It’s no news that Canadians have been coming to the United States for many years to be treated by US physicians, out of pocket, because of the lack of timely care within their own country’s medical system. Now, patients from Canada, which has one of the world’s highest rates of MS, are flocking to America, Europe and even India for a new treatment that has been at the center of a heated debate since Dr. Paolo Zamboni from the University of Ferrara in Italy presented his initials findings from the procedure back in the fall of 2009.
While Zamboni’s data has undergone intense scrutiny, physicians have continued to independently investigate the possible link between MS and CC SVI in order to further understand the complex set of variables that seem to surround the two disorders. In June 2011, the decision by the Canadian federal government to fund clinical trials of Zamboni’s procedure came after a panel of scientific experts agreed unanimously that enough evidence exists to warrant them.
CCSVI: A Cure for MS?
MS has a long, nasty list of debilitating symptoms – chronic headaches, numbness or weakness in the limbs, vision blurring and pain, tingling and “shock” sensations, tremor, lack of coordination, fatigue, and dizziness. Muscle stiffness, spasms, paralysis, bladder and bowel problems, forgetfulness, depression and epilepsy can complicate matters worse. The possibility of developing multiple sclerosis increases if thyroid disease, type 1 diabetes or inflammatory bowel disease already exist. Indeed, MS is one overwhelming disease. Patients and physicians alike are actively searching for answers in hopes of a cure. So how does CC SVI fit into the picture?
Dr. Michael Arata, an interventional radiologist and board certified phlebologist with Synergy, the Newport Beach, California-based surgical group, was invited by the Nancy Davis Foundation to present his data to a roomful of neurosurgeons in December. His presentation started off like this:
“How many of you here today think that CC SVI is a cure for MS?”
As no hands were raised in response, Dr. Arata continued, “Good. That establishes all of us on common ground.”
What exactly is CC SVI , then? According to Dr. Arata, “CC SVI is a chronic venous disorder and in some respects, it’s like having chronic venous insufficiency of the legs and turning it upside down 180 degrees. This is something that physicians should be aware of.” Arata also points out that the main CC SVI symptoms are really fatigue, constipation, urination issues, temperature regulation issues and the lack of ability to find the words one wants to say within the context of a normal conversation, or “brain fog.” Symptoms of CC SVI and the range of neurologic disorders like MS sometimes get confused. Arata explains, “This ‘new’ venous abnormality involves the valves of the jugular vein.
The symptoms are a result of the venous drainage problem that occurs when the valves, which are supposed to monitor and manage the blood flow, are sort of stuck open. The result is reflux. The trap door is stuck, and we don’t have the technology to make it normal. Since we don’t have the skill to make it work like new, we use a balloon that works like a hammer to open the door.”
Another abnormality would be that the valve never developed during maturity. The area stays small and it creates a funnel with the same type of blood restriction. “In that case, we do a venous angioplasty. Venous angioplasty works about 50% of the time,” explains Arata.
In the last year, we have seen more and more sessions on the topic of CC SVI at meetings and events. “Speaking from the pulpit of understanding the process and providing the info,” says Arata, “I realize that it may not be something your readers will ever treat. But I think that there is value in learning more about it. The more we make people aware, the more they will become interested and involved, and possibly drive more research and involvement in research.”
Why was Zamboni’s information so controversial? Dr. Arata speculates, “I think the extreme part of it was presented as a cure for MS. I really emphasize the point that it isn’t a cure, but a treatment for those issues that parallel MS and other neurological disorders.”
So while many get caught up in the debate, it is apparent that CC SVI symptoms can mirror MS symptoms, causing increased discomfort and disability – and confusion about which is which. “There is something connecting MS and CC SVI . But we [at Synergy] also see people with Parkinson’s Disease, Lou Gherig’s Disease and neuro lyme – those that run the same symptoms – and they have improvement as well. I don’t know what the link is, but I don’t think it’s actually that important right now,” says Arata. “More importantly, let’s work on finding out what exactly CC SVI is and let’s work together on finding a treatment for CC SVI – not trying to prove one is associated with or a cure for the other. It’s all still a matter of discovery and it really is fascinating. I wish it was more than observations; I just wish there was something with more scientific evidence being published about it.”
Regardless of the lack of scientific data regarding CC SVI , Dr. Arata has seen a significant number of patients – more than 800 in the last two years – and their treatments with the procedure have made drastic differences in the poor quality of life they had experienced before, compared to that which he saw after their visits to the operating room.
Is this still controversial since it is not a cure for MS? “In my perspective, it is still pretty controversial. There are articles that have been really damaging against it and the research we do have has not been conducted properly, so the confidence has been dismissed. I wouldn’t be surprised if most of my peers are hesitant to do this procedure. There are probably only a handful of doctors that I am aware of who are doing this out west in Arizona, California, Washington, Oregon, and Utah. There may be others that are emerging and this may become a subspecialty after more people dedicate their time and efforts together.
“For me, choosing to specialize in this – I’ve given up everything for something that’s pretty controversial – it was a bit of a roll of the dice. But the successes I’ve seen are amazing and the personal aspect of improvement from one day to another is definitely rewarding,” says Arata.
