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A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities.

ABSTRACT: Objectives * Varithena 017 Investigator Group: Michael Vasquez, MD, Venous Institute of Buffalo, Amherst, NY; Antonios Gasparis, MD, Stony Brook University Medical Center, Stony Brook, NY; Kathleen Gibson, MD, Lake Washington Vascular, Bellevue, WA; James Theodore King, MD, Vein Clinics of America, Oakbrook Terrace, IL; Nick Morrison, MD, Morrison Vein Institute, Scottsdale, AZ; Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC; Eulogio J. Sanchez, MD, Batey Cardiovascular Center, Bradenton, FL. Varithena® is a trademark of Provensis Ltd, a BTG International group company. To determine the efficacy and safety of polidocanol endovenous microfoam (PEM 0.5%, 1.0%) and placebo each administered with endovenous thermal ablation. Methods A multicenter, randomized, placebo-controlled, blinded study was conducted in patients with great saphenous vein incompetence and symptomatic and visible superficial venous disease. Co-primary endpoints were physician-assessed and patient-assessed appearance change from Baseline to Week 8. Results A total of 117 patients received treatment (38 placebo, 39 PEM 0.5%, 40 PEM 1%). Physician-rated vein appearance at Week 8 was significantly better with PEM ( p?=?0.001 vs. placebo); patient-assessed appearance trended similarly. Polidocanol endovenous microfoam provided improvements in clinically meaningful change in patient-assessed and physician-assessed appearance ( p?

SUBMITTER: Vasquez M

PROVIDER: S-EPMC5405840 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities.

Vasquez Michael M Gasparis Antonios P AP

Phlebology 20160307 4

Objectives * Varithena 017 Investigator Group: Michael Vasquez, MD, Venous Institute of Buffalo, Amherst, NY; Antonios Gasparis, MD, Stony Brook University Medical Center, Stony Brook, NY; Kathleen Gibson, MD, Lake Washington Vascular, Bellevue, WA; James Theodore King, MD, Vein Clinics of America, Oakbrook Terrace, IL; Nick Morrison, MD, Morrison Vein Institute, Scottsdale, AZ; Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC; Eulogio J. Sanchez, MD, B ...[more]

PMID: 26957489

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Project description:BackgroundThe objective of this study is to examine factors associated with thrombus extension after early experience with mechanochemical ablation, which combines mechanical damage to the venous endothelium with infusion of a sclerosant.MethodsA retrospective review was performed of patients who underwent mechanochemical ablation to treat saphenous vein insufficiency in the thigh including the saphenofemoral junction. Data abstracted included patient demographics, procedural details, and postprocedural outcomes. Thrombus extension was determined by postprocedural duplex ultrasound and classified as flush closure with the femoral vein and any extension of thrombus into the femoral vein.ResultsSeventy-three patients met inclusion criteria. The mean age of the population was 60, 17.8% were female, and the mean body mass index (BMI) was 30.7. Seven (9.6%) patients who underwent mechanochemical ablation experienced saphenous vein closure flush with the femoral vein. Eleven (15%) patients experience extension of thrombus to less than 50% of the diameter of the femoral vein and one patient experienced complete thrombosis of the femoral vein. There was no significant difference in age, sex, or comprehensive classification system for chronic venous disorders between the group with thrombus extension and the group without, with the exception of BMI. The mean BMI in the group with thrombus extension was 26.8 vs. 32 in the group without (P = 0.02). There was no significant difference between the 2 groups in sclerosant volume used, distance between catheter tip and SFJ, and mean diameter of GSV in the thigh.ConclusionsIn this cohort, the incidence of thrombus extension into the femoral vein with mechanochemical ablation was high relative to rates of thrombus extension associated with reported rates of thermal ablation. Further investigation with larger cohorts, and standardized reporting is required to characterize the true rate of thrombus extension after mechanochemical ablation and identify maneuvers which may prevent thrombus extension.

