A large database study of hospitalization charges and follow-up re-admissions in US lumbar fusion surgeries using a cellular bone allograft (CBA) versus recombinant human bone morphogenetic protein-2 (rhBMP-2)

Bradley Wetzell, Julie B McLean, Mark A Moore, Venkateswarlu Kondragunta, Kimberly Dorsch, Bradley Wetzell, Julie B McLean, Mark A Moore, Venkateswarlu Kondragunta, Kimberly Dorsch

Abstract

Background: The objective of this study was to retrospectively compare initial procedure and 12-month follow-up hospitalization charges and resource utilization (lengths of stay; LOS) for lumbar fusion surgeries using either recombinant human bone morphogenetic protein-2 (rhBMP-2) or a cellular bone allograft comprised of viable lineage-committed bone cells (V-CBA) via a large US healthcare system database. Potentially relevant re-admissions during the follow-up period were also assessed.

Methods: A total of 16,172 patients underwent lumbar fusion surgery using V-CBA or rhBMP-2, of whom 3503 (21.66%) patients had follow-up re-admission data. Initial patient, procedure, and hospital characteristics were assessed to determine confounding factors. Multivariate regression modeling compared differences in hospitalization charges (in 2018 US dollars) and LOS (in days) between the groups, as well as incidences of potentially relevant re-admissions during the 12-month follow-up period.

Results: The adjusted mean initial procedure and 12-month follow-up hospital charges were significantly lower in the V-CBA group versus the rhBMP-2 group ($109,061 and $108,315 versus $160,191 and $130,406, respectively; P < 0.0001 for both comparisons). This disparity remained in an ad hoc comparison of charges for initial single-level treatments only (V-CBA = $103,064, rhBMP-2 = $149,620; P < 0.0001). The adjusted mean initial LOS were significantly lower in the V-CBA group (3.77 days) versus the rhBMP-2 group (3.88 days; P < 0.0001), but significantly higher for the cumulative follow-up hospitalizations in the 12-month follow-up period (7.87 versus 7.46 days, respectively; P < 0.0001). Differences in rates of follow-up re-admissions aligned with comorbidities at the initial procedure. Subsequent lumbar fusion rates were comparable, but significantly lower for V-CBA patients who had undergone single-level treatments only, in spite of V-CBA patients having significantly higher rates of initial comorbidities that could negatively impact clinical outcomes.

Conclusions: The results of this study indicate that use of V-CBA for lumbar fusion surgeries performed in the US may result in substantially lower overall hospitalization charges versus rhBMP-2, with both exhibiting similar rates of 12-month re-admissions and subsequent lumbar fusion procedures.

Keywords: CBA; Cellular bone allograft; Economics; Infuse; Lumbar fusion; Recombinant human bone morphogenetic protein-2; ViviGen; rhBMP-2.

Conflict of interest statement

BW, JBM, MAM, and KD are employees of LifeNet Health®, a non-profit organization, which funded the study. VK was an independent biostatistical consultant for LifeNet Health® in the preparation of this manuscript. However, potential bias was minimized through a study design where real-world data were obtained from a third-party database offered by Premier Healthcare Solutions, Inc. (Charlotte, NC), which allows for evidence- and population-based analyses of drugs, devices, other treatments, disease states, epidemiology, resource utilization, healthcare economics, and clinical outcomes.

Figures

Fig. 1
Fig. 1
Data-selection flow chart for patients who underwent lumbar fusion-related procedures using V-CBA or rhBMP-2 during the initial procedure. Data for patients re-admitted during the 12-month follow-up period did not include those who may have received follow-up treatment outside of the Premier Healthcare System
Fig. 2
Fig. 2
Adjusted mean initial procedure and follow-up hospital charges (95% CIs) were significantly lower with V-CBA versus rhBMP-2. **P < 0.0001. Multivariate regression models were adjusted with the following confounding factors as covariates: race, ethnicity, Charlson comorbidity index, health insurance status, initial admission type, initial admission source, initial discharge status, cage insertion, multiple levels treated, hospital size, hospital teaching status, hospital population served, and hospital region. Data for patients re-admitted during the 12-month follow-up period did not include those who may have received follow-up treatment outside of the Premier Healthcare System
Fig. 3
Fig. 3
Adjusted mean initial procedure hospital charges (95% CIs) for single-level lumbar fusion surgeries only were significantly lower with V-CBA versus rhBMP-2. **P < 0.0001. Multivariate regression models were adjusted with the following confounding factors as covariates: race, ethnicity, Charlson comorbidity index, health insurance status, initial admission type, initial admission source, initial discharge status, cage insertion, hospital size, hospital teaching status, hospital population served, and hospital region

