BUPA and Foam Sclerotherapy - The views of the BAS: This treatment is safe and effective
Recently BUPA has decided not to consider foam sclerotherapy (procedure codes L8620, L8621) for benefit under their insurance policies. This is apparently on the basis of a letter to the NEJM (New England Journal of Medicine) which reports two instances of visual disturbance in patients following foam sclerotherapy. More disturbingly BUPA have been advising patients that foam sclerotherapy is 'not a safe treatment' thus causing considerable alarm to patients who had already been treated! Patients have been advised that they were put at risk of heart attack or blindness!!!
The view of the BAS, the Vascular Society, the Venous Forum of the Royal Society of Medicine and a large body of experts in venous disease from all over the world is that foam sclerotherapy is a safe procedure when carried out by a suitably trained expert. Tens of millions of patients have been treated worldwide with very few adverse events. No instance of heart attack or blindness has been reported. However, in a small proportion of patients transient visual disturbance, especially in migraine patients, has been noted. All symptoms usually subside witn 30 minutes of onset.
I have personally treated 2000 patients using this method in over 6000 sessions of foam sclerotherapy. No case of heart attack or blindness has occurred. I have previously reported the outcome in the medical literature (EJVES 2006; 32: 577-83) and reported a 2% incidence of transient visual disturbance.
Many surgeons have written to BUPA, including the President of the Vascular Society. No substantial reply has been received. Below I have included the text of my own letter which details the excellent safety record of foam sclerotherapy as well as the more chequered outcome of surgical treatment.
Philip Coleridge Smith, Consultant Vascular Surgeon President BAS
www.medi-data.co.uk www.bvi.uk.com
Re: L8620, L8621 ultrasound
guided foam sclerotherapy.
BUPA seem to have decided to become a regulatory body in post-marketing
surveillance of this treatment. However, you have taken a very blinkered view
of the available evidence, the reasons for which remain unclear to me. You have
focussed on two patients mentioned in a letter to NEJM, but ignored the
millions of patients successfully treated without serious adverse events in
clinical practice. If there were significant numbers of serious neurological
events reported in the literature this would be understandable. However, such
cases don't exist.
The extensive NICE review published in 2007 makes it clear that
transient visual disturbance may occur following liquid or foam sclerotherapy,
a fact which has been known for many years and carries no permanent sequelae.
Since 'bubbles' are not required to produce visual disturbance Ceulen et al
have shown an association, but not a causal relationship. In fact, their
article fails to show the exact nature of the echoes seen in the right heart
after foam sclerotherapy, the authors simply assume that they are looking at
bubbles. The significance of the NEJM
article therefore remains – theoretical. Bubbles are seen in the venous system
after any intravenous injection, infusion, canulation, catheterisation and
there is no evidence that these give rise to adverse events.
However, detailed studies of the consequences of foam sclerotherapy
have been reported at a scientific meeting (SIRS) by a surgeon from the USA.
This was part of a safety study by British Technology Group to address the
safety of foam sclerotherpay. The study, carried out in patients selected to
have a PFO, shows that 'Varisolve', the BTG sclerosant which uses carbon dioxide
and oxygen as the gaseous parts of the foam mixture, does not have any effect
on the cerebral circulation as studied by high resolution MRI over a 28 day
period. This is the same gas mixture that I use in sclerosant foam. I have
attached an account of the study from the BTG website, since the final study
report has yet to be published.
As an aside, you mention that you think that an adverse event rate of
2% is high. However, most surgeons would be pleased to achieve such a low
figure. Varicose veins surgery patients (still an approved procedure according
to BUPA) carries the following risks: post-op ecchymoses (100%), wound
infection (5-30%), nerve injury (5-10%), scars (100%), anaesthetic death
1:100,000. The reason that surgeons are keen to use foam sclerotherapy is to
avoid these and other problems associated with surgery.
I request a meeting with those responsible for reaching the decision
that has been made and to discuss possible solutions.
Philip Coleridge Smith DM
FRCS
Consultant Vascular Surgeon
and Reader in Surgery
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