To compare local tumor progression (LTP) and overall survival (OS) after image-guided thermal ablation (IGTA; microwave/radiofrequency ablation) versus stereotactic body radiation therapy (SBRT) in patients with pulmonary metastases. A systematic literature review was performed to capture studies that used IGTA or SBRT for patients with pulmonary metastases and studies that reported one, two, and threeyear LTP/OS were included. Patients with pulmonary metastases, and a subgroup with metastases from colorectal or renal cell carcinoma, or sarcoma (termed subgroup) which are considered more radioresistant, were analyzed. Single-arm pooled analyses, univariable, and multivariable random-effects meta-regressions were conducted to compare LTP and OS between IGTA and SBRT treated patients. Analyses included 3,264 IGTA and 5,486 SBRT patients. IGTA patients with pulmonary metastases had higher LTP than SBRT patients at one year, 13

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 PrimeTM System and ExpediumTM Spine System, respectively.Results: Base case deterministic analysis results showed cost savings of euro207,370 for MI-TLIF compared with O-TLIF. MI-TLIF costs were lower for LOS (euro215,277), transfusion for blood loss (euro16,881), and surgical tray sterilization (euro28,232), whereas device costs were lower for O-TLIF (euro53,020). The probabilistic result was similar, with MI-TLIF resulting in savings of euro211,026 (95% credible interval [CR]: euro208,725 - euro213,327). All 1000 base case probabilistic sensitivity analysis runs were cost saving. Deterministic scenario analysis results showed cost savings of euro166,719 for MI-TLIF. MI-TLIF costs were lower for LOS (euro190,813), transfusion for blood loss (euro16,881), surgical tray sterilization (euro28,232), and complications (euro2076), whereas O-TLIF costs were lower for OR time (euro18,263) and devices used (euro53,020).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.

This correspondence has not been published previously and is not under consideration elsewhere. This correspondence is a reply to the following letter to the editor: Chow R, McMillan MT, Simone CB 2nd. Microwave Ablation for Early-Stage Non-Small Cell Lung Cancer: Don't Put the Cart Before the Stereotactic Horse. Lung Cancer. 2023 Nov;185:107382. https://doi.org/10.1016/j.lungcan.2023.107382. Epub 2023 Sep 23. PMID: 37757574.

For thirty years, the Harmonic scalpel has been used for precise dissection, sealing and transection. There are numerous meta-analyses on individual surgical procedures with Harmonic, but no overarching review covering all the areas. This umbrella review seeks to summarize the clinical results from the use of Harmonic across surgical fields and broadly quantify its effects on patient outcomes.MEDLINE, EMBASE, and Cochrane Databases were searched for meta-analyses (MAs) of randomized controlled trials (RCTs) comparing Harmonic devices to conventional techniques or advanced bipolar (ABP) devices. For each procedure type, the most comprehensive MAs were evaluated. RCTs not already analysed in a MA were also included. Operating time, length of stay, intraoperative blood loss, drainage volume, pain, and overall complications were evaluated, and the methodological quality and certainty of evidence were assessed.Twenty-four systematic literature reviews were identified on colectomy, hemorrhoidectomy, gastrectomy, mastectomy, flap harvesting, cholecystectomy, thyroidectomy, tonsillectomy, and neck dissection. There were also 83 RCTs included. In every MA evaluated, Harmonic devices were associated with either statistically significant or numerical improvements in every outcome compared with conventional techniques; most MAs reported a reduction in operating time of ≥ 25 min. Harmonic versus ABP device MAs in colectomy and thyroidectomy showed no significant differences in outcomes.Across surgical procedures, Harmonic devices demonstrated improved patient outcomes for operating time, length of stay, intraoperative bleeding, drainage volume, pain, and overall complications compared to conventional techniques. Additional studies are required to assess differences between Harmonic and ABP devices.