Project description:INTRODUCTION:Endovenous ablations are the new standard procedures for treatment of great saphenous vein reflux including endovenous laser ablation (EVLA), radio frequency ablation (RFA), endovenous steam ablation (EVSA), mechanochemical ablation (MOCA), cyanoacrylate injection and ultrasound-guided foam sclerotherapy (UGFS). EVLA and RFA have demonstrated similar anatomical success for short-term outcome, but results are controversial for longer term (≥5 years). Additional evidences from randomised controlled trials have been published. This study is, therefore, conducted to, directly and indirectly, compare outcomes among all procedures stratifying by short-term and long-term follow-up. METHODS AND ANALYSIS:Medline and Scopus will be searched from 2000 to September 2018 with predefined search strategy. Interventions of interest are open surgery (ie, saphenofemoral or high ligation (HL) with stripping) and endovenous ablations (ie, EVLA, RFA, EVSA, MOCA, cyanoacrylate injection and UGFS). The primary outcome is anatomical success. Two independent reviewers will select studies, extract data and assess risk of bias. Disagreement will be adjudicated by the third party. Outcomes will be directly pooled if there are at least three studies in that comparison. A fixed-effect model will be used unless heterogeneity is present, in which case a random-effect model will be applied. Sources of heterogeneity will be explored using meta-regression analysis, and sub-group analysis will be done accordingly. Publication bias will be assessed using Egger's test and funnel plot. A network meta-analysis will be applied to indirect compare all interventions including RFA, EVLA, EVLA with HL, UGFS, UGFS with HL and HL with stripping. Probability of being best intervention will be estimated and ranked. Inconsistency assumption will be checked using a design-by-treatment interaction model. ETHICS AND DISSEMINATION:Ethical approval is not required for systematic review and network meta-analysis. The study will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER:CRD42018096794.

Project description:BackgroundRecurrent varicosities after endovascular laser ablation (EVLA) of the great saphenous vein (GSV) are frequently due to varicose transformed, initially unsealed major ascending tributaries of the saphenofemoral junction (SFJ). Preventive ablation of these veins, especially the anterior accessory saphenous vein, is discussed as an option, along with flush occlusion of the GSV. However, few related data exist to date.MethodsA consecutive case series of 278 EVLA procedures of the GSV for primary varicosis in 213 patients between May and December 2019 was retrospectively reviewed. The ablations were performed with a 1470 nm dual-ring radial laser and always included flush occlusion of the GSV, and concomitant ablation of its highest ascending tributaries by additional cannulation and ablation when this seemed anatomically appropriate. The initial technical success, comprising occlusion of the GSV and its major tributaries, was set as the primary endpoint. Possible determinants were explored using downstream multiple logistic regression analysis.ResultsThe early technical success was 92.8%, with the GSV occluded in 99.6% and the highest ascending SFJ tributary, if present, in 92.4%. Additional ablations of ascending tributaries were performed in 171 cases (61.5%), the latter being associated with success (OR 10.39; 95% CI [3.420-36.15]; p < 0.0001). Presence of anterior as opposed to posterior accessory saphenous vein was another positive predictor (OR 3.959; 95% CI [1.142-13,73]; p = 0.027), while a confluence of the tributary in the immediate proximity to the SFJ had a negative impact (OR 0.2253; 95% CI [0.05456-0.7681]; p = 0.0253). An endothermal heat-induced thrombosis (EHIT) ≥ grade 2 was observed in three cases (1.1%).ConclusionsA co-treatment of the tributaries is feasible and could improve the technical success of EVLA if a prophylactic closure of these veins is desired, especially if their distance to the SFJ is short. Its effect on the recurrence rate needs further research.

Project description:ImportanceEndovenous 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).ObjectiveTo 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.InterventionsPatients 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.ResultsOf 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 relevanceTo 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 registrationClinicalTrials.gov Identifier: NCT03392753.

Dataset Information

A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities.

Publications

A multicenter, randomized, placebo-controlled trial of endovenous thermal ablation with or without polidocanol endovenous microfoam treatment in patients with great saphenous vein incompetence and visible varicosities.

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