Studies Support Endovascular Treatment of CCSVI in MS Patients

March 26, 2012—Two single-center studies on the management of chronic cerebrospinal venous insufficiency (CCSVI) with endovascular therapy were presented at the 37th annual scientific meeting of the Society of Interventional Radiology (SIR) in San Francisco. The abstracts are available online from the Journal of Vascular and Interventional Radiology.

“Short-Term Outcomes After Endovascular Treatment for Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Patients With Multiple Sclerosis,” (SIR abstract 48) reports findings by Kiran P. Sekhar, MD, et al from an investigation at the Albany Medical Center in Albany, New York. The investigators reported that at short-term follow-up, patients showed significant symptom relief and that the data support evidence that angioplasty of azygos and jugular veins is safe and improves the quality of life for multiple sclerosis (MS) patients.

The second study, “Clinical Experience in the Management of Chronic Cerebral Venous Insufficiency: Single-Center Experience,” (SIR abstract 49) was conducted by Hector Ferral, MD, et al at Rush University Medical Center in Chicago, Illinois. These results indicated that angioplasty for treating vein obstructions mitigated symptoms and improved quality of life. The investigators stressed the safety of angioplasty and urged a multidisciplinary approach to treatment.

In the Albany Medical Center study, patient subtypes included 96 patients with relapsing remitting MS, 66 with secondary progressive MS, and 30 with primary progressive MS. The study population included those who underwent angioplasty alone and three patients who underwent angioplasty and stent placement.

“Results of the study were quite exciting and promising,” commented investigator Kenneth Mandato, MD. “We can attest to significant physical improvements reported in > 75% of those with relapsing remitting and primary progressive forms of multiple sclerosis. Additionally, mental health scores improved in > 70% of individuals studied. People with secondary progressive multiple sclerosis showed statistically significant improvements in both physical and mental health scores at a rate of 59% and 50%, respectively.”

Study investigator Meredith J. Englander, MD, explained, “During a 4-month period, we treated 213 individuals, 192 of these patients (72 men, 141 women; average age 49 years) responded to a standard questionnaire that evaluated key quality-of-life components including changes in physical abilities, health perception, energy/fatigue, sexual function, emotional well-being, cognition, and pain.”

She continued, “We ultimately broke this data down into physical and mental health scores for each person and found improvement in both components of quality of life. In addition, we found a trend that patients undergoing this treatment more than 10 years after diagnosis did not respond as well as those with a more recent diagnosis.”

Dr. Mandato noted, “To address the needs and concerns of those with MS who feel they cannot wait until definitive studies are completed, many doctors are currently offering treatments with the hope of helping individuals with hard-to-manage symptoms of MS. Physicians who perform these treatments hope that this work will provide insights into the design of a prospective, randomized trial that is needed to rigorously evaluate the role of this treatment in MS.”

“As we are still early in fully understanding the condition and its relation to treatment of CCSVI, it is our hope that future double-blinded prospective studies will be performed to further assess the durability of these results,” concluded Dr. Mandato.

In the study conducted at Rush University Medical Center in Chicago, the investigators reported that performing angioplasty in veins in the neck and chest is a safe—and possibly effective—therapy to treat and provide symptom relief of venous abnormalities found in patients with MS.

Dr. Ferral, who was Lead Investigator of the study, commented, “These early results show that performing angioplasty on azygos and jugular vein lesions may have a positive impact on the symptoms of those individuals with MS and also could be an effective palliative treatment geared toward improving their quality of life. Our experience showed that 95% of the individuals we evaluated had venous obstructions, supporting the concept that venous lesions are common in individuals with multiple sclerosis.”

He added, “Based on follow-up that included ultrasound 1 week postprocedure and clinic visits every 3 months, our results showed that people who have this treatment are not exposed to fatal risks. It is our belief that portraying venous angioplasty of the azygos and jugular veins as a high-risk procedure is a widespread misconception that needs to be addressed and corrected. In addition to these significant safety findings, we noted that angioplasty provided symptomatic benefit in 55% of the individuals we treated.”

“These important results revealed that, for people with multiple sclerosis who experience debilitating symptoms, minimally invasive interventional radiology treatments can be an effective, palliative treatment that also may improve their quality of life,” concluded Dr. Ferral. “As interventional radiologists, our biggest challenge is to bring to the attention of other specialists, especially those physicians specialized in multiple sclerosis, the evidence that venous lesions, often classified as chronic cerebrospinal venous insufficiency or CCSVI, may be a true entity that deserves further attention and serious research.”

According to an SIR press release, this retrospective review examined results of 105 procedures performed in 94 individuals with MS (age range, 26–67 years; 35 men, 59 women). The study's subgroups included patients with relapsing remitting MS (50%), those with secondary progressive MS (39%), those with primary progressive MS (6.4%), and unknown (4.2%). Jugular and azygos veins were evaluated with selective venography and intravascular ultrasound. Angioplasty was performed if the imaging confirmed reflux or > 50% decrease in the vessel's diameter. If necessary, stents were then used to treat nonresponsive lesions or blockages. These individuals were given blood-thinning medications for 6 weeks after the treatment.

The investigators found symptomatic improvement in 55% of the individuals treated, and 38% reported no improvement. Seven percent of patients did not comply with their follow-up visits and were considered to be lost to follow-up. Approximately 60% of those patients with relapsing remitting MS reported improvement in symptoms, the highest of all the subgroups in this study.

Members of the SIR Foundation's Research Consensus Panel advised in 2011 that evaluating people with MS who have narrowed jugular and azygos veins—and examining the value of widening those veins with angioplasty—warranted careful, well-designed research. The multidisciplinary panel indicated that the “mandatory goal” should be through large-scale, pivotal multicenter trials to explore CCSVI.