Rationale: Stereotactic body radiation therapy (SBRT) is the standard of care for inoperable early stage non-small cell lung cancer (NSCLC). Use of image guided thermal ablation (IGTA; including microwave ablation [MWA] and radiofrequency ablation [RFA]) has increased in NSCLC, however there are no studies comparing all three.Objective: To compare the efficacy of IGTA (including MWA and RFA) and SBRT for the treatment of NSCLC.Methods: Published literature databases were systematically searched for studies assessing MWA, RFA, or SBRT. Local tumor progression (LTP), disease-free survival (DFS), and overall survival (OS) were assessed with single-arm pooled analyses and meta-regressions in NSCLC patients and a stage IA subgroup. Study quality was assessed with a modified methodological index for non-randomized studies (MINORS) tool.Results: Forty IGTA study-arms (2,691 patients) and 215 SBRT study-arms (54,789 patients) were identified. LTP was lowest after SBRT at one and two years in single-arm pooled analyses (4% and 9% vs. 11% and 18%) and at one year in meta-regressions when compared to IGTA (OR = 0.2, 95% CI = 0.07-0.63). MWA patients had the highest DFS of all treatments in single-arm pooled analyses. In meta-regressions at two and three-years, DFS was significantly lower for RFA compared to MWA (OR = 0.26, 95% CI = 0.12-0.58; OR = 0.33, 95% CI = 0.16-0.66, respectively). OS was similar across modalities, timepoints, and analyses. Older age, male patients, larger tumors, retrospective studies, and non-Asian study region were also predictors of worse clinical outcomes. In high-quality studies (MINORS score & GE; 7), MWA patients had better clinical outcomes than the overall analysis. Stage IA MWA patients had lower LTP, higher OS, and generally lower DFS, compared to the main analysis of all NSCLC patients.Conclusions: NSCLC patients had comparable outcomes after SBRT and MWA, which were better than those with RFA.

BACKGROUND:Standard treatment for early-stage or locoregionally advanced non-small cell lung cancer (NSCLC) includes surgical resection. Recurrence after surgery is commonly reported, but a summary estimate for postsurgical recurrence-free survival (RFS) in patients with NSCLC is lacking. RESEARCH QUESTION:What is the RFS after surgery in patients with stage I-III NSCLC at different time points, and what factors are associated with RFS? STUDY DESIGN AND METHODS:A systematic search was performed in MEDLINE, EMBASE, and Cochrane databases between January 2011 and June 2021. The primary outcome was RFS at 1, 2, 3, and 5 years postresection. Single-arm, random-effects meta-analyses were done to calculate effect estimates and 95% CIs. Analyses were stratified by stage/substage as per the AJCC Cancer Staging Manual, and RFS was estimated (1) after pooling studies, using seventh or eighth edition staging criteria; and (2) among studies using only the eighth edition. Meta-regressions were performed to assess associations between RFS and patient demographic/clinical characteristics of interest. RESULTS:Data from 471 studies comprising 1,060 surgical study arms were extracted. RFS estimates from 60,695 patients staged with the seventh or eighth edition were analyzed. RFS ranged from 96% at 1 year postresection to 82% at 5 years for stage I, and from 68% at 1 year to 34% at 5 years for stage III. Estimates for patients staged using only eighth edition criteria were slightly higher. Older age, higher percentage of male patients, advancing stage, larger tumor size, and geographic region (North America/Europe vs Asia) were significantly associated with worse RFS. INTERPRETATION:This study presents a comprehensive assessment of reported RFS from published clinical literature, offering estimates at multiple postsurgical time points and by geographic region. Findings can inform treatment decisions, clinical trial design, and future research to improve outcomes among patients with NSCLC.

AIMS:Advanced energy devices are commonly used in electrosurgery, including ultrasonic and advanced bipolar (ABP) devices. Smoke evacuation and reusable dispersive electrodes are also utilized during electrosurgery to improve staff and patient safety. This study assessed the budget impact of adopting a portfolio of Ethicon energy devices compared to devices from other manufacturers from a Spanish hospital perspective. METHODS:The main analysis compared the Ethicon advanced energy device portfolio (ultrasonic and ABP devices) to Non-Ethicon advanced energy devices. It was assumed that 4,000 procedures using one advanced energy device each were performed annually, and the cost impact of operating room time, length of stay, and transfusions were considered. A probabilistic budget impact analysis with 10,000 iterations was conducted for generalizability to other hospitals in Spain and Europe. Secondary analysis assessed whether cost savings from the Ethicon advanced energy device portfolio could offset costs of adopting smoke evacuation and reusable dispersive electrodes (Full Ethicon energy portfolio). RESULTS:In the main analysis, the annual budget impact of introducing the Ethicon advanced energy device portfolio was cost saving in 79.8% of probabilistic iterations (mean: -€945,214; 95% credible interval [CrI]: -€3,242,710; €1,285,942) with a mean budget impact per procedure of -€236 (95% CrI: -€811; €321). In the secondary analysis, adding smoke evacuation and reusable dispersive electrodes was still cost saving in 75.3% of iterations compared to Non-Ethicon advanced energy devices (mean: -€778,208; 95% CrI: -€3,075,086; €1,464,728) with a mean budget impact per procedure of -€97 (95% CrI: -€384; €183). Savings resulted from differences in operating room time, length of hospital stay, and volume of disposable electrodes. CONCLUSIONS:Adopting Ethicon advanced energy devices demonstrated economic benefits compared to non-Ethicon devices. Introducing the advanced portfolio may improve surgical care quality and the full portfolio was cost saving while improving OR safety for staff and patients.

