A novel femoral artery compression device compared with manual compression for hemostasis after femoral artery access in coronary artery catheterizations

A novel femoral artery compression device compared with manual compression for hemostasis after femoral artery access in coronary artery catheterizations | 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 A novel femoral artery compression device compared with manual compression for hemostasis after femoral artery access in coronary artery catheterizations Sathienwit Rowsathien, Muenpetch Muenkaew, Ramez Vessawan, Wiroj Limtrakarn This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7834897/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Femoral arterial access remains widely used in contemporary coronary catheterization procedures. Following the removal of the femoral sheath, hand compression is commonly employed to achieve hemostasis. Nevertheless, this method is time-consuming and imposes a burden on both the operator and the patient. Objective: This study aims to investigate the hemostatic efficacy of the novel external femoral artery compression device (the TU device). Materials and Methods: Patients enrolled in this study were randomly assigned in a 1:1 ratio to either the TU device (with a 3-2-1 protocol for compression) or the conventional hand compression group. The primary efficacy outcome was the time to achieve hemostasis within 15 minutes, and the safety outcomes were major vascular complications. Other secondary outcomes included minor vascular complications, time to hospital discharge, reports of vasovagal symptoms, discomfort levels, as well as user and patient satisfaction. Results: A total of 52 patients were included in this study (TU device, n = 26 vs. hand compression, n = 26). The baseline characteristics of the groups were mostly similar. We found that achieving hemostasis within 15 minutes was successful in the TU device group more than in the hand compression group (84.6% vs. 46.2%, p = 0.004). Small hematomas were reported more frequently in the device group (34.6% vs. 7.7%, p = 0.017). Interestingly, there was an absence of any vasovagal response in patients using the device (0% vs. 15.4%, p = 0.037). There were no significant differences in major vascular complications, time to hospital discharge, patient discomfort, and satisfaction scores between the groups. Conclusions: The TU device is effective for achieving femoral artery hemostasis with an acceptable rate of access site complications compared to conventional hand compression. Coronary catheterization femoral access compression pneumatic novel device Figures Figure 1 Figure 2 Figure 3 Figure 4 Introduction The femoral artery is commonly utilized as a site for coronary catheterization due to its convenience, large size, and ease of device insertion for various procedures. However, upon catheter removal, it frequently necessitates manual pressure application by the operator for a minimum of 10–15 minutes to mitigate bleeding. Current post procedural complications in this region persist at relatively high rates, with reported incidences ranging from 0.5% − 16.8% as per data from multiple studies ( 1 ) . Numerous factors contribute to these complications, encompassing patient characteristics, procedural type, catheter dimensions, duration of pressure application, and operator experience. Currently, various devices have been invented to assist in hemostasis of the femoral artery, including hemostasis pads, vascular closure devices, and external compression devices. Within the category of external compression devices, there are primarily two main types based on their compression design ( 2 ) . The first type involves wrapping around the waist, exemplified by Femostop TM( 3 ) and the Butterfly compression device ( 4 ) . The second type is designed with a clamp-like structure for compression, such as ClampEase™ and CompressAR TM( 5 ) . The Butterfly compression device requires less time for compression compared to manual compression, while Femostop™ takes approximately 2 minutes for hemostasis ( 5 ) . However, neither group of devices demonstrates superiority over manual compression concerning complications associated with the artery, duration of hospital stay, and cost-effectiveness ( 6 ) . The novel femoral artery compression device investigated in this study is classified as a C-Clamp device. It represents a new design that integrates direct pneumatic pressure application at the site of artery compression. This device can regulate pneumatic pressure within the range of 0–3 atm, thus effectively preventing bleeding and halting the foot pulse. It is manufactured utilizing self-produced components within Thailand, with the primary objective of enhancing comfort levels for both operators and patients, mitigating complications associated with artery compression, reducing hospital stay durations, and promoting the use of domestically manufactured medical equipment by Thai manufacturers. This initiative contributes significantly to the global advancement and endorsement of Thai innovation, while simultaneously alleviating the financial burden associated with medical equipment expenses in the country. Methods Study Design: This study describes an investigator-initiated, prospective, randomized, single-center trial evaluating the efficacy of a novel external femoral compression device (TU device). All patients were randomly assigned using block randomization to achieve balanced allocation (1:1) to receive either the TU device or conventional manual hand compression (Figure 1). Study population: Patients aged 18 years and older requiring transcatheter coronary angiography via the femoral artery using a 5-7 Fr catheter were eligible for inclusion in this study. Participants meeting any of the following criteria were excluded from the study: severe abnormality of the ankle-brachial index (ABI) with values 1.4 at the puncture site, severe coagulopathy, cirrhosis with Child-Turcotte-Pugh (CTP) class B or C, end-stage renal disease (ESRD) not receiving renal replacement therapy, unstable hemodynamic status, pregnancy, and