Once again the Ministry of Health, guided by the Ontario MS Expert Advisory Group, tell the world that CCSVI Treatment is not safe!
They say "there is insufficient evidence that it is safe" on their updated web site.
Below is a copy of the Health Minstry statement updated on September 2 2011, and three easy to find research papers that looked at 826 procedures in three different centres around the globe. Don't their MS experts know how to use Google?
Each study below, clearly shows that the CCSVI treatment procedure is very safe.
I guess this is more scare mongering from the Ontario Health Ministry and their talking heads.
The way it stands now, it's just a complete joke to have so many non-blood flow experts advising the Ontatio Health Minstry on a simple angioplasty treatment to correct a documented blood flow problem. Shouldn't all Canadians be allowed to have normal blood flow? Maybe they should put some IR's on their so called Expert Panel?
I hope the Doctors on the MS Expert Panel appreciate the fact that I burned up 10-minutes of my precious Labour Day long-weekend, to Google those studies for them to look at.
Well I must turn off my laptop and get back to my sunny holiday. Thank god this beach has WiFi...
WaYnE
Ontario Ministry Reports - Caring For Patients With Multiple Sclerosis Who Have Undergone an Endoluminal Vein Dilation Procedure for the treatment of Multiple Sclerosis
August 2011
Some recent research has suggested a relationship between narrowed veins in the neck and chest and the development of multiple sclerosis (MS), although this relationship has not been proven.
It has also been suggested, but not proven, that endoluminal vein dilation procedures can improve the symptoms of MS. This procedure is frequently referred to as the Chronic Cerebro-Spinal Venous Insufficiency (CCVSI) procedure, Liberation therapy, and/or the Zamboni procedure, after the Italian doctor who first suggested it.
At the present time, this procedure for the treatment of MS is not an insured service in Ontario, as there is insufficient evidence that it is safe and effective.
Since 2009, a number of Ontarians have chosen to undergo this procedure outside of the country.
These guidelines are designed to educate people on the follow-up care that patients with MS who have undergone an endoluminal vein dilation procedure can expect from their health care practitioner in Ontario. These guidelines are based on the guidelines developed by The Ontario Multiple Sclerosis Expert Advisory Group for health care practitioners in Ontario.
http://www.health.gov.on.ca/en/public/publications/ministry_reports/ms_ccvsi/ms_ccvsi.aspx#
CCSVI Treatment Safety Studies:
Endovascular treatment for chronic cerebrospinal venous insufficiency: is the procedure safe?
Ludyga T, Kazibudzki M, Simka M, Hartel M, Swierad M, Piegza J, Latacz P, Sedlak L, Tochowicz M.
EUROMEDIC Specialist Clinics, Department of Vascular & Endovascular Surgery, Katowice, Poland.
Abstract
Objectives:
The aim of this report is to assess the safety of endovascular treatment for chronic cerebrospinal venous insufficiency (CCSVI). Although balloon angioplasty and stenting seem to be safe procedures, there are currently no data on the treatment of a large group of patients with this vascular pathology.
Methods:
A total of 564 endovascular procedures (balloon angioplasty or, if this procedure failed, stenting) were performed during 344 interventions in 331 CCSVI patients with associated multiple sclerosis.
Results:
Balloon angioplasty alone was performed in 192 cases (55.8%), whereas the stenting of at least one vein was required in the remaining 152 cases (44.2%). There were no major complications (severe bleeding, venous thrombosis, stent migration or injury to the nerves) related to the procedure, except for thrombotic occlusion of the stent in two cases (1.2% of stenting procedures) and surgical opening of femoral vein to remove angioplastic balloon in one case (0.3% of procedures). Minor complications included occasional technical problems (2.4% of procedures): difficulty removing the angioplastic balloon or problems with proper placement of stent, and other medical events (2.1% of procedures): local bleeding from the groin, minor gastrointestinal bleeding or cardiac arrhythmia.
Conclusions:
The procedures appeared to be safe and well tolerated by the patients, regardless of the actual impact of the endovascular treatments for venous pathology on the clinical course of multiple sclerosis, which warrants long-term follow-up.
http://www.ncbi.nlm.nih.gov/pubmed/21107001
Abstract No. 3: Safety of outpatient endovascular treatment of the internal jugular and azygos veins for chronic cerebrospinal venous insufficiency (CCSVI) in multiple sclerosis: A retrospective analysis
K. Mandato*, P. Hegener, G. Siskin, M. Englander, S. Garla, A. Herr
Purpose
To evaluate the safety of outpatient endovascular treatment of the internal jugular and azygos veins in MS patients with CCSVI.
