Becker's Spine Review

38 Executive Briefing: Sponsored by: H undreds of thousands of Americans suffer back pain related to vertebral compression fractures (VCF) every year, in many cases related to osteoporosis, but the spine specialist community at large has not agreed upon the most effective clinical care pathway. 1 Vertebral augmentation procedures — vertebroplasty (VP) and balloon kyphoplasty (BKP) — were developed to treat VCFs due to osteoporosis, cancer or, at times benign lesions of bone. However two 2009 studies cast vertebroplasty in a negative light, and procedural volumes dropped nationwide. Joshua Hirsch, MD, vice chair of procedural services as well as chief of the neurointerventional spine service at Boston- based Massachusetts General Hospital, led multiple studies investigating vertebral augmentation and is committed to expanding access to care for properly selected VCF patients. He co-authored an article published last year in The Spine Journal titled "Management of vertebral fragility fractures: a clinical care pathway developed by a multispecialty panel using the RAND™/UCLA Appropriateness Method," which brought together multidisciplinary specialists to develop the foundation for a VCF clinical care pathway. 2 "The purpose of this exercise was to look at a variety of scenarios and design a system where [healthcare providers] could see a patient and recommend the appropriate next steps, whether that's conservative therapy, imaging or vertebral augmentation," said Dr. Hirsch. This article briefly outlines influential studies on vertebral augmentation and offers discussion on a clinical care pathway for VCF patients. History In 2009, two studies published in the New England Journal of Medicine compared vertebral augmentation to an active sham control. 3 In the smaller of the two trials from Australia, the authors outlined findings from a multicenter, randomized, double-blinded, active sham-controlled trial comparing vertebroplasty to a sham procedure in 71 patients. Study authors reported results were similar between both groups. 4 The second study, the INVEST trial, included 131 patients with painful osteoporotic vertebral fractures. The patients were randomized into groups that underwent vertebroplasty or a simulated procedure without cement, and patients could cross over between study groups one month after beginning treatment. In this study, authors concluded both groups had similar improvement. 5 As mentioned above, Dr. Hirsch and collaborators including Kevin Ong, PhD, a principal engineer with Exponent, examined the steep reduction in vertebral augmentation volume over the five years after the articles were published. 6 Based on Medicare data gathered from 2005 to 2014, in the five years prior to publication of the NEJM studies, 24 percent of VCF patients underwent balloon kyphoplasty or vertebroplasty. This dropped to 14 percent in the five years after the studies were published. Additionally, Dr. Hirsch pointed out, "The 10-year risk of mortality for patients with VCF was 85.1 percent, which is quite high." Several recent, large clinical studies followed for at least 12 months after VCF have concluded that mortality rates following VCFs are significantly higher for patients treated conservatively versus VP or BKP, while other studies have concluded no difference. Five studies concluded that patients treated with vertebral augmentation experienced lower mortality risk than patients treated with non-surgical management. 7, a, b, c, d, e, f How a clinical care pathway ignites treatment options for vertebral compression fracture patients Joshua Hirsch, MD Vice Chair, Procedural Services Massachusetts General Hospital

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