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agate
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 Posted: Mon Mar 18, 2013 6:28 pm Post subject: Medical News Today: CCSVI liberation procedure no help |
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From Medical News Today, March 17, 2013:
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Opening Veins Does Not Help Multiple Sclerosis Patients
Opening a Multiple Sclerosis patient's veins, a procedure often referred to as "liberation treatment," does not improve patient outcomes, researchers from the University at Buffalo [State University of New York at Buffalo] revealed. In some cases patients ended up with worse symptoms, the investigators added. They will present their findings at an "Emerging Science" poster session at the annual American Academy of Neurology meeting in San Diego on March 20th, 2013.
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 consider endovascular treatment for CCSVI (chronic cerebrospinal venous insufficiency) only 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.
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."
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.
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agate
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Joined: 17 May 2006
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Location: Oregon
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| Posted: Wed Apr 03, 2013 6:14 pm Post subject: NY Times: MS balloon therapy fails in study |
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This study has been getting considerable attention.
From the New York Times, April 1, 2013:
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Multiple Sclerosis Balloon Therapy Fails in Study
By DENISE GRADY
Published: April 1, 2013
A treatment that many people with multiple sclerosis had hoped would prove effective has failed its first rigorous test, according to a new study.
The treatment uses balloons — the type commonly employed to open blocked arteries in people with heart disease — to widen veins in the head and neck. The technique is based on the unproven theory that narrowed veins cause multiple sclerosis by stopping blood from draining out of the brain properly, which is thought to damage nerves and the fatty sheath, myelin, that insulates them. A vascular surgeon from Italy, Dr. Paolo Zamboni, is the leading proponent of the idea.
In recent years, 30,000 people around the world have flocked to clinics offering the balloon treatment, despite the lack of solid evidence for it. Many patients want it because the standard drug treatments have not helped. Multiple sclerosis is incurable and causes progressive disability that eventually forces many patients to use wheelchairs. Some people think the balloon treatment has helped them, and testimonials on the Internet have helped create a powerful demand for the procedure.
Researchers at the University at Buffalo recruited 20 patients with the disease to test the theory. Half were picked at random to receive the treatment, and the other half underwent a “sham” procedure in which doctors did not actually use balloons. The patients did not know whether their veins had been expanded, and neither did the people who assessed them later. The patients were monitored for six months.
There were no significant differences between the two groups in symptoms or tests used to measure the quality of life, the researchers reported last month at a meeting of the American Academy of Neurology in San Diego. In a few cases, brain lesions associated with the disease actually seemed to worsen after the treatment.
Dr. Adnan Siddiqui, who led the study, said the increased lesions were a sign of potential harm from the treatment. He said the results surprised even the researchers because they thought there might be some benefit. He emphasized that the study was small and needed to be verified by more research.
But based on the findings, he said, the balloon treatment should not be used except in studies that are carefully designed to find out whether there are any patients who might be helped by it.
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