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Unblocking veins in multiple sclerosis: New U.S. study supports Zamboni’s CCSVI theory
Eight months ago, on the advice of Canadian Institutes of Health Research (CIHR) president, Alain Beaudet, federal Health Minister Leona Aglukkaq announced funding for an early (phase 1/2) clinical study of venoplasty (the so-called “ liberation treatment ”) for chronic cerebrospinal venous insufficiency ( CCSVI).

This condition, resulting from blockages in neck or chest veins that drain blood from the brain, has been postulated by Dr. Paolo Zamboni to be an underlying cause of multiple sclerosis.

Several months prior to Ms. Aglukkaq’s announcement, Saskatchewan Premier Brad Wall, whose province has one of the world’s highest rates of MS, committed $5 million for a clinical trial of liberation therapy. However, at the time of the federal go-ahead, plans for the Saskatchewan trial remained in limbo after a proposed study was rejected by the premier’s panel of experts.

Then, in early January, with a national Canadian trial still far off, Saskatchewan moved forward, signing a $2.5 million agreement to send patients to participate in a U.S. government-approved clinical CCSVI trial headed by Dr. Gary Siskin, an interventional radiologist at the Albany Medical Center in New York.

Given the already considerable expertise of Siskin and his colleagues in safely performing venoplasties on hundreds of patients with MS, Saskatchewan’s decision appeared to be a savvy one.

Commenting on his province’s commitment, health minister Don McMorris stated, "Patients need answers as soon as possible about the efficacy of the Liberation Therapy as a treatment for MS. We owe it to them to explore every opportunity to advance MS research and find answers about this treatment. This clinical study will enable Saskatchewan patients to be involved quite quickly in a [double-blind] controlled, reputable research process."

In reply, Dr. Siskin stated, "Our research team is very excited about this partnership. We welcome the opportunity to involve Saskatchewan patients in our efforts to gather reliable data that can help determine whether [venoplasty] effectively relieves MS symptoms.”

Now, just three months after signing the agreement with Saskatchewan, Dr. Siskin’s team has reported the results of an earlier phase 2 study that suggest it does.

Here are the findings, presented by Siskin’s colleague, Dr. Ken Mandato, at this weekend’s annual meeting of the Society of Interventional Radiologists in San Francisco.

During a 4-month period, the Albany group performed venoplasties on 192 MS patients (average age 48.5 years; one-third were male and two-thirds were female). The study group included:

96 patients (50%) with relapsing remitting (RR) MS
66 (34%) with secondary progressive (SP) MS
30 (16%) with primary progressive (PP) MS.

In all, 189 patients (98.4%) underwent balloon venoplasty alone; three (1.6%) underwent venoplasty with stent placement. An average of 2.2 blocked veins were treated per procedure.

Both before and after undergoing venoplasty, all patients completed a Multiple Sclerosis Quality of Life (MSQOL-54) questionnaire that scored 14 components of physical health (PH) and mental health (MH). Pre- and post-treatment PH/MH scores were compared to determine the effect of the venoplasty treatment on the quality of life based on each patient’s subtype of MS and the number of years since diagnosis.

The result? A significant improvement in PH/MH scores was observed in approximately 75% of patients with RRMS and PPMS and in approximately 55% of patients with SPMS.

PH and MH improvement was seen in approximately 75% of patients with a diagnosis of MS made less than 10 years previously and in approximately 63% whose diagnosis was made more than 10 years previously.

On average, patients benefited for 3.5 months following venoplasty.

Commenting on his group’s findings, Dr. Mandato, stated:

“Results of the study were quite exciting and promising. We can attest to significant physical improvements…in greater than 75 percent of those with relapsing remitting and primary progressive forms of multiple sclerosis. Additionally, mental health scores improved in greater than 70 percent of individuals studied.

“[We] hope that this work will provide insights into the design of a prospective, randomized trial that is needed to rigorously evaluate the role of this treatment in MS,” he continued. "As we are still early in fully understanding the condition and its relation to treatment of CCSVI, it is our hope that future double-blinded prospective studies will be performed to further assess the durability of these results."

Happily that “future” trial is to start this month (March, 2012) and, thanks to Premier Brad Wall and his government, it will include Saskatchewan residents.

According to the government of Saskatchewan website:

“Applications are now closed for Saskatchewan multiple sclerosis (MS) patients interested in volunteering for a clinical trial in Albany, New York. The two-year, double-blind clinical trial at Albany Medical Centre will accept 86 Saskatchewan MS patients. In total, 682 people submitted applications online or by phone before the February 24 deadline.

"The high interest in this opportunity shows just how committed Saskatchewan people are to finding answers about MS and being part of a possible solution," Highways Minister Jim Reiter said on behalf of Health Minister Don McMorris. "We will be watching the research process unfold with great interest and with the hope that it will help MS patients in the future.”

