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Vertebral Augmentation Involving Vertebroplasty Or Kyphoplasty for Cancer-Related Vertebral Compression Fractures: a Systematic Review

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Vertebral Augmentation Involving Vertebroplasty Or Kyphoplasty for Cancer-Related Vertebral Compression Fractures: a Systematic Review Health Quality Ontario The provincial advisor on the quality of health care in Ontario ONTARIO HEALTH TECHNOLOGY ASSESSMENT SERIES Vertebral Augmentation Involving Vertebroplasty or Kyphoplasty for Cancer-Related Vertebral Compression Fractures: A Systematic Review KEY MESSAGES Cancer can start in one part of the body and spread to other regions, often involving the spine, causing significant pain and reducing a patient’s ability to walk or carry out everyday activities such as bathing, dressing, and eating. When cancer spreads to or occurs in a bone of the spine (a vertebral bone), the cancer can weaken and break this bone. These fractures, if left untreated, can negatively affect the quality of life of terminally ill patients and their families. Vertebroplasty and kyphoplasty are two types of procedures called vertebral augmentation. During vertebral augmentation, the physician injects bone cement into the broken vertebral bone to stabilize the spine and control pain. Kyphoplasty is a modified form of vertebroplasty in which a small balloon is first inserted into the vertebral bone to create a space to inject the cement; it also attempts to lift the fracture to restore it to a more normal position. Medical therapy and bed rest are not very effective in cancer patients with painful vertebral fractures, and surgery is not usually an option for patients with advanced disease and who are in poor health. Vertebral augmentation is a minimally invasive treatment option, performed on an outpatient basis without general anesthesia, for managing painful vertebral fractures that limit mobility and self-care. We reviewed the evidence to evaluate the safety and effectiveness of vertebroplasty and kyphoplasty in cancer patients. Both procedures rapidly reduce pain, decrease the need for pain medicine, and improve patients’ ability to walk and carry out basic everyday activities. Serious complications after these procedures are rare. MAY 2016 VOL. 16, NO. 11 Let’s make our health system healthier HEALTH TECHNOLOGY ASSESSMENT AT HEALTH QUALITY ONTARIO This report was developed by a multi-disciplinary team from Health Quality Ontario. The lead clinical epidemiologist was Gaylene Pron, the medical librarians were Corinne Holubowich and Kellee Kaulback, and the medical editors were Susan Harrison and Jeanne McKane. Others involved in the development and production of this report were Irfan Dhalla, Nancy Sikich, Andree Mitchell, Farhad Samsami, Christopher Pagano, and Jessica Verhey. We are grateful to the following expert reviewers: Mark Baerlocher, MD, FRCPC, Vascular and Interventional Therapies, Department of Medical Imaging, Royal Victoria Hospital, Barrie, Ontario. Elizabeth David, MD, FRCPC, Assistant Professor, Faculty of Medicine, University of Toronto, Department of Medical Imaging; Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario. Michael Ford, MD, FRCSC, Orthopedic Spine and Trauma, Integrated Spine Unit, Sunnybrook Health Sciences Centre, Toronto, Ontario. Daryl Fourney, MD, FRCPC, Department of Neurosurgery, Royal University Hospital, Saskatoon, Saskatchewan. Stephen Lutz, MD, Department of Radiation Oncology, Blanchard Valley Health System, Findlay, Ohio. Hany Soliman, MD, FRCPC, Assistant Professor, Department of Radiation Oncology, Faculty of Medicine, University of Toronto, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario. Suggested Citation Health Quality Ontario. Vertebral augmentation involving vertebroplasty or kyphoplasty for cancer- related vertebral compression fractures: a systematic review. Ont Health Technol Assess Ser [Internet]. 2016 May;16(11):1–202. Available from: http://www.hqontario.ca/Evidence-to-Improve- Care/Journal-Ontario-Health-Technology-Assessment-Series. Ontario Health Technology Assessment Series; Vol. 16: No. 11, pp. 1–202, May 2016 2 ABSTRACT Background Cancers that metastasize to the spine and primary cancers such as multiple myeloma can result in vertebral compression fractures or instability. Conservative strategies, including bed rest, bracing, and analgesic use, can be ineffective, resulting in continued pain and progressive functional disability limiting mobility and self-care. Surgery is not usually an option for cancer patients in advanced disease states because of their poor medical health or functional status and limited life expectancy. The objectives of this review were to evaluate the effectiveness and safety of percutaneous image-guided vertebral augmentation techniques, vertebroplasty and kyphoplasty, for palliation of cancer-related vertebral compression fractures. Methods We performed a systematic literature search for studies on vertebral augmentation of cancer- related vertebral compression fractures published from January 1, 2000, to October 2014; abstracts were screened by a single reviewer. For those studies meeting the eligibility criteria, full-text articles were obtained. Owing to the heterogeneity of the clinical reports, we performed a narrative synthesis based on an analytical framework constructed for the type of cancer- related vertebral fractures and the diversity of the vertebral augmentation interventions. Results The evidence review identified 3,391 citations, of which 111 clinical reports (4,235 patients) evaluated the effectiveness of vertebroplasty (78 reports, 2,545 patients) or kyphoplasty (33 reports, 1,690 patients) for patients with mixed primary spinal metastatic cancers, multiple myeloma, or hemangiomas. Overall the mean pain intensity scores often reported within 48 hours of vertebral augmentation (kyphoplasty or vertebroplasty), were significantly reduced. Analgesic use, although variably reported, usually involved parallel decreases, particularly in opioids, and mean pain-related disability scores were also significantly improved. In a randomized controlled trial comparing kyphoplasty with usual care, improvements in pain scores, pain-related disability, and health- related quality of life were significantly better in the kyphoplasty group than in the usual care group. Bone cement leakage, mostly asymptomatic, was commonly reported after vertebroplasty and kyphoplasty. Major adverse events, however, were uncommon. Conclusions Both vertebroplasty and kyphoplasty significantly and rapidly reduced pain intensity in cancer patients with vertebral compression fractures. The procedures also significantly decreased the need for opioid pain medication, and functional disabilities related to back and neck pain. Pain palliative improvements and low complication rates were consistent across the various cancer populations and vertebral fractures that were investigated. Ontario Health Technology Assessment Series; Vol. 16: No. 11, pp. 1–202, May 2016 3 TABLE OF CONTENTS LIST OF TABLES ...................................................................................................................... 6 LIST OF FIGURES .................................................................................................................... 7 BACKGROUND ......................................................................................................................... 8 Objectives of Analysis ................................................................................................................................... 8 Clinical Need and Target Population ............................................................................................................ 8 Vertebral Augmentation Techniques ........................................................................................................... 10 Regulatory Status ................................................................................................................................ 10 Research Questions .................................................................................................................................... 11 METHODS ................................................................................................................................12 Literature Search ......................................................................................................................................... 12 Inclusion Criteria ......................................................................................................................................... 12 Exclusion Criteria ........................................................................................................................................ 12 Outcomes of Interest ................................................................................................................................... 12 Quality of Evidence ..................................................................................................................................... 13 RESULTS .................................................................................................................................14 Section A. Systematic Reviews of Vertebral Augmentations ...................................................................... 16 Section B. Effectiveness of Vertebral Augmentation for Cancer-Related Vertebral Compression Fractures .................................................................................................................................................................... 19 B1. Effectiveness of Vertebroplasty .................................................................................................... 21 B2. Effectiveness
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