Analysis of Long-Term Medical Expenses in Vertebral Fracture Patients.

Background: The objective of this study was to analyze the direct medical expenses of a vertebral fracture cohort (VC) and a matched cohort (MC) over 5 years preceding and following the fracture, analyze the duration of the rise in medical expenses due to the fracture, and examine whether the expenses vary with age group, utilizing a national claims database. Methods: Subjects with vertebral fractures and matched subjects were chosen from the National Health Insurance Service Sample cohort (NHIS-Sample) of South Korea. Patients with vertebral fractures were either primarily admitted to acute care hospitals (index admissions) or those who received kyphoplasty or vertebroplasty during the follow-up period (2002-2015). A risk-set matching was performed using 1 : 5 random sampling to simulate a real-world situation. Individual-level direct medical expenses per quarter were calculated for 5 years prior and subsequent to the vertebral fracture. In this analysis using a comparative interrupted time series design, we examined the direct medical expenses of a VC and an MC. Results: A total of 3,923 incident vertebral fracture patients and 19,615 matched subjects were included in this study. The mean age was 75.5 ± 7.4 years, and 69.5% were women. The mean difference in medical expenses between the two groups increased steadily before the fracture. The medical expenses of the VC peaked in the first quarter following the fracture. The cost changes were 1.82 times higher for the VC than for the MC (95% confidence interval, 1.62-2.04; p < 0.001) in the first year. Subsequently, there were no differential changes in medical expenses between the two groups (p > 0.05). In the < 70-year subgroup, there were no differential changes in medical expenses between the two groups (p > 0.05). However, in the ≥ 80-year subgroup, the cost changes for the VC were higher than those for the MC up to 5 years after time zero. Conclusions: Based on our study results, we suggest that health and medical policies for vertebral fractures should be designed to last up to approximately 1 year after the fracture. Health policies should be differentiated according to age group.

Cost-effectiveness and willing-to-pay thresholds for vertebral augmentation of osteoporotic vertebral fractures, what are they based on: a systematic review.

OBJECTIVE: Although there is substantial clinical evidence on the safety and effectiveness of vertebral augmentation for osteoporotic vertebral fractures, cost-effectiveness is less well known. The objective of this study is to provide a systematic review of cost-effectiveness studies and policy-based willingness-to-pay (WTP) thresholds for different vertebral augmentation (VA) procedures, vertebroplasty (VP) and balloon kyphoplasty (BK), for osteoporotic vertebral fractures (OVFs). DESIGN: A systematic review targeting cost-effectiveness studies of VA procedures for OVFs. DATA SOURCES: Six bibliographic databases were searched from inception up to May 2021. ELIGIBILITY CRITERIA FOR STUDY SELECTION: Studies were eligible if meeting all predefined criteria: (1) VP or BK intervention, (2) OVFs and (3) cost-effectiveness study. Articles not written in English, abstracts, editorials, reviews and those reporting only cost data were excluded. DATA EXTRACTION AND SYNTHESIS: Information was extracted on study characteristics, cost-effective estimates, summary decisions and payer WTP thresholds. Incremental cost-effective ratio (ICER) was the main outcome measure. Studies were summarised by a structured narrative synthesis organised by comparisons with conservative management (CM). Two independent reviewers assessed the quality (risk of bias) of the systematic review and cost-effectiveness studies by peer-reviewed checklists. RESULTS: We identified 520 references through database searching and 501 were excluded as ineligible by titles and abstract. Ten reports were identified as eligible from 19 full-text reviews. ICER for VP versus CM evaluated as cost per quality-adjusted life-year (QALY) ranged from €22 685 (*US$33 395) in Netherlands to £-2240 (*US$-3273), a cost-saving in the UK. ICERs for BK versus CM ranged from £2706 (*US$3954) in UK to kr600 000 (*US$90 910) in Sweden. ICERs were within payer WTP thresholds for a QALY based on historical benchmarks. CONCLUSIONS: Both VP and BK were judged cost-effective alternatives to CM for OVFs in economic studies and were within WTP thresholds in multiple healthcare settings.