According to the minister, “The first of the eligible Saskatchewan patients are expected to travel to Albany in March. Half of those participating [in the trial] will receive the Liberation Therapy procedure and half will receive a placebo procedure.”

So there we have it. Less than two years after committing to a clinical trial to test the CCSVI hypothesis, Brad Wall has kept his promise. Hooray for him.

Yet, I would be remiss if I failed to note my disappointment that, in doing so, Premier Wall has had to turn south, to Albany. Then again, what choice did he have? Over the last two years, while doctors and bureaucrats north of the border made a lot of noise (much of it “no-can-do” and anti-CCSVI), the Americans quietly got on with it, developed the necessary procedures, and generated preliminary clinical data, leaving Canadian medicine and scientific know-how far behind.

Will lessons be learned for the future? One can only hope...

Source: CTV © 2012 Bell Media (26/03/12)

It's good news. There's a slight difference between the title of the article, which is that the study supports Zamboni's theory, and the title of the thread, that it proves Zamboni's theory. Proof is level 1 evidence is randomized trials. Although I also think that proof is what can be seen such as imaging, ivus, and autopsy studies. Whatever the case, this is great news! It's nice to hear pro-American talk too. "The Americans quietly got on with it, developed the necessary procedures, and generated preliminary clinical data, leaving Canadian medicine and scientific know-how far behind." I wouldn't say though that Canada is far behind. There are many talented IRs in Canada who will learn as soon as they are allowed. Thanks for posting, milesap.

Success at this point is important. Albany has the experience necessary to produce some solid numbers. Far better than involving CDN IRs at this point.

I was surprised to hear average re-stenosis at 3.5 months! Clearly, we need to tame the veins in some way.

PN

PointsNorth, the part about 3.5 months was misstated in the article. The data only went up to 3.5 months, if this is the same study I think it is. So the benefits are known to last that long, and who knows how much longer.

http://www.news-medical.net/news/201203 ... th-MS.aspx

Just thought to include a different article, same info. Encouraging nonetheless.


Minimally invasive endovascular treatment for CCSVI is safe in patients with MS

Researchers who investigated the connection between chronic cerebrospinal venous insufficiency (a reported condition characterized as a blockage in the veins that drain blood from the brain and spinal cord and returns it to the heart) and multiple sclerosis indicate that a minimally invasive endovascular treatment for CCSVI, is safe and may produce "significant," short-term improvement in physical- and mental health-related quality of life in individuals with MS. These findings were presented at the Society of Interventional Radiology's 37th Annual Scientific Meeting in San Francisco, Calif.

An estimated 400,000 people in the United States with MS-generally thought of as an incurable, disabling neurologic disease-may find hope that symptom relief is possible. MS is typically treated with disease-modifying drugs, which modulate or suppress the immune response believed to be central in the progression of the disease.

"Traditional theories surrounding treatment for multiple sclerosis in large part focus on autoimmune causes for brain pathology and neurologic symptoms. Based on this, treatment has been predominantly medications by mouth or injection," stated Kenneth Mandato, M.D., an interventional radiologist at Albany Medical Center in Albany, N.Y. "Interventional radiologists, pioneers in the field of minimally invasive therapies, have been performing an endovascular therapy called angioplasty for years, to treat blocked or narrowed arteries and veins. We have been using angioplasty to open jugular and azygos veins in the neck and chest respectively to improve blood flow in people with MS. On follow-up, we have seen many of these individuals report significant symptom relief," he added.

Classifications within a diagnosis of MS include primary progressive, which means a gradually progressive disease without remission; relapsing remitting, which demonstrates acute attacks with intervals of slow improvements in symptoms; secondary progressive, where a disease that was once relapsing remitting is now slowly progressing. MS subtypes within the Albany study group included 96 individuals with relapsing remitting, 66 with secondary progressive and 30 with primary progressive. The study population included those who underwent angioplasty alone and three who underwent angioplasty with a stent (a tiny mesh tube used to hold the vessel open) placement.

"Results of the study were quite exciting and promising," stated Mandato. "We can attest to significant physical improvements reported in greater than 75 percent of those with relapsing remitting and primary progressive forms of multiple sclerosis. Additionally, mental health scores improved in greater than 70 percent of individuals studied. People with secondary progressive multiple sclerosis showed statistically significant improvements in both physical and mental health scores at a rate of 59 percent and 50 percent, respectively," he added.

Page 2 of 2
"During a four-month period, we treated 213 individuals. 192 of these patients (72 men, 141 women; average age 49 years) responded to a standard questionnaire that evaluated key quality of life components including changes in physical abilities, health perception, energy/fatigue, sexual function, emotional well-being, cognition and pain," explained Meridith J. Englander, M.D., also an interventional radiologist at Albany Medical Center and one of the study's co-authors. "We ultimately broke this data down into physical and mental health scores for each person, and found improvement in both components of quality of life," she added. "In addition, we found a trend that patients undergoing this treatment more than 10 years after diagnosis did not respond as well as those with a more recent diagnosis."

