The Liberation Treatment: A whole new approach to MS
Nine videos about CCSVINov. 21 2009CTV.ca News Staff
Amid the centuries-old castles of the ancient city of Ferrara is a
doctor who has come upon an entirely new idea about how to treat
multiple sclerosis, one that may profoundly change the lives of
patients.
Dr. Paolo Zamboni, a former vascular surgeon and professor at the
University of Ferrara in northern Italy, began asking questions about
the debilitating condition a decade ago, when his wife Elena, now 51,
was diagnosed with MS.
Watching his wife Elena struggle with the fatigue, muscle weakness
and visual problems of MS led Zamboni to begin an intense personal
search for the cause of her disease. He found that scientists who had
studied the brains of MS patients had noticed higher levels of iron in
their brain, not accounted for by age. The iron deposits had a unique
pattern, often forming in the core of the brain, clustered around the
veins that normally drain blood from the head. No one had ever fully
explained this phenomenon, considering the excess iron a toxic
byproduct of the MS itself.
Dr. Zamboni wondered if the iron came from blood improperly
collecting in the brain. Using Doppler ultrasound, he began examining
the necks of MS patients and made an extraordinary finding. Almost 100
per cent of the patients had a narrowing, twisting or outright blockage
of the veins that are supposed to flush blood from the brain. He then
checked these veins in healthy people, and found none of these
malformations. Nor did he find these blockages in those with other
neurological conditions.
"In my mind, this was unbelievable evidence that further study was
necessary to understand the link between venous function and iron
deposits on the other," Zamboni told W5 from his research lab in
Ferrara.
What was equally astounding, was that not only was the blood not
flowing out of the brain, it was "refluxing" reversing and flowing back
upwards. Zamboni believes that as the blood moves into the brain,
pressure builds in the veins, forcing blood into the brain's grey
matter where it sets off a host of reactions, possibly explaining the
symptoms of MS.
"For me, it was really unbelievable to understand that iron deposits
in MS were exactly around the veins. So probably, it is a dysfunction
of drainage of the veins," Zamboni said.
"This is very important, because iron is very dangerous, because it
produces free radicals, and free radicals are killers for cells. So we
need to eliminate iron accumulation."
Zamboni dubbed the vein disorder he discovered CCSVI, or Chronic
Cerebrospinal Venous Insufficiency, and began publishing his
preliminary research in neurology journals.
He soon found that the severity of the vein blockages were located
corresponded to the severity of the patient's symptoms. Patients with
only one vein blocked usually had milder forms of the disease; those
with two or more damaged veins had more severe illness.
Zamboni found blockages not only in the veins in the neck directly
beneath the brain -- the jugular veins --but in a central drainage
vein, the azygos vein, which flushes blood down from the brain along
the spine. Blockages here, he found were associated with the most
severe form of MS, primary progressive, in which patients rapidly
deteriorate. For this form of MS, there currently is no effective
treatment.
As for how these vein abnormalities form, Zamboni isn't sure. He
believes, though, that congenital defects, problems that likely formed
before birth, can be blamed for most of the problems, though this has
not been conclusively proven.
Most neurologists Zamboni initially approached with his findings
dismissed them. But one specialist, Dr. F. Salvi, at Bellaria Hospital
in Bologna, was intrigued by the concept. He began sending Zamboni MS
patients for CCSVI testing, to see if what he was finding was correct.
The images of narrowed or blocked veins, called "strictures," were
irrefutable for Salvi.
Focus on a treatment
But Dr. Zamboni had an even more important idea. If key veins of MS
patients were blocked, perhaps he could open them and restore normal
blood flow?
Taking a page from standard angiography, in which doctors use
balloons to open up blocked arteries that feed blood from the heart, he
enlisted the help of vascular surgeon Dr. R. Galeotti, also at the
University of Ferrara and Santa Anna Hospital. Three years ago, the
team began a study in which they treated 65 MS patients to see if
endovascular surgery would restore flow in these vessels and lessen MS
symptoms.
The study detailing those results will be published in the Journal
of Vascular Surgery on Nov. 24. But preliminary results, already
released, show patients had a decrease in the number of new MS attacks,
a big reduction in the number of brain lesions that define MS, and
improved quality of life. The only time symptoms returned for the
patients was when the veins re-narrowed.
Because the surgery freed the blood flow, the team dubbed the procedure "The Liberation Treatment."
Zamboni's sense is that the earlier patients are diagnosed and
treated, the more function they will preserve, and the less damage the
improper blood flow will do to the brain.
"Because MS is a progressive disease and strikes young people, if we
lose time, there are a lot of young people that will progress without
possibility to get back. This is very heavy for me," he says.
Zamboni has also been studying the prevalence of CCSVI with a team
at the University of Buffalo in New York, in collaboration with Dr. Robert Zivadinov. That study, to be published in January, has looked at
16 MS patients, including eight from the U.S and eight from Italy. All
have been found to have blocked veins of CCSVI, just as Zamboni
described, and all eventually underwent the Liberation Treatment.
Relief for patients
One of those patients was Buffalo resident Kevin Lipp. Lipp had MS
for over a decade, and as part of the study, discovered he had five
blocked veins in his neck. After undergoing the Liberation Treatment 10
months ago, he says he hasn't had a single new MS attack.
