Use of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma and its performance in Japan over the past 18 years: A nationwide descriptive study

Use of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma and its performance in Japan over the past 18 years: A nationwide descriptive study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Use of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma and its performance in Japan over the past 18 years: A nationwide descriptive study Hiromasa Hoshi, Akira Endo, Ryo Yamamoto, Kazuma Yamakawa, Keisuke Suzuki, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4220678/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Background: Resuscitative endovascular balloon occlusion of the aorta (REBOA) has been used to control massive hemorrhages. Although there is no consensus on the efficacy of REBOA, it remains an option as a bridging therapy in non-trauma centers where trauma surgeons are not available. To better understand the current landscape of REBOA application, we examined changes in its usage, target population, and treatment outcomes in Japan, where immediate hemostasis procedures sometimes cannot be performed. Methods: This retrospective observational study used the Japan Trauma Data Bank data. All cases in which REBOA was performed between January 2004 and December 2021 were included. The primary outcome was the in-hospital mortality rate. We analyzed mortality trends over time according to the number of cases, number of centers, severity of injury, and overall and subgroup mortality associated with REBOA usage. We performed a logistic analysis of mortality trends over time, adjusting for probability of survival based on the trauma and injury severity score. Results: Overall, 2557 patients were treated with REBOA and were deemed eligible for inclusion. The median age of the participants was 55 years, and male patients constituted 65.3% of the study population. Blunt trauma accounted for approximately 93.0% of the cases. The number of cases and facilities that used REBOA increased until 2019. While the injury severity score and revised trauma score did not change throughout the observation period, the hospital mortality rate decreased from 91.3% to 50.9%. The REBOA group without severe head or spine injuries showed greater improvement in mortality than the all-patient group using REBOA and all-trauma patient group. The greatest improvement in mortality was observed in patients with systolic blood pressure ≥80 mmHg. The adjusted odds ratios for hospital mortality steadily declined, even after adjusting for the probability of survival. Conclusions: While there was no significant change in patient severity, mortality of patients treated with REBOA decreased over time. Further research is required to determine the reasons for these improvements in trauma care. resuscitative endovascular balloon occlusion of the aorta trauma hemorrhage aortic cross-clamping Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Background Hemorrhage is one of the primary causes of mortality in trauma cases and accounts for an estimated 30–40% of traumatic deaths [1]. Resuscitation of massive hemorrhages often requires massive transfusions and fluids, and rapid hemorrhage control is essential. Traditionally, aortic cross-clamping (ACC) has been used to temporarily control massive hemorrhage. However, ACC adds further invasiveness to a patient who has already sustained severe trauma, and managing bleeding from the incision site poses additional challenges [2]. Resuscitative endovascular balloon occlusion of the aorta (REBOA) has emerged as an alternative approach for controlling hemorrhages with minimal invasion [3]. However, its effectiveness is controversial. Some studies have shown that compared to ACC, REBOA has a better prognosis [2, 4], while others suggested that it is associated with a poorer prognosis [5-7]. Recently, a randomized trial conducted in major trauma centers in the United Kingdom suggested that REBOA increased the risk of death and prolonged the time to definitive hemostasis [7]. However, REBOA remains an option as a bridging therapy in non-trauma centers where trauma surgeons are not always available. The situation surrounding REBOA is progressing without sufficient evidence. Off-the-job training courses for REBOA have been conducted worldwide, and devices have been improved, including the release of a narrower-diameter access route [8, 9], based on theoretical benefits. However, the validation of these efforts is insufficient. To better understand the current situation surrounding REBOA, we examined changes in its usage, target population, and treatment outcomes in Japan, where immediate hemostasis procedures sometimes cannot be performed. Methods Study design and settings This retrospective observational study used data from the Japan Trauma Data Bank. The study was conducted from January 2004 to December 2021. The JTDB is required to register all severe trauma cases with AIS 3 or higher injuries and was established by the Japanese Association for Acute Medicine and Japanese Association for The Surgery of Trauma to understand the current status and improve the quality of trauma care, akin to the Trauma Quality Improvement Program in the United States. By the end of December 2021, the JTDB included 303 facilities providing trauma care in Japan, of which 95% were government-certified tertiary care centers. This study complied with the principles of the 1964 Declaration of Helsinki and its amendments and was approved by the Ethics Committee of Tsuchiura Kyodo General Hospital (approval number: 2022FY10). The requirement for informed consent from each patient was waived because of the study’s retrospective nature. We used the opt-out method, which provides opportunities to refuse to participate in the study through online information disclosure in our hospital. The study was conducted in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting statement. Study participants The study included all cases for which REBOA was used between 2004 and 2021. Measurements We collected the following patient information from the JTDB: age; sex; year of injury; trauma classification (blunt or penetrating); pre-hospital vital signs [systolic blood pressure (SBP), heart rate (HR), respiratory rate (RR), and percutaneous oxygen saturation (SpO2)]; Glasgow coma scale (GCS) score; time from emergency medical service dispatch to emergency department (ED) arrival; vital signs at ED arrival [SBP, HR, RR, and SpO2, body temperature, and GCS, abbreviated injury scale (AIS) score for each region, injury severity score (ISS), revised trauma score (RTS), status at hospital discharge (survival or death)]; lactic acid level; focused assessment with sonography in trauma (FAST) results; number of REBOA cases, cases of cardiac arrest on arrival, and ACC cases; and probability of survival based on the trauma and injury severity score (TRISS-Ps). Definitions and outcomes The AIS was calculated based on AIS 98 