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.

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.

Percutaneous Vertebroplasty: A History of Procedure, Technology, Culture, Specialty, and Economics.

Percutaneous vertebroplasty (VP) progressed from a virtually unknown procedure to one performed on hundreds of thousands of patients annually. The development of VP provides a historically exciting case study into a rapidly adopted procedure. VP was the synthesis of information gained from spinal biopsy developments, the inception of biomaterials used in medicine, and the unique health care climate in France during the 1980s. It was designed as a revolutionary technique to treat vertebral body fractures with minimal side effects and was rapidly adopted and marketed in the United States. The impact of percutaneous vertebroplasty on spine surgery was profound.

Percutaneous vertebroplasty vs balloon kyphoplasty in the treatment of newly onset osteoporotic vertebral compression fractures: A retrospective cohort study.

To compare percutaneous vertebroplasty (VP) and balloon kyphoplasty (BKP) for their effectiveness and safety in the treatment of newly onset osteoporotic vertebral compression fractures (VCF).Patients with confirmed diagnosis of newly onset osteoporotic VCF and treated in our center between January 2008 and December 2016 were retrospectively included in the study. Patients were divided into 2 groups according the surgical treatment they have received. They were followed for 12 months after surgery by outpatient visits and phone interviews. Changes in VAS and ODI scores, quantity of injected bone cement, cost of treatment, changes in the height of the vertebra, incidence of complications such as bone cement leakage, adjacent level vertebral fracture during follow up and total were compared between the 2 groups.A total of 338 patients were included in the final analysis. Demographic characteristics were similar in 2 groups. There were no significant differences between the 2 groups concerning VAS and ODI scores after the surgery and at last follow up (P > .05). However, total cost of treatment, quantity of injected bone cement, incidence of adjacent level fracture, restored vertebral height and the loss of vertebral body height at the last follow up were significantly higher in the BKP group than the VP group (P < .05).Considering the similar key outcome parameters such as VAS and ODI scores and significantly more cost of BKP, VP can be prioritized over BKP in the treatment of patients with newly onset osteoporotic VCF.

Medial Branch Block Versus Vertebroplasty for 1-Level Osteoporotic Vertebral Compression Fracture: 2-Year Retrospective Study.

OBJECTIVE: Percutaneous vertebroplasty (VP) and medial branch block (MBB) are used to treat osteoporotic vertebral compression fractures (VCF). We compared the clinical outcomes, radiologic changes, and economic results of MBB with those of VP in treating osteoporotic VCFs. METHODS: A total of 164 patients with 1-level osteoporotic VCF were reviewed retrospectively. The clinical outcomes were measured with a visual analogue scale (VAS) and the Oswestry Disability Index (ODI). To compare economic costs between groups, total hospital costs at the last follow-up day were calculated. RESULTS: The patients were divided into 2 groups: 72 patients in the conservative group treated by MBB (MBB group) and 92 patients in the group who underwent VP (VP group). The VAS and ODI scores improved significantly within postoperative week 1 in the VP group compared with the MBB group. However, the VAS and ODI scores did not differ between the groups after 1 postoperative year. After 2 years of follow-up, 14 new fractures occurred in the VP group and 3 in the MBB group. The improvement in compression ratio was statistically greater in the VP group than in the MBB group. However, after 2 years the radiologic changes between groups did not differ statistically. After the final follow-up visits, the hospital costs were significantly lower in the MBB group. CONCLUSIONS: After 2 years of follow-up, VP and MBB both had similar efficacy in terms of pain relief and radiologic changes. MBB was more cost effective than VP. Thus, MBB alone can be a possible alternative to VP in patients with 1-level osteoporotic VCFs.

The unreimbursed costs of preventing revision surgery in adult spinal deformity: analysis of cost-effectiveness of proximal junctional failure prevention with ligament augmentation.

