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The purpose of this study was to determine the real-world incidence and predictors of additional vertebroplasty or balloon kyphoplasty after initial vertebral augmentation, as a proxy for subsequent symptomatic vertebral fracture. Of patients, 15.5% underwent subsequent vertebral augmentation. The patient's comorbidities are strongly associated with risk of subsequent treatment., Purpose: To determine the real-world incidence and predictors of additional vertebroplasty or balloon kyphoplasty after initial vertebral augmentation, as a proxy for subsequent symptomatic and disabling vertebral fracture., Methods: We conducted a retrospective cohort study using commercial insurance claims data (Optum's de-identified Clinformatics® Data Mart Database). Adult patients who underwent subsequent treatment for vertebral fracture within 24 months of initial balloon kyphoplasty (BKP) or vertebroplasty (VP) were classified into "subsequent treatment" or "no subsequent treatment" cohorts. Survival analysis was applied to investigate the effect of risk factors on subsequent treatment., Results: Between 1 January 2008 and 30 June 2020, a total of 32,513 adult patients underwent a BKP/VP procedure following a diagnosis of vertebral compression fracture in the preceding 12 months. Five thousand thirty-five patients (15.5%) underwent a subsequent BKP/VP treatment within 2 years; 90% had a single fracture level treated. An increased hazard of subsequent treatment was associated with a number of fractures treated at initial BKP/VP (≥ 4 levels, adjusted hazard ratio (AHR) 1.68 (95% CI 1.24-2.26); steroid use, AHR 1.9 (95% CI 1.31-1.48); Elixhauser Comorbidity Index ≥ 4, AHR 1.44 (95% CI 1.17-1.77); and multiple myeloma, AHR 1.31 (95% CI 1.13-1.53)). Age < 70 years was associated with reduced hazard of subsequent treatment (AHR 0.81, 95% CI 0.74-0.89)., Conclusions: One in seven patients underwent subsequent treatment for vertebral fracture after initial vertebral augmentation. Baseline patient characteristics were associated with increased risk of subsequent fracture within 2 years, suggesting that a patient's natural history is strongly associated with risk of subsequent treatment rather than the initial surgical procedure itself., Competing Interests: Declarations. Ethics approval and consent to participate: This was an observational study of de-identified data. Sterling IRB (Atlanta, GA, USA) has determined that the study is exempt from full IRB review. Formal consent for this retrospective study was not required. Sterling IRB (Atlanta, GA, USA) has determined that no patient consent to participate was required. Conflicts of interest: NCG, CNR and CW are current employees of Medtronic. JAH was a consultant for Medtronic, Relievant, and Cerenovus in the last 12 months, and provided DMC and DSMB chair work for Rapid Medical, Balt, and Arsenal in the last 12 months. JAH’s effort is supported in part by a grant from the Harvey L. Neiman Health Policy Institute. CG consulted for Mainstay, Persica, Saluda, Iliad Lifesciences, Biotronik, and Presidio; has stock options with Mainstay; is on the board of directors of the International Neuromodulation Society; and is Editor-in-Chief of Pain Practice. AB was an advisor for Medtronic, NEVRO, and Boston Scientific. RVC declares no competing interests., (© 2024. The Author(s).)

Objectives: Percutaneous vertebroplasty and kyphoplasty are common interventions for osteoporotic vertebral compression fractures. However, there is concern about an increased risk of adjacent-level fractures after treatment. This study aimed to compare the risk of adjacent-level fractures after vertebroplasty and kyphoplasty with the natural history after osteoporotic vertebral compression fractures., Materials and Methods: A network meta-analysis of randomized controlled trials (RCTs) was conducted to evaluate the risk of adjacent-level fractures after vertebroplasty and kyphoplasty compared to the natural history after osteoporotic vertebral compression fractures. Frequentist network meta-analysis was conducted using the "netmeta" package, and heterogeneity was assessed using Q statistics. The pooled risk ratio (RR) and 95% confidence intervals (CI) were calculated using random effects., Results: Twenty-three RCTs with a total of 2838 patients were included in the analysis. The network meta-analysis showed comparable risks of adjacent-level fractures between vertebroplasty, kyphoplasty, and natural history after osteoporotic vertebral compression fractures with a mean follow-up of 21.2 (range: 3-49.4 months). The pooled RR for adjacent-level fractures after kyphoplasty compared to natural history was 1.35 (95% CI, 0.78-2.34, p = 0.23) and for vertebroplasty compared to natural history was 1.16 (95% CI, 0.62-2.14) p = 0.51. The risk of bias assessment showed a low to moderate risk of bias among included RCTs., Conclusion: There was no difference in the risk of adjacent-level fractures after vertebroplasty and kyphoplasty compared to natural history after osteoporotic vertebral compression fractures. The inclusion of a large patient number and network meta-analysis of RCTs serve evidence-based clinical practice., Clinical Relevance Statement: The risk of adjacent-level fracture following percutaneous vertebroplasty or kyphoplasty is similar to that observed in the natural history after osteoporotic vertebral compression fractures., Key Points: RCTs have examined the risk of adjacent-level fracture after intervention for osteoporotic vertebral compression fractures. There was no difference between vertebroplasty and kyphoplasty patients compared to the natural disease history for adjacent compression fractures. This is strong evidence that interventional treatments for these fractures do not increase the risk of adjacent fractures., (© 2024. The Author(s), under exclusive licence to European Society of Radiology.)

