Ultrasound guided femoral venous access decreases vascular complications in catheter ablation procedures

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Pavel, S. C. R. Erlhöfer, J. Wörmann, S. Dittrich, C. Scheurlen, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5005610/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 03 Oct, 2025 Read the published version in Scientific Reports → Version 1 posted 4 You are reading this latest preprint version Abstract Background Ultrasound (US) guidance is increasingly used in invasive cardiac electrophysiology (EP) procedures for femoral vascular access. In this study, we assessed the occurrence of vascular access-related complications in EP procedures which were performed with the routine use of anatomical landmark (LM) versus US-guided vascular access. Methods A total of 1119 consecutive EP procedures in 1012 patients performed in a two-year period from September 10, 2020 to September 10, 2022 were included. The endpoint of the present study consisted of any vascular access-related complication, classified as hematoma, aneurysm, or AV-fistula. Different risk factors for increased bleeding risk were analyzed. Results During the evaluation period, 777 procedures were performed using LM-guiding and 342 procedures using US-guided access. Overall, 19 (1.7%) relevant vascular complications occurred including: 15 (1.3%) hematoma, 2 (0.18%) aneurysm and 2 (0.18%) AV-fistula. 17 (2.2%) complications occurred in the LM-guided group and 2 (0.6%) in the US-guided group. A significant reduction of femoral complications by 89% was observed with introduction of routine US-guided access. 3.8% in the LM-group vs. 0.4% in the US-group (OR 0.1, 95% CI 0.0135-0.8515, p=0.034). Intraprocedural ACT and the HASBLED score [range 0-4; mean=1.47; maximum=4) were shown to be independent predictors for vascular complications (OR 2.826, 95% CI 1.631-4.895, p< 0.001). Conclusion The use of US-guided vascular access significantly decreased the access-related complication rate in EP procedures. Higher procedural ACT and HASBLED score independently predicted a higher risk of vascular access complications. Health sciences/Medical research Health sciences/Medical research/Outcomes research Vascular complications Pulmonary Vein Isolation Ultrasound guided access Atrial fibrillation ablation Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Introduction The number of catheter interventions in cardiology, particularly in cardiac electrophysiology (EP), is rising. [ 1 ]. Amongst the most common complications in EP procedures is vascular damage due to access related trauma. A meta-analysis of 89 RCTs found a procedure-related complication rate in catheter ablations for atrial fibrillation of up to 1.3%, representing 45% of all complications [ 2 ]. Complication rates vary depending on the type of the procedure: Catheter ablation aiming for pulmonary vein isolation (PVI) has the highest rate of vascular related complications (1.8% vs. non-PVI ablations 0.4%) [ 3 ] and represents the highest volume of EP procedures. The conventional method of landmark (LM) guided access by palpation of the femoral artery and puncturing medially to the femoral pulsation is still commonly used. However, accumulating evidence indicates that LM-guided access may be insufficient to locate and safely access the femoral vein reliably. Computer tomography (CT) studies showed that the femoral artery overlaps the femoral vein in two-thirds of examined cases [ 4 ] with a high risk of accidental damage to the artery when performing a puncture without direct visualization. Ultrasound guided access is an easily adoptable technique and detailed description of its application is readily available [ 5 ]. The use of ultrasound (US) to establish vascular access has the potential to lower the rate of major and minor vascular complications by approximately 60% [ 6 ]. Different risk factors for vascular complications after femoral access were examined with heterogenous results. The duration of applied compression after the procedure predicted the number of access related bleeding complications in one study [ 7 ]. Arterial access [ 8 ] and a greater femoral vein depth [ 9 ] (correlating with a higher BMI) were reported as risk factors associated with a higher complication rate. But especially regarding the role of BMI, antiplatelet therapy [ 7 ] and gender [ 8 , 10 ] disparate results were published. There is a need to identify patients at risk and predictors of complications to further lower the risk of EP procedures, while measures to reduce procedural costs must also be considered as health care systems become increasingly strained and incremental expenses caused by complications can amount to €15,544.71 for certain complications [ 11 ]. In earlier studies, including meta-analyses, US-guided access was associated with a 71% relative risk reduction of major vascular complications compared to standard technique [ 6 , 12 ], reduced time to attain access, and improved outcomes for minor complications, accidental artery puncture and post-procedural pain [ 13 ]. The present evaluation analyzed the potential advantages of US-guided access to decrease the number of vascular complications and identified further clinical risk factors of vascular access related complications in a clinical routine setting for EP procedures. Methods Study Design: This analysis was designed as a retrospective, non-randomized, single-center trial aiming to investigate the potential advantages of US-guided access to decrease vascular complications, and to identify risk factors of vascular complications in patients undergoing catheter ablation of atrial fibrillation or other symptomatic supraventricular arrhythmia. We analyzed a total of 1119 consecutive EP procedures in 1012 patients performed from September 10, 2020 to September 10, 2022. An exclusive US-guided access regimen was implemented on September 10th 2021. The endpoint consisted of any vascular access-related complication classified as hematoma, aneurysm, or AV-fistula for two groups (conventional vs US-guided access) within 4 weeks after the ablation procedure. For further analysis risk factors including HASBLED Score, intraprocedural activated clotting time (ACT), use of platelet aggregation inhibitors or oral anticoagulants (OAC), age, diabetes mellitus and body mass index (BMI) were examined. The trial complied with the Declaration of Helsinki, the local ethics committee approved the protocol and all patients provided written informed consent for the procedure, general data acquisition, processing and analysis. Study population We included patients over a period of two years who were scheduled for ablation of atrial fibrillation, and other types of symptomatic supraventricular tachycardias one year prior and one year after implementation of routine use of US-guided access at our center. Ablation procedures for premature ventricular contractions and ventricular tachycardia were not included in the analysis as the focus was on a consistent group of patients with a comparable peri- and intraprocedural anticoagulation regime. Vascular access All patients gave prior informed written consent and were prepared for the scheduled intervention by removal of body hair in the inguinal region and positioned in supine position. Fentanyl, propofol and midazolam were used to achieve deep sedation followed by the preparation of a sterile area by application of disinfectant solution ( Kodan ®, Schuelke, Norderstedt, Germany ) and use of a fenestrated sterile drape ( Bisping, Aachen, Germany ). For the first group, LM guidance was performed by palpating the right femoral artery and puncturing medially to the palpated pulse. In the second group, access in the right femoral vein was established with direct visualization of the inguinal anatomy (Figs. 5 and 6 ). Identification of the vein using a linear ultrasound probe ( Philips Sparq, Hamburg, Germany or GE vivid E95, Boston, Massachusetts, USA ) with a sterile cover ( FlexaSoft ®, Udo Heisig GmbH, Putzbrunn, Germany ) was secured by compression testing and color doppler signaling. The number of inserted sheaths varied according to the procedure: four for atrial tachycardia or atrial flutter and three for PVI. For all procedures body-weight-adjusted unfractionated heparin (UFH) was administered with a calculated dose of 160 IE per kg in patients taking direct oral anticoagulants (DOAC). DOAC taken twice daily were withheld in the morning before the scheduled procedure and resumed in the evening of the same day. Oral anticoagulants taken once daily were also interrupted for one dose in the morning and resumed at half the dose in the evening. Patients taking vitamin K antagonists were instructed to maintain an INR between 2.0 and 2.5 on the day of the procedure. The UFH dose was determined and applied based on the INR (INR 1.0-1.3 > 100 U/kg, 1.3–1.9 75–100 U/kg, 1.9–2.3 75 U/kg, > 2.3 50–75 U/kg). Endpoint evaluation After sheath removal, manual pressure at the puncture site for at least 10 minutes and figure of eight-sutures were