Risk assessment for sandwich vertebral fractures in the treatment of osteoporosis vertebral compression fractures using two methods of bone cement reinforcement.

PURPOSE: Bone cement augmentation surgery includes percutaneous vertebroplasty (PVP) and percutaneous kyphoplasty (PKP). In this study, we aimed to investigate the risk of sandwich vertebral fractures in the treatment of osteoporotic vertebral compression fractures via PVP and PKP. METHODS: We performed a retrospective analytical study and included 61 patients with osteoporotic vertebral compression fractures who underwent PVP and PKP at the Spinal Surgery Department of The Second Hospital of Liaocheng Affiliated with Shandong First Medical University from January 2019 to January 2022. These patients were divided into the following two groups by simple random sampling: group A (N = 30) underwent PVP treatment and group B (N = 31) underwent PKP treatment. The surgical time, fluoroscopy frequency, visual analog scale (VAS) score, amount of bone cement, the leakage rate of bone cement in intervertebral space, Cobb angle, and the incidence of fractures in both groups of sandwich vertebral were recorded after 1 year of follow-up. RESULTS: No statistically significant difference was found in terms of surgical time, fluoroscopy frequency, and VAS score between the two groups (P > 0.05). However, a statistically significant difference was found in terms of the amount of bone cement, the leakage rate of bone cement intervertebral space, Cobb angle, and the incidence of vertebral body fractures in both groups (P < 0.05). The amount of bone cement, the leakage rate of bone cement in intervertebral space, Cobb angle, and sandwich vertebral fractures were higher in Group A than in Group B. CONCLUSIONS: When PVP and PKP were performed to treat osteoporotic vertebral compression fractures, the sandwich vertebral exhibited a risk of fracture. PVP exhibited a greater relative risk than PKP, which may be due to the relatively larger amount of bone cement, higher rate of bone cement leakage in the intervertebral space, and larger Cobb angle.

An independent inter- and intra-observer agreement assessment of Yeom classification for bone cement leakage following vertebroplasty/kyphoplasty.

STUDY DESIGN: An inter- and intra-observer agreement study. BACKGROUND: In recent years, vertebroplasty and kyphoplasty have been widely used in treating osteoporotic vertebral compression fractures (OVCF) though the clinical efficacy of them is still controversial. However, there are also inevitable complications, first and foremost is bone cement leakage (BCL). Yeom classification is commonly used to evaluate BCL. The objective of this study is to assess its reliability and reproducibility, and to explore its clinical application value. METHODS: All 58 patients with BCL following vertebroplasty/kyphoplasty were involved. Six spine surgeons were selected to be evaluators as they were unaware of the identity of the patients and the treatment they received. They classified BCL according to Yeom system, we used kappa (K) to assess the inter- and intra-observer agreement. After 12 weeks, we repeated the analysis. RESULTS: The inter-observer reliability of Yeom classification was substantial with K value of 0.71 (1st assessment) and 0.73 (2nd assessment). The intra-observer reproducibility of Yeom classification was near perfect with K value of 0.88. CONCLUSION: Yeom classification system has substantial inter-observer reliability and near perfect intra-observer reproducibility in BCL following vertebroplasty/kyphoplasty, which can be widely used in clinical care as an appropriate instrument for early observation, mechanism and severity cognition, and prognosis predicting of BCL. Besides, the adding of type M (the mixed type) may improve the classification.

AOSRV: Development and preliminary performance assessment of a new robotic system for autonomous percutaneous vertebroplasty.

