Dr. Ponec at ISNVD

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

Dr. Ponec at ISNVD

Postby Cece » Tue Feb 21, 2012 1:38 pm

page 52
A national approach to gather prospective data for MS outcomes
(Donald J. Ponec, USA and David Hubbard, USA)

The Society for Interventional Radiology Consensus Panel, published in 2011, recommended that all
interventional radiologists doing the CCSVI procedure participate in studies or registries to promote the
collection of clinical outcome and adverse event data. At the present time in the United States we are aware of
only one placebo-controlled trial conducted by Dr. Zivadinov and colleagues at the University of Buffalo, and
two uncontrolled registries, one by Dr. Siskin at the University of Albany and one by the Hubbard Foundation
based in San Diego. It is currently unknown how many venoplasty procedures on MS patients are being
performed by IRs or vascular surgeons outside of any study or registry. We call on the ISNVD, SIR, AAN and
the various MS societies to strongly encourage patients who choose to pursue treatment to do so only under
the auspices of a study or registry. Minimal requirements include collection of adverse events, a measure of
clinical outcome such as a quality of life measure, documentation of pre-treatment testing such as Dopplerultrasound
and MR venography, and documentation of the procedure including sites treatment, balloon sizes
and pressures and stents. We recognize that serial MRIs to monitor lesion load and atrophy may be unrealistic
given the costs and lack of funding sources, and that more data is needed before a comprehensive
randomized, blinded placebo controlled study can be designed and implemented. However, every effort should
be made to include this data in order to properly document and understand if possible why this procedure
works for some sub-category of MS patients while not for others.
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