Cost-Utility Analysis of rhBMP-2 Use in Adult Spinal Deformity Surgery.

STUDY DESIGN: Economic modeling of data from a multicenter, prospective registry. OBJECTIVE: The aim of this study was to analyze the cost utility of recombinant human bone morphogenetic protein-2 (BMP) in adult spinal deformity (ASD) surgery. SUMMARY OF BACKGROUND DATA: ASD surgery is expensive and presents risk of major complications. BMP is frequently used off-label to reduce the risk of pseudarthrosis. METHODS: Of 522 ASD patients with fusion of five or more spinal levels, 367 (70%) had at least 2-year follow-up. Total direct cost was calculated by adding direct costs of the index surgery and any subsequent reoperations or readmissions. Cumulative quality-adjusted life years (QALYs) gained were calculated from the change in preoperative to final follow-up SF-6D health utility score. A decision-analysis model comparing BMP versus no-BMP was developed with pseudarthrosis as the primary outcome. Costs and benefits were discounted at 3%. Probabilistic sensitivity analysis was performed using mixed first-order and second-order Monte Carlo simulations. One-way sensitivity analyses were performed by varying cost, probability, and QALY estimates (Alpha = 0.05). RESULTS: BMP was used in the index surgery for 267 patients (73%). The mean (±standard deviation) direct cost of BMP for the index surgery was $14,000 ±â€Š$6400. Forty patients (11%) underwent revision surgery for symptomatic pseudarthrosis (BMP group, 8.6%; no-BMP group, 17%; P = 0.022). The mean 2-year direct cost was significantly higher for patients with pseudarthrosis ($138,000 ±â€Š$17,000) than for patients without pseudarthrosis ($61,000 ±â€Š$25,000) (P < 0.001). Simulation analysis revealed that BMP was associated with positive incremental utility in 67% of patients and considered favorable at a willingness-to-pay threshold of $150,000/QALY in >52% of patients. CONCLUSION: BMP use was associated with reduction in revisions for symptomatic pseudarthrosis in ASD surgery. Cost-utility analysis suggests that BMP use may be favored in ASD surgery; however, this determination requires further research. LEVEL OF EVIDENCE: 2.

Quality of Life and Cost Implications of Pseudarthrosis After Anterior Cervical Discectomy and Fusion and its Subsequent Revision Surgery.

BACKGROUND: More than 120,000 anterior cervical discectomy and fusions (ACDFs) are performed annually. Pseudarthrosis is a potential delayed adverse event that affects up to 33% of patients. The degree to which this adverse event affects both patient quality-of-life (QOL) outcomes and health care costs is poorly understood. METHODS: Patients who underwent revision surgery for pseudarthrosis between 2007 and 2012 were identified and matched to controls not experiencing pseudarthrosis in a 1:2 fashion (case/control). Cases and controls were compared regarding total health care costs incurred in the year after the index ACDF and QOL outcomes on the following metrics: EuroQol Five-Dimensions Questionnaire, Patient Health Questionnaire-9, and Pain Disability Questionnaire. RESULTS: Of 738 patients who underwent ACDF, 11 underwent surgery for pseudarthrosis. No differences were noted between cases and controls regarding any of the matched variables. Patients in the pseudarthrosis cohort had poorer postoperative scores on the EuroQol Five-Dimensions Questionnaire mobility, usual activities, pain/discomfort, and quality-adjusted life-year dimensions. In addition, 64% of patients with pseudarthrosis had worsened quality-adjusted life-year scores compared with only 9% of controls (P < 0.01). Patients with pseudarthrosis also had poorer mental health (P < 0.01) and pain disability outcomes (P < 0.01) than did controls. Pseudarthrosis was associated with significant increases in direct costs, direct postoperative costs, and total costs (all P < 0.01). CONCLUSIONS: This is the first study to characterize the effect of surgical revision for pseudarthrosis on both QOL outcomes and care costs after ACDF. Patients requiring revision experienced significantly poorer QOL outcomes and higher care costs relative to controls.

[Pseudarthroses of the long bones]. / Pseudarthrosen der langen Röhrenknochen.

Pseudarthrosis development is dependent on the presence of individual risk factors in approximately 10% as a result of fractures and are more frequently located in the region of the long bones. The development of non-union regularly results in prolonged pain and reduced functionality of the affected limb. The resulting clearly increased socioeconomic costs are caused by the complex operative treatment strategies and increased indirect costs, which include lost wages, social benefits and compensation. Altogether, non-unions require a differentiated therapeutic treatment strategy. The analysis of the non-union based on the diamond concept is the key for a successful planning and therapy. In this context, the use of focused, high-energy extracorporeal shock waves may be possible under specific circumstances; however, in most cases an operative revision is necessary to optimize the biomechanical stability and/or improve the local biology.

