Retrospective Review of Saphenous Vein Incompetence: Venaseal Versus Endovenous Thermal Ablation

Study Overview
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Brief Summary
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This study is a retrospective, chart review of treatment of patients with symptomatic varicose veins. Treated limbs must have the Great Saphenous Vein and/or Small Saphenous Vein treated with either cyanoacrylate closure (VenaSeal) or Endothermal Ablation (either Radiofrequency Ablation or Endovenous Laser Ablation).

Detailed Description
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This single site, retrospective, comparison study aims to review up to 400 treated limbs with symptomatic varicose veins to compare the need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure in conjunction with either cyanoacrylate closure versus endothermal ablation of incompetent saphenous veins through 6 months of the index procedure. The overall cost of treatment for both groups will be compared. Some of the secondary aims of this study include: To assess changes in Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class after completion of treatment. To assess changes in revised Venous Clinical Severity Score (rVCSS) and compare the two groups. To assess the need for adjunctive therapies. To record and compare retrospectively the adverse events between the two groups.

Official Title
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Venaseal Versus Ablation With Endothermal Laser or Radiofrequency for Saphenous Vein Incompetence: a Comparison of Utilization of Adjunctive Phlebectomy

Conditions
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Varicose Veins, Venous Reflux, Venous Insufficiency

Intervention / Treatment
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* Other: Chart review


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Limb with saphenous vein incompetence, treated with one of the following: VenaSeal ™ Endovenous Laser Ablation Radiofrequency Ablation CEAP Clinical Class between 2-5 Limb treated from October 1st, 2015-present At least 2 months of follow-up post index procedure Treatment of either the great saphenous vein (GSV), the small saphenous vein (SSV), or both. Treatment of accessory saphenous veins (ASV) is allowed as long as either the GSV, SSV, or both the GSV and SSV were treated as well in that limb at the index procedure. Exclusion Criteria: Limb treatment of the accessory saphenous vein (ASV) without concomitant great saphenous vein (GSV) and/or small saphenous vein (SSV) treatment Limb treatment for reasons other than symptomatic varicose veins Limbs without follow-up information at least 2 months following the index procedure Subjects who participated in another clinical trial as part of their saphenous vein treatment Investigator decision (concurrent condition that would make inclusion inappropriate, protected subject population) -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endovenous Thermal Ablation<br>Limbs treated with either radiofrequency ablation or endovenous laser ablation | Other: Chart review<br>* Retrospective review of medical records at a single site with six physicians<br>|
| Cyanoacrylate Closure<br>Limbs treated with cyanoacrylate closure system | Other: Chart review<br>* Retrospective review of medical records at a single site with six physicians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjunctive phlebectomy | Compare need for/utilization of adjunctive phlebectomy performed as a concomitant or staged procedure | Through 6 months of index procedure | 
| Cost of Treatment | A cost analysis will be performed calculating the total cost of treatment between groups | Through six months of index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Disease | Assess potential change in clinical class using the Clinical, Etiology, Anatomy, and Pathology (CEAP) clinical class | At treatment through six months of index procedure | 
| Severity of Disease | Assess potential change in clinical severity score using the Revised Venous Clinical Severity Score (rVCSS). | At treatment through six months of index procedure | 
| Utilization of adjunctive treatments | Assess utilization of adjunctive sclerotherapy, either for cosmetic or medical need | Through six months of index procedure | 
| Adverse events reported during clinic visits | If adverse events were reported and documented in chart, these will be collected and categorized to assess for comparison between groups | Though six months of index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venaseal, Symptomatic Varicose Veins