An expanding array of image-guided spine interventions have the potential to provide immediate and effective pain relief. Innovations in spine intervention have proceeded rapidly, with clinical adoption of new techniques at times occurring before the development of bodies of evidence to establish efficacy. Although new spine interventions have been evaluated by clinical trials, acceptance of results has been hindered by controversies regarding trial methodology. This article explores controversial aspects of four categories of image-guided interventions for painful conditions: spine interventions for postdural puncture headache resulting from prior lumbar procedures, epidural steroid injections for cervical and lumbar radiculopathy, interventions for facet and sacroiliac joint pain, and vertebral augmentations for compression fractures. For each intervention, we summarize the available literature, with an emphasis on persistent controversies, and discuss how current areas of disagreement and challenge may shape future research and innovation. Despite the ongoing areas of debate regarding various aspects of these procedures, effective treatments continue to emerge and show promise for aiding relief of a range of debilitating conditions.

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.

Purpose: Osteoporotic vertebral compression fractures are treated conservatively or in selected cases with percutaneous vertebroplasty (PV). The purpose of this retrospective analysis is to determine predictive factors for a high visual analogue scale (VAS) pain score after conservative, sham or PV and is based on previously published randomized trials., Methods: The VERTOS II compared conservative versus PV, and VERTOS IV compared sham versus PV treatment. The conservative group received pain medication. The sham and PV group received subcutaneous lidocaine/bupivacaine. In addition, the PV group received cementation, which was simulated in the sham group. Nineteen different predictors of high (≥ 5) versus low (< 5) VAS pain score at 12 months were investigated., Results: 20.7% of patients in the PV group demonstrated a VAS ≥ 5 at the 12-month, compared to 40.1% in the conservative or sham group, with a significant difference (χ 2 (1) = 15.26, p < 0.0001, OR = 2.57, 95% CI = 1.59 to 4.15). In the subgroup analysis, we detected five predictors for the risk of high pain scores (VAS ≥ 5 after 12 months follow-up), namely: female, baseline VAS > 8, long-term baseline pain, mild/severe Genant and new fractures., Conclusions: Statistically significant more patients had a high pain score at 12 months in the sham and conservative group when compared with the PV group. Five predictors were identified for sustained high local back pain, regardless of the received treatment. Patients with moderate fracture deformity were less likely to have high pain scores at 12 months if they received PV than if they had sham or conservative therapy., (© 2022. The Author(s).)

This retrospective analysis of insurance claims evaluated real-world trends in prescription fills among patients treated with balloon kyphoplasty (N = 6,656) or vertebroplasty (N = 2,189) following diagnosis of vertebral compression fracture. Among those with evidence of opioid use, nearly half of patients discontinued or reduced prescription fills relative to pre-operative levels., Introduction: Vertebral compression fractures (VCF) are associated with debilitating pain, spinal misalignment, increased mortality, and increased healthcare-resource utilization in elderly patients. This study evaluated the effect of balloon kyphoplasty (BKP) or vertebroplasty (VP) on post-procedure opioid prescription fills and payer costs in patients with VCF., Methods: This was a retrospective analysis of a large, nationally representative insurance-claims database. Clinical characteristics, opioid prescription patterns, and payer costs for subjects who underwent either BKP or VP to treat VCF were evaluated beginning 6 months prior to surgery through 7-month follow-up that included a 30-day, postoperative medication washout. Patient demographics, changes in opioid utilization, and payer costs were analyzed., Results: A total of 8,845 patients met eligibility criteria (75.3% BKP and 24.7% VP) with a mean of age 77 and 74% female. Among the 75% of patients who used opioids, 48.7% of patients discontinued opioid medication and 8.4% reduced prescription fills versus preoperative baseline. Patients who reduced or discontinued prescriptions exhibited a decrease in all-cause payer costs relative to pre-intervention levels, which was a significantly greater change relative to patients with no change, increase, or new start of opioids., Conclusions: Interventional treatment for VCF was associated with decreased or discontinued opioid prescription fills and reduced payer costs in follow-up in a significant proportion of the study population. Reduction of opioid-based harms may represent a previously unrecognized benefit of vertebral augmentation for VCF, especially in this elderly and medically fragile population., (© 2021. The Author(s).)

