I received the following question:

"I've read where Dr. X has a 2-3% restenosis rate with his patients.  What would that be attributed to?  Use of larger balloons?  If so, what size?  Anything else?"

My response:

     I've seen reference to that mythical figure myself, and I am not quite sure where it comes from. Dr. X performed twelve ccsvi treatments in his home country, and then began flying to a nearby country once a month for three days beginning in May to perform angioplasties there. Including in the count the original twelve patients in his home country, I was his twenty-sixth patient. In October he extended his stay in Nearby Country to four days, he skipped November, and in December he extended his stay to one week. He has not kept records nor done the necessary follow-up to be able to claim, based on rigorous methodology, a restenosis rate with any scientific accuracy. Plus, he has been performing ccsvi angioplasties on a regular basis for less than a year, so it would be premature to cite any definitive numbers.

     I made several trips to the country where he was treating patients and, because of my background in quantitative and qualitative data analysis, I cast covetous eyes on that rich body of data that grew with every angioplasty performed. I began formulating relevant schemata. Unfortunately, the planned study did not come to fruition. However, I know who many of his North American, European and Gulf region patients are, and I've been keeping track of them informally. I know of cases in which there was no improvement, cases that involved minimal improvement, cases that involved initial improvement and then regression, cases of thrombosis, cases of unsuccessful retreatment, and one case in which the patient got worse after her second treatment. I also know of cases of dramatic improvements with no relapse or restenosis as of yet, and one case of dramatic improvement with a serious restenosis that required stenting (me).  

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     However, having said that, Dr. X has had very impressive results with his innovative protocol, and many doctors in the U.S. have adopted his philosophy and his protocol. His philosophy is that blood flow disruptions are a valve issue, not a vein issue, so he first performs valvuloplasties (he balloons open the valve, or tears it with a cutting balloon, or a scored balloon, or positions two wires on the outside of the balloon to create his own cutting balloon, and then balloons the rest of the valve against the vein wall). He then uses big balloons and does up to six dilations, and holds each dilation for two minutes. Hence, the phrase, "Go low (valves) and go slow (two minute dilations)." He sizes balloons according to the widest part of the vein above and below the stenotic area. He also routinely balloons the azygous vein. Many doctors will just "eyeball the monitor" when they enter the azygous, but when it is ballooned, abnormalities are frequently detected that cannot be seen with the naked eye, so a thorough practitioner will balloon the azygous.

     You ask what size balloons are used. I asked the vascular surgeon if the size of the balloon had anything to do with the size of the person. I asked this when I saw a size 23 balloon used in the jugular of a very large man. His response was that the size of the balloon has more to do with the chronicity of the stenosis than with the size of the person. (By the way, the size 23 balloon burst, and all in the operating room heard it pop.) While there, I saw and heard of many cases of thrombosis occurring, and the doctors wondered if the hospital was stocking lower quality anti-coagulants. I wondered if the aggressive ballooning technique was perhaps too aggressive. We are learning as we go.

     I am committed to sharing my experience as honestly, as accurately, and with as much integrity as possible. It is truly my hope that this does not read as a condemnation of Dr. X. I have great respect and admiration for him, and I've come to know three different Dr. X's: Dr. X, The Myth; Dr. X, the Medical Doctor; and Dr. X, the Man. Dr. X, the Myth does not exist; Dr. X, the Medical Doctor has is a creative problem-solver and has mad skills, and Dr. X the Man feels things deeply, and spends his “days off” treating people with little or no money. He is courageous, innovative, aggressive, and does not play by the rules if the rules do not serve the patient. These traits led him to ccsvi treatment in the first place (his specialty as an Interventional Radiologist originally was minimally invasive spinal treatment), and he led the way for many, many others. He should be commended. I also believe he was surprised by and unprepared for the worldwide attention he received for doing what he believed to be the right thing to do - help people feel better. The pressure he experienced was enormous. He once told me "The whole world is waiting for me to screw up," or words to that effect. I felt enormous compassion for him in that moment.

     Creating a mythology around any one person, practice or philosophy can be inherently problematic. When we do so, we pin all our hopes on one person, one practice or one philosophy, and in doing so, we stop thinking critically. There is no one Perfect Answer, Perfect Doctor, or Perfect Protocol. We do a disservice to the doctor, to ourselves, and to the advancement of ccsvi treatment when we engage in this kind of magical thinking.

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