OBJECTIVE:To conduct a systematic review and meta-analysis comparing microwave ablation (MWA) and cryoablation for renal cell carcinoma (RCC). METHODS:The systematic search was performed in MEDLINE, Embase, and Cochrane databases. Studies published in English from January 2006 to February 2022 that assessed adults with primary RCC who received MWA or cryoablation were included. Study arms from RCTs, comparative observational, and single-arm studies were eligible. The outcomes included local tumor recurrence (LTR), overall survival, disease-free survival, overall/major complications, procedure/ablation time, 1- to 3-month primary technique efficacy, and technical success. Single-arm meta-analyses were performed using the random effects model. Sensitivity analyses excluding low-quality studies assessed using the MINORs scale were performed. Univariable and multivariable examined the effects of prognostic factors. RESULTS:Baseline characteristics were similar between groups and mean tumor size for MWA and cryoablation were 2.74 and 2.69 cm. Single-arm meta-analyses were similar for LTR and secondary outcomes between cryoablation and MWA. Ablation time was significantly shorter with MWA than with cryoablation (meta-regression weighted mean difference 24.55 minutes, 95% confidence interval -31.71, -17.38, P < .0001). One-year LTR was significantly lower with MWA than cryoablation (odds ratio 0.33, 95% confidence interval 0.10-0.93, P = .04). There were no significant differences for other outcomes. CONCLUSION:MWA provides significantly improved 1-year LTR and ablation time compared with cryoablation for patients with RCC. Other outcomes appeared similar or favorable for MWA; however, results were not statistically significant. MWA of primary RCC is as safe and effective as cryoablation, which should be confirmed with future comparative studies.

Budget impact models (BIM) for pharmaceuticals often follow a consistent structure; however, this is often not the case for medical devices given varying stakeholders, types of devices, settings of use, and data availability. Several costing perspectives may be relevant which necessitates additional considerations for model parameters to inform a cost-offset structure. The objective of this research is to illustrate these key methodological considerations within ophthalmology given the range of device types and costing perspectives.

Background In US hospitals, the liquid embolic systems (LESs) n-butyl cyanoacrylate (n-BCA) and ethylene vinyl alcohol copolymer (EVOH) are used for brain arteriovenous malformation (bAVM) embolization to achieve presurgical devascularization. The aim of this study was to perform an economic analysis comparing four techniques for bAVM embolization based on LES, ancillary device, and angiography suite time costs. Methods An economic model was developed comparing the embolization costs for n-BCA, EVOH with the plug and push technique, EVOH with detachable-tip microcatheters, and EVOH with balloon microcatheters. Per procedure costs were calculated for bAVMs with one to four pedicles. Annual cohort analyses were performed to evaluate the potential impact for low and high-volume centers. Sensitivity analyses were performed to determine cost drivers. Results The analyses showed that the n-BCA technique was the least costly of the four techniques. Total per procedure costs for one to four embolized pedicles ranged from $5941 to $10,074 for the n-BCA technique, $8428 to $30,345 for the EVOH balloon microcatheter technique, $12,711 to $47,477 for the EVOH plug and push technique, and $13,900 to $52,233 for the EVOH detachable-tip microcatheter technique. Cohort analyses costs for 52 annual cases ranged from $308,953 to $523,838 with the n-BCA technique and from $722,816 to $2,716,096 with the EVOH detachable-tip microcatheter technique. Conclusions Procedure costs associated with n-BCA are lower than those with each of the three EVOH techniques examined. Future cost analyses should compare the costs of new LES products once available.

