Closure procedure, radiofrequency ablation confer similar results in venous reflux disease

Patients with symptomatic refluxing great saphenous veins treated by a closure procedure or radiofrequency ablation experienced improved quality of life and clinical benefits, according to results presented at the Charing Cross Symposium.

“[The results give the] clinician confidence that [the closure procedure] is yet another tool that they can use for treating their patients with superficial venous disease,” Kathleen Gibson, MD, FACS, vascular surgeon at Lake Washington Vascular Surgeons in Bellevue, Washington, told Cardiology Today’s Intervention. “This offers them a procedure which does not require tumescent anesthesia and where the patients don’t have to wear compression stockings during recovery, and there’s no risk of thermal injury.”

The VeClose trial was a U.S. multicenter, randomized controlled study that compared the effectiveness and safety of VenaSeal (Medtronic), a closure procedure, with ClosureFast (Medtronic), which involved radiofrequency ablation. Researchers analyzed data from 222 patients who were assigned VenaSeal (n = 108; mean age, 49 years; mean BMI, 27 kg/m²) or ClosureFast (n = 114; mean age, 51 years; mean BMI, 27 kg/m²).

Kathleen Gibson

The primary endpoint was complete closure of the treated vein at 3 months. Secondary endpoints were intraoperative pain evaluation and ecchymosis along the treated area at day 3 after the procedure. Other endpoints were included, such as changes in quality-of-life scores and venous disease severity, adverse events related to the target great saphenous vein and disease-specific adverse events.

Three days after the procedure, patients treated with the Venaseal procedure had less ecchymosis vs. those assigned radiofrequency ablation (P < .01).

At 36 months, 94.4% (n = 72) of patients assigned the Venaseal procedure experienced complete closure vs. 91.9% (n = 74) of patients who underwent radiofrequency ablation (P = .005), Gibson said during a presentation.
Patients assigned both techniques experienced similar improvement in Venous Clinical Severity Score (P = .5643), Aberdeen Varicose Vein Questionnaire (P = .6778) and EQ-5D (P = .8024) up to 6 months after the procedure, which were sustained up to 36 months.

At 36 months, patients from both groups did not experience deep vein thrombosis, allergic events or unanticipated adverse events. Mild adverse events occurred in patients in the first 30 days after the procedure.

“The 3-year outcomes for this randomized trial reinforce the consistent clinical performance of VenaSeal and ClosureFast,” Gibson said in a press release. “These long-term VenaSeal data … continue to build on the prior findings for this innovative treatment option for venous reflux disease, demonstrating safety, effectiveness and quality of life.” – by Darlene Dobkowski

Reference:

Gibson K, et al. Varicose vein management. Presented at: Charing Cross Symposium; April 25-28, 2017; London.

Disclosure: The study was funded by Medtronic. Gibson reports serving on an advisory board for Medtronic.