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      Budget Impact Analysis of Minimally Invasive versus Open Transforaminal Lumbar Interbody Fusion for Lumbar Degenerative Disease: A European Hospital Perspective

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          Abstract

          Purpose

          When traditional therapies fail to provide relief from debilitating lower back pain, surgeries such as transforaminal lumbar interbody fusion (TLIF) may be required. This budget impact analysis (BIA) compared minimally-invasive (MI)-TLIF versus open (O)-TLIF for single-level fusion from an Italian hospital perspective.

          Methods

          The BIA compared costs of 100 MI-TLIF and 100 O-TLIF procedures from an Italian hospital perspective over a one-year time horizon. The base case included costs for length of hospital stay (LOS), blood loss, and sterilizing surgical trays. The scenario analysis also included operating room (OR) time and complication costs. Base case inputs were from the Miller et al meta-analysis; scenario analysis inputs were from the Hammad et al meta-analysis. The device costs for MI-TLIF and O-TLIF procedures were from Italian tender prices for Viper Prime™ System and Expedium™ Spine System, respectively.

          Results

          Base case deterministic analysis results showed cost savings of €207,370 for MI-TLIF compared with O-TLIF. MI-TLIF costs were lower for LOS (€215,277), transfusion for blood loss (€16,881), and surgical tray sterilization (€28,232), whereas device costs were lower for O-TLIF (€53,020). The probabilistic result was similar, with MI-TLIF resulting in savings of €211,026 (95% credible interval [CR]: €208,725 – €213,327). All 1000 base case probabilistic sensitivity analysis runs were cost saving. Deterministic scenario analysis results showed cost savings of €166,719 for MI-TLIF. MI-TLIF costs were lower for LOS (€190,813), transfusion for blood loss (€16,881), surgical tray sterilization (€28,232), and complications (€2076), whereas O-TLIF costs were lower for OR time (€18,263) and devices used (€53,020).

          Conclusion

          Despite the increase incremental cost for medical device innovation and OR time, this study demonstrates the economic savings of MI-TLIF compared to O-TLIF from a European hospital perspective. The findings will be useful to policy and hospital decision makers in assessing purchasing, funding and reimbursement decisions.

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          Most cited references39

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          Lumbar interbody fusion: techniques, indications and comparison of interbody fusion options including PLIF, TLIF, MI-TLIF, OLIF/ATP, LLIF and ALIF.

          Degenerative disc and facet joint disease of the lumbar spine is common in the ageing population, and is one of the most frequent causes of disability. Lumbar spondylosis may result in mechanical back pain, radicular and claudicant symptoms, reduced mobility and poor quality of life. Surgical interbody fusion of degenerative levels is an effective treatment option to stabilize the painful motion segment, and may provide indirect decompression of the neural elements, restore lordosis and correct deformity. The surgical options for interbody fusion of the lumbar spine include: posterior lumbar interbody fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), minimally invasive transforaminal lumbar interbody fusion (MI-TLIF), oblique lumbar interbody fusion/anterior to psoas (OLIF/ATP), lateral lumbar interbody fusion (LLIF) and anterior lumbar interbody fusion (ALIF). The indications may include: discogenic/facetogenic low back pain, neurogenic claudication, radiculopathy due to foraminal stenosis, lumbar degenerative spinal deformity including symptomatic spondylolisthesis and degenerative scoliosis. In general, traditional posterior approaches are frequently used with acceptable fusion rates and low complication rates, however they are limited by thecal sac and nerve root retraction, along with iatrogenic injury to the paraspinal musculature and disruption of the posterior tension band. Minimally invasive (MIS) posterior approaches have evolved in an attempt to reduce approach related complications. Anterior approaches avoid the spinal canal, cauda equina and nerve roots, however have issues with approach related abdominal and vascular complications. In addition, lateral and OLIF techniques have potential risks to the lumbar plexus and psoas muscle. The present study aims firstly to comprehensively review the available literature and evidence for different lumbar interbody fusion (LIF) techniques. Secondly, we propose a set of recommendations and guidelines for the indications for interbody fusion options. Thirdly, this article provides a description of each approach, and illustrates the potential benefits and disadvantages of each technique with reference to indication and spine level performed.
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            Open versus minimally invasive TLIF: literature review and meta-analysis

