SAN FRANCISCO -- Performing angioplasty to remove blockages in neck and chest veins appeared to improve symptoms of multiple sclerosis, according to two small studies presented here.
Although they were retrospective and neither included a placebo group, both studies concluded that angioplasty of the jugular and/or azygos veins was associated with significantly improved quality of life for MS patients, researchers reported at the Society of Interventional Radiology meeting.
"We're encouraged to know that patients are clearly getting better," Kenneth Mandato, MD, of Albany Medical Center in Albany, N.Y., told MedPage Today. "These results can serve as a springboard to a larger study where both the patient and a neurologist are blinded."
The studies lend support to the controversial theory that MS is linked to chronic cerebrospinal venous insufficiency (CCSVI).
The idea of CCSVI comes from the work of Paolo Zamboni, MD, a vascular surgeon at the University of Ferrara in Italy. In 2009, Zamboni reported a study that found MS patients were more likely to have narrowed jugular or azygos veins than healthy patients.
These blockages cause high pressures, which adversely impact inflammation in the brain and may contribute to the formation of characteristic MS plaques. Treating these veins in the neck and chest could help treat the disease, Zamboni suggested.
But the neurological community has remained highly skeptical of the theory. Questions remain about how to properly measure what a 'normal' jugular or azygos vein looks like, and techniques for assessing these parameters need to be standardized.
In the first study, Mandato and colleagues conducted a retrospective study of 213 MS patients who were treated at their center during a four-month period; 192 responded to follow-up surveys on quality of life using the MSQOL-54.
Most (96) had relapsing-remitting disease, 66 had secondary progressive MS, and 30 had primary progressive disease.
A total of 189 had angioplasty and another three also had a stent placed.
Mandato and colleagues found that patients reported significant improvements in both physical and mental health scores (P<0.05 for both).
Physical health scores improved by 77% for both relapsing-remitting and primary progressive patients, and by 59% for those with secondary progressive disease (P<0.05 for all). Mental health scores were also similarly improved, but Mandato noted that those with secondary progressive disease were significantly less likely to benefit than those with the other two disease types (P<0.05).
They also found that those who'd been diagnosed more than 10 years ago had the least improvements, but in further analyses, years since diagnosis weren't associated with changes in physical or mental health scores.
In a second study, Hector Ferral, MD, of NorthShore University Healthcare System in Evanston, Ill., and colleagues also conducted a retrospective review of 107 procedures in 95 patients with MS who were evaluated at their facility from June 2010 to September 2011.
Half of patients had relapsing-remitting disease, 39% had secondary progressive MS, 6.4% had primary progressive MS, and disease was unclassified in 4.2%.
Clinicians assessed patients' jugular and azygos veins and conducted an angioplasty in those who needed it; some were also stented. All patients were given anticoagulants for six weeks following treatment.
Overall, Ferral and colleagues reported seeing stenosis in 94.9% of patients, and angioplasty was associated with a sustained improvement (more than four weeks) in 55.5% of patients.
On the other hand, 38.8% of patients reported no improvement at all.
The greatest improvements in symptoms were reported in relapsing-remitting patients, the researchers said.
Only 7.7% of patients reported any complications, and most were minor, such as bleeding at the puncture site.
Major complications, including clot formation in the treated veins, occurred in 3.3% of patients, which was a relatively low rate, Ferral and colleagues said.
They concluded that venous abnormalities are common in MS patients and angioplasty appears to be associated with some improvement.
Timothy Coetzee, MD, chief research officer for the National MS Society, said in an email to MedPage Today that even though these studies lacked a placebo group and were retrospective, they add to the literature on CCSVI.
"To truly understand the CCSVI hypothesis and what it means for people with MS requires conducting well-designed studies," he said. He add that society has teamed with a Canadian MS society to support CCSVI research using rigorous controls and standardized assessment techniques and technologies.
Mandato agreed that prospective, double-blind randomized controlled trials are needed to further evaluate the role of endovascular therapies in MS, and encouraged more collaboration between interventionalists and neurologists.
"The medical community needs to take a multidisciplinary approach to this procedure before it can be validated," he said, adding that skepticism of the hypothesis is "healthy" and is necessary to drive further research.
http://www.medpagetoday.com/clinical-context/MultipleSclerosis/31868