A Medico-economic Study of Thermal Ablation, Ultrasound Guided Foam Sclerotherapy and Conventional Surgery for Patients with Great Saphenous Varicose Veins in Real Life in France: Preliminary Results

Monday, September 18, 2023

2:50 PM – 3:00 PM US EDT

Location: Grand Ballroom A

Introduction, Objectives, and/or Purpose: To compare the ratio cost/benefit for patients treated for great saphenous vein (GSV) varicosities by thermal ablation (TA), ultrasound guided foam sclerotherapy (UGFS) and conventional surgery (high ligation plus stripping - HLS).

Methods: Patients with GSV incompetence were enrolled in an observational, multicenter, prospective and comparative study. Depending on the practice of the physician, participants were treated either by TA , UGFS, or HLS. Eauch center collected the patient’s demographic and clinical data (CEAP classification, pain VAS, VCSS), generic QoL EQ-5D-3L and specific QoL CIVIQ 14 scores, the characteristics of the treatment and the potential side effects and complications. All expenses and clinical events related to the chronic venous disease were reported by both the physician and the patient thanks to a specific smartphone application. Participants were assessed at eight days and were scheduled for a 5-year follow-up with yearly clinical and ultrasound evaluations. The primary endpoints were: - the total cost covered by the health governmental authorities, including the cost of the initial treatment and the expenses induced by the chronic venous disease during the follow-up; - clinical scores and QoL scores. Secondary outcomes included the absence of GSV reflux.

Results: 281 patients were enrolled in 22 centers: 121 in TA group (61 EVL and 60 RF), 138 in UGFS group and 22 in HLS group. Clinical class ranged from C2 to C6. VCSS was higher in HLS group.
The assessment of cost, including the cost of the initial treatment of the GSV plus the additional expenses during the first week showed a significant difference (p < 0.0001) in favor of UGFS group compared to TA and HLS groups.
Complications: one distal deep vein thrombosis occurred in UGFS group. One case of fiber laser rupture was reported in TA group. Pain, superficial vein thrombosis, inflammatory reaction, pigmentation or hematoma were reported in 21 patients (7.5%).

Conclusion(s): This study is the first medico-economic evaluation performed to assess the different techniques for patients with great saphenous varicose veins in real life in France. Previous studies have shown no difference regarding the clinical scores and QoL though there was a higher rate of recanalization after UGFS. The preliminary results of our study demonstrate a significant lower cost at height days for patients treated by UGFS. They need to be confirmed at 1, 3 and 5-year follow-up.
Results at 1-year follow-up, which are not available today, will be presented at the UIP meeting.

Presenting Author(s)

JG

Jean-Luc Gillet, Medical Doctor

Doctor
University Hospital Grenoble-Voiron
38300, France

Kreussler Pharma (Products/Services: Aetoxisclerol - Trombovar) (Consultant/Advisory Board)

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Co-Author(s)

ED

Emilie Ducloux-Guihard, Medical Doctor

Doctor
Vascular Medicine, France

Disclosure(s):
The forementioned Program Planner, Faculty, Author, Moderator, or Speaker, has declared for this educational activity, having no relevant financial relationship(s) with ineligible companies to disclose.
Pierre Combes, Medical Doctor (MD)

Doctor
French Society of Phlebology
BIARRITZ, Aquitaine, France

Disclosure(s):
The forementioned Program Planner, Faculty, Author, Moderator, or Speaker, has declared for this educational activity, having no relevant financial relationship(s) with ineligible companies to disclose.
FA

Fabrice Abbadie, French DESC of Vascular Medicine

Doctor
Vascular Medicine Unit, Vichy District Hospital, France, France

Bayer healthcare (Products/Services: Xarelto (Rivaroxaban) and Aspirine Protect) (Speaker/Honoraria includes speakers bureau, symposia, and expert witness)
Serge Mako, Manager

International Medical strategy
Kreussler Pharma
Paris, France

Kreussler Pharma (Products/Services: sclerosing agent) (Consultant/Advisory Board, Board Member / Officer / Trustee)
FA

François-André Allaert, Professor

Professor
Dijon University, United States

Disclosure(s):
The forementioned Program Planner, Faculty, Author, Moderator, or Speaker, has declared for this educational activity, having no relevant financial relationship(s) with ineligible companies to disclose.