At the 2016 Charing Cross Symposium (26–29 April, London, UK) and the International Vein Congress (28–30 April, Miami, USA) Medtronic unveiled clinical data for the VenaSeal closure system demonstrating consistent long-term durability and improved quality of life in patients with venous reflux disease.
The new data presented included two-year outcomes from the VeClose pivotal clinical study, with two additional subanalyses evaluating quality of life and physician ease-of-use; and three-year results from the European Sapheon Closure System Observational ProspectivE (eSCOPE) study.
VenaSeal is a non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive to close superficial veins of the lower extremities, such as the great saphenous vein (GSV), in patients with symptomatic venous reflux.
Two-year results from the VeClose trial were presented at Charing Cross by Raghu Kolluri, medical director of vascular medicine at Riverside Methodist Hospital in Columbus, USA, and by Kathleen Gibson, Lake Washington Vascular, Seattle, USA, at the International Vein Congress.
At two years, the complete closure of the GSV was achieved in 94.3% of patients treated with VenaSeal compared to 94% of patients treated with ClosureFast, showing continued, similar long-term non-inferiority outcomes (p=0.0075).
The VeClose US pivotal clinical study is a prospective, randomised, controlled, non-inferiority study that compares the safety and effectiveness of the VenaSeal closure system to the gold standard ClosureFast endovenous radiofrequency ablation procedure. Two hundred and forty-two patients with symptomatic refluxing great saphenous veins were enrolled in the trial. Patients were randomised to receive treatment with VenaSeal and treatment with ClosureFast.
In a separate session presented by Gibson at Charing Cross, a one-year subanalysis from the VeClose trial compared quality of life improvement factors following treatment with VenaSeal and ClosureFast. Patient improvement was rated on a Venous Clinical Severity Score (VCSS) and an Aberdeen Varicose Vein Questionnaire (AVVQ) that included factors such as age (45–65 years), body mass index (25–35), gender and the diameter size of the GSV. For subjects treated with VenaSeal, mean change in VCSS and AVVQ at 12 months compared to baseline was statistically significant at -4.02 (SD 2.48, p<0.0001) and -8.8 (SD 7.5, p<0.0001), respectively. Findings showed improvement in VCSS and quality of life across all ages, body mass index, gender and vein diameter size.
“This randomised trial demonstrates VenaSeal’s ability to provide a safe and effective treatment for patients with varicose veins,” said Kathleen Gibson. “With excellent outcomes at two years, VenaSeal offers patients an alternative treatment to traditional therapies for varicose veins, allowing a rapid recovery with minimal downtime and diminished post-procedure bruising.”
In another Charing Cross session, a roll-in phase analysis from the VeClose trial was also presented by Kolluri. The subset analysis evaluated the safety and effectiveness of 20 patients treated with the VenaSeal closure system by trained physicians with no prior VenaSeal device experience. The roll-in group included the first two patients treated with VenaSeal at 10 enrolling sites. Three-month outcomes were then compared to the randomised patients treated with VenaSeal and ClosureFast.
Three-month follow-up results show that 19 of the 20 patients returned for follow-up. The investigators achieved complete closure of the GSV in 100% of these follow-up patients, demonstrating comparable efficacy and safety outcomes to the randomised patients treated with VenaSeal (99%, n=103) and ClosureFast (95.4%, n=103).
“Despite having no prior physician experience with VenaSeal, these data demonstrated remarkable ease-of-use and a limited learning curve for first-time-users as compared to experienced users,” said Nick Morrison, Morrison Vein Institute, Scottsdale, USA, and national principal investigator of the VeClose trial.
Three-year results from the eSCOPE study were also presented at Charing Cross by Thomas Proebstle, University Medical Center Mainz, Germany. Of the 70 patients treated with VenaSeal, results showed 88.5% closure rate at three years, demonstrating durable and consistent outcomes over the long term.
eSCOPE is an international, multicentre, prospective, single-arm, observational, post-market study designed to record the clinical outcomes of the CE marked VenaSeal.