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.

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.

Resources utilisation and economic burden of percutaneous vertebroplasty or percutaneous kyphoplasty for treatment of osteoporotic vertebral compression fractures in China: a retrospective claim database study.

BACKGROUND: Osteoporotic vertebral compression fractures (OVCF) is a common and often debilitating complication of osteoporosis, leading to significant morbidity and increased mortality. Percutaneous vertebroplasty (PVP) and Percutaneous kyphoplasty (PKP) are recommendable surgical treatments for OVCF. OBJECTIVE: To evaluate PVP/PKP utilisation and their related direct medical costs for OVCF treatment in China from the payer perspective. METHODS: A population-based medical claims database of a metropolitan city in China was analysed from the payer perspective, which included all inpatient claims from 01/01/2015 to 31/12/2017. All vertebral fractures patients that met the eligibility criteria (aged ≥50 years old, having vertebral fracture diagnosis, without unrelated diseases diagnoses such as tumour and scoliosis, received PVP/PKP) were deemed as OVCF patients. Baseline characteristics, surgery rate, length of stay in hospital, time to re-surgery, and costs (including costs per hospitalisation and annual costs) were described. Survival analysis function was used to estimate the re-surgery rate. RESULTS: Of the 50,686 patients with OVCF identified, 14,527 (28.66%) received a total number of 15,599 records of PVP/PKP surgeries from 2015 to 2017. Mean age was 75 at the first surgery captured in the database analysis period; females accounted for 79.54% of all cases. The median length of surgery stay was 9 days. Cumulative re-surgery rates were 1.22% in 30 days, 2.58% in 90 days, 3.61% in 183 days, 5.42% in 1 year, and 7.95% in 2 years. There was no significant difference in re-surgery rate between PVP and PKP (p = 0.3897). The median time to the re-surgery was 139 days. Mean costs per PVP/PKP-related hospitalisation were 35,906 CNY/5122 USD (34,195 CNY/4878USD for PVP, 44,414 CNY/6336 USD for PKP, p < 0.01). The overall costs of hospitalisation averaged 186.61 million CNY (26.62 million USD) per year in this metropolitan city. CONCLUSION: From 2015 to 2017, nearly one-third of OVCF inpatients received PVP/PKP and the re-surgery rate was 7.95%. PVP/PKP procedures for OVCF place a high economic burden for both the healthcare system and patients. Early detection and treatment of patients with osteoporosis are critical in China.

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.

Cost-effectiveness of Balloon Kyphoplasty for Patients With Acute/Subacute Osteoporotic Vertebral Fractures in the Super-Aging Japanese Society.

STUDY DESIGN: A propensity score matching study. OBJECTIVE: The aim of this study was to assess the cost-effectiveness of balloon kyphoplasty (BKP) in Japan. SUMMARY OF BACKGROUND DATA: Osteoporotic vertebral fracture (OVF) is a common disease in elderly people. In Japan, the incidence of painful OVF in 2008 was estimated as 880,000, and approximately 40% of patients with painful OVF are hospitalized due to the severity of pain. Japan is the front runner among super-aged societies and rising health care costs are an economic problem. METHODS: BKP and nonsurgical management (NSM) for acute/subacute OVF were performed in 116 and 420 cases, respectively. Quality-adjusted life years (QALY) and incremental costs were calculated on the basis of a propensity score matching study. QALY was evaluated using the SF-6D questionnaire. Finally, using a Markov model, incremental cost-effectiveness ratios (ICERs) were calculated for 71 matched cases. RESULTS: In the comparison between BKP and NSM, mean patients age was 78.3 and 77.7 years, respectively (P = 0.456). The BKP procedure cost 402,988 JPY more than NSM and the gains in QALY at the 6-month follow-up were 0.153 and 0.120, respectively (difference = 0.033). ICERs for 3 and 20 years were 4,404,158 JPY and 2,416,406 JPY, respectively. According to sensitivity analysis, ICERs ranged from 652,181 JPY to 4,896,645 JPY (4418-33,168 GBP). CONCLUSION: This study demonstrated that BKP is a cost-effective treatment option for OVF in Japan. However, the effect might be blunted in patients aged > 80 years. Further research is necessary to elucidate the cost-effectiveness of BKP in this population. LEVEL OF EVIDENCE: 4.

Is it Beneficial to Reuse the Balloon in Percutaneous Kyphoplasty for the Treatment of Non-Neoplastic Vertebral Compression Fractures?

BACKGROUND Percutaneous kyphoplasty (PKP) has been widely used to treat vertebral compression fractures (VCFs). Bilateral percutaneous punctures are always performed to access the fractured vertebrae. However, the procedure has expensive clinical costs, especially the cost for the device, which creates a heavy financial burden for patients. MATERIAL AND METHODS Data from 49 patients who have single-level non-neoplastic vertebral compression fracture (VCF) were collected for 12 months after treated by PKP, including 21 cases that used bilateral puncture with single balloon (S group) and 28 cases that used bilateral puncture with double balloon (D group). We assessed the clinical (visual analogue scale, VAS) and radiological (vertebral height and kyphotic angle, KA) outcomes. Cost data (gross medical cost, cost for the device and cost for drugs) were obtained from the medical bill of each patient. RESULTS Baseline patient variables were similar between the two groups except the compensation (S group

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.