routinely utilized followed by application of a compression bandage. A dedicated groin compression device ( FemoStop™ ฏ Gold, Abbott, Lake County, Illinois, USA ) was applied in case of postprocedural bleeding after suturing at the discretion of the operator and applied for four hours following two to four hours of passive compression. Bed rest and immobilization were mandated for a minimum of 6 hours for all procedures. Patients were then mobilized under supervision. Z-stich sutures were removed on the following day. During hospitalization, daily clinical visits including groin inspection and auscultation were performed in all patients followed by ultrasound of the groin in case of suspicious auscultation or clinical aspect. Patients were discharged after two nights post-procedure. The endpoint of the study consisted of any vascular access-related complication, classified as hematoma, aneurysm, or AV-fistula. Relevant postprocedural bleeding and hematoma was defined in accordance with Bleeding Academic Research Consortium (BARC) criteria [ 14 ] as greater than type 2 bleeding. AV-fistula and aneurysm were diagnosed using US and treated with manual compression followed by the application of a compression bandage. Statistical analysis: Data acquisition was conducted using an electronic data capture system ( RedCap Database, Nashville, Tennessee, USA ). The following statistical analysis was performed using IBM SPSS Version 28 ( SPSS, Chicago, Illinois ). Risk factors including HASBLED Score, intraprocedural ACT, OAC, use of platelet aggregation inhibitors, age, diabetes mellitus, BMI and sex were analyzed using binary logistic regression analysis and reported as Odds Ratio (OR) with a 95% confidence interval. Linearity was tested assessed using the Box-Tidwell procedure and Bonferroni-correction was applied to all terms in the model. All variables in the model were shown to follow a linear relationship. Correlations between predictor variables were low (r < 0.70), indicating that multicollinearity was not a confounding factor in the analysis. The binomial logistic regression model was statistically significant (χ²(9) = 22.152, p = 0.008) and presented with a good model fit (χ²(8) = 8.434, p > .05) in Hosmer-Lemeshow-Test. Correlation analysis was conducted using nonparametric testing of Spearman’s Rho. A p-value less than 0.05 was considered significant. Fishers exact test was used as the observed cases in the 2x2 crosstabulation were less than five and tested as one-tailed hypothesis. Association analysis using Fisher‘s exact test revealed a significant association between US-access and vascular complications (p = 0.040) with negative effect size presented as ϕ= -0,057 that showed a lower complication rate in patients after US-guided groin access. Results During the study period, 777 procedures were performed using anatomical LM-guided and 342 procedures using US-guided access. Mean age at time of procedure was 67.2 years (range 20–93) with a mean body mass index of 27.1 kg/m 2 (range 17–52). Baseline characteristics of the enrolled patient cohort are presented in Table 1 . Table 1 Descriptive baseline characteristics N % Mean Range Sex (male) 685 61.2 Sex (female) 434 38.8 OAC 983 87.8 Antiplatelet therapy 41 3.7 Diabetes Renal insufficiency Hepatic insufficiency History of bleeding Labile INR Hypertension > 160 mmHg 168 34 10 18 6 75 15.0 3.0 0.9 1.6 0.5 6.7 Age (years) 67.2 20–93 BMI (kg/m²) 27.1 17–52 ACT (sec) 256 174–320 HASBLED Score 1.47 0–4 ACT = activated clotting time. HASBLED = Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly. The examined procedures (Fig. 1 ) were performed for PVI (56%), Repeat-PVI (14%), atrial substrate modification in AF (11%), atrial tachycardia (11%) and atrial flutter (8%). In most cases a cryo-balloon technique was used (64.3%), followed by radiofrequency ablation (RF, 28.7%), pulsed field ablation (4.8%), and RF-balloon (2.2%) as shown in Fig. 2 . Overall, 19 (1.7%) relevant vascular complications meeting the above-mentioned criteria occurred, including: 15 (1.3%) hematoma, 2 (0.18%) aneurysm, and 2 (0.18%) AV-fistula. 17 (2.2%) complications occurred in the control group using LM-guided access and 2 (0.6%) in the US-access group. The results indicate a significant association between US access and decreased vascular complications (p = 0.040 ϕ= -0.057) with a reduction of the observed complication rate by 89%: 3.8% complication rate in the LM-guided group vs. 0.4% in the US-guided group (OR 0.1; 95% CI 0.0135–0.8515, p = 0.034) as depicted in Fig. 4. Moreover, complications in the US-guided group were less severe: Both cases presented with hematoma, no cases of AV-fistula or aneurysm were observed. One case of arterial pseudo-aneurysm in the landmark group required surgical intervention. Regression analysis demonstrated that only HASBLED Score count (range 0–4; mean = 1.47; maximum = 4, OR 2.826, 95% CI 1.631–4.895, p < 0.001) and the first intraprocedural ACT (activated coagulation time, range 174–320 sec, mean = 256 sec, OR 0.985, 95% CI 0.972–0.998, p = 0.019) were independent predictors of the 19 vascular complications. Regarding ACT values, no significant difference in heparin dosage (13141.3 Units vs. 12277.7 Units; p = 0.120) or dosage per kg bodyweight (mean 156.9 U/kg vs. 148.2 U/kg; p = 0.263) was found in patients who suffered a complication. Maximum ACT was 320 sec in patients with a diagnosed vascular complication (range 174–320 sec; mean 256 sec) and the maximum HASBLED Score count was 4 (range 0–4; mean 1.47). Oral anticoagulation, use of platelet aggregation inhibitors, BMI, prediagnosed diabetes mellitus, age at time of procedure and sex did not predict the number of complications (Table 2 ). Table 2 Predictor analysis for vascular complication OR 95% CI p-value Sex (male) 0.549 0.211–1.430 0.220 OAC 0.980 0.158–6.075 0.982 Antiplatelet therapy 0.749 0.069–8.195 0.813 Diabetes 4.085 0.467–35.74 0.203 Age (years) 0.956 0.910–1.004 0.074 BMI (kg/m2) 1.051 0.954–1.159 0.316 ACT (sec) 0.985 0.972–0.998 0.019 HASBLED 2.810 1.634–4.832 < 0.001 Discussion The results of the present study confirm that adverse vascular events are infrequent in EP procedures. Still, the implementation of routine use of US-guided access significantly reduced the occurrence of vascular complications. In addition, we found that a higher ACT and higher HASBLED Score count were independent predictors of vascular complications in patients undergoing EP ablation procedures. US-guided access Association analysis showed a lower complication rate after US-guided groin access as comparable to other studies with a similar sample size [ 13 ]. The utilization of ultrasound provides an easy to use and cost-effective method that does not prolong the procedure [ 13 ]. Previous studies have calculated the incremental expenses caused by complications to be up to €15,544.71 per patient[ 11 ]. Adopting US-guided access may decrease health care costs through its potential to reduce the number of vascular complications. Outcomes We observed 17 (2.2%) complications in the LM access group and 2 (0.6%) in the US-guided access group (Fig. 3 ) over the course of the study. The most significant decrease was observed at the beginning of the study with a complication rate of 3.8% before the implementation of US-guided access compared to 0.4% after the transition to a US-only regime by the end of the study (OR 0.1, p = 0.034) corresponding to a reduction of 89%. The variations in group sizes stem from the sequential nature of the real-world study design and the gradual transition from traditional landmark-guided to ultrasound-guided puncture methods following the implementation of the Standard Operating Procedure (SOP). Additionally, the occurrence of a significant work strike by the nursing staff led to a reduction in interventions during the specified timeframe after the release of the SOP, therefore delaying the implementation of a US-only approach resulting in an uneven cohort size. Furthermore, alongside correlation analysis of the entire cohort, we conducted comparisons between the initial and final phases of the observation period to account for any potential learning effects among the investigators and the unequal cohort size. Observed complication rates in the US-group are in line with findings of other study groups [ 6 ] and indicate a reassuringly low risk of harm to the patient during ablation procedures. Moreover, less severe complications were observed in the US-guided access group: both cases presented with hematoma which did not require therapeutic intervention, while in the control group two cases of AV-fistula and two aneurysm were observed, requiring surgical intervention in one. These results favor the use of US guidance to improve patient safety. While the Yamagata et al. conducted the first randomized trial comparing an US-guided vs. a conventional access approach found no significant difference in major complications due to a lower than expected number of access-related complications [ 13 ], a broader body of evidence has shown the benefits of