OBJECTIVE Proximal junctional kyphosis (PJK) is a well-recognized complication of surgery for adult spinal deformity and is characterized by increased kyphosis at the upper instrumented vertebra (UIV). PJK prevention strategies have the potential to decrease morbidity and cost by reducing rates of proximal junctional failure (PJF), which the authors define as radiographic PJK plus clinical sequelae requiring revision surgery. METHODS The authors performed an analysis of 195 consecutive patients with adult spinal deformity. Age, sex, levels fused, upper instrumented vertebra (UIV), use of 3-column osteotomy, pelvic fixation, and mean time to follow-up were collected. The authors also reviewed operative reports to assess for the use of surgical adjuncts targeted toward PJK prevention, including ligament augmentation, hook fixation, and vertebroplasty. The cost of surgery, including direct and total costs, was also assessed at index surgery and revision surgery. Only revision surgery for PJF was included. RESULTS The mean age of the cohort was 64 years (range 25-84 years); 135 (69%) patients were female. The mean number of levels fused was 10 (range 2-18) with the UIV as follows: 2 cervical (1%), 73 upper thoracic (37%), 108 lower thoracic (55%), and 12 lumbar (6%). Ligament augmentation was used in 99 cases (51%), hook fixation in 60 cases (31%), and vertebroplasty in 71 cases (36%). PJF occurred in 18 cases (9%). Univariate analysis found that ligament augmentation and hook fixation were associated with decreased rates of PJF. However, in a multivariate model that also incorporated age, sex, and UIV, only ligament augmentation maintained a significant association with PJF reduction (OR 0.196, 95% CI 0.050-0.774; p = 0.020). Patients with ligament augmentation, compared with those without, had a higher cost of index surgery, but ligament augmentation was overall cost effective and produced significant cost savings. In sensitivity analyses in which we independently varied the reduction in PJF, cost of ligament augmentation, and cost of reoperation by ± 50%, ligament augmentation remained a cost-effective strategy for PJF prevention. CONCLUSIONS Prevention strategies for PJK/PJF are limited, and their cost-effectiveness has yet to be established. The authors present the results of 195 patients with adult spinal deformity and show that ligament augmentation is associated with significant reductions in PJF in both univariate and multivariate analyses, and that this intervention is cost-effective. Future studies will need to determine if these clinical results are reproducible, but for high-risk cases, these data suggest an important role of ligament augmentation for PJF prevention and cost savings.

Medicare Utilization of Vertebral Augmentation 2001 to 2014: Effects of Randomized Clinical Trials and Guidelines on Vertebroplasty and Kyphoplasty.

PURPOSE: Vertebral fractures have a substantial impact on the health and quality of life of elderly individuals as one of the most common complications of osteoporosis. Vertebral augmentation procedures including vertebroplasty and kyphoplasty have been supported as means of reducing pain and mitigating disability associated with these fractures. However, use of vertebroplasty is debated, with negative randomized controlled trials published in 2009 and divergent clinical guidelines. The effect of changing evidence and guidelines on different practitioners' utilization of both kyphoplasty and vertebroplasty in the years after these developments and publication of data supporting their use is poorly understood. METHODS: Using national aggregate Medicare claims data from 2002 through 2014, vertebroplasty and kyphoplasty procedures were identified by provider type. Changes in utilization by procedure type and provider were studied. RESULTS: Total vertebroplasty billing increased 101.6% from 2001 (18,911) through 2008 (38,123). Total kyphoplasty billing frequency increased 17.2% from 2006 (54,329) through 2008 (63,684). Vertebroplasty billing decreased 60.9% from 2008 through 2014 to its lowest value (14,898). Kyphoplasty billing decreased 8.4% from 2008 (63,684) through 2010 (58,346), but then increased 7.6% from 2010 to 2013 (62,804). CONCLUSIONS: Vertebroplasty billing decreased substantially beginning in 2009 and continued to decrease through 2014 despite publication of more favorable studies in 2010 to 2012, suggesting studies published in 2009 and AAOS guidelines in 2010 may have had a persistent negative effect. Kyphoplasty did not decrease as substantially and increased in more recent years, suggesting a clinical practice response to favorable studies published during this period.