Background: Up to 70% of multiple myeloma (MM) patients develop vertebral metastasis and subsequent pathological vertebral fractures (PVF). With contemporary systemic therapies, life expectancy of MM patients has improved drastically, and the need to manage pain and associated disability from PVF is increasingly a high priority. The aim of this review is to provide an updated comprehensive synthesis of evidence in the use of vertebral augmentation, including percutaneous vertebroplasty (PV) and balloon kyphoplasty (BKP), to treat MM-related PVF., Methods: A comprehensive multi-database search in accordance with PRISMA guidelines was performed up to 10 February 2021. Relevant English language articles were selected and critically reviewed., Findings: A total of 23 clinical studies have been included in the review. PV and BKP showed significant pain and functional improvements in terms of analgesia requirements, Cervical Spine Function Score, Eastern Cooperative Oncology Group scale, EQ-5D score, Karnofsky score, Neck Pain Disability Index, Oswestry Disability Index, Short form-36 (SF-36) questionnaire and VAS pain scale. Both procedures also reported promising radiographic outcomes in terms of vertebral height improvement, maintenance and restoration, as well as kyphotic deformity correction. Asymptomatic cement leakage was commonly reported. There was no significant difference between the two procedures., Conclusion: PV and BKP are safe and effective procedure that offers pain relief, reduction in pain associated disability and reduction of fracture incidence. Its minimally invasive approach is associated with minimal morbidity risk, making it a viable option in frail patients., Level of Evidence Iv: Narrative review., (© 2021. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Despite the high prevalence of vertebral compression fractures (VCFs) associated with refractory pain, deformity, or progressive neurological symptoms, minimally invasive vertebral augmentation procedures, including vertebroplasty and kyphoplasty, have been declining in their relative utilization, along with expenditures., Objectives: This investigation was undertaken to assess utilization and expenditures for vertebral augmentation procedures, including vertebroplasty and kyphoplasty, in the fee-for-service (FFS) Medicare population from 2009 to 2018., Study Design: The present study was designed to assess utilization and expenditures in all settings, for all providers in the FFS Medicare population from 2009 to 2018 in the United States. In this manuscript:• A patient was described as receiving vertebral augmentation over the course of the year.• An episode was considered as one treatment per region per day utilizing primary codes only. • Services or procedures were considered to be procedures including multiple levels.A standard 5% national sample of the Centers for Medicare and Medicaid Services (CMS) physician outpatient billing claims data for those enrolled in the FFS Medicare program from 2009 to 2018 was utilized. All the expenditures were presented with allowed costs and adjusted for inflation to 2018 US dollars., Results: In 2009, there were 76,860 episodes of vertebral augmentation with a rate of 168 per 100,000 Medicare population, which declined to 58,760, or 99 per 100,000 population for a total decline of 41%, or an annual rate of decline of 5.7% per 100,000 Medicare population. Vertebroplasty interventions declined more dramatically than kyphoplasty from 2009. Total episodes of vertebroplasty were 27,380 with an annual rate of 60 per 100,000 Medicare population, decreasing to 9,240, or 16 per 100,000 Medicare population, a 66% decline in episodes and a 74% decline in overall rate with an annual decline of 11.4% and 13.9%. In contrast, kyphoplasty interventions were 49,480, for a rate per 100,000 population of 108 in 2009 compared to 49,520 in 2018 with a rate of 83, for a decrease of 23% and 2.9% annual decrease. Evaluation of expenditures showed a net decrease of $30,102,809, or 8%, from $378,758,311 in 2009 to $348,655,502 in 2018. However, inflation-adjusted expenditures decreased overall by 21% and 3% annually from $443,147,324 in 2009 to $345,655,502 in 2018. In addition, inflation-adjusted total expenditures per 100,000 Medicare population decreased from $967,549 to $584,992, for an overall decrease of 40%, or an annual decrease of 5%. Per patient expenditures decreased 2% overall with 0% decrease per year., Limitations: Vertebral augmentation procedures were assessed only in the FFS Medicare service population. This excluded over 30% of the Medicare population, which is enrolled in Medicare Advantage plans., Conclusions: This study shows a significant decline in relative utilization patterns of vertebroplasty and kyphoplasty procedures, along with reductions in overall expenditures. The inflation-adjusted total expenditures of kyphoplasty and vertebroplasty decreased 21% with an annual decline of 3%. The inflation-adjusted expenditures per 100,000 of Medicare population decreased 40% overall and 5% per year. In addition, vertebroplasty has seen substantial declines in utilization and expenditure patterns compared to kyphoplasty procedures, which showed trends of decline.