extreme obesity defined as a body weight > 110 kg or a body mass index (BMI) > 40 kg/m². Procedures and device description All patient underwent femoral puncture of the common femoral artery under fluoroscopic guided with the modified Seldinger’s technique. The TU device (Figure 2) comprises a base with a hand-adjustable handle, along with a pneumatically controlled pressure shaft (0-3 atmosphere-atm) and a replaceable pressure plate at the end of the shaft. Following the completion of coronary angiography, the operator will verify the position of catheter's placement and gently withdraw it by approximately 1-2 cm before sealing the wound with a transparent sterile patch. Following this, the machine is strategically placed beneath the patient's hips, ensuring the base is appropriately positioned (Figure 3). The pressure shaft's level is then adjusted to the required setting. To maintain contact with the catheter insertion site, the tip of the handle is securely positioned against the pressure plate. Upon activation, the machine initiates the application of air pressure, commencing at a maximum dose of 3 atm. At intervals of 5 minutes, the compression area undergoes assessment to confirm the absence of bleeding, leading to a gradual reduction in air pressure to 2 atm and then to 1 atm, adhering to the established 3-2-1 protocol. This compression regimen spans a total duration of 15 minutes, aimed at achieving effective hemostasis and cessation of bleeding, thereby signifying the completion of the procedure. Device failure is defined as the inability to stop bleeding within the designated timeframe, patient intolerance during compression, or the development of a hematoma measuring ≥ 5 cm. For the conventional hand compression group, compression was achieved by applying direct pressure at the site until bleeding ceased. Ambulation was permitted at least 6 hours after the completion of the procedure in both groups. Definitions and outcomes Time to Hemostasis : The time, measured in minutes, from the removal of the catheter sheath to the achievement of complete hemostasis. Time to Hospital Discharge : The time, measured in days, from the removal of the catheter sheath to the attainment of stable hospital discharge. Primary efficacy outcome Time to hemostasis with a cut-off point of 15 minutes. Primary safety outcomes Major vascular complications defined as: active bleeding resulting in a hemoglobin (Hb) drop of ≥ 3 gm/dL or ≥ 1 gm/dL with anemic symptoms requiring blood transfusion, Hematoma size ≥ 5 cm, pseudoaneurysm at the puncture site and arteriovenous (AV) fistula requiring surgical management. Secondary outcomes Including minor vascular complications such as small hematomas, time to hospital discharge, reporting of patient vasovagal symptoms, discomfort levels (measured using the Wong-Baker faces pain rating scale), and assessment of patient and user satisfaction (using a Likert scale). Data Collection and Follow-Up Data were collected as follows: age, sex, body mass index (BMI), weight, history of hypertension, diabetes, myocardial infarction, smoking status, and medications such as antithrombotic and anticoagulants taken during the periprocedural period. Additionally, the size of the common femoral artery (CFA) and the puncture zone (divided into 5 zones relative to the femoral head (7) ) was recorded from peripheral angiographic data. Follow-up data were obtained from the hospital's medical records. Statistical analysis The intention-to-treat analysis was conducted. Continuous data were expressed as means ± standard deviations (SD). Categorical data were reported as frequencies and percentages. Differences in normally distributed variables were assessed using Student’s t-tests, and for those with abnormal distributions, the Mann-Whitney U test was employed. Chi-square or Fisher’s exact test was utilized for dichotomous data. Statistical significance was defined as a p-value < 0.05. Data analysis was performed using SPSS software (Version 25.0, SPSS Inc., Chicago, IL, USA). The study protocol received approval from the Ethics Committee of Thammasat University Hospital in accordance with the Declaration of Helsinki regarding research and medical ethics. Results From January 2024 through April 2024, a total of 52 patients were enrolled, with 26 patients assigned to use the TU device and conventional hand compression in a 1:1 ratio (Figure 1). The baseline characteristics are shown in Table 1. The overall mean age of patients in this study was 69.4 years, with 19.2% being octogenarians and 40.4% being women. In the hand compression group, patients appeared to have a higher weight and BMI (66.1 ± 12.1 kg and 26.6 ± 4.2 kg/m²). Ankle-brachial index (ABI), systolic blood pressure before compression, general underlying diseases such as hypertension, diabetes mellitus, dyslipidemia, chronic kidney disease, history of previous myocardial infarction, presentation with acute coronary syndrome (ACS), and baseline laboratory data (hemoglobin, hematocrit, international normalized ratio (INR), and platelet level) were well-balanced between the groups. Pre-procedural aspirin use seemed to be more common among patients in the hand compression group (65.4% in the TU device group and 92.3% in the hand compression group, p = 0.017). From the angiographic characteristics (Table 2), the most commonly used catheter sheath size was 6 French (Fr). The mean CFA diameter was 6.91 mm and the same in both groups. Almost all procedures used the right femoral approach. Regarding the puncture site, the most common was the third zone, which was more represented in the hand compression group. Only three patients (5.8%) in this study had angiographically normal coronary arteries. For the outcomes (Table 3), the device's 3-2-1 protocol achieved an 84.6% success rate. Comparing between the groups, the TU device performed better than manual hand compression in achieving hemostasis within 15 minutes, as shown in Figure 4 (84.6% vs. 46.2%, respectively, p = 0.004). Four patients in the device group crossed over to hand compression and achieved successful hemostasis thereafter, as