COmpressioN following endovenous TreatmenT of Incompetent varicose veins by sclerotherapy (CONFETTI).

OBJECTIVE: The evidence for post-foam sclerotherapy compression stockings for varicose veins is limited. Thus, we examined the effects of post-procedural compression stockings on varicose vein patients undergoing foam sclerotherapy. METHODS: The CONFETTI study was a prospective, single-center, randomized controlled trial. Patients with foam sclerotherapy-suitable varicose veins were randomly assigned to the compression group (CG) or the no compression stockings group (NCG) for 7 days. The primary outcome was post-procedural pain measured on a 100-mm visual analog scale for 10 days. Secondary outcomes included clinical severity, generic and disease-specific quality of life scores, return to normal activities and/or work, occlusion rates, degree of ecchymosis, CG compliance, and complications. Patients were reviewed at 2 weeks and 6 months. RESULTS: A total of 139 patients were consented to and randomly assigned. The intention-to-treat analysis included 15 patients who did not receive the allocated intervention. Both groups had similar baseline characteristics. Of the patients, 63.3% and 55.4% returned for follow-up at 2 weeks and 6 months, respectively. Most of the veins treated were tributaries. The CG experienced significantly lower pain scores than the NCG, with median scores of 7 mm and 19 mm, respectively (Mann-Whitney U-test; P = .001). At 2 weeks, no differences were observed in ecchymosis or the time to return to normal activities or work. Both groups showed improvements in clinical severity and quality of life, and occlusion rates were comparable. The NCG experienced one deep venous thrombosis and superficial thrombophlebitis, whereas the CG experienced two superficial thrombophlebitis. CONCLUSIONS: The CONFETTI study suggests that short-term post-procedural compression stockings are beneficial for reducing post-procedure pain.

Pain Outcomes Following Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Vein Incompetence: The MOCCA Randomized Clinical Trial.

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 Participants: The 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 Measures: The 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, 24 [11.5-44.7] mm vs CAE, 20 [9.0-42.0] mm; P = .23) or by number scale (MOCA, 4 [2-5] 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: ClinicalTrials.gov Identifier: NCT03392753.

Randomized Controlled Trial of Compression After Endovenous Thermal Ablation of Varicose Veins (COMETA Trial).

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. Post-intervention 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 (±16) 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.

A systematic review assessing the quality of clinical practice guidelines in chronic venous disease.

OBJECTIVE: Our aim was to assess the methodologic quality of clinical practice guidelines (CPGs), which inform the diagnosis and management of chronic venous disease (CVD), using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool. METHODS: A systematic review was performed through the Medline and Embase databases to identify CPGs relevant to CVD. The included articles were evidence-based CPGs available in English and reported in the past 20 years. Consensus documents, expert opinions, and studies providing guidance for diagnosis or treatment alone were excluded. Four independent reviewers assessed the CPGs using the AGREE II tool across six domains. Overall quality scaled scores were calculated for each guideline, and the interrater reliability was measured using an intraclass correlation coefficient. SPSS, version 25 (IBM Corp, Armonk, NY) was used for statistical analysis. RESULTS: Six CPGs reported from 2004 to 2018 were identified; all were of European and North American origin. The interrater reliability when scoring each CPG was high, with an intraclass correlation coefficient of >0.8 (P ≤ .002) for all six CPGs. One CPG had an average score of 95.83% across all domains, qualifying as a high quality CPG. The remaining five CPGs had scores ranging from 29% to 71%. The CPGs generally performed poorly in outlining stakeholder involvement and evaluating the applicability of the guideline to clinical practice. CONCLUSIONS: Scores from the AGREE II tool were reproducible when different users evaluated the CPGs. We identified one CPG for CVD of high methodologic quality. The AGREE II appraisal tool can be used to identify aspects of CPGs that can be developed to improve their methodologic quality.

Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial.

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.

Endovenous Management of Varicose Veins.

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 that can be daunting when making the transition from traditional surgery. All modalities offer excellent results in the right situation, and each has its own treatment profile. Thermal ablation techniques have matured and have a reassuring and reliable outcome, but the arrival of nonthermal 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.

Mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins: study protocol for a randomised controlled trial.

BACKGROUND: Thermal 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/DESIGN: This 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. DISCUSSION: The 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 REGISTRATION: ClinicalTrials.gov, ID: NCT03392753 . Registered on 17 November 2017.