Lara C. Pullen, PhD

April 05, 2011

April 5, 2011 (Chicago, Illinois) — Endovascular treatment of chronic cerebrospinal venous insufficiency (CCSVI) in patients with multiple sclerosis (MS) is safe and can be performed on an outpatient basis.

Kenneth Mandato, MD, interventional radiologist at Albany Medical Center in New York, presented the results of a retrospective analysis of a single center's safety data here at the Society of Interventional Radiology (SIR) 36th Annual Scientific Meeting.

Ziv J. Haskal, MD, FSIR, FACR, FAHA, FCIRSE, chief of vascular and interventional radiology at the University of Maryland Medical Center in Baltimore, spoke with Medscape Medical News and described this approach to treating MS as "the most controversial thing I've seen in almost 30 years."

Dr. Mandato specifically evaluated the results of outpatient endovascular treatment of the internal jugular and azygos veins, identifying and describing adverse events and complications that occurred within 30 days of the procedure. The study consisted of 247 procedures that were performed on 231 patients (147 women and 84 men), who ranged in age from 25 to 70 years. For 99.2% (245 of 247) of the procedures, patients were discharged within 3 hours.

The authors note that procedure-induced arrhythmias occurred in 3 patients during the procedure, so cardiac monitoring is essential. Furthermore, additional studies are required to determine the utility of this procedure as a treatment option for MS. Specifically, research is needed to elucidate patient selection, angioplasty technique, and efficacy.

Dr. Haskal is one of the lead investigators of the SIR Research Consensus Panel on the Interventional Endovascular Management of Chronic Cerebrospinal Venous Insufficiency in Patients with MS, convened on October 18, 2010. Last fall, the consensus panel issued a position statement supporting high-quality clinical research to determine the safety and efficacy of interventional treatments for MS.

Approximately 500,000 people in the United States have MS — generally considered an incurable and disabling disease. According to Dr. Haskal, many patients with MS travel to Costa Rica, Kuwait, India, and other countries to receive angioplasty. He described the approach as "Facebook-driven medicine," and explained that there is a concern that patients will be preyed on by individuals who do not have their best interests at heart. He goes even further and adds that the majority of neurologists find this treatment approach to MS to be abhorrent. According to Dr. Haskal, "I cannot overstate the uproar over [angioplasty as a treatment for MS]."

The SIR's position statement notes that the use of any treatment in patients with MS should be determined on a patient-specific basis and should be based on the patient's disease status and tolerance of previous therapies, as well as the scientific plausibility of the treatment. SIR encourages patients with MS to continue to discuss treatment options with their neurologists. At this time, the scientific data do not support the routine use of angioplasty and stents as treatments for MS, but the SIR agrees that the preliminary results are very promising.

Dr. Mandato's research indicates that angioplasty for CCSVI is a safe procedure. If a patient is suspected of having CCSVI, Dr. Mandato suggested to Medscape Medical News that they first receive an ultrasound to determine venous insufficiency. When discussing the technique with Medscape Medical News, Dr. Mandato indicated that this initial research should help physicians understand the safety of the procedure.

Dr. Mandato also discussed the scientific basis of this approach. He explained that the initial idea came from Paolo Zamboni, MD, a vascular surgeon in Italy whose wife was diagnosed with MS. Dr. Zamboni made the connection between venous outflow and pathology in the brain. He published a series of cases of patients with MS who were improving after angioplasty of the jugular vein. This 2009 publication by Dr. Zamboni suggested that CCSVI might contribute to MS and its symptoms (J Neurol Neurosurg Psychiatry. 2009;80:392-399).

Dr. Mandato explained that from a medical standpoint, this publication received a great deal of interest — both positive and negative. Dr. Mandato also noted that more work needs to be done to understand the science behind any efficacy. He asked: "Is the venous outflow adding insult to injury, or are we dealing with abnormal veins that were there from the beginning?" He explained that there are still many theories that have yet to be supported by evidence.

He is currently performing a retrospective analysis of efficacy data from the cohort studied in the safety analysis and is currently gathering data from a prospective trial.

Dr. Mandato and Dr. Haskal have disclosed no relevant financial relationships.

Society of Interventional Radiology (SIR) 36th Annual Scientific Meeting: Abstract 3. Presented March 28, 2011.

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