Cost per quality-adjusted life year gained of revision fusion for lumbar pseudoarthrosis: defining the value of surgery.

STUDY DESIGN: Single cohort study of patients undergoing revision fusion for lumbar pseudoarthrosis. OBJECTIVE: To assess the 2-year comprehensive costs of revision arthrodesis for lumbar pseudoarthrosis at our institution and determine the associated cost per quality-adjusted life year (QALY) gained in this patient population. SUMMARY OF BACKGROUND DATA: The proportion of lumbar spine operations involving a fusion procedure has increased over the past 2 decades. Similarly, there has been a corresponding increase in the incidence and prevalence of pseudoarthrosis. However, the cost-effectiveness of revision surgery for pseudoarthrosis-associated back pain has yet to be examined. METHODS: Forty-seven patients undergoing revision instrumented arthrodesis for pseudoarthrosis-associated back pain were included. Two-year total back-related medical resource utilization, missed work, and health-state values (QALYs, calculated from EuroQuol 5D with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts (direct cost) and patient and care-giver work-day losses were multiplied by the self-reported gross-of-tax wage rate (indirect cost). The mean total 2-year cost per QALY gained after revision surgery was assessed. RESULTS: The mean (±SD) duration of time between prior fusion and development of symptomatic pseudoarthrosis was 2.69±3.09 years. None of the patients developed symptomatic pseudoarthrosis after 2 years of revision surgery. A mean cumulative 2-year gain of 0.35 QALYs was reported. The mean (±SD) total 2-year cost of revision fusion was $41,631±$9691 (surgery cost: $23,865±$270; outpatient resource utilization cost: $4885±$2301; indirect cost: $12,879±$8171). Revision instrumented arthrodesis was associated with a mean 2-year cost per QALY gained of $118,945. CONCLUSIONS: Revision arthrodesis was associated with improved 2-year quality of life in patients with pseudoarthrosis-related back pain. Nevertheless, in our experience revision surgery was shown to be marginally cost-effective at $118,945 per QALY gained.

Revision lumbar surgery in elderly patients with symptomatic pseudarthrosis, adjacent-segment disease, or same-level recurrent stenosis. Part 2. A cost-effectiveness analysis: clinical article.

OBJECT: Despite advances in technology and understanding in spinal physiology, reoperation for symptomatic adjacent-segment disease (ASD), same-level recurrent stenosis, and pseudarthrosis in elderly patients continues to occur. While revision lumbar surgery is effective, attention has turned to questions on the utility and value of the revision decompression and fusion procedure. To date, an analysis of the cost and health state gain associated with revision lumbar surgery in elderly patients with symptomatic pseudarthrosis, ASD, or same-level recurrent lumbar stenosis has yet to be performed. The aim of this study was to assess the long-term outcomes and cost-effectiveness of revision surgery in elderly patients with recurrent or persistent back and leg pain. METHODS: After reviewing their institutional database, the authors found 69 patients 65 years of age and older who had undergone revision decompression and instrumented fusion for back and leg pain associated with pseudarthrosis (17 patients), same-level recurrent stenosis (24 patients), or ASD (28 patients) and included them in this study. Total 2-year back-related medical resource utilization and health state values (quality-adjusted life years [QALYs], calculated from the EQ-5D, the EuroQol-5D health survey, with US valuation) were assessed. Two-year resource use was multiplied by unit costs based on Medicare national allowable payment amounts. The mean total 2-year cost per QALY gained after revision surgery was assessed. RESULTS: The mean (± standard deviation) time between the index surgery and revision surgery was 3.51 ± 3.63 years. A mean cumulative 2-year gain of 0.35 QALY was observed after revision surgery. The mean total 2-year cost of revision surgery was $28,256 ± $3000 (ASD: $28,829 ± $3812, pseudarthrosis: $28,069 ± $2508, same-level recurrent stenosis: $27,871 ± $2375). Revision decompression and extension of fusion was associated with a mean 2-year cost of $80,594 per QALY gained. CONCLUSIONS: Revision decompression and fusion provided a significant gain in health state utility for elderly patients with symptomatic pseudarthrosis, same-level recurrent stenosis, or ASD, with a mean 2-year cost of $80,594 per QALY gained. When indicated, revision surgery for symptomatic ASD, same-level recurrent stenosis, and pseudarthrosis is a valuable treatment option for elderly patients experiencing persistent back and leg pain. Findings in this study provided a value measure of surgery that can be compared with future cost-per-QALY-gained studies of medical management or alternative surgical approaches.

