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CCSVI

County surgeon to pursue Multiple Sclerosis trials

With health officials clamouring for more scientific research before green-lighting the new liberation treatment for multiple sclerosis (MS), local supporter and cardiovascular-thoracic surgeon Sandy Mc is stepping up to provide it.

“I’m working with colleagues to design a double-blinded study for assessing CCSVI and its treatment,” he said, anticipating a more extensive test group than the preliminary trials first published by pioneering Italian vascular surgeon Paolo Zamboni.

“We have two neurologists, three vascular surgeons and interventional radiologists interested in being involved.”

In the process of gaining Institutional Review Board approval, Mc said the trial is moving forward as quickly as possible, but “we have a lot of hurdles to get past before we get there.”

Zamboni rocked the global MS community last November by linking blocked veins in the head, neck and shoulders to the symptoms of the disease – a condition he dubbed Chronic Cerebrospinal Venous Insufficiency (CCSVI). He took his hypothesis a step further when his team performed balloon angioplasties to free the blood flow. The reported results, detailing alleviated MS symptoms, were groundbreaking.

Mc traveled to Italy to study Zamboni’s unique vein-scanning techniques first hand to avoid the false negatives often obtained through more traditional imaging.

He has since provided the non-subsidized tests at no cost to patients or the health-care system upon physician referral to his Alliance Boulevard clinic.

The actual procedure, however, is currently not available in Canada.

Earlier this year, Mc requisitioned six MS-related angioplasties for patients showing the tell-tale vein abnormality and associated iron debris, with follow-up visits revealing encouraging results across the board.

Some reported increased mobility and speech, and another claimed no further symptoms at all.

One young man’s parents had installed an elevator in their house to help their son’s mobility prior to the procedure. Now he is not only able to climb stairs without hesitation, but Mc reports his patient has since moved into his own home where he lives independently.

After the positive results in his first few cases, Mc and the interventional radiologists who performed the procedure decided to take a brief hiatus to first establish a method of capturing the data and tracking the results in order to share their findings.

Although the timeframe has stretched on longer than he initially anticipated, the surgeon now hopes to accept qualified patients into a full-scale research trial, complete with a treatment arm, come fall.

In the meantime, Mc said the approximately 1,000 successful liberation treatments done to date around the world should be enough to encourage the Canadian health-care system to allow the treatment as an option to patients – even if on a pay-per-service basis.

Source: Simcoe.com © Copyright Metroland 2010 (23/07/10)

Study raises new questions about vascular theory for MS

A new study from Germany has found that multiple sclerosis (MS) patients showed no evidence of chronic cerebrospinal venous insufficiency (CCSVI) -- striking a blow against the theory that obstructed blood flow in veins exiting the brain may be a cause of MS.

Ultrasound exams of jugular and vertebral veins in 56 MS patients and 20 controls yielded normal findings in nearly all of them, reported Florian Doepp, MD, of Humboldt University in Berlin, and colleagues online in ls of Neurology.

The findings directly contradict results reported last year and in 2007 by Paolo Zamboni, MD, of the University of Ferrara in Italy, and colleagues from a 300-participant ultrasound study, in which nearly all the MS patients but few controls had CCSVI.

MS is thought to be an autoimmune disease caused by the destruction of the fatty myelin coating that surrounds and protects nerve cells, hampering or interrupting nerve impulses traveling to and from the brain and spinal cord, leading to a variety of symptoms and disabilities.

The disease is thought to affect 2.5 million people worldwide and around 400,000 patients in the U.S., according to the National Multiple Sclerosis Society (NMSS).

The hypothesis behind CCSVI is that obstructed blood flow due to stenosis of veins exiting the brain causes blood to back up, leading to inflammation.

In the new German study, blood flow direction in both jugular and vertebral veins was found to be normal in 55 of the patients and all of the controls, and no evidence of internal jugular stenosis was seen in any participant, the researchers reported.

Zamboni had listed five criteria for a diagnosis of CCSVI. However, "none of the subjects investigated in this study fulfilled more than one" of those criteria, Doepp and colleagues wrote.