detailed in Table 4. The incidence of hematoma after compression appeared slightly higher in the device group (34.6% vs. 7.7%, p = 0.017). Although the hematoma size was slightly larger in the device group, it did not reach statistical significance (1.54 ± 2.79 vs. 0.35 ± 1.29, p = 0.054), nor did the incidence of large hematomas (>5 cm). No vagal symptoms were demonstrated during compression in patients using the TU device (0% vs. 15.4%, p = 0.037). Mild compressive pain was equally reported, and the time of hospital discharge was comparable between both groups. In this study, there were no incidences of major vascular complications (AV fistula, perforation, or pseudoaneurysm), overt bleeding, or significant anemia after the completion of the procedure. The ambulation time in this study was six hours for all patients without groin limitation. Both user and patient satisfaction were above average in both groups. Discussion Although more coronary catheterizations are nowadays performed through the radial artery due to data indicating reduced bleeding and vascular complications (8) , catheter placement through the femoral artery remains necessary and common. This is especially true when performing procedures in specific situations such as bypass graft angiograms, older age where patients may have brachiocephalic artery tortuosity, or even in complex coronary lesions. However, performing procedures via the femoral artery carries the risk of complications such as hematoma, AV fistula, pseudoaneurysm, arterial dissection, and perforation, all of which can be dangerous and potentially life-threatening (9) . Many procedural techniques are currently being developed to reduce complications in femoral arterial access, such as ultrasound-guided vascular puncture, micropuncture techniques, fluoroscopic guidance, and femoral angiograms (10) . After catheter sheath removal, the most common, simplest, and possibly the gold standard hemostatic method for the femoral artery is manual hand compression. However, it is laborious, time-consuming, and relies on the operator's hand force, which may cause discomfort for both the patient and the operator. Many inventions of other hemostatic methods aim to solve this problem, including collagen plug arterial closure devices such as Angioseal TM . The risk of device embolization may limit the use of Angioseal TM , especially in patients with peripheral arterial disease (11) . Another device, such as the single vascular suture device named Proglide TM , carries a risk of arterial stenosis and requires a skillful operator to handle it (12) . The incidence of complications, especially infection and thrombotic events following the use of vascular closure devices, may be higher than with manual hand compression (13) . This study involved a randomized comparison between the novel external femoral arterial compression device, the “TU device,” and hand compression for patients undergoing coronary catheterization. Based on our laboratory data, we found that applying 2 atm of pressure can fully compress the femoral artery, resulting in the absence of distal pulsation in healthy volunteers. Therefore, we decided to establish a pressure-tailored fifteen-minute protocol (3-2-1) based on regular hand compression data, which typically takes around 15-20 minutes for complete femoral hemostasis (14) . Interestingly, even with the fixed fifteen-minute protocol of the device competing with manual hand compression, the human hand still took more time to achieve hemostasis (23.5 ± 15.5 min) with a minimum time of 10 minutes and a maximum of 80 minutes. This data shows that the timing of manual compression of the femoral artery varies significantly between individuals, even within specialized fields such as cardiovascular care, including cardiology fellows and nurses who are responsible for these cases. The variety of force applied during hand compression may cause discomfort to the patient and aggravate the vasovagal response; however, this response was not found in any case involving the TU device compression due to the constant and stable force at the compression site. Additionally, the device demonstrates a high successful compression rate with complete hemostasis and the absence of major vascular complications after using this device. The small hematomas found in this study all completely resolved after a two-week follow-up. The TU device can be operated by one person, eliminating the risk of embolization due to foreign body implantation, and a repeat procedure at the same site can be resumed shortly after completion of hemostasis. Finally, this device should reduce workload, increase operator comfort, and lower complications, especially symptoms caused by the vasovagal response in patients. Limitation Meta-analysis data have not clearly demonstrated a difference between manual compression and vascular closure device complication rates (15) ; the same was found in this study. However, this study had a small sample size. The rate of successful compression and potential vascular complications resulting from the device were expected outcomes. Incidentally, the equipment used in this study is of a new type, consisting of only one size of plate and shaft (with a plate size of 1.5 cm and shaft depth of 3 cm), which may not be suitable for the anatomy of some patients. This limitation may have contributed to device failure in four patients (due to incorrect point of compression or device slippage), all of which were corrected by standard hand compression without major vascular or bleeding complication. Additionally, the catheter sheath used in this study was 5-7 Fr, so there is no data available for other sizes. Further large-scale studies with longer follow-up periods are required. Conclusions The TU device with the 3-2-1 protocol is feasible and comfortable exhibiting a high successful hemostasis rate. It may shorten the time to hemostasis for patients, with an acceptable and similar rate of access site complications compared to conventional hand compression. Declarations Conflict of interest and funding: No References Chen H-Z, et al. Compression