Vertebral Augmentation Involving Vertebroplasty or Kyphoplasty for Cancer-Related Vertebral Compression Fractures: An Economic Analysis.

BACKGROUND: Untreated vertebral compression fractures can have serious clinical consequences and impose a considerable impact on patients' quality of life and on caregivers. Since non-surgical management of these fractures has limited effectiveness, vertebral augmentation procedures are gaining acceptance in clinical practice for pain control and fracture stabilization. The objective of this analysis was to determine the cost-effectiveness and budgetary impact of kyphoplasty or vertebroplasty compared with non-surgical management for the treatment of vertebral compression fractures in patients with cancer. METHODS: We performed a systematic review of health economic studies to identify relevant studies that compare the cost-effectiveness of kyphoplasty or vertebroplasty with non-surgical management for the treatment of vertebral compression fractures in adults with cancer. We also performed a primary cost-effectiveness analysis to assess the clinical benefits and costs of kyphoplasty or vertebroplasty compared with non-surgical management in the same population. We developed a Markov model to forecast benefits and harms of treatments, and corresponding quality-adjusted life years and costs. Clinical data and utility data were derived from published sources, while costing data were derived using Ontario administrative sources. We performed sensitivity analyses to examine the robustness of the results. In addition, a 1-year budget impact analysis was performed using data from Ontario administrative sources. Two scenarios were explored: (a) an increase in the total number of vertebral augmentation procedures performed among patients with cancer in Ontario, maintaining the current proportion of kyphoplasty versus vertebroplasty; and (b) no increase in the total number of vertebral augmentation procedures performed among patients with cancer in Ontario but an increase in the proportion of kyphoplasties versus vertebroplasties. RESULTS: The base case considered each of kyphoplasty and vertebroplasty versus non-surgical management. Kyphoplasty and vertebroplasty were associated with an incremental cost-effectiveness ratio of $33,471 and $17,870, respectively, per quality-adjusted life-year gained. The budgetary impact of funding vertebral augmentation procedures for the treatment of vertebral compression fractures in adults with cancer in Ontario was estimated at about $2.5 million in fiscal year 2014/15. More widespread use of vertebral augmentation procedures raised total expenditures under a number of scenarios, with costs increasing by $67,302 to $913,386. CONCLUSIONS: Our findings suggest that the use of kyphoplasty or vertebroplasty in the management of vertebral compression fractures in patients with cancer may be a cost-effective strategy at commonly accepted willingness-to-pay thresholds. Nonetheless, more widespread use of kyphoplasty (and vertebroplasty to a lesser extent) would likely be associated with net increases in health care costs.

[The cost effectiveness analysis of minimally invasive surgery and conservative treatment in elderly osteoporotic spinal fracture].

OBJECTIVE: To evaluate the cost effectiveness of conservative treatment, percutaneous vertebroplasty(PVP)and percutaneous kyphoplasty(PKP)for elderly osteoporotic vertebral compression fracture(OVCF). METHODS: The clinical data of 152 patients with osteoporotic vertebral compression fractures, collected in the orthopedic department of 309th Hospital of PLA from October 2013 to July 2014, was retrospectively analyzed. According to the therapeutic methods, the patients who met the inclusion criteria were divided into conservative treatment group (51 cases), percutaneous vertebroplasty group (50 cases) and percutaneous kyphoplasty group(51 cases). The average medical cost (C) in hospital period and 1 year after discharging, and the treatment effect (E) according to standard of "cure" (VAS score less than or equal to 2) or "improvement" (VAS score was 3 to 8) was recorded. Then the C/E value indicated the cost effectiveness in different standards. RESULTS: The average hospitalization days of the PVP and PKP group was 3 to 5 days with an average of(3.4±0.6) days. The conservative group was 12 to 15 days with an average of (14.0±0.6) days. During the hospitalization period, the cost effectiveness of the conservative group, PVP group and PKP group were RMB 1 253.88, 935.75, 983.99 yuan, respectively, according to the standard of "cure". The PVP group was superior to the PKP group and the latter was superior to the conservative group. If "improvement" was used as the standard of evaluation, the results were RMB 97.80, 449.16, 501.84 yuan, respectively, suggesting that the conservative group was better than the PVP group and the latter was better than the PKP group. After hospital discharge, the cost effectiveness of the conservative group, PVP group and PKP group were RMB 3 834.05, 1 878.41 and 1 916.11 yuan, respectively, according to the standard of "cure". The PVP group was superior to the PKP group and the latter exceeded the conservative group. CONCLUSIONS: The study showed that the PVP was the best choice at the evaluation criterion of "cure", while taking "improvement" as the evaluation criterion, the conservative treatment was the best one. Either way, the PVP was the best choice after hospital discharge.

