Synchronous Prophylactic Ablation of the AASV in Patients Undergoing Thermal GSV Ablation Is Safe – 6-month Follow-up Safety Data for the SYNCHRONOUS Trial

Tuesday, September 19, 2023

3:30 PM – 3:40 PM US EDT

Location: Grand Ballroom A

Introduction, Objectives, and/or Purpose: Studies on endovenous treatment, stripping and high ligation of the insufficient GSV show that the AASV is often the cause of recurrences. To date, there are no prospective studies that evaluate whether the simultaneous ablation of a competent AASV in patients undergoing endovenous laser ablation (EVLA) of the GSV reduces recurrence rates.

Methods: The authors conducted a prospective, multicenter, controlled, exploratory clinical study of patients with a medical indication for the ablation of a refluxing GSV (CEAP C2s – C6). A total of 1,173 patients with GSV reflux, but competent AASV, were enrolled in the study between February 2019 and April 2022. In 604 patients, only the incompetent GSV was ablated (Group A). Additional AASV ablation was performed in 569 patients (Group B). The primary aim was to achieve a flush ablation of the truncal veins (Figure 1). All subjects were treated using 600μ radial laser fibers (wavelength: 1,470nm). In Group B, only subjects with a puncturable course and an AASV diameter ≥2mm were included. The operations were performed on all subjects under local tumescent anesthesia in an out-patient setting.
Patients are being followed-up over a five-year period that includes seven study visits.
Primary study endpoint is the recurrence rate. Secondary endpoints include complication rate (hematoma, ecchymosis, nerve damage, deep venous thrombosis, EHIT), post-operative pain intensity, and quality of life (VCSS, AVVQ). The level of patient satisfaction was evaluated on a five-point scale (1 – very satisfied, 2 – quite satisfied, 3 – moderately satisfied, 4 – quite unsatisfied, 5 – very dissatisfied).
The study was prospectively registered at the German Clinical Trial Register (DRKS): DRKS00015486 (https:// www.germanctr.de/).

Results: The primary closure rate of all GSVs was 100%. At 6 months (n=953), a total of 10 GSVs (1.0%) showed partial recanalization with antegrade flow, and 13 (1.4%) with reflux. Safety data from the first follow-up visits (visit 3, week 1; visit 4, week 24) are available (Table 1) and show that the additional ablation of a competent AASV is not associated with an increased rate of nerve lesions, deep vein thrombosis, or EHIT compared to the GSV-only procedure. On average, 79.51% of the patients included in the study had no peri- and postoperative complications (A/B: 81.48% vs. 77.44%, p=0.1574). The most common adverse effects were bruising (A/B: 7.63% vs. 7.75%, p=1.00), and dysesthesia (A/B: 7.19% vs. 8.65%, p=0.4899). Numbness was reported in 0.22% (A) and 1.14% (B) (p=0.1992) of cases. Hyperpigmentation was documented within 24 weeks in 0.89% of cases (A/B: 0.44% vs. 1.37%, p=0.2589). One patient from Group A and two from Group B developed a deep vein thrombosis.
There are no significant differences in the safety data between Groups A and B.
The overall satisfaction after 6 months was 1.34 (Group A: 1.42, Group B: 1.28).

Conclusion(s): The six-month follow-up data demonstrate that the simultaneous endovenous thermal treatment of the GSV and AASV is safe with regard to nerve damage, EHIT, and deep vein thrombosis.

Presenting Author(s)

Tobias Hirsch, MD, PhD (he/him/his)

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

Disclosure(s): Biolitec: Speaker/Honoraria; Essity: Consultant/Advisory Board, Speaker/Honoraria; Jobst: Consultant/Advisory Board, Speaker/Honoraria; Kreussler: Speaker/Honoraria; Medtronic: Consultant/Advisory Board; Sigvaris: Consultant/Advisory Board, Research Grant, Speaker/Honoraria

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Co-Author(s)

KH

Karsten Hartmann, MD

Dr. med.
Venenzentrum Freiburg, Germany
Freiburg, Germany

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.
TM

Thomas Mattausch, M.D.

Physician, PI
Venenzentrum am Brühl, Leipzig, Germany, Germany

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.
CW

Christian Wenzel

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.
PZ

Philipp Zollmann, M.D.

Physician, PI
MVZ Dr. Zollmann und Kollegen, Jena, Germany, Germany

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.
JV

Jürgen Veltmann

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.
TW

Thomas K. Weiler

Venenzentrum Pforzheim
Pforzheim, Baden-Wurttemberg, Germany

Biolitec GmbH (Consultant/Advisory Board)
GL

Guido Lengfellner

BD (Products/Services: Venclose RF catheter) (Independent Contractor)
MS

Markus Stücker

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.
LM

Lars Müller

Biolitec (Products/Services: ELVeS laser fibers) (Speaker/Honoraria includes speakers bureau, symposia, and expert witness)
FP

Felizitas Pannier

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.
CD

Carmen Dietrich, M.D.

Physician, PI
Department of Dermatology, University of Heidelberg, Germany, Germany

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.
LU

Lorenz Uhlmann, M.A.

Statistician
Institute of Medical Biometry, University of Heidelberg, Germany, Germany

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.
CF

Christine Fink, MD, PhD

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

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.