The report by German researchers is the second study in recent months to cast doubt on the prevalence of CCSVI among MS patients.

Interim findings from a large, ongoing trial led by researchers at the State University of New York at Buffalo, reported in April at the American Academy of Neurology annual meeting, found middling percentages of MS patients, as well as a large minority of controls, met criteria for CCSVI.

At the AAN meeting, Zivadinov, MD, PhD, presented data from the first 500 participants in the projected 1,700-subject study.

He reported that 56% of MS patients, 43% of those with other neurologic illnesses, and 22% of healthy volunteers met at least two of the CCSVI criteria, which include venous reflux, stenosis, missing flow, and abnormal blood flow in the jugular or vertebral veins following postural changes.

In the study by Doepp and colleagues, there were some differences in venous flow responses to postural changes between patients and controls, but they fell short of confirming CCSVI, the researchers indicated.

They found a decrease of total jugular blood volume flow when patients sat upright that was less pronounced in patients. The decrease was about half the magnitude seen in controls, Doepp and colleagues reported, such that blood flow volume in the sitting position was nearly three times as great in MS patients relative to controls.

There were no differences between patients and controls in intracranial venous flow, or in jugular flow when the Valsalva maneuver was performed.

"Against this backdrop we discourage interventional procedures as more work is being done to investigate 'CCSVI' and its possible role in MS," Doepp and colleagues wrote.

J. Fox, MD, a neurologist at the Cleveland Clinic, said the findings from the German and Buffalo studies suggested "caution before we jump up and embrace [the CCSVI theory] fully."

Fox spoke this week during a live webcast sponsored by the NMSS, which recently awarded $2.4 million in grants for seven research projects -- including one led by Fox -- evaluating the CCSVI hypothesis in detail.

He noted that the Buffalo data found a substantially lower prevalence of CCSVI among the MS patients and a greater prevalence in the healthy controls than in the Italian studies.

Moreover, Fox said, the finding that nearly half the non-MS patients with other neurological conditions met CCSVI criteria might argue against a causative role in MS specifically.

"This raises the question of, maybe the venous findings are not directly related to MS, but are related to some injury of the brain -- maybe a downstream but maybe an upstream effect of injury," he said.

O'Looney, PhD, vice president for biomedical research at the NMSS, echoed the cautions about CCSVI, particularly as it relates to treatment.

Zamboni and colleagues have reported successful reversal of symptoms in MS patients following venoplasty, with stenting performed in some patients.

But there was no blinding or control group, raising the question of a placebo effect or, as Fox suggested, a natural regression in MS symptoms often seen in patients.

Nevertheless, neurologists have reported that patients are now asking about such treatments and even traveling overseas to receive them.

Indeed, during the NMSS webcast, questions from patients focused on the advisability and availability of ultrasound evaluations and venoplasty treatment.

"The society shares in the public urgency to advance the understanding of CCSVI as quickly as possible," O'Looney said during the webcast.

But she noted the "conflicting results in the current reported studies" and said the society's research grants were intended to "quickly and comprehensively determine the significance of CCSVI."

In the meantime, she said, the U.S. and Canadian MS societies agree that data supporting treatment based on the CCSVI theory "are not yet available," and hence it would be premature to recommend them to patients.

Fox said he tells patients not to seek venous ultrasonography precisely because any treatments based on the findings remain scientifically untested.

"As with any therapy, it comes down to the cost-benefit ratio," he said. "What are the risks of treatment, and what are the benefits? Without a controlled trial and further study, I think we really don't know the answer to either part of that tradeoff."

The study by Doepp and colleagues was funded by the German Research Foundation.

One author reported speaking fees from Sanofi-aventis, Novartis, and Merck Serono.

O'Looney reported no potential conflicts. Fox has had relationships with Biogen Idec, Teva, and Genentech.

Primary source: ls of NeurologySource reference:Doepp F, et al "No cerebro-cervical venous congestion in patients with multiple sclerosis" Ann Neurol 2010; DOI: 10.1002/ana.22085.

Source: Medpage Today © 2004-2010 MedPage Today, LLC. (05/07/10)