On The Road to Liberation?

I just got back from Albany, New York and wanted to share my experience with the CCSVI procedure, aka the MS 'Liberation' treatment, one of the most controversial subjects in the MS community, pitting patients against neurologists, patients against politicians, politicians against each other, and even doctors against doctors (neurologists vs interventional radiologists).

Before delving into my weekend experience, I would like you to read Mark Walker's article which was published in the Telegraph a couple of weeks ago, 'MS experts in Britain have to open their minds’ (that's him above):

My wife’s reaction when she touched my feet on July 1 2010 was unexpected but very welcome. “They’re the same temperature and nearly the same colour,” Natasha announced excitedly. I should explain that my right foot has felt cold to the touch and been purplish in appearance for many years.

The day before, I had undergone a controversial treatment at a clinic in Athens and this was tantalising evidence that something had changed in my body as a result.

I am 51 years old and I have multiple sclerosis (MS). The first symptom – double vision lasting several weeks – developed in November 1991, although I did not receive a definitive diagnosis until April 1997. By 2000, I had accumulating symptoms including numbness, balance and bladder problems and a general feeling that, while it might not be yet apparent to my friends, MS was slowing me down in every way.

In January 2003, I was hit by physical and mental fatigue so debilitating that I could hardly get out of bed. I was forced to give up my much-loved job as a management consultant with IBM, something that left me depressed. I have never recovered sufficiently to return to work. Despite treatment with conventional drugs and therapies, my MS progressed steadily, with mobility on my right side increasingly impaired, and I have had several serious relapses when symptoms have increased in severity. As a qualified pharmacist, I have used my scientific knowledge to research the disease and its management thoroughly. I am what doctors call an “expert patient”. After 20 years of living with MS, I am willing to try any safe, logical therapy.

It was in October 2009 that I first heard about Professor Paolo Zamboni, director of the Centre for Vascular Diseases at the University of Ferrara in Italy. In 2005, his wife Elena was diagnosed with MS, and he embarked on a personal mission to discover everything he could about the disease, from medical literature dating back 100 years to the use of state-of-the-art body scanning techniques.

He concluded that the MS was, in part, a vascular disease caused by restricted, blocked, malformed or twisted veins or vein valves in the neck and trunk. A small clinical study appeared to back his claims. He named the syndrome “chronic cerebrospinal venous insufficiency” (CCSVI – see below) and set about developing treatment to unblock – or “de-stenose” – the veins so that healthy blood flow was restored. He claimed a dramatic improvement in his wife’s condition and that of other MS patients he treated.

News of Zamboni’s theory and treatment spread within the MS community via chatrooms and websites, leading hundreds of people around the world to seek the treatment, known as venoplasty (similar to angioplasty, in which a balloon is inserted into a blood vessel and inflated to remove a blockage).

In June last year I was interviewed by The Daily Telegraph about my battle – and failure – to obtain a diagnosis of, and treatment (if required) for, CCSVI in Britain and my decision to seek help abroad. Neurologists at my local hospital, the John Radcliffe in Oxford, claimed that it was not ethical or prudent to even attempt to diagnose CCSVI because of doubts about Zamboni’s work. Quite why it wasn’t “ethical” to use a safe, non-invasive diagnostic procedure (colour Doppler sonography) – which I was willing to pay for – to look at my veins continues to baffle me.

So I took my quest for venoplasty to a clinic in Athens which had treated many MS patients for CCSVI. You are reading the update on the treatment and my condition that readers were promised in that article.

I was the 45th MS patient to be seen by Constantinos “Costas” Kartkaletsis, a consultant vascular surgeon. After an initial examination, blood tests and a chest X-ray, he explained that a catheter would be inserted into the femoral vein in my groin and guided into my main trunk and neck veins. I was injected with anti-coagulant and put on a drip. I would have a local anaesthetic only and be fully conscious for the whole procedure.

I could feel the balloon inflating inside my veins but there was no pain. Restrictions were diagnosed in four major veins (the azygos vein, hemi-azygos, and the left and right internal jugular veins) in the trunk and neck, and all were treated using balloon venoplasty over three hours.

I had not expected any immediate impact, but Natasha’s surprise at the improved condition of my feet next morning left me elated. I could not explain what had happened but something had changed. Mr Kartkaletsis was interested in Natasha’s observation but he has a policy of treating restricted veins rather than commenting on any change in MS symptoms following treatment.

Back home, I planned complete relaxation for two months. I decided not to try to record frequent changes but to note trends on a monthly basis, as MS symptoms can vary daily.

At the end of the first month I felt my concentration had improved. People with MS use the term “cog fog” to describe the deterioration in cognitive functioning. Friends noticed that I no longer needed regular naps and that I focused better on conversations. After three months, I felt I was functioning mentally at least as well as I was a decade ago.

