News & Discussion

Drug Eluting Balloons in Liberation Treatment by Doctor Rafael Moguel

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:

1. 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.

2. 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.

3. Thrombosis. It can take, classically 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 this stents are diverse and were considered after their use in several medical conditions such as the prevention 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. These balloons have a substance capable of attach to them the medication (Paclitaxel) but release it and adhere it in 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 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 trials with such balloons with success that were so conclusive that justified their approval by the European regulations as well as their release in market.

We are using these 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/

Here is why we want to offer our patients with MS the liberation treatment with the use of these balloons. No matters of it is the initial or one subsequent treatment we think that the Freeway balloon can reduce the so 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 happens 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 what they showed in coronary and large arteries.

Rafael Moguel MD

The Clinics of the Heart

Patients requesting additional information regarding this breakthrough procedure may contact: info@cardioabroad.com

CCSVI Treatment and Restenosis Breakthrough

The team of cardiologists of Clinics of the Heart in Los Cabos, Mexico led
by Dr. Rafael Moguel has become one of the most experienced group of
medical professionals treating patients who suffer from Multiple Sclerosis
and the condition known as CCSVI (Chronic Cerebral Spinal Venous
Innsufficiency) having succesfully treated more than 500 patients since
July, 2010 have yet again proven to be on the leading edge of treatment
innovation.

As one of the leading Interventional Cardiologists, Dr. Moguel has
implemented techniques borrowed from coronary cases to treat veins and
CCSVI. These medicated balloons that are capable of delivering medication
directly to the treated vein are commonly used to treat arteries, they are
safe and have been used widely in treating arteries, showing clear
benefits in reducing re-stenosis.

Beggining August 15, 2011, The Clinics of the Heart will begin to offer
the CCSVI Liberation utilizing an optional drug delivery capable balloon
that will reduce the possibility of restenosis. This option is available
for patients who are having the procedure done for the first time and for
those who have had the procedure and re-stenosed.

Patients who wish to receive more information regarding this CCSVI
Liberation Treatment breakthrough should contact Andrés Brakke/CCSVI
Coordinator at the Clinics of the Heart for information regarding cost,
appointments or waiting list provinding us with the following information:

- Name of Patient
- Email
- Phone Number
- First procedure? Second? Where?
- Do you wish to make an appointment to be treated at The Clinics of the Heart?

Contact:

CCSVI Coordinator Clinics of the Heart
info@cardioabroad.com

daniela@cardioabroad.com

The Reformed MS Society meeting in West Kelowna last April.

This society is trying to speed up the process of getting the CCSVI angioplasty made legal and available in Canada.

http://www.reformedms.org/ccsvi-testimonials/videos/ccsvi-ms-westbank-meeting-part-1

CLINICS OF THE HEART LOS CABOS CCSVI TREATMENT OPEN STUDY RESULTS

We started inviting patients with diagnosed multiple sclerosis (ME) with actual treatment on June 2010, after it was accepted by the Ethics Committee.

Methods

Every patient was informed about the procedure and read and signed the inform consent form.

Every patient received the following tests before admittance in the hospital:

Basic pre-procedure laboratory work
Brain magnetic resonance image
Neurological evaluation using the following tests:
- Expanded Disability Status Scale (EDSS) which summarizes the level of disability of every person with MS, from 0 through 10, the higher this scale, the most severe disability
- Multiple Sclerosis Functional Composite (MSFC) which included three tests as follows:
  - Twenty five feet walk against time (T25FW)
  - Both hands test putting and removing nine magnetic pieces in a metallic board against time (9HPT)
  - Math test (PASAT)
Bilateral jugular ultrasound Doppler
Auditive test from September 2010

Every patient was admitted in the hospital for catheterization and angiography of both jugular and azygous veins, under mild sedation, subcutaneous enoxaparine 1mg/kg and local anesthesia.

The first 100 patients received post-treatment with subcutaneous enoxaparine 1mg/Kg and the last patients received pre-treatment with fast and slow release betamethasone as anti-inflammatory and post-treatment with either Rivaroxaban or Dabigatran for 10 days to three months decided by the staff depending on the estimate risk for thrombosis.

During the venography it was decided to treat every vein, based on any evidence of chronic insufficiency such as narrowings, impaired flow or collateral circulation.

Every obstruction was initially treated mainly directed to the valves of the veins with balloon angioplasty using compliant balloons. The last patients were treated mainly with non-compliant, high pressure balloons to increase the likelihood of valve opening and reduce the damage to the walls.

Every patient was intended to hospital discharge after 2-4 hours from the end of the treatment unless contraindicated.

The neurological and Auditive tests were repeated 24-48 post treatment and an e-mail follow up was done for symptomatic status and clinical recurrence estimation.

Results

These are the statistical characteristics derived from the first 350 patients.