Rationale and objective: This study aimed to develop a cosmesis scale to evaluate the cosmetic appearance of hemodialysis (HD) arteriovenous (AV) accesses from the perspective of the patient and clinician, which could be incorporated into clinical trials. Study design: Using a modified Delphi process, two AV access cosmesis scale (AVACS) components were developed in a four-round Delphi panel consisting of two surveys and two consensus meetings with two rounds of patient consultation. Setting and participants: The Delphi panel consisted of 15 voting members including five interventional or general nephrologists, five vascular surgeons, three interventional radiologists, and two vascular access nurse coordinators. Four patients experienced with vascular access were involved in patient question development. Analytical approach: For a component to be included in the AVACS, it had to meet the prespecified panel consensus agreement of ⩾70%. Results: The clinician component of the AVACS includes nine questions on the following AV access features: scarring, skin discoloration, aneurysm/pseudoaneurysms and megafistula appearance. The patient component includes six questions about future vascular access decisions, interference with work or leisure activities, clothing choices, self-consciousness or attractiveness, emotional impact, and overall appearance. Limitations: Delphi panel methods are subjective by design, but with expert clinical opinion are used to develop classification systems and outcome measures. The developed scale requires further validation testing but is available for clinical trial use. Conclusions: While safety and efficacy are the primary concerns when evaluating AV access for HD, cosmesis is an important component of the ESKD patient experience. The AVACS has been designed to assess this important domain; it can be used to facilitate patient care and education about vascular access choice and maintenance. AVACS can also be used to inform future research on developing new techniques for AV access creation and maintenance, particularly as relates to AV access cosmesis.