the US-approach [ 16 ]. The current ESC-guideline for the treatment of atrial fibrillation therefore recommends the use of US-guided vascular access for all interventional ablation procedures [ 17 ]. Anticoagulation and intraprocedural ACT Encouragingly, the use of oral anticoagulation or antiplatelet therapy were no predictors of vascular complications, but our protocol dictated to pause the administration of oral anticoagulants prior to ablation must be taken into account when interpreting these results. We found a negative correlation between vascular complications and the first measured ACT during ablation, though no significant difference in the absolute or bodyweight adjusted heparin dosage was present. We found no difference in ACT levels between different types of DOAC, with apixaban being the most commonly used DOAC. Different levels of confounding factors in the coagulation cascade might be at play in addition to varying levels of interacting plasma-binding proteins. HASBLED Score as independent predictor of vascular complications We identified the HASBLED score as a predictor of vascular complications in patients undergoing ablation. The HASBLED score count is a readily available tool for risk factor assessment in all patients presenting with AF. Previous studies have found an effect of renal insufficiency as predictor of complications [ 3 , 15 ] after AF ablation, which may at least partially explain the impact of the HASBLED score count. Nonetheless, only 3% of patients in our cohort suffered from a severe renal insufficiency. The increased risk for bleeding complications indicated by a high HASBLED score can also be applied specifically to the individual risk for vascular groin complications in patients receiving ablation for atrial fibrillation. Limitations: This was a retrospective, non-randomized, single-center study designed to identify clinical predictors of vascular complications in a group of consecutive patients undergoing EP procedures. Therefore, our findings cannot be applied to the general population. Despite the study’s retrospective nature, we sought to reduce selection bias by gathering information on consecutive patients who received EP procedures in our center. Nevertheless, selection bias regarding BMI is possible since our protocol comprises mandatory weight loss for patients with a BMI ≥35 with the indication for AF ablation and in the absence of arrhythmia induced cardiomyopathy or very severe symptoms (EHRA stage IV) before scheduling AF ablation. As a result, severely obese patients are underrepresented in this study. Also, our study did not account for a potential learning curve of the operator. We presumed this to be negligible due to experienced expert level operators who had prior experience using ultrasound. Therefore, no specific training was mandated. Previous studies took this fact into account but did not find a significant difference in the performance of expert and less experienced electrophysiologists [ 13 ]. Lastly, the respective cohort sizes were not ideally equal between both groups (LM vs. US-guided) as the presence of a notable strike by the nursing staff resulted in decreased interventions during the study, consequently yielding a diminished ultrasound group. Nevertheless, post-hoc power analysis verified an acceptable sample size (87.4% power at an alpha niveau of 5%). Conclusion The use of ultrasound-guidance for vascular access significantly further reduced the rate of groin complications in this retrospective analysis of EP procedures. Therefore, adopting the US-guided vascular access method into routine practice should be considered. To minimize the risk of vascular complications, it is essential to screen patients who present with a high HASBLED Score count. Tailored heparin dosage and conducting frequent ACT checks during ablation is advisable. Declarations Additional Information No financial support was received for this study. Competing interests: JL* and DS* report having received lecture fees from Abbott, Boston Scientific, and Johnson&Johnson AS received lecture fees from Abbott, Medtronic, Bayer, Johnson&Johnson, honoraria for advisory board activities from Medtronic, Abbott, Pfizer, Johnson&Johnson and educational grants from Biosense Webster, Abbott and Medtronic. *contributed equally Author contributions statements 1. F. Pavel* 2. S. C. R. Erlhöfer 3. J. Wörmann 4. S. Dittrich 5. C. Scheurlen 6. K. Filipovic 7. J.-H. Schipper 8. J.-H. van den Bruck 9. A. Sultan 10. J. Lüker 11. D. Steven 1. FP wrote the main manuscript text and conducted the statistical analysis. 2.– 6. and 8.-9. Reviewed the manuscript and provided and compiled data. 7. provided photografic images and reviewed the manuscript 10. and 11. 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Cite Share Download PDF Status: Published Journal Publication published 03 Oct, 2025 Read the published version in Scientific Reports → Version 1 posted Editorial decision: Accepted 22 Sep, 2025 Reviewers invited by journal 14 Aug, 2025 Submission checks completed at journal 08 Aug, 2025 First submitted to journal 01 Aug, 2025 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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Pavel","email":"data:image/png;base64,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","orcid":"","institution":"Department of Electrophysiology, Heart Center of the University of Cologne","correspondingAuthor":true,"prefix":"","firstName":"F.","middleName":"","lastName":"Pavel","suffix":""},{"id":500458940,"identity":"104a0ccd-0d6c-41b8-9794-105580236d82","order_by":1,"name":"S. C. R. Erlhöfer","email":"","orcid":"","institution":"Department of Electrophysiology, Heart Center of the University of Cologne","correspondingAuthor":false,"prefix":"","firstName":"S.","middleName":"C. R.","lastName":"Erlhöfer","suffix":""},{"id":500458941,"identity":"fdb8d26e-a212-433b-916f-92707c4e6d9b","order_by":2,"name":"J. Wörmann","email":"","orcid":"","institution":"Department of Electrophysiology, Heart Center of the University of Cologne","correspondingAuthor":false,"prefix":"","firstName":"J.","middleName":"","lastName":"Wörmann","suffix":""},{"id":500458942,"identity":"216ddb9f-4712-492a-97e2-3217e4e711f7","order_by":3,"name":"S. Dittrich","email":"","orcid":"","institution":"Department of Electrophysiology, Heart Center of the University of Cologne","correspondingAuthor":false,"prefix":"","firstName":"S.","middleName":"","lastName":"Dittrich","suffix":""},{"id":500458944,"identity":"4afe10d6-7709-4df1-874b-d0a1e0e0a481","order_by":4,"name":"C. Scheurlen","email":"","orcid":"","institution":"Department of Electrophysiology, Heart Center of the University of Cologne","correspondingAuthor":false,"prefix":"","firstName":"C.","middleName":"","lastName":"Scheurlen","suffix":""},{"id":500458946,"identity":"5b21db84-aeb2-411e-8318-2edcc83680d6","order_by":5,"name":"K. Filipovic","email":"","orcid":"","institution":"DRK-Hospital Berlin Westend","correspondingAuthor":false,"prefix":"","firstName":"K.","middleName":"","lastName":"Filipovic","suffix":""},{"id":500458948,"identity":"3dab9fa2-644c-4a61-8bca-eff2f36f3bf7","order_by":6,"name":"J.-H. Schipper","email":"","orcid":"","institution":"Department of Electrophysiology, Heart Center of the University of Cologne","correspondingAuthor":false,"prefix":"","firstName":"J.-H.","middleName":"","lastName":"Schipper","suffix":""},{"id":500458949,"identity":"603d83f9-9c0c-47a2-be26-4f67f4d0c9ee","order_by":7,"name":"J.-H. van den Bruck","email":"","orcid":"","institution":"Department of Electrophysiology, Heart Center of the University of Cologne","correspondingAuthor":false,"prefix":"","firstName":"J.-H.","middleName":"van den","lastName":"Bruck","suffix":""},{"id":500458950,"identity":"10689f6c-1c19-441f-bdfa-64dc74c53983","order_by":8,"name":"A. Sultan","email":"","orcid":"","institution":"Asklepios-Hospital St. Georg","correspondingAuthor":false,"prefix":"","firstName":"A.","middleName":"","lastName":"Sultan","suffix":""},{"id":500458952,"identity":"d34c9d00-d0e2-4ce1-8754-f64298f4b139","order_by":9,"name":"J. Lüker","email":"","orcid":"","institution":"Department of Electrophysiology, Heart Center of the University of Cologne","correspondingAuthor":false,"prefix":"","firstName":"J.","middleName":"","lastName":"Lüker","suffix":""},{"id":500458953,"identity":"5fe86754-956c-493e-abe9-650f216780ca","order_by":10,"name":"D. Steven","email":"","orcid":"","institution":"Department of Electrophysiology, Heart Center of the University of Cologne","correspondingAuthor":false,"prefix":"","firstName":"D.","middleName":"","lastName":"Steven","suffix":""}],"badges":[],"createdAt":"2024-08-30 18:27:30","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5005610/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5005610/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41598-025-21481-w","type":"published","date":"2025-10-03T15:58:12+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":90298769,"identity":"bf578383-d1a7-43ce-b790-5f0ed84abf57","added_by":"auto","created_at":"2025-09-01 08:47:34","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":16394,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eAblation procedure types\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eNote:\u003c/em\u003e Ablation procedures percentage of total ablation number devided by procedure type.