Material and Methods
A retrospective analysis of MS patients with CCSVI undergoing endovascular treatment of the internal jugular and/or azygos veins was performed to identify and describe the adverse events occurring within 30 days.
Results
Over 7 months, 247 procedures were performed in 231 patients. The mean patient age was 48.2 years (range: 25.7–70.2 years); 63.7% were female and 36.3% were male. 49.0% (121/247) of the procedures were performed in a hospital and 51.0% (126/247) were performed in the office setting. 92.7% (229/247) were primary procedures while 7.3% (18/247) were secondary due to restenosis. For patients treated primarily, 86.5% (198/229) underwent angioplasty and 11.4% (26/229) underwent stent placement of at least one vessel; the remaining 5 patients were not treated. For patients treated due to restenosis, 50% (9/18) underwent angioplasty and 50% (9/18) underwent stent placement. After 99.2% (245/247) of the procedures, patients were discharged within 3 hours. A post-procedure, transient headache was reported in 8.5% (21/247); this persisted beyond 30 days in 1 patient. Neck pain was reported in 15.8% of patients (39/247); 53.8% (21/39) of these patients underwent stent placement. 1.7% (4/231) of patients were retreated within 30 days due to symptomatic restenosis. Sustained cardiac arrhythmias were observed in 3 patients during the procedure with 2/3 patients requiring hospital admission. One of these patients, who underwent a complex procedure for in-stent thrombosis, required a prolonged hospitalization due to a stress-induced cardiomyopathy.
Conclusion
Endovascular treatment of CCSVI in MS patients is a safe procedure when performed on an outpatient basis. Cardiac monitoring is essential to permit detection and rapid treatment of patients with procedure-induced arrhythmias. Post-procedure ultrasound is recommended to detect venous thrombosis. In addition, consideration should be given to performing complex re-interventions in a hospital given the complication risk in this sub-population of patients. Endovascular treatment of CCSVI in MS patients is a safe procedure when performed on an outpatient basis. Cardiac monitoring is essential to permit detection and rapid treatment of patients with procedure-induced arrhythmias. Post-procedure ultrasound is recommended to detect venous thrombosis. In addition, consideration should be given to performing complex re-interventions in a hospital given the complication risk in this sub-population of patients.
http://www.jvir.org/article/S1051-0443(11)00005-4/fulltext
Venous Angioplasty in Patients with Multiple Sclerosis: Results of a Pilot Study
P. Zamboni, R. Galeotti, B. Weinstock-Guttman, C. Kennedy, F. Salvi, R. Zivadinov published online 12 August 2011.
Abstract
Objectives
Chronic cerebrospinal venous insufficiency (CCSVI) is associated with multiple sclerosis (MS). The objective of the study was to see if percutaneous transluminal angioplasty (PTA) of duplex-detected lesions, of the internal jugular and/or azygous veins, was safe, burdened by a significant restenosis rate, and whether there was any evidence that treatment reduced MS disease activity.
Design: This was a case-control study.Materials: We studied 15 patients with relapsing–remitting MS and duplex-detected CCSVI.
Methods
Eight patients had PTA in addition to medical therapy (immediate treatment group (ITG)), whereas seven had treatment with PTA after 6 months of medical therapy alone (delayed treatment group (DTG)).
Results
No adverse events occurred. At 1 year, there was a restenosis rate of 27%. Overall, PTA was followed by a significant improvement in functional score compared with baseline (p < 0.02). The annualized relapse rate was 0.12% in the ITG compared with 0.66% in the DTG (p = NS). Magnetic resonance imaging (MRI) blindly demonstrates a trend for fewer T2 lesions in the ITG (p = 0.081), corresponding to a 10% decrease in the ITG compared with a 23% increase in the DTG over the first 6 months of the study.
Conclusions
This study further confirms the safety of PTA treatment in patients with CCSVI associated with MS. The results, despite the significant rate of restenosis, are encouraging and warrant a larger multicentre double-blinded, randomized study.
http://www.sciencedirect.com/science/article/pii/S1078588411002012