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| |  Society of Interventional Radiology Supports Vertebroplasty, Patient Selection Key FAIRFAX, Va -- January 19, 2010 -- Given the current controversy over vertebroplasty for the treatment of individuals with painful osteoporotic vertebral compression fractures that fail to respond to conventional medical therapy, the Society of Interventional Radiology (SIR) addresses the issue. “Hundreds of thousands of patients have greatly benefited from vertebroplasty with almost complete resolution of their pain; tens of thousands dependent on intravenous narcotics have been discharged from the hospital virtually pain- and drug-free following their treatment,” said Brian F. Stainken, MD, Imaging Network of Rhode Island, and Roger Williams Medical Center, Providence, Rhode Island, on behalf of the SIR. “Before treatment, many of these osteoporotic patients are in constant pain and cannot manage everyday activities. Many are confined to bed for up to 6 weeks. These are the people we help; with vertebroplasty they can go home in 1 to 2 days.” “Candidates for the procedure are those who have failed to respond to conventional medical treatment,” he said. “Vertebroplasty can give patients their lives back. Interventional radiologists have the critical skills in imaging and patient care that make them experts at determining which patients are the most appropriate candidates to receive the treatment.” Two studies published in the New England Journal of Medicine in August 2009 were the first clinical trials to test vertebroplasty against a placebo, and many experts were stunned by the results that suggested that patients got equal amounts of modest pain relief whether they got vertebroplasty, where medical-grade bone cement is injected into broken vertebrae, or a dummy injection. “SIR supports the use of vertebral augmentation (vertebroplasty and kyphoplasty) for patients with painful compression fractures,” said Dr. Stainken. “In addition, SIR supports the important role of research regarding the role of vertebral augmentation, but we should take note that it is increasingly clear that these studies did not tell the whole story. The groups of patients studied and the analysis raised as many questions as were answered.” Based on the NEJM findings, the society recommended that interventional radiologists inform patients of the studies’ controversial results during consultation. “The studies demonstrate the importance of debate and rigorous analysis of all data prior to rushing to conclusions,” he said. “We must closely monitor trends in vertebroplasty research. There will be additional studies at SIR’s Annual Scientific Meeting in March that will provide new perspective on the aforementioned studies and reaffirm our perspective that vertebroplasty provides long-term and rapid pain relief for appropriately selected patients.” J. Kevin McGraw, MD, Interventional Radiology, Riverside Radiology and Interventional Associates, Columbus, Ohio, said: “While we welcome the 2 studies by researchers David F. Kallmes, MD, and Rachelle Buchbinder, PhD, to the body of literature on this technique, the results of these trials are discordant with personal experience and more than 15 years of accumulated medical literature espousing the benefits of vertebroplasty.” “SIR recognizes the value of randomised controlled trials and evidence-based medicine; however, the weakness in the studies and the degree of discordance between the outcomes of these studies, prior studies and experience, suggest that it is premature -- and possibly incorrect -- to conclude that vertebroplasty is no better than a control sham procedure,” he noted. Criticisms of both studies include the small numbers of patients treated; the small percentage of eligible patients who were actually enrolled in the trial; inclusion of patients with milder degrees of pain and disability than are usually treated in a typical practice; the small amount of cement injected; treatment of patients with chronic compression fractures; the incomplete use of magnetic resonance imaging or computed tomography to confirm that the fracture was the likely source of pain; and the high rate of crossover from placebo to vertebroplasty in one of the studies, explained Dr. McGraw.
SOURCE: Society of Interventional Radiology
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