BACKGROUND: Percutaneous vertebroplasty (PVP) is one of the most effective treatments for patients with vertebral fracture that need surgical treatment, and surgical robotics are promising tools to provide surgeons with improved precision, surgical efficiency and reduce radiation exposure. However, there are currently few robotics that are developed to help assist with PVP. METHODS: A new spinal surgical robotic system 'AOSRV' for autonomous vertebral puncture and bone cement injection was designed and customised in this study. To investigate its practical abilities and the advantages, we performed single-segment/double-segment PVP simulation surgeries on pig spinal specimens manually and using AOSRV. RESULTS: By contrast with the freehand group (FG) in single-segment (SS)/double-segment (DS) surgery, the robotic group (RG) was superior in the operation time (RGSS = 21.14 ± 4.11 min, FGSS = 33.17 ± 6.83 min; RGDS = 42.39 ± 7.31 min, FGDS = 62.86 ± 20.39 min), puncture adjustments (RGSS = 2.30 ± 1.77, FGSS = 14.86 ± 5.46; RGDS = 3.91 ± 1.76, FGDS = 20.00 ± 7.76), intraoperative fluoroscopies (RGSS = 4.10 ± 1.52, FGSS = 20.57 ± 5.44; RGDS = 7.82 ± 1.40, FGDS = 25.91 ± 7.23) and bone cement leakage rate (RGSS = 30%, FGSS = 71.4%; RGDS = 38.6%, FGDS = 83.3%). CONCLUSIONS: AOSRV was successfully developed and had a promising preliminary performance. An innovative attempt was made for the blank space of the autonomous vertebroplasty surgical robotics, and it may shed a light on more promising applications in the future.

A preliminary safety assessment of vertebral augmentation with32P brachytherapy bone cement.

Comprehensive treatment for vertebral metastatic lesions commonly involves vertebral augmentation (vertebroplasty or kyphoplasty) to relieve pain and stabilize the spine followed by multiple sessions of radiotherapy. We propose to combine vertebral augmentation and radiotherapy into a single treatment by adding32P, aß-emitting radionuclide, to bone cement, thereby enabling spinal brachytherapy to be performed without irradiating the spinal cord. The goal of this study was to address key dosimetry and safety questions prior to performing extensive animal studies. The32P was in the form of hydroxyapatite powder activated by neutron bombardment in a nuclear reactor. We performedex vivodosimetry experiments to establish criteria for safe placement of the cement within the sheep vertebral body. In anin vivostudy, we treated three control ewes and three experimental ewes with brachytherapy cement containing 2.23-3.03 mCi32P ml-1to identify the preferred surgical approach, to determine if32P leaches from the cement and into the blood, urine, or feces, and to identify unexpected adverse effects. Ourex vivoexperiments showed that cement with 4 mCi32P ml-1could be safely implanted in the vertebral body if the cement surface is at least 4 mm from the spinal cord in sheep and 5 mm from the spinal cord in humans.In vivo, a lateral retroperitoneal surgical approach, ventral to the transverse processes, was identified as easy to perform while allowing a safe distance to the spinal cord. The blood, urine, and feces of the sheep did not contain detectable levels of32P, and the sheep did not experience any neurologic or other adverse effects from the brachytherapy cement. These results demonstrate, on a preliminary level, the relative safety of this brachytherapy cement and support additional development and testing.

Cost-effectiveness studies of vertebral augmentation for osteoporotic vertebral fractures: a systematic review.

