SIR: Vascular MS Treatments Safe, but Efficacy Unclear

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

SIR: Vascular MS Treatments Safe, but Efficacy Unclear

Postby Onthelake » Fri Apr 01, 2011 8:28 pm

http://www.medpagetoday.com/MeetingCoverage/SIR/25651

There is a video on the web page....here is the written part...Dr. Dake is quoted here...

SIR: Vascular MS Treatments Safe, but Efficacy Unclear

CHICAGO -- Angioplasty for obstructed veins leading away from the brain and spine appears safe for multiple sclerosis patients, although whether it holds any more than a placebo effect for the degenerative disease remains to be proven.

That was the conclusion of several single-center series reported here at the Society of Interventional Radiology meeting on the controversial treatments for what has been termed chronic cerebrospinal venous insufficiency (CCSVI).

No Shortage of Questions

"Currently there are many unknowns and lots of uncertainty," said Michael D. Dake, MD, of Stanford University in Palo Alto, Calif., who called the field "a zone of chaos" in a session dedicated to the debate.

Venous angioplasty for CCSVI has generated enormous demand among MS patients, but there has been deep skepticism from the neurology community.

The theory is that blocked venous flow leaves iron deposits in the central nervous system that create the hallmark inflammation of MS -- not the autoimmune process conventionally thought responsible for the disease. The idea was raised by an Italian group that reported CCSVI in nearly every MS patient they studied; they then found MS symptoms improved in many patients who were treated with angioplasty.

Diagnosis has proven challenging, with many studies failing to replicate this high incidence of CCSVI.

Another problem is that poor central venous flow, malformed venous valves, and other problems in the jugular and azygos veins found in MS patients don't always translate to elevated pressure or other clear clinical relevance, noted Dake, who spoke at the session.

"Just because we see anatomic problems, does that really have any physiologic relevance?" he asked attendees, noting that diagnosing serious and significant lesions in veins is totally different from doing so for arteries.

No Room for Cowboys

An Ann Arbor, Mich., interventionist in the audience said he had treated one MS patient to spectacular effect despite no clear venous stenosis but "felt like the emperor putting on his new clothes, treating something I wasn't really sure what I was doing."

"We acknowledge that maybe the genie is out of the bottle with a lot of centers doing this," responded session moderator Ziv J. Haskal, MD, of the University of Maryland Medical Center in Baltimore.

He and others leading the charge in vascular MS treatments urged others at the meeting who are considering doing the procedure to practice safely in a controlled environment with methodical collection of data "and not have this become a Wild West situation."

That's what Kenneth Mandato, MD, of Albany Medical Center, Albany, N.Y., and colleagues decided to do.

The group reported outcomes of 231 CCSVI patients with MS treated with angioplasty under mild sedation at their hospital or medical offices nearby.

In their experience, 99.2% of patients were discharged within three hours of treatment. One patient had to be hospitalized for sustained arrhythmia (0.4%).

Major complications occurred in three patients (1.2%), all of whom had post-procedural venous thrombosis within 30 days and one of whom also had stress-induced cardiomyopathy (0.4%). Minor complications included the following:

•Thrombosis or dissection after angioplasty requiring stent placement in 10.5%
•Transient headache for 9.1%
•Transient neck discomfort for 16.9%
•Hives from x-ray contrast in 2.8%
•Transient arrhythmia in 0.9%

Since then, more MS patients have been treated with fewer complications, driving down the center's complication rates, Mandato noted.

"This is not a new technology," Mandato emphasized at a press conference where the results were discussed.

A second study of 24 MS patients treated by angioplasty with stenting in some cases for CCSVI yielded one case of inguinal bleeding, two cases of inguinal hematoma, and one retroperitoneal hematoma.

The initial clinical effect was "significant" improvement in MS symptoms in 16 of the 24 and "slight" improvement in five, with the other three seeing no benefit, reported João Martins Pisco, MD, of Hospital Pulido Valente and St. Louis Hospital in Lisbon, Portugal.

By six to eight months later, eight patients had a recurrence of venous obstruction, and one patient each downgraded their improvement to slight or none.

Haskal reported on another series of 18 consecutive MS patients treated for CCSVI with "uniformly positive" patient-reported improvements in outcomes and quality of life. The group also documented objective motor and balance improvements.

Complications included one case of contained left internal jugular vein valve rupture, resolved with balloon tamponade and stenting.

Mandato also anecdotally reported positive changes in symptoms for treated MS patients across the board for those with less severe disease to wheelchair-bound patients.

No Blanket Solution

While confirmation of efficacy will take much larger trials, these early safety reports are a reassuring backbone to support them, according to Mandato co-author Gary P. Siskin, MD, also of Albany Medical Center.

Three deaths have been reported in the worldwide experience with vascular treatments for MS, he noted, but all have been related to blood thinner or anticoagulant use.

"We acknowledge there are risks with this procedure, and we do believe, based on the data presented here, that overall this is a safe procedure with a very low risk of major complications," he told MedPage Today.

The Society of Interventional Radiology position is that physicians, in the face of inconclusive evidence, have to make the decision with patients and their families on an individual basis, taking into consideration disease status and response to prior therapies.

"The problem is these are really desperate patients," Lindsay Machan, MD, of the University of British Columbia Hospital in Vancouver, told MedPage Today.

With MS patient groups promoting the procedure over the Internet and through social networking, patients are jumping ahead of the scientific process to call asking for treatment, he said.

"This is an insight into our future as physicians," he predicted.


Action Points
--------------------------------------------------------------------------------

■Note that these studies were published as abstracts and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.




