Papers Reviewed in March 2015

Posted on by Mike

Hill D. A.
Neurological and chest symptoms following sclerotherapy: A single centre experience
Phlebology 2014, Vol. 29(9) 619–627

Objectives: Documentation and analysis of adverse neurological and chest symptoms in a large single centre series of sclerotherapy treatments.
Method: In this retrospective study, patient-reported adverse events occurring during liquid or foam sclerotherapy were recorded over a 30 month period and subsequently analyzed. The relevant patient records were reviewed to determine patient characteristics, treatment details and results of subsequent investigations.
Results: A total of 1744 ultrasound guided sclerotherapy treatments were performed during the study period. Almost all treatments were done with air-based sodium tetradecyl sulphate foam. During the same time period, 6504 direct vision surface vein sclerotherapy treatments were completed. Approximately 1/4 of these utilized air-based foam in varying concentrations.
There were 14 adverse events in 14 patients involving neurological or chest symptoms for an incidence of 0.17%. Five patients injected with foam complained of isolated chest discomfort, tightness or shortness of breath. Nine patients reported various brief neurological symptoms. These events occurred with both liquid and foam, although the majority involved foam. More neurological events were associated with direct vision sclerotherapy of smaller superficial veins than with ultrasound guided injection of intrafascial truncular veins. Seven patients who experienced neurological symptoms had a history of migraine. Five of the patients who had neurological events were investigated for right to left shunts and found to be positive.
Conclusions: These events were uncommon and brief. The incidence of neurological and chest symptoms was higher with foam sclerotherapy than with liquid. A history of migraine with aura was associated with an increased risk of post treatment neurological symptoms. Events occurred with both large vein and small vein treatment. Some events were associated with liquid sclerotherapy rather than foam and with carbon dioxide based foam as well as air foam. There were no long-term adverse consequences.

Gillet J. L. et al
Is the treatment of the small saphenous veins with foam sclerotherapy at risk of deep vein thrombosis?
Phlebology 2014, Vol. 29(9) 600–607

Objective: To assess the deep vein thrombosis risk of the treatment of the small saphenous veins depending on the anatomical pattern of the veins.
Method: A multicenter, prospective and controlled study was carried out in which small saphenous vein trunks were treated with ultrasound-guided foam sclerotherapy. The anatomical pattern (saphenopopliteal junction, perforators) was assessed by Duplex ultrasound before the treatment. All patients were systematically checked by Duplex ultrasound 8 to 30 days after the procedure to identify a potential deep vein thrombosis.
Results: Three hundred and thirty-one small saphenous veins were treated in 22 phlebology clinics. No proximal deep vein thrombosis occurred. Two (0.6%) medial gastrocnemius veins thrombosis occurred in symptomatic patients. Five medial gastrocnemius veins thrombosis and four cases of extension of the small saphenous vein sclerosis into the popliteal vein, which all occurred when the small saphenous vein connected directly into the popliteal vein, were identified by systematic Duplex ultrasound examination in asymptomatic patients. Medial gastrocnemius veins thrombosis were more frequent (p¼0.02) in patients with medial gastrocnemius veins perforator. A common outlet or channel between the small saphenous vein and the medial gastrocnemius veins did not increase the risk of deep vein thrombosis.
Conclusion: Deep vein thrombosis after foam sclerotherapy of the small saphenous vein are very rare. Only 0.6% medial gastrocnemius veins thrombosis occurred in symptomatic patients. However, the anatomical pattern of the small saphenous vein should be taken into account and patients with medial gastrocnemius veins perforators and the small saphenous vein connected directly into the popliteal vein should be checked by Duplex ultrasound one or two weeks after the procedure. Recommendations based on our everyday practice and the findings of this study are suggested to prevent and treat deep vein thrombosis.

Todd K. L et al
The VANISH-2 study: a randomized, blinded, multicenter study to evaluate the efficacy and safety of polidocanol endovenous microfoam 0.5% and 1.0% compared with placebo for the treatment of saphenofemoral junction incompetence.
Phlebology 2014, Vol. 29(9) 608–618