Vertebral augmentation, including vertebroplasty and kyphoplasty, is a minimally invasive, image-guided procedure in which cement (typically polymethylmethacrylate (PMMA)) is injected into a vertebral body to treat painful fractures. The majority of vertebroplasty and kyphoplasty procedures are performed to treat symptomatic osteoporotic compression fractures refractory to conservative medical therapy; however, there is also evidence to suggest the benefits of augmentation in patients with refractory pain in the acute compression setting. The primary goal of augmentation is decreasing pain and improving a patient's functional status. The secondary goal of augmentation is vertebral body stabilization. This chapter outlines the indications, contraindications, techniques, and literature behind vertebral augmentation., (Copyright © 2021 Elsevier B.V. All rights reserved.)

Background: The treatment of severe osteoporotic vertebral compression fractures (VCFs) with middle-column (MC) involvement, high fragmentation, large cleft and/or pedicular fracture is challenging. Minimally invasive 'stent-screw-assisted internal fixation' (SAIF) can reduce the fracture, reconstruct the vertebral body (VB) and fix it to the posterior elements., Objective: To assess feasibility, safety, technical and clinical outcome of the SAIF technique in patients with severe osteoporotic VCFs., Methods: 80 treated vertebrae were analyzed retrospectively. Severe VCFs were characterized by advanced collapse (Genant grade 3), a high degree of osseous fragmentation (McCormack grade 2 and 3), burst morphology with MC injury, pediculo-somatic junction fracture, and/or large osteonecrotic cleft. VB reconstruction was evaluated on postprocedure radiographs and CT scans by two independent raters. Clinical and radiological follow-ups were performed at 1 and 6 months., Results: SAIF was performed at 28 thoracic and 52 lumbar levels in 73 patients. One transient neurological complication occurred. VB reconstruction was satisfactory in 98.8% of levels (inter-rater reliability 96%, κ=1). Follow-up at 1 month was available for 78/80 levels and at 6 months or later (range 6-24, mean 7.9 months) for 73/80 levels. Significant improvement in the Visual Analog Scale score was noted at 1 and 6 months after treatment (p<0.05). Patients reported global clinical benefit during follow-up (Patient's Global Impression of Change Scale 5.6±0.9 at 1 month and 6.1±0.9 at 6 months). Fourteen new painful VCFs occurred at different levels in 11 patients during follow-up, treated with vertebral augmentation or SAIF. Target-level stability was maintained in all cases., Conclusions: SAIF is a minimally invasive, safe, and effective treatment for patients with severe osteoporotic VCFs with MC involvement., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Purpose of Review: To review the utilization patterns of vertebral augmentation procedures in the US Medicare population from 2004 to 2017 surrounding concurrent developments in the literature and the enactment of the Affordable Care Act (ACA)., Recent Findings: The analysis of vertebroplasty and kyphoplasty utilization patterns was carried out using specialty utilization data from the Centers for Medicare and Medicaid Services Database. Of note, over the period of time between 2009 and 2017, the number of people aged 65 or older showed a 3.2% rate of annual increase, and the number of Medicare beneficiaries increased by 27.6% with a 3.1% rate of annual increase. Concurrently, vertebroplasty utilization decreased 72.8% (annual decline of 15% per 100,000 Medicare beneficiaries), and balloon kyphoplasty utilization decreased 19% (annual decline of 2.6% per 100,000 Medicare beneficiaries). This translates to a 38.3% decrease in vertebroplasty and balloon kyphoplasty utilization (annual decline of 5.9% per 100,000 Medicare beneficiaries) from 2009 to 2017. By contrast, from 2004 to 2009, there was a total 188% increase in vertebroplasty and balloon kyphoplasty utilization (annual increase rate of 23.6% per 100,000 Medicare beneficiaries). The majority of vertebroplasty procedures were done by radiologists, and the majority of kyphoplasties were done by aggregate groups of spine surgeons. These results illustrate a significant decline in vertebral augmentation procedures in the fee-for-service Medicare population between 2004 and 2017, with dramatic decreases following the publication of two 2009 trials that failed to demonstrate benefit of vertebroplasty over sham and the enactment of the ACA.

