Initial Results of the SYNCHRONOUS Study Show That Synchronous Prophylactic Ablation of the AASV in GSV Patients Does Not Increase the Risk for Paresthesia and EHIT

Friday, October 14, 2022

3:11 PM – 3:21 PM US CDT

Location: Celestin D/E (Live Stream)

Presenting Author(s)

Tobias Hirsch, MD, PhD

Angiologist
Vein Competency Centre Halle, Germany
Halle, Sachsen-Anhalt, Germany

Disclosure: Biolitec (Self, Products/Services: laser technology): Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support, Speaker/Honoraria includes speakers bureau, symposia, and expert witness; Medtronic (Self, Products/Services: RFA devices, Acrylate sealing devices): Consultant/Advisory Board, Speaker/Honoraria includes speakers bureau, symposia, and expert witness; Sigvaris group (Self, Products/Services: Coolflex, compression stockings): Other Research Support includes receipt of drugs, supplies, equipment or other in-kind support, Speaker/Honoraria includes speakers bureau, symposia, and expert witness

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Co-Author(s)

KH

Karsten Hartmann, MD

Dr. med.
Venenzentrum Freiburg, Germany
Freiburg, Germany

Disclosure: Disclosure information not submitted.
TM

Thomas Mattausch, MD

Dr. med.
Venenzentrum am Brühl, Leipzig, Germany
Leipzig, Sachsen, Germany

Disclosure: Disclosure information not submitted.
TW

Thomas K. Weiler

Venenzentrum Pforzheim
Pforzheim, Baden-Wurttemberg, Germany

Disclosure: Disclosure information not submitted.
CF

Christine Fink, MD, PhD

Dr. med.
Department of Dermatology, University of Heidelberg, Germany
Heidelberg, Germany

Disclosure: Disclosure information not submitted.
CW

Christian Wenzel

Disclosure: Disclosure information not submitted.
PZ

Phillip Zollmann

Disclosure: Disclosure information not submitted.
JV

Jürgen Veltmann

Disclosure: Disclosure information not submitted.
GL

Guido Lengfellner

Disclosure: Disclosure information not submitted.
LM

Lars Müller

Disclosure: Disclosure information not submitted.
MS

Markus Stücker

Disclosure: Disclosure information not submitted.
FP

Felizitas Pannier

Disclosure: Disclosure information not submitted.
CH

Christian Hagendorf

Disclosure: Disclosure information not submitted.
MT

Marko Turek

Disclosure: Disclosure information not submitted.

Introduction, Objectives, and/or Purpose: The anterior accessory saphenous vein (AASV) is a frequently observed cause of the development of recurrent varicose veins. Studies show that up to 30% of recurrences after great saphenous vein (GSV) treatment can be attributed to newly developed incompetence of the AASV. To date, there are no prospective studies evaluating the prevention of recurrent veins by the simultaneous treatment of a sufficient AASV in patients undergoing endovenous laser ablation (EVLA) of an insufficient GSV.

Methods: This is a multicenter, prospective, controlled, exploratory clinical study in 1150 patients with a medical indication for EVLA of a refluxing great saphenous vein. Within seven study visits, patients will be followed-up over a time period of five years. Primary study endpoint is the recurrence rate; secondary endpoints include inter alia, complication rate (paresthesia, deep venous thrombosis, EHIT), post-operative pain intensity, quality of life and patient satisfaction. The study was prospectively registered at the German Clinical Trial Register (DRKS): DRKS00015486 (https://www.germanctr.de/).

Results: A total of 1031 patients with GSV reflux but competent AASV were enrolled in the study from February 2019 to December 2021. In 509 patients only the incompetent GSV was closed. Additional AASV ablation was performed in 522 patients (FIGURE 1). Basically, a flush ablation of the truncal veins was aimed at. A radial laser system 1470nm, 600μ was used for all subjects. In the GSV + AASV ablation group, only subjects with a punctureable course and a diameter of the AASV ≥2mm were included. The primary closure rate of all GSV was 100%. Further follow-up data on the closure rate is currently pending. Safety data from the first visits (weeks 1 and 24) are already available (TABLE 1) and show that the additional ablation of competent AASV is not associated with an increased rate of nerve lesions, deep vein thrombosis, or EHIT.

Conclusion(s): To date, there are no controlled prospective studies evaluating the impact of a simultaneous EVLA of AASV for prevention of a secondary reflux in patients undergoing EVLA of an insufficient GSV. Therefore, it remains unclear whether patients benefit from this procedure. This exploratory study addresses this important open question for the first time in a prospective controlled setting under real-life clinical conditions based on a relatively large sample size. First follow-up data demonstrate that simultaneous endovenous thermal treatment of GSV and AASV is safe in terms of nerve damage, EHIT, and deep vein thrombosis.