Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis (MS) Patients

What Liberation Treatment is all about?

This is a whole new approach for treating the patients with Multiple Sclerosis. In recent days it has become a new hope for millions of Multiple Sclerosis patients across the world. Dr. Paolo Zamboni, a former vascular surgeon and professor at the University of Ferrara in northern Italy developed this procedure while he was trying to understand the underlying causes for the condition which his wife was into a, Multiple Sclerosis (MS).

What is Multiple Sclerosis (MS)

First diagnosed in the year 1849, Multiple sclerosis (MS) is a nervous system disease that affects brain and the spinal cord. It is also known as disseminated sclerosis or encephalomyelitis disseminata. The disease affects an estimated 2.5 million people around the world, causing physical and mental disabilities that can gradually destroy a patient's quality of life. It damages the myelin sheath, the material that surrounds and protects your nerve cells. This damage slows down or blocks messages between your brain and your body, leading to the symptoms of MS like visual disturbances, muscle weakness, trouble with coordination and balance, sensations such as numbness, prickling, thinking and memory problems etc. Multiple sclerosis affects women more than men. It often begins between the ages of 20 and 40. Usually, the disease is mild, but some people lose the ability to write, speak or walk. MS is five times more prevalent in temperate climates-such as those found in the northern United States, Canada, and Europe-than in tropical regions.

What is CSSVI all about?

CCSVI stands for Chronic cerebrospinal venous insufficiency is a chronic problem where blood from the brain and spine has trouble getting back to the heart. It’s caused by stenosis (a narrowing) in the veins that drain the spine and brain. Blood takes longer to get back to the heart, and it can reflux back into the brain and spine or cause edema and leakage of red blood cells and fluids into the delicate tissue of the brain and spine. Blood that stays in the brain for too long creates “slowed perfusion” and a delay in deoxygenated blood leaving the head. This can cause a lack of oxygen (hypoxia) in the brain.

1. Relation between CCSVI and MS; Dr. Zamboni’s finding

It all started with the Dr. Paolo Zamboni’s search to find out the root cause of debilitating condition of his wife who was suffering with Multiple Sclerosis. After studying many patients suffering from the same condition, he found that that almost all of them had a abnormal narrowing, twisting or outright blockage of the veins that are supposed to flush blood from the brain. Further Dr. Paolo Zamboni found that whichever patient had this condition, had a high level of deposition of Iron in the veins. Lack of free flow of the blood to the brain possibly explaining the symptoms of MS.

2. The Liberation Treatment or the Liberation Procedure;- Dr.
    Zamboni’s Invention

Now the idea was to open up such blocks and allow the free flow of blood through veins to brain. This is the reason why this procedure is called as Liberation Procedure or Liberation Treatment. This is done in the similar way as it is done in Coronary Balloon procedure. The patient may have single blockage or multiple blockages. Accordingly the treatment is decided.

How is this connected to Multiple Sclerosis?

It is believed that due to CCVSI, iron builds up in the brain, blocking and damaging crucial blood vessels. This causes the vessels to rupture, which allows both the iron and immune cells from the bloodstream, to cross the blood-brain barrier into the cerebro-spinal fluid. Once the immune cells have direct access to the immune system, they begin to attack the myelin sheathing of the cerebral nerves, and result in the development of Multiple Sclerosis.

1. Purpose and Background Information:

The Endovascular procedure for Chronic Cerebro Spinal Venous Insufficiency (CCSVI) with Multiple Sclerosis (MS) will be performed by Dr. Santosh Prabhu. Please not that this procedure is not FDA approved treatment for Multiple Sclerosis and is still being studied for its benefits in patients of Multiple Sclerosis . 

2. Procedure For CCSVI Related To Multiple Sclerosis:

In this procedure, an angiographic catheter will be moved from the inferior to the superior vena cava and the venous pressure is measured. Catheterization will be proceeded to Azygous (AZY) vein for few millimeters and then to the distal Internal jugular vein (IJV).

In this procedure Compliant-type balloon catheters will be used because of their greater flexibility allows for insertion in the narrow arch of the AZY. Inflations are maintained as per requirement and will be repeated several times.

At the end of the therapeutic procedure, the post-procedure venous pressure measurement and selective phlebograpy of the AZY or IJVs, or both, is repeated to document the immediate outcome of the treatment.

The exact  mode of intervention undertaken and the associated local anesthesia procedure will be performed in keeping with your physician’s standard treatment practices and your individual condition at the time of examination and will be discussed in detail with you.

3. Eligibility Criteria For The Procedure:

Patients who are eligible as per the following inclusion and exclusion criteria and who wish to undergo this procedure will be asked to sign the consent form.

Inclusion Criteria:

• Age: 18 – 65 years; Gender: Male and Female
   Expanded Disability Disease Scale Score (EDSS) ranging from 0 to 6.5

• Active Diagnosis / Relapse of MS with CCSVI according to the revised Mc Donald Criteria

• Therapy with currently Food and Drug Administration (FDA)-approved disease-modifying treatments

• Evidence of more than two Echo Color Doppler parameters or MRV of suspicious abnormal extracranial cerebral venous outflow

• Normal renal function

Exclusion Criteria

• Relapse and disease progression related to MS other than CCSVI.