until 2018 and AIS 2008 after 2019 in accordance with the change in JTDB registration rule. Data for pre-hospital GCS score, SpO 2 , and lactic acid levels on ED arrival were only available after 2019 in the JTDB. Cardiac arrest was characterized by a recorded SBP of 0 mmHg based on the registration instructions of the JTDB. The primary outcome was survival at hospital discharge. Statistical analysis The trend of the number, characteristics, and outcomes of patients treated with REBOA and the number of facilities where REBOA was used, according to admission year, was described. Trends in hospital mortality were also compared among specific subgroups, including all patients with trauma, patients treated with REBOA, patients treated with REBOA without severe head or spine injuries defined by AIS ≥3, patients treated with REBOA with shock upon hospital arrival (SBP <80 mmHg), and patients treated with REBOA without shock upon hospital arrival. Patient characteristics were described using median and interquartile range (IQR) for continuous variables and number and percentage (%) for categorical variables. The chi-square test was used with a significance level of 0.05 to test the association of variables. We conducted a single regression analysis to show the changes in annual mortality rates across some subgroups: all patients with trauma in the database, all cases in which REBOA was used, the REBOA group without severe head or spine injury of AIS ≥3, cases with SBP <80 mmHg among patients for whom REBOA was used, and patients with SBP ≥80 mmHg among patients for whom REBOA was used. We conducted a logistic regression analysis for the annual mortality rate adjusted by TRISS-Ps. All statistical analyses were performed using R software version 4.3.1 (R Foundation for Statistical Computing, Vienna, Austria). Results A total of 427,561 patients were registered with the JTDB between 2004 and 2021. Of them, 2557 patients were treated with REBOA and were deemed eligible for inclusion. Table 1 presents the baseline patient characteristics. Overall, the median age of the participants was 55 years, with male patients constituting 65.3% of the study population. Blunt trauma accounted for approximately 93.0% of the cases. The median transport time was 37 min. The median SBP at ED arrival was 70 mm Hg. The thoracic region had the highest median AIS score. FAST-positive cases accounted for 45.9% of the cases. The median ISS and RTS values were 34.0 and 4.7, respectively. The median TRISS-Ps was 0.35. The overall mortality rate was 59.7%, and 16.9% of the patients experienced cardiac arrest upon arrival. ACC was performed in 16.7% of the cases. The number of REBOA cases was 24 in 2004, which increased to 262 in 2019. The number of REBOA cases declined from 2020 to 167 by 2021. The in-hospital mortality rate decreased from 91.3% to 50.9% during the observation period. The number of facilities using REBOA in 2004 increased from 10 to 105 in 2019. The number of facilities using REBOA has decreased since 2020, reaching 62 by 2021 ( Figure 1 ). Although RTS changed substantially from 2004 to 2006, the median and IQR for both RTS ( Figure 2 ) and ISS ( Figure 3 ) were similar after these periods. Univariate regression analysis was conducted in various subgroups to compare the trends in mortality rates ( Figure 4 ). The REBOA group without severe head or spine injury of AIS ≥3 had greater improvement in mortality than that of all-patient group using REBOA and all-trauma patient group. The greatest improvement in mortality was observed in patients with SBP ≥80 mmHg among all patients for whom REBOA was performed. Logistic regression analysis for the outcome of annual mortality indicated steadily declined mortality even after adjusting for TRISS-Ps ( Figure 5 ). Discussion A retrospective observational study analyzing data from the Japanese nationwide trauma registry over the past 18 years was conducted on 2,557 patients who underwent REBOA. A consistently decreasing trend in mortality was observed. The physiological and anatomical severities of the patients were similar over the years, and a reduction in mortality was observed, regardless of the severity of their conditions. Several previous studies evaluated the mortality rate associated with REBOA, ranging from 34% to 70.8% [10-13]. Aoki et al. showed that the mortality rate of patients undergoing REBOA decreased between 2004 and 2015 [14]. Our study further enriched these results by adding 6 years of data, demonstrating changes over time in the number of cases in which REBOA was used, number of facilities using REBOA, and analysis of specific subgroups. The results of the present study revealed that mortality continued improving after 2016. The increase in the use of REBOA and the number of facilities implementing it until 2019 may be attributed to the growing recognition of the procedure. The introduction of hybrid emergency room system in Japan in 2011 partially could have contributed to this trend [15, 16]. Furthermore, 7 Fr narrow-diameter balloons were approved for clinical use in 2013. They were shown to reduce complications related to REBOA [17], including lower extremity ischemia. This technical progress in REBOA may have resulted in its increased number of REBOA uses. The decrease in the number of patients and facilities after 2020 could be attributed to the COVID-19 pandemic. Given that the RTS and ISS remained similar over the years, it was suggested that the indications for REBOA were consistent over 18 years. While trauma-related mortality has decreased over the years [18], the mortality rate of patients treated with REBOA was further reduced compared to that of the all-trauma cohort [18]. There are several possible explanations for this. The improvement in mortality rate among patients without severe head or spine trauma was lower than that among all patients treated with REBOA. This suggests that REBOA and the overall hemostatic strategy, including damage control resuscitation, have improved. It is also possible that the REBOA insertion technique has been partially improved by disseminating off-the-job REBOA training courses in Japan [8, 19]. Among the cases of REBOA, a significant reduction in mortality was observed in patients with an SBP of 80 mmHg or higher, indicating that REBOA had a particularly significant effect on improving outcomes in bleeding patients with relatively stable conditions. The UK-REBOA randomized clinical trial suggested that there may be more deaths in the REBOA group, which may have been influenced by the longer time to hemostasis in the REBOA group. The present study suggests that using REBOA as a bridge to achieve hemostasis in relatively stable patients who do not require immediate hemostasis may be an evolving strategy. This study has some limitations. Information regarding when and where REBOA was used during the resuscitation is unavailable in the JTDB. The zone, extent, and duration of the REBOA inflation are also unclear. The expertise level of the