Summary: In a Multiple Sclerosis Society-funded study, researchers confirm that venoplasty (a procedure that involves inserting a balloon that widens the veins and improves blood flow) versus sham (mock-treatment) procedure in people with multiple sclerosis (MS) who displayed signs of chronic cerebrospinal venous insufficiency (CCSVI) does not change patient-reported outcomes or clinical findings.
Background: Chronic cerebrospinal venous insufficiency (CCSVI) is a theory in which the veins in the head and neck are narrowed or blocked, and therefore unable to efficiently drain blood from the central nervous system. CCSVI had been proposed initially by Dr. Paolo Zamboni, to be the cause of the pathogenesis and disabling symptoms experienced by those diagnosed with MS due to impaired draining leading to inflammation. Multiple research groups, including Dr. Zamboni’s subsequently showed that venoplasty did not alter the course of MS in individuals that had undergone the procedure.
Recently, a study funded by the MS Society of Canada and the Canadian Institutes of Health Research (CIHR), with additional funding from the Michael Smith Foundation for Health Research, Research Manitoba, and Ministère de la Santé et des Services Sociaux du Québec, investigated the safety and efficacy of venoplasty versus sham procedure in individuals who displayed signs of CCSVI in MS. The study led by MS researcher and neurologist, Dr. Anthony L. Traboulsee from the University of British Columbia, was published in the Neurology journal.
The Study: The study recruited 104 participantswith relapsing-remitting and progressive MS. Participants were screened to confirm greater than 50 per cent narrowing of veins and then randomized to either receive the venoplasty or sham treatment and followed for a 48-week period. The primary safety outcome measure was the number of adverse effects experienced during the 48 weeks. The researchers also examined changes in the Multipe Sclerosis Quality of Life-54 (MSQOL-54) measure, a patient-reported outcome on areas such as pain, physical function, social function, cognitive function, and overall quality of life. In addition to these outcomes, the researchers also performed magnetic resonance imaging (MRI) to identify if any changes in lesions could be witnessed.
The Results: No significant differences were observed in the adverse effects experienced by individuals that received the two procedures. The MSQOL-54 revealed no differences on all patient-reported outcomes from baseline to 48 weeks. Finally, imaging (MRI) did not detect any benefit of the venoplasty procedure.
Comment: This study adds to the growing evidence supporting venoplasty as a safe yet ineffective procedure for MS. It also provides additional information for people living with MS to make safe and informed decisions about their health. The MS Society of Canada respects and honours an individual’s right to make decisions for the benefit of their own health and encourages those who want to explore venoplasty as a treatment for MS to visit the following pages: Risks and Safety with CCSVI-Related Procedures and Accessing Treatments Outside of Canada.
Source:
Traboulsee AL et al. (2018) Safety and efficacy of venoplasty in MS: A randomized, double-blind, sham-controlled, phase II trial. Neurology. [Epub ahead of print].