Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2019 Jul;34(6):380-390.
doi: 10.1177/0268355518810259. Epub 2018 Nov 7.

Comparison of cyanoacrylate closure and radiofrequency ablation for the treatment of incompetent great saphenous veins: 36-Month outcomes of the VeClose randomized controlled trial

Nick Morrison  1 , Raghu Kolluri  2 , Michael Vasquez  3 , Monte Madsen  4 , Andrew Jones  5 , Kathleen Gibson  6
Affiliations
Randomized Controlled Trial

Comparison of cyanoacrylate closure and radiofrequency ablation for the treatment of incompetent great saphenous veins: 36-Month outcomes of the VeClose randomized controlled trial

Nick Morrison et al. Phlebology. 2019 Jul.

Abstract

Objective: To evaluate the 36-month efficacy and safety of cyanoacrylate closure for the treatment of incompetent great saphenous veins in comparison with radiofrequency ablation.

Methods: In this multicenter, prospective, randomized controlled trial, 222 symptomatic subjects with incompetent great saphenous veins were assigned to either cyanoacrylate closure or radiofrequency ablation. The primary endpoint, complete closure of the target great saphenous vein, was determined using duplex ultrasound examination starting from three-month visit.

Results: At month 36, the great saphenous vein closure rates were 94.4% for the cyanoacrylate closure group and 91.9% for the radiofrequency ablation group. Stable improvement in symptoms and quality of life was observed in both groups. Adverse event rates between the 24- and 36-month visits were similar between the groups as were serious adverse events which were infrequent and judged unrelated to either the device or the procedure in both groups.

Conclusions: This trial continues to demonstrate the safety and efficacy of cyanoacrylate closure for the treatment of great saphenous vein incompetence with great saphenous vein closure rate at 36 months similar to that of radiofrequency ablation, indicating non-inferiority of cyanoacrylate closure to radiofrequency ablation. The improvement in quality of life outcomes were also sustained and similar between the two treatment groups.

Keywords: Radiofrequency ablation; endovenous technique; great saphenous vein.

PubMed Disclaimer

Figures

Figure 1.
Figure 1.
Survival from recanalization of the target vein for the CAC and RFA treatment groups. Black line = CAC; blue line = RFA.
Figure 2.
Figure 2.
Change in VCSS in the treatment groups over 36 months. Data points represent the number of patients with available data.
Figure 3.
Figure 3.
Change in AVVQ and EQ-5D health thermometer in the treatment groups over 36 months. The change in AVVQ (a) and EQ-5D health thermometer as assessed by VAS (b) are shown by time for the CAC and RFA treatment groups. Black line = CAC; blue line = RFA. SE: standard error. Data points represent the number of patients with available data.
Figure 4.
Figure 4.
(a) Transverse view of great saphenous vein (GSV) at one-month post-treatment (black arrow points to occluded vein). (b) Transverse view of great saphenous vein (GSV) at one-year post-treatment (black arrow points to occluded vein). Images reproduced with permission of Morrison Vein Institute.
See this image and copyright information in PMC

References

    1. Rabe E, Guex J, Puskas A, et al. Epidemiology of chronic venous disorders in geographically diverse populations: results from the Vein Consult Program. Int Angiol 2012; 31: 105–115. - PubMed
    1. Vuylsteke ME, Thomis S, Guillaume G, et al. Epidemiological study on chronic venous disease in Belgium and Luxembourg: prevalence, risk factors, and symptomatology. Eur J Vasc Endovasc Surg 2015; 49: 432–439. - PubMed
    1. Valencia IC, Falabella A, Kirsner RS, et al. Chronic venous insufficiency and venous leg ulceration. J Am Acad Dermatol 2001; 44: 401–424. - PubMed
    1. Gibson K, Ferris B. Cyanoacrylate closure of incompetent great, small and accessory saphenous veins without the use of post-procedure compression: initial outcomes of a post-market evaluation of the VenaSeal System (the WAVES Study). Vascular 2017; 25: 149–156. - PubMed
    1. Morrison N, Gibson K, Vasquez M, et al. VeClose trial 12-month outcomes of cyanoacrylate closure versus radiofrequency ablation for incompetent great saphenous veins. J Vasc Surg Venous Lymphat Disord 2017; 5: 321–330. - PubMed

Publication types