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

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.

Improving perioperative management of surgical sets for trauma surgeries: the 4S approach.

BACKGROUND: The perioperative management of the surgical instruments and implants that comprise sets for trauma surgeries has been identified as a complex and resource-intensive activity due to non-standardized inventories, redundant surgical instruments and unnecessary sterilization cycles. The 4S Intelligent Trauma Care program aims to improve perioperative management and thereby reduce environmental impact by utilizing standardized inventories, a sterile implant portfolio, a barcode that enables a digital safety certification, and a digitized restocking service. OBJECTIVE: The objective of this study was to investigate the impact of the introduction of the 4S program for the management of surgical sets in open reduction internal fixation (ORIF) trauma surgeries. METHODS: This was a single-center, quality improvement study of ORIF trauma surgeries, comparing the current practice (30 procedures) to the procedure following the introduction of the 4S program (30 procedures). The primary outcome was the proportion of procedures requiring only one sterilization cycle. Secondary outcomes were the number of sterilization cycles per procedure, set processing time across departments, total set processing costs, number of missing or damaged implants, number of cleaning cycles per procedure, time taken to assemble containers for sterilization, number of containers entering the autoclave per procedure, environmental impact, number of baskets entering the cleaning machine per procedure, and staff satisfaction. RESULTS: Introduction of the 4S program resulted in a reduction in the mean number of sterilization cycles required from 2.1 to 1.0 (p < 0.001). In the current practice, only 30.0% of procedure sets were sterilized within one cycle, compared to 100.0% following introduction of the 4S program (p < 0.001). A reduction in the mean set processing time of 24.1% in the OR and 35.3% in the sterilization department was observed. Mean set processing costs for the current practice were €81.23, compared to €50.30 following introduction of the 4S program. Furthermore, following the introduction of the 4S program, procedures were associated with significant reductions in water and electricity usage, and increased staff satisfaction. CONCLUSIONS: This quality improvement study demonstrates the substantial time and cost savings, positive environmental impact and staff satisfaction that could be achieved by streamlining surgical set management through the 4S program. To our knowledge, this is the first study of this type and our findings may be instructive to other hospitals and surgical specialties.

SpaceOAR Hydrogel Spacer for Reducing Radiation Toxicity During Radiotherapy for Prostate Cancer. A Systematic Review.

OBJECTIVE: To evaluate the association between SpaceOAR and radiation dosing, toxicity and quality-of-life vs no spacer across all radiotherapy modalities for prostate cancer. METHODS: A systematic search of the Cochrane Central Register of Controlled Trials, MEDLINE, and Embase was performed from database inception through May 2020. Two reviewers independently screened titles/abstracts and full papers. Data extraction was performed, and quality assessed by 1 reviewer and checked by a second, using a third reviewer as required. The synthesis was narrative. RESULTS: 19 studies (3,622 patients) were included (only 1 randomized controlled trial, in image-guided intensity-modulated radiotherapy (IG-IMRT), 18 comparatives non-randomized controlled trials in external-beam radiotherapy (EBRT), brachytherapy, and combinations thereof). No hypofractionation studies were found. Regardless of radiotherapy type, SpaceOAR significantly reduced rectal radiation dose (eg, V40 average difference -6.1% in high dose-rate brachytherapy plus IG-IMRT to -9.1% in IG-IMRT) and reduced gastrointestinal and genitourinary toxicities (eg, late gastrointestinal toxicity 1% vs 6% (P = .01), late genitourinary toxicity of 15% vs 32% (P < .001) in stereotactic body radiotherapy). Improvements were observed in most Expanded Prostate Cancer Index Composite quality-of-life domains (eg, bowel function score decrease at 3 and 6 months: Average change of zero vs -6.25 and -3.57 respectively in low dose-rate brachytherapy plus EBRT). CONCLUSION: The randomized controlled trial in IG-IMRT demonstrated that SpaceOAR reduces rectal radiation dose and late gastrointestinal and genitourinary toxicities, with urinary, bowel, and sexual quality-of-life improvement. These advantages were verified in observational studies in various radiotherapy types. Further research is required in hypofractionation.