March 28, 2011
A study of 231 patients demonstrated that the use of angioplasty to widen veins is a safe, minimally invasive option for individuals with multiple sclerosis (MS), according to research presented at the Society of Interventional Radiology's (SIR) 36th annual scientific meeting in Chicago. The findings open the door for further research into the clinical role of the treatment.
In a retrospective study, 231 MS patients (age range, 25 to 70 years old; 147 women) underwent 247 endovascular procedures of the internal jugular and azygos veins with or without placement of a stent.
"Our results show that such treatment is safe when performed in the hospital or on an outpatient basis—with 97 percent treated without incident," Kenneth Mandato, MD, an interventional radiologist at Albany Medical Center in Albany, N.Y., noted.
In 99 percent of procedures, patients were discharged within three hours of treatment. Complications included transient headache in 8.5 percent of patients and neck pain in 15.8 percent of patients. Sustained cardiac arrhythmias occurred in three patients. The researchers indicated that cardiac monitoring is essential for rapid treatment of procedure-induced arrhythmias and recommended post-procedure ultrasound to detect venous thrombosis.
About 500,000 people in the U.S. have MS, generally thought of as an incurable, disabling autoimmune disease in which a person's body attacks its own cells. "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," said Mandato.
In 2009, Paolo Zamboni, a doctor from Italy, published a study that suggested that a blockage in the veins that drain blood from the brain and spinal cord and return it to the heart (a condition called chronic cerebrospinal venous insufficiency or CCSVI) might contribute to MS and its symptoms. The idea is that if these veins were widened, blood flow may be improved, which may help lessen the severity of MS-related symptoms.
The Society of Interventional Radiology issued a position statement last fall 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 interventional radiologist via angioplasty or stents to open up veins could be transformative for patients. "This is an entirely new approach to the treatment of patients with neurologic conditions, such as multiple sclerosis. 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," said Gary P. Siskin, MD, an interventional radiologist and chair of the radiology department at Albany Medical Center and the co-chair of the SIR research consensus panel on MS that was held in October.
"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," said Siskin.
"Patients are learning about this therapy and the role of interventional radiology in venous angioplasty through the internet. They are discussing it among themselves—through blogs and social networking sites—and then turning to interventional radiologists for this treatment," he noted. "This is a new entity and one where researchers are clearly very early in their understanding of both the condition and the treatment."
While the use of angioplasty and stents cannot be endorsed yet as a routine clinical treatment for MS, SIR agrees that the preliminary research is very promising and supports studies aimed at understanding the role of CCSVI in MS, at identifying methods to screen for the condition and at designing protocols for exploratory therapeutic trials.
Mandato noted that research still needs to be done concerning patient selection, technique and the outcomes after this procedure, including improvement in symptoms and quality of life and the durability of the response.