methods after femoral artery puncture, a protocol for systematic review and network meta-analysis. Medicine 2021; 100: 4(e24506). Huang PH, Hassan AKM, Resnic FS. Manual, mechanical, and device hemostasis. In: Lanzer P, ed. Textbook of Catheter-Based Cardiovascular Interventions: A Knowledge-Based Approach. Cham: Springer; 2018. p. 435-63. Courtesy of Abbott vascular, Comparison of the FemoStop device and manual pressure in reducing groin puncture site complications, International Journal of Nursing Practice 2001; 7 : 366–375. He Yi, et al. (2022) A novel femoral artery compression device versus manual compression for hemostasis after femoral artery puncture: a randomized comparison, Minimally Invasive Therapy & Allied Technologies, 31:1, 50-57. Courtesy of advance vascular dynamics, Semler, H J. Transfemoral catheterization: mechanical versus manual control of bleeding. Radiology 1985; 154:234-235. Ayman K.M. Hassan, et al. A new femoral compression device compared with manual compression for bleeding control after coronary diagnostic catheterizations, The Egyptian Heart Journal, Volume 66, Issue 3, 2014, 233-239. Mahmoud Khalil, MD et al. Common Femoral Artery Anatomy and Relations to Bony Landmarks: A Computed Tomography Angiogram Study. Vascular disease management 2021;18(11):E198-E203. Valgimigli M, Gagnor A, Calabró P, et al. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet. 2015;385(9986):2465-2476. Muller DW, Shamir KJ, Ellis SG, Topol EJ. Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures. Am J Cardiol. 1992;69(1):63-68. Lee MS, Applegate B, Rao SV, Kirtane AJ, Seto A, Stone GW. Minimizing femoral artery access complications during percutaneous coronary intervention: a comprehensive review. Catheter Cardiovasc Interv. 2014;84(1):62-69. Fokkema TM, Minnee RC, Kock GA, Blomjous JG, Vahl AC, Leijdekkers VJ. Comparison of a collagen plug arterial closure device with manual compression after endovascular interventions for peripheral artery disease. J Vasc Surg. 2016;64(1):104-108.e1. Wagner SC, Gonsalves CF, Eschelman DJ, Sullivan KL, Bonn J. Complications of a percutaneous suture-mediated closure device versus manual compression for arteriotomy closure: a case-controlled study. J Vasc Interv Radiol. 2003;14(6):735-741. Noori VJ, Eldrup-Jørgensen J. A systematic review of vascular closure devices for femoral artery puncture sites. J Vasc Surg. 2018;68(3):887-899. Kern MJ, Back to Basics: Femoral Artery Access and Hemostasis. Cath Lab digest. 2013;21(10). Turi ZG. An evidence-based approach to femoral arterial access and closure. Rev Cardiovasc Med. 2008;9(1):7-18. Tables Tables 1 to 4 are available in the Supplementary Files section. Additional Declarations The authors declare no competing interests. Supplementary Files Tables1234.docx Cite Share Download PDF Status: Posted Version 1 posted 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. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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09:04:59","extension":"html","order_by":20,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":56081,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7834897/v1/1a914d2a338c088105a9c32d.html"},{"id":93570507,"identity":"db24f3cd-3867-4b75-ba42-417b5619397f","added_by":"auto","created_at":"2025-10-15 08:56:58","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":48942,"visible":true,"origin":"","legend":"\u003cp\u003eThe study design.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-7834897/v1/92b62f2ff31b0b6b7e0b1b4b.png"},{"id":93571668,"identity":"c39b8e86-e8c0-44c8-a352-701dadf15663","added_by":"auto","created_at":"2025-10-15 09:04:59","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":122397,"visible":true,"origin":"","legend":"\u003cp\u003eDiagram of a novel external femoral compression device (TU device).\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-7834897/v1/51e101f30e30965ee930df1b.png"},{"id":93571671,"identity":"7c8c4cb3-bff8-4e1f-95e1-70a41ded056c","added_by":"auto","created_at":"2025-10-15 09:04:59","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":187338,"visible":true,"origin":"","legend":"\u003cp\u003ePatient with TU device.\u003c/p\u003e","description":"","filename":"floatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-7834897/v1/a3bb45dc847cf3a1ba2c49b3.png"},{"id":93570508,"identity":"fb70b0da-326f-4a98-bbbe-ed53a844bf0f","added_by":"auto","created_at":"2025-10-15 08:56:59","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":9391,"visible":true,"origin":"","legend":"\u003cp\u003eTime to hemostasis based on group assignment.\u003c/p\u003e","description":"","filename":"floatimage7.png","url":"https://assets-eu.researchsquare.com/files/rs-7834897/v1/29c4ff10a803ec4bedf569cc.png"},{"id":93573827,"identity":"869dbc67-95f4-4179-93fb-b44abb4da4d0","added_by":"auto","created_at":"2025-10-15 09:13:04","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":832258,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7834897/v1/e3b5a658-79e1-4ac2-a873-bd7886c194d7.pdf"},{"id":93570512,"identity":"ed86a64b-7c86-4f63-8136-8f066a1c4114","added_by":"auto","created_at":"2025-10-15 08:56:59","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":175132,"visible":true,"origin":"","legend":"","description":"","filename":"Tables1234.docx","url":"https://assets-eu.researchsquare.com/files/rs-7834897/v1/d91f50179e0ed2027dcc1b41.docx"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eA novel femoral artery compression device compared with manual compression for hemostasis after femoral artery access in coronary artery catheterizations\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe femoral artery is commonly utilized as a site for coronary catheterization due to its convenience, large size, and ease of device insertion for various procedures. However, upon catheter removal, it frequently necessitates manual pressure application by the operator for a minimum of 10\u0026ndash;15 minutes to mitigate bleeding. Current post procedural complications in this region persist at relatively high rates, with reported incidences ranging from 0.5% \u0026minus;\u0026thinsp;16.8% as per data from multiple studies\u003csup\u003e(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e)\u003c/sup\u003e. Numerous factors contribute to these complications, encompassing patient characteristics, procedural type, catheter dimensions, duration of pressure application, and operator experience.