            Study design This study is a comparative, literature review. Objective The aim of this study is to provide a comparative analysis of open vs. minimally invasive TLIF using a literature review and a meta-analysis. Summary of background data Lumbar interbody fusion is a well-established surgical procedure for treating several spinal disorders. Transforaminal lumbar interbody fusion (TLIF) was initially introduced in the early 1980s. To reduce approach-related morbidity associated with traditional open TLIF (OTLIF), minimally invasive TLIF (MITLIF) was developed. We aimed to provide a comparative analysis of open vs. minimally invasive TLIF using a literature review. Methods We searched the online database PubMed (2005–2017), which yielded an initial 194 studies. We first searched the articles’ abstracts. Based on our inclusion criteria, we excluded 162 studies and included 32 studies: 18 prospective, 13 retrospective, and a single randomized controlled trial. Operative time, blood loss, length of hospital stay, radiation exposure time, complication rate, and pain scores (visual analogue scale, Oswestry Disability Index) for both techniques were recorded and presented as means. We then performed a meta-analysis. Results The meta-analysis for all outcomes showed reduced blood loss (P < 0.00001) and length of hospital stay (P < 0.00001) for MITLIF compared with OTLIF, but with increased radiation exposure time with MITLIF (P < 0.00001). There was no significant difference in operative time between techniques (P = 0.78). The complication rate was lower with MITLIF (11.3%) vs. OTLIF (14.2%), but not statistically significantly different (P = 0.05). No significant differences were found in visual analogue scores (back and leg) and Oswestry Disability Index scores between techniques, at the final follow-up. Conclusion MITLIF and OTLIF provide equivalent long-term clinical outcomes. MITLIF had less tissue injury, blood loss, and length of hospital stay. MITLIF is also a safe alternative in obese patients and, in experienced hands, can also be used safely in select cases of spondylodiscitis even with epidural abscess. MITLIF is also a cost-saving procedure associated with reduced hospital and social costs. Long-term studies are required to better evaluate controversial items such as operative time.
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              Trends in hospital admissions and surgical procedures for degenerative lumbar spine disease in England: a 15-year time-series study

              Objectives Low back pain (LBP), from degenerative lumbar spine disease, represents a significant burden on healthcare resources. Studies worldwide report trends attributable to their country's specific demographics and healthcare system. Considering England's specific medico-socioeconomic conditions, we investigate recent trends in hospital admissions and procedures for LBP, and discuss the implications for the allocation of healthcare resources. Design Retrospective cohort study using Hospital Episode Statistics data relating to degenerative lumbar spine disease in England, between 1999 and 2013. Regression models were used to analyse trends. Outcome measures Trends in the number of admissions and procedures for LBP, mean patient age, gender and length of stay. Results Hospital admissions and procedures have increased significantly over the study period, from 127.09 to 216.16 and from 24.5 to 48.83 per 100 000, respectively, (p<0.001). The increase was most marked in the oldest age groups with a 1.9 and 2.33-fold increase in admissions for patients aged 60–74 and ≥75 years, respectively, and a 2.8-fold increase in procedures for those aged ≥60 years. Trends in hospital admissions were characterised by a widening gender gap, increasing mean patient age, and decreasing mean hospital stay (p<0.001). Trends in procedures were characterised by a narrowing gender gap, increasing mean patient age (p=0.014) and decreasing mean hospital stay (p<0.001). Linear regression models estimate that each hospital admission translates to 0.27 procedures, per 100 000 (95% CI 0.25 to 0.30, r 0.99, p<0.001; r, Pearson's correlation coefficient). Hospital admissions are increasing at 3.5 times the rate of surgical procedures (regression gradient 7.63 vs 2.18 per 100 000/year). Conclusions LBP represents a significant and increasing workload for hospitals in England. These trends demonstrate an increasing demand for specialists involved in the surgical and non-surgical management of this disease, and highlight the need for services capable of dealing with the increased comorbidity burden associated with an ageing patient group.
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                Author and article information

                Journal
                Clinicoecon Outcomes Res
                Clinicoecon Outcomes Res
                ceor
                ClinicoEconomics and Outcomes Research: CEOR
                Dove
                1178-6981
                18 January 2024
                2024
                : 16
                : 13-24
                Affiliations
                [1 ]II Spinal Surgery Unit, IRCCS Galeazzi-Sant’Ambrogio Hospital , Milano, Italy
                [2 ]Johnson and Johnson MedTech , Issy-les-Moulineaux, France
                [3 ]Johnson and Johnson MedTech , Pomezia, Italy
                [4 ]Johnson and Johnson MedTech , London, UK
                [5 ]EVERSANA , Burlington, Ontario, Canada
                Author notes
                Correspondence: George Wright, EVERSANA , 113-3228 South Service Road, Burlington, Ontario, L7N 3H8, Canada, Tel +1 513-827-3035, Email george.wright@eversana.com
                Author information
                http://orcid.org/0000-0002-7089-1203
                Article
                445141
                10.2147/CEOR.S445141
                10802124
                38259876
                f0815ad0-2565-4776-897e-7a0cd21d60e2
                © 2024 Bassani et al.

                This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms ( https://www.dovepress.com/terms.php).

                History
                : 20 October 2023
                : 29 December 2023
                Page count
                Figures: 4, Tables: 4, References: 44, Pages: 12
                Categories
                Original Research

                Economics of health & social care
                spine surgery,incremental cost,budget impact analysis,italy,medical device innovation,health economic model

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