individual performing REBOA is unknown. Detailed information on the preparation and operation of hemostatic procedures, such as the availability of trauma surgeons and operating theaters at each facility, is unavailable in the JTDB. Conclusions While there was no significant change in patient severity, mortality of patients treated with REBOA decreased over time. Further research is required to determine the reasons for these improvements in trauma care. List Of Abbreviations REBOA, resuscitative endovascular balloon occlusion of the aorta; ACC, aortic cross-clamping; SBP, systolic blood pressure; HR, heart rate; RR, respiratory rate; SpO2, percutaneous oxygen saturation; GCS, Glasgow coma scale; ED, emergency department; AIS, abbreviated injury scale; ISS, injury severity score; RTS, revised trauma score; FAST, focused assessment with sonography in trauma; TRISS-Ps, trauma and injury severity score; IQR, interquartile range; percentage, % Declarations Ethics approval and consent to participate: This study was approved by the Ethics Committee of Tsuchiura Kyodo General Hospital (approval number: 2022FY10). The requirement for informed consent from each patient was waived because of the study’s retrospective nature. We used the opt-out method, which provides opportunities to refuse to participate in the study through online information disclosure in our hospital. Consent for publication: Not applicable. Availability of data and materials: The data that supported the findings of this study are available from the Japan Trauma Data Bank, but the availability of these data is restricted. Competing interests : The authors declare that they have no competing interests. Funding: Not applicable. Authors’ contributions: HH drafted and revised the manuscript, developed the study concept and design and was involved in statistical analysis and data interpretation. HH also takes responsibility for the research, final approval, and study supervision. AE assisted in manuscript revision, study concept and design development, and data interpretation and assumed responsibility for research conduct and final approval. RY, KY, KS, and TA were involved in data acquisition and manuscript revision and accepted responsibility for the research conduct and final approval. KM contributed to manuscript revision and data interpretation and took responsibility for conducting the research and obtaining final approval. All the authors have read and approved the final manuscript. Acknowledgments: The authors would like to thank Editage (www.editage.com) for the English language editing. Authors’ information Hiromasa Hoshi: [email protected] Akira Endo: [email protected] Ryo Yamamoto: [email protected] Kazuma Yamakawa: [email protected] Keisuke Suzuki: [email protected] Tomohiro Akutsu: [email protected] Koji Morishita: [email protected] References Perkins JG, Cap AP, Weiss BM, Reid TJ, Bolan CD. Massive transfusion and nonsurgical hemostatic agents. Crit Care Med. 2008;36(7);Suppl:S325–39. https://doi.org/10.1097/CCM.0b013e31817e2ec5 Haruta K, Endo A, Shiraishi A, Otomo Y. Usefulness of resuscitative endovascular balloon occlusion of the aorta compared to aortic cross-clamping in severely injured trauma patients: Analysis from the Japan Trauma Data Bank. Acute Med Surg. 2023;10:e830. https://doi.org/10.1002/ams2.830 DuBose JJ, Scalea TM, Brenner M, Skiada D, Inaba K, Cannon J, et al. The AAST prospective Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry: Data on contemporary utilization and outcomes of aortic occlusion and resuscitative balloon occlusion of the aorta (REBOA). J Trauma Acute Care Surg. 2016;81:409–19. https://doi.org/10.1097/TA.0000000000001079 Cralley AL, Vigneshwar N, Moore EE, Dubose J, Brenner ML, Sauaia A, et al. Zone 1 endovascular balloon occlusion of the aorta vs resuscitative thoracotomy for patient resuscitation after severe hemorrhagic shock. JAMA Surg. 2023;158:140–50. https://doi.org/10.1001/jamasurg.2022.6393 Kinslow K, Shepherd A, McKenney M, Elkbuli A. Resuscitative endovascular balloon occlusion of aorta: A systematic review. Am Surg. 2022;88:289–96. https://doi.org/10.1177/0003134820972985 Joseph B, Zeeshan M, Sakran JV, Hamidi M, Kulvatunyou N, Khan M, et al. Nationwide analysis of resuscitative endovascular balloon occlusion of the aorta in civilian trauma. JAMA Surg. 2019;154:500–8. https://doi.org/10.1001/jamasurg.2019.0096 Jansen JO, Hudson J, Cochran C, MacLennan G, Lendrum R, Sadek S, et al. Emergency department resuscitative endovascular balloon occlusion of the aorta in trauma patients with exsanguinating hemorrhage: The UK-REBOA randomized clinical trial. JAMA. 2023;330:1862–71. https://doi.org/10.1001/jama.2023.20850 Birrenbach T, Wespi R, Hautz WE, Berger J, Schwab PR, Papagiannakis G, et al. Development and usability testing of a fully immersive VR simulation for REBOA training. Int J Emerg Med. 2023;16:67. https://doi.org/10.1186/s12245-023-00545-6 Sykes AG, Sisson WB, Wang LJ, Martin MJ, Thangarajah H, Naheedy J, et al. Balloons for kids: Anatomic candidacy and optimal catheter size for pediatric resuscitative endovascular balloon occlusion of the aorta. J Trauma Acute Care Surg. 2022;92:743–7. https://doi.org/10.1097/TA.0000000000003521 Gupta BK, Khaneja SC, Flores L, Eastlick L, Longmore W, Shaftan GW. The role of intra-aortic balloon occlusion in penetrating abdominal trauma. J Trauma. 1989;29:861–5. https://doi.org/10.1097/00005373-198906000-00026 Saito N, Matsumoto H, Yagi T, Hara Y, Hayashida K, Motomura T, et al. Evaluation of the safety and feasibility of resuscitative endovascular balloon occlusion of the aorta. J Trauma Acute Care Surg. 2015;78:897–903; discussion 4. https://doi.org/10.1097/TA.0000000000000614 Irahara T, Sato N, Moroe Y, Fukuda R, Iwai Y, Unemoto K. Retrospective study of the effectiveness of Intra-Aortic Balloon Occlusion (IABO) for traumatic haemorrhagic shock. World J Emerg Surg. 2015;10:1. https://doi.org/10.1186/1749-7922-10-1 Moore LJ, Brenner M, Kozar RA, Pasley J, Wade CE, Baraniuk MS, et al. Implementation of resuscitative endovascular balloon occlusion of the aorta as an alternative to resuscitative thoracotomy for noncompressible truncal hemorrhage. J Trauma Acute Care Surg. 2015;79:523–30; discussion 30–2. https://doi.org/10.1097/TA.0000000000000809 Aoki M, Abe T, Hagiwara S, Saitoh D, Oshima K. Resuscitative endovascular balloon occlusion of the aorta may contribute to improved survival. Scand J Trauma Resusc Emerg Med. 2020;28:62. https://doi.org/10.1186/s13049-020-00757-2 Watanabe H, Shimojo Y, Hira E, Kuramoto S, Muronoi T, Oka K, et al. First establishment of a new table-rotated-type hybrid emergency room system. Scand J Trauma Resusc Emerg Med. 2018;26:80. https://doi.org/10.1186/s13049-018-0532-z Kinoshita T, Yamakawa K, Matsuda H, Yoshikawa Y, Wada D, Hamasaki T, et al. The survival benefit of a novel trauma workflow that includes immediate whole-body computed tomography, surgery, and interventional radiology, all in one trauma resuscitation room: A retrospective