A prospective pilot study led by Dr. Manish Mehta, vascular surgeon of Albany, NY, does suggest an association between MS and CCSVI which results in slowed emptying of the internal jugular veins (IJV). Of 50 CCSVI-MS patients with IJV stenosis (narrowing) greater than 70% who underwent balloon angioplasty (ie. “liberation” treatment), 78 percent (44/50) experienced successful treatment as defined by less than 20 percent residual stenosis. [There seems to be a discrepancy between the stats of 78% and 44/50.] CCSVI-MS patients who underwent balloon angioplasty had hemodynamic results which were comparable to healthy non-MS subjects who received no treatment (Mehta, 2012).
In February 2012, the FDA issued an additional warning letter to Dr. Mehta regarding the failure to obtain FDA approval prior to conducting a clinical trial involving angioplasty balloon treatment for CCSVI. While the FDA “encourages research to evaluate the relationship between CCSVI and MS and to characterize the safety and effectiveness of treatment procedures,” it also warns of the risk of serious adverse events associated with the use of balloon angioplasty devices or stents in the internal jugular or azygos veins.
“The FDA has received reports of one patient who died from bleeding in the brain and one patient who suffered permanent paralysis from a stroke after CCSVI treatment. Other serious complications of the CCSVI procedure reported primarily as individual incidents or case series in medical journals include: at least one death, stents migrating from their original location to another part of the body (including the heart), venous injury, blood clots forming in the jugular vein or in stents, blood clots in a vein in the brain, cranial nerve damage, and abdominal bleeding. The frequency of these serious complications is not known.” - FDA Safety Communication, May 10, 2012.
For clinical investigators and institutional review boards (IRBs), the FDA emphasizes that investigations of medical devices for use in CCSVI treatment are “significant risk studies” which require approval through an IRB and the FDA’s Investigational Device Exemption (IDE) program. Clinical investigators are encouraged to discuss trial design with the FDA early in the planning process and throughout formal and less formal meetings and conferences. Patients who experience any complication related to CCSVI treatment should report the adverse event to the FDA MedWatch program.
The serious events which the FDA references in their safety alert almost seem like old news to those of us who may have been following the development of CCSVI activism, study, and treatment over the past three years. However, I think that it is a sign of progress that CCSVI has gained enough attention and study that the FDA is publicly discussing the subject with caution.
Here is part of the response (pdf) from the Society of Interventional Radiologists (SIR) to the FDA announcement - “SIR supports and agrees with the FDA’s recommendations to encourage research on CCSVI and the current knowledge regarding the safety and effectiveness of treatment procedures. SIR also agrees that clinical research of CCSVI should be performed through well-designed clinical trials, which should require approval through the FDA investigational device exemption (IDE) program.”