High Intensity Focused Ultrasound for Great Saphenous Vein Incompetence: First Initial United States Experience and Results

Friday, October 14, 2022

3:01 PM – 3:11 PM US CDT

Location: Celestin D/E (Live Stream)

Presenting Author(s)

Steve Elias, MD, FACS, DFAVF DABVLM

Director, Center for Vein Disease
Englewood Health Network
Englewood, New Jersey

Disclosure: Avail Inc. (Self, Products/Services: No): Consultant/Advisory Board, Ownership Interest includes stock, stock options, patent or other intellectual property; BD Bard (Self, Products/Services: No): Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness; Boston Scientific (Self, Products/Services: NO): Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness; Cook Maedical (Self, Products/Services: No): Speaker/Honoraria includes speakers bureau, symposia, and expert witness; Crossfire Medical (Self, Products/Services: No): Consultant/Advisory Board; Evveno (Self, Products/Services: No): Ownership Interest includes stock, stock options, patent or other intellectual property; Medtronic Inc. (Self, Products/Services: No): Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness; Philips Inc. (Self, Products/Services: No): Consultant/Advisory Board; USA Therm (Self, Products/Services: No): Consultant/Advisory Board, Ownership Interest includes stock, stock options, patent or other intellectual property; VVT Medical (Self): Consultant/Advisory Board, Ownership Interest includes stock, stock options, patent or other intellectual property

Co-Author(s)

Antonios Gasparis, MD

Professor of Surgery
Stony Brook Medicine
Dix Hills, New York

Disclosure: TACTILE MEDICAL (Self) : Consultant/Advisory Board (Products and Services: Flexitouch, Entre)
Nicos Labropoulos, PhD

Professor of Surgery and Radiology
Stony Brook Medicine
Stony Brook University
Stony Brook, New York

Disclosure: Disclosure information not submitted.

Introduction, Objectives, and/or Purpose:

Introduction: Endovenous thermal ablation for saphenous vein reflux advanced the treatment of chronic venous disease. Subsequent innovations using non-thermal techniques eliminated the need for tumescent anesthesia and multiple needle sticks. High-intensity focused ultrasound (HIFU) is a non-invasive technology that has been used for many years to treat several non-venous disorders. This technology can be used to deliver a large amount of sound energy to a focal point which rapidly induces tissue heating to 85° - 90°C. This study involved the use of an ultrasound-guided HIFU device, Sonovein (Theraclion, Malakoff, France) to ablate incompetent greatsaphenous veins.

Methods: This is a single-center prospective study to evaluate the safety and efficacy of the Sonovein HIFU device in 20 consecutive patients with symptomatic C2 disease or higher and great saphenous vein (GSV) reflux. Patient demographics and baseline clinical characteristics (CEAP and VCSS) were collected. Ultrasound was used to evaluate for reflux, vein diameter and treatment length. Prior to treatment of the GSV, the treatment length and vein course were mapped and marked on the skin. No tumescent or local anesthesia or oral/intravenous analgesia was given to patients during or post-procedure. No compression stockings were used.
Patients had a follow-up visit at 7 days (1 to 10 days) and wall changes in veins and flow characteristics (occlusion/reflux) were evaluated by ultrasound. Physical exam, CEAP, VCSS and VAS were also recorded. Adverse events (AE) were assessed following HIFU treatment.

Results: Reported are early results on the first 10 patients enrolled in the study. There were ¬¬¬4 women and 6 men with an average age of 50. There were 6 C2, 1 C3, 2 C4, 0 C5, 1 C6. The average VCSS was 9.5. The average vein diameter pre-treatment was 6.5mm and post-treatment decreased to 3.8mm and the treatment length was ¬¬¬10cm. The immediate post-procedure VAS (0-100) score was 14.5. At initial follow up within the first week of treatment, VAS was 0 and 9 of 10 treated segments were occluded. The only patient with flow had a pre-treatment diameter of 10mm which did decrease to 2.7mm but reflux was still present. There was no reported adverse events. The results of the second round of the next 10 patients will be available at the time of presentation and these results will be included. Therefore, 1 week and 3 month results of all 20 patients will be presented.

Conclusion(s):

Conclusion: HIFU ablation of an incompetent GSV is a completely non-invasive technique that is safe and feasible with promising early results. Patients require no analgesia, no needle punctures (access to vein or tumescence) and no post-procedure compression. Patients return immediately to normal activity. Mid-term and long-term follow-up will determine the role of HIFU in patients with chronic venous disease.