There were other changes, too: I’d had neuropathic pain (caused by damage to the nervous system) in my right leg for many years. That went and has not returned. After years of not recalling my dreams – an observation reported by many with long-term MS – I have, for the past six months, remembered them again. My need to get up at night to urinate also improved slightly, from three to six times to one to three times a night – something much appreciated by my wife.

My walking and balance have not changed over the past six months, and I still rely on my Musmate walking aid and trekking poles to get about. But, on the plus side, my osteopath David Harsant, at Oxfordshire’s Multiple Sclerosis Therapy Centre, who made extensive notes before and since the procedure, reports gradual improvement in muscle tone, stiffness and spasm in my neck and back. He says my neck muscles felt ''matted, congested and were indistinguishable.’’ but after the venoplasty ''the matted sensation reduced and the palpability of individual muscles increased”.

Professor Zamboni has reported that some patients may require repeat treatments if their veins “re-stenose” after venoplasty. Vascular specialists are defining the best way to diagnose restricted veins, the veins to check, the best size, position, pressure and duration of ballooning. I expect to undergo another procedure when the method is finalised.

CCSVI remains a controversial diagnosis, as does its treatment. However, MS patients are at the forefront of spreading the word and the internet is making that easier. I have watched a doctor from Kuwait present his work on CCSVI to vascular specialists in New York, and heard an interview with a research neurologist who has collated doctors’ reports on CCSVI. Expert patients like me are frustrated by the refusal of the MS establishment in Britain – neurologists and the MS Society – to accept the existence of this condition and consider testing for it. Since I went to Athens, testing for CCSVI and balloon venoplasty has become available to private patients at a clinic in Glasgow. The package costs £7,990 and there is already a waiting list.

Would I recommend the treatment to other MS patients? I would certainly encourage those with progressive MS to think about balloon venoplasty. There is a small risk of vein injury but, based on doctors’ web reports on 2,000 people treated, I believe there is a chance that it may slow or halt progression of the disease. I was lucky that the cost of private treatment was not prohibitive but sadly this is not the case for many. I have tried explaining to neurologists and vascular doctors why CCSVI syndrome should at least be considered as a possibility in patients with MS but to no avail. Only my caring, supportive GP was prepared to listen. Medical journals refuse to publish patients’ point of view – I know because I’ve tried that, too. One has to ask what the neurology establishment is so frightened of: opening the veins of those with MS or opening their own minds.

The Essential Health Clinic http://www.essentialhealthclinic.com/

MS and CCSVI syndrome

Multiple sclerosis (MS) is a degenerative disease of the nervous system affecting 100,000 people, most of them young adults, in the UK. It is believed to be autoimmune in origin, (meaning the immune system mistakenly attacks the body’s own cells) and triggered by genetic or environmental factors, or a combination of both. These cause immune cells to cross the blood/brain barrier (which keeps blood and cerebrospinal fluid separate) and attack the fatty, white myelin sheath that surrounds and insulates nerves in the brain and spinal cord.

The symptoms of MS vary widely, as does the severity of the disease. In some people, it progresses relentlessly. Other patients suffer the relapsing and remitting form – periods of relative good health interspersed with flare-ups and neurological deterioration. Several treatments are available of varying efficacy, including immuno-modulator drugs (which, as the name suggests, inhibit the immune system) and steroids.

Research by Professor Paolo Zamboni, director of the Centre for Vascular Diseases at the University of Ferrara in Italy, has led him to call for a radical rethink on MS. He suggests that MS is not only an autoimmune disease, but also a vascular one, caused by restricted, blocked, malformed or twisted veins in the trunk and neck. A small study showed that 90 per cent of his patients with MS had venous obstruction. Prof Zamboni has named the condition chronic cerebrospinal venous insufficiency (CCSVI) syndrome. It is characterised by stenoses (narrowing) of the internal jugular vein (which runs down the side of the neck) and/or the azygous veins (which run up the side of the vertebrae). These veins drain blood from the brain and the spine into the heart.

Prof Zamboni said that two pilot studies demonstrated the safety and feasibility of day surgery for treating CCSVI by means of balloon angioplasty, also called balloon venoplasty, using minimally invasive techniques to unblock the obstruction. As yet, only initial pilot studies have been published as to the effectiveness of this experimental treatment.

He also suggests that an excess of iron, which causes inflammation and cell death, was responsible for tipping the immune system out of balance, resulting in MS symptoms.

British neurologists and the Multiple Sclerosis Society are extremely sceptical of Prof Zamboni’s work, stating that MS patients should wait until ongoing research into his claims is completed before embarking on treatment.

