Unproven procedure halted after serious adverse events

02 March 2010

The latest issue of the journal Annals of Neurology reports on two serious incidents which led to the suspension of further procedures to treat CCSVI at Stanford Medical Center.

The action was taken after two people with MS who had undergone stenting of the jugular veins proceeded to develop serious complications.

One patient with a family history of stroke, suffered a fatal brain haemorrhage a few days after the operation, leading to concerns that the procedure was being performed without adequate evaluation of potential risks. The second complication led to a patient having to undergo open heart surgery after a jugular vein stent dislodged into the right ventricle.

These two incidents have encouraged further comments about the potential dangers of what is essentially an unproven procedure.

Quoted in the article, Dr Jeffrey Dunn, associate director of Stanford's MS Center, called on other neurologists to 'speak out about the dangers of the unproven procedure'. He says, "Patients remain insufficiently aware of the active and serious risks... If I can do anything to protect MS patients from the potentially devastating effects of false hopes or the risks of invasive and unproven treatment, I am happy to do so."

His colleague Dr Larry Steinman stressed the experimental nature of the treatment. "Only by testing this hypothesis under rigorous experimental conditions will we learn whether or not the hypothesis has validity."

Dr Robert Zivadinov, a supporter of the theory and leader of the ongoing study of CCSVI at the University of Buffalo (preliminary results from which were recently publicised) is quoted as saying media coverage of CCSVI is 'unrealistic and premature'. " We are three to five years away from the possible treatment options. Even with Dr Zamboni's new paper there was very little improvement in patients and it calls for caution - a reasonable approach."