historical control study. Ann Surg. 2019;269:370–6. https://doi.org/10.1097/SLA.0000000000002527 Teeter WA, Matsumoto J, Idoguchi K, Kon Y, Orita T, Funabiki T, et al. Smaller introducer sheaths for REBOA may be associated with fewer complications. J Trauma Acute Care Surg. 2016;81:1039–45. https://doi.org/10.1097/TA.0000000000001143 Endo A, Shiraishi A, Matsui H, Hondo K, Otomo Y. Assessment of progress in early trauma care in Japan over the past decade: Achievements and areas for future improvement. J Am Coll Surg. 2017;224:191–198.e5. https://doi.org/10.1016/j.jamcollsurg.2016.10.051 Thabouillot O, Boddaert G, Travers S, Dubecq C, Derkenne C, Kedzierewicz R, et al. Effectiveness of short training in resuscitative endovascular balloon occlusion of the aorta (REBOA) by emergency physicians: The applied course for internal aortic clamping on field mission. J Spec Oper Med. 2021;21:36–40. https://doi.org/10.55460/NYAW-F69L Tables Table 1 is available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Table1.docx Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 19 Apr, 2024 Reviews received at journal 17 Apr, 2024 Reviews received at journal 10 Apr, 2024 Reviewers agreed at journal 06 Apr, 2024 Reviewers agreed at journal 06 Apr, 2024 Reviewers invited by journal 06 Apr, 2024 Editor assigned by journal 06 Apr, 2024 Submission checks completed at journal 05 Apr, 2024 First submitted to journal 05 Apr, 2024 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4220678","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":288304066,"identity":"c6350c75-bd7e-4898-aeb1-0eb32662d228","order_by":0,"name":"Hiromasa Hoshi","email":"","orcid":"","institution":"Tsuchiura Kyodo General Hospital","correspondingAuthor":false,"prefix":"","firstName":"Hiromasa","middleName":"","lastName":"Hoshi","suffix":""},{"id":288304067,"identity":"05a587d9-484a-43c9-bc2d-b4536432c211","order_by":1,"name":"Akira Endo","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABCklEQVRIiWNgGAWjYDACHsYGCOMAECUY2MiB2Q+I1ML44EFBmjGYnYBXC4xxgIHZ8MGHw4lgE/Bp4e853PbhB4NNHt/xBjaJBAPm9Plhhx8CbbGT023ArkXibGPzzB6GtGLJMwdAWthyN95OMwBqSTY2O4DDmvOMzUDHHU7ccCMBpIUnd+PsBJCWA4nbcGiRB2ph/MPwH6ZFIt1wdvoHvFoMgA5j5gEqAGphNkgwMEiQl87Bb4vhmYPNzDIGyYkzzxxsfJBgkGC4QTqnABhBuP0idyb9MeObCrvEvuPNBw7++PNfXn52+uYPHyrs5HB6H+I8EAGNU4MDcBFigXwDKapHwSgYBaNgJAAARRhnr//dVPQAAAAASUVORK5CYII=","orcid":"","institution":"Tsuchiura Kyodo General Hospital","correspondingAuthor":true,"prefix":"","firstName":"Akira","middleName":"","lastName":"Endo","suffix":""},{"id":288304068,"identity":"ff271efd-25d3-47af-b038-3c31666c6414","order_by":2,"name":"Ryo Yamamoto","email":"","orcid":"","institution":"Keio University","correspondingAuthor":false,"prefix":"","firstName":"Ryo","middleName":"","lastName":"Yamamoto","suffix":""},{"id":288304069,"identity":"a0ccb1c6-8d7d-43b7-ae2c-a1b15768b4e1","order_by":3,"name":"Kazuma Yamakawa","email":"","orcid":"","institution":"Osaka Medical and Pharmaceutical University","correspondingAuthor":false,"prefix":"","firstName":"Kazuma","middleName":"","lastName":"Yamakawa","suffix":""},{"id":288304070,"identity":"23bb9e11-4c3c-44b9-b005-f6950a4fd804","order_by":4,"name":"Keisuke Suzuki","email":"","orcid":"","institution":"Tsuchiura Kyodo General Hospital","correspondingAuthor":false,"prefix":"","firstName":"Keisuke","middleName":"","lastName":"Suzuki","suffix":""},{"id":288304071,"identity":"090b26d3-4eea-47d1-b72b-5a9a03d87442","order_by":5,"name":"Tomohiro Akutsu","email":"","orcid":"","institution":"Tsuchiura Kyodo General Hospital","correspondingAuthor":false,"prefix":"","firstName":"Tomohiro","middleName":"","lastName":"Akutsu","suffix":""},{"id":288304072,"identity":"587c5dc8-2c73-4649-adcb-95a447d00f89","order_by":6,"name":"Koji Morishita","email":"","orcid":"","institution":"Tokyo Medical and Dental University","correspondingAuthor":false,"prefix":"","firstName":"Koji","middleName":"","lastName":"Morishita","suffix":""}],"badges":[],"createdAt":"2024-04-05 04:38:13","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4220678/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4220678/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":54445699,"identity":"b768d625-77a4-4400-bdf4-aef2ce312f3a","added_by":"auto","created_at":"2024-04-10 16:17:13","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":50789,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eNumber of facilities over time\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-4220678/v1/213fd831a7b1d5fdf58a8fbe.png"},{"id":54445695,"identity":"cc20e946-9b88-42d5-bb12-a426cb79fa72","added_by":"auto","created_at":"2024-04-10 16:17:13","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":59094,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eChanges in revised trauma score of the patients for whom REBOA was used\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe box shows the interquartile range; the horizontal line is the median.\u003c/p\u003e\n\u003cp\u003eAbbreviations: REBOA, resuscitative endovascular balloon of aorta\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-4220678/v1/6c82c8b08282346edd601a85.png"},{"id":54446881,"identity":"569bdf08-acf3-4d5c-b0d8-4b186e45a3c0","added_by":"auto","created_at":"2024-04-10 16:25:13","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":59527,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eChanges in injury severity score of the patients for whom REBOA was used\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe box shows the interquartile range; the horizontal line is the median.\u003c/p\u003e\n\u003cp\u003eAbbreviations: REBOA, resuscitative endovascular balloon of aorta\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-4220678/v1/94287ad8be99dc95108cffe2.png"},{"id":54445698,"identity":"d4b6b4ce-a575-4f6b-8e4f-7cf000c859c7","added_by":"auto","created_at":"2024-04-10 16:17:13","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":197171,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eMortality rate in subgroups and overall trauma over time\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSingle regression analysis was conducted in various subgroups to compare the trends in mortality rates. The black line shows the REBOA group without severe head or spine injury of AIS ≥3. The red lines show the cases in which REBOA was used. The blue line indicates trauma cases in the database. The purple line shows cases with SBP \u0026lt;80 mmHg among those where REBOA was used. The green line shows cases with SBP ≥80 mmHg among cases where REBOA was used.\u003c/p\u003e\n\u003cp\u003eAbbreviations: REBOA, resuscitative endovascular balloon of the aorta; AIS, Abbreviated injury scale; SBP, systolic blood pressure\u003c/p\u003e","description":"","filename":"Figure4.png","url":"https://assets-eu.researchsquare.com/files/rs-4220678/v1/4f80472b5e497a67c166fb6a.png"},{"id":54445700,"identity":"a82517f9-85d6-4e51-956c-6b04ea776b10","added_by":"auto","created_at":"2024-04-10 16:17:14","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":54473,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eTrends in adjusted odds ratio of mortality\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLogistic regression analysis was performed to determine the outcome of annual mortality adjusted by TRISS-PS. Adjusted odds ratios and 95% confidence intervals are shown.