The FDA today released a safety communication concerning risks associated with off-label balloon angioplasty procedures intended to treat autonomic dysfunction, warning of serious health risks and a lack of supporting data.
The procedure, called trans venous autonomic modulation, involves a catheter being threaded into a patients’ venous system where an attached balloon is inflated to widen the vein walls. Physician Dr. Michael Arata claims the procedure can treat the signs and symptoms of autonomic dysfunction in a number of neurological disorders, according to the FDA.
The federal watchdog warned of possible serious risks to patients from such procedures, with serious complications from such treatments being indicated in at least 1 death, blood clots in veins in the brain, cranial nerve damage and abdominal bleeding.
While the safety and effectiveness of angioplasty procedures were tested in arteries, they were not tested in patients’ venous systems, according to the FDA. In addition, a clear lack of scientific evidence exists showing that the treatment is safe, positively impacts symptoms or health conditions or improves the quality of life for patients with autonomic dysfunctions.
The warning comes the same day that new data emerged showing that similar venoplasty procedures in the brain and spine have no effect on treating patients with multiple sclerosis.
Researchers, led by the University of British Columbia and Vancouver Coastal Health, sought to explore the effects of “liberation therapy” on treating patients with MS.
The use of venoplasty in the brain and spine to treat MS was established by Dr. Paulo Zamboni of Italy, who claimed that narrowing of veins in the neck could cause iron to accumulate in the brain and spinal cord and trigger an autoimmune response, according to the study.
1-year results from the 104-patient, sham-controlled trial showed no statistical difference between the groups, as measured by brain imaging, standard MS assessments of symptoms and patient self-assessments.
“We hope these findings, coming from a carefully controlled, ‘gold standard’ study, will persuade people with MS not to pursue liberation therapy, which is an invasive procedure that carries the risk of complications, as well as significant financial cost. Fortunately, there are a range of drug treatments for MS that have been proven, through rigorous studies, to be safe and effective at slowing the disease progression,” Djavad Mowafaghian Centre for Brain Health MS Clinic director Dr. Anthony Traboulsee said in a prepared statement.
Study researchers used magnetic resonance imaging to count the number of new myelin lesions, and found no difference at 6 months and 1 year between the sham and treatment groups.
“Despite the negative findings of that diagnostic study, many patients wanted to know if the venous dilation procedure could help. We were committed to meticulously evaluating this treatment with robust methods and patient-focused outcomes,” Dr. Lindsay Machan of UBC said in a prepared release.
The FDA released a warning notice covering “liberation therapy” treatments back in 2012, based on a lack of evidence that the procedure would be beneficial for patients with MS. The federal watchdog sent a warning to Dr. Arata that same year concerning performing such treatments.