Complications reported by Dr. Zamboni ... -please post other issues if I have forgotten any.
Thanks for starting this topic. Dr Zamboni's work holds the most hope I've had for 20 years.
I have Multiple Sclerosis. I’ve been intrigued by Dr. Zamboni’s work which shows what appears to be a direct connection between vascular blockages and restrictions preventing or slowing down blood draining from the brain. This results in reversal of blood flow towards the brain which results in high levels of iron, free radicals which destroy brain cells and general inflammation. (1)
In other words, if true it appears we now know the pathology of MS is not viral or immunological but a vascular problem resulting in a basket of immunological symptoms called Multiple Sclerosis.
As a patient who has taken charge of my own treatment, I’ve commenced research into the theory behind Zamboni’s work, an historical review of our current theories regarding the pathogenesis of multiple sclerosis, and the risks associated with the procedures being suggested - percutaneous coronary intervention commonly known as angioplasty.
The first thing that has become apparent is that angioplasty is big business. More than a million of these procedures are carried out each year in the U.S. alone. From the reading I’ve done attempting to nail down the mortality rates associated with the procedure, it appears 1-2 percent of people undergoing the angioplasty procedure die during the procedure. (2)
Not after, during.
That was higher than I’d expected. And those stats are “soft” in the sense they are based on the review of angioplasty procedures found in a database that cannot claim for its data quantifiable characterizations required to give its data clinical context. In other words, the data was not collected for the purpose of determining the risks of angioplasty but as a matter of public record. Thus the data is not exhaustive nor can it claim it is sufficiently representative of heart patients to be the last word on anything. The stats could be significantly higher or lower given various details of the patients’ condition, age, etc.
Nonetheless, these stats are revealing. In my short period of research I’ve discovered the full statistics (e.g. showing statistical dependancies such as age, condition etc.) are not that easy to come by in a form easily comparable or transferrable to other situations. (3)
So I used these statistics as they are conservative when compared to any of the specific issues like age or condition, showing angioplasty in the best light. (4)
So is a mortality rate of 1-2 percent acceptable for this procedure?
Since I have absolutely no idea, except that it seems awfully high, I thought about giving this risk some context by comparing it to something we all understand - traffic fatalities. People are aware we take a risk venturing out onto the public roads yet we assume that risk without much question or comment unless the weather prevents us from going out. So what is this risk that appears acceptable to most of us?
Public statistics tell us that 15 people out of 100,000 registered drivers die in traffic accidents each year. (5) A little educated extrapolation can convert this to deaths per use of vehicle which is perhaps easier to compare to the statistic we are attempting to compare and thereby characterize - deaths per procedure. A little math and educated guessing can easily bring us to a million uses of a vehicle brings about 15 deaths.
That means that based on conservative guesses as to how many vehicular deaths there are per use of a vehicle, conservative statistics regarding angioplasty mortality, angioplasty is still about 700 times riskier than dying due to a traffic accident
So the mortality risk is certainly higher than traffic fatalities. Whether or not this will give the MS patient pause is of course up to the patient. And we each will have to consider not just mortality, but the non-lethal risks which are many. For example, we haven't mentioned stroke, paralysis, inflammation or other problems with stints which are used by most surgeons, re-blockage, excessive bleeding, etc.
I suppose I’ll get over the small shock of these mortality statistics and make a more educated decision over the next little while as I let these facts and the many others I will be researching over the next few weeks “settle”. I haven't fully considered or examined these stats not having obtained the raw data - yet. But all the “big” words aside, this ain’t rocket science. And putting foreign objects in my body IS invasive, notwithstanding how angioplasty is characterized by supporters.(6)
I'd like to see stats on the MS procedural angioplasties. I have no doubt they’d be significantly lower than those related to vascular based angioplasty. One important difference, I think is that people with MS aren't typically as at risk for stroke and other dangerous and potentially lethal cardio-vascular events as are patients already suffer suffering heart disease. This will undoubtedly reduce the cardio risks to people with MS who undergo the procedure.
And stints do indeed have problems with rejection, collapsing, re-blocking etc. The most modern stints have slow release medication to prevent clotting and scaring and rejection of the stint.
My research is far from over and any thoughts you have are appreciated.
I’ll also leave you with a quote from an article from 1962 which article spent a great deal of effort dismissing the vasular basis for MS without any relevant clinical trials whatsoever. However, the article ended with the following almost prescient words:
"It may be of aetiological significance that the sites where plaques were commonly formed are areas where relative vascular insufficiency can be postulated."
Brownell, Betty and Hughs, J. Trevor - The distribution of plaques in the cerebrum in multiple sclerosis, Oxford (1962)
Here is Dr. Zamboni's paper where his iniitial results are given where he found 95% of people with ms having blood drainage problems resulting in iron build up in the grey matter.
This study is based on a review of a 300,000-patient national database owned and administered by the American College of Cardiology. Marilynn Marchione and Linda A. Johnson, Associated Press – “Study supports angioplasty safety”, March 30, 2008. http://seattletimes.nwsource.com/cgi-bi ... 518&zsecti
There is even a debate in some circles regarding whether or not the procedure is contraindicated. This little report will set aside these issues and do a best attempt at accessing the risks. See http://www.heartprotect.com/about.shtml
They are quoted in an Associated Press article regarding the issue of whether or not the regulatory requirements to carry out angioplasty should be limited to institutions with cardio emergency staff and expertise. The article argues it should be allowed and thus the statistic is, if not quite accurate, used to support the procedure and thus would represent the mortality rate as low as possible to retain credibility.
U.S. Traffic statistics: http://www-fars.nhtsa.dot.gov/Main/index.aspx
Angioplasty is merely opening restricted arteries/veins. This is typically done with a “balloon” which is inflated in the restricted area, pushing the veins walls out, and then removed. Sometimes a stint is used to maintain the opening. 70% of angioplasty procedures are done with stints which are a piece of wire mesh that simply holds open the artery/vein. Dr. Zamboni has gone on record saying that stints are too risky to use.(See CTV W5 interviews.) However, in the normal course of angioplasty the decision to use stints is made at the time of the procedure. This may explain what appears to me to be a high level of use of these products.