BACKGROUND CONTEXT: Osteoporotic vertebral fractures (OVF) dramatically increase with age and are serious life altering adverse events for seniors resulting in increased rates of institutionalization, morbidity and mortality. Given the expanding population of the elderly and increasing prevalence of OVFs, cost-effective treatment strategies need to be considered. Percutaneous vertebral augmentation (VA) procedures such as vertebroplasty (VP) or balloon kyphoplasty (BK) are increasingly employed to treat painful vertebral fractures not responding to conservative management (CM) of bedrest and analgesia. Both VA procedures have been shown to be effective treatments for OVFs in multiple systematic reviews of randomized controlled trials. In this systematic review, analytical strategies, designs and results were compared for health economic studies evaluating cost-effectiveness of VA procedures, VP or BK for OVFs. Furthermore, assessments of quality (risk of bias) were conducted for the systematic review and the individual studies with peer-reviewed checklists recommended for cost-effectiveness studies. PURPOSE: To provide an up-to-date systematic review of peer-reviewed studies evaluating cost-effectiveness of VA procedures, VP or KP for OVFs to support treatment and health care funding decisions. STUDY DESIGN: This study is a systematic literature review and structured narrative synthesis. STUDY SAMPLE: Peer reviewed health economic studies reporting cost-effectiveness for VA procedures, VP or BK for OVFs OUTCOME MEASURES: The following information extracted from the studies included: report country and year, study design, comparators, population, perspective, health valuations, costing sources and cost-effectiveness measures. For economic studies involving modeling, information was also extracted for model type, time horizon, key model drivers, and handling of uncertainty. Incremental cost-effectiveness ratio (ICER), the ratio of differences between comparator treatment groups in costs and health benefits, was considered the main cost-effectiveness measure. METHODS: A systematic review was conducted of MEDLINE, EMBASE, CINAHL, ECONLIT, Cochrane Library and DARE databases up to the review date May 2021. Studies were reviewed for those reporting cost-effectiveness analyses on VA procedures including VP or BK for OVFs. Studies including only costs, abstracts, editorials, methodologies and reviews were not included. The selection of articles was reported in line with PRISMA guidance. A descriptive framework was developed to classify types of cost-effectiveness studies based on methodological differences and a structured narrative synthesis was used to summarize studies. Quality assessments were made with British Medical Journal checklist for individual cost-effectiveness studies and the CiCERO checklist for systematic reviews of cost-effectiveness studies. RESULTS: In this systematic review, 520 references were identified through database searching and 501 were excluded as ineligible by titles and abstract based on prior eligibility criteria. From full-text reviews of 19 reports, ten were identified as eligible for the systematic review evaluating cost-effectiveness of VA procedures for OVFs. All references were published between 2008 and 2020. The ten cost-effectiveness studies, three for VP, three for BK and four for both VP and BK, all involved CM for OVFs as a treatment comparator. The studies involved different methods of economic analysis, modeling assumptions, cost and health valuations conducted in different health care setting over different time periods. A framework for the review outlines key features of cost-effectiveness study designs consisting of unmatched, matched, or randomized controls involving cost-effectiveness or cost-utility) analyses. Both VP and BK were cost-effective alternatives to CM for OVFs with earlier health gains and significantly shorter hospital stays. Cost-effectiveness estimates, ICERs, remained relatively stable and within willingness-to-pay thresholds under a range of sensitivity analyses. Comparisons between VP and BK were variable depending on modeling assumptions, but generally the procedures had similar health benefit gains with VP having lower acute procedural costs. CONCLUSIONS: Both VP and BK, have been shown to be cost-effective alternatives to CM for osteoporotic vertebral fractures in diverse cost-effectiveness studies conducted in multiple health care settings. Trial-based cost-utility contributed the strongest evidence supporting cost-effectiveness determination for VP and BK for OVFs.

Assessment of clinical, imaging, surgical risk factors for subsequent fracture following vertebral augmentation in osteoporotic patients.

INTRODUCTION: Currently, the risk factors for subsequent fracture following vertebral augmentation remain incomplete and controversial. To provide clinicians with accurate information for developing a preventive strategy, we carried out a comprehensive evaluation of previously controversial and unexplored risk factors. METHODS: We retrospectively reviewed patients with osteoporotic vertebral compression fracture in lumbar spine who received vertebral augmentation between January 2019 and December 2020. Based on whether refracture occurred, patients were assigned to refracture and non-refracture group. The clinical characteristics, imaging parameters (severity of vertebral compression, spinal sagittal alignment, degeneration of paraspinal muscles), and surgical indicators (cement distribution and leakage, correction of spinal sagittal alignment) were collected and analyzed. RESULTS: There were 128 patients and 16 patients in non-refracture and refracture group. The incidence of previous fracture, multiple fractures, and cement leakage were notably higher, relative cross-sectional area of psoas (r-CSAPS) was significantly smaller, CSA ratio, fatty infiltration of erector spinae plus multifidus (FIES+MF), FIPS, postoperative lumbar lordosis (post-LL), correction of body angel (BA), and LL were significantly greater in refracture group. Binary logistic regression analysis revealed previous fracture, cement leakage, post-LL, and correction of BA were independent risk factors. According to the ROC curve, correction of BA showed the highest prediction accuracy, and the critical value was 3.45°. CONCLUSIONS: The occurrence of subsequent fracture might be the consequence of multiple factors. Previous fracture, cement leakage, post-LL, and correction of BA were identified as independent risk factors. Furthermore, the correction of BA should not exceed 3.45°, especially in patients with risk factors.