CCSVI From Two Patients’ Points of View
Dr. Arata was gracious enough to allow me to profile two of his patients through the procedure, in an effort to chronicle the typical experiences from the patient’s point of view.
Until this December, neither Georgette nor Robin knew one another, and if it weren’t for the fact that they both came from The Great White North on the same day for the controversial CC SVI treatment at Synergy’s facilities in Newport Beach, they never would have met. However, each of them flew south hoping for a miracle and ready to greet the New Year with a liberation of their very own.
Robin is a 51-year-old from Alberta who was diagnosed with MS in 1989. His first symptom was a loss of feeling in his fingertips. “I’m a mechanic, and I can’t fiddle with wires underneath the dash without feeling.” Another symptom was that one of his eyes started to shift, “It would go shooting off in one direction. I can see out of it a little, but I’m legally blind. I wouldn’t want to rely upon it.”
Utilizing a wheelchair for mobility, Robin has similar complaints to other CC SVI patients – fatigue, brain fog, sleep disturbance, frequent urination, and heat and cold intolerance are all at the top of Robin’s list. “Too much heat and I totally melt, and I wouldn’t be able to do anything because it drains all the strength from me. Too much cold, I shut down. Where I live, I have to have air conditioning because I can’t control my temperature at all. My feet have had so many problems; I have had to have four toenails removed.”
“I really want to show you the left valve, Robin,” commented Dr. Arata when reviewing the images he took of Robin’s jugular anatomy. “The valve itself is not working. Flow is present, but abnormal. If I improve the flow, we improve the symptoms. If we have a problem with a clot, your symptoms can actually get worse. This is why we recommend the blood thinner. We are exposing you to a risk of a bleeding complication.”
How did he find Dr. Arata and why did he choose him? “A friend of mine came here a year ago in January and he had a good outcome. Unfortunately, we’ve had a rough year. Maureen, [Robin’s wife,] was diagnosed with breast cancer in March of 2011, and so we had to put this procedure on hold. She finally finished radiation in November, so we were able to turn around and get this arranged in less than two weeks.”
Donations to the Canadian MS Society were used to fund Robin’s and Maureen’s trip to California for the treatment.
At 60, MS has been a part of Georgette’s daily grind for the majority of her life. Having been diagnosed at 27, she’s endured the decline in her ability to walk without assistance, she awakens from a poor sleep several times at night to urinate, and she suffers from a lack of ability to control her
core temperature. Referring to how others perceive her symptoms, she half-heartedly jokes, “I don’t drink alcohol, but it certainly seems as though I have been.
“When I was diagnosed, I went to the Canadian MS Society. ‘How did I get this?’ I asked. The answer was always, ‘We don’t know. We don’t know. We don’t know.’ No one person has the same symptoms as another; it’s a very personalized disease.”
Before coming to California, Georgette’s biggest complaint focused on her bladder problems. “I have to think about urination all the time. I’m the one who knows where all the bathrooms are at all of the places we go. There was a time that I used to sleep through the night, and then gradually, it sneaks up on you. It has gotten especially bad lately.”
What are the expectations from the procedure? “Nothing is 100 percent, and I don’t expect guarantees, but I hope for improvement in small degrees. Dr. Arata was saying that he could see things so clearly with the MR that he can foresee me not having any problems or return of problems, so we’ll find out.”
Georgette also expects that this will address many of the major fatigue issues and her purple feet resulting from poor circulation. “I’m sure everybody lumps all the symptoms they have together under some label. My ‘aha’ moment was when I read about other people with MS and learned about others who have gone through this procedure. I want to be able to get up tomorrow and go trotting around, feel active, walk the dogs. I don’t get to do the gardening anymore because of the fatigue. Maybe I’ll be able to go to New Zealand with Martin, [her husband]. I don’t expect this to be instantaneous. I understand the procedure.”
Martin’s take on the operation is also important to consider. “The only thing available to help her [frequent urination] before this was a drug and that came with undesirable side effects. And I like the fact that she’s not going to have to recover from a big procedure. Other than traveling from Canada, the walk-in process really is a benefit versus having to spend weeks in recovery. If you have the money, it is certainly worth a try.”
A monetary gift from Martin’s late aunt upon her death made it possible for Georgette and Martin to travel so far away from home for this expensive out-of-pocket procedure.
Placebo Effect or Real Results?
Dr. Arata brings up an interesting point to ponder. “Many people wonder if this could this be a placebo effect. Half of the time I go into a follow-up exam, the patient says there is no change initially. So, how do you say that this is a placebo when it’s only after I go through each symptom that the patient realizes what has happened?
“So many symptoms occur at one time, it does get
overwhelming. But when I break down the symptoms, they
say there has been a change. The CC SVI symptom effect is
essentially immediate. Pull the cork, and it drains. There is
actually some physiology to the blood flow changes. We can
see some changes within minutes to hours, but generally
speaking, you have experienced everything that will come
from the procedure within 24-48 hours.”
