Drug Eluting Balloons in Liberation Treatment
Since the introduction of the concept that the chronic cerebro-spinal venous insufficiency (CCSVI) is the cause for the development of multiple sclerosis (MS), many sufferers from this disease have been treated in several places in Europe, Asia, Latin America and recently, in the USA.
The vast majority of patients have experienced immediate objective improvements as well as in life quality.
I had the honor yesterday to give an oral presentation of our experience in the first 390 patients treated at our clinic (The Clinics of the Heart) during the XVII Congress of the Latin American Society of Interventional Cardiology (SOLACI from the Spanish “Sociedad Latinoamericana de Cardiología Intervencionista) where we showed a statistically significant 91% neurological improvement to the international Interventional Cardiology community.
Nonetheless we know that a very important fraction of patients, possibly more than the 25% described in the original paper from Dr. Zamboni are suffering the recurrence of the symptoms alleviated soon after the initial treatment which obligates them to search for subsequent treatments or other options.
The recurrence of treatment could be caused by one of the following conditions:
- Restenosis. It takes weeks to months and means that the vein was opened successfully but narrowed again after a severe inflammatory response of the same vessel after the balloon dilation.
- Elastic recoil. It takes hours to days and means that the vein opened only using its elastic properties but returned again to its previous status after the balloon is deflated. If this happens in the Cath Lab during the treatment, the doctors may be aware of it and treat as well but if happens later it can only be diagnosed by a second angiogram.
- Thrombosis. It can take, tipically days to weeks and means that a clot has been formed inside of the vein and needs to be treated very soon to try to dissolve or aspirate this clot.
Restenosis must be considered in the context of the huge experience in coronary angioplasty and stenting that was a nightmare during the beginning of this procedure during late 70’s and the complete decade of the 80’s, when the cardiologists observed more than 30% restenosis rate.
This restenosis was reduced importantly after the introduction of stents during the 90’s to less than that 30% but it was only that after the first experience in Brazil, with medicated stents when the restenosis dropped dramatically to even less than 10%.
During the past decade millions of patients around the world have received the benefit of this Drug Eluting Stents (DES) with great benefit as well as there are thousands of scientific publications concerning DES in coronary arteries.
The drugs that cover these stents are diverse and were considered after their use in several medical conditions such as the prevention of rejection of transplanted organs and the treatment for several cancers. Those are the case of certain drugs such as sirolimus, tactolimus, everolimus, paclitaxel, etc.
All these medications are deployed by the stent in the inner surface of the coronary artery in minimal doses just enough to reduce the cell growing and the inflammatory response and never approach the systemic doses that cause their known side effects. So they are efficient and safe.
Nonetheless the carrier for these medications is the stent and a polymer that have their own inconveniences such as the permanence of a foreign material inside of the artery. That’s why very recently a new therapeutic era has emerged with the advent of the Drug Delivering Balloons. This balloons have a substance capable of attaching to them the medication (Paclitaxel) but releasing it and adhering it to the contact surface during inflation inside of the artery. So after treatment and balloon deployment there is only the medication acting for a short period of time just to avoid the acute inflammation and later the artery is totally free from any foreign substance.
Very recently this same technology has been applied to large balloons to treat the arteries in the legs while reducing the restenosis rate and consequently the need for subsequent dilation treatments, with the benefit of minimal stent placement.
There are several successful trials with such balloons that were so conclusive that they justified their approval by the European regulations as well as their release into the market.
We have been using the Paclitaxel Eluting Balloons (Dior, Freeway) for more than one year with great efficacy and no complications.
The especial characteristics of these products can be consulted in the manufacturer web site:
http://www.eurocor.de/
http://www.eurocor.de/products/dior/product_information/
http://www.eurocor.de/products/freeway_035/product_information/
This is why we want to offer our patients with MS the liberation treatment with the benefit of these balloons. Regardless if it is the initial or one subsequent treatment we think that the Freeway balloon can reduce the high restenosis rate and the need for further invasive treatments, based on the concept that the restenosis in veins must be mediated by inflammation after dilation such as occurs in the arteries.
We encourage the MS-CCSVI sufferers to use these balloons during their first as well as subsequent liberation treatment with the possibility of benefit based on the results shown in coronary and large arteries.
We realize that this new treatment will have many detractors just as the neurologists have opined
against the vascular approach of treatment since the very beginning, we suspect that most negative
comments will probably come from those emerging treatment centers in the U.S. that do not yet have
access to these materials.
Rafael Moguel MD
The Clinics of the Heart