June 15, 2011
SIR Panel Addresses Research Needs for Interventional Treatment of CCSVI in MS Patients
June 16, 2011—The Society of Interventional Radiology (SIR) announced the publication of proceedings from a multidisciplinary research consensus panel that was charged with developing a research agenda for evaluating imaging and interventional therapies for chronic cerebrospinal venous insufficiency (CCSVI) in patients with multiple sclerosis (MS). The proceedings were published in the May issue of the Journal of Vascular and Interventional Radiology (2011;22:587–593).
In October 2010, SIR's clinical trials division commissioned and convened the 11-member panel of leading physicians and scientists with expertise in the clinical management of MS, basic sciences, neuroradiologic imaging, and vascular and venous interventions. Gary P. Siskin, MD, and Ziv J. Haskal, MD, were the panel's lead investigators. SIR Foundation Chair Gordon McLennan, MD, moderated the session. The panel included members from the fields of interventional radiology, imaging physics, surgery, and neurology. Representatives from industry and the federal government were also present as observers.
As summarized in the Journal of Vascular and Interventional Radiology, the committee came to the general consensus that the mechanisms for evaluating patients with MS for jugular and azygous venous compromise and the value of treating these lesions with angioplasty warrant careful, well-designed additional study. The committee believed the specific parameters needed for a large-scale, pivotal multicenter trial were not necessarily available at this time but that these types of trials are the mandatory goal for study of CCSVI.
The panel stated that prospective safety and efficacy trials should be conducted in well-defined and potentially smaller, controlled populations under institutional review board approval. In addition, it was deemed critical to support and continue the basic science work that is underway to better understand the relationship between venous stenoses and hypertension and the subsequent contribution of CCSVI to patients with MS. Animal models will likely prove useful, although inflammatory mediators may be assessed with serum sampling in the context of human trials.
The panel noted that there will be many practitioners who offer endovascular therapy to patients with MS in advance of the availability of definitive peer-reviewed data in support of the practice. It was the general hope of the committee that this work would lead to additional peer-reviewed studies, generating data that clarify the role of treating venous disease with angioplasty, and possibly stent placement, and the potential adverse events associated with these interventions in MS patients.
If additional studies confirm the initial reports in favor of CCSVI diagnosis and treatment and appropriate study cohorts and standardized procedural technique and reporting are developed, it will then be appropriate to pursue prospective multicenter trials.
According to the panel, enrollment in these trials will require confirmation of the diagnosis of MS based on currently accepted criteria, assessment of disease activity with conventional magnetic resonance imaging, determination of clinical and functional status, listing of previous treatment for MS or other significant medical issues, noninvasive screening documentation of venous disease with ultrasound and/or magnetic resonance imaging/venography, and catheter-based venographic documentation of venous stenoses.
Randomization against catheter venography without angioplasty would be required, with blinding of research personnel and examining neurologists. The potential role of stents would emerge from discussions of trial design. Imaging follow-up and clinical assessments might occur at 3, 6, 9, and 12 months after treatment, with a crossover permissible after a period that has yet to be defined. This type of study defines an ultimate goal in determining the contributory role of CCSVI and catheter-based interventions in patients affected with MS, concluded the consensus panel in the Journal of Vascular and Interventional Radiology.
“Much work needs to be done to better define, explore, and prove the concept of vein obstruction playing a role in causing multiple sclerosis,” commented Dr. Siskin. “This is an entirely new approach to the treatment of patients with neurologic conditions, such as MS, and could be transformative for patients. Continued investigation is needed in this area. Researchers are clearly very early in their understanding of both the condition and the treatment.”
Dr. Siskin also noted that patients are learning about this therapy and the role of interventional radiology in venous angioplasty through the Internet. He stated, “Individuals are discussing it among themselves—through blogs and social networking sites—and then turning to interventional radiologists for this minimally invasive treatment.”
Dr. McLennan added, “The idea that there may be a venous component that causes some symptoms in patients with MS is a radical departure from current medical thinking. There is a healthy level of skepticism in both the neurology and interventional radiology communities about the condition, the treatment, and the outcomes.”
In related news, Course Director Salvatore J.A. Sclafani, MD, will lead the second annual CCSVI Update Symposium to be held on July 16 through 17 at the Crown Plaza Times Square in New York City. The meeting will bring together experts including Paolo Zamboni, MD, who is the originator of the CCSVI theory, and an international faculty of investigators and clinicians to review relevant data and share firsthand accounts. More information about the CCSVI Update Symposium is available online at http://ccsvisymposium.com.