• Treatment with Steroids in the 30 days preceding the procedure

• Pre-existing medical condition known to be associated with brain pathology, including neurodegenerative disorder, cerebro-vascular disease, and history of alcohol abuse

• Abnormal renal function

• Refusal to undergo the endovascular treatment

1.  Informed Consent:

The decision to perform the Endovascular treatment will be made based solely on the reconfirmation of the CCSVI diagnosis at Hospital by means of  a physical examination and relevant diagnostic procedures.

After detailed explanation of the procedure to you by the Surgeon and his team, and after explaining about the alternative treatments available, you will be asked to read, understand and  sign the Informed Consent Form,  duly explained by Dr. Santosh Prabhu and accepted by you. A copy of your signed Informed Consent Form will be given to you.

2. Procedure and Follow – Up:

On signing the voluntary Informed Consent Form, the planned treatment procedure will be carried out as per standard treatment protocol. The procedure will be carried out only after relevant pre-procedure laboratory investigations and Carotid Doppler at Hospital.

Immediate post-op follow-up procedure will be carried out at Hospital and long term periodic follow up in coordination with your treating physician in your country.

3. Cost Related To The Procedure:

Cost related to the liberation treatment before and after the procedure will be sent as medical trip package format for you and for onward passing on to your insurance company. Kindly note the Hospital at this stage does not entertain MS Insurance cases.  [See para 9 for cost estimations and inclusions details]

4. Potential Risks And Discomforts:

It is to be understood that this Endovascular procedure  may or may not benefit the patient

Based on the previous study following anticipated Events have been identified as possible complications of this procedure.

•  Infection at the puncture site

•  Risk of damage to the blood vessel

•  Restenosis (where veins narrowed again)

•  Relapse in Relapsing Remitting patients

•  Minor and major bleeding

• Aneurysm

• Contrast allergy

• Air Embolism

• Any other new event 

5.  Confidentiality:

Data will be kept confidential and will only be accessible to the treating surgeon, team members at Hospital, Ethics Committee and if required, to your treating physician in your country.

6.   Disclosure of Data:

You give your permission to use and share your health information by signing the consent form for benefit of humanity. Your authorization for your biological samples and records to be used or disclosed for research has no expiration date.

7.  Is there any waiting period?

No, there is absolutely no waiting time. Mediescapes India ensures Zero Waiting Time at associated World Class hospital for liberation treatment for MS patients.

8.  Is the cost too high?

The cost CCSVI Screening and the Liberation Treatment is much lower than what you might end up paying in Canada, USA or Europe. Mediescapes India ensures lowest price from World Class hospital in India.

Cost estimations for the Liberation procedure can be suggested upon request.

This will include:

• Medical trip planning advise regarding travel documents, regarding Air
  Transport to Mumbai and on to Kolhapur, regarding India Visa and regarding return air ticketing related advises. 

• We can provide a travel companion if required (male or female) ex Mumbai –  extra cost

• Pickup of Patient and companion at Mumbai International Airport and will be looked after in Mumbai and taken to the Domestic Airport to travel to Kolhapur. In some cases we may drive you to Kolhapur from Mumbai 9cost extra).

• Pickup of patient and companion from the Kolhapur airport and transport to the hospital - Kolhapur Airport.

• All Pre-op procedures and meds.

• MRI - 3 

• Ultrasound if necessary – 2

• The actual procedure of doing the angioplasty

• Anesthesiologist costs – a general most likely Not required

• Hospital supplies costs (eg. 1 stent / extra stents cost extra)

• All medications for the patient

• All food for the patient and the companion for 5 days

• Patient care for five days

• Departure transfer of Patient and Companion delivery to the Kolhapur airport for  boarding flight to Mumbai

• Pickup of patient and companion at Mumbai Domestic Airport and will be looked   after in Mumbai and   taken to the International Airport to travel home.

• 2 Nights value for money Star rating Hotel stay in Mumbai (because of
   international flight arrival /   departure and domestic flight to / from Kolhapur timings).

9. What about travel, do you arrange it?

A return economy ticket from any major city in Canada or USA or UK to Mumbai India usually averages from US$ 1,200/- to US$ 1,750/-. around

 To travel / enter into India you must have a valid Passport for travel with atleast 4 unstamped pages and will have to apply for Indian Visa at the Indian Consulate Generals Office / Indian Embassy nearest to your home country before you can fly to India for the CCSVI Screening and the Liberation Treatment. Mediescapes India will promptly arrange a invitation letter for speedy Visa grant on priority to MS patients.
 

10. Contact Details  For Additional Information On The Procedure:

You have the right to ask any questions you may have about the procedure. Please contact mktg@mediescapes.com