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-5005610/v1/b8e1764b5d8f23ffee741b1b.png"},{"id":90298774,"identity":"45f1416c-9dc7-4b95-b4a1-26e938840dd8","added_by":"auto","created_at":"2025-09-01 08:47:34","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":13641,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eMethod of Ablation\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eNote:\u003c/em\u003e Ablation procedures divided by method of ablation technique.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-5005610/v1/db3e1fff881c3a3fdf68bcbd.png"},{"id":90300897,"identity":"d2f4677b-a4d3-442f-a66c-a1499f3f886e","added_by":"auto","created_at":"2025-09-01 08:55:34","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":8992,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eNumber of Vascular complications\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eNote:\u003c/em\u003e Number of vascular complications grouped by selected access.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-5005610/v1/2ff7d5b32274bbeac68b521a.png"},{"id":90298784,"identity":"5453d313-420a-4196-9563-da9ac36c8864","added_by":"auto","created_at":"2025-09-01 08:47:34","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":9388,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eComplication rate\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eNote:\u003c/em\u003e vascular complication rate before and after implementation of US-guided access.\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-5005610/v1/97ace994f1341a441cf1432d.png"},{"id":90300898,"identity":"87485085-6e57-494b-b8cb-a319eb1abd57","added_by":"auto","created_at":"2025-09-01 08:55:34","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":265319,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eNote:\u003c/em\u003e Venous access using ultrasound guidance via direct visualization.\u003c/p\u003e\n\u003cp\u003e(Photo rights by J. Schipper MD)\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-5005610/v1/3a5a6c7c8312fcf9b7a06147.png"},{"id":90298776,"identity":"372c014c-31fe-47fe-b0b1-b4d5c63bc197","added_by":"auto","created_at":"2025-09-01 08:47:34","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":265237,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cem\u003eNote: \u003c/em\u003eUS-visualization of the right groin. Femoral artery (arrow) overlapping the femoral vein (asterisk).\u003c/p\u003e\n\u003cp\u003e(Photo rights by J. Schipper MD)\u003c/p\u003e","description":"","filename":"6.png","url":"https://assets-eu.researchsquare.com/files/rs-5005610/v1/81902cbf6ffffd9fb1811a57.png"},{"id":92883893,"identity":"e7de3d10-f1e5-403f-bfa7-61f0ccda7592","added_by":"auto","created_at":"2025-10-06 16:10:30","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1392586,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5005610/v1/4e1da327-7c2a-4f32-afcd-c4530953a5cc.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Ultrasound guided femoral venous access decreases vascular complications in catheter ablation procedures","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe number of catheter interventions in cardiology, particularly in cardiac electrophysiology (EP), is rising. [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Amongst the most common complications in EP procedures is vascular damage due to access related trauma. A meta-analysis of 89 RCTs found a procedure-related complication rate in catheter ablations for atrial fibrillation of up to 1.3%, representing 45% of all complications [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Complication rates vary depending on the type of the procedure: Catheter ablation aiming for pulmonary vein isolation (PVI) has the highest rate of vascular related complications (1.8% vs. non-PVI ablations 0.4%) [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] and represents the highest volume of EP procedures.\u003c/p\u003e\u003cp\u003eThe conventional method of landmark (LM) guided access by palpation of the femoral artery and puncturing medially to the femoral pulsation is still commonly used. However, accumulating evidence indicates that LM-guided access may be insufficient to locate and safely access the femoral vein reliably. Computer tomography (CT) studies showed that the femoral artery overlaps the femoral vein in two-thirds of examined cases [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] with a high risk of accidental damage to the artery when performing a puncture without direct visualization.\u003c/p\u003e\u003cp\u003eUltrasound guided access is an easily adoptable technique and detailed description of its application is readily available [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. The use of ultrasound (US) to establish vascular access has the potential to lower the rate of major and minor vascular complications by approximately 60% [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Different risk factors for vascular complications after femoral access were examined with heterogenous results. The duration of applied compression after the procedure predicted the number of access related bleeding complications in one study [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Arterial access [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] and a greater femoral vein depth [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e] (correlating with a higher BMI) were reported as risk factors associated with a higher complication rate. But especially regarding the role of BMI, antiplatelet therapy [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] and gender [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e] disparate results were published.\u003c/p\u003e\u003cp\u003eThere is a need to identify patients at risk and predictors of complications to further lower the risk of EP procedures, while measures to reduce procedural costs must also be considered as health care systems become increasingly strained and incremental expenses caused by complications can amount to \u0026euro;15,544.71 for certain complications [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eIn earlier studies, including meta-analyses, US-guided access was associated with a 71% relative risk reduction of major vascular complications compared to standard technique [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e], reduced time to attain access, and improved outcomes for minor complications, accidental artery puncture and post-procedural pain [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe present evaluation analyzed the potential advantages of US-guided access to decrease the number of vascular complications and identified further clinical risk factors of vascular access related complications in a clinical routine setting for EP procedures.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStudy Design:\u003c/h2\u003e\u003cp\u003eThis analysis was designed as a retrospective, non-randomized, single-center trial aiming to investigate the potential advantages of US-guided access to decrease vascular complications, and to identify risk factors of vascular complications in patients undergoing catheter ablation of atrial fibrillation or other symptomatic supraventricular arrhythmia. We analyzed a total of 1119 consecutive EP procedures in 1012 patients performed from September 10, 2020 to September 10, 2022. An exclusive US-guided access regimen was implemented on September 10th 2021. The endpoint consisted of any vascular access-related complication classified as hematoma, aneurysm, or AV-fistula for two groups (conventional vs US-guided access) within 4 weeks after the ablation procedure.\u003c/p\u003e\u003cp\u003eFor further analysis risk factors including HASBLED Score, intraprocedural activated clotting time (ACT), use of platelet aggregation inhibitors or oral anticoagulants (OAC), age, diabetes mellitus and body mass index (BMI) were examined. The trial complied with the Declaration of Helsinki, the local ethics committee approved the protocol and all patients provided written informed consent for the procedure, general data acquisition, processing and analysis.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eStudy population\u003c/h3\u003e\n\u003cp\u003eWe included patients over a period of two years who were scheduled for ablation of atrial fibrillation, and other types of symptomatic supraventricular tachycardias one year prior and one year after implementation of routine use of US-guided access at our center. Ablation procedures for premature ventricular contractions and ventricular tachycardia were not included in the analysis as the focus was on a consistent group of patients with a comparable peri- and intraprocedural anticoagulation regime.