Utilization and Expenditures of Vertebral Augmentation Continue to Decline: An Analysis in Fee-For-Service (FFS) Recipients from 2009 to 2018.

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.

Vertebroplasty and kyphoplasty in the USA from 2004 to 2017: national inpatient trends, regional variations, associated diagnoses, and outcomes.

BACKGROUND: To explore the national inpatient trends, regional variations, associated diagnoses, and outcomes of vertebral augmentation (vertebroplasty and kyphoplasty) in the USA from 2004 to 2017. METHODS: Data from the National Inpatient Sample were used to study hospitalization records for percutaneous vertebroplasty and kyphoplasty. Longitudinal projections of trends and outcomes, including mortality, post-procedural complications, length of stay, disposition, and total hospital charges were analyzed. RESULTS: Following a period of decreased utilization from 2008 to 2012, hospitalizations for vertebroplasty and kyphoplasty plateaued after 2013. Total hospital charges and overall financial burden of hospitalizations for vertebroplasty and kyphoplasty increased to a peak of $1.9 billion (range $1.7-$2.2 billion) in 2017. Overall, 8% of procedures were performed in patients with a history of malignancy. In multivariable modeling, lung cancer (adjusted OR (aOR) 2.6 (range 1.4-5.1)) and prostate cancer (aOR 3.4 (range 1.2-9.4)) were associated with a higher risk of mortality. The New England region had the lowest frequency of routine disposition (14.1±1.1%) and the lowest average hospital charges ($47 885±$1351). In contrast, 34.0±0.8% had routine disposition in the West Central South region, and average hospital charges were as high as $99 836±$2259 in the Pacific region. The Mountain region had the lowest number of procedures (5365±272) and the highest mortality rate (1.2±0.3%). CONCLUSION: National inpatient trends of vertebroplasty and kyphoplasty utilization remained stable after a period of decline from 2008 to 2012, while the financial burden of hospitalizations increased. Despite recent improvements in outcomes, significant regional variations persisted across the USA.

Demonstrating the influence of HTA: INAHTA member stories of HTA impact.

A central function of health technology assessment (HTA) agencies is the production of HTA reports to support evidence-informed policy and decision making. HTA agencies are interested in understanding the mechanisms of HTA impact, which can be understood as the influence or impact of HTA report findings on decision making at various levels of the health system. The members of the International Network of Agencies for HTA (INAHTA) meet at their annual Congress where impact story sharing is one important activity. This paper summarizes four stories of HTA impact that were finalists for the David Hailey Award for Best Impact Story.The methods to measure impact include: document review; claims analysis and review of reimbursement status; citation analysis; qualitative evaluation of stakeholders' views; and review of media response. HTA agency staff also observed changes in government activities and priorities based on the HTA. Impact assessment can provide information to improve the HTA process, for example, the value of patient and clinician engagement in the HTA process to better define the assessment question and literature reviews in a more holistic and balanced way.HTA reports produced by publicly funded HTA agencies are valued by health systems around the globe as they support decision making regarding the appropriate use, pricing, reimbursement, and disinvestment of health technologies. HTAs can also have a positive impact on information sharing between different levels of government and across stakeholder groups. These stories show how HTA can have a significant impact, irrespective of the health system and health technology being assessed.

Medicare Utilization and Reimbursement for Vertebroplasty and Kyphoplasty: A National Analysis From 2012-2017.