Economic Analysis of Kiva VCF Treatment System Compared to Balloon Kyphoplasty Using Randomized Kiva Safety and Effectiveness Trial (KAST) Data.

BACKGROUND: Vertebral compression fractures (VCFs) are the most common osteoporotic fractures and cause persistent pain, kyphotic deformity, weight loss, depression, reduced quality of life, and even death. Current surgical approaches for the treatment of VCF include vertebroplasty (VP) and balloon kyphoplasty (BK). The Kiva® VCF Treatment System (Kiva System) is a next-generation alternative surgical intervention in which a percutaneously introduced nitinol Osteo Coil guidewire is advanced through a deployment cannula and subsequently a PEEK Implant is implanted incrementally and fully coiled in the vertebral body. The Kiva System's effectiveness for the treatment of VCF has been evaluated in a large randomized controlled trial, the Kiva Safety and Effectiveness Trial (KAST). The Kiva System was non-inferior to BK with respect to pain reduction (70.8% vs. 71.8% in Visual Analogue Scale) and physical function restoration (38.1 % vs. 42.2% reduction in Oswestry Disability Index) while using less bone cement. The economic impact of the Kiva system has yet to be analyzed. OBJECTIVE: To analyze hospital resource use and costs of the Kiva System over 2 years for the treatment of VCF compared to BK. SETTING: A representative US hospital. STUDY DESIGN: Economic analysis of the KAST randomized trial, focusing on hospital resource use and costs. METHODS: The analysis was conducted from a hospital perspective and utilized clinical data from KAST as well as unit-cost data from the published literature. The cost of initial VCF surgery, reoperation cost, device market cost, and other medical costs were compared between the Kiva System and BK. The relative risk reduction rate in adjacent-level fracture with Kiva [31.6% (95% CI: -22.5%, 61.9%)] demonstrated in KAST was used in this analysis. RESULTS: With 304 vertebral augmentation procedures performed in a representative U.S. hospital over 2 years, the Kiva System will produce a direct medical cost savings of $1,118 per patient and $280,876 per hospital. This cost saving with the Kiva System was attributable to 19 reduced adjacent-level fractures with the Kiva System. LIMITATIONS: This study does not compare the Kiva System with VP or any other non-surgical procedures for the treatment of VCF. CONCLUSION: This first-ever economic analysis of the KAST data showed that the Kiva System for vertebral augmentation is hospital resource and cost saving over BK in a hospital setting over 2 years. These savings are attributable to reduced risk of developing adjacent-level fractures with the Kiva System compared to BK.

Health economic aspects of vertebral augmentation procedures.

