Venoplasty, a surgical procedure that involves opening up narrowed veins from the brain and spinal cord, is not effective in treating multiple sclerosis (MS), according to a study led by the University of British Columbia (UBC) and Vancouver Coastal Health.
The conclusions about venoplasty, also known as liberation therapy, which thousands of people with MS have undergone since 2009, represent the most definitive debunking of the claim that MS patients could achieve dramatic improvements from a one-time medical procedure.
"We hope these findings, coming from a carefully controlled, gold-standard study, will persuade people with MS not to pursue liberation therapy, an invasive procedure that carries the risk of complications, as well as significant financial cost," says Anthony Traboulsee, MD, an associate professor of neurology at UBC and director of the MS clinic at the Djavad Mowafaghian Center for Brain Health. "Fortunately, there are a range of drug treatments for MS that have been proven through rigorous studies to be safe and effective at slowing disease progression."
The study compared individuals with MS who either underwent venoplasty or a sham procedure, the surgical equivalent of a placebo. The 104 people in the study all had MS and narrowing of the jugular vein, which drains blood from the brain, or the azygos vein, which drains blood from the spinal cord. The study was double-blinded; neither the patients nor the physicians who evaluated them knew who was receiving the actual treatment or the sham procedure.
All patients were put under minor sedation and all of them had a catheter threaded through an incision in the groin to the area of vessel narrowing. Of the 104 patients in the study, 49 received the actual treatment—the balloon was inflated once or twice; 55 received the sham, meaning the catheter simply remained in the narrowed area for the same amount of time, about one minute.
The researchers found no statistically significant difference between the treatment group and the sham group in patient symptoms, either as reported by the patients or as determined by physicians, three days after the procedure and a year later. Both groups showed slight but equal improvements a year later in the patients' own assessments; physician assessments showed no improvement in either group.
MRIs of their brains were used to count the number of new lesions in their myelin, and researchers found no difference between the treatment group and the placebo group at six months and one year later.
The findings from the $5.4 million study, funded by the Canadian Institutes of Health Research, the MS Society of Canada, and the provinces of British Columbia, Manitoba, and Quebec, were presented at the 2017 Society for Interventional Radiology's (SIR) annual scientific meeting in Washington, D.C. The researchers are preparing an article to be published in a peer-reviewed journal.
Using venoplasty as a treatment for MS was introduced by Paolo Zamboni, MD, of Italy, who asserted that narrowing of the veins in the neck could be causing iron to accumulate in the brain and spinal cord, triggering an autoimmune response. Zamboni called his theory chronic cerebrospinal venous insufficiency (CCSVI), and cited several dozen cases of patients who improved after undergoing venoplasty performed by him.
Many patients in Canada and Europe, upon learning of those anecdotal results through the news media, asked for imaging of their veins and subsequent venoplasty. But almost all Canadian physicians, citing the lack of supporting evidence, would not perform it, prompting some patients to seek the treatment in the United States, Latin America, and Eastern Europe.
This is the second study, led by the UBC and Vancouver Coastal Health, aimed at seeking more evidence on the CCSVI theory. The first study, published in The Lancet in 2013 and supported by the MS Society of Canada, sought to determine whether narrowed veins were a distinct feature of MS and found that narrowing was as common in people without MS.
"Despite the negative findings of that diagnostic study, many patients wanted to know if the venous dilation procedure could help," says Lindsay Machan, MD, an associate professor of radiology at UBC, who presented the findings at the 2017 SIR annual scientific meeting. "We were committed to meticulously evaluating this treatment with robust methods and patient-focused outcomes."Source: University of British Columbia