\u003c/p\u003e\u003cp\u003eCurrently, various devices have been invented to assist in hemostasis of the femoral artery, including hemostasis pads, vascular closure devices, and external compression devices. Within the category of external compression devices, there are primarily two main types based on their compression design\u003csup\u003e(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e)\u003c/sup\u003e. The first type involves wrapping around the waist, exemplified by Femostop\u003csup\u003eTM(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/sup\u003e and the Butterfly compression device\u003csup\u003e(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e)\u003c/sup\u003e. The second type is designed with a clamp-like structure for compression, such as ClampEase\u0026trade; and CompressAR\u003csup\u003eTM(\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/sup\u003e. The Butterfly compression device requires less time for compression compared to manual compression, while Femostop\u0026trade; takes approximately 2 minutes for hemostasis\u003csup\u003e(\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/sup\u003e. However, neither group of devices demonstrates superiority over manual compression concerning complications associated with the artery, duration of hospital stay, and cost-effectiveness\u003csup\u003e(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e)\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eThe novel femoral artery compression device investigated in this study is classified as a C-Clamp device. It represents a new design that integrates direct pneumatic pressure application at the site of artery compression. This device can regulate pneumatic pressure within the range of 0\u0026ndash;3 atm, thus effectively preventing bleeding and halting the foot pulse. It is manufactured utilizing self-produced components within Thailand, with the primary objective of enhancing comfort levels for both operators and patients, mitigating complications associated with artery compression, reducing hospital stay durations, and promoting the use of domestically manufactured medical equipment by Thai manufacturers. This initiative contributes significantly to the global advancement and endorsement of Thai innovation, while simultaneously alleviating the financial burden associated with medical equipment expenses in the country.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy Design:\u0026nbsp;\u003c/strong\u003eThis study describes an investigator-initiated, prospective, randomized, single-center trial evaluating the efficacy of a novel external femoral compression device (TU device). All patients were randomly assigned using block randomization to achieve balanced allocation (1:1) to receive either the TU device or conventional manual hand compression (Figure 1).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy population:\u0026nbsp;\u003c/strong\u003ePatients aged 18 years and older requiring transcatheter coronary angiography via the femoral artery using a 5-7 Fr catheter were eligible for inclusion in this study. Participants meeting any of the following criteria were excluded from the study: severe abnormality of the ankle-brachial index (ABI) with values \u0026lt; 0.7 or \u0026gt; 1.4 at the puncture site, severe coagulopathy, cirrhosis with Child-Turcotte-Pugh (CTP) class B or C, end-stage renal disease (ESRD) not receiving renal replacement therapy, unstable hemodynamic status, pregnancy, and extreme obesity defined as a body weight \u0026gt; 110 kg or a body mass index (BMI) \u0026gt; 40 kg/m\u0026sup2;.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProcedures and device description\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll patient underwent femoral puncture of the common femoral artery under fluoroscopic guided with the modified Seldinger\u0026rsquo;s technique. The TU device (Figure 2) comprises a base with a hand-adjustable handle, along with a pneumatically controlled pressure shaft (0-3 atmosphere-atm) and a replaceable pressure plate at the end of the shaft. Following the completion of coronary angiography, the operator will verify the position of catheter\u0026apos;s placement and gently withdraw it by approximately 1-2 cm before sealing the wound with a transparent sterile patch. Following this, the machine is strategically placed beneath the patient\u0026apos;s hips, ensuring the base is appropriately positioned (Figure 3). The pressure shaft\u0026apos;s level is then adjusted to the required setting. To maintain contact with the catheter insertion site, the tip of the handle is securely positioned against the pressure plate. Upon activation, the machine initiates the application of air pressure, commencing at a maximum dose of 3 atm. At intervals of 5 minutes, the compression area undergoes assessment to confirm the absence of bleeding, leading to a gradual reduction in air pressure to 2 atm and then to 1 atm, adhering to the established 3-2-1 protocol. This compression regimen spans a total duration of 15 minutes, aimed at achieving effective hemostasis and cessation of bleeding, thereby signifying the completion of the procedure.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eDevice failure\u003c/em\u003e is defined as the inability to stop bleeding within the designated timeframe, patient intolerance during compression, or the development of a hematoma measuring \u0026ge; 5 cm. For the conventional hand compression group, compression was achieved by applying direct pressure at the site until bleeding ceased. Ambulation was permitted at least 6 hours after the completion of the procedure in both groups.