\u003c/p\u003e\n\u003ch3\u003eVascular access\u003c/h3\u003e\n\u003cp\u003eAll patients gave prior informed written consent and were prepared for the scheduled intervention by removal of body hair in the inguinal region and positioned in supine position. Fentanyl, propofol and midazolam were used to achieve deep sedation followed by the preparation of a sterile area by application of disinfectant solution (\u003cem\u003eKodan\u003c/em\u003e\u0026reg;, \u003cem\u003eSchuelke, Norderstedt, Germany\u003c/em\u003e) and use of a fenestrated sterile drape (\u003cem\u003eBisping, Aachen, Germany\u003c/em\u003e). For the first group, LM guidance was performed by palpating the right femoral artery and puncturing medially to the palpated pulse. In the second group, access in the right femoral vein was established with direct visualization of the inguinal anatomy (Figs.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e5\u003c/span\u003e and \u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e6\u003c/span\u003e). Identification of the vein using a linear ultrasound probe (\u003cem\u003ePhilips Sparq, Hamburg, Germany\u003c/em\u003e or \u003cem\u003eGE vivid E95, Boston, Massachusetts, USA\u003c/em\u003e) with a sterile cover (\u003cem\u003eFlexaSoft\u003c/em\u003e\u0026reg;, \u003cem\u003eUdo Heisig GmbH, Putzbrunn, Germany\u003c/em\u003e) was secured by compression testing and color doppler signaling.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eThe number of inserted sheaths varied according to the procedure: four for atrial tachycardia or atrial flutter and three for PVI. For all procedures body-weight-adjusted unfractionated heparin (UFH) was administered with a calculated dose of 160 IE per kg in patients taking direct oral anticoagulants (DOAC). DOAC taken twice daily were withheld in the morning before the scheduled procedure and resumed in the evening of the same day. Oral anticoagulants taken once daily were also interrupted for one dose in the morning and resumed at half the dose in the evening. Patients taking vitamin K antagonists were instructed to maintain an INR between 2.0 and 2.5 on the day of the procedure. The UFH dose was determined and applied based on the INR (INR 1.0-1.3\u0026thinsp;\u0026gt;\u0026thinsp;100 U/kg, 1.3\u0026ndash;1.9 75\u0026ndash;100 U/kg, 1.9\u0026ndash;2.3 75 U/kg, \u0026gt;\u0026thinsp;2.3 50\u0026ndash;75 U/kg).\u003c/p\u003e\n\u003ch3\u003eEndpoint evaluation\u003c/h3\u003e\n\u003cp\u003eAfter sheath removal, manual pressure at the puncture site for at least 10 minutes and figure of eight-sutures were routinely utilized followed by application of a compression bandage. A dedicated groin compression device (\u003cem\u003eFemoStop\u0026trade;\u003c/em\u003eฏ \u003cem\u003eGold, Abbott, Lake County, Illinois, USA\u003c/em\u003e) was applied in case of postprocedural bleeding after suturing at the discretion of the operator and applied for four hours following two to four hours of passive compression. Bed rest and immobilization were mandated for a minimum of 6 hours for all procedures. Patients were then mobilized under supervision. Z-stich sutures were removed on the following day. During hospitalization, daily clinical visits including groin inspection and auscultation were performed in all patients followed by ultrasound of the groin in case of suspicious auscultation or clinical aspect. Patients were discharged after two nights post-procedure.\u003c/p\u003e\u003cp\u003eThe endpoint of the study consisted of any vascular access-related complication, classified as hematoma, aneurysm, or AV-fistula. Relevant postprocedural bleeding and hematoma was defined in accordance with Bleeding Academic Research Consortium (BARC) criteria [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] as greater than type 2 bleeding. AV-fistula and aneurysm were diagnosed using US and treated with manual compression followed by the application of a compression bandage.\u003c/p\u003e\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003eStatistical analysis:\u003c/h2\u003e\u003cp\u003eData acquisition was conducted using an electronic data capture system (\u003cem\u003eRedCap Database, Nashville, Tennessee, USA\u003c/em\u003e). The following statistical analysis was performed using IBM SPSS Version 28 (\u003cem\u003eSPSS, Chicago, Illinois\u003c/em\u003e). Risk factors including HASBLED Score, intraprocedural ACT, OAC, use of platelet aggregation inhibitors, age, diabetes mellitus, BMI and sex were analyzed using binary logistic regression analysis and reported as Odds Ratio (OR) with a 95% confidence interval. Linearity was tested assessed using the Box-Tidwell procedure and Bonferroni-correction was applied to all terms in the model. All variables in the model were shown to follow a linear relationship. Correlations between predictor variables were low (r\u0026thinsp;\u0026lt;\u0026thinsp;0.70), indicating that multicollinearity was not a confounding factor in the analysis.\u003c/p\u003e\u003cp\u003eThe binomial logistic regression model was statistically significant (χ\u0026sup2;(9)\u0026thinsp;=\u0026thinsp;22.152, p\u0026thinsp;=\u0026thinsp;0.008) and presented with a good model fit (χ\u0026sup2;(8)\u0026thinsp;=\u0026thinsp;8.434, p\u0026thinsp;\u0026gt;\u0026thinsp;.05) in Hosmer-Lemeshow-Test. Correlation analysis was conducted using nonparametric testing of Spearman\u0026rsquo;s Rho. A p-value less than 0.05 was considered significant. Fishers exact test was used as the observed cases in the 2x2 crosstabulation were less than five and tested as one-tailed hypothesis. Association analysis using Fisher\u0026lsquo;s exact test revealed a significant association between US-access and vascular complications (p\u0026thinsp;=\u0026thinsp;0.040) with negative effect size presented as ϕ= -0,057 that showed a lower complication rate in patients after US-guided groin access.\u003c/p\u003e\u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eDuring the study period, 777 procedures were performed using anatomical LM-guided and 342 procedures using US-guided access. Mean age at time of procedure was 67.2 years (range 20\u0026ndash;93) with a mean body mass index of 27.1 kg/m\u003csup\u003e2\u003c/sup\u003e (range 17\u0026ndash;52). Baseline characteristics of the enrolled patient cohort are presented in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003e\u003cem\u003eDescriptive baseline characteristics\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"5\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eN\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003e%\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003eMean\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003eRange\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSex (male)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e685\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e61.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSex (female)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e434\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e38.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOAC\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e983\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e87.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAntiplatelet therapy\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e41\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e3.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDiabetes\u003c/p\u003e\u003cp\u003eRenal insufficiency\u003c/p\u003e\u003cp\u003eHepatic insufficiency\u003c/p\u003e\u003cp\u003eHistory of bleeding\u003c/p\u003e\u003cp\u003eLabile INR\u003c/p\u003e\u003cp\u003eHypertension\u0026thinsp;\u0026gt;\u0026thinsp;160 mmHg\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e168\u003c/p\u003e\u003cp\u003e34\u003c/p\u003e\u003cp\u003e10\u003c/p\u003e\u003cp\u003e18\u003c/p\u003e\u003cp\u003e6\u003c/p\u003e\u003cp\u003e75\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e15.0\u003c/p\u003e\u003cp\u003e3.0\u003c/p\u003e\u003cp\u003e0.9\u003c/p\u003e\u003cp\u003e1.6\u003c/p\u003e\u003cp\u003e0.5\u003c/p\u003e\u003cp\u003e6.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e67.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e20\u0026ndash;93\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBMI (kg/m\u0026sup2;)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e27.1\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e17\u0026ndash;52\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eACT (sec)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e256\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e174\u0026ndash;320\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHASBLED Score\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c4\"\u003e\u003cp\u003e1.47\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e0\u0026ndash;4\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"5\"\u003eACT\u0026thinsp;=\u0026thinsp;activated clotting time. HASBLED\u0026thinsp;=\u0026thinsp;Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly.\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eThe examined procedures (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e1\u003c/span\u003e) were performed for PVI (56%), Repeat-PVI (14%), atrial substrate modification in AF (11%), atrial tachycardia (11%) and atrial flutter (8%). In most cases a cryo-balloon technique was used (64.3%), followed by radiofrequency ablation (RF, 28.7%), pulsed field ablation (4.8%), and RF-balloon (2.2%) as shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eOverall, 19 (1.7%) relevant vascular complications meeting the above-mentioned criteria occurred, including: 15 (1.3%) hematoma, 2 (0.18%) aneurysm, and 2 (0.18%) AV-fistula. 17 (2.2%) complications occurred in the control group using LM-guided access and 2 (0.6%) in the US-access group. The results indicate a significant association between US access and decreased vascular complications (p\u0026thinsp;=\u0026thinsp;0.040 ϕ= -0.057) with a reduction of the observed complication rate by 89%: 3.8% complication rate in the LM-guided group vs. 0.4% in the US-guided group (OR 0.1; 95% CI 0.0135\u0026ndash;0.8515, p\u0026thinsp;=\u0026thinsp;0.034) as depicted in Fig.\u0026nbsp;4.\u003c/p\u003e\u003cp\u003eMoreover, complications in the US-guided group were less severe: Both cases presented with hematoma, no cases of AV-fistula or aneurysm were observed. One case of arterial pseudo-aneurysm in the landmark group required surgical intervention.\u003c/p\u003e\u003cp\u003eRegression analysis demonstrated that only HASBLED Score count (range 0\u0026ndash;4; mean\u0026thinsp;=\u0026thinsp;1.47; maximum\u0026thinsp;=\u0026thinsp;4, OR 2.826, 95% CI 1.631\u0026ndash;4.895, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001) and the first intraprocedural ACT (activated coagulation time, range 174\u0026ndash;320 sec, mean\u0026thinsp;=\u0026thinsp;256 sec, OR 0.985, 95% CI 0.972\u0026ndash;0.998, p\u0026thinsp;=\u0026thinsp;0.019) were independent predictors of the 19 vascular complications.\u003c/p\u003e\u003cp\u003eRegarding ACT values, no significant difference in heparin dosage (13141.3 Units vs. 12277.7 Units; p\u0026thinsp;=\u0026thinsp;0.120) or dosage per kg bodyweight (mean 156.9 U/kg vs. 148.2 U/kg; p\u0026thinsp;=\u0026thinsp;0.263) was found in patients who suffered a complication.\u003c/p\u003e\u003cp\u003eMaximum ACT was 320 sec in patients with a diagnosed vascular complication (range 174\u0026ndash;320 sec; mean 256 sec) and the maximum HASBLED Score count was 4 (range 0\u0026ndash;4; mean 1.47).\u003c/p\u003e\u003cp\u003eOral anticoagulation, use of platelet aggregation inhibitors, BMI, prediagnosed diabetes mellitus, age at time of procedure and sex did not predict the number of complications (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003e\u003cem\u003ePredictor analysis for vascular complication\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"4\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eOR\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003e95% CI\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003ep-value\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSex (male)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.549\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.211\u0026ndash;1.430\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.220\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eOAC\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.980\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.158\u0026ndash;6.075\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.982\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAntiplatelet therapy\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.749\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.069\u0026ndash;8.195\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.813\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDiabetes\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e4.085\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.467\u0026ndash;35.74\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.203\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (years)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.956\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.910\u0026ndash;1.004\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.074\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eBMI (kg/m2)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e1.051\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.954\u0026ndash;1.159\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e0.316\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eACT (sec)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e0.985\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e0.972\u0026ndash;0.998\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e\u003cb\u003e0.019\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eHASBLED\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e\u003cp\u003e2.810\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e\u003cp\u003e1.634\u0026ndash;4.832\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e\u003cb\u003e\u0026lt;\u0026thinsp;0.001\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe results of the present study confirm that adverse vascular events are infrequent in EP procedures. Still, the implementation of routine use of US-guided access significantly reduced the occurrence of vascular complications. In addition, we found that a higher ACT and higher HASBLED Score count were independent predictors of vascular complications in patients undergoing EP ablation procedures.\u003c/p\u003e\n\u003ch3\u003eUS-guided access\u003c/h3\u003e\n\u003cp\u003eAssociation analysis showed a lower complication rate after US-guided groin access as comparable to other studies with a similar sample size [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. The utilization of ultrasound provides an easy to use and cost-effective method that does not prolong the procedure [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Previous studies have calculated the incremental expenses caused by complications to be up to \u0026euro;15,544.71 per patient[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. Adopting US-guided access may decrease health care costs through its potential to reduce the number of vascular complications.\u003c/p\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eOutcomes\u003c/h2\u003e\u003cp\u003eWe observed 17 (2.2%) complications in the LM access group and 2 (0.6%) in the US-guided access group (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e3\u003c/span\u003e) over the course of the study. The most significant decrease was observed at the beginning of the study with a complication rate of 3.8% before the implementation of US-guided access compared to 0.4% after the transition to a US-only regime by the end of the study (OR 0.1, p\u0026thinsp;=\u0026thinsp;0.034) corresponding to a reduction of 89%.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eThe variations in group sizes stem from the sequential nature of the real-world study design and the gradual transition from traditional landmark-guided to ultrasound-guided puncture methods following the implementation of the Standard Operating Procedure (SOP). Additionally, the occurrence of a significant work strike by the nursing staff led to a reduction in interventions during the specified timeframe after the release of the SOP, therefore delaying the implementation of a US-only approach resulting in an uneven cohort size. Furthermore, alongside correlation analysis of the entire cohort, we conducted comparisons between the initial and final phases of the observation period to account for any potential learning effects among the investigators and the unequal cohort size.\u003c/p\u003e\u003cp\u003eObserved complication rates in the US-group are in line with findings of other study groups [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e] and indicate a reassuringly low risk of harm to the patient during ablation procedures. Moreover, less severe complications were observed in the US-guided access group: both cases presented with hematoma which did not require therapeutic intervention, while in the control group two cases of AV-fistula and two aneurysm were observed, requiring surgical intervention in one. These results favor the use of US guidance to improve patient safety.\u003c/p\u003e\u003cp\u003eWhile the Yamagata et al. conducted the first randomized trial comparing an US-guided vs. a conventional access approach found no significant difference in major complications due to a lower than expected number of access-related complications [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e], a broader body of evidence has shown the benefits of the US-approach [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. The current ESC-guideline for the treatment of atrial fibrillation therefore recommends the use of US-guided vascular access for all interventional ablation procedures [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e].