The 2023 annual meeting of the American Venous Forum (AVF) heard the final results from the first U.S. trial of the emerging varicose vein treatment, Sonovein echotherapy, with data showing a 100% technical feasibility at three months—which was the principal study objective.
Antonios Gasparis, MD, director of the Center for Vein Care at Stony Brook University in Stony Brook, New York, told the AVF gathering in San Antonio, Texas (Feb. 22–25), that the Food and Drug Administration (FDA)-approved trial saw 20 great saphenous veins (GSVs) in 18 patients receive treatment using the high-intensity focused ultrasound (HIFU) procedure.
Gasparis said no anesthesia was used during the cases and that no post-procedure compression was performed. The study results further revealed that ablation of venous reflux was achieved in 95% of the cases, or 19 of the 20; ablation to flow was recorded at 65%; no complications were reported; and venous clinical severity score (VCSS) improved from 6.9 pre-procedure to 1.1 at three months.
Gasparis said the next step in assessment of the procedure is for the HIFU technology to be evaluated in a multicenter trial after FDA approval. “It’s here to stay,” he added.
Meanwhile, separately, Ferdinand Steinbacher, MD, from the Karl Landsteiner Institute for Functional Phlebosurgery in Melk, Austria, delivered the latest data from Europe on the Sonovein S+ and Sonovein HD iterations of the technology.
From the end of November 2021 through mid-December 2022, 40 GSVs and anterior accessory saphenous veins were treated, he revealed. Overall efficacy was 88%, Steinbacher said, with the first period of treatment (Nov. 30, 2021, to March 9, 2022) yielding a 71% occlusion rate (12 of 17) when only the Sonovein S+ was used. During the second period (April 26, 2022, to Dec. 14, 2022), during which both the Sonovein S+ and HD version were utilized, a 100% occlusion rate was achieved among the 23 veins ablated—10 with the S+ and 13 with the HD.