Zamboni emphasizes that the Liberation Treatment does not make
people in wheelchairs walk again. Rather, it seems to stop the
development of further MS attacks, and in some cases, improves movement
and decreases the debilitating fatigue that are the hallmarks of MS.
The foundation that has sponsored Zamboni's research, the Hilarescere Foundation, also urges cautious restraint.
"We can't give the illusion to patients that this is a guaranteed
treatment and it is easy. This is not right. And we have never done
this," says Hilarescere President Fabio Roversi-Monaco. "We don't say
this is a cure for M.S. We only say that research is advancing, and
there is encouraging data but we are waiting for more conclusions."
Dr. Zivadinov in Buffalo is now starting a new study, recruiting
1,600 adults and 100 children, half of them MS patients. He plans to
use ultrasound and MRI scans to confirm if those with MS also have
CCSVI and if their family members have the abnormalities too.
Prof. Mark Haake, a neuro-imaging scientist at McMaster University
and Wayne State University in Detroit is also intrigued by Zamboni's
findings. He has long been seeing iron deposits in the brains of MS
patients using a specialized MRI analysis called SWI - specific
weighted imaging. When he saw Zamboni's initial publications, he
immediately contacted the Italian doctor and began collaborating.
Population studies under way
Haake too is initiating a study, asking neurological centres across
North America and Europe to take some extra MRI scans of the neck and
upper chest of MS patients. The scans can then be electronically sent
to his research team for analysis. He believes this grassroots approach
could spur larger and more in depth studies. He's hoping he can engage
MS specialists and vascular surgeons, interventional radiologist around
the world to study the theory and then move to diagnosing and treating
MS patients quickly.
"I think patients do play a role, because there are millions and
millions of dollars donated to MS Societies and a lot of money set
aside by the government to study MS research and right now, 99.9 per
cent of that money goes somewhere else," he told W5.
"So the patients need to speak up and say 'We want something like
this investigated, at least at an early stage, to see if there is
credence to this theory.' Even if it is 10 or 20 per cent of these
people who can be helped, that needs to be investigated," says Haacke.
Haake's research is being done with no funding; he's unwilling to
wait the nine months to a year needed to get formal research funding
applications approved. Urgency, he says, is needed in finding the
answer to the question of whether Dr. Zamboni is right.
"Certainly, I continue my battle because I am fully convinced that this is the right thing for the patient," he says.
The MS Societies of Canada and the U.S. are reticent to support
Zamboni's theories. They maintain that: "Based on results published
about these findings to date, there is not enough evidence to say that
obstruction of veins causes MS... It is still not clear whether
relieving venous obstructions would be beneficial."
Interest in CCSVI growing
But CCSVI has become a subject of intense interest among MS patients
who are texting and emailing details of Zamboni's work, locating the
few centres around the world that have started to work on studies on
CCSVI and the Liberation Treatment.
Zamboni says every day, MS patients hear about his theory and either
write, email or call him asking for treatment he can't yet provide.
Still, some surgeons in the U.S. are now offering the surgery Zamboni's
team has pioneered.
Jeff Beal, an L.A-based, Emmy-Award-winning musical director has
already paid to have the surgery procedure. After he was diagnosed with
MS five years ago, he was left unable to work a full day and worrying
he would spend the rest of his life in a wheelchair. Unable to come to
terms with the diagnosis, his wife, Joan, set to find new treatments
and eventually came upon Zamboni's work.
Unable to get her husband
treated in Italy, she convinced a Californian vascular surgeon who
already performs similar surgery on leg veins to look at Zamboni's work
and test Jeff for CCSVI. Jeff was diagnosed with two blocked jugular
veins and treated with the Liberation Treatment. (with a slightly
different procedure than the italan one..using Stents) He now says he
has much more energy and none of the chronic fatigue that used to limit
his activity.
"I reached what I would call sort of a higher plateau, in the sense
of the most debilitating symptom, which is the fatigue. So, I still
have fatigue every day, I still battle it; it's still one of my
symptoms. But in terms of the total reservoir of energy, it's much
greater than it used to be. And that's a huge gift, especially to my
family," Beal told W5.
His wife Joan was delighted with the surgery's results.
"Suddenly, he's helping Henry with his homework and he's playing
trumpet duets with Henry and he's awake. And there's this presence in
the house that hadn't been there for two years," she said.
Joan has now become a "cheerleader" of Zamboni's work on MS chat sites, urging other patients to show their neurologists the material
being published by the Italian team and to ask them to consider setting
up a study in other MS clinics.
Among all of Zamboni's success stories and the patients who sing his
praises is his wife Elena. Her MS caused her to lose her vision for a
time and develop what she called "violent" attacks. She had difficulty
walking and was losing her balance and feared a life in a wheelchair
unable to care for herself. Elena became one of her husband's first
ultrasound test patients and was found to have a complete closure of
the azygos vein in her central chest. She was one of the first to be
liberated almost three years ago. After having regular debilitating MS
attacks for nearly a decade before, Elena has been symptom-free ever
since. An elegant, intelligent woman, she now has a quick walk, with no
sign of disability. Her husband couldn't be happier.
"What I think is this is probably the best prize of the research," says Zamboni.