SESSION TITLE: Lung Cancer: Procedures, Outcomes, and Palliative CareSESSION TYPE: Rapid Fire Original InvPRESENTED ON: 10/17/2022 12:15 pm - 1:15 pmPURPOSE: Local treatment strategies including, Stereotactic Body Radiation Therapy (SBRT) and Image-guided Thermal Ablation (IGTA) [Microwave (MWA) and Radiofrequency (RFA) ablation] are accepted treatment options for patients with pulmonary metastases. However, systematic literature reviews (SLRs) on the outcomes after local treatments are limited. The objective of this study was to evaluate local tumor progression (LTP) and overall survival (OS) after IGTA (MWA and RFA) and SBRT in patients with pulmonary metastases.METHOD: An SLR was conducted in MEDLINE, Embase, and Cochrane databases, to identify studies published from January 1, 2005 to January 16, 2022, that reported LTP and OS, in patients with pulmonary metastases treated with MWA, RFA, or SBRT. Patients with recurrent disease were included. Studies that administered concurrent therapy with local treatments, interventions as salvage therapy, and/or those that did not report outcomes by treatment (ie, grouped thermal ablation together) were excluded. Studies were not excluded based on previous or subsequent treatments. Only MWA and RFA studies that utilized the percutaneous approach, and SBRT studies utilizing X-ray photon technology were included. Comparative studies, single-arm studies, and single arms from comparative studies (with a comparator not of interest), which included 40 or more patients, were included in the SLR. Random effects single-arm meta-analyses were conducted to provide pooled estimates of LTP and OS for IGTA and SBRT.RESULTS: Data from 7 MWA studies with 341 patients, 22 RFA studies with 1,914 patients, and 26 SBRT studies with 2,727 patients were included. LTP in patients with pulmonary metastases after IGTA and SBRT, was 7% (95%CI=5%-10%) and 3% (95%CI=2%-5%) at 6 months; 12% (95%CI=9%-16%) and 8% (95%CI=6%-11%) at 1 year; and 14% (95%CI=11%-18%) and 16% (95%CI=13%-20%) at 2 years, respectively. In patients with pulmonary metastases, OS was similar across timepoints for IGTA and SBRT, respectively, with 96% (95%CI=95%-97%) and 95% (95%CI=92%-96%) at 6 months; 88% (95%CI=83%-91%) and 86% (95%CI=81%-89%) at 1 year; 72% (95%CI=64%-78%) and 68% (95%CI=59%-76%) at 2 years; and 55% (95%CI=48%-62%) and 56% (95%CI=45%-65%) at 3 years. Although there were fewer MWA studies compared to RFA studies, there were no differences in OS and LTP between these two technologies.CONCLUSIONS: Patients with pulmonary metastases treated with SBRT had lower LTP than those treated with IGTA at 6 months, however, there were minimal differences in LTP between these technologies with longer term follow-up. OS was similar between IGTA and SBRT across all timepoints examined. No clear evidence of superiority was found for either technology for treating pulmonary metastases.CLINICAL IMPLICATIONS: Data from this SLR support the clinical use of both IGTA and SBRT as local treatment strategies in patients with pulmonary metastases.DISCLOSURES: Employee relationship with EVERSANA Please note: 2009 to 2022 Added 04/05/2022 by Nicole Ferko, value=SalaryEmployee relationship with Johnson & Johnson / ETHICON Please note: 2010 - Current Added 04/04/2022 by Sudip Ghosh, value=SalaryEmployee relationship with EVERSANA Please note: Dec 2021 to present Added 04/04/2022 by Alexandra Hall, value=SalaryEmployee relationship with Johnson and Johnson Please note: June 2015 - Present Added 04/06/2022 by Iftekhar Kalsekar, value=Salaryno disclosure on file for Paul Laeseke;Employee relationship with Johnson & Johnson Please note: 9/2020 - Present Added 04/05/2022 by Balaji Laxmanan, value=SalaryEmployee relationship with EVERSANA Please note: Jan 11, 2021-present Added 04/04/2022 by Andrada Naghi, value=SalaryConsultant relationship with Medtronic Please note: $1001 - $5000 by Calvin Ng, value=HonorariaConsultant relationship with Johnson and Johnson Please note: $1001 - $5000 by Calvin Ng, value=HonorariaSpeaker relationship with Intuitive Please note: Since December 2019 Added 04/04/2022 by Michael Pritchett, value=Consulting feeConsultant relationship with Medtronic Please note: Since 2014 Added 04/04/2022 by Michael Pritchett, value=Consulting feeConsultant relationship with Johnson&Johnson Please note: Since December 2018 Added 04/04/2022 by Michael Pritchett, value=Consulting feeConsultant relationship with Philips Please note: Since 2019 Added 04/04/2022 by Michael Pritchett, value=Consulting feeEmployee relationship with Johnson & Johnson Please note: 2007-present Added 04/04/2022 by Philippe Szapary, value=SalaryEmployee relationship with EVERSANA Please note: Feb 2017 to present Added 04/04/2022 by George Wright, value=SalaryNo relevant relationships by Yuxin ZhangEmployee relationship with Johnson & Johnson Please note: Sept 2019 to present Added 04/06/2022 by Meijia Zhou, value=Salary SESSION TITLE: Lung Cancer: Procedures, Outcomes, and Palliative Care SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/17/2022 12:15 pm - 1:15 pm PURPOSE: Local treatment strategies including, Stereotactic Body Radiation Therapy (SBRT) and Image-guided Thermal Ablation (IGTA) [Microwave (MWA) and Radiofrequency (RFA) ablation] are accepted treatment options for patients with pulmonary metastases. However, systematic literature reviews (SLRs) on the outcomes after local treatments are limited. The objective of this study was to evaluate local tumor progression (LTP) and overall survival (OS) after IGTA (MWA and RFA) and SBRT in patients with pulmonary metastases. METHOD: An SLR was conducted in MEDLINE, Embase, and Cochrane databases, to identify studies published from January 1, 2005 to January 16, 2022, that reported LTP and OS, in patients with pulmonary metastases treated with MWA, RFA, or SBRT. Patients with recurrent disease were included. Studies that administered concurrent therapy with local treatments, interventions as salvage therapy, and/or those that did not report outcomes by treatment (ie, grouped thermal ablation together) were excluded. Studies were not excluded based on previous or subsequent treatments. Only MWA and RFA studies that utilized the percutaneous approach, and SBRT studies utilizing X-ray photon technology were included. Comparative studies, single-arm studies, and single arms from comparative studies (with a comparator not of interest), which included 40 or more patients, were included in the SLR. Random effects single-arm meta-analyses were conducted to provide pooled estimates of LTP and OS for IGTA and SBRT. RESULTS: Data from 7 MWA studies with 341 patients, 22 RFA studies with 1,914 patients, and 26 SBRT studies with 2,727 patients were included. LTP in patients with pulmonary metastases after IGTA and SBRT, was 7% (95%CI=5%-10%) and 3% (95%CI=2%-5%) at 6 months; 12% (95%CI=9%-16%) and 8% (95%CI=6%-11%) at 1 year; and 14% (95%CI=11%-18%) and 16% (95%CI=13%-20%) at 2 years, respectively. In patients with pulmonary metastases, OS was similar across timepoints for IGTA and SBRT, respectively, with 96% (95%CI=95%-97%) and 95% (95%CI=92%-96%) at 6 months; 88% (95%CI=83%-91%) and 86% (95%CI=81%-89%) at 1 year; 72% (95%CI=64%-78%) and 68% (95%CI=59%-76%) at 2 years; and 55% (95%CI=48%-62%) and 56% (95%CI=45%-65%) at 3 years. Although there were fewer MWA studies compared to RFA studies, there were no differences in OS and LTP between these two technologies. CONCLUSIONS: Patients with pulmonary metastases treated with SBRT had lower LTP than those treated with IGTA at 6 months, however, there were minimal differences in LTP between these technologies with longer term follow-up. OS was similar between IGTA and SBRT across all timepoints examined. No clear evidence of superiority was found for either technology for treating pulmonary metastases. CLINICAL IMPLICATIONS: Data from this SLR support the clinical use of both IGTA and SBRT as local treatment strategies in patients with pulmonary metastases. DISCLOSURES: Employee relationship with EVERSANA Please note: 2009 to 2022 Added 04/05/2022 by Nicole Ferko, value=Salary Employee relationship with Johnson & Johnson / ETHICON Please note: 2010 - Current Added 04/04/2022 by Sudip Ghosh, value=Salary Employee relationship with EVERSANA Please note: Dec 2021 to present Added 04/04/2022 by Alexandra Hall, value=Salary Employee relationship with Johnson and Johnson Please note: June 2015 - Present Added 04/06/2022 by Iftekhar Kalsekar, value=Salary no disclosure on file for Paul Laeseke; Employee relationship with Johnson & Johnson Please note: 9/2020 - Present Added 04/05/2022 by Balaji Laxmanan, value=Salary Employee relationship with EVERSANA Please note: Jan 11, 2021-present Added 04/04/2022 by Andrada Naghi, value=Salary Consultant relationship with Medtronic Please note: $1001 - $5000 by Calvin Ng, value=Honoraria Consultant relationship with Johnson and Johnson Please note: $1001 - $5000 by Calvin Ng, value=Honoraria Speaker relationship with Intuitive Please note: Since December 2019 Added 04/04/2022 by Michael Pritchett, value=Consulting fee Consultant relationship with Medtronic Please note: Since 2014 Added 04/04/2022 by Michael Pritchett, value=Consulting fee Consultant relationship with Johnson&Johnson Please note: Since December 2018 Added 04/04/2022 by Michael Pritchett, value=Consulting fee Consultant relationship with Philips Please note: Since 2019 Added 04/04/2022 by Michael Pritchett, value=Consulting fee Employee relationship with Johnson & Johnson Please note: 2007-present Added 04/04/2022 by Philippe Szapary, value=Salary Employee relationship with EVERSANA Please note: Feb 2017 to present Added 04/04/2022 by George Wright, value=Salary No relevant relationships by Yuxin Zhang Employee relationship with Johnson & Johnson Please note: Sept 2019 to present Added 04/06/2022 by Meijia Zhou, value=Salary