\u003c/p\u003e","description":"","filename":"Figure5.png","url":"https://assets-eu.researchsquare.com/files/rs-4220678/v1/666e8aa2f9580f62de9ad085.png"},{"id":54447248,"identity":"f2c74904-d0a2-40b2-a6da-1a33aa521d05","added_by":"auto","created_at":"2024-04-10 16:33:14","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":585370,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4220678/v1/38224c12-e9e5-4098-8ed0-19b46391cfc8.pdf"},{"id":54445694,"identity":"ec926a98-8f19-4c1d-b4a2-1969159b9c25","added_by":"auto","created_at":"2024-04-10 16:17:13","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":35483,"visible":true,"origin":"","legend":"","description":"","filename":"Table1.docx","url":"https://assets-eu.researchsquare.com/files/rs-4220678/v1/c8446354270e54924065cb3f.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Use of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma and its performance in Japan over the past 18 years: A nationwide descriptive study","fulltext":[{"header":"Background","content":"\u003cp\u003eHemorrhage is one of the primary causes of mortality in trauma cases and accounts for an estimated 30\u0026ndash;40% of traumatic deaths [1]. Resuscitation of massive hemorrhages often requires massive transfusions and fluids, and rapid hemorrhage control is essential. Traditionally, aortic cross-clamping (ACC) has been used to temporarily control massive hemorrhage. However, ACC adds further invasiveness to a patient who has already sustained severe trauma, and managing bleeding from the incision site poses additional challenges [2]. Resuscitative endovascular balloon occlusion of the aorta (REBOA) has emerged as an alternative approach for controlling hemorrhages with minimal invasion [3]. However, its effectiveness is controversial. Some studies have shown that compared to ACC, REBOA has a better prognosis [2, 4], while others suggested that it is associated with a poorer prognosis [5-7]. Recently, a randomized trial conducted in major trauma centers in the United Kingdom suggested that REBOA increased the risk of death and prolonged the time to definitive hemostasis [7]. However, REBOA remains an option as a bridging therapy in non-trauma centers where trauma surgeons are not always available.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe situation surrounding REBOA is progressing without sufficient evidence. Off-the-job training courses for REBOA have been conducted worldwide, and devices have been improved, including the release of a narrower-diameter access route [8, 9], based on theoretical benefits. However, the validation of these efforts is insufficient. To better understand the current situation surrounding REBOA, we examined changes in its usage, target population, and treatment outcomes in Japan, where immediate hemostasis procedures sometimes cannot be performed.\u0026nbsp;\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy design and settings\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis retrospective observational study used data from the Japan Trauma Data Bank. The study was conducted from January 2004 to December 2021. The JTDB is required to register all severe trauma cases with AIS 3 or higher injuries and was established by the Japanese Association for Acute Medicine and Japanese Association for The Surgery of Trauma to understand the current status and improve the quality of trauma care, akin to the Trauma Quality Improvement Program in the United States. By the end of December 2021, the JTDB included 303 facilities providing trauma care in Japan, of which 95% were government-certified tertiary care centers.\u003c/p\u003e\n\u003cp\u003eThis study complied with the principles of the 1964 Declaration of Helsinki and its amendments and was approved by the Ethics Committee of Tsuchiura Kyodo General Hospital (approval number: 2022FY10). The requirement for informed consent from each patient was waived because of the study\u0026rsquo;s retrospective nature. We used the opt-out method, which provides opportunities to refuse to participate in the study through online information disclosure in our hospital. The study was conducted in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting statement.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy participants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study included all cases for which REBOA was used between 2004 and 2021.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMeasurements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe collected the following patient information from the JTDB: age; sex; year of injury; trauma classification (blunt or penetrating); pre-hospital vital signs [systolic blood pressure (SBP), heart rate (HR), respiratory rate (RR), and percutaneous oxygen saturation (SpO2)]; Glasgow coma scale (GCS) score; time from emergency medical service dispatch to emergency department (ED) arrival; vital signs at ED arrival [SBP, HR, RR, and SpO2, body temperature, and GCS, abbreviated injury scale (AIS) score for each region, injury severity score (ISS), revised trauma score (RTS), status at hospital discharge (survival or death)]; lactic acid level; focused assessment with sonography in trauma (FAST) results; number of REBOA cases, cases of cardiac arrest on arrival, and ACC cases; and probability of survival based on the trauma and injury severity score (TRISS-Ps).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDefinitions and outcomes\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe AIS was calculated based on AIS 98 until 2018 and AIS 2008 after 2019 in accordance with the change in JTDB registration rule. Data for pre-hospital GCS score, SpO\u003csub\u003e2\u003c/sub\u003e, and lactic acid levels on ED arrival were only available after 2019 in the JTDB. Cardiac arrest was characterized by a recorded SBP of\u0026thinsp;0 mmHg based on the registration instructions of the JTDB. The primary outcome was survival at hospital discharge.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trend of the number, characteristics, and outcomes of patients treated with REBOA and the number of facilities where REBOA was used, according to admission year, was described. Trends in hospital mortality were also compared among specific subgroups, including all patients with trauma, patients treated with REBOA, patients treated with REBOA without severe head or spine injuries defined by AIS \u0026ge;3, patients treated with REBOA with shock upon hospital arrival (SBP \u0026lt;80 mmHg), and patients treated with REBOA without shock upon hospital arrival.