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDefinitions and outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTime to Hemostasis\u003c/em\u003e: The time, measured in minutes, from the removal of the catheter sheath to the achievement of complete hemostasis.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTime to Hospital Discharge\u003c/em\u003e: The time, measured in days, from the removal of the catheter sheath to the attainment of stable hospital discharge.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003ePrimary efficacy outcome\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTime to hemostasis with a cut-off point of 15 minutes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003ePrimary safety outcomes\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMajor vascular complications defined as: active bleeding resulting in a hemoglobin (Hb) drop of \u0026ge; 3 gm/dL or \u0026ge; 1 gm/dL with anemic symptoms requiring blood transfusion, Hematoma size \u0026ge; 5 cm, \u0026nbsp;pseudoaneurysm at the puncture site and arteriovenous (AV) fistula requiring surgical management.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cu\u003eSecondary outcomes\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIncluding minor vascular complications such as small hematomas, time to hospital discharge, reporting of patient vasovagal symptoms, discomfort levels (measured using the Wong-Baker faces pain rating scale), and assessment of patient and user satisfaction (using a Likert scale).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Collection and Follow-Up\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData were collected as follows: age, sex, body mass index (BMI), weight, history of hypertension, diabetes, myocardial infarction, smoking status, and medications such as antithrombotic and anticoagulants taken during the periprocedural period. Additionally, the size of the common femoral artery (CFA) and the puncture zone (divided into 5 zones relative to the femoral head\u003csup\u003e(7)\u003c/sup\u003e) was recorded from peripheral angiographic data. Follow-up data were obtained from the hospital\u0026apos;s medical records.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe intention-to-treat analysis was conducted. Continuous data were expressed as means \u0026plusmn; standard deviations (SD). Categorical data were reported as frequencies and percentages. Differences in normally distributed variables were assessed using Student\u0026rsquo;s t-tests, and for those with abnormal distributions, the Mann-Whitney U test was employed. Chi-square or Fisher\u0026rsquo;s exact test was utilized for dichotomous data. Statistical significance was defined as a p-value \u0026lt; 0.05. Data analysis was performed using SPSS software (Version 25.0, SPSS Inc., Chicago, IL, USA). The study protocol received approval from the Ethics Committee of Thammasat University Hospital in accordance with the Declaration of Helsinki regarding research and medical ethics.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eFrom January 2024 through April 2024, a total of 52 patients were enrolled, with 26 patients assigned to use the TU device and conventional hand compression in a 1:1 ratio (Figure 1). The baseline characteristics are shown in Table 1. The overall mean age of patients in this study was 69.4 years, with 19.2% being octogenarians and 40.4% being women. In the hand compression group, patients appeared to have a higher weight and BMI (66.1 \u0026plusmn; 12.1 kg and 26.6 \u0026plusmn; 4.2 kg/m\u0026sup2;). Ankle-brachial index (ABI), systolic blood pressure before compression, general underlying diseases such as hypertension, diabetes mellitus, dyslipidemia, chronic kidney disease, history of previous myocardial infarction, presentation with acute coronary syndrome (ACS), and baseline laboratory data (hemoglobin, hematocrit, international normalized ratio (INR), and platelet level) were well-balanced between the groups. Pre-procedural aspirin use seemed to be more common among patients in the hand compression group (65.4% in the TU device group and 92.3% in the hand compression group, p = 0.017). From the angiographic characteristics (Table 2), the most commonly used catheter sheath size was 6 French (Fr). The mean CFA diameter was 6.91 mm and the same in both groups. Almost all procedures used the right femoral approach. Regarding the puncture site, the most common was the third zone, which was more represented in the hand compression group. Only three patients (5.8%) in this study had angiographically normal coronary arteries.\u003c/p\u003e\n\u003cp\u003eFor the outcomes (Table 3), the device\u0026apos;s 3-2-1 protocol achieved an 84.6% success rate. Comparing between the groups, the TU device performed better than manual hand compression in achieving hemostasis within 15 minutes, as shown in Figure 4 (84.6% vs. 46.2%, respectively, p = 0.004). Four patients in the device group crossed over to hand compression and achieved successful hemostasis thereafter, as detailed in Table 4. The incidence of hematoma after compression appeared slightly higher in the device group (34.6% vs. 7.7%, p = 0.017). Although the hematoma size was slightly larger in the device group, it did not reach statistical significance (1.54 \u0026plusmn; 2.79 vs. 0.35 \u0026plusmn; 1.29, p = 0.054), nor did the incidence of large hematomas (\u0026gt;5 cm). No vagal symptoms were demonstrated during compression in patients using the TU device (0% vs. 15.4%, p = 0.037). Mild compressive pain was equally reported, and the time of hospital discharge was comparable between both groups. In this study, there were no incidences of major vascular complications (AV fistula, perforation, or pseudoaneurysm), overt bleeding, or significant anemia after the completion of the procedure. The ambulation time in this study was six hours for all patients without groin limitation. Both user and patient satisfaction were above average in both groups.