Addressing a “gap” in evidence concerning long-term follow-up and unique complications associated with VenaSeal (Medtronic) cyanoacrylate glue, Kathleen Gibson (Bellevue, USA) presented podium-first randomised data which demonstrated that the device is comparable to standard of care, defined as surgical vein stripping.
During Wednesday afternoon’s superficial venous, lymphatic and chronic wound consensus session at the 2026 Charing Cross (CX) Symposium (21–23 April, London, UK),, Gibson shared data on safety events, anatomic vein closure, patient satisfaction and quality-of-life symptoms in 106 patients. At one year follow-up, 43 patients were evaluable in the VenaSeal arm and 39 in the stripping arm.
The two cohorts were “well-matched and similar” Gibson noted. Enrolees were 58% and 67.3% female and had an average age of 60.3 and 61.5 years in the VenaSeal and surgical vein stripping arm, respectively. The great saphenous vein was the most commonly treated and the length of vein treated was similar between groups, at approximately 55cm on average.
Regarding clinical event committee (CEC)-adjudicated events through to 12 months, 11.3% of patients experienced hypersensitivity to VenaSeal—“a higher rate than what we observed in the randomised trial between VenaSeal and endothermal ablation”, stated Gibson.
There were no granulomas or thrombus extensions; however, the speaker reported two episodes of phlebitis in the VenaSeal group and one in the surgical vein stripping group.
“Compared to the literature, the hypersensitivity rate fell within what we would expect, as did the other side effects, and the rate of phlebitis was on the lower end of what we’ve seen,” said Gibson. She added that most of the adverse events occurred soon after intervention and that there were similar anatomic closure rates between the two arms at 12 months.
Gibson described the Venous Treatment Satisfaction Questionnaire (VenousTSQ)—a unique endpoint developed for this study to report ongoing patient satisfaction.
“We knew from earlier studies that the VenousTSQ, which looked at the satisfaction with the procedure itself, showed an advantage for VenaSeal over stripping. Here, in the longer-term data, we can see the patient is satisfied with their treatment and that numerically there was some advantage to the device, but this did not reach statistical significance,” Gibson noted.
Finalising her presentation, Gibson reiterated that VenaSeal is comparable to standard of care with no new device-specific adverse events discovered in this trial. She underscored the initially higher periprocedural satisfaction and equivalent long-term improvements in quality of life and other satisfaction measures.
During subsequent discussion, Gibson acknowledged that surgical vein stripping is largely no longer standard of care internationally. She described their rationale, explaining that the trial was initiated in 2017 when the procedure was still widely used, enrolling patients in Asia and Europe through 2019.
“We all know what happened in 2020, so we were only able to continue in recruiting in South Korea, as many European hospitals were closed for elective surgeries. There was a preponderance of patients in Korea who were being treated with surgical stripping, so we decided to continue our investigation,” Gibson finalised.