	Pre treatment	Post treatment
Age	51±11 years
Gender male/women	31.6/68.4 %
Time from MS diagnosis	17 years
Relapsing remitting patients	29.9%
Primary progressive patients	24.1%
Secondary progressive patients	46.0%
Affected left brain hemisphere	32.2%
Affected right brain hemisphere	37.7%
Both hemisphere affected	30.1%
Azygous vein treated	20.4%
Left jugular vein treated	93.5%
Right jugular vein treated	96.4%
EDSS scale	5.46	5.06 (p<0.001)
MSFC scale	0.07	0.15 (p<0.01)
Objective neurological improvement		91.2%
One month clinical restenosis		15.6%
Three months clinical restenosis		24.5%
Instability	60%	2%
Hypoacusis	31.8%	16.1%
Tinnitus (ringing)	35%	5.5%
An ophthalmologic examination was performed only in six patients that showed clear abnormalities that improved after treatment. This part of the trial will be studied on more patients later because the changes also reflect neurological improvement.

Fourteen self expanding stents were implanted mainly to improve the dilations of some treated veins.

Most of the patients were discharged from the hospital the same day with minimal complications.

The severe complications were 1.4% on these patients and were:

One azygous vein thrombosed in the follow up
Two patients with left jugular thrombosis at home
One patient with left jugular thrombosis at third day, successfully treated with direct intervention of the thrombosed vein with balloon angioplasty
One patient with a femoral artery aneurysm
Two patients with balloon rupture that required small surgery

Conclusions

The actual results shows a clear benefit derived from the balloon angioplasty treatment on these “real world” patients with multiple sclerosis, as it was shown previously by Zamboni et al, but we are describing the acute changes present in less than 48 hours after treatment.

There is a discussion about the validity of the hypothesis that multiple sclerosis is caused by the chronic cerebral spinal venous insufficiency and the very ne –so called- liberation treatment but these results are very consistent with it as they are supported by the statistically significant objective improvement of more than 90%.

These 350 patient series shows that the azygous and jugular vein angioplasty for multiple sclerosis is feasible and safe with very small complication rate plus a very high clinical efficacy of more than 90%.

In the opinion of the investigators that participated in this trial, there is clear benefit weighing efficacy and security enough to perform this procedure as a regular treatment for the multiple sclerosis patients.

GERRY PETERS, DON'T LET GERRY DRAG HIS FEET

On February 8th it will be 6 months since my CCSVI treatment in Los Cabos Mexico. In short I still feel great. Compared to how I was before I had my treatment it is a complete life change.

It became apparent to me the other week. I went to the bike show here in Abbotsford. Other years I’ve gone but my buddies pushed me around in my wheelchair and i could only stay a couple hours. This year, no wheelchair and i walked for 3 hours. I was mighty sore and tired after that but the point is that I did it.

Thanks to the many that still follow this blog. I’m amazed. I’m still getting phone calls asking for info on the procedure and I’m loving the opportunity. If you have friends that have MS, or are caregivers of someone with MS, and they need to talk to someone about the procedure, I’ll be more than happy. read more

TEN BIGGEST LESSONS LEARNED FROM MY BROTHERS’ CCSVI VENOPLASTY in MEXICO

These are some personal thoughts (no advice) about a recent trip to the Clinics of the Heart in Los Cabo San Lucas. I accompanied my twin brothers who have been diagnosed with CCSVI as well as MS, to open their vein restrictions there. Yesterday, they returned home, proud of doing the treatment and looking forward to their "new legs" and lives. read more »

I got back more than expected

As a 54 year old woman with secondary progressive multiple sclerosis I was getting really anxious to find something that would stop my MS and help give me a better quality of life. I began research into CCSVI information in November. read more »

Quebec willing to test Multiple Sclerosis treatment

Aug 18, 2010
A call for a national trial of a controversial M-S treatment has gained support. Quebec Health Minister Yves Bolduc says the province would be willing to join a national clinical trial of the so-called liberation procedure. The treatment is based on an unproven theory that blocked veins in the neck or spinal cord are to blame for M-S, a chronic disease of the nervous system. read more »

Controversial therapy frees woman from prison of MS

ANNE MacDONALD feels like a child again, slipping beneath the waves and letting the salt water lick at her skin for the first time in 15 years. On rainy days, she stays inside, mixing blue and gold paint to mimic the artwork she saw in Mexico in June. MacDonald, 55, stopped painting shortly before she was diagnosed with multiple sclerosis in 1992. read more »

MS patient doing well after Mexican treatment

Breathing is easier, talking is less of a chore and her feet are no longer purple – a week in Mexico has done Cathy Clements a world of good. The South Surrey woman returned from a week in the southern country's warmth last month. But she is confident the good weather isn't to credit for her marked improvement in health. read more »