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eAlthough more coronary catheterizations are nowadays performed through the radial artery due to data indicating reduced bleeding and vascular complications\u003csup\u003e(8)\u003c/sup\u003e, catheter placement through the femoral artery remains necessary and common. This is especially true when performing procedures in specific situations such as bypass graft angiograms, older age where patients may have brachiocephalic artery tortuosity, or even in complex coronary lesions. However, performing procedures via the femoral artery carries the risk of complications such as hematoma, AV fistula, pseudoaneurysm, arterial dissection, and perforation, all of which can be dangerous and potentially life-threatening\u003csup\u003e(9)\u003c/sup\u003e. Many procedural techniques are currently being developed to reduce complications in femoral arterial access, such as ultrasound-guided vascular puncture, micropuncture techniques, fluoroscopic guidance, and femoral angiograms\u003csup\u003e(10)\u003c/sup\u003e.\u0026nbsp;After catheter sheath removal, the most common, simplest, and possibly the gold standard hemostatic method for the femoral artery is manual hand compression. However, it is laborious, time-consuming, and relies on the operator\u0026apos;s hand force, which may cause discomfort for both the patient and the operator. Many inventions of other hemostatic methods aim to solve this problem, including collagen plug arterial closure devices such as Angioseal\u003csup\u003eTM\u003c/sup\u003e. The risk of device embolization may limit the use of Angioseal\u003csup\u003eTM\u003c/sup\u003e, especially in patients with peripheral arterial disease\u003csup\u003e(11)\u003c/sup\u003e. Another device, such as the single vascular suture device named Proglide\u003csup\u003eTM\u003c/sup\u003e, carries a risk of arterial stenosis and requires a skillful operator to handle it\u003csup\u003e(12)\u003c/sup\u003e. The incidence of complications, especially infection and thrombotic events following the use of vascular closure devices, may be higher than with manual hand compression\u003csup\u003e(13)\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThis study involved a randomized comparison between the novel external femoral arterial compression device, the \u0026ldquo;TU device,\u0026rdquo; and hand compression for patients undergoing coronary catheterization. Based on our laboratory data, we found that applying 2 atm of pressure can fully compress the femoral artery, resulting in the absence of distal pulsation in healthy volunteers. Therefore, we decided to establish a pressure-tailored fifteen-minute protocol (3-2-1) based on regular hand compression data, which typically takes around 15-20 minutes for complete femoral hemostasis\u003csup\u003e(14)\u003c/sup\u003e. Interestingly, even with the fixed fifteen-minute protocol of the device competing with manual hand compression, the human hand still took more time to achieve hemostasis (23.5 \u0026plusmn; 15.5 min) with a minimum time of 10 minutes and a maximum of 80 minutes. This data shows that the timing of manual compression of the femoral artery varies significantly between individuals, even within specialized fields such as cardiovascular care, including cardiology fellows and nurses who are responsible for these cases. The variety of force applied during hand compression may cause discomfort to the patient and aggravate the vasovagal response; however, this response was not found in any case involving the TU device compression due to the constant and stable force at the compression site. Additionally, the device demonstrates a high successful compression rate with complete hemostasis and the absence of major vascular complications after using this device. The small hematomas found in this study all completely resolved after a two-week follow-up. The TU device can be operated by one person, eliminating the risk of embolization due to foreign body implantation, and a repeat procedure at the same site can be resumed shortly after completion of hemostasis. Finally, this device should reduce workload, increase operator comfort, and lower complications, especially symptoms caused by the vasovagal response in patients.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLimitation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMeta-analysis data have not clearly demonstrated a difference between manual compression and vascular closure device complication rates\u003csup\u003e(15)\u003c/sup\u003e; the same was found in this study. However, this study had a small sample size. The rate of successful compression and potential vascular complications resulting from the device were expected outcomes. Incidentally, the equipment used in this study is of a new type, consisting of only one size of plate and shaft (with a plate size of 1.5 cm and shaft depth of 3 cm), which may not be suitable for the anatomy of some patients. This limitation may have contributed to device failure in four patients (due to incorrect point of compression or device slippage), all of which were corrected by standard hand compression without major vascular or bleeding complication. Additionally, the catheter sheath used in this study was 5-7 Fr, so there is no data available for other sizes. Further large-scale studies with longer follow-up periods are required.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eThe TU device with the 3-2-1 protocol is feasible and comfortable exhibiting a high successful hemostasis rate. It may shorten the time to hemostasis for patients, with an acceptable and similar rate of access site complications compared to conventional hand compression.\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch2\u003eConflict of interest and funding:\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eNo\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eChen H-Z, et al. Compression methods after femoral artery puncture, a protocol for systematic review and network meta-analysis. Medicine 2021; 100: 4(e24506).\u003c/li\u003e\n \u003cli\u003eHuang PH, Hassan AKM, Resnic FS. Manual, mechanical, and device hemostasis. In: Lanzer P, ed. Textbook of Catheter-Based Cardiovascular Interventions: A Knowledge-Based Approach. Cham: Springer; 2018. p. 435-63.