Aims The electrosurgical technology category is used widely, with a diverse spectrum of devices designed for different surgical needs. Historically, hospitals are supplied with electrosurgical devices from several manufacturers, and those devices are often evaluated separately; it may be more efficient to evaluate the category holistically. This study assessed the health economic impact of adopting an electrosurgical device-category from a single manufacturer. Methods A budget impact model was developed from a U.S. hospital perspective. The uptake of electrosurgical devices from EES (Ethicon Electrosurgery), including ultrasonic, advanced bipolar, smoke evacuators, and reusable dispersive electrodes were compared with similar MED (Medical Energy Devices) from multiple manufacturers. It was assumed that an average hospital performed 10,000 annual procedures 80% of which involved electrosurgery. Current utilization assumed 100% MED use, including advanced energy, conventional smoke mitigation options (e.g. ventilation, masks), and single-use disposable dispersive electrode devices. Future utilization assumed 100% EES use, including advanced energy devices, smoke evacuators (i.e. 80% uptake), and reusable dispersive electrodes. Surgical specialties included colorectal, bariatric, gynecology, thoracic and general surgery. Systematic reviews, network meta-analyses, and meta-regressions informed operating room (OR) time, hospital stay, and transfusion model inputs. Costs were assigned to model parameters, and price parity was assumed for advanced energy devices. The costs of disposables for dispersive electrodes and smoke-evacuators were included. Results The base-case analysis, which assessed the adoption of EES instead of MED for an average U.S. hospital predicted an annual savings of $824,760 ($101 per procedure). Savings were attributable to associated reductions with EES in OR time, days of hospital stay, and volume of disposable electrodes. Sensitivity analyses were consistent with these base-case findings. Conclusions Category-wide adoption of electrosurgical devices from a single manufacturer demonstrated economic advantages compared with disaggregated product uptake. Future research should focus on informing comparisons of innovative electrosurgical devices.

Network meta-analyses (NMAs) generally include direct comparative evidence from randomized controlled trials (RCTs) and/or comparative observational studies; however, comparative evidence is limited in many disease/treatment areas. The objective of this analysis was to discuss opportunities and pitfalls associated with incorporating single-arm studies into NMAs, illustrated in a case study assessing the effectiveness of ablation/radiation therapies in lung cancer. A systematic literature review was conducted to identify RCTs, comparative observational studies, and single-arm studies assessing ablation/radiation therapies among adults with lung cancer. The outcomes were local tumor recurrence, overall survival, and complications. First, Bayesian hierarchical NMAs using direct comparative studies, down-weighting lower quality evidence, were conducted. Second, simulated comparative studies were obtained by matching relevant single-arm studies using optimal 1:1 matching; propensity scores were estimated by fitting a logistic regression model that included age, sex, tumor type, tumor size, and average number of tumors as covariates. Third, Bayesian hierarchical NMAs using both comparative and simulated comparative studies, down-weighting lower quality evidence, were conducted. One RCT, 10 comparative observational studies, and 147 single-arm studies were identified. Seven to 22 simulated comparative studies were incorporated within each NMA, depending on the outcome. The conclusions of the Bayesian hierarchical NMAs were aligned between analyses using comparative or comparative and simulated comparative studies; however, differences in effect estimate magnitudes (0% - 44%) and treatment rankings were sometimes observed. Limitations of this analysis included sub-optimal reporting of covariates among single-arm studies limiting the ability to sufficiently match for cross-study differences and poor matching where cross-study differences existed. Thoughtful integration of single-arm studies in NMAs may offer opportunities to utilize all available evidence and be especially useful in disease/treatment areas with many single-arm studies and limited direct comparative evidence or incomplete evidence networks. However, studies should clearly state the methodological limitations and present results stratified by study design.

Given medical device growth, there is a need to optimize efficiencies in health system value analysis decision-making. Holistic evaluations of device categories may be more efficient and practical than traditional item-by-item comparisons. This study aimed to develop a model that evaluates the economic value of introducing the class of interrelated electrosurgical devices into U.S. hospitals. An economic model was developed including hospital resource use and costs of the CEP (comprehensive electrosurgical portfolio; manufactured by Ethicon, Inc.) vs. IEC (individual electrosurgical components; manufactured by Medtronic plc and respective manufacturers). CEP comprised complementary devices that enable safe and effective electrosurgery: reusable patient return electrodes, handheld smoke evacuation, advanced bipolar and ultrasonic devices. Comparator IEC was defined as the individual devices within this category: single-use patient return electrodes, conventional smoke evacuation methods (e.g., masks, wall suction), advanced bipolar and ultrasonic devices. Hospital resources included device costs, operating time, length of stay, blood loss and transfusions, and surgical complications. Price parity was assumed between advanced electrosurgical devices. Model inputs were derived from randomized trials, indirect treatment comparisons, and literature-reported U.S. unit costs. In thoracic procedures, the model predicted $186-$439 USD per patient cost savings with CEP vs. IEC, for advanced bipolar or ultrasonic devices, respectively. In gynecological and bariatric procedures, CEP yielded $31-$86 USD per patient cost savings, respectively. Also, when including reusable return electrodes, economic value with CEP showed an additional $1,658 per unit savings per year. Incremental economic benefits may also be realized with complementary use of handheld smoke evacuation devices, via optimized procedure workflow and HCP productivity. Introducing effective electrosurgical devices can lead to optimized hospital resources and cost savings, particularly with a category-wide evaluation. Future studies should further examine electrosurgical resource use to more accurately quantify economic value across procedure types and outcomes.

