Clinical Trial Venous Angioplasty for Patients With Multiple Sclerosis
We started inviting patients with diagnosed multiple sclerosis (ME) with actual treatment on June 2010, after it was accepted by the Ethics Committee.
MethodsEvery 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 ft. walk against time (T25FW)
- Both hands test placing 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 estimated 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.
ResultsThese 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 on 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. |
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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
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.