STUDY DESIGN: Retrospective cohort study OBJECTIVE.: This study seeks to identify recent trends in utilization and reimbursements of these procedures between 2012and 2017, a period which experienced a change in national guideline recommendations for these procedures. SUMMARY OF BACKGROUND DATA: Minimally invasive vertebral augmentation procedures, including vertebroplasty and kyphoplasty, have been typically reserved for fractures associated with refractory pain, deformity, or progressive neurological symptoms. However, controversy exists regarding the safety and effectiveness of these procedures, in particular vertebroplasty. METHODS: Annual Medicare claims and payments to surgeons were aggregated at the county level to assess regional trends. Descriptive statistics and multivariate regression models were used to evaluate trends in procedure volume, utilization rates, and reimbursement rates, and to examine associations between county-specific variables and outcome variables. RESULTS: A total of 24,316 vertebroplasties and 138,778 kyphoplasties were performed in the Medicare population between 2012 and 2017. Annual vertebroplasty volume fell by 48.0% from 5744 procedures in 2012 to 2987 in 2017, with a compound annual growth rate (CAGR) of -12.3%. Annual kyphoplasty volume also declined by 12.7% (CAGR -2.7%), from 24,986 in 2012 to 21,681 in 2017. Surgeon reimbursements for vertebral augmentation procedures increased by a weighted average of 93.7% (inflation-adjusted increase of 78.2%) between 2012 and 2017, which was primarily driven by a dramatic 113.3% (inflation-adjusted increase of 96.2%) increase in mean reimbursements for kyphoplasty procedures from an average of $895 to $1764, between 2012 and 2017, respectively. CONCLUSION: This large national Medicare database study found that vertebroplasty and kyphoplasty procedure volume and utilization of both procedures have declined significantly. Although average reimbursements to surgeons for vertebroplasties have significantly declined, payments for kyphoplasty procedures have risen significantly. Although vertebroplasty volume has significantly decreased, it is still being performed and being reimbursed for, in spite of its controversial role in its treatment of vertebral fractures. LEVEL OF EVIDENCE: 3.

Cost-Benefit Analysis of Routine Bone Biopsy During Augmentation of Osteoporotic Vertebral Compression Fractures.

STUDY DESIGN: Multi-center prospective study. OBJECTIVE: To analyze the cost of routine biopsy during augmentation of osteoporotic vertebral compression fractures (VCF) and the affect it has on further treatment. SUMMARY OF BACKGROUND DATA: Vertebroplasty (VP) and Balloon Kyphoplasty (BKP) are accepted treatments for VCF. Bone biopsy is routinely performed during every VCF surgery in many centers around the world to exclude an incidental finding of malignancy as the cause of the pathological VCF. The incidence been reported as 0.7% to 7.3%, however the published cohorts are small and do not discuss cost-benefit aspects. METHODS: From 2008 to 2016 we performed 122 vertebral biopsies routinely on 116 patients in three hospitals. Twenty-three patients had history of malignancy (26 biopsies) and four were suspected of having malignancy based on imaging findings. The remaining 86 patients (99 biopsies) were presumed osteoporotic VCF. RESULTS: Out of 99 biopsies in the VCF cohort group only one yielded an unsuspected malignancy (1.16%), positive for multiple myeloma (MM). The ability of clinical assessment and imaging alone to diagnose malignancy was found to be 91.7% sensitive and 84.2% specific in our cohort. CONCLUSION: Routine bone biopsy during vertebral augmentation procedure is a safe option for evaluating the cause of the VCF but has significant cost to the health system. The cost of one diagnosed case of unsuspected malignancy was $31,000 in our study. The most common pathology was MM, which has not been proven to benefit from early diagnosis. When comparing clinical diagnosis with imaging, a previous history of malignancy was found in only 40.7% of VCF patients, while imaging was 100% accurate in predicting presence of malignancy on biopsy. This study reassures spine surgeons in their ability to diagnose malignant VCFs and does not support the significant cost of routine bone biopsies. LEVEL OF EVIDENCE: 3.

Cost-effectiveness of balloon kyphoplasty and vertebroplasty versus conservative medical management in the USA.

The cost-effectiveness of surgical versus conservative medical management of vertebral compression fractures in the US was analyzed in the context of inpatient versus outpatient treatment. Surgical intervention (balloon kyphoplasty and vertebroplasty) was found to be cost-effective relative to conservative medical management at a US willingness-to-pay threshold. INTRODUCTION: To date, only one published study has evaluated the cost-effectiveness (C/E) of balloon kyphoplasty (BKP) or vertebroplasty (VP) in US Medicare patients with osteoporotic vertebral compression fractures. This study further evaluates the C/E of surgical treatment vs. conservative medical management (CMM), expanding on prior modeling by accounting for quality-adjusted life-years gained. METHODS: A Markov microsimulation model of 1000 patients was constructed. Cost data were based on an analysis of Medicare claims payments, with propensity-score matching performed for BKP and VP vs. controls (CMM). Mortality inputs were based on US life tables, modified to account for age at initial fracture, presence of subsequent fracture(s), and relative risk of mortality by treatment. Separate incremental cost-effectiveness ratios (ICERs) were calculated for BKP and VP in inpatient and outpatient surgical treatment locations to account for individual clinical profiles presenting to each. RESULTS: The discounted ICER for inpatient BKP vs. CMM was $43,455 per QALY gained; for outpatient BKP vs. CMM, $10,922; for inpatient VP vs. CMM, $39,774; and for outpatient VP vs. CMM, $12,293. Probabilistic sensitivity analysis confirmed that both BKP and VP would be considered C/E vs. CMM at a US willingness-to-pay (WTP) threshold of $50,000/QALY in 80% and 100% of 500 model simulations, respectively. The most sensitive parameters included quality of life estimates and hazard ratios for mortality. CONCLUSION: While VP and BKP are more expensive treatment options than CMM in the short term, model results suggest interventional treatment is cost-effective, among patients eligible for surgery, at a US WTP threshold. This conclusion supports those from economic analyses conducted in EU-member countries.

Association of early vertebroplasty with risk of hip replacement: A nationwide population-based cohort study in Taiwan.

Studies show that vertebral fractures could predict the risk of hip fractures. We aimed to evaluate the potential benefits of whether the timing of vertebroplasty (VP) for vertebral fracture associated with the risk of hip fracture for hip replacement.We identified 142,782 patients from the Taiwan National Health Insurance Database with thoracolumbar vertebral fracture (International Classification of Diseases, Ninth Revision, Clinical Modification:805.2-805.9) who were followed up from 2000 to 2013. These patients were divided into those who underwent VP (VP group) (International Classification of Diseases, Ninth Revision, Clinical Modification : 78.49) within 3 months and those who did not (non-VP group). After adjusting for the confounding factors, the Cox proportional hazards analysis was used to estimate the effect of early VP on reducing the risk of hip fracture. The difference in the risk of hip replacement, between the VP group and non-VP group was estimated using the Kaplan-Meier method with the log-rank test.In the 14-year follow-up, the cumulative incidence rate of hip replacement in the VP group was lower than that in the non-VP group (0.362% and 0.533%, respectively, long-rank P < .001). There was a significant difference between the 2 groups since the first-year follow-up.Our study showed that early VP performed to avoid progression of the kyphotic changes following thoracolumbar vertebral fracture may reduce the risk of hip fracture. These results, obtained from retrospective data, indicate that a prospective study is warranted.

Comparison of Costs and Postoperative Outcomes between Vertebroplasty and Kyphoplasty for Osteoporotic Vertebral Compression Fractures: Analysis from a State-Level Outpatient Database.

