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A new University of Calgary study documenting complications in patients who have undergone treatment for CCSVI amounts to little more than fear-mongering. The researchers looked at potential complications in five patients who were treated with angioplasty in Eastern Europe. However, they appear to have no information about the circumstances of the actual procedures. Were the people doing the surgery well trained? We have no idea. We don’t know what they did, or what happened during the procedure.
It’s estimated that more than 12,000 people have been treated for CCSVI worldwide. There has been no data collection on either outcomes or complications, so to focus on complications for five patients is fear-mongering.
No surgery is without risk. But it is irresponsible to attribute complications to a procedure when we don’t have complete information. For example, the University of Calgary researchers make the assumption that a stent has migrated in one patient, but there is no proof of where the stent was originally placed.
What the Calgary researchers did was to look at five people. What they didn’t do was to conduct a trial that investigates the safety of angioplasty. In fact, such a trial has already been done, by interventional radiologists at the Albany Medical Center in Albany, NY. Their study, released in March 2011, followed 231 patients. “Our results show that such treatment is safe when performed in the hospital or on an outpatient basis — with 97 percent treated without incident,” said Kenneth Mandato, who led the research.
People with CCSVI who choose to be surgically treated should have access to well-trained, experienced doctors and full information about the potential risks and benefits of the procedure. Randomized, controlled double-blind studies need to be done to assess the efficacy and potential risks of this treatment.
Sandy McDonald MD
Cardiovascular and thoracic surgeon
Barrie, Ont.
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