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePatient characteristics were described using median and interquartile range (IQR) for continuous variables and number and percentage (%) for categorical variables. The chi-square test was used with a significance level of 0.05 to test the association of variables. We conducted a single regression analysis to show the changes in annual mortality rates across some subgroups: all patients with trauma in the database, all cases in which REBOA was used, the REBOA group without severe head or spine injury of AIS \u0026ge;3, cases with SBP \u0026lt;80 mmHg among patients for whom REBOA was used, and patients with SBP \u0026ge;80 mmHg among patients for whom REBOA was used. We conducted a logistic regression analysis for the annual mortality rate adjusted by TRISS-Ps. All statistical analyses were performed using R software version 4.3.1 (R Foundation for Statistical Computing, Vienna, Austria).\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 427,561 patients were registered with the JTDB between 2004 and 2021. Of them, 2557 patients were treated with REBOA and were deemed eligible for inclusion. \u003cstrong\u003eTable 1\u003c/strong\u003e presents the baseline patient characteristics. Overall, the median age of the participants was 55 years, with male patients constituting 65.3% of the study population. Blunt trauma accounted for approximately 93.0% of the cases. The median transport time was 37 min. The median SBP at ED arrival was 70 mm Hg. The thoracic region had the highest median AIS score. FAST-positive cases accounted for 45.9% of the cases. The median ISS and RTS values were 34.0 and 4.7, respectively. The median TRISS-Ps was 0.35. The overall mortality rate was 59.7%, and 16.9% of the patients experienced cardiac arrest upon arrival. ACC was performed in 16.7% of the cases. The number of REBOA cases was 24 in 2004, which increased to 262 in 2019. The number of REBOA cases declined from 2020 to 167 by 2021. The in-hospital mortality rate decreased from 91.3% to 50.9% during the observation period.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe number of facilities using REBOA in 2004 increased from 10 to 105 in 2019. The number of facilities using REBOA has decreased since 2020, reaching 62 by 2021 (\u003cstrong\u003eFigure 1\u003c/strong\u003e). Although RTS changed substantially from 2004 to 2006, the median and IQR for both RTS (\u003cstrong\u003eFigure 2\u003c/strong\u003e) and ISS (\u003cstrong\u003eFigure 3\u003c/strong\u003e) were similar after these periods.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eUnivariate regression analysis was conducted in various subgroups to compare the trends in mortality rates (\u003cstrong\u003eFigure 4\u003c/strong\u003e). The REBOA group without severe head or spine injury of AIS \u0026ge;3 had greater improvement in mortality than that of all-patient group using REBOA and all-trauma patient group. The greatest improvement in mortality was observed in patients with SBP \u0026ge;80 mmHg among all patients for whom REBOA was performed.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eLogistic regression analysis for the outcome of annual mortality indicated steadily declined mortality even after adjusting for TRISS-Ps (\u003cstrong\u003eFigure 5\u003c/strong\u003e).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eA retrospective observational study analyzing data from the Japanese nationwide trauma registry over the past 18 years was conducted on 2,557 patients who underwent REBOA. A consistently decreasing trend in mortality was observed. The physiological and anatomical severities of the patients were similar over the years, and a reduction in mortality was observed, regardless of the severity of their conditions.\u003c/p\u003e\n\u003cp\u003eSeveral previous studies evaluated the mortality rate associated with REBOA, ranging from 34% to 70.8% [10-13]. Aoki et al. showed that the mortality rate of patients undergoing REBOA decreased between 2004 and 2015 [14]. Our study further enriched these results by adding 6 years of data, demonstrating changes over time in the number of cases in which REBOA was used, number of facilities using REBOA, and analysis of specific subgroups. The results of the present study revealed that mortality continued improving after 2016. The increase in the use of REBOA and the number of facilities implementing it until 2019 may be attributed to the growing recognition of the procedure. The introduction of hybrid emergency room system in Japan in 2011 partially could have contributed to this trend [15, 16].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFurthermore, 7 Fr narrow-diameter balloons were approved for clinical use in 2013. They were shown to reduce complications related to REBOA [17], including lower extremity ischemia. This technical progress in REBOA may have resulted in its increased number of REBOA uses. The decrease in the number of patients and facilities after 2020 could be attributed to the COVID-19 pandemic. Given that the RTS and ISS remained similar over the years, it was suggested that the indications for REBOA were consistent over 18 years.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWhile trauma-related mortality has decreased over the years [18], the mortality rate of patients treated with REBOA was further reduced compared to that of the all-trauma cohort [18]. There are several possible explanations for this. The improvement in mortality rate among patients without severe head or spine trauma was lower than that among all patients treated with REBOA. This suggests that REBOA and the overall hemostatic strategy, including damage control resuscitation, have improved. It is also possible that the REBOA insertion technique has been partially improved by disseminating off-the-job REBOA training courses in Japan [8, 19]. Among the cases of REBOA, a significant reduction in mortality was observed in patients with an SBP of 80 mmHg or higher, indicating that REBOA had a particularly significant effect on improving outcomes in bleeding patients with relatively stable conditions. The UK-REBOA randomized clinical trial suggested that there may be more deaths in the REBOA group, which may have been influenced by the longer time to hemostasis in the REBOA group. The present study suggests that using REBOA as a bridge to achieve hemostasis in relatively stable patients who do not require immediate hemostasis may be an evolving strategy.\u003c/p\u003e\n\u003cp\u003eThis study has some limitations. Information regarding when and where REBOA was used during the resuscitation is unavailable in the JTDB. The zone, extent, and duration of the REBOA inflation are also unclear. The expertise level of the individual performing REBOA is unknown. Detailed information on the preparation and operation of hemostatic procedures, such as the availability of trauma surgeons and operating theaters at each facility, is unavailable in the JTDB.