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J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):2-7. doi: 10.1016/j.jvsv.2014.09.001. Epub 2014 Oct 18.

The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins.

Author information

1
Department of Dermatology, University Medical Center, Mainz, Germany. Electronic address: thomas.proebstle@web.de.
2
Dermatologikum Hamburg, Hamburg, Germany.
3
Countess of Chester Hospital, Chester, United Kingdom.
4
The Danish Vein Centers, Naestved, Denmark.
5
The Whiteley Clinic, Guildford, United Kingdom.
6
Centrum Oosterwal, Alkmaar, The Netherlands.
7
Wild Iris Consulting LLC, Palo Alto, Calif.
8
Imperial College London, London, United Kingdom.

Abstract

OBJECTIVE:

Cyanoacrylate (CA) embolization of refluxing great saphenous veins (GSVs) has been previously described. The outcomes from a multicenter study are still lacking.

METHODS:

A prospective multicenter study was conducted in seven centers in four European countries to abolish GSV reflux by endovenous CA embolization. Neither tumescent anesthesia nor postinterventional compression stockings were used. Varicose tributaries remained untreated until at least 3 months after the index treatment. Clinical examination, quality of life assessment, and duplex ultrasound evaluation were performed at 2 days and after 1, 3, 6, and 12 months.

RESULTS:

In 70 patients, of whom 68 (97.1%) were available for 12-month follow-up, 70 GSVs were treated. Two-day follow-up showed one proximal and one distal partial recanalization. Three additional proximal recanalizations were observed at 3-month (n = 2) and 6-month (n = 1) follow-up. Cumulative 12-month survival free from recanalization was 92.9% (95% confidence interval, 87.0%-99.1%). Mean (standard deviation) Venous Clinical Severity Score improved from 4.3 ± 2.3 at baseline to 1.1 ± 1.3 at 12 months. Aberdeen Varicose Vein Questionnaire score showed an improvement from 16.3 at baseline to 6.7 at 12 months (P < .0001). Side effects were generally mild; a phlebitic reaction occurred in eight cases (11.4%) with a median duration of 6.5 days (range, 2-12 days). Pain without a phlebitic reaction was observed in five patients (8.6%) for a median duration of 1 day (range, 0 -12 days). No serious adverse event occurred. Paresthesia was not observed.

CONCLUSIONS:

Endovenous CA embolization of refluxing GSVs is safe and effective without the use of tumescent anesthesia or compression stockings.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01570101.

PMID:
26993674
DOI:
10.1016/j.jvsv.2014.09.001
[Indexed for MEDLINE]
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