We reviewed all peer-reviewed papers analysing the cost-effectiveness of vertebroplasty and balloon kyphoplasty for osteoporotic vertebral compression fractures. In general, the procedures appear to be cost effective but are very dependent upon model input details. Better data, rather than new models, are needed to answer outstanding questions. Vertebral augmentation procedures (VAPs), including vertebroplasty (VP) and balloon kyphoplasty (BKP), seek to stabilise fractured vertebral bodies and reduce pain. The aim of this paper is to review current literature on the cost-effectiveness of VAPs as well as to discuss the challenges for economic evaluation in this research area. A systematic literature search was conducted to identify existing published studies on the cost-effectiveness of VAPs in patients with osteoporosis. Only peer-reviewed published articles that fulfilled the criteria of being regarded as full economic evaluations including both morbidity and mortality in the outcome measure in the form of quality-adjusted life years (QALYs) were included. The search identified 949 studies, of which four (0.4 %) were identified as relevant with one study added later. The reviewed studies differed widely in terms of study design, modelling framework and data used, yielding different results and conclusions regarding the cost-effectiveness of VAPs. Three out of five studies indicated in the base case results that VAPs were cost effective compared to non-surgical management (NSM). The five main factors that drove the variations in the cost-effectiveness between the studies were time horizon, quality of life effect of treatment, offset time of the treatment effect, reduced number of bed days associated with VAPs and mortality benefit with treatment. The cost-effectiveness of VAPs is uncertain. In answering the remaining questions, new cost-effectiveness analysis will yield limited benefit. Rather, studies that can reduce the uncertainty in the underlying data, especially regarding the long-term clinical outcomes of VAPs, should be conducted.

Gold fiducials are a unique marker for localization in the thoracic spine: a cost comparison with percutaneous vertebroplasty.

We present a unique application of the gold fiducial as a preoperative, radiographic marker placed in the thoracic spine and used for intraoperative localization. In comparison to percutaneous vertebroplasty marking of thoracic spinal levels with polymethyl methacrylate (PMMA) cement, implantation of the gold fiducial is technically facile with a minimal learning curve. The fiducial markers are also associated with significantly less financial resources. Following 2013 Current Procedural Terminology (CPT) coding, the cost of vertebroplasty under fluoroscopic guidance, $3195·43, or under computed tomography (CT) guidance, $3232·54, is more than double the cost of the gold fiducial implantation - $1237·55 and $1267·03, under similar imaging techniques, respectively. In the first description of gold fiducials in the thoracic spine, we conclude that the marker is a safe and cost-effective method for preoperative localization of the thoracic levels.

Percutaneous vertebroplasty and percutaneous balloon kyphoplasty for the treatment of osteoporotic vertebral fractures: a systematic review and cost-effectiveness analysis.