More information from http://www.ccsvi.org/

I suggest you also read all the comments at the end of Mr. Walker's article. I had my procedure done by Dr. Gary Siskin, a vascular and interventional radiologists at Albany, New York (read his bio by clicking here). Dr. Siskin is the one interventional radiologist in North America who has the most experience with this procedure having performed over 600 of them. I embedded a YouTube discussion below which someone posted from a conference he gave last year (things have changed since then as he's become more knowledgeable).

Another benefit of Albany, New York is that it's close to Montreal. My younger brother, a psychiatrist, accompanied me down there. We left on Friday morning and went straight to the clinic which was relatively close to the hotel we stayed at (Hilton Garden Inn). Below, are my notes in point form with some humor to lighten up the topic:

• We got to the community health center right on time on Friday. My brother and his IPhone Apps! We also stopped off along the way and grabbed a quick bite at McDonald's (gross, we both regretted that move).
  
• The community health center on 711 Troy-Schenectady Rd looks like a huge shopping mall. Everything around there looks like a series of shopping malls. Total suburbia USA, which turned us off. And no wonder everyone has cars down there. If you don't have a car, you're screwed because public transportation sucks. (Update: I was told that my comments on suburbia USA are rude and they are! I apologize for these comments. People in these small towns work hard and they're very nice.)
• Once we reached Dr. Siskin's office (suite 113), the staff were very nice. A technician performed an ultrasound on my neck but she told us that the venogram would be done Saturday morning along with the procedure. This part is a little bullshit. An ultrasound isn't the best way to check for venal strenosis. A close buddy of mine, a radiologist at the Jewish General Hospital in Montreal, told me that only CT venogram can show you if your veins are truly blocked. Also, an ultrasound cannot tell you about blockage in your azygos vein, which they did mention in Albany (see update below with Dr. Siskin's comments).
  
• On Friday night, we went driving around Albany to find a decent restaurant. There aren't many good ones. Americans love fast food crap. I personally would pass a law banning all these restaurant chains because they're killing millions of people every year (I know, people can choose not to eat fast food crap but when crap is all they're offering you, then you're bound to eat it).
• We took the advice from a lady working at the hotel and found a decent restaurant on Delaware avenue called New World Bistro Bar. They have a funky menu and offer gluten free meals. All I remember is that their organic salmon was the best salmon I ever ate in my life! Went back to the hotel, rented The Fighter, which was a pretty good movie and hit the sack.
• On Saturday morning, I was a bit nervous. We got to the clinic at around 11:00 a.m. where I filled out a questionnaire and consent form. I paid $8,150 for the procedure. It would have cost me less ($6,500) but I was on a cancellation list since I live close by and because Dr. Siskin and his staff were working on a weekend, it cost me more. I just wanted to get it over with as soon as possible (the waiting list is over a year; I called them back in October. Canadians should know this procedure is tax deductible).
  
• In the waiting room, I spoke with a man who's wife was undergoing the treatment ahead of me. She had MS roughly as long as I did (14 years). I was surprised because he, his wife and her sister traveled all the way from San Francisco for the procedure. I told him that another lady I know did her treatment at Pacific Interventionalist at Newport, California and she was very pleased with her results. I also told him that I take no medication whatsoever now except for high dose vitamin D in drops (I'm up to 30,000 IUs but lost a lot of weight so will have to go through blood tests to make sure everything is fine).
• I also saw a severely disabled MS patient in the waiting room. It was tough for me to see that because I know this treatment isn't a cure and while it may slow the progression of the disease, it doesn't remyelinate nerves. We need to find ways to grow nerves safely for a true cure (there is hope on the horizon, but it's years away).
• I finally got called into the operating area, undressed and waited for Dr. Siskin. My brother was with me prior to the procedure so we can ask him some questions. Dr. Siskin doesn't sell hope or hype (see video below), but he did neglect to mention something to me which concerned my brother. He said that stents are not a first line treatment but in case of a complication, "we may need to put one in". "What complication?," I asked. "If for example you vein gets worse following the balloon angioplasty, then it can clot so we recommend a stent. Stents have bad press but if your vein gets worse after angioplasty, your risk of clotting is high and you'll need a stent and will take blood thinner for the rest of your life. Luckily, this rarely happens (less than 5%) but it's possible". (This should be told to patients prior to traveling to Albany).
• Took my risk and decided to follow through. I took two Valiums to calm me (everyone has to), they did a blood test for my kidneys and off I went into the operating room. The whole procedure lasts about 40 minutes. They made a small incision next to my groin to pass the tube and get into all my veins. Some contrast is used for imaging (make sure you're not allergic).
  