Background Osteoporotic vertebral compression fractures (OVCFs) are prevalent, with associated morbidity and mortality. Vertebral augmentation (VA), defined as either vertebroplasty and/or balloon kyphoplasty (BKP), is a minimally invasive surgical treatment to reduce pain and further collapse and/or renew vertebral body height by introducing bone cement into fractured vertebrae. Nonsurgical management (NSM) for OVCF carries inherent risks. Purpose To summarize the literature and perform a meta-analysis on the mortality outcomes of patients with OVCF treated with VA compared with those in patients treated with NSM. Materials and Methods A single researcher performed a systematic literature review using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, or PRISMA, guidelines. Online scientific databases were searched in April 2018 for English-language publications. Included studies investigated mortality in patients with OVCF with VA as the primary intervention and NSM as the comparator. A meta-analysis was performed for studies that reported hazard ratios (HRs) and 95% confidence intervals (CIs). HR was used as a summary statistic and was random-effect-models tested. The χ 2 test was used to study heterogeneity between trials, and the I 2 statistic was calculated to estimate variation across studies. Results Of the 16 included studies, eight reported mortality benefits in VA, seven reported no mortality difference, and one reported mixed results. Seven studies were included in a meta-analysis examining findings in more than 2 million patients with OVCF (VA = 382 070, NSM = 1 707 874). The pooled HR comparing VA to NSM was 0.78 (95% CI: 0.66, 0.92; P = .003), with mortality benefits across 2- and 5-year periods (HR = 0.70, 95% CI: 0.69, 0.71, P < .001; and HR = 0.79, 95% CI: 0.62, 0.9999, P = .05; respectively). Balloon kyphoplasty provided mortality benefits over vertebroplasty, with HRs of 0.77 (95% CI: 0.77, 0.78; P < .001) and 0.87 (95% CI: 0.87, 0.88; P < .001), respectively. Conclusion In a meta-analysis of more than 2 million patients, those with osteoporotic vertebral compression fractures who underwent vertebral augmentation were 22% less likely to die at up to 10 years after treatment than those who received nonsurgical treatment. © RSNA, 2020 See also the editorial by Jennings in this issue.

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.)

Background and Purpose: Burst fractures are characterized by middle column disruption and may feature posterior wall retropulsion. Indications for treatment remain controversial. Recently introduced vertebral augmentation techniques using intravertebral distraction devices, such as vertebral body stents and SpineJack, could be effective in fracture reduction and fixation and might obtain central canal clearance through ligamentotaxis. This study assesses the results of armed kyphoplasty using vertebral body stents or SpineJack in traumatic, osteoporotic, and neoplastic burst fractures with respect to vertebral body height restoration and correction of posterior wall retropulsion., Materials and Methods: This was a retrospective assessment of 53 burst fractures with posterior wall retropulsion and no neurologic deficit in 51 consecutive patients treated with armed kyphoplasty. Posterior wall retropulsion and vertebral body height were measured on pre- and postprocedural CT. Clinical and radiologic follow-up charts were reviewed., Results: Armed kyphoplasty was performed as a stand-alone treatment in 43 patients, combined with posterior instrumentation in 8 and laminectomy in 4. Pre-armed kyphoplasty and post-armed kyphoplasty mean posterior wall retropulsion was 5.8 and 4.5 mm, respectively ( P < .001), and mean vertebral body height was 10.8 and 16.7 mm, respectively ( P < .001). No significant clinical complications occurred. Clinical and radiologic follow-up (1-36 months; mean, 8 months) was available in 39 patients. Three treated levels showed a new fracture during follow-up without neurologic deterioration, and no retreatment was deemed necessary., Conclusions: In the treatment of burst fractures with posterior wall retropulsion and no neurologic deficit, armed kyphoplasty yields fracture reduction, internal fixation, and indirect central canal decompression. In selected cases, it might represent a suitable minimally invasive treatment option, stand-alone or in combination with posterior stabilization., (© 2019 by American Journal of Neuroradiology.)