BACKGROUND: Vertebral cement augmentation techniques are routinely used to treat osteoporotic vertebral compression fractures (VCFs). In the current study, we used a state-level outpatient database to compare costs and postoperative outcomes between vertebroplasty and kyphoplasty. METHODS: We queried the 2016 Florida State-Ambulatory Surgery Database of the Healthcare Cost and Utilization Project for patients undergoing thoracolumbar vertebroplasty or kyphoplasty for osteoporotic VCFs. Demographic and clinical characteristics, as well as postoperative outcomes were compared between the 2 groups. RESULTS: A total of 105 patients (11.6%) who underwent vertebroplasty and 801 patients (88.4%) who underwent kyphoplasty were identified. Patients undergoing kyphoplasty were more likely to stay overnight or longer, with the P value trending toward significance (kyphoplasty with >1 day stay: 7.4% vs. vertebroplasty with >1 day stay: 1.9%; P = 0.086). Patients undergoing vertebroplasty had a significantly higher rate of discharge to home routine compared with patients undergoing kyphoplasty (97.1% [n = 102] vs. 94.1% [n = 754]; P < 0.001). Undergoing kyphoplasty was also associated with higher index admission costs ($40,706 vs. $18,965; P < 0.001) and higher readmission costs ($27,038 vs. $11,341; P = 0.046). The rates of 30-day and 90-day readmission were similar between the 2 groups (all P > 0.05). The rates of 30-day, 90-day, and overall readmission because of a new-onset fracture were also similar (all P > 0.05). However, vertebroplasty had a higher rate of readmissions associated with a procedure within a year (21.9% [n = 23] vs. 14.5% [n = 116]; P = 0.047). CONCLUSIONS: Our analyses from a state-level database of patients undergoing vertebroplasty and kyphoplasty for osteoporotic VCFs show similar postoperative outcomes for the 2 procedures but a higher cost for kyphoplasty.

Trends of utilization and physician payments for vertebroplasty and kyphoplasty procedures by physician specialty and practice setting: 2010 to 2018.

BACKGROUND CONTEXT: In 2010, the American Academy of Orthopedic Surgeons published guidelines strongly recommending against the use of vertebroplasty following the publication of randomized control trials that failed to show significant improvement in pain. Vertebroplasty has remained controversial since those findings. PURPOSE: To study and provide an update on utilization of vertebroplasty and kyphoplasty procedures among Medicare beneficiaries by physician specialty and practice setting following publication of recommendations against vertebroplasty in 2010. STUDY DESIGN/SETTING: This study uses Medicare Part B Physician/Supplier Procedure Summary Master File (PSPSMF) for the years 2010 to 2018 to determine trends in volume and reimbursement by physician specialty and practice setting. PATIENT SAMPLE: All vertebral augmentation procedures with a physician reimbursement claims approved by Medicare Part B from 2010 to 2018. OUTCOME MEASURES: This study analyzes trends in volume and physician payment of vertebroplasty and kyphoplasty procedures by physician specialty for the time period 2010 to 2018. METHODS: Claims from the Medicare Part B PSPSMF for the years 2010 to 2018 were extracted using the Current Procedural Terminology codes for vertebroplasty and kyphoplasty. Total volumes, payment amounts (professional component), and trends were analyzed by physician specialty. RESULTS: Between 2010 and 2018, the total volume of vertebroplasties decreased by 61.2% (29,995 to 11,654), whereas the volume of kyphoplasties increased modestly by 14.4% (59,691 to 68,294). Radiologists performed an increasing share of both procedures over this time period, from 68.5% to 75.1% for vertebroplasties and 28.9% to 37.1% for kyphoplasties. Total payment for vertebroplasties decreased by 74.3% from $14.8 million in 2010 to $3.8 million in 2018; whereas it increased by 235.3% for kyphoplasty procedures from $26.7 million to $89.7 million. This is driven in large part by a 6,833% increase in office based kyphoplasties which bill at the higher nonfacility rate that incorporates overhead, staff, and equipment. CONCLUSIONS: Previous studies have demonstrated mixed evidence for benefits of vertebroplasty procedures and decreasing volumes over time. Data show continued downtrend in vertebroplasty and increased utilization of kyphoplasty among Medicare beneficiaries. In addition, the growing number of kyphoplasties correlated with a sharp rise in volume and increased reimbursement for office-based procedures. Radiologists have been performing an increasing share of both procedures.

Utilization of Vertebral Augmentation Procedures in the USA: a Comparative Analysis in Medicare Fee-for-Service Population Pre- and Post-2009 Trials.

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.