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Vertebral augmentation has been used to treat painful vertebral compression fractures and metastatic lesions in millions of patients around the world. An international group of subject matter experts have considered the evidence, including but not limited to mortality. These considerations led them to ask whether it is appropriate to allow the subjective measure of pain to so dominate the clinical decision of whether to proceed with augmentation. The discussions that ensued are related below.

Background and Purpose: Evidence from randomized controlled trials for the efficacy of vertebral augmentation in vertebral compression fractures has been mixed. However, claims-based analyses from national registries or insurance datasets have demonstrated a significant mortality benefit for patients with vertebral compression fractures who receive vertebral augmentation. The purpose of this study was to calculate the number needed to treat to save 1 life at 1 year and up to 5 years after vertebral augmentation., Materials and Methods: A 10-year sample of the 100% US Medicare data base was used to identify patients with vertebral compression fractures treated with nonsurgical management, balloon kyphoplasty, and vertebroplasty. The number needed to treat was calculated between augmentation and nonsurgical management groups from years 1-5 following a vertebral compression fracture diagnosis, using survival probabilities for each management approach., Results: The adjusted number needed to treat to save 1 life for nonsurgical management versus kyphoplasty ranged from 14.8 at year 1 to 11.9 at year 5. The adjusted number needed to treat for nonsurgical management versus vertebroplasty ranged from 22.8 at year 1 to 23.8 at year 5., Conclusions: Both augmentation modalities conferred a prominent mortality benefit over nonsurgical management in this analysis of the US Medicare registry, with a low number needed to treat. The calculations based on this data base resulted in a low number needed to treat to save 1 life at 1 year and at 5 years., (© 2020 by American Journal of Neuroradiology.)

The 5-year period following 2009 saw a steep reduction in vertebral augmentation volume and was associated with elevated mortality risk in vertebral compression fracture (VCF) patients. The risk of mortality following a VCF diagnosis was 85.1% at 10 years and was found to be lower for balloon kyphoplasty (BKP) and vertebroplasty (VP) patients., Introduction: BKP and VP are associated with lower mortality risks than non-surgical management (NSM) of VCF. VP versus sham trials published in 2009 sparked controversy over its effectiveness, leading to diminished referral volumes. We hypothesized that lower BKP/VP utilization would lead to a greater mortality risk for VCF patients., Methods: BKP/VP utilization was evaluated for VCF patients in the 100% US Medicare data set (2005-2014). Survival and morbidity were analyzed by the Kaplan-Meier method and compared between NSM, BKP, and VP using Cox regression with adjustment by propensity score and various factors., Results: The cohort included 261,756 BKP (12.6%) and 117,232 VP (5.6%) patients, comprising 20% of the VCF patient population in 2005, peaking at 24% in 2007-2008, and declining to 14% in 2014. The propensity-adjusted mortality risk for VCF patients was 4% (95% CI, 3-4%; p < 0.001) greater in 2010-2014 versus 2005-2009. The 10-year risk of mortality for the overall cohort was 85.1%. BKP and VP cohorts had a 19% (95% CI, 19-19%; p < 0.001) and 7% (95% CI, 7-8%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the NSM cohort, respectively. The BKP cohort had a 13% (95% CI, 12-13%; p < 0.001) lower propensity-adjusted 10-year mortality risk than the VP cohort., Conclusions: Changes in treatment patterns following the 2009 VP publications led to fewer augmentation procedures. In turn, the 5-year period following 2009 was associated with elevated mortality risk in VCF patients. This provides insight into the implications of treatment pattern changes and associated mortality risks.

The treatment of painful vertebral compression fractures has changed substantially since the introduction of vertebroplasty in the mid-1980s and balloon kyphoplasty in the late 1990s. Both procedures were widely accepted with the vertebral fractures treated reaching 150,000 per annum in 2009 prior to the publication of 2 randomized controlled trials comparing vertebroplasty with a sham treatment published in the New England Journal of Medicine in August 2009. Since then, there has been a flood of information on vertebral augmentation and balloon kyphoplasty. It is worth evaluating this information especially because it relates to current recommendations that are often followed blindly by medical and administrative groups unfamiliar with either the procedure or the high level of evidence surrounding vertebral augmentation. To streamline the evaluation of some current recommendations, we limited the analysis to the recommendations found on UpToDate.com. This Web site is an evidence-based, peer-reviewed source of information available for patients, doctors, health insurance companies, and population-based medical decision-making., (© 2015 by American Journal of Neuroradiology.)