Objective: To determine efficacy and safety of polidocanol endovenous microfoam in treatment of symptoms and appearance in patients with saphenofemoral junction incompetence due to reflux of the great saphenous vein or major accessory veins.
Method: Patients were randomized equally to receive polidocanol endovenous microfoam 0.5%, polidocanol endovenous microfoam 1.0% or placebo. The primary efficacy endpoint was patient-reported improvement in symptoms, as measured by the change from baseline to Week 8 in the 7-day average electronic daily diary VVSymQTM score. The co-secondary endpoints were the improvement in appearance of visible varicosities from baseline to Week 8, as measured by patients and by an independent physician review panel.
Results: In 232 treated patients, polidocanol endovenous microfoam 0.5% and polidocanol endovenous microfoam 1.0% were superior to placebo, with a larger improvement in symptoms (VVSymQ ( 6.01 and–5.06, respectively, versus – 2.00; P<0.0001) and greater improvements in physician and patient assessments of appearance (P<0.0001). These findings were supported by the results of duplex ultrasound and other clinical measures. Of the 230 polidocanol endovenous microfoam-treated patients (including open-label patients), 60% had an adverse event compared with 39% of placebo; 95% were mild or moderate. No pulmonary emboli were detected and no clinically important neurologic or visual adverse events were reported. The most common adverse events in patients treated with polidocanol endovenous microfoam were retained coagulum, leg pain and superficial thrombophlebitis; most were related to treatment and resolved without sequelae.
Conclusion: Polidocanol endovenous microfoam provided clinically meaningful benefit in treating symptoms and appearance in patients with varicose veins. Polidocanol endovenous microfoam was an effective and comprehensive minimally invasive treatment for patients with a broad spectrum of vein disease (clinical, etiology, anatomy, pathophysiology clinical class C2 to C6) and great saphenous vein diameters ranging from 3.1 to 19.4 mm. Treatment with polidocanol endovenous microfoam was associated with mild or moderate manageable side effects. VVSymQ is an important new, validated instrument for symptom assessment in patients with varicose veins.

Frullini A. et al
Prevention of Excessive Endothelin-1 Release in Sclerotherapy: In Vitro and In Vivo Studies
Dermatol Surg 2014;40:769–775

Background: The foam sclerotherapy technique has become one of the most commonly used treatments for superficial venous insufficiency. Despite excellent results, few visual/neurologic disturbances have been recently reported; their pathogenesis is still debated but a correlation with endothelin-1 (ET-1) release from the treated vein has been proposed.
Objective: The purpose of this work was to evaluate the ET-1 release after sclerotherapy and to investigate the effects of the anti-endothelin drug aminaphtone.
Methods and Materials: As in vitro sclerotherapy model, an endothelial cell culture, mimicking vascular endothelium, was pretreated with aminaphtone and exposed to detergents. Cell survival and ET-1 release were measured. In in vivo experiments, 45 rats, fed with different aminaphtone-rich diets, were subjected to sclerotherapy, and the systemic ET-1 was measured.
Results: Aminaphtone cell exposure caused a statistically significant reduction in ET-1 release, both before and after in vitro sclerotherapy. Rats fed with aminaphtone showed a trend toward reduced mortality and a significant decrease of ET-1 release after sclerotherapy.
Conclusion: This is the first study in which an anti-endothelin agent was able to cause a significant reduction of ET-1 release during sclerotherapy. Although clinical studies are required, these findings might advocate the use of anti-endothelin agents in prophylaxis of neurologic or visual disturbances after sclerotherapy.

Sloane J et al
An assessment of ultrasound guided foam sclerotherapy (UGFS) using the Aberdeen Varicose Vein Questionnaire (AVVQ)
International Journal of Surgery, Volume 11, Issue 8, Page 595, October 2013

Aims: The effectiveness of ultrasound guided foam sclerotherapy (UGFS) on health-related quality of life (HRQL) in varicose vein treatment is unknown. We evaluated this using the Aberdeen Varicose Vein Questionnaire (AVVQ).
Methods: 146 patients with venous disease of clinical severity class 1-6 completed the AVVQ prior to and 6-weeks after UGFS. Paired t-test analysis was performed.
Results: Following UGFS there was a significant improvement in HRQL, assessed by AVVQ scoring: mean 20.1 ± SD 11.5 versus 15.3 ± SD 12.1 (p< 0.02). Improvements in pain in the right leg (0.58 vs. 0.31, p< 0.02) and left leg (0.64 vs. 0.4, p=0.007) and ability to perform daily activities (0.7 vs. 0.4, p<0.0001) were evident postoperatively. There was a significant reduction in pruritis bilaterally: right leg (1.3 vs. 0.5, p< 0.0001); left leg (1.0 vs. 0.6, p<0.008). Treatment led to a reduced concern over cosmetic appearance (2.88 vs. 1.91, p=0.0002) and choice of clothing (2.13 vs. 1.91, p=0.02). A significant reduction of analgesic usage, ankle swelling or stocking use was not demonstrated.
Conclusion: UGFS is associated with significant improved functional performance and HRQL. A randomised control trial is indicated to compare the long-term clinical outcomes of UGFS with conventional techniques.

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