ORIGINAL ARTICLE  VENOUS DISEASE Editor’s choice • Free access

International Angiology 2024 April;43(2):223-8

DOI: 10.23736/S0392-9590.24.05147-2

Copyright © 2024 EDIZIONI MINERVA MEDICA

language: English

Empty vein ablation (EVA) technique: an in-vivo animal model to assess the effects of sclerosing agent concentration and wall contact time on intima and media tunicae structure

Mario SALERNO ^{1, 2}, Daniele BISSACCO ³ ✉, Yung-Wei CHI ⁴, Sryram NARAYANAN ⁵, Alessandro ADDIS ⁶, Claudia DELLAVIA ⁷, Elena CANCIANI ⁸, Paolo C. RIGHINI ⁹, Giovanni NANO ^{9, 10}, Sergio GIANESINI ^{11, 12}

¹ Unit of Angiology, Department of Medicine and Cardiopulmonary Rehabilitation, Istituti Clinici Scientifici Maugeri IRCCS, Institute of Tradate, Varese, Italy; ² I-VASC S.r.l, Milan, Italy; ³ Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy; ⁴ Vascular Center, University of California, Sacramento, CA, USA; ⁵ The Harley Street Heart and Vascular Center, Singapore; ⁶ CRABCC, Biotechnology Research Center for Cardiothoracic Applications, Rivolta D’Adda, Cremona, Italy; ⁷ Department of Biomedical Surgical and Dental Sciences, University of Milan, Milan, Italy; ⁸ Department of Health Sciences "Amedeo Avogadro", University of Eastern Piedmont, Vercelli, Italy; ⁹ Operative Unit of Vascular Surgery, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy; ¹⁰ Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy; ¹¹ Department of Translational Medicine, University of Ferrara, Ferrara, Italy; ¹² Department of Surgery, Uniformed Services University of the Health Sciences, Bethesda, MD, USA

BACKGROUND: Sclerotherapy is a cornerstone of the treatment of chronic venous disease, despite some technical aspects (e.g., sclerosant liquid agent concentration [SLAC] and contact time between sclerosant agent and vein wall [ctSA/VW]) to maximize outcomes remain an unsolved problem and a source of debate. An innovative three-balloon catheter has been developed to allow sclerotherapy in empty vein conditions (Empty Vein Ablation technique, EVA), revolutionizing the definition of SLAC and ctSA/VW. Aim of this experimental study is to analyze EVA effects on intima and media vessel tunicae using different SLAC and ctSA/VW in an in-vivo animal model.
METHODS: Two adult sheep were treated by EVA using jugular and common iliac vein axes (eight vein segments). Different SLAC (polidocanol 0.5% or 1%) and different ctSA/VW (3 or 5 minutes) were combined for testing residual circumferential intima percentage and media thickness after EVA.
RESULTS: Intact circumferential residual intima after the treatment was 21.3±4.9%, 18.2±7.4%, 15.7±2.4% and 8.9±2.0% using 0.5% (3 min), 0.5% (5 min), 1% (3 min) and 1% (5 min), respectively (R²=0.945; control sample: 97.6%). Media thickness after the treatment was 121.6±35.3 µm, 110.9±7.8 µm, 96.1±30.4 µm and 79.1±34.1 µm using 0.5% (3 min), 0.5% (5 min), 1% (3 min) and 1% (5 min), respectively (R²=0.990; control sample 125.7 µm). No significant modifications were detected analyzing the adventitia in all samples.
CONCLUSIONS: EVA proved to be effective in venous wall destruction even with a very low SLAC and ctSA/VW (0.5% in 3 minutes), in quite large caliber veins. Direct comparisons with foam/liquid sclerotherapy should be done to confirm therapeutic effectiveness of these results, despite EVA has provided a maximized and controlled SA/VW contact time and ratio.

KEY WORDS: Empty vein ablation; Varicose veins; Sclerotherapy; Chronic venous disease