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eWhile there was no significant change in patient severity, mortality of patients treated with REBOA decreased over time. Further research is required to determine the reasons for these improvements in trauma care.\u003c/p\u003e"},{"header":"List Of Abbreviations","content":"\u003cp\u003eREBOA, resuscitative endovascular balloon occlusion of the aorta; ACC, aortic cross-clamping; SBP, systolic blood pressure; HR, heart rate; RR, respiratory rate; SpO2, percutaneous oxygen saturation; GCS, Glasgow coma scale; ED, emergency department; AIS, abbreviated injury scale; ISS, injury severity score; RTS, revised trauma score; FAST, focused assessment with sonography in trauma; TRISS-Ps, trauma and injury severity score; IQR, interquartile range; percentage, %\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate:\u0026nbsp;\u003c/strong\u003eThis study was approved by the Ethics Committee of Tsuchiura Kyodo General Hospital (approval number: 2022FY10). The requirement for informed consent from each patient was waived because of the study\u0026rsquo;s retrospective nature. We used the opt-out method, which provides opportunities to refuse to participate in the study through online information disclosure in our hospital.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u0026nbsp;\u003c/strong\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u0026nbsp;\u003c/strong\u003eThe\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003edata that supported the findings of this study are available from the Japan Trauma Data Bank, but the availability of these data is restricted.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003cstrong\u003e:\u0026nbsp;\u003c/strong\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions:\u0026nbsp;\u003c/strong\u003eHH drafted and revised the manuscript, developed the study concept and design and was involved in statistical analysis and data interpretation. HH also takes responsibility for the research, final approval, and study supervision. AE assisted in manuscript revision, study concept and design development, and data interpretation and assumed responsibility for research conduct and final approval. RY, KY, KS, and TA were involved in data acquisition and manuscript revision and accepted responsibility for the research conduct and final approval. KM contributed to manuscript revision and data interpretation and took responsibility for conducting the research and obtaining final approval. All the authors have read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments:\u0026nbsp;\u003c/strong\u003eThe authors would like to thank Editage (www.editage.com) for the English language editing.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; information\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eHiromasa Hoshi: [email protected]\u003c/p\u003e\n\u003cp\u003eAkira Endo: [email protected]\u003c/p\u003e\n\u003cp\u003eRyo Yamamoto: [email protected]\u003c/p\u003e\n\u003cp\u003eKazuma Yamakawa: [email protected]\u003c/p\u003e\n\u003cp\u003eKeisuke Suzuki: [email protected]\u003c/p\u003e\n\u003cp\u003eTomohiro Akutsu: [email protected]\u003c/p\u003e\n\u003cp\u003eKoji Morishita: [email protected]\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003ePerkins JG, Cap AP, Weiss BM, Reid TJ, Bolan CD. Massive transfusion and nonsurgical hemostatic agents. Crit Care Med. 2008;36(7);Suppl:S325\u0026ndash;39. https://doi.org/10.1097/CCM.0b013e31817e2ec5\u003c/li\u003e\n \u003cli\u003eHaruta K, Endo A, Shiraishi A, Otomo Y. Usefulness of resuscitative endovascular balloon occlusion of the aorta compared to aortic cross-clamping in severely injured trauma patients: Analysis from the Japan Trauma Data Bank. Acute Med Surg. 2023;10:e830. https://doi.org/10.1002/ams2.830\u003c/li\u003e\n \u003cli\u003eDuBose JJ, Scalea TM, Brenner M, Skiada D, Inaba K, Cannon J, et al. The AAST prospective Aortic Occlusion for Resuscitation in Trauma and Acute Care Surgery (AORTA) registry: Data on contemporary utilization and outcomes of aortic occlusion and resuscitative balloon occlusion of the aorta (REBOA). J Trauma Acute Care Surg. 2016;81:409\u0026ndash;19. https://doi.org/10.1097/TA.0000000000001079\u003c/li\u003e\n \u003cli\u003eCralley AL, Vigneshwar N, Moore EE, Dubose J, Brenner ML, Sauaia A, et al. Zone 1 endovascular balloon occlusion of the aorta vs resuscitative thoracotomy for patient resuscitation after severe hemorrhagic shock. JAMA Surg. 2023;158:140\u0026ndash;50. https://doi.org/10.1001/jamasurg.2022.6393\u003c/li\u003e\n \u003cli\u003eKinslow K, Shepherd A, McKenney M, Elkbuli A. Resuscitative endovascular balloon occlusion of aorta: A systematic review. Am Surg. 2022;88:289\u0026ndash;96. https://doi.org/10.1177/0003134820972985\u003c/li\u003e\n \u003cli\u003eJoseph B, Zeeshan M, Sakran JV, Hamidi M, Kulvatunyou N, Khan M, et al. Nationwide analysis of resuscitative endovascular balloon occlusion of the aorta in civilian trauma. JAMA Surg. 2019;154:500\u0026ndash;8. https://doi.org/10.1001/jamasurg.2019.0096\u003c/li\u003e\n \u003cli\u003eJansen JO, Hudson J, Cochran C, MacLennan G, Lendrum R, Sadek S, et al. Emergency department resuscitative endovascular balloon occlusion of the aorta in trauma patients with exsanguinating hemorrhage: The UK-REBOA randomized clinical trial. JAMA. 2023;330:1862\u0026ndash;71. https://doi.org/10.1001/jama.2023.20850\u003c/li\u003e\n \u003cli\u003eBirrenbach T, Wespi R, Hautz WE, Berger J, Schwab PR, Papagiannakis G, et al. Development and usability testing of a fully immersive VR simulation for REBOA training. Int J Emerg Med. 2023;16:67. https://doi.org/10.1186/s12245-023-00545-6\u003c/li\u003e\n \u003cli\u003eSykes AG, Sisson WB, Wang LJ, Martin MJ, Thangarajah H, Naheedy J, et al. Balloons for kids: Anatomic candidacy and optimal catheter size for pediatric resuscitative endovascular balloon occlusion of the aorta. J Trauma Acute Care Surg. 2022;92:743\u0026ndash;7. https://doi.org/10.1097/TA.0000000000003521\u003c/li\u003e\n \u003cli\u003eGupta BK, Khaneja SC, Flores L, Eastlick L, Longmore W, Shaftan GW. The role of intra-aortic balloon occlusion in penetrating abdominal trauma. J Trauma. 