References

    1. Buser Z, Ortega B, D’Oro A, et al. Spine degenerative conditions and their treatments: national trends in the United States of America. Glob Spine J. 2018;8(1):57–67.
    1. Rosenthal NA, Heinrich KH, Chung J, Yu H. Cost and hospital resource utilization of Staphylococcus aureus infection post elective posterior instrumented spinal fusion surgeries in US Hospitals: a retrospective cohort study. Spine (Phila Pa 1976) 2019;44(9):637.
    1. Khan SN, Cammisa FP, Jr, Sandhu HS, Diwan AD, Girardi FP, Lane JM. The biology of bone grafting. J Am Acad Orthop Surg. 2005;13(1):77–86.
    1. Younger EM, Chapman MW. Morbidity at bone graft donor sites. J Orthop Trauma. 1989;3(3):192–195.
    1. Lykissas M, Gkiatas I. Use of recombinant human bone morphogenetic protein-2 in spine surgery. World J Orthop. 2017;8(7):531.
    1. Cahill KS, Chi JH, Day A, Claus EB. Prevalence, complications, and hospital charges associated with use of bone-morphogenetic proteins in spinal fusion procedures. Jama. 2009;302(1):58–66.
    1. Lao L, Cohen JR, Lord EL, Buser Z, Wang JC. Trends analysis of rhBMP utilization in single-level posterior lumbar fusion (PLF) in the United States. Eur Spine J. 2016;25(3):783–788.
    1. Walker B, Koerner J, Sankarayanaryanan S, Radcliff K. A consensus statement regarding the utilization of BMP in spine surgery. Curr Rev Musculoskelet Med. 2014;7(3):208–219.
    1. Epstein NE. Complications due to the use of BMP/INFUSE in spine surgery: the evidence continues to mount. Surg Neurol Int. 2013;4(Suppl 5):S343.
    1. Fu R, Selph S, McDonagh M, et al. Effectiveness and harms of recombinant human bone morphogenetic protein-2 in spine fusion: a systematic review and meta-analysis. Ann Intern Med. 2013;158(12):890–902.
    1. Zhang H, Wang F, Ding L, et al. A meta analysis of lumbar spinal fusion surgery using bone morphogenetic proteins and autologous iliac crest bone graft. PLoS One. 2014;9(6):e97049.
    1. Alvin MD, Derakhshan A, Lubelski D, et al. Cost-utility analysis of 1-and 2-level dorsal lumbar fusions with and without recombinant human bone morphogenic protein-2 at 1-year follow-up. J Spinal Disord Techn. 2016;29(1):E28–E33.
    1. Jain A, Yeramaneni S, Kebaish KM, et al. Cost-utility analysis of rhBMP-2 use in adult spinal deformity surgery. Spine (Phila Pa 1976). 2020;45(14):1009-15.
    1. Epstein NE. Pros, cons, and costs of INFUSE in spinal surgery. Surg Neurol Int. 2011;2:10.
    1. Magnus MK, Iceman KL, Roukis TS. Living cryopreserved bone allograft as an adjunct for hindfoot arthrodesis. Clin Podiatr Med Surg. 2018;35(3):295–310.
    1. Hall JF, McLean JB, Jones SM, Moore MA, Nicholson MD, Dorsch KA. Multilevel instrumented posterolateral lumbar spine fusion with an allogeneic cellular bone graft. J Orthop Surg Res. 2019;14(1):372.
    1. Corso KA, Etter K, Menzie AM, Bhattacharyya S, Pracyk JB. Characteristics and rate of subsequent lumbar spine fusion surgery among patients treated with allogenic cellular bone matrix for posterior lumbar spinal fusion. Value in Health. 2018;21:S106.
    1. Birmingham E, Niebur G, McHugh PE. Osteogenic differentiation of mesenchymal stem cells is regulated by osteocyte and osteoblast cells in a simplified bone niche. Eur Cells Mater. 2012;23:13–27.
    1. Ghanaati S, Unger RE, Webber MJ, et al. Scaffold vascularization in vivo driven by primary human osteoblasts in concert with host inflammatory cells. Biomaterials. 2011;32(32):8150–8160.
    1. Tortelli F, Tasso R, Loiacono F, Cancedda R. The development of tissue-engineered bone of different origin through endochondral and intramembranous ossification following the implantation of mesenchymal stem cells and osteoblasts in a murine model. Biomaterials. 2010;31(2):242–249.
    1. Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, Office of Combination Products. Regulatory considerations for human, cells, tissues, and cellular and tissue-based products: minimal manipulation and homologous use. Guidance for Industry and Food and Drug Administration Staff. In: US Department of Health and Human Services, Food and Drug Administration, eds. December ed 2017.
    1. Premier Healthcare Database: Data that informs and performs. 2018. Available at: . Accessed September 2018.
    1. Quan H, Sundararajan V, Halfon P, et al. Coding algorithms for defining comorbidities in ICD-9-CM and ICD-10 administrative data. Med Care. 2005;43(11):1130-9.
    1. Charlson M, Szatrowski TP, Peterson J, Gold J. Validation of a combined comorbidity index. J Clin Epidemiol. 1994;47(11):1245–1251.
    1. Glassman SD, Carreon LY, Campbell MJ, et al. The perioperative cost of Infuse bone graft in posterolateral lumbar spine fusion. Spine J. 2008;8(3):443–448.
    1. Glassman SD, Carreon LY, Djurasovic M, et al. RhBMP-2 versus iliac crest bone graft for lumbar spine fusion: a randomized, controlled trial in patients over sixty years of age. Spine (Phila Pa 1976) 2008;33(26):2843–2849.
    1. Safaee MM, Dalle Ore CL, Zygourakis CC, Deviren V, Ames CP. Estimating a price point for cost-benefit of bone morphogenetic protein in pseudarthrosis prevention for adult spinal deformity surgery. J Neurosurg Spine. 2019;30(6):814–821.
    1. Medtronic Sofamor Danek USA Inc. Infuse bone graft: instructions for use. 2020. Document #0381204E Rev.D. Available from: . Accessed August 2020.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi