Entries in CCSVI (2)


FDA Issues Warning About Experimental Therapy

iStockphoto/Thinkstock(WASHINGTON) -- The U.S. Food and Drug Administration has issued a warning about the potential risks of an experimental therapy used to treat a condition -- chronic cerebrospinal venous insufficiency, or CCSVI -- often linked to multiple sclerosis.

CCSVI is characterized by a narrowing of veins in the neck and chest, and some researchers believe that the narrowing can lead to some of the central nervous system inflammation that is a hallmark of multiple sclerosis.

"However, studies exploring a link between MS and CCSVI are inconclusive, and the criteria used to diagnose CCSVI have not been adequately established," the FDA said in a news release.

CCSVI therapy, which has not yet been tested in clinical trials, consists of widening narrowed veins in the chest and neck through the use of balloon angioplasty or stents, both commonly used to treat atherosclerosis, or hardening of the arteries. The intervention is sometimes known as "liberation therapy," or a "liberation procedure," the agency said.

But the FDA added that so far, it has not approved the use of balloon angioplasty devices or stents to treat CCSVI. It also encouraged clinical trials that could solidify the link between the two conditions, and urged patients to discuss the risks and benefits of CCSVI therapy with their doctors.

CCSVI was first identified in 2009 by Dr. Paolo Zamboni, an Italian vascular surgeon. He later tried inflating the veins using the balloon procedure in 65 patients and, despite the fact that the study was unblinded and had no placebo group, Zamboni found some improvement in MS symptoms among most of them.

Despite Zamboni's reported success, MS researchers in the U.S. said it's too soon to know for certain how -- and if -- CCSVI and MS are related. There have been many patients in the U.S. and Europe who have had CCSVI therapy, though not as part of any clinical trial. Feedback about the therapy, experts said, has been mixed.

"Some patients will say they've had improvement, and others will say there's been no symptom improvement," said Timothy Coetzee, chief research officer at the National Multiple Sclerosis Society. "We need to assess whether or not opening up veins has any beneficial effect in changing the course of the disease."

The CCSVI Alliance, a group dedicated to promoting education and research on CCSVI, says on its website that while it does not promote or deter against having CCSVI therapy, patients should make risk assessments based on their individual situation and by careful discussion with their doctor.

A clinical trial to assess the safety and efficacy of the treatment is about to get underway in Canada, and as research continues, so will the debate over CCSVI.

Copyright 2012 ABC News Radio


Multiple Sclerosis: Studies Probe Role of Clogged Neck Veins

Jupiterimages/Thinkstock(NEW YORK) -- Almost six years after she was diagnosed with multiple sclerosis, Sharon Richardson heard that blockages in neck veins draining blood from her brain could have triggered the debilitating disease, which is marked by fatigue, weakness and pain. She quickly took to the Web to investigate the theory, proposed by Dr. Paolo Zamboni, a vascular surgeon in Italy, in April 2009.

Two months later, Richardson was one of the first MS patients in the U.S. to undergo testing for the blockage, called chronic cerebrospinal venous insufficiency, or CCSVI.

"I had what's called a 'pancake vein,'" said Richardson, 68, describing the three-inch stretch of flattened jugular vein that was apparently slowing the flow of used blood from her brain.

Drawing from a study of 65 patients in Italy, Zamboni concluded that inflating flattened, twisted or blocked veins in the neck with a balloon -- a technique called angioplasty commonly used to widen arteries narrowed by atherosclerosis -- improved MS symptoms. Despite the study's limitations -- it was small, unblinded and had no placebo group -- Richardson believed the theory made sense and had two wire mesh stents implanted into her jugular vein to puff it back out (the standard balloon angioplasty wouldn't hold in her 99-percent flattened vein).

She felt better instantly.

Zamboni's exciting but preliminary results and the personal testimonies of people like Richardson prompted MS patients worldwide to clamor for the unproven procedure, which costs about $10,000 and is not covered by insurance. But most neurologists agree it's too soon to tell whether clogged veins play a role in triggering MS, and whether Zamboni's fix, dubbed "liberation therapy," has a role in treating it.

"It certainly is an active area of debate," said Dr. Timothy Coetzee, chief research officer for the National MS Society. "As with many emerging areas in MS research, I'm hopeful that investing in research and exploring this hypothesis will give us the answer to the question, 'What is the role of CCSVI?'"

But some patients believe neurologists and other MS researchers have a financial stake in knocking down the CCSVI theory and keeping MS under their purview. Using online forums, they argue that MS drugs represent a multi-billion-dollar market that a simple one-time fix, such as unclogging neck veins, would squash. Some forums, including the Canadian MS Society's Facebook page, were even shut down after anonymous users posted nasty, threatening comments about liberation therapy skeptics.

The latest research, reported Friday at the annual American Academy of Neurology meeting in Honolulu, suggests that not everyone with MS has blocked neck veins, and not everyone with blocked neck veins has MS -- a finding that some researchers argue pokes holes in the CCSVI theory.

In 2010, the National MS Society and the Multiple Sclerosis Society of Canada pledged a combined $2.4 million to examine the role of CCSVI in MS and, hopefully, lay the CCSVI debate to rest for good. But it could be a while before neurologists, radiologists and patients are all on the same page about CCSVI.

Copyright 2011 ABC News Radio 

ABC News Radio