Medtronic’s VenaSeal Closure Compared to Surgical Stripping in 6-Month Data

November 3, 2024—Secondary outcomes through 6 months were reported from the VenaSeal Spectrum Surgical Stripping study, a randomized controlled trial comparing cyanoacrylate closure (CAC) using VenaSeal (Medtronic) to surgical stripping (SS), which is the standard care for venous disease in several countries.

The findings were presented by Manj Gohel, MD, in the late-breaking clinical trials session at The VEINS, the Venous Endovascular Interventional Strategies annual venous education symposium held by The VIVA Foundation on November 2-3 in Las Vegas, Nevada.

According to The VEINS press release, the study was conducted at six sites in three countries and included patients with CEAP (clinical, etiology, anatomy, pathophysiology) C2 to C5 venous disease. Multiple clinical, patient-reported anatomic and safety outcomes were assessed through 6 months. Previously presented early outcomes demonstrated higher patient satisfaction at 30 days in participants randomized to CAC compared to SS.

The investigators found that improvements in revised Venous Clinical Severity Score (rVCSS) and Aberdeen Varicose Vein Questionnaire (AVVQ) trended in favor of CAC (P = .0086 and P = .0039, respectively) at 30 days and were similar at 6 months. Additionally, postprocedure pain scores were similar in the CAC and SS groups, although general anesthesia was commonly used for SS.

From baseline to 6 months, changes in EuroQoL five dimensions and 36-Item Short Form Health Survey were similar between groups.

As further summarized in The VEINS press release:

• No physicians using CAC expressed neutrality or dissatisfaction, whereas 20.9% of SS physicians were neutral and 7% were dissatisfied with the procedure.
• Hypersensitivity to CAC occurred in 11.3% of participants, and most were self-limiting.
• There were no cases of granuloma or endovenous glue-induced thrombosis.
• Serious adverse event rates were low, with one event (1.9%) after CAC and two events (3.8%) after SS.
• More patients receiving CAC returned to work through 6 months compared to SS (85.7% [30/35] vs 73.7% [28/38]).
• Technical success in both groups was 100%.

Patients treated with CAC showed trends toward greater improvements in rVCSS and AVVQ at 30 days compared to SS. Additionally, the safety profile was good in both groups, noted the press release from The VEINS.