\u003c/li\u003e\n \u003cli\u003eCourtesy of Abbott vascular, Comparison of the FemoStop device and manual pressure in reducing groin puncture site complications, International Journal of Nursing Practice 2001; \u003cstrong\u003e7\u003c/strong\u003e: 366\u0026ndash;375.\u003c/li\u003e\n \u003cli\u003eHe Yi, et al. (2022) A novel femoral artery compression device versus manual compression for hemostasis after femoral artery puncture: a randomized comparison, Minimally Invasive Therapy \u0026amp; Allied Technologies, 31:1, 50-57.\u003c/li\u003e\n \u003cli\u003eCourtesy of advance vascular dynamics, Semler, H J. Transfemoral catheterization: mechanical versus manual control of bleeding. Radiology 1985; 154:234-235.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eAyman K.M. Hassan, et al. A new femoral compression device compared with manual compression for bleeding control after coronary diagnostic catheterizations, The Egyptian Heart Journal, Volume 66, Issue 3, 2014, 233-239.\u003c/li\u003e\n \u003cli\u003eMahmoud Khalil, MD et al.\u0026nbsp;Common Femoral Artery Anatomy and Relations to Bony Landmarks: A Computed Tomography Angiogram Study. Vascular disease management 2021;18(11):E198-E203.\u003c/li\u003e\n \u003cli\u003eValgimigli M, Gagnor A, Calabr\u0026oacute; P, et al.\u0026nbsp;Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet. 2015;385(9986):2465-2476.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eMuller DW, Shamir KJ, Ellis SG, Topol EJ. Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures. Am J Cardiol. 1992;69(1):63-68.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eLee MS, Applegate B, Rao SV, Kirtane AJ, Seto A, Stone GW. Minimizing femoral artery access complications during percutaneous coronary intervention: a comprehensive review. Catheter Cardiovasc Interv. 2014;84(1):62-69.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eFokkema TM, Minnee RC, Kock GA, Blomjous JG, Vahl AC, Leijdekkers VJ. Comparison of a collagen plug arterial closure device with manual compression after endovascular interventions for peripheral artery disease. J Vasc Surg. 2016;64(1):104-108.e1.\u003c/li\u003e\n \u003cli\u003eWagner SC, Gonsalves CF, Eschelman DJ, Sullivan KL, Bonn J. Complications of a percutaneous suture-mediated closure device versus manual compression for arteriotomy closure: a case-controlled study.\u0026nbsp;J Vasc Interv Radiol. 2003;14(6):735-741.\u003c/li\u003e\n \u003cli\u003eNoori VJ, Eldrup-J\u0026oslash;rgensen J. A systematic review of vascular closure devices for femoral artery puncture sites.\u0026nbsp;J Vasc Surg. 2018;68(3):887-899.\u003c/li\u003e\n \u003cli\u003eKern MJ, Back to Basics: Femoral Artery Access and Hemostasis. Cath Lab digest. 2013;21(10).\u003c/li\u003e\n \u003cli\u003eTuri ZG. An evidence-based approach to femoral arterial access and closure. Rev Cardiovasc Med. 2008;9(1):7-18.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 4 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"Thammasat University Hospital","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Coronary catheterization, femoral access, compression, pneumatic, novel device","lastPublishedDoi":"10.21203/rs.3.rs-7834897/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7834897/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e Femoral arterial access remains widely used in contemporary coronary catheterization procedures. Following the removal of the femoral sheath, hand compression is commonly employed to achieve hemostasis. Nevertheless, this method is time-consuming and imposes a burden on both the operator and the patient.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjective:\u003c/strong\u003e This study aims to investigate the hemostatic efficacy of the novel external femoral artery compression device (the TU device).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaterials and Methods:\u003c/strong\u003e Patients enrolled in this study were randomly assigned in a 1:1 ratio to either the TU device (with a 3-2-1 protocol for compression) or the conventional hand compression group. The primary efficacy outcome was the time to achieve hemostasis within 15 minutes, and the safety outcomes were major vascular complications. Other secondary outcomes included minor vascular complications, time to hospital discharge, reports of vasovagal symptoms, discomfort levels, as well as user and patient satisfaction.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults:\u003c/strong\u003e A total of 52 patients were included in this study (TU device, n = 26 vs. hand compression, n = 26). The baseline characteristics of the groups were mostly similar. We found that achieving hemostasis within 15 minutes was successful in the TU device group more than in the hand compression group (84.6% vs. 46.2%, p = 0.004). Small hematomas were reported more frequently in the device group (34.6% vs. 7.7%, p = 0.017). Interestingly, there was an absence of any vasovagal response in patients using the device (0% vs. 15.4%, p = 0.037). There were no significant differences in major vascular complications, time to hospital discharge, patient discomfort, and satisfaction scores between the groups.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusions:\u003c/strong\u003e The TU device is effective for achieving femoral artery hemostasis with an acceptable rate of access site complications compared to conventional hand compression.\u003c/p\u003e","manuscriptTitle":"A novel femoral artery compression device compared with manual compression for hemostasis after femoral artery access in coronary artery catheterizations","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-15 08:56:54","doi":"10.21203/rs.3.rs-7834897/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"fe747541-2875-4b6a-8fbc-7b10d79ecde0","owner":[],"postedDate":"October 15th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-10-15T08:56:54+00:00","versionOfRecord":[],"versionCreatedAt":"2025-10-15 08:56:54","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7834897","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7834897","identity":"rs-7834897","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}