOCA) have been developed to address some of the negative aspects associated with ETA. This article reviews this technique from a patient selection and perspective point view.
IMPORTANCE Endovenous thermal ablations (ETAs) are recommended as first-line treatment for truncal vein reflux, have a short recovery time, and are cost-effective. However, ETAs are associated with discomfort during tumescent anesthesia infiltration. To minimize discomfort, nonthermal, nontumescent ablation techniques had emerged in the form of mechanochemical ablation (MOCA) and cyanoacrylate adhesive injection (CAE).OBJECTIVE To assess pain scores immediately after truncal ablation using a 100-mm visual analog scale and 10-point number scale to compare pain-related outcomes following mechanochemical ablation vs cyanoacrylate adhesive treatment. DESIGN, SETTING, AND PARTICIPANTSThe Multicenter Randomized II Clinical Trial Comparing Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Veins Incompetence study was a prospective multicenter randomized clinical trial conducted at 3 sites between November 2017 and January 2020. Inclusion criteria were primary great or small saphenous varicose veins; exclusion criteria included recurrent varicose veins, current deep venous thrombosis, or serious arterial disease. There were 392 participants screened, 225 were excluded, and 167 participants underwent randomization. Four participants did not receive allocated intervention and were included in the intention-to-treat analysis. Follow-up took place at 2 weeks, and 3, 6, and 12 months.INTERVENTIONS Patients with primary truncal vein incompetence were randomized to receive either MOCA or CAE. MAIN OUTCOMES AND MEASURESThe primary outcome measure was pain score immediately after completing truncal ablation using a 100-mm visual analog scale (VAS) and a 10-point number scale. Secondary outcome measures included degree of ecchymosis, occlusion rates, clinical severity, and generic and disease-specific quality of life (QoL) scores.RESULTS Of 167 study participants, 99 (59.3%) were women, and the mean (SD) age was 56 (15.8) years. Overall, 155 truncal veins treated (92.8%) were great saphenous veins. Demographic data and baseline status were comparable between treatment groups. A total of 73 patients (47%) underwent adjunctive treatment of varicosities. Overall median (IQR) maximum pain score after truncal treatment was 23 mm (10-44) on the VAS and 3 (2-5) on the number scale, showing no significant difference in median (IQR) pain measured by VAS (MOCA,] mm vs CAE, 20 [9.0-42.0] mm; P = .23) or by number scale (MOCA,(4)(5) vs CAE, 3 [2-4]; P = .18). Both groups demonstrated significant and comparable improvement in clinical severity, generic and disease-specific QoL scores, and complete occlusion rates. Four patients treated with CAE developed minor complications (superficial thrombophlebitis and thrombus extensions). CONCLUSIONS AND RELEVANCE To our knowledge, this was the first randomized clinical trial directly comparing nontumescent ablation techniques. The study demonstrated that the MOCA and CAE techniques have a similar periprocedural pain score. TRIAL REGISTRATION ClinicalTrial...
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