"To address the needs and concerns of those with MS who feel they cannot wait until definitive studies are completed, many doctors are currently offering treatments with the hope of helping individuals with hard-to-manage symptoms of MS," said Mandato. "Physicians who perform these treatments hope that this work will provide insights into the design of a prospective, randomized trial that is needed to rigorously evaluate the role of this treatment in MS," he added

"As we are still early in fully understanding the condition and its relation to treatment of CCSVI, it is our hope that future double-blinded prospective studies will be performed to further assess the durability of these results," said Mandato.

Source: Society of Interventional Radiology

CureIous wrote: http://www.news-medical.net/news/201203 ... th-MS.aspx

Just thought to include a different article, same info. Encouraging nonetheless.


Minimally invasive endovascular treatment for CCSVI is safe in patients with MS

Researchers who investigated the connection between chronic cerebrospinal venous insufficiency (a reported condition characterized as a blockage in the veins that drain blood from the brain and spinal cord and returns it to the heart) and multiple sclerosis indicate that a minimally invasive endovascular treatment for CCSVI, is safe and may produce "significant," short-term improvement in physical- and mental health-related quality of life in individuals with MS. These findings were presented at the Society of Interventional Radiology's 37th Annual Scientific Meeting in San Francisco, Calif.

An estimated 400,000 people in the United States with MS-generally thought of as an incurable, disabling neurologic disease-may find hope that symptom relief is possible. MS is typically treated with disease-modifying drugs, which modulate or suppress the immune response believed to be central in the progression of the disease.

"Traditional theories surrounding treatment for multiple sclerosis in large part focus on autoimmune causes for brain pathology and neurologic symptoms. Based on this, treatment has been predominantly medications by mouth or injection," stated Kenneth Mandato, M.D., an interventional radiologist at Albany Medical Center in Albany, N.Y. "Interventional radiologists, pioneers in the field of minimally invasive therapies, have been performing an endovascular therapy called angioplasty for years, to treat blocked or narrowed arteries and veins. We have been using angioplasty to open jugular and azygos veins in the neck and chest respectively to improve blood flow in people with MS. On follow-up, we have seen many of these individuals report significant symptom relief," he added.

Classifications within a diagnosis of MS include primary progressive, which means a gradually progressive disease without remission; relapsing remitting, which demonstrates acute attacks with intervals of slow improvements in symptoms; secondary progressive, where a disease that was once relapsing remitting is now slowly progressing. MS subtypes within the Albany study group included 96 individuals with relapsing remitting, 66 with secondary progressive and 30 with primary progressive. The study population included those who underwent angioplasty alone and three who underwent angioplasty with a stent (a tiny mesh tube used to hold the vessel open) placement.

"Results of the study were quite exciting and promising," stated Mandato. "We can attest to significant physical improvements reported in greater than 75 percent of those with relapsing remitting and primary progressive forms of multiple sclerosis. Additionally, mental health scores improved in greater than 70 percent of individuals studied. People with secondary progressive multiple sclerosis showed statistically significant improvements in both physical and mental health scores at a rate of 59 percent and 50 percent, respectively," he added.

Page 2 of 2
"During a four-month period, we treated 213 individuals. 192 of these patients (72 men, 141 women; average age 49 years) responded to a standard questionnaire that evaluated key quality of life components including changes in physical abilities, health perception, energy/fatigue, sexual function, emotional well-being, cognition and pain," explained Meridith J. Englander, M.D., also an interventional radiologist at Albany Medical Center and one of the study's co-authors. "We ultimately broke this data down into physical and mental health scores for each person, and found improvement in both components of quality of life," she added. "In addition, we found a trend that patients undergoing this treatment more than 10 years after diagnosis did not respond as well as those with a more recent diagnosis."

"To address the needs and concerns of those with MS who feel they cannot wait until definitive studies are completed, many doctors are currently offering treatments with the hope of helping individuals with hard-to-manage symptoms of MS," said Mandato. "Physicians who perform these treatments hope that this work will provide insights into the design of a prospective, randomized trial that is needed to rigorously evaluate the role of this treatment in MS," he added

"As we are still early in fully understanding the condition and its relation to treatment of CCSVI, it is our hope that future double-blinded prospective studies will be performed to further assess the durability of these results," said Mandato.

Source: Society of Interventional Radiology

Have any of the other Canadian studies published or presented any results? Perhaps it was a good thing that this canadian trial was performed in the united states

there's the 18 month progress report from those studies:
http://www.nationalmssociety.org/news/n ... x?nid=5898

Dr. Fox's autopsy study was among them, and that has been presented at ECTRIMS, as well as this one: http://registration.akm.ch/einsicht.php ... KEN_ID=900
Skimming down, I see that Dr. Aaron Field has seven CCSVI-related abstracts submitted to three different conferences.
The problem is that these are all imaging studies, and not endovascular treatment studies.