Factors influencing 2-year health care costs in patients undergoing revision lumbar fusion procedures.

OBJECT: Revision lumbar fusion procedures are technically challenging and can be associated with tremendous health care resource utilization and cost. There is a paucity of data regarding specific factors that significantly contribute to increased cost of care. In light of this, the authors set out to identify independent risk factors predictive of increasing 2-year direct health care costs after revision lumbar fusion. METHODS: One hundred fifty patients undergoing revision instrument-assisted fusion for adjacent-segment disease (50 cases), pseudarthrosis (47 cases), or same-level stenosis (53 cases) were included in this study. Patient demographics, comorbidities, preoperative health states as assessed by patient-reported outcome questionnaires and perioperative complications were collected and analyzed. Two-year back-related medical resource utilization and direct health care costs were assessed. The independent association of all variables to increasing cost was assessed using multivariate linear regression analysis. RESULTS: There was a wide range ($24,935-$63,769) in overall 2-year direct costs for patients undergoing revision lumbar fusion (mean $32,915 ± $8344 [± SD]). Preoperative variables independently associated with 2-year direct health care costs included diagnosis of congestive heart failure, more severe leg pain (visual analog scale), greater back-related disability (Oswestry Disability Index), and worse mental health (12-Item Short Form Health Survey Mental Component Summary score). There was a 1.1- to 1.2-fold increase in cost for patients in the greatest quartiles compared with those in the lowest quartiles for these variables. Surgical site infection, return to the operating room, and spine-related hospital readmission during the 90-day global health period were postoperative variables independently associated with 2-year cost. Patients in the greatest versus lowest quartiles had a 1.7- to 1.9-fold increase in cost for these variables. CONCLUSIONS: Revision lumbar fusion can be associated with considerable 2-year health care costs. These costs can also vary widely among patients, as evidenced by the 2.6-fold overall cost range in this series. Although comorbidities and preoperative severity of disease states contribute to cost of care, the primary drivers of increased cost include perioperative complications such as surgical site infection, return to the operating room, and readmission during the global health period. Measures focused on health service improvement will be most successful in reducing the cost of care for patients undergoing revision lumbar fusion.

Cost analysis of three different surgical procedures for treatment of a pelvic tumour.

INTRODUCTION: Malignant pelvic tumours are rare, but adequate treatment is difficult because of anatomical and functional reasons. Different surgical procedures are recommended. Besides aspects influencing the quality of life due to the different surgical techniques, costs of these surgical procedures and the perioperative time interval, depending on the chosen surgical procedure, must also be considered. METHODS: Costs of three kinds of surgical treatment - internal hemipelvectomy vs external hemipelvectomy and application of an orthotic device vs ilio-femoral pseudoarthrosis - were compared, including costs of the immediate period of rehabilitation. Costs of the preoperative diagnostic procedure were excluded because they were assumed to be equal. For all calculations, treatment of a periacetabular pelvic tumour type II-b was assumed, according to the Enneking classification, with the need for a pelvic resection with wide margins including removal of the hipjoint. This analysis was performed based on the average costs per hour of physicians, nurses and physiotherapists, including a basic daily rate for additional costs, such as housekeeping and administrative costs of the hospital. In all cases, the costs of the operative procedure and the perioperative period up to 3 months were calculated, including the costs for the endoprosthetic device after internal hemipelvectomy and those for the orthotic devices after necessary external hemipelvectomy. RESULTS: For a postoperative period of 3 months, the cost for treatment with resection of the tumour and performing an ilio-femoral pseudoarthrosis is nearly DM 56,741.54; treatment with an internal hemipelvectomy including the endoprosthetic pelvic replacement costs DM 81,439.34; and treatment with external hemipelvectomy and application of an orthotic device with a pelvic cage costs DM 69,138.46. In this analysis, social costs due to the different rates of disability for years or costs of a new prosthetic device after years and aspects related to resulting quality of life were excluded. In contrast, costs of three different actual cases can differ significantly from the estimated costs. The most important influencing items are surgical implants, blood units and similar products, and surgical treatment of postoperative complications. CONCLUSIONS: Regarding all these aspects, limb salvage seems to be advantageous over amputation. Whether an ileo-femoral pseudoarthrosis or endoprosthetic pelvic replacement should be performed is a decision that should be made by the physicians. based on the underlying diagnosis and the correlated expected survival. Furthermore, additional factors probably reducing the rate of postoperative complications, such as infections or necrosis following radiotherapy and being summarised under the term "quality of life", should also be regarded.