■Note that endovascular treatment of the internal jugular and azygos veins for chronic cerebrospinal venous insufficiency in patients with MS was a safe procedure when performed on an outpatient basis in this study.




■Point out that sustained cardiac arrhythmias were observed in three patients during the procedure, suggesting that cardiac monitoring should be considered as an essential component.
Onthelake

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Postby EJC » Sat Apr 02, 2011 11:12 am

That reads like a pretty balanced article to me.

All of this is in it's infancy. It's nice to read that people are honest enough to say they've found it safe to do, they are getting results they don't fully understand and they are not sure why it's producing these results.

Step in the right direction as far as i'm concerned.

Medicine advances with people asking questions like these.
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Postby Cece » Mon Apr 04, 2011 9:51 pm

Some interesting points raised:

Is CCSVI treatment "a zone of chaos," as Dr. Dake suggested?

He says that diagnosing serious and significant lesions in veins is totally different from doing so for arteries, do we understand how it is different? Do all our IRs understand?

Is it more similar to "emperor's new clothes" (treating something despite little understanding of what's being done), "wild wild west" with our cowboy IRs, or "genie out of the bottle" with so many IRs starting up? (The Michigan IR suggested the first analogy, the latter two are Dr. Haskal.) Or do we have even more analogies?

What about this: "'This is not a new technology,' Mandato emphasized at a press conference where the results [edited: of their safety study, with the conclusion that it was safe] were discussed."
This is not a new technology! Cowboy up.... :)

Dr. Haskal has findings, including motor improvements!
Haskal reported on another series of 18 consecutive MS patients treated for CCSVI with "uniformly positive" patient-reported improvements in outcomes and quality of life. The group also documented objective motor and balance improvements.


And this is very positive:
Mandato also anecdotally reported positive changes in symptoms for treated MS patients across the board for those with less severe disease to wheelchair-bound patients.

It helped people with less severe disease, it helped people in wheelchairs. Just having something that helps is really needed.

I agree with this:
While confirmation of efficacy will take much larger trials, these early safety reports are a reassuring backbone to support them, according to Mandato co-author Gary P. Siskin, MD, also of Albany Medical Center.


Three deaths have been reported in the worldwide experience with vascular treatments for MS, he noted, but all have been related to blood thinner or anticoagulant use.

Is there a third death? Does anyone know?
Does thombolysis causing internal bleeding count as a blood thinner-related death? That's not really a blood thinner, it's a clot busting drug. I know it's nitpicky but details matter. Some patients here may end up in a situation with a clot treated with thombolysis, it is good to know if there are risks.

With MS patient groups promoting the procedure over the Internet and through social networking, patients are jumping ahead of the scientific process to call asking for treatment, he said.

The scientific process has shown that there's a high association between jugular and azygos blockages and MS. Maybe we are not jumping ahead of the scientific process, maybe we are the scientific process. The pioneers, the guinea pigs.
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Postby 1eye » Tue Apr 05, 2011 1:34 am

Cece wrote:Some interesting points raised:

Is CCSVI treatment "a zone of chaos," as Dr. Dake suggested?

He says that diagnosing serious and significant lesions in veins is totally different from doing so for arteries, do we understand how it is different? Do all our IRs understand?

....

maybe we are the scientific process. The pioneers, the guinea pigs.


As people are fond of saying around here: BINGO!

Who else? Not all the ones treated, because there are a lot more of those, but the ones willing to talk about it. There are the unwilling private experimenters, but we denizens of the Internet are eager to seek truth and shed light, including both CCSVI's failures and successes.

To me, the most significant thing about it is what it may offer to the hopeless, the wheelchair and bed bound, and the dying, and their loved ones. Descriptions of the effects of this treatment on them bring tears.

When they were finding treatments for rabies, leprosy, polio, diabetes, were there very many besides patients, family, and friends, who were even interested, let alone skeptical? I think the pathological interest shown by doctors in this, and attempts to derail it are directly proportional to the ungodly huge sums of money being made by some drug companies and their paid medical experts.

I have always found these sums of money, when compared to the costs of real treatments such as insulin, to be obscene. The incomes of many perfectly healthy and gainfully employed citizens in poorer countries would be required to provide for even one North American person's 'MS' drugs, and they hardly even do anything! I gave myself Interferon for 7 years, because of the snow-job done on me by the neurologists. I think there are a lot fewer 'MS' than other kinds of neurologists, because the rest are too ashamed to participate. This has got to be the biggest scam of all time. Considering what has happened with AIDS drugs in poorer countries, 'MS' must be a forgotten disease in those places.

So yes, such as it is, we are the scientific process. We who have no great sums invested in our treatment, but only our more modest interest in our own health. We are called desperate a lot, but I think it pales in comparison to the desperation of those trying to protect the scam, those who would sell invisible clothes to emperors.
"Try - Just A Little Bit Harder" - Janis Joplin
CCSVI procedure Albany Aug 2010
'MS' is over - if you want it
Patients sans/without patience
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Re: SIR: Vascular MS Treatments Safe, but Efficacy Unclear

Postby Cece » Tue Mar 20, 2012 5:48 pm

From last year's SIR, as we look forward to this year's SIR!
This came up in a google search for something else, but I thought I'd add it here:
http://www.medscape.com/viewarticle/740291
Cerebrospinal Venous Angioplasty Safe in MS
Ziv J. Haskal, MD, FSIR, FACR, FAHA, FCIRSE, chief of vascular and interventional radiology at the University of Maryland Medical Center in Baltimore, spoke with Medscape Medical News and described this approach to treating MS as "the most controversial thing I've seen in almost 30 years."
Controversial indeed!
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