Advances in electrosurgical technologies may improve clinical outcomes and economic value across various procedure types. Holistic evaluations of devices may be more pragmatic and efficient than product-by-product comparisons, especially important in cost-constrained environments. This study aimed to develop a model that evaluates the economic value of introducing a category of electrosurgical devices into Chinese hospitals. An economic model was developed including hospital resource use and costs of a CEP (comprehensive electrosurgical portfolio; manufactured by Ethicon, Inc.) vs. IEC (individual electrosurgical components; manufactured by Medtronic plc and respective manufacturers). The CEP comprised complementary devices that enable safe and effective electrosurgery: reusable patient return electrodes, handheld smoke evacuation, advanced bipolar and ultrasonic devices. Comparator IEC comprised single-use return electrodes, conventional smoke evacuation methods (e.g., masks, wall suction), and conventional electrosurgical modalities (mechanical, monopolar, basic bipolar). Hospital resources included device costs, operating time, length of stay, blood loss and transfusions, and surgical complications. Model inputs were derived from randomized trials and literature-reported Chinese unit costs, converted to USD. For thoracic procedures, the model predicted cost savings with CEP compared with IEC, from $617-$1,512 USD per patient, with advanced bipolar or ultrasonic devices, respectively. For gynecological, colorectal, and hepato-pancreato-biliary surgical specialties, CEP implementation resulted in cost savings from $219-$9,457 USD per patient, depending on procedure type. Also, when including reusable return electrodes, economic value with CEP showed an additional $1,658 per unit savings per year. Further economic benefits may be realized with complementary use of handheld smoke evacuation devices, via optimized procedure workflow and surgeon/nurse productivity. Introducing effective electrosurgical devices with a holistic view of this category’s interconnected technologies can save hospital resources and lead to cost savings. Future studies should further examine electrosurgery resource use to allow more accurate quantification of economic value across surgery types and outcomes.

BACKGROUND: Colorectal surgical procedures place substantial burden on health care systems because of the high complication risk, of surgical site infections in particular. The risk of surgical site infection after colorectal surgery is one of the highest of any surgical specialty. OBJECTIVE: The purpose of this study was to determine the incidence, cost of infections after colorectal surgery, and potential economic benefit of using antimicrobial wound closure to improve patient outcomes. DESIGN: Retrospective observational cohort analysis and probabilistic cost analysis were performed. SETTINGS: The analysis utilized a database for colorectal patients in the United States between 2014 and 2018. PATIENTS: A total of 107,665 patients who underwent colorectal surgery were included in the analysis. MAIN OUTCOME MEASURES: Rate of infection was together with identified between 3 and 180 days postoperatively, infection risk factors, infection costs over 24 months postoperatively by payer type (commercial payers and Medicare), and potential costs avoided per patient by using an evidence-based innovative wound closure technology. RESULTS: Surgical site infections were diagnosed postoperatively in 23.9% of patients (4.0% superficial incisional and 19.9% deep incisional/organ space). Risk factors significantly increased risk of deep incisional/organ-space infection and included several patient comorbidities, age, payer type, and admission type. After 12 months, adjusted increased costs associated with infections ranged from $36,429 to $144,809 for commercial payers and $17,551 to $102,280 for Medicare, depending on surgical site infection type. Adjusted incremental costs continued to increase over a 24-month study period for both payers. Use of antimicrobial wound closure for colorectal surgery is projected to significantly reduce median payer costs by $809 to $1170 per patient compared with traditional wound closure. LIMITATIONS: The inherent biases associated with retrospective databases limited this study. CONCLUSIONS: Surgical site infection cost burden was found to be higher than previously reported, with payer costs escalating over a 24-month postoperative period. Cost analysis results for adopting antimicrobial wound closure aligns with previous evidence-based studies, suggesting a fiscal benefit for its use as a component of a comprehensive evidence-based surgical care bundle for reducing the risk of infection. See Video Abstract at http://links.lww.com/DCR/B358.