Download FAQ Brochures

Medanta Institute Of Neurosciences
CCSVI and LIBERATION PROCEDURE:
A Novel treatment concept for Multiple Sclerosis
WHAT IS MULTIPLE SCL EROSIS?
Multiple Sclerosis is a chronic often disabling disease of the central nervous system.
In young adults, it is one of the most common central nervous system diseases.
Sclerosis is "scars" such as plaques or lesions in the brain and spinal cord. Multiple
Sclerosis can be a progressive disease in which scattered patches of the protective
myelin sheath covering of the nerve fibres in the brain and spine (the central nervous
system) are damaged or destroyed.
Myelin is a fatty material around nerves that acts like the insulation around electrical
wires. When the myelin sheath is damaged, the electrical impulses along the nerves
are disrupted. This disruption affects many functions of the body.
Page 1 of 12
COMMON SYMPTOMS AND SIGNS
Symptoms may be mild (e.g., numbness in the limbs) or severe (e.g., paralysis or
loss of vision).
The progress, severity and specific symptoms of Multiple Sclerosis in any one
person cannot yet be predicted, but advances in research and treatment are giving
hope to those affected by the disease.
Page 2 of 12
TYPES
The following descriptions for these three types of MS are
Relapsing-remitting MS (RRMS) is characterized by partial or total recovery
after attacks. It is the most common form of MS. Eighty-five percent of people with
MS usually have a relapsing-remitting course.
Secondary-progressive MS (SPMS) is a relapsing-remitting course which
becomes steadily progressive. Attacks and partial recoveries may continue to occur.
Of the 85 percent who start with relapsing-remitting disease, more than 60 percent
will develop SPMS within 10 years.
Primary-progressive MS (PPMS) is progressive from the onset; symptoms
generally do not remit — i.e., decrease in intensity. Fifteen percent of people with
MS are diagnosed with PPMS. The diagnosis usually needs to be made after a
person has been living for a period of time with progressive disability but not acute
attacks.
HOW IS MS DIAGNOSED?
1. There are no specific tests for multiple sclerosis. Your doctor may base a
multiple sclerosis diagnosis on the following:
2. Analysis of your blood can help rule out some infectious or inflammatory
diseases that have symptoms similar to multiple sclerosis.
3. Spinal tap (lumbar puncture)
In this procedure, a doctor removes a small sample of cerebrospinal fluid from
within your spinal canal for laboratory analysis. This sample can show
abnormalities associated with multiple sclerosis, such as abnormal levels of
white blood cells or proteins.
4. MRI This test uses a powerful magnetic field and radio waves to produce
detailed images of internal organs. MRI can reveal lesions, indicative of the
myelin loss caused by multiple sclerosis, on your brain and spinal cord. You
may also receive an intravenous dye that may help highlight "active" lesions.
This helps doctors know whether your disease is in an active phase, even if
Page 3 of 12
no symptoms are present. Newer MRI techniques can provide even greater
detail about the degree of nerve fiber injury or permanent myelin loss and
recovery.
5. Evoked potential test.
This test measures the electrical signals sent by your brain in response to
stimuli. An evoked potential test may use visual stimuli or electrical stimuli, in
which short electrical impulses are applied to your legs or arms.
HOW IS MS TREATED?
There is no treatment which can claim to cure Multiple Sclerosis
However, treatment protocols address four primary areas of the disease:

Reducing the effects on an "attack"

Addressing long term symptoms

Slowing the progress of the disease

Minimizing the impact of the disease
Reducing the effects of an attack
The most common therapy for an attack, also called an exacerbation, is the use of
steroids. Steroids reduce the swelling and permit more rapid healing. Intravenous
methylprednisolone is the commonest used steroid for this purpose.
Addressing long term symptoms
Long term symptoms (e.g., fatigue, bladder and sexual dysfunction, depression) can
be addressed with medications and therapies, many of which are not specific to
Multiple Sclerosis.
Slowing the progress of the disease
There are many medications which are available and have been used for more than
a decade for slowing the progression of the disease in MS. These include interferon,
Copolymers, anticancer drugs, antimetabolite drugs, IV immunoglobulins, Plasma
exchange etc. Many of these drugs are backed by strong evidence while others are
still in the experimental stage.
Page 4 of 12
Minimizing the impact of the disease
Areas of therapy include:

Physical therapies

Mental therapies

Social therapies

Spiritual therapies
WHAT IS CCSVI?
Chronic cerebro-spinal venous insufficiency (CCSVI) is a proposed syndrome in
which the flow of blood in the cervical and thoracic veins, from the brain and spine to
the heart, is compromised and less efficient. It is proposed that insufficient venous
blood flow, in turn, promotes development of brain dysfunction, especially multiple
sclerosis.
The reported blood flow compromises involve both reduced and intermittently
reversed (reflux) flow in the cerebral veins, changed flow patterns in small vessels
of the brain (altering the barrier between blood and brain), and are reportedly
associated with narrowing of the veins draining blood from brain and spine ( jugular
and azygos veins). Such a vascular picture was described by Paolo Zamboni in
2008, who also reported an association of CCSVI with multiple sclerosis (MS). It has
been theorized by Zamboni and colleagues that the malformed blood vessels caused
increased deposition of iron in the brain, which in turn triggers self immunity and
degeneration of the nerve’s sheath (myelin).
T his has generated optimism, especially from patients, for more effective treatment
options for multiple sclerosis.
HOW IS CCSVI DIAGNOS ED?
After consultation and evaluation by an expert Neurologist the patients of MS are
screened initially with combining extracranial and transcranial doppler sonography.
Various parameters of venous drainage have been proposed to be characteristic of
the syndrome on doppler. In the doppler study the presence of flow, direction of flow,
Page 5 of 12
narrowing of veins and the change in flow patterns in different positions of the body
are studied.
Use of Magnetic resonance venography with contrast for the diagnosis of CCSVI in
MS patients is the next step to identify the area of narrowing.
If the doppler and MRV findings are indicative, then angiography is done.
Angiography is the most accurate to study the narrowing of the veins.
The
procedure is done with patient in awake condition after giving a local anesthetic in
the groin. Through a small needle prick in the either of the groin vein
a thin tube
(catheter) is passed into neck and brain vessels. The dye is injected through the
catheter and high resolution images are captured. Pressure inside the veins is also
studied during the procedure.
H O W C A N W E T RE A T T H E C C S V I ?
If areas of narrowing are identified on diagnostic evaluation and confirmed on
angiography, balloon angioplasty of narrowed area is done in the same sitting. The
majority of venous narrowing is treatable at the time of angiography with this
conventional, minimally invasive, and safe endovascular technique, the so called
LIBERATION PROCEDURE. The procedure is done by experienced interventionist
under local anesthesia. Through groin (femoral) vein a balloon catheter is taken to
the site of narrowing and balloon is inflated to dilate the narrowed segment. In case
the narrowed segment is not adequately dilated a stent can be placed.
W H A T S H OU L D I E X P E C T A F T E R T H E T R E A T M E N T ?
The studies have shown that the treatment improves significantly the validated
outcome measure in multiple sclerosis. In addition, studies have shown four times
decrease in relapse rate of the disease after angioplasty in the year subsequent to
the procedure, as compared to the preceding year. However, persistence of disease,
Page 6 of 12
disease relapse and restenosis of the angioplasty segment can also occur in the
follow up period. The CCVSI and the Liberation treatment is being studied in various
centre and future research will confirm the efficacy of the treatment. As of now, this
form of treatment has not gained sanction of US FDA.
W H A T I S T H E F O L L O W U P P R O T OC O L A F T E R T H E T R E A T M E N T ?
Patient has to be on regular follow-up in which clinical evaluation as well as repeat
doppler studies are performed. Repeat stenosis of some of the dilated segments
has been reported in the literature and the patient may need further treatment in
future.
MEDANTA CCSVI STUDY
AIM
To study for evidence of CCVSI in patients with multiple sclerosis and to evaluate the
outcome of Liberation treatment
METHOD
We are selecting patients affected by clinically defined MS diagnosed according to the
revised McDonald criteria
SELECTION CRITERIAS
●
Age 18 to 65 years;
●
Expanded Disability Disease Scale Score (EDSS) ranging from 0 to 6.5
●
Diagnosis of MS according to the revised McDonald criteria
●
Therapy with currently Food and Drug Administration (FDA)-approved diseasemodifying treatments
●
Evidence of more than two ECD parameters of suspicious abnormal extracranial
cerebral venous outflow
●
Normal renal function
Page 7 of 12
EXCLUSION CRITERIAS
●
Relapse, disease progression, and steroid treatment in the 30 days preceding study
entry (all conditions significantly modify clinical parameters, rendering unreliable any
postoperative assessment)
●
Pre-existing medical conditions known to be associated with brain pathology,
including neurodegenerative disorder, cerebrovascular disease, and history of
alcohol abuse
●
Abnormal renal function
●
Refusal to undergo the endovascular treatment
After consultation and evaluation by an expert Neurologist the patients of MS are
screened initially with combining extracranial and transcranial doppler sonography.
Five parameters of venous drainage have been proposed to be characteristic of the
syndrome on doppler, although having two of them is enough for diagnosis of CCSVI:

Reflux in the internal jugular and vertebral veins,

Reflux in the deep cerebral veins,

High-resolution B-mode evidence of stenosis of the internal jugular,

Flow in the internal jugular or vertebral veins that could not be detected with Doppler, and

Reverted postural control of the main cerebral venous outflow pathways.

Use of Magnetic resonance venography for the diagnosis of CCSVI in MS patients is the next
step to identify the area of narrowing.

If the doppler and MRV findings are indicative, then angiography is done. Angiography is the
gold standard procedure.

If areas of narrowing are identified on diagnostic evaluation and confirmed on angiography,
Balloon angioplasty of narrowed area is done in the same sitting. The majority of venous
narrowing is treatable at the time of angiography with conventional, minimally invasive, and
safe endovascular techniques, the so called LIBERATION PROCEDURE. The procedure will be
done by experienced interventional neuroradiologist under local anesthesia. Through groin
(femoral) vein is cannulated under all aseptic precautions and a balloon catheter is taken at
the site of narrowing and balloon is inflated to dilate the narrowed segment. In case the
Page 8 of 12
narrowed segment is not adequately dilated a stent may be placed at the discretion of the
interventionist.
V A S C U L A R O U T C O M E M E A S U R ES
Vascular outcome measures are described separately from the neurologic outcome
measures of the associated MS, which was independently assessed by our neurologic team.
W E E V A L U A T E T H E F O L L O W I N G V A S C U L A R V A R I A B L ES
1.
Venous pressure expressed in cm H2O measured preoperatively and postoperatively
by means of a manometer in the superior vena cava, in the AZY, and in both IJVs;
2.
The postoperative course and rate of complications; in particular, we assessed
patients’ tolerance to the procedure, investigated pain by the means of the validated
visual analogue scale (VAS),20 and also postoperative thrombosis, major and minor
bleeding, and adverse effects from contrast media; and
3.
Patency rate by using a ECD surveillance at 1, 3, 6, 12, 15, and 18 months, assessing
the same preoperative variables.4,6 At the end of the 18 months of follow-up,
patients with ECD-suspected restenosis will undergo venography as well as an
eventual second PTA treatment.
N E U R O L O G I C O U T C O M E M E A S U R ES
Neurologic outcome measures
Neurologic outcome will be assessed by the nonblinded team of neurologists who followed
up the clinical course of associated MS. The outcome measures are those usually used in
clinical trials evaluating MS treatment:
1.
Disease severity: When a treatment evaluation is contemplated, MS severity should
be scored by means of the Multiple Sclerosis Functional Composite (MSFC) instead of
the widely used but insufficiently detailed EDSS. The MSFC gives the comprehensive
index Z for scoring the motility of upper and lower extremities as well as cognitive
function. The same physician will perform the MSFC preoperative and postoperative
assessment always at the same hour and in the same location and condition.
2.
Relapse in RR patients: This clinical variable is expressed by the proportion of
patients who were relapse- free at 1 year and by the annualized relapse rate
compared with that reported during the 2 years preceding PTA.
Page 9 of 12
3.
Quality of life (QOL): This was evaluated by using a validated 54-item questionnaire,
the Multiple Sclerosis Quality of Life-54 Instrument, addressed to MS patients and
subdivided in two parts evaluating physical and mental status
F A C I L I T I ES

Dedicated Interventional neuroradiology unit

Vascular surgery unit

Doppler system for neck as well as transcranial Doppler. Transcranial doppler is
capable of B mode study to directly study the intracranial veins

3 Tesla MRI with 22 channel head coil for high resolution study of brain and vascular
structures

Biplane Neurointerventional unit with 3D and dynaCT facility- among the most
advanced unit in our country

