Endovenous glue has long-term sticking power
London, UK, 16 April 2019 – A “superglue” treatment for varicose veins remains effective in 94.6% of patients five years after the procedure, according to new data presented at the Charing Cross Symposium 2019 on Tuesday 16 April.
Minimally invasive treatments such as radiofrequency ablation (RFA) and endovenous laser ablation (EVLA) are an increasingly popular alternative to surgical treatments for varicose veins and other chronic venous disorders. Yet both these endovenous treatments require the administration of tumescent anesthesia via multiple injections and are often associated with postprocedural pain and bruising.
The VenaSeal closure system (Medtronic) was developed to overcome some of these issues. It uses an advanced medical glue called cyanoacrylate to safely and effectively close segments of diseased veins. Cyanoacrylate closure (CAC) does not require anaesthesia, carries no risk of thermal injury, and most patients are not required to wear compression stockings in the days and weeks after treatment.
The original VeClose Study was a US pivotal clinical trial that was conducted under an investigational device exemption (IDE) as a prospective, randomised, controlled trial. The study enrolled 222 patients with incompetent great saphenous veins, which compared the safety and efficacy of the VenaSeal Closure System to the ClosureFast™ radiofrequency ablation (RFA) device (Medtronic) for the long-term closure of the great saphenous vein (GSV) to alleviate symptoms of venous reflux. Thirty-six month outcomes of the study were published in the Phlebology: The Journal of Venous Disease in 2018 and suggested that CAC had similar efficacy to RFA in terms of occlusion, durability and symptom relief (https://journals.sagepub.com/doi/10.1177/0268355518810259).
The purpose of the VeClose Five Year Follow-up Extension Study is to continue to assess the safety and efficacy of the VenaSeal Closure System for the long-term effect on closure of the great saphenous vein, by conducting a follow-up visit with patients five years after they enrolled in the original study.
Nick Morrison, from the Center for Vein Restoration in Mesa, Arizona, presented data on the first 89 randomised (n=47) and roll-in (n=9) subjects to have completed this follow-up so far. Complete closure rates were sustained long term, with 94.6% of patients treated with the VenaSeal system, and all of those treated with RFA meeting the primary endpoint of complete vein closure at 60-months. No new GSV failures were reported between the 36- and 60-month visits.
Patients also experienced sustained improvements in disease-specific, generic quality of life and functional outcomes, as assessed by the Venous Clinical Severity Score, Aberdeen Varicose Vein Questionnaire and EQ-5D instrument which measures generic health status.
All 47 randomised VenaSeal patients reported being “somewhat or very satisfied” with the treatment at the 60-month follow-up, while 93.6% (44/47) said they would “definitely choose it again”.
References
‘VeClose Extension Study five-year results’ will be presented during the Venous and Lymphatic Challenges, Truncal vein treatment session, which takes place on 16 April at 08:00–10:00 in the Lower Main Auditorium at Olympia Grand, London, UK.
About the Charing Cross (CX) Symposium
The Charing Cross (CX) Symposium is Europe’s largest and longest-running vascular symposium. CX first took place in 1978 at Charing Cross Hospital, Hammersmith, London, and had around 100 attendees. In 2018, the CX Symposium had over 4,000 participants, from 86 countries, making it a leading global vascular meeting. CX 2019 takes place once again at Olympia London from 15–18 April 2019. This year, CX Symposium has lined up a record number of 26 high-impact Podium 1st presentations.
