A cutting-edge vascular treatment program for multiple sclerosis (MS) at Stanford Medical School was terminated in December after some patients undergoing the therapy had complications.
Michael Dake, a Stanford professor of cardiovascular surgery, had surgically widened the internal jugular veins of select MS patients with stents, or mesh wire tubes. The procedure, called an angioplasty, attempted to fix a blockage limiting blood flow from the brain to the heart.
This insufficiency, termed CCSVI, was originally discovered by Dr. Paolo Zamboni, the director of the Vascular Diseases Center at the University of Ferrara in Italy. Zamboni hypothesized that the limited blood flow through the veins contributed to inflammation in the brain associated with MS.
MS patients who had angioplasties in Italy reported improved quality of life, leading to considerable excitement among members of the MS blog community. The wave of interest spread across the globe to Stanford, where Dake became the primary American doctor to perform the new surgery on MS patients.
Although the U.S. Food and Drug Administration (FDA) had not yet approved stents for this particular purpose, physicians have leeway in applying previously approved devices in new ways, according to the Stanford School of Medicine’s public affairs office. The office said Dake lawfully attempted the new surgery on MS patients — some 40 altogether, although the school would not confirm the exact number.
“Dake has used balloon angioplasty and stents in his practice of medicine, based on his knowledge of vascular insufficiency and of certain medical devices and his experience as a cardiovascular surgeon,” wrote Paul Costello, a spokesperson for the medical school, in an e-mail to The Daily.
Then one of Dake’s patients died of a brain hemorrhage on a flight back from visiting the doctor at Stanford. There is now a Facebook group in her memory attempting to raise money to aid further research into CCSVI therapy.
Another patient had to undergo emergency surgery, The Wall Street Journal reported.
In an e-mail to colleagues in December, Dake announced the termination of his angioplasty program until clinical trials could be secured.
“In the interval before our clinical protocol is approved by the appropriate regulatory agencies and necessary trial management infrastructure is secured, no further endovascular procedures including venograms, balloon angioplasty or stent placement will be performed for the evaluation or management of extracranial venous obstruction in any patients, with or without a diagnosis of Multiple Sclerosis,” he wrote. “I have made this decision after deep soul-searching.”
Stanford is now in the process of applying for grants and clearance to undertake a clinical trial of the therapy to begin late this year or early next year.
An advisory on the Department of Neurology’s Web site dissuades patients from pursuing the therapy at the moment.
“No, [the MS center does not recommend the procedure] at this time,” it said. “There is insufficient evidence of benefit, and possible risk.”
Costello confirmed that the University was no longer performing the procedures.
“The procedure is no longer taking place at Stanford awaiting a clinical trial,” Costello said.
It remains to be seen whether or not the FDA grants Stanford clearance for a clinical trial involving 100 patients in which neuroimaging could confirm whether or not vein blockage is actually a problem related to MS, and whether or not treatments like Dake’s and Zamboni’s could be effective.