Vein-Opening Treatment for MS Stirs Controversy
TUESDAY Jan. 18, 2011 -- Preliminary research and reports from patients suggest that a controversial treatment for multiple sclerosis can help relieve fatigue and other symptoms, but many physicians remain highly skeptical of the claims.
The debate started in 2009, when Dr. Paolo Zamboni, a vascular surgeon from Italy, published an intriguing study that suggested that a blockage in the veins that drain blood from the brain and spinal cord and return it to the heart might contribute to multiple sclerosis (MS).
Calling it chronic cerebrospinal venous insufficiency, or CCSVI, Zamboni's theory was that the blockages disrupt the flow of blood from the brain and spinal cord, causing blood to back up and damage the brain and the spinal cord.
Zamboni began surgically treating people with MS with balloon angioplasty to open their veins. Other CCSVI researchers have tried stents, in which a wire mesh is placed in the vein to prop it open.
The methods of Zamboni and the others set off a heated debate among physicians and patients. Many MS physicians consider the claims utter hooey. But many people with MS, desperate for relief, pressed for research, and some, unwilling to wait, sought out physicians abroad who'd do the surgery.
Despite the skepticism, U.S. researchers began investigating venous blockage. In June, the National Multiple Sclerosis Society announced $2.4 million in funding for CCSVI studies, most of which are trying to answer the basic question of whether there is actually a link between venous blockages and MS.
Among those conducting CCSVI research is Dr. Michael Dake, a professor of cardiothoracic surgery at Stanford University School of Medicine.
Dake followed 30 people with MS who had stents implanted to open their veins. Two months after surgery, they reported feeling 50 percent less fatigued than before surgery, Dake said. They continued to be less fatigued at the one-year mark, even improving slightly from where they were two months after surgery, he said.
People who saw the most benefit were those with the relapsing-remitting form of MS, in which periods of remission, when the person feels relatively good, are followed by MS flares, Dake said.
People with more aggressive or more advanced forms of MS, including primary and secondary progressive MS, reported about a 40 percent drop in fatigue two months after the surgery, but the effect did not last at the one-year mark, Dake said.
MS is believed to be an autoimmune disease in which the body's immune system attacks myelin, or the substance that insulates nerve fibers of the central nervous system. The damage disrupts nerve signals traveling to and from the brain, which can lead to numbness, movement difficulties and blurred vision. Other symptoms can include fatigue and cognitive problems, sometimes described by those with MS as being in a fog.
Vein opening is unlikely to help regenerate damaged myelin, which causes the movement difficulties, Dake said, but opening blocked veins looks like it may help alleviate fatigue, at least in people with relapsing-remitting MS.
"It's a stretch to think opening up veins is going to deal with or reverse an injury that is due to demyelinating plaque, whereas the symptoms that are more general, such as fatigue and brain fog that are much more related to an obstruction in venous outflow from the brain -- those could potentially be reversed," he said.
Dake was scheduled to present his findings this week at the International Symposium on Endovascular Therapy in Miami Beach.
He cautioned that his research was not a randomized, controlled, clinical trial but rather a review of his clinical experience with 30 patients.
Therein lies the problem with CCSVI and its treatments, said Dr. Lily Jung, medical director of the neurology clinic at the Swedish Neuroscience Institute in Seattle.
"There is no clear evidence that MS has anything to do with blocked veins, and to then jump to therapy for blocked veins is premature," Jung said.
The research done on CCSVI has not consistently established that people with MS are more likely to have venous blockage than are healthy people or those with other neurological diseases, Jung said. Nor is it known when venous blockage occurs during the course of the disease or why such a blockage, if it occurs, would cause symptoms of MS.
Until much more is learned, Jung warned people against seeking treatment for CCSVI because of the danger of complications. According to the National Multiple Sclerosis Society, a Canadian man with MS died after seeking angioplasty in Costa Rica, and another had to have emergency open heart surgery to retrieve a stent that dislodged.
"It is not ready for prime time," Jung said. "We need to first establish how firm the basis for the theory is and, secondly, have a widely accepted agreement about how to diagnose CCSVI before you try treatment for it," she said.
Dr. James Benenati, president of the Society of Interventional Radiologists, described MS as a heterogeneous disease -- meaning that not every person with MS has venous blockages, and not every person with venous blockages has MS. And that, he said, makes the research more difficult.
Benenati said he plans to begin offering the treatment to MS patients at Baptist Cardiac & Vascular Institute in Miami as part of a research study.
"My feeling and the society's feeling is we don't have enough data yet to say 100 percent yes or no," Benenati said. "But to basically condemn something because there isn't good data at this time is premature -- and not very scientifically sound, either. My own feeling is it is going to pan out to be something of great value."
In the meantime, not everyone with MS seems willing to wait for the lengthy clinical trials to be completed. "We're getting a huge number of calls on this," Benenati said. "It can be overwhelming."
The National Multiple Sclerosis Society has more on CCSVI.
Posted: January 2011