1989;29:861\u0026ndash;5. https://doi.org/10.1097/00005373-198906000-00026\u003c/li\u003e\n \u003cli\u003eSaito N, Matsumoto H, Yagi T, Hara Y, Hayashida K, Motomura T, et al. Evaluation of the safety and feasibility of resuscitative endovascular balloon occlusion of the aorta. J Trauma Acute Care Surg. 2015;78:897\u0026ndash;903; discussion 4. https://doi.org/10.1097/TA.0000000000000614\u003c/li\u003e\n \u003cli\u003eIrahara T, Sato N, Moroe Y, Fukuda R, Iwai Y, Unemoto K. Retrospective study of the effectiveness of Intra-Aortic Balloon Occlusion (IABO) for traumatic haemorrhagic shock. World J Emerg Surg. 2015;10:1. https://doi.org/10.1186/1749-7922-10-1\u003c/li\u003e\n \u003cli\u003eMoore LJ, Brenner M, Kozar RA, Pasley J, Wade CE, Baraniuk MS, et al. Implementation of resuscitative endovascular balloon occlusion of the aorta as an alternative to resuscitative thoracotomy for noncompressible truncal hemorrhage. J Trauma Acute Care Surg. 2015;79:523\u0026ndash;30; discussion 30\u0026ndash;2. https://doi.org/10.1097/TA.0000000000000809\u003c/li\u003e\n \u003cli\u003eAoki M, Abe T, Hagiwara S, Saitoh D, Oshima K. Resuscitative endovascular balloon occlusion of the aorta may contribute to improved survival. Scand J Trauma Resusc Emerg Med. 2020;28:62. https://doi.org/10.1186/s13049-020-00757-2\u003c/li\u003e\n \u003cli\u003eWatanabe H, Shimojo Y, Hira E, Kuramoto S, Muronoi T, Oka K, et al. First establishment of a new table-rotated-type hybrid emergency room system. Scand J Trauma Resusc Emerg Med. 2018;26:80. https://doi.org/10.1186/s13049-018-0532-z\u003c/li\u003e\n \u003cli\u003eKinoshita T, Yamakawa K, Matsuda H, Yoshikawa Y, Wada D, Hamasaki T, et al. The survival benefit of a novel trauma workflow that includes immediate whole-body computed tomography, surgery, and interventional radiology, all in one trauma resuscitation room: A retrospective historical control study. Ann Surg. 2019;269:370\u0026ndash;6. https://doi.org/10.1097/SLA.0000000000002527\u003c/li\u003e\n \u003cli\u003eTeeter WA, Matsumoto J, Idoguchi K, Kon Y, Orita T, Funabiki T, et al. Smaller introducer sheaths for REBOA may be associated with fewer complications. J Trauma Acute Care Surg. 2016;81:1039\u0026ndash;45. https://doi.org/10.1097/TA.0000000000001143\u003c/li\u003e\n \u003cli\u003eEndo A, Shiraishi A, Matsui H, Hondo K, Otomo Y. Assessment of progress in early trauma care in Japan over the past decade: Achievements and areas for future improvement. J Am Coll Surg. 2017;224:191\u0026ndash;198.e5. https://doi.org/10.1016/j.jamcollsurg.2016.10.051\u003c/li\u003e\n \u003cli\u003eThabouillot O, Boddaert G, Travers S, Dubecq C, Derkenne C, Kedzierewicz R, et al. Effectiveness of short training in resuscitative endovascular balloon occlusion of the aorta (REBOA) by emergency physicians: The applied course for internal aortic clamping on field mission. J Spec Oper Med. 2021;21:36\u0026ndash;40. https://doi.org/10.55460/NYAW-F69L\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1 is available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"world-journal-of-emergency-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"wjes","sideBox":"Learn more about [World Journal of Emergency Surgery](http://wjes.biomedcentral.com)","snPcode":"13017","submissionUrl":"https://submission.nature.com/new-submission/13017/3","title":"World Journal of Emergency Surgery","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"resuscitative endovascular balloon occlusion of the aorta, trauma, hemorrhage, aortic cross-clamping","lastPublishedDoi":"10.21203/rs.3.rs-4220678/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4220678/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eResuscitative endovascular balloon occlusion of the aorta (REBOA) has been used to control massive hemorrhages. Although there is no consensus on the efficacy of REBOA, it remains an option as a bridging therapy in non-trauma centers where trauma surgeons are not available. To better understand the current landscape of REBOA application, we examined changes in its usage, target population, and treatment outcomes in Japan, where immediate hemostasis procedures sometimes cannot be performed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eThis retrospective observational study used the Japan Trauma Data Bank data. All cases in which REBOA was performed between January 2004 and December 2021 were included. The primary outcome was the in-hospital mortality rate. We analyzed mortality trends over time according to the number of cases, number of centers, severity of injury, and overall and subgroup mortality associated with REBOA usage. We performed a logistic analysis of mortality trends over time, adjusting for probability of survival based on the trauma and injury severity score.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults: \u003c/strong\u003eOverall, 2557 patients were treated with REBOA and were deemed eligible for inclusion. The median age of the participants was 55 years, and male patients constituted 65.3% of the study population. Blunt trauma accounted for approximately 93.0% of the cases. The number of cases and facilities that used REBOA increased until 2019. While the injury severity score and revised trauma score did not change throughout the observation period, the hospital mortality rate decreased from 91.3% to 50.9%. The REBOA group without severe head or spine injuries showed greater improvement in mortality than the all-patient group using REBOA and all-trauma patient group. The greatest improvement in mortality was observed in patients with systolic blood pressure ≥80 mmHg. The adjusted odds ratios for hospital mortality steadily declined, even after adjusting for the probability of survival.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions: \u003c/strong\u003eWhile there was no significant change in patient severity, mortality of patients treated with REBOA decreased over time. Further research is required to determine the reasons for these improvements in trauma care.\u003c/p\u003e","manuscriptTitle":"Use of resuscitative endovascular balloon occlusion of the aorta (REBOA) for trauma and its performance in Japan over the past 18 years: A nationwide descriptive study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-04-10 16:17:08","doi":"10.21203/rs.3.rs-4220678/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2024-04-19T15:09:54+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-04-17T11:51:35+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2024-04-10T20:48:42+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"031e5e33-1c14-4159-84c7-6d00ee5c59cf","date":"2024-04-06T21:10:28+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"0b506643-9a03-469a-b799-83ba571094dc","date":"2024-04-06T14:14:43+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2024-04-06T05:59:18+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2024-04-06T05:55:04+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2024-04-05T11:15:35+00:00","index":"","fulltext":""},{"type":"submitted","content":"World Journal of Emergency Surgery","date":"2024-04-05T04:37:03+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"world-journal-of-emergency-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"wjes","sideBox":"Learn more about [World Journal of Emergency Surgery](http://wjes.biomedcentral.com)","snPcode":"13017","submissionUrl":"https://submission.nature.com/new-submission/13017/3","title":"World Journal of Emergency Surgery","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"ccc4e873-55d3-471d-b806-7a5cb0747951","owner":[],"postedDate":"April 10th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2024-05-20T22:12:28+00:00","versionOfRecord":[],"versionCreatedAt":"2024-04-10 16:17:08","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4220678","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4220678","identity":"rs-4220678","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}