Single-balloon versus double-balloon bipedicular kyphoplasty for osteoporotic vertebral compression fractures.

Twenty-eight patients with osteoporotic vertebral compression fractures (OVCF) were treated with single-balloon bipedicular kyphoplasty (Group A), and 40 patients were treated with double-balloon bipedicular kyphoplasty (Group B). Visual Analogue Scale (VAS) score, vertebral height, and kyphotic angle (KA) were evaluated pre-operatively, post-operatively (3 days after surgery) and at final follow-up. Operative time, X-ray exposure frequency and costs were recorded. The mean operative time and X-ray exposure frequency in Group A were greater than in Group B (p<0.05). Significant improvement of the VAS score was noted in each group, and remained unchanged at final follow-up. Mean increases of anterior and middle height of the fractured vertebral body were 5.14mm and 4.14mm in Group A, respectively, and 6.22mm and 5.06mm in Group B, respectively, and the differences between the groups were statistically significant (p<0.05). Mean reduction of KA was 6.9° in Group A and 8.8° in Group B, which was statistically significant (p<0.05). No statistically significant difference was observed in terms of cement leakage between groups. The mean cost of Group A (US$4202) was significantly less than that of Group B (US$6220) (p<0.001). Single-balloon bipedicular kyphoplasty is a safe and cost-effective surgical method for the treatment of OVCF. It can achieve pain relief comparable with double-balloon bipedicular kyphoplasty. However, double-balloon bipedicular kyphoplasty is more efficacious in terms of the restoration of vertebral height and reduction of KA, and the operative time and X-ray exposure frequency are lower.

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.

[Clinical cost analysis of balloon kyphoplasty--is there a possibility of cost-covering treatment?]. / Klinische Kostenanalyse der Ballonkyphoplastie--ist eine kostendeckende Durchführung möglich?

Financial pressure on hospitals has been a major issue in the health care system of the past years and the financial situation is often what decides about the future of the hospitals. Therefore today the economic feasibility of patient treatment in hospitals is more important than ever before. After the degradation of the case-based lump sum of I09D to I09F on a one and two level kyphoplasty we took that as motivation to do a cost analysis on 10 randomised cases. The average age of the patients was 75 years (m : f = 2 : 8), the average stay in hospital was 8 days (3-12 d). The analysis was done by a searching of documents in cooperation with the firm GFG-Beratungsgesellschaft mbH (Mönchengladbach, Germany). We found that the average overall cost which includes the cost of hospital stay and the expenditure on material was 7512.53 € and the average earnings of the cases was 7610,97 €, the difference and in that way the proceeds was 98.44 €. On that result performance of a one-level kyphoplasty especially after the degradation of the case-based lump sum in 2013 is possible in a cost-covering way, an increase in profit may be possible by a decrement of hospital stay. In 2014 one- and two-stage kyphoplasty once underwent a reduction of G-DRG from I09F to I09E. At the same time the cost weight of lump compensation I09E was increased by 0.071 with the result that in 2014, with an increased federal base value of 3156.82 € (in 2013 the federal base rate value was 3068.37 €), additional proceeds of 404,92 € can be realised in the field of one- and two-stage kyphoplasty compared to in 2013. On that result a one-level kyphoplasty especially after the degradation of the case-based lump sum in 2013 and in 2014 is possible in a cost-covering manner, an increase in profit may be possible by a decrement of hospital stay.

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.

Kyphopasty and vertebroplasty.

Vertebroplasty and balloon kyphoplasty are percutaneous techniques performed under radioscopic control. They were initially developed for tumoral and osteoporotic lesions; indications were later extended to traumatology for the treatment of pure compression fracture. They are an interesting alternative to conventional procedures, which are often very demanding. The benefit of these minimally invasive techniques has been demonstrated in terms of alleviation of pain, functional improvement and reduction in both morbidity and costs for society. The principle of kyphoplasty is to restore vertebral body anatomy gently and progressively by inflating balloons and then reinforcing the anterior column of the vertebra with cement. In vertebroplasty, cement is introduced directly under pressure, without prior balloon inflation. Both techniques can be associated to minimally invasive osteosynthesis in certain indications. In our own practice, we preferably use acrylic cement, for its biomechanical properties and resistance to compression stress. We use calcium phosphate cement in young patients, but only associated to percutaneous osteosynthesis due to the risk of secondary correction loss. The evolution of these techniques depends on improving personnel radioprotection and developing new systems of vertebral expansion.

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.