The Clinics of the Heart statement after the FDA warning for "high risk" procedure
Posted by Rafael Moguel on May 21, 2012
Dear patients with multiple sclerosis, relatives and caregivers.
This is a statement from The Clinics of the Heart staff about the recent FDA news released this may 10thalerting from injuries and death after the liberation treatment for CCSVI.
We, The Clinics of the Heart started an initial experience to test this procedure with ten patients suffering Multiple Sclerosis (MS) on diverse stages of the disease, based on the paper from Dr. Zamboni which resulted on slowing the progression and reducing the relapses on the majority of the patients.
We started this way because the published results sounded too good to be true. So we proposed a protocol that had the IRB authorization and we invited these ten patients that came to Los Cabos and received the treatment. We found that all of them had immediate changes to justify continuing doing the liberation treatment. I have to say that the operators at The Clinics of the Heart are Interventional Cardiologists and this is our most extreme experience looking improvements never seen before with any previous endovascular treatment for cardiovascular diseases, including the coronary intervention.
All patients signed the IRB approved informed consent form after the understanding of the characteristics of the procedure and the possible risks and we completed the analysis on the first 400 patients. The interim results were exposed as oral presentations in the last Congress of the Latin-American Society of Interventional Cardiology in Santiago (SOLACI), Chile 2011 and in the M3 Course of the Society for Cardiac Angiography and Intervention (SCAI) held in Miami on October 2011.

The results were as follows:
• N = 390 patients from June/2010 through Jan/2011
• (51±11 years old, male/women 31.6/68.4%)
• Average time from diagnosis 17 years
• Type of MS:
o Relapsing-remitting 29.9%
o Primary progressive 24.1%
o Secondary progressive 46%
• Left jugular was treated in 93.5% of patients
• Right jugular in 96.4% of patients
• Azygous in 20.4% of patients
• Objective clinical improvement in 91.2% of patients
• pre and post Expanded disability status (EDSS) scale (5.46 Vs 5.06)
• Multiple sclerosis functional composite (MSFC) scale (0.07 Vs 0.15)
• Instability (60 Vs 2%)
• Hypoacusis (31.8 Vs 16.1%)
• Tinnitus (35 Vs 5.5%)
all p<0.01
Fourteen self expanding stents were implanted to improve results.
Complications:
1.4% severe complications:
• Thrombosis of jugular or azygous veins
• Femoral artery pseudo-aneurysm
• Balloon rupture
• Allergic reactions
As noted above we initially treated few azygous veins in order to avoid complications in this vein that is not accessible for surgery because it is behind the heart but there is clear that +90% of the patients had neurological improvements. Note also the very few complications rate even when we accepted patients on EDSS up to 8-9 and we found many patients with other diseases not previously diagnosed, such as symptomatic carotid obstructions, cardiac blockages (two of them requiring temporary pacemaker during treatment), severe coronary obstructions and one patient with thrombocytopenia. None of these complications terminated in death or more inability.
What the people against the liberation treatment have only seen is the unfortunate very few deaths but after looking at the results, the benefit/risk ratio is amazing. The (p value) at the end of the results means that they are not casual (p<0.05 gives a true statistical significance).
We are sure that this CCSVI experience is causing a groundbreaking point in Medicine as it was for the cardiac surgery and coronary angioplasty. Note that many doctors in the 60’s hesitated about the relationship between the coronary obstructions and the heart attacks.
We are sure that the implementation of the jugular/azygous angioplasty into the treatment options for MS is a must in the next few years after the following evidence is confirmed:
• Clear constant histopathological relationship between MS and blood vessels (Rindfleisch)
• Clear constant presence of blood elements out of the blood vessels in the brain
• Experimental reproducibility of MS lesions in animals (Putnam)
• Neurological improvements after treatment with very low complication rate (many publications are in progress from many treating centers in the world)
• Curative vs. palliative effect of treatment
• Future research to identify causes and risk factors for valve obstructions in veins
• Relationship of internal jugular/azygous valve veins obstructions with MS. Consider in this crucial point that:
o There are several studies that excludes this relationship using non-invasive diagnostic methods such as ultrasound, computed tomography and magnetic resonance
o Angiography is the diagnostic gold standard
o Not all patients presenting venous obstructions will develop symptoms. Please remember that not all patients having coronary obstructions develop angina
o The majority of medical procedures in the world, including USA and Canada are off label. This is because every indication based on clinical evidence rises from inclusion/exclusion criteria and many patients are not represented in such trials. A clear example is when cardiovascular diagnostic and treatment procedures are done in women or aging population
o The angioplasty and stent placement in veins is regular practice to treat obstructions in coronary venous grafts, a-v fistulae for hemodialysis, proximal deep venous thrombosis, etc.
A special problem to resolve is related to restenosis. It means that after an angioplasty the vessel narrows again as an exaggerated response to trauma. It happens in all treated vessels and is cause of the return of symptoms in many patients.
Unfortunately all the CCSVI lovers (Doctors, patients and relatives) have some very hard obstacles to deal with:
• Opposing pharmacy, doctors and establishment
• Lack of follow up in the original countries (patients are treated abroad with the reluctance to be followed by local medical system) even after complications
• Low price war by competing centers pushed by patients. This will end in cheap medicine, lower efficacy and higher complications risk
We like to thank to all the patients, as well as to their relatives, caregivers and supporters for their trust in the liberation procedure.

Thank you very much
Rafael Moguel MD FSCAI
Director
The Clinics of the Heart
Cozumel, Los Cabos
Source: http://ccsvi-ms.ning.com/profiles/blogs/the-clinics-of-the-heart-statement-after-the-fda-warning-for-high



CCSVI Locator
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The venous hypothesis Chronic cerebro-spinal venous insufficiency (CCSVI) is advocated by researcher Paolo Zamboni for Multiple Sclerosis