Purpose: Vertebral augmentation procedures such as vertebroplasty and kyphoplasty are utilized in the treatment of vertebral compression fractures (VCFs). However, their capacity for providing analgesia, reducing disability, and improving quality of life in patients with osteoporotic VCFs remains a topic of debate. The objective of this narrative review is to summarize the latest evidence for the safety and efficacy of vertebral augmentation for osteoporotic vertebral compression fractures (VCFs)., Methods: A systematic literature search was conducted using the PubMed and Cochrane electronic databases for systematic reviews, review articles, meta-analyses, and randomized clinical trials prior to May 2017. The keywords were "vertebroplasty," "kyphoplasty," and "vertebral augmentation.", Results: Thirty-three papers (7 systematic reviews, 6 cohort studies, 15 randomized clinical trials, and 5 international guidelines) were included in this narrative review., Conclusion: Vertebral augmentation is a safe procedure, with low rates of serious complications and no increase in subsequent post-treatment fracture risk.

Osteoporotic vertebral compression fractures frequently result in significant morbidity and health care resource use. For patients with severe and disabling pain, vertebral augmentation (vertebroplasty and kyphoplasty) is often considered. Although vertebroplasty was introduced >30 years ago, there are conflicting opinions regarding the role of these procedures in the treatment of osteoporotic vertebral compression fractures. This review article updates clinicians on the published prospective randomized controlled data, including the most recent positive trials that followed initial negative trials in 2009. Analysis of multiple national claim datasets has also provided further insight into the utility of these procedures. Finally, we considered the recent recommendations of national organizations and medical societies that advise on the use of vertebral augmentation procedures for osteoporotic vertebral compression fractures., (© 2018 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.

Although over 300 articles have been published annually on vertebral augmentation in the last 5 years, there remains much debate about a fundamental question - is vertebral augmentation a safe and effective treatment to achieve analgesia, reduce disability, and improve quality of life in patients with a vertebral fracture? In this modern era of evidence-based clinical practice and public health care policy and funding, an evidentiary basis is needed to continue to perform vertebral augmentation. The aim of this narrative review is to summarize the latest and highest quality evidence for efficacy, safety, cost effectiveness, and potential survival benefit after vertebroplasty and kyphoplasty. The design, major inclusion criteria, primary outcome measures, relevant primary baseline characteristics, primary outcomes, relevant secondary outcomes, and limitations of prospective multicenter randomized sham-controlled and conservative management-controlled trials are summarized. Recently published meta-analyses or systematic reviews of efficacy that include these recent prospective studies of vertebral augmentation are examined. The highest quality procedural safety data relating to medical complications, cement leaks, and subsequent vertebral fracture are reviewed. Publications from national databases analyzing potential reduction in length of hospital stay and reduction in mortality after vertebral augmentation are presented. Finally, emerging literature assessing the potential cost-effectiveness of vertebral augmentation is considered. This narrative review will provide interventional pain physicians a summary of the latest and highest quality data published on vertebral augmentation. This will allow integration of the best available evidence with clinical expertise and patient wishes to make the most appropriate evidence-based clinical decisions for patients with symptomatic vertebral fracture.