• I was awake throughout. The staff was excellent. I chatted with them about the US economy and they told me only the folks on Wall Street are doing well. One nurse blasted unions and she told me liked Gov Christie in New Jersey. But they told me things have stabilized and there are jobs in health care (but nobody wants to work in their field).
• When Dr. Siskin came in, he started ballooning my left jugular vein which was painless. But when he ballooned the azygos, I felt pain (it wasn't pleasant at all!). But before I knew it, it was all over. I was wheeled out and spent 45 minutes outside as they monitored my blood pressure. I was told that I would need to take an aspirin a day for six months (325 mg and then a baby aspirin for the rest of my life, which is another thing you should know).
  
• I was very woozy and very tired. I took it easy for the rest of the day. Drove around Albany with my brother (not much to see but some nice historic buildings downtown), had some dinner at the Real Seafood Company (nothing great), and went back to the hotel to sleep.
  
• This morning I woke up feeling much better, had breakfast, got ready and we took I-87 North to head back to Montreal. And we made no pitstops to any fast food place!
  

So how do I feel? I'm glad I did it but can't say I feel any difference yet. My father, a psychiatrist, tells me it's only normal since I just did it (see video below, some patients see improvements months after). I'm hopeful but remain cognizant that there are no guarantees with this procedure. Dr. Siskin told me he's now conducting a double-blind placebo controlled trial with a neurologist at Albany Medical Center and they hope to find out more. He also told me that he's seen some patients with significant improvements which is why he continues doing the procedure even if "there are no guarantees as to the efficacy or durability".

One final warning to anyone considering doing this procedure. There are a lot of scams out there. The latest email I got from some outfit claiming to do "enhanced CCSVI" with stem cell therapy using your body's own stem cells. Steer clear away from these scams. Also, I know a lot of people like going to Poland, Bulgaria, or other exotic places for their CCSVI procedure but I would tell you to think twice. Dr. Siskin told me some of these places are very aggressive opening up the veins to "dangerous" diameters (and they charge a hell of a lot more!). "I wouldn't do anything to any patient that I wouldn't do on myself". Sound advice, even for the investment world.

I thank Dr. Siskin and his wonderful staff. I also thank my family, friends, colleagues who supported me and my brother for taking time off work and his family to accompany me on this trip. To all MS patients, eat very well, sleep, take elevated doses of vitamin D, exercise as much as you can and enjoy life. Keep fighting this disease with everything you got. We will eventually beat it, I promise.

***UPDATE: Dr. Siskin's feedback***

Dr. Siskin was kind enough to share these comments with me:

Thanks for sending me the link to your blog. I found it really interesting to read. I appreciate the offer to correct or add anything. In my opinion, a blog is a personal account of your own experience/view of things so it would really be wrong for me to jump in there and make suggestions. The only thing I will say to you (and I guess you can change something if you want), is the following...and they are definitely not in order of importance:

1) I do not necessarily agree with either comment about the imaging aspect of CCSVI. By that I mean the comments about CT venography or ultrasound (or MR venography for that matter). I disagree that ultrasound is not able to tell if a vein is occluded. Of course it can. Is CT venography better...maybe but on the other hand, you have to get iodinated contrast to have this test and there is radiation exposure involved. The reason why we perform ultrasounds before and after is not so much for the individual value of each ultrasound as a stand alone diagnostic test. It is for comparative purposes. You may not see it now, but a few months from now, we may be wanting to know how your veins are looking. If we have an ultrasound from before and after a procedure, we can look down the road with an ultrasound and know if you look more like you did before the procedure or more like you did after. Is it perfect? Of course not. However, if everyone evaluating these patients uses the "Zamboni" ultrasound protocol, then at least the results of a single test may be transferable and therefore comparable to a previous test. That is the value of the test. I do like the idea of CT venography, but that is often times very technique dependent with timing issues that can vary from site to site, which may make comparing tests difficult. At the very least, you can see why many places disagree about the best non-invasive test for diagnosing CCSVI.

2) I completely agree with your take on Albany restaurants although for the record, they have gotten much better over the past 15 years that I have been here (and that's from someone who spent a lot of time in NYC).

3) We have taken a lot of time to make sure that the FAQs on our website reflect the current state of our practice. Everything we talked about regarding stents prior to your procedure is on our website under the FAQ section. We have found that most patients have read those before they got here. Therefore, I apologize if you were surprised about the risk of "complications" associated with this procedure. That said, I do make it a point of reviewing these things with everybody in person before the procedure, which is what I did with you and your brother prior to your procedure. We continue to try and make our website as comprehensive as possible and will continue to direct people there before coming to Albany so there are no surprises. It is certainly not our intent.

I really would be interested in your feedback about this because we take it seriously and want to improve things as much as possible. Hope you continue to feel well and start to notice some positive changes.

The only suggestion I made was to send a PDF file of FAQs to patients before, highlighting any possible complication and why stents might have to be used. Also, patients need to know that they have to take aspirin for the rest of their life (regular strength for six months and then baby aspirin). You will likely be very tired after this procedure so get plenty of rest.