Monday, July 15, 2013

Safety and Efficacy of Foam Sclerotherapy

Ultrasound Guided Foam Sclerotherapy was described (as presently used) by a Spanish surgeon nearly 20 years ago. It has been in common use in the UK for over 10 years. Some doubts have been cast on the safety of this procedure since a small proportion of patients experience visual disturbance following treatment and a very small number of severe neurological events have arisen. Fortunately, complete resolution of all of these neurological symptoms occurred within 2-4 weeks of the onset. Should this cause us concern? In fact, a considerable research effort has been put in to answering this point.

The French Phlebological Society have studied a series of patients who suffered visual disturbance following sclerotherapy. All patients were investigated by a neurologist and in every case he concluded that the visual disturbance was part of migraine. It is common for people with migraine to suffer an aura (usually a visual disturbance) if they are exposed to a triggering factor which might include foods such as chocolate or cheese. Sclerotherapy appears to act in much the same way. The visual disturbance is of short duration in these patients and resolves completely, usually within an hour or two.

Examination of published medical reports shows that stroke has been known to occur in a very tiny number of patients following almost any varicose vein treatment, including surgery and laser ablation of varicose veins. Millions of patients worldwide have received foam sclerotherapy and there is no evidence to show that this treatment is any more risky than other techniques.

A recent paper in the Annals of the Royal College of Surgeons studied the frequency of deep vein thrombosis after varicose vein operations performed in the NHS. The risk of DVT was the same for surgery, laser ablation, radiofrequency ablation and foam sclerotherapy. The only deaths which were reported were in the surgical group.

The safety and efficacy of foam sclerotherapy has been studied carefully by the medicines regulator in the UK, the Medicines and Healthcare Products Regulator Agency (MHRA). They have now issued a licence for the use of Fibrovein foam to treat varicose veins. This is not a step that is taken lightly and has been supported by much research and evidence of safety. Ultrasound guided foam sclerotherapy has also been approved for use in the UK by the National Institute for Health and Clinical Excellence (NICE).

Foam sclerotherapy is therefore a licensed treatment in the UK of established safety and efficacy.

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