Background: Vertebral augmentation (VA) techniques such as vertebroplasty and kyphoplasty are increasingly performed minimally invasive procedures for osteoporotic or malignant compression fractures (MCFs) and involve injection of polymethylmethacrylate (PMMA) cement directly into a compressed vertebral body., Objective: This article will evaluate the efficacy of VA in relieving fracture-related pain. We also intend to identify procedural and clinical variables that could potentially influence outcomes in this population. In the subset of patients with cancer who received both external beam radiation therapy (EBRT) and VA, we will assess the impact of the treatment sequence on pain outcomes., Study Design: We performed a retrospective analysis of 201 cases of patients with cancer and MCFs who underwent one or more vertebral augmentation procedures at our institution between 2003 and 2009. The majority of cancers represented were multiple myeloma, metastatic lung cancer, and metastatic breast cancer. The primary outcome measure was pain relief, as measured by the Visual Analog Scale and a 4-point pain scale., Setting: We present an institutional experience at an academic medical center of 201 cases of MCFs., Methods: We compiled an institutional database of vertebroplasty and kyphoplasty cases using paper and electronic medical records. Our data collection methodology has been previously reported and includes variables such as procedure dates, gender, age, type of malignancy, fracture etiology, history of cancer treatment, type of procedure performed, vertebral level treated, the number of levels treated per procedure, complications, and follow-up information on pain response. The updated dataset incorporates new variables including information on pain medications and standardized questionnaires such as the Visual Analog Scale (VAS) for pain and the Roland Morris Disability Questionnaire (RMDQ)., Results: In the 201 cases of MCFs, a total of 316 vertebral levels were treated with either vertebroplasty or kyphoplasty. Follow-up data on pain relief was available for 190 out of 201 cases (95%). Among this subgroup, 168 cases (88%) with MCFs responded. Thirty-nine percent (39%) of the time patients experienced complete pain resolution. In only 4% of cases did patients report worsening of their fracture-related pain post-procedure. There was no difference in pain outcomes with regard to sequencing of EBRT and VA., Limitations: One of the limitations of our analysis is that it did not evaluate the effect of pain improvement or resolution before and after EBRT alone and on activities of daily living in the majority of patients. However, one of the main goals of this analysis is to address previous limitations. We attempt to standardize outcome measures by using the Visual Analog Scale (VAS) for pain and the Roland Morris Disability Questionnaire (RMDQ)., Conclusion: A multimodality approach for the management of MCFs includes VA procedures. The majority of patients with MCFs have excellent palliation with this approach. In patients who receive both EBRT and VA, the sequence in which they are given does not affect pain improvement outcomes.

Aim: To evaluate the efficacy of vertebral augmentation (VA) in cancer patients., Materials and Methods: From a retrospectively compiled database, 147 cancer cases (236 levels) were treated with VA. Mean age was 71±12 years and 56.5% were female. Variables evaluated include age, sex, procedure type, vertebral level treated, number of levels treated per procedure and technical approach. Outcomes were assessed by a previously described method retrospectively applied from medical records: a binary system of 'responders' versus 'non-responders' and further subcategorization with a four level pain scale. Two patient groups were analyzed: (1) 147 cancer patients with either osteoporotic or malignant vertebral compression fractures (all compression fractures (ACFs)) and (2) 102 cases with documented metastatic compression fractures (MCFs). Univariate and multivariate analyses determined outcomes., Results: 93% of MCFs and 88.5% of ACFs showed response to treatment (pain improvement or resolution): 30% of ACFs and 31% of MCFs experienced pain resolution. MCFs showed increasing age to be a predictor of response to treatment in univariate (OR=1.79, p=0.04) and multivariate (OR=2.05, p=0.03) analysis. In ACFs, bipedicular needle approach decreased the odds of pain resolution (OR=0.28, p=0.01). In MCFs, lung cancer (OR=0.06, p=0.03) and multiple myeloma (OR=0.10, p=0.01) decreased the odds of pain resolution., Conclusions: VA provides pain relief for a majority of ACFs and MCFs. Increasing age may be predictive of pain relief outcomes in MCFs. There are special planning, imaging and technical considerations (eg, needle placement) in using VA to treat cancer patients.

We recently reported a novel concept for combining radioactive isotope technology with polymethylmethacrylate (PMMA) cement used for vertebral augmentation and have advocated that pain physicians become aware of this new concept when treating malignant compression fractures. The use of vertebral augmentation for malignant compression fractures is steadily increasing, and the goal of this novel approach would be to stabilize the fractured vertebral body while also controlling proliferation of the tumor cells in the vertebral body that caused the vertebral fracture. This approach would therefore provide mechanical stabilization of the fractured vertebral body at the same time as direct targeting of the cancer cells causing the fracture. For our analysis, we investigated six specific radioisotopes with regard to physical and biologic properties as they would interact with PMMA and local bone metastatic disease, taking into consideration anatomical, biological and physical characteristics. The radioisotopes investigated include beta emitting (plus and minus) sources, as well as low energy and mid-energy photon sources and are: P-32, Ho-166, Y-90, I-125, F-18, and Tc-99m. We review the advantages and disadvantages of each radioisotope. In addition, this paper serves to provide pain physicians with a basic background of the biologic principles (Biologically Effective Dose) and statistical modeling (Monte Carlo method) used in that analysis. We also review the potential complications when using radioactive sources in a clinical setting. Understanding the methodologies employed in determining isotope selection empowers the practitioner by fostering understanding of this presently theoretical treatment option. We believe that embedding radioisotopes in PMMA is merely a first step in the road of local treatment for symptomatic local lesions in the setting of systemic disease.