What was one of Dr. Arata’s biggest successes? “One patient I saw had literally zero percent short-term memory. More than 20 times during the procedure she asked me what she was having done. After I was done, she had the benefit of her short term memory return, and she actually remembered that she had the procedure done! How can that be a placebo? And if it is a placebo, patients find that months down the road, this was the best ‘placebo’ they’ve ever had!”
Robin – One Day Post-op
“Any improvements, Robin?” asks Arata. “I think so,” answers Robin. “Oh, wow! Your hand is hot!” smiles Arata. “That’s a big difference from Monday!” Following the list of complaints from two days earlier, Dr. Arata reviews each one with Robin.
Lower extremity strength? “Seems better today, I’m usually really stiff in my legs and today my legs were much more flexible. I was able to transfer myself to my wheelchair without help.” Dr. Arata explains, “Well, that is your core strength, which is not CC SVI . However, when we see improvements like these, it’s very encouraging. These are the best prognostic signs of recovery.”
Bowel movements improved? “Let’s just say ‘Yes,’ I was a bit surprised! This last year I was only going once every four days.”
Hands and feet? “They’re warmer, my feet are warmer.
My right hand feels good and limber. My left arm, which is usually very shaky, is steady. My ankle is a bit puffy, which I haven’t recognized before. But my toes don’t hurt. They usually hurt, but they don’t seem to right now.”
How about sleep? “I rested so much during the day that at night I had a hard time sleeping, but I felt much better.”
How’s your energy? “Great. I feel pretty good.” Arata replies, “Great. Now exercise is the most important element to your recovery. This is not just for now, this is for the rest of your life. I also encourage you to follow some lifestyle modifications, like trying a gluten-free diet. Nowadays, it is not as hard as it used to be to go gluten free. But you can’t just do it here and there, you’re either gluten free or you’re not.”
What about urination? “Well, not so good. In the eight hours that I was lying down, I had to get up five times.” Dr. Arata comments that they’ve encouraged Robin to drink fluids, and during the procedure, IV fluids are used, so the urination issue isn’t going to be any better for another day or so, after his body has had time to eliminate the extra fluids.
The key to all of this, explains Arata, is that this is just one piece to the puzzle. The 20-minute proced re is just a brief snapshot of time. “We’ve relieved that pressure so many of your symptoms will improve immediately. They will continue to improve, too.”
Robin – One Month Follow-up (via email)
“My MS fatigue is gone, my eyesight is returning to my right eye, my hands and feet are warm. I still cannot walk, but I am working on strengthening my legs. Most noteworthy is that my fatigue is gone. On Christmas day, for the first time in a long time, we went to my mom’s for dinner and then over to my sister’s place and I didn’t get tired.” And what about the urination and frequency? Do you still have to get up at night? “At night I still have to get up every hour, but during the day, it is now only every three to four hours.”
Georgette – One Day Post-op
“How do you feel today?” asks Arata. “Well, I’m not sure exactly. My foot is still swollen, but not purple like it always is. My temperature is pretty normal. Martin didn’t levitate off the bed when my feet touched him, which usually happens.”
How did you sleep? “Like a rock, except for getting up to go to the bathroom. It still interrupted my sleep.” Dr. Arata explains that the symptoms still may change due to the amount of fluids she was given orally and through IV .
How is your energy? “I feel pretty good. I don’t know about doing anything because I haven’t really done anything yet. I did notice that my right foot, which usually drags, didn’t today.” Dr. Arata notes that “foot drop” is an MS complaint, but that this improvement is a good sign.
How is the constipation? “I’m a little less constipated. I’m used to being constipated and I actually went to the bathroom and wasn’t.” Arata points out, “This is related to CC SVI , not MS, so that’s great.”
And your brain fog? Do you feel like you are thinking more clearly? “Yes, I feel more chipper.” Martin chimes in, “Yes, she’s getting more mouthy! There seems to be less word-finding issues.” Dr. Arata says this is one of the biggest components of CC SVI .
Okay, how about your temperature issues? “I seem warmer, but we’ll see when I get back home.” Arata explains, “Thermal issues, extremities, change in temperature – with CC SVI , your body can’t adjust temperature like it should. Since you can’t maintain the normal pressure, your core temperature is going to change and you’ll be uncomfortable. Hopefully that part will change and you’ll see improvements in those areas. Normally, CC SVI response is delayed.”
And do you have any other changes? “I haven’t noticed any numbness, which is an improvement.” Dr. Arata describes the process, “The signal that tells the muscle to move is increased with the CC SVI procedure. Muscle is atrophied, so that process to repair it will take months. Walking is going to reverse that process; as the signal reaches the muscles, it will continue to increase the strength. Exercise is most important in my opinion. I also recommend a glutenfree diet. It’s really important.”
Until we have more data from clinical trials, all we can go on is patient results. While the industry works to obtain evidence-based research on this phenomenon, we will just have to wait for the hard data. But in the meantime, patients are booking appointments at a steady pace, bringing more opportunities to liberate Canadians, and in some way the physicians themselves, who continue to provide what they believe to be a viable solution for CC SVI sufferers.