BACKGROUND: Percutaneous vertebroplasty (PVP) is a minimally invasive surgical procedure in which bone cement is injected into a fractured vertebra. Percutaneous balloon kyphoplasty (BKP) is a variation of this approach, in which an inflatable balloon tamp is placed in the collapsed vertebra prior to cement injection. OBJECTIVES: To systematically evaluate and appraise the clinical effectiveness and cost-effectiveness of PVP and percutaneous BKP in reducing pain and disability in people with osteoporotic vertebral compression fractures (VCFs) in England and Wales. DATA SOURCES: A systematic review was carried out. Ten databases including MEDLINE and CINAHL were searched from inception to November 2011, and supplemented by hand-searching relevant articles and contact with an expert. Studies met the inclusion criteria if they were randomised controlled trials (RCTs) including people with painful osteoporotic VCFs with a group receiving PVP or BKP. In addition, lead authors of identified RCTs were contacted for unpublished data. REVIEW METHODS: Primary outcomes were health-related quality of life; back-specific functional status/mobility; pain/analgesic use; vertebral body height and angular deformity; incidence of new vertebral fractures and progression of treated fracture. A manufacturer provided academic-in-confidence observational data indicating that vertebral augmentation may be associated with a beneficial mortality effect, and that, potentially, BKP was more efficacious than PVP. These data were formally critiqued. A mathematical model was constructed to explore the cost-effectiveness of BKP, PVP and operative placebo with local anaesthesia (OPLA) compared with optimal pain management (OPM). Six scenario analyses were conducted that assessed combinations of assumptions on mortality (differential beneficial effects for BKP and PVP; equal beneficial effects for BKP and PVP; and no effect assumed) and derivation of utility data (either mapped from visual analogue scale pain score data produced by a network meta-analysis or using direct European Quality of Life-5 Dimensions data from the trials). Extensive sensitivity analyses were conducted on each of the six scenarios. This report contains reference to confidential information provided as part of the National Institute for Health and Care Excellence appraisal process. This information has been removed from the report and the results, discussions and conclusions of the report do not include the confidential information. These sections are clearly marked in the report. RESULTS: A total of nine RCTs were identified and included in the review of clinical effectiveness. This body of literature was of variable quality, with the two double-blind, OPLA-controlled trials being at the least risk of bias. The most significant methodological issue among the remaining trials was lack of blinding for both study participants and outcome assessors. Broadly speaking, the literature suggests that both PVP and BKP provide substantially greater benefits than OPM in open-label trials. However, in double-blinded trials PVP was shown to have no more benefit than local anaesthetic; no trials of BKP compared with local anaesthesia have been conducted. A formal analysis of observational mortality data undertaken within this report concluded that it was not possible to say with certainty if there is a difference in mortality between patients undergoing BKP and PVP compared with OPM. Results from the cost-effectiveness analyses were varied, with all of BKP, PVP and OPLA appearing the most cost-effective treatment dependent on the assumptions made regarding mortality effects, utility, hospitalisation costs and OPLA costs. LIMITATIONS: Data on key parameters were uncertain and/or potentially confounded, making definitive conclusions difficult to make. CONCLUSION: For people with painful osteoporotic VCFs refractory to analgesic treatment, PVP and BKP perform significantly better in unblinded trials than OPM in terms of improving quality of life and reducing pain and disability. However, there is as yet no convincing evidence that either procedure performs better than OPLA. The uncertainty in the evidence base means that no definitive conclusion on the cost-effectiveness of PVP or BKP can be provided. Further research should focus on establishing whether or not BKP and PVP have a mortality advantage compared with OPLA and on whether or not these provide any utility gain compared with OPLA. STUDY REGISTRATION: This study was registered as PROSPERO number CRD42011001822. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Survival and cost comparison of kyphoplasty and percutaneous vertebroplasty using German claims data.

STUDY DESIGN: Observational study. OBJECTIVE: Examine the overall survival and treatment costs from a third-party-payer perspective for patients with osteoporotic vertebral compression fractures (OVCFs) treated by vertebral augmentation or conservative treatment in Germany. SUMMARY OF BACKGROUND DATA: OVCFs are associated with increased morbidity, mortality and thus reduced quality of life. Vertebral augmentation has been shown to be effective in these fractures. The association between treatment and survivorship as well as cost per life year gained for balloon kyphoplasty (BKP) and percutaneous vertebroplasty (PVP) was analyzed in the Medicare population. Replication of these analyses is warranted for confidence in findings. METHODS: Claims data from a major health insurance fund were used. Mortality risk differences between operated (BKP, PVP) and nonoperated cohorts were assessed by Cox regression. Operated patient groups were established by propensity score matching adjusting for covariates. For the matched operated patients with OVCF, (2006-2010) survival was estimated by Kaplan-Meier method. RESULTS: A total of 598 newly diagnosed patients with OVCF were operated of 3607 patients with OVCF. The operated cohort was 43% less likely to die than the nonoperated one in the 5-year study period (hazard ratio = 0.57; P < 0.001). Patients who received BKP had higher 60-month adjusted survival rate (66.7%) than those who received PVP (58.7%) (P = 0.68). Cumulative 4-year mean overall costs after first diagnosis were lower for the BKP cohort (PVP: €42,510 vs. BKP: €39,014). Initial upfront higher costs driven by surgical treatment for patients who received BKP are offset by considerable pharmacy costs in patients who received PVP. There were differences between the values of painkiller consumption (PVP: €3321 vs. BKP: €2224). CONCLUSION: Results suggest a higher overall survival rate for operated than nonoperated patients with OVCF and indicate a potential survival benefit for patients who received BKP compared with patients who received PVP. The reasons merit further investigation. Total costs were lower after 4 years for patients who received BKP versus PVP due to less consumption of pharmaceuticals. LEVEL OF EVIDENCE: 3.