Purpose: To determine the effectiveness of vertebral augmentation in relieving pain, differences in pain relief outcomes based on procedure type were investigated. Variables that potentially influence outcomes were identified., Materials and Methods: A database of 525 cases (740 levels) treated for compression fractures with vertebroplasty, kyphoplasty, or S1-level sacroplasty was compiled. Average age was 75 years +/- 12, and 72.4% of patients were female. Variables evaluated included age, sex, fracture etiology, procedure type, vertebral level treated, number of levels treated per procedure, and technical approach. Outcomes were assessed by a binary system of "responders" (ie, patients with improvement/resolution of pain) versus "non-responders" (ie, those with no change/worsening of pain) and with a four-level pain scale (1, pain resolution; 2, pain improvement; 3, no change; 4, worse pain) retrospectively applied from medical records. Univariate and multivariate analyses determined outcomes., Results: Four-hundred and sixty-seven patients (89%) showed a response to treatment: 40% had pain resolution and 49% had pain improvement. Multivariate analysis showed that women and older patients had greater odds of being responders (odds ratios [ORs], 0.56 and 0.98, respectively; P = .016 and P = .048, respectively). Patients without cancer (OR, 1.60; P = .012) and women (OR, 2.05; P = .0002) were more likely to experience pain resolution. Increasing numbers of levels treated per case were associated with decreased odds of pain resolution (OR, 0.69; P = .0081). Sex and number of levels treated were independently predictive of pain scale outcomes (ORs, 2.0 and 0.71, respectively; P = .0003 and P = .015)., Conclusions: Vertebral augmentation procedures provide pain relief for a majority of patients regardless of underlying fracture etiology. There was no difference in pain outcomes among procedure types. Age and sex may be predictive of pain outcomes.

Purpose: Vertebral compression fractures (VCFs), a major cause of morbidity and debilitating pain, often results from secondary tumor metastases to the skeleton. Vertebral augmentation is a palliative technique developed to treat VCFs and involves the injection of polymethyl methacrylate (PMMA) to augment the fractured vertebral body. The authors investigate the feasibility of radionuclide therapy coupled with vertebral augmentation to treat both the tumor metastases and VCFs. Six therapeutic radioisotopes, uniformly mixed in a PMMA bolus, were investigated for their dosimetric properties., Methods and Materials: The MCNP5 Monte Carlo computer code was used to characterize the therapeutic dosimetric distribution within a cortical bone phantom for a 1 mm radial bolus of isotope-infused PMMA. Based on these data, the minimum activity required for a therapeutic treatment was calculated., Results: The dosimetry from beta emitting Y-90, P-32, and Ho-166 decreased to 10% of its maximum therapeutic dose (R10%) after traveling 1.20 mm, 1.03 mm, and 0.97 mm, respectively, through cortical bone. Low photon energy I-125 had a slightly larger calculated R10% of 1.32 mm. Although F-18 and Tc-99m exhibited a more uniform distribution (R10%=1.72 mm and 1.94 mm, respectively), the lower dosimetric gradients resulted in significantly greater therapeutic implant activities relative to the other isotopes studied in this report., Conclusions: Radionuclide therapy coupled with vertebral augmentation is shown to be a feasible technique for the treatment of secondary skeletal metastases and its resulting side effects. Future studies will include a full clinical investigation to determine optimal treatment isotope(s).

Osteoporotic vertebral compression fractures result in an enormous medical, social and economic burden to society. Here, we review osteoporotic vertebral compression fractures, focusing on both their diagnosis and the treatment options, particularly vertebral augmentation.

Purpose: The treatment of painful compression fractures has been revolutionized by vertebroplasty and kyphoplasty, two recently developed techniques that continue to evolve. This article describes a new device for the performance of kyphoplasty that uses a polymer device rather than a balloon to create a void in the bone., Materials and Methods: In nine consecutive patients, kyphoplasty was performed at 12 vertebral levels with osteoporotic compression with use of the new SKy bone expander polymer device., Results: The device was successful in creating a void in the bone at all levels. The procedure was also effective in alleviating pain from compression fractures. There were no technical failures or complications., Conclusion: The SKy bone expander polymer device is effective and safe for the performance of kyphoplasty to alleviate pain from vertebral compression fractures.