\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003eAnticoagulation and intraprocedural ACT\u003c/h2\u003e\u003cp\u003eEncouragingly, the use of oral anticoagulation or antiplatelet therapy were no predictors of vascular complications, but our protocol dictated to pause the administration of oral anticoagulants prior to ablation must be taken into account when interpreting these results.\u003c/p\u003e\u003cp\u003eWe found a negative correlation between vascular complications and the first measured ACT during ablation, though no significant difference in the absolute or bodyweight adjusted heparin dosage was present. We found no difference in ACT levels between different types of DOAC, with apixaban being the most commonly used DOAC. Different levels of confounding factors in the coagulation cascade might be at play in addition to varying levels of interacting plasma-binding proteins.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\u003ch2\u003eHASBLED Score as independent predictor of vascular complications\u003c/h2\u003e\u003cp\u003eWe identified the HASBLED score as a predictor of vascular complications in patients undergoing ablation. The HASBLED score count is a readily available tool for risk factor assessment in all patients presenting with AF. Previous studies have found an effect of renal insufficiency as predictor of complications [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] after AF ablation, which may at least partially explain the impact of the HASBLED score count. Nonetheless, only 3% of patients in our cohort suffered from a severe renal insufficiency. The increased risk for bleeding complications indicated by a high HASBLED score can also be applied specifically to the individual risk for vascular groin complications in patients receiving ablation for atrial fibrillation.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003eLimitations:\u003c/h2\u003e\u003cp\u003e\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eThis was a retrospective, non-randomized, single-center study designed to identify clinical predictors of vascular complications in a group of consecutive patients undergoing EP procedures. Therefore, our findings cannot be applied to the general population. Despite the study\u0026rsquo;s retrospective nature, we sought to reduce selection bias by gathering information on consecutive patients who received EP procedures in our center. Nevertheless, selection bias regarding BMI is possible since our protocol comprises mandatory weight loss for patients with a BMI \u0026ge;35 with the indication for AF ablation and in the absence of arrhythmia induced cardiomyopathy or very severe symptoms (EHRA stage IV) before scheduling AF ablation. As a result, severely obese patients are underrepresented in this study.\u003c/p\u003e\u003cp\u003eAlso, our study did not account for a potential learning curve of the operator. We presumed this to be negligible due to experienced expert level operators who had prior experience using ultrasound. Therefore, no specific training was mandated. Previous studies took this fact into account but did not find a significant difference in the performance of expert and less experienced electrophysiologists [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e].\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eLastly, the respective cohort sizes were not ideally equal between both groups (LM vs. US-guided) as the presence of a notable strike by the nursing staff resulted in decreased interventions during the study, consequently yielding a diminished ultrasound group. Nevertheless, post-hoc power analysis verified an acceptable sample size (87.4% power at an alpha niveau of 5%).\u003c/p\u003e\u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe use of ultrasound-guidance for vascular access significantly further reduced the rate of groin complications in this retrospective analysis of EP procedures. Therefore, adopting the US-guided vascular access method into routine practice should be considered.\u003c/p\u003e\u003cp\u003eTo minimize the risk of vascular complications, it is essential to screen patients who present with a high HASBLED Score count. Tailored heparin dosage and conducting frequent ACT checks during ablation is advisable.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003e\u003cu\u003eAdditional Information\u003c/u\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo financial support was received for this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eJL* and DS* report having received lecture fees from Abbott, Boston Scientific, and Johnson\u0026amp;Johnson\u003c/p\u003e\n\u003cp\u003eAS received lecture fees from Abbott, Medtronic, Bayer, Johnson\u0026amp;Johnson, honoraria for advisory board activities from Medtronic, Abbott, Pfizer, Johnson\u0026amp;Johnson and educational grants from Biosense Webster, Abbott and Medtronic.\u003c/p\u003e\n\u003cp\u003e*contributed equally\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contributions statements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e1. \u0026nbsp; F. Pavel*\u003c/p\u003e\n\u003cp\u003e2. \u0026nbsp; S. C. R. Erlh\u0026ouml;fer\u003c/p\u003e\n\u003cp\u003e3. \u0026nbsp; J. W\u0026ouml;rmann\u003c/p\u003e\n\u003cp\u003e4. \u0026nbsp; S. Dittrich\u003c/p\u003e\n\u003cp\u003e5. \u0026nbsp; C. Scheurlen\u003c/p\u003e\n\u003cp\u003e6. \u0026nbsp; K. Filipovic\u003c/p\u003e\n\u003cp\u003e7. \u0026nbsp; J.-H. Schipper\u003c/p\u003e\n\u003cp\u003e8. \u0026nbsp; J.-H. van den Bruck\u003c/p\u003e\n\u003cp\u003e9. \u0026nbsp; A. Sultan\u003c/p\u003e\n\u003cp\u003e10.\u0026nbsp;J.\u0026nbsp;L\u0026uuml;ker\u003c/p\u003e\n\u003cp\u003e11. \u0026nbsp;D. Steven\u003c/p\u003e\n\u003cp\u003e1. \u0026nbsp; FP wrote the main manuscript text and conducted the statistical analysis.\u003c/p\u003e\n\u003cp\u003e2.\u0026ndash; 6. and 8.-9. Reviewed the manuscript and provided and compiled data.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;7. provided photografic images and reviewed the manuscript\u003c/p\u003e\n\u003cp\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;10. and 11. Reviewed the manuscript and assisted with statistical analysis\u003cbr\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData availability statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eEckardt, L., Frommeyer, G., Sommer, P., Steven, D., Deneke, T., Estner, H., Kriatselis, C., Kuniss, M., Busch, S., Tilz, R. R., Bonnemeier, H., Von Bary, C., Voss, F., Meyer, C., Thomas, D., \u0026amp; Neuberger, H. (2018). Updated Survey on Interventional Electrophysiology. \u003cem\u003eJACC: Clinical Electrophysiology\u003c/em\u003e, \u003cem\u003e4\u003c/em\u003e(6), 820\u0026ndash;827. https://doi.org/10.1016/j.jacep.2018.01.001\u003c/li\u003e\n \u003cli\u003eBenali, K., Khairy, P., Hammache, N., Petzl, A., Da Costa, A., Verma, A., Andrade, J. G. \u0026amp; Macle, L. (2023). Procedure-Related Complications of Catheter Ablation for Atrial Fibrillation. \u003cem\u003eJournal Of The American College Of Cardiology\u003c/em\u003e, 81(21), 2089\u0026ndash;2099. https://doi.org/10.1016/j.jacc.2023.03.418\u003c/li\u003e\n \u003cli\u003eBohnen, M., Stevenson, W. G., Tedrow, U. B., Michaud, G. F., John, R. M., Epstein, L. M., Albert, C. M., \u0026amp; Koplan, B. A. (2011). Incidence and predictors of major complications from contemporary catheter ablation to treat cardiac arrhythmias. \u003cem\u003eHeart Rhythm\u003c/em\u003e, \u003cem\u003e8\u003c/em\u003e(11), 1661\u0026ndash;1666. https://doi.org/10.1016/j.hrthm.2011.05.017\u003c/li\u003e\n \u003cli\u003eBaum, P. A., Matsumoto, A., Teitelbaum, G. P., Zuurbier, R. A., \u0026amp; Barth, K. H. (1989). Anatomic relationship between the common femoral artery and vein: CT evaluation and clinical significance. \u003cem\u003eRadiology\u003c/em\u003e, \u003cem\u003e173\u003c/em\u003e(3), 775\u0026ndash;777. https://doi.org/10.1148/radiology.173.3.2813785\u003c/li\u003e\n \u003cli\u003eWiles, B. M., Child, N. D., \u0026amp; Roberts, P. H. (2017). How to achieve ultrasound-guided femoral venous access: the new standard of care in the electrophysiology laboratory. \u003cem\u003eJournal of Interventional Cardiac Electrophysiology\u003c/em\u003e, \u003cem\u003e49\u003c/em\u003e(1), 3\u0026ndash;9. https://doi.org/10.1007/s10840-017-0227-9\u003c/li\u003e\n \u003cli\u003eSobolev, M., Shiloh, A. L., Di Biase, L., \u0026amp; Slovut, D. P. (2016). Ultrasound-guided cannulation of the femoral vein in electrophysiological procedures: a systematic review and meta-analysis. \u003cem\u003eEuropace\u003c/em\u003e, euw113. https://doi.org/10.1093/europace/euw113\u003c/li\u003e\n \u003cli\u003eArai, H., Mizukami, A., Hanyu, Y., Kawakami, T., Shimizu, Y., Hiroki, J., Yoshioka, K., Otani, H., Kuroda, S., Iwatsuka, R., Ueshima, D., Hayashi, T., Matsumura, A., Goya, M., \u0026amp; Sasano, T. (2020). Risk factors for venous bleeding complication at the femoral puncture site after catheter ablation of atrial fibrillation. \u003cem\u003eJournal of Arrhythmia\u003c/em\u003e, \u003cem\u003e36\u003c/em\u003e(4), 