The researchers reported that while percutaneous transluminal venous angioplasty (PTCA) is safe, it did not improve blood flow in cerebrospinal veins. PTCA is a procedure for enlarging a narrowed arterial/venous lumen by introducing a balloon-tip catheter, which when blown up dilates the lumen.
Principal investigator, Adnan Siddiqui, MD, explained that "The Prospective Randomized Endovascular Therapy in MS (PREMiSe) trial is believed to be the first prospective randomized double-blinded, controlled study of balloon angioplasty for MS being performed with Institutional Review Board approval in a rigorous fashion in the U.S. with significant safeguards in place to ensure careful determination of risks and benefits."
All the procedures in this study were provided to patients free-of-charge.
The study concluded that while percutaneous transluminal venous angioplasty is safe and not linked to any serious adverse events, it did not provide sustained improvements in multiple sclerosis patients.
The University of Buffalo researchers say that doctors and patients with MS should only consider endovascular treatment for CCSVI (chronic cerebrospinal venous insufficiency) in the context of randomized, double-blinded, controlled studies, such as PREMiSe.
Dr. Siddiqui said:
"Our strong recommendation to patients and to practitioners, who have, in earnest, been seeking betterment for their disease and a cure for MS is that they should instead consider enrolling in trials, rather than undergoing these procedures on a fee-for-service basis."
Since 2009, over 30,000 patients with MS have undergone the endovascular procedure that clears blockages in the veins that drain blood from the brain. Most of these interventions were performed free of charge, and not as part of clinical trials.
What is CCSVI (chronic cerebrospinal venous insufficiency)?
CCSVI (chronic cerebrospinal venous insufficiency) is a condition in which blood flow in the veins that drains the brain and spinal cord (central nervous system) is obstructed. According to research, CCSVI is common among people with MS.
These vein obstructions can slow down the flow of blood returning from the CNS (central nervous system) towards the heart, resulting in blood refluxing back into the spine and brain.
Patients with CCSVI have at least one of the vein blockages listed below (in veins that drain blood from the CNS):
Stenosis - abnormal narrowing of the vein. This restricts blood flow. This could be because the vein has collapsed, twisted, has ring-like narrowings, or some other obstruction.
A faulty valve - which inhibits the flow of blood.
Atresia, hypoplasia, or agenesis - the vein may be partially closed (atresia), not fully developed (hypoplasia), or nearly entirely missing (agenesis).
Robert Zivadinov, MD, PhD, FAAN:
"Our findings over the last three years have indicated that CCSVI is more prevalent in MS patients than in healthy controls, but the cause or consequence of these venous abnormalities has not been established."
Why did experts think endovascular intervention might help MS patients?
The hypothesis was that if veins in the neck and chest do not drain the brain properly, there could eventually be injury to brain tissue.
Dr. Zivadinov explained that experts thought that angioplasty - a treatment widely used by cardiologists and endovascular surgeons to treat atherosclerosis - could unblock the veins.
Bianca Weinstock-Guttman, MD, said "The whole idea of PREMiSe was to find out if opening up the veins that drain blood from the brain and the spinal cord would improve outcomes for MS patients."
Italian cardiovascular surgeon, Dr. Paolo Zamboni was the first to develop the theory that CCSVI may play a role in causing MS, which resulted in much debate and controversy, as well as sparking huge interest among the millions of patients with MS worldwide regarding the potential cause of MS.
Paolo Zamboni
The term chronic cerebrospinal venous insufficiency (CCSVI) was developed by Paolo Zamboni in 2008
In 2011, Canadian researchers carried out a meta-analysis involving eight different studies in the USA, Germany, Jordan and Italy. They found immense variations regarding how common CCSVI is among MS patients, ranging from 100% (in the case of Zamboni's study) to 0%.
In 2010, researchers at Stanford University halted treatment for CCSVI because two patients experienced serious side effects following stenting of jugular veins, a procedure they thought would correct CCSVI in MS patients - one of the patients died from a brain hemorrhage while the other required open heart surgery after a jugular vein stent dislodged in the right ventricle of the heart.
Endovascular intervention had the opposite effect to what experts had expected
Dr. Siddiqui said that what they found was completely the opposite to what they had expected. Endovascular treatment for narrowed veins had no effect on multiple sclerosis patients.
The PREMiSe trial involved 30 patients, all of them with MS and from Western New York. The trial consisted of two phases:
Phase I - a safety trial involving 10 patients
Phase II - 20 patients were randomly selected to either receive endovascular intervention or placebo (sham treatment)
The researchers found that between those in the intervention (who underwent balloon angioplasty) group and placebo groups, there was no difference in:
clinical symptoms
brain lesions (after undergoing magnetic resonance imaging scans)
quality of life
The investigators emphasized that theirs was a small study, and that large ones should be carried out to confirm their findings.
Dr. Siddiqui concluded:
"This is not the last word on this endovascular treatment for MS. This is the first word because this was the first double-blinded, randomized sham-controlled trial on the subject. However, these findings lead us to caution strongly against the general acceptance of this invasive procedure for MS patients."
'Opening Veins Does Not Help Multiple Sclerosis Patients'
Published on Mar 15, 2013
A new University at Buffalo study finds that while a surgical intervention for MS is safe and not associated with serious adverse events, it did not provide sustained improvement in MS patients.
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License: Standard YouTube License
The following researchers were involved in the trial: Adnan Siddiqui, Nelson Hopkins, Bianca Weinstock-Guttman, Ralph H.B. Benedict, Elad Levy, Yuval Karmon, Jihnhee Yu, Karen Marr, Vesela Valnarov, Murali Ramanathan, Deepa P. Ramasmamy, Kresimir Dolic, David Hojnacki, Ellen Carl and Cheryl Kennedy.
Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today
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Opening Veins Does Not Help Multiple Sclerosis Patients
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