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Purpose: To evaluate the technical success and complication rates of vascular closure devices (VCDs) in the axillary artery., Materials and Methods: MEDLINE and Embase were searched independently by two reviewers to identify observational studies from inception through October 2021. The following outcomes were meta-analyzed: technical success, hematoma, dissection, pseudoaneurysm, infection, and local neurological complications. Complications were also graded as mild, moderate, and severe. A logistic regression evaluating the influence of sheath size for the outcome of technical success rate was performed using individual patient-level data., Results: Of 1496 unique records, 20 observational studies were included, totaling 915 unique arterial access sites. Pooled estimates were as follows: technical success 84.8% (95% confidence interval [CI]: 78%-89.7%, I 2 =60.4%), hematoma 7.9% (95% CI: 5.8%-10.6%, I 2 =0%), dissection 3.1% (95% CI: 1.3%-7.3%, I 2 =0%), pseudoaneurysm 2.7% (95% CI: 1.3%-5.7%, I 2 =0%), infection <1% (95% CI: 0%-5.7%, I 2 =20.5%), and local neurological complications 2.7% (95% CI: 1.7%-4.4%, I 2 =0%). There was a significant negative association between sheath size and technical success rate (odds ratio [OR]: 0.87 per 1 French (Fr) increase in sheath size, 95% CI: 0.80-0.94, p=0.0005). Larger sheath sizes were associated with a greater number of access-site complications (adjusted odds ratio [aOR]: 1.21 per 1 Fr increase sheath size, 95% CI: 1.04-1.40, p=0.013)., Conclusions: Off-label use of VCDs in the axillary artery provides an 85% successful closure rate and variable complication rate, depending on the primary procedure and sheath size. Larger sheaths were associated with a lower technical success and greater rate of access-related complications., Clinical Impact: Safe arterial access is the foundation for arterial intervention. While the common femoral artery is a well established access site, alternative arterial access sites capable of larger sheath sizes are needed in the modern endovascular era. This article provides the largest synthesis to date on the use of vascular closure devices for percutaneous axillary artery access in endovascular intervention. It should serve clinicians with added confidence around this approach in terms of providing a reference for technical success and complications. Clinically, this data is relevant for patient consent purposes as well as for practice quality improvement in setting safety standards for this access site., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Transfemoral access is nowadays required for an increasing number of percutaneous procedures, such as structural heart interventions, mechanical circulatory support, and interventional electrophysiology/pacing. Despite technological advancements and improved techniques, these devices necessitate large-bore (≥12 French) arterial/venous sheaths, posing a significant risk of bleeding and vascular complications, whose occurrence has been related to an increase in morbidity and mortality. Therefore, optimizing large-bore vascular access management is crucial in endovascular interventions. Technical options, including optimized preprocedural planning and proper selection and utilization of vascular closure devices, have been developed to increase safety. This review explores the comprehensive management of large-bore accesses, from optimal vascular puncture to sheath removal. It also discusses strategies for managing closure device failure, with the goal of minimizing vascular complications., Competing Interests: Drs Burzotta and Trani received speaker fees from Abbott Vascular, Abiomed, Medtronic, and Terumo. Dr Paraggio received speaker fees from Abiomed and Terumo. Dr Aurigemma received speaker fees from Abbott Vascular, Abiomed, Medtronic, Terumo, and Daiichi Sankyo. Dr Romagnoli received speaker fees from Abiomed, Abbott Vascular, and Terumo. Dr Bianchini received a research grant from Abbott Vascular. The other authors report no conflicts of interest to declare.

Background: MynxGrip is a non-suture, balloon catheter- and extravascular sealant-based vascular closure device designed to help hemostasis after an arterial puncture. This study evaluated the efficacy and safety of MynxGrip versus manual compression for femoral artery access closure in patients undergoing diagnostic or interventional procedures., Methods: The PANDA multicenter, parallel-group, open-label, randomized controlled trial enrolled patients undergoing a diagnostic or interventional procedure through femoral artery access between April 2019 and September 2020 at six centers in China. The participants were randomized 2:1 to the MynxGrip group and the manual compression group. Time to hemostasis and incidence of severe complications were the primary efficacy and safety endpoints, respectively., Results: A total of 304 consecutive participants were included. The baseline characteristics were similarly distributed in the MynxGrip ( n  = 203) versus manual compression ( n  = 101) groups. Compared with the manual compression group, the median time to hemostasis and time to ambulation were significantly shorter (3.0 (interquartile range: 2.0, 4.0) vs 18.0 (11.0, 22.0) min, and 479.0 (275.0, 932.0) vs 1410.3 (1121.0, 1476.0) min, respectively; both p  = 0.0001) in the MynxGrip group, with similar procedural success rate, and without severe complications in either group. The incidence of device-related adverse events was 11.8% in the MynxGrip group, most possibly or definitely unrelated., Conclusions: Compared with manual compression, the MynxGrip vascular closure device significantly shortens the times to hemostasis and ambulation without severe complications after diagnostic or interventional procedures through the femoral artery access., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Introduction: Access site complications remain common following atrial fibrillation (AF) catheter ablation. Femoral vascular closure devices (VCDs) reduce time to hemostasis compared with manual compression, although large-scale data comparing clinical outcomes between the two approaches are lacking., Methods: Two cohorts of patients undergoing AF ablation were identified from 36 healthcare organizations using a global federated research network (TriNetX): those receiving a VCD for femoral hemostasis, and those not receiving a VCD. A 1:1 propensity score matching (PSM) model based on baseline characteristics was used to create two comparable cohorts. The primary outcome was a composite of all-cause mortality, vascular complications, bleeding events, and need for blood transfusion. Outcomes were assessed during early (within 7 days of ablation) and extended follow-up (within 8-30 days of ablation)., Results: After PSM, 28 872 patients were included (14 436 in each cohort). The primary composite outcome occurred less frequently in the VCD cohort during early (1.97% vs. 2.60%, odds ratio (OR) 0.76, 95% confidence interval (CI) 0.65-0.88; p < .001) and extended follow-up (1.15% vs. 1.43%, OR 0.80, 95% CI 0.65-0.98; p = .032). This was driven by a lower rate of vascular complications during early follow-up in the VCD cohort (0.83% vs. 1.26%, OR 0.66, 95% CI 0.52-0.83; p < .001), and fewer bleeding events during early (0.90% vs. 1.23%, OR 0.73, 95% CI 0.58-0.92; p = .007) and extended follow-up (0.36% vs. 0.59%, OR 0.61, 95% CI 0.43-0.86; p = .005)., Conclusion: Following AF ablation, femoral venous hemostasis with a VCD was associated with reduced complications compared with hemostasis without a VCD., (© 2024 The Author(s). Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Background: Radial access is the default approach in interventional cardiology. The Axiostat® surgical hemostatic dressing, using chitosan as its active component, has demonstrated potential in accelerating blood clotting. This study aims to assess the efficacy and the safety of the Axiostat® dressing in achieving hemostasis in patients undergoing transradial coronary angioplasty (TRCA)., Methods: This prospective, single-center observational study, conducted in 2022, enrolled consecutive patients undergoing TRCA, with a target of 150 participants. The primary outcome was the success rate of radial artery hemostasis at 120 min, without bleeding necessitating immediate re-compression. The secondary outcome included Axiostat® performance at 24 h and 30 days Postprocedure., Results: The study was terminated prematurely for ethical and patient safety reasons, after inclusion of 41 consecutive TRCA patients due to an unexpectedly high radial artery thrombosis rate (19.5%, n = 8/41) observed 24 h Postprocedure. The success rate of radial hemostasis with the Axiostat® dressing was 78.0%. Procedural details and patient characteristics were comparable between successful Axiostat® removal and device failure cases., Conclusion: The use of the Axiostat® dressing to achieve hemostasis after TRCA is effective but is associated with an unexpectedly high incidence of radial thrombosis. Our results should encourage caution in the future evaluation and use of this device for radial artery compression following TRCA., (© 2024 Wiley Periodicals LLC.)

Objectives: Manual compression (MC) or vascular closure devices (VCDs) are used to achieve hemostasis after percutaneous transluminal angioplasty (PTA). However, limited data on the comparative safety and effectiveness of VCDs vs MC in patients with end-stage renal disease (ESRD) undergoing PTA are available. Accordingly, this study compared the safety and effectiveness of VCD and MC in patients with ESRD undergoing PTA., Methods: This single-center retrospective cohort study included the data of patients with ESRD undergoing peripheral intervention at Chang Gung Memorial Hospital, Taiwan, from January 1, 2019, to June 30, 2022. The patients were divided into VCD and MC groups. The primary endpoint was a composite of puncture site complications, including acute limb ischemia, marked hematoma, pseudoaneurysm, and puncture site bleeding requiring blood transfusion., Results: We included 264 patients with ESRD undergoing PTA, of whom 60 received a VCD and 204 received MC. The incidence of puncture site complications was 3.3% in the VCD group and 4.4% in the MC group (hazard ratio: .75; 95% confidence interval: .16-3.56 L P = 1.000), indicating no significant between-group difference., Conclusion: VCDs and MC had comparable safety and effectiveness for hemostasis in patients with ESRD undergoing peripheral intervention., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Background: Endovascular aortic surgery is increasingly becoming the standard treatment. Percutaneous access preclosing systems appear to be effective and notably the Proglide (PG). We aimed to prospectively assess the clinical effectiveness of combining ultrasound-guided femoral puncture with ultrasound-guided PG deployment., Methods: Our single-center study consecutively included patients managed at a tertiary center from May to September 2023, undergoing endovascular aortic surgery. The placement of PG was performed under ultrasound guidance. Preoperative patient characteristics were evaluated using preoperative computed tomography scans. Clinical and technical success were defined, respectively, as the ability to achieve complete hemostasis confirmed by ultrasound 48 hr postprocedure and as the successful placement of a PG under ultrasound guidance contributing to final hemostasis., Results: Twenty patients were included over a 6-month period, totaling 34 common femoral arteries (CFAs). Fourteen were male, with an average age of 72.8 ± 8.2 years. Among the 34 CFA, CFA had diameter of 12.05 ± 2.4 mm and a depth of 38.0 ± 13.4 mm. The mean introducer sheath diameter was 6.2 ± 1.5 mm with a sheath to femoral artery ratio of 0.54 ± 0.18. Successful Proglide placement under ultrasound guidance was achieved in 100% of cases. No PG