adverse events in an Italian ccsvi registry

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

adverse events in an Italian ccsvi registry

Postby Cece » Tue Feb 12, 2013 8:44 pm ... 1.abstract

Although it is debated whether chronic cerebro-spinal venous insufficiency (CCSVI) plays a role in multiple sclerosis (MS) development, many patients undergo endovascular treatment (ET) of CCSVI. A study is ongoing in Italy to evaluate the clinical outcome of ET. Severe adverse events (AEs) occurred in 15/462 subjects at a variable interval after ET: jugular thrombosis in seven patients, tetraventricular hydrocephalus, stroke, paroxysmal atrial fibrillation, status epilepticus, aspiration pneumonia, hypertension with tachicardia, or bleeding of bedsore in the remaining seven cases. One patient died because of myocardial infarction 10 weeks after ET. The risk of severe AEs related to ET for CCSVI must be carefully considered.

Jugular clotting is the most common. At 7 out of 462, it was fairly rare, happening in 1.5% of people who had venoplasty.
Tetraventricular hydrocephalus ? Is that something that venoplasty can cause?
Stroke, not good. It could be unrelated but it could be related.
Atrial fibrillation can be a result of venoplasty. Hopefully it would result in an overnight hospital stay and no further troubles. I think this one was reported in Dr. Siskin's safety study as well.
Status epilepticus ?
Aspiration pneumonia ? This would seem to be a result of the MS.
Hypertension with tachycardia ?
Bleeding of bedsore - that would be a result of MS paralysis, not of venoplasty
Last edited by Cece on Wed Feb 13, 2013 10:02 am, edited 1 time in total.
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Re: adverse events in the cosmo study

Postby cheerleader » Tue Feb 12, 2013 11:05 pm

Comi is a co-author, but this isn't part of the Cosmo study,'s an Italian registry which is evaluating clinical outcome for those who sought treatment outside of Zamboni's Brave Dreams clinical trial. Sadly, medical tourism is happening in Italy---just as it is in other countries. And Zamboni has stressed that follow up and local treatment with knowledgable IRs is essential. This has caused quite a problem in Italy. And adverse events.
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
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