Gibson K, Ferris B, et al.
Vascular. Date of publication 2017 Apr 1;volume 25(2):149-156.
1. Vascular. 2017 Apr;25(2):149-156. doi: 10.1177/1708538116651014. Epub 2016 Jul
9.
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).
Gibson K(1), Ferris B(1).
Author information:
(1)Lake Washington Vascular Surgeons, Bellevue, WA, USA.
Purpose Cyanoacrylate closure of the great saphenous vein with the VenaSeal™
Closure System is a relatively new modality. Studies have been limited to
moderate-sized great saphenous veins and some have mandated postoperative
compression stockings. We report the results of a prospective study of
cyanoacrylate closure for the treatment of great saphenous vein, small saphenous
veins, and/or accessory saphenous veins up to 20 mm in diameter. Methods Fifty
subjects with symptomatic great saphenous vein, small saphenous veins, and/or
accessory saphenous veins incompetence were each treated at a single session.
Compression stockings were not used post-procedure. Subjects returned to clinic
at week 1 and again at one month. Post-procedure evaluations were performed at
seven days and one month and included numerical pain rating score, revised
venous clinical severity score, the Aberdeen Varicose Vein Questionnaire score,
and time to return to work and normal activities. Duplex ultrasound was
performed at each visit. Findings Procedural pain was mild (numerical pain
rating scale 2.2 ± 1.8). All treated veins (48 great saphenous vein, 14
accessory saphenous veins, and 8 small saphenous veins) had complete closure by
duplex ultrasound at seven days and one month. Mean time to return to work and
normal activities was 0.2 ± 1.1 and 2.4 ± 4.1 days, respectively. The revised
venous clinical severity score was improved to 1.8 ± 1.4 ( p < .001) and
Aberdeen Varicose Vein Questionnaire score to 8.9 ± 6.6 ( p < .001) at one
month. Phlebitis in the treatment area or side branches occurred in 10 subjects
(20%) and completely resolved in all but one subject (2%) by one month; 98% of
subjects were "completely" or "somewhat" satisfied, and 2% "unsatisfied" with
the procedure at one month, despite the protocol disallowance of concomitant
side branch treatment. Conclusions Cyanoacrylate closure is safe and effective
for the treatment of one or more incompetent saphenous or accessory saphenous
veins. Closure rates were high even in the absence of the use of compression
stockings or side branch treatment. Time back to work or normal activities was
short and improvements in venous severity scores and QOL were significant,
comparing favorably with alternative treatment methods.
DOI: 10.1177/1708538116651014
PMID: 27206470 [Indexed for MEDLINE]