678\u0026ndash;684. https://doi.org/10.1002/joa3.12378\u003c/li\u003e\n \u003cli\u003eDing, W. Y., Khanra, D., Kozhuharov, N., Shaw, M., Luther, V., Ashrafi, R., Borbas, Z., Mahida, S., Modi, S., Hall, M., Snowdon, R., Waktare, J. E., Todd, D., \u0026amp; Gupta, D. (2022). Incidence of vascular complications for electrophysiology procedures in the ultrasound era: a single-centre experience over 10,000 procedures in the long term. \u003cem\u003eJournal of Interventional Cardiac Electrophysiology\u003c/em\u003e. https://doi.org/10.1007/s10840-022-01386-8\u003c/li\u003e\n \u003cli\u003eDe Sensi, F., Miracapillo, G., Addonisio, L., Breschi, M., Scalese, M., Cresti, A., Paneni, F., \u0026amp; Limbruno, U. (2018). Predictors of Successful Ultrasound Guided Femoral Vein Cannulation in Electrophysiological Procedures. \u003cem\u003eJournal of Atrial Fibrillation\u003c/em\u003e. https://doi.org/10.4022/jafib.2083\u003c/li\u003e\n \u003cli\u003ePl\u0026aacute;\u0026scaron;ek, J., Wichterle, D., Peichl, P., Čih\u0026aacute;k, R., Jarkovsk\u0026yacute;, P., Roub\u0026iacute;ček, T., Stojadinović, P., Haskova, J., \u0026amp; Kautzner, J. (2021). Gender differences in major vascular complications of catheter ablation for atrial fibrillation. \u003cem\u003eJournal of Cardiovascular Electrophysiology\u003c/em\u003e, \u003cem\u003e32\u003c/em\u003e(3), 647\u0026ndash;656. https://doi.org/10.1111/jce.14878\u003c/li\u003e\n \u003cli\u003eBode, K., Ueberham, L., Gawlik, S., Hindricks, G., \u0026amp; Bollmann, A. (2019). Inguinal vascular complications after ablation of atrial fibrillation: an economic impact assessment. \u003cem\u003eEuropace\u003c/em\u003e, \u003cem\u003e21\u003c/em\u003e(1), 91\u0026ndash;98. https://doi.org/10.1093/europace/euy132\u003c/li\u003e\n \u003cli\u003eKup\u0026oacute;, P., Pap, R., S\u0026aacute;ghy, L., T\u0026eacute;nyi, D., B\u0026aacute;lint, A., Debreceni, D., Basu-Ray, I., \u0026amp; Kom\u0026oacute;csi, A. (2020). Ultrasound guidance for femoral venous access in electrophysiology procedures\u0026mdash;systematic review and meta-analysis. \u003cem\u003eJournal of Interventional Cardiac Electrophysiology\u003c/em\u003e, \u003cem\u003e59\u003c/em\u003e(2), 407\u0026ndash;414. https://doi.org/10.1007/s10840-019-00683-z\u003c/li\u003e\n \u003cli\u003eYamagata, K., Wichterle, D., Roub\u0026iacute;ček, T., Jarkovsk\u0026yacute;, P., Sato, Y., Kogure, T., Peichl, P., Konečn\u0026yacute;, P., Jansova, H., Kucera, P., Aldhoon, B., Cihak, R., Sugimura, Y., \u0026amp; Kautzner, J. (2018). Ultrasound-guided versus conventional femoral venipuncture for catheter ablation of atrial fibrillation: a multicentre randomized efficacy and safety trial (ULTRA-FAST trial). \u003cem\u003eEuropace\u003c/em\u003e, \u003cem\u003e20\u003c/em\u003e(7), 1107\u0026ndash;1114. https://doi.org/10.1093/europace/eux175\u003c/li\u003e\n \u003cli\u003eMehran, R., Rao, S. V., Bhatt, D. L., Gibson, C. M., Caixeta, A., Eikelboom, J. W., Kaul, S., Wiviott, S. D., Menon, V., Nikolsky, E., Serebruany, V. L., Valgimigli, M., Vranckx, P., Taggart, D., Sabik, J. F., Cutlip, D. E., Krucoff, M. W., Ohman, E. M., Steg, P. G., \u0026amp; White, H. D. (2011). Standardized Bleeding Definitions for cardiovascular clinical trials. \u003cem\u003eCirculation\u003c/em\u003e, \u003cem\u003e123\u003c/em\u003e(23), 2736\u0026ndash;2747. https://doi.org/10.1161/circulationaha.110.009449\u003c/li\u003e\n \u003cli\u003ePadala, S. K., Gunda, S., Sharma, P. S., Kang, L., Koneru, J. N., \u0026amp; Ellenbogen, K. A. (2017). Risk model for predicting complications in patients undergoing atrial fibrillation ablation. \u003cem\u003eHeart Rhythm\u003c/em\u003e, \u003cem\u003e14\u003c/em\u003e(9), 1336\u0026ndash;1343. https://doi.org/10.1016/j.hrthm.2017.04.042\u003c/li\u003e\n \u003cli\u003eKupo, P., Riesz, T. J., Saghy, L., Vamos, M., Bencsik, G., Makai, A., Kohari, M., Benak, A., Miklos, M. \u0026amp; Pap, R. (2023). Ultrasound guidance for femoral venous access in patients undergoing pulmonary vein isolation: A quasi‐randomized study. \u003cem\u003eJournal Of Cardiovascular Electrophysiology, 34\u003c/em\u003e(5), 1177\u0026ndash;1182. https://doi.org/10.1111/jce.15893\u003c/li\u003e\n \u003cli\u003eTzeis, S., Gerstenfeld, E. P., Kalman, J., Saad, E. B., Shamloo, A. S., Andrade, J. G., Barbhaiya, C. R., Baykaner, T., Boveda, S., Calkins, H., Chan, N., Chen, M., Chen, S., Dagres, N., Damiano, R. J., De Potter, T., Deisenhofer, I., Derval, N., Di Biase, L., Trines, S. A. (2024). 2024 European Heart Rhythm Association/Heart Rhythm Society/Asia Pacific Heart Rhythm Society/Latin American Heart Rhythm Society expert consensus statement on catheter and surgical ablation of atrial fibrillation. \u003cem\u003eEP Europace, 26\u003c/em\u003e(4). https://doi.org/10.1093/europace/euae043\u003c/li\u003e\n\u003c/ol\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":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Vascular complications, Pulmonary Vein Isolation, Ultrasound guided access, Atrial fibrillation ablation","lastPublishedDoi":"10.21203/rs.3.rs-5005610/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5005610/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground \u003c/strong\u003eUltrasound (US) guidance is increasingly used in invasive cardiac electrophysiology (EP) procedures for femoral vascular access. In this study, we assessed the occurrence of vascular access-related complications in EP procedures which were performed with the routine use of anatomical landmark (LM) versus US-guided vascular access.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods \u003c/strong\u003eA total of 1119 consecutive EP procedures in 1012 patients performed in a two-year period from September 10, 2020 to September 10, 2022 were included. The endpoint of the present study consisted of any vascular access-related complication, classified as hematoma, aneurysm, or AV-fistula. Different risk factors for increased bleeding risk were analyzed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults \u003c/strong\u003eDuring the evaluation period, 777 procedures were performed using LM-guiding and 342 procedures using US-guided access. Overall, 19 (1.7%) relevant vascular complications occurred including: 15 (1.3%) hematoma, 2 (0.18%) aneurysm and 2 (0.18%) AV-fistula. 17 (2.2%) complications occurred in the LM-guided group and 2 (0.6%) in the US-guided group.\u003c/p\u003e\n\u003cp\u003eA significant reduction of femoral complications by 89% was observed with introduction of routine US-guided access. 3.8% in the LM-group vs. 0.4% in the US-group (OR 0.1, 95% CI 0.0135-0.8515, p=0.034).\u003c/p\u003e\n\u003cp\u003eIntraprocedural ACT and the HASBLED score [range 0-4; mean=1.47; maximum=4) were shown to be independent predictors for vascular complications (OR 2.826, 95% CI 1.631-4.895, p\u0026lt; 0.001).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion \u003c/strong\u003eThe use of US-guided vascular access significantly decreased the access-related complication rate in EP procedures. Higher procedural ACT and HASBLED score independently predicted a higher risk of vascular access complications.\u003c/p\u003e","manuscriptTitle":"Ultrasound guided femoral venous access decreases vascular complications in catheter ablation procedures","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-01 08:47:28","doi":"10.21203/rs.3.rs-5005610/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Accepted","date":"2025-09-22T07:08:31+00:00","index":"","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-08-14T10:19:48+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-08-08T12:19:02+00:00","index":"","fulltext":""},{"type":"submitted","content":"Scientific Reports","date":"2025-08-01T14:46:03+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"scientific-reports","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"scirep","sideBox":"Learn more about [Scientific Reports](http://www.nature.com/srep/)","snPcode":"","submissionUrl":"","title":"Scientific Reports","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Scientific Reports","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"77a5210a-95ab-4913-bb5a-1d806e37adc0","owner":[],"postedDate":"September 1st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":53164052,"name":"Health sciences/Medical research"},{"id":53164053,"name":"Health sciences/Medical research/Outcomes research"}],"tags":[],"updatedAt":"2025-10-06T16:05:02+00:00","versionOfRecord":{"articleIdentity":"rs-5005610","link":"https://doi.org/10.1038/s41598-025-21481-w","journal":{"identity":"scientific-reports","isVorOnly":false,"title":"Scientific Reports"},"publishedOn":"2025-10-03 15:58:12","publishedOnDateReadable":"October 3rd, 2025"},"versionCreatedAt":"2025-09-01 08:47:28","video":"","vorDoi":"10.1038/s41598-025-21481-w","vorDoiUrl":"https://doi.org/10.1038/s41598-025-21481-w","workflowStages":[]},"version":"v1","identity":"rs-5005610","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5005610","identity":"rs-5005610","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}