Studies of Interventional Treatments for CCSVI and MS Presented at SIR
March 28, 2011—The Society of Interventional Radiology (SIR) announced that Kenneth Mandato, MD, presented findings from a retrospective study of 231 multiple sclerosis (MS) patients (age range, 25–70 years; 147 women, 84 men) who underwent angioplasty of the internal jugular and azygous veins with or without placement of a stent to improve MS-related symptoms.
The background of this study is that in 2009, Paolo Zamboni, MD, published findings in the Journal of Vascular Surgery suggesting that chronic cerebrospinal venous insufficiency (CCSVI) might contribute to MS and its symptoms, and that if these veins were widened, blood flow may be improved, which may help lessen the severity of MS-related symptoms (2009;50:1348–1358). Endovascular Today’s news coverage of current literature provided a summary of the study in December 2009.
Dr. Mandato presented the study at SIR’s 36th annual scientific meeting in Chicago. Abstract No. 3, which summarizes the study, was published in SIR’s meeting supplement of the Journal of Vascular and Interventional Radiology (2011;22:S4). The SIR supplement also includes abstracts of other CCSVI and MS-related studies presented at this year’s meeting.
“There are few treatment options that truly improve the quality of life of those with the disease, and some of the current drug treatment options for MS carry significant risk,” commented Dr. Mandato. “Our study will provide researchers the confidence to study it as an MS treatment option for the future. Our results show that such treatment is safe when performed in the hospital or on an outpatient basis—with 97% treated without incident.”
He added, “Our study, while not specifically evaluating the outcomes of this endovascular treatment, has shown that it can be safely performed with only a minimal risk of significant complication. It is our hope that future prospective studies are performed to further assess the safety of this procedure.”
Complications included abnormal heart rhythm in three patients and the immediate renarrowing of treated veins in four patients. All but two of the patients were discharged within 3 hours of receiving treatment.
As reported by Endovascular Today on August 26, 2010, SIR issued a position statement supporting high-quality clinical research to determine the safety and effectiveness of interventional MS treatments, recognizing that the role of CCSVI in MS and its endovascular treatment by an interventionist via angioplasty and/or stents to open up veins could be transformative for patients. The statement was published in SIR’s Journal of Vascular and Interventional Radiology (2010;21:1335–1337).
“This is an entirely new approach to the treatment of patients with neurologic conditions, such as multiple sclerosis,” stated Gary P. Siskin, MD, co-chair of the SIR research consensus panel on MS that was held in October. “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.”
Dr. Siskin was a co-investigator with Dr. Mandato on the retrospective study of the safety of the procedure. They also collaborated on a study of the impact of internet-based social networking on the evolution of endovascular treatment for MS patients with CCSVI that was presented at the SIR meeting and published as Abstract No. 257 in the meeting supplement of the Journal of Vascular and Interventional Radiology (2011;22:S110).
Dr. Siskin cautioned, “It is important to understand that this is a new approach to MS. As a result, there is a healthy level of skepticism in both the neurology and interventional radiology communities about the condition, the treatment, and the outcomes.”
According to SIR, approximately 500,000 people in the United States have MS, which is generally thought of as an incurable, disabling autoimmune disease in which a person’s body attacks its own cells. The SIR position statement agrees with MS advocates, doctors, and other caregivers that the use of any treatment (anti-inflammatory, immunomodulatory, interventional, or other) in MS patients should be based on an individualized assessment of the patient’s disease status, his or her tolerance of previous therapies, the particular treatment’s scientific plausibility, and the strength and methodological quality of its supporting clinical evidence.
SIR stated that although the use of angioplasty and stents cannot be endorsed yet as a routine clinical treatment for MS, the preliminary research is very promising, and the society supports studies aimed at understanding the role of CCSVI in MS, identifying methods to screen for the condition, and designing protocols for exploratory therapeutic trials. Dr. Mandato advised that research has to be conducted concerning patient selection, technique, and the outcomes after this procedure, including improvement in symptoms and quality of life and the durability of the response.
The July 2010 issue of Endovascular Today included an overview of the possible role of CCSVI and its endovascular treatment as a new paradigm and therapy for MS by Salvatore J. A. Sclafani, MD, along with commentary by Michael D. Dake, MD, and Barry T. Katzen, MD (2010;9:41–46).