ICU with dedicated critical care unit
MEDANTA INSTITUTE OF NEUROSCIENCES – MS STUDY TEAM
Refer to doctors profile attachment.
For any further queries; Write to Dr. Aruna Bhoy, Sr. Manager +919999282333 write at
[email protected]
Page 10 of 12
Dr. Sumit Singh
(MD, DM Neurology (AIIMS))
A topper in DM neurology at All India Institute of Medical Sciences
(AIIMS), New Delhi, Dr Sumit Singh was awarded the “BL Soni Gold
Medal” for being the best Resident in Neurology. He was Associate
Professor of Neurology at AIIMS since the year 2000, where he started the first headache
clinic in north India at AIIMS in 2002. He also established the Neuromuscular disorders
centre at AIIMS and is known for his contribution in the field of Movement disorders. He
initiated the use of botulinium toxin in Headache for the first time in the country, and
extended its usage in trigeminal Neuralgia. He was also involved with using Botulinum toxin
in Spasticity, Limb dystonias and facial and limb dyskinesias, spasmodic dysphonias and
writer’s cramps. Dr Sumit has been with Deep Brain Stimulation Program for Parkinson’s
disease at AIIMS and was involved in intraoperative assessment and post operative
programming of these patients. He has innovated the plasma exchange protocols for AIDP,
Myasthenic crisis, Polymyositis, and has introduced the same for Multiple Sclerosis for the
first time in the country. Dr Sumit has more than 80 publications in National and
international journals and has written several chapters in books. His main areas of interest
are Movement disorders, headache and Neuromuscular disorders.
Dr Sumit Singh is available for consultation and clinical services at Medanta – the medicity,
Gurgaon.
Current Appointments
Senior Consultant Neurology, Medanta – the Medicity, Gurgaon.
Education and Training
Medical School
MLB Medical College, Jhansi, Uttar Pradesh, India.
Neurological Residency
LLRM Medical College, Meerut
All India Institute of Medical sciences, New Delhi, INDIA
Memberships



International Headache Society
Movement Disorders Society.
Indian Academy of Neurology.
To refer Patients to Dr Sumit Singh, write to [email protected], or call him on his number +919810052615
Page 11 of 12
Dr. Vipul Gupta
MD
Dr. Vipul Gupta has joined Medanta as Head Interventional
Neuroradiology with primary focus on Endovascular Neurosurgery.
Before joining Medanta, he was the Head Interventional
Neuroradiology (Endovascular Neurosurgery) at Max Super Speciality
Hospital, Saket, New Delhi. He has worked as Associate Professor in
dept. of Neuroradiology (AIIMS) premier tertiary care teaching Institute of India, New
Delhi. Fellow of Foundation Rothschild, Paris; Cleveland clinic (USA) and in Italy; He is
among the first in our country to use dedicated intra cranial stents and 3D-DSA for
aneurysm embolization, and has been visiting Professor in UMASS General Hospital,
Boston, USA. Among the first in our country to use dedicated intra cranial stents and 3DDSA for aneurysm embolization, to perform intra cranial venous sinus stenting and one of
the few full time Neurointerventionists specializing in endovascular interventions in
Stroke. He specializes intracranial aneurysms embolization (coiling), ArterioVenous
malformation (AVMs) and tumour embolization, Angioplasty and stenting of arterial
stenosis including carotid stenting, Intra-arterial Thrombolysis for stroke and Percutaneous
spinal procedures such as vertebroplasty and other interventional procedures etc.
Current Appointments
Head, Interventional Neuroradiology (Endovascular Neurosurgery)
Education and Training
Medical School
Maulana Azad Medical College, Delhi
Interventional Neuro-radiology training
All India Institute of Medical Sciences (AIIMS)
Fellowships
Foundation Rothschild, Paris; Cleveland clinic (USA) and in Italy
Memberships






World Federation of Interventional and Therapeutic Neuroradiology
Indian Society of Vascular & Interventional Radiology (Previously, convener of Delhi
branch of ISVIR)
Indian Society of Neuroradiology
Indian Radiology & Imaging Association
Neurological Society of India
Delhi Neurological Association
To refer patients to Dr. Vipul Gupta, write to (email) [email protected] or you may call his mobile number:
+91 9810542372
Page 12 of 12