Experimental multiple sclerosis vascular shunting procedure halted at Stanford.

Last August, 51-year-old multiple sclerosis (MS) patient Holly Shean was flying home to Arizona after undergoing an experimental surgical endovascular procedure at Stanford School of Medicine, during which two self-regulating stents were inserted to open a ste-nosis in her right jugular vein. Her surgeon believed the stents could restore normal blood flow from the brain and alleviate some of her symptoms, a procedure developed by an Italian researcher but one that has never been evaluated for safety and efficacy in a clinical trial. Shortly after her return, Shean suffered a fatal hemorrhage to her brain stem while on coumadin following the procedure. Although her family has stated publi-cally that her death was not due to the experimental procedure – noting that her mother suffered a similar stroke – many experts, including some of the surgeon's colleagues at Stanford, are openly critical that the procedure was being performed without adequate evaluation. Shean's death marked a turning point in what has become one of the most contentiously debated issues in MS today: chronic cerebrospinal venous insufficiency, or CCSVI. Dr Paolo Zamboni, a vascular surgeon at Italy's University of Ferrara, began studying what became known CCSVI in 2002. Using Doppler ultrasound and venograms, he and his colleagues reported that 100 percent of MS patients they had studied had stenoses or malformations of the internal jugular and/or azygous veins. They theorized that these blockages constrict the flow of blood, causing a reflux back into the brain and/or spine, leading to edema and inflammation. This, they reasoned, might cause the immune response and lead to the lesions that are the hallmark of MS. Zamboni and his colleagues then began inserting en-dovascular stents or balloons to open the blocked or malformed veins, a technique they named " the liberation procedure. " They report being able to correct the problem in 100 percent of patients, relieving symptoms in many. Zamboni published results of a study of the procedure in 65 patients with either relapsing/remitting, primary progressive or secondary progressive MS. Using sono-grams to detect abnormalities of venous drainage, they reported significant functional gains in patients with relapsing/remitting (RR) disease, and better quality of life scores after one year in patients with RR and primary progressive disease. But because their research has yet to be confirmed by others, or replicated in a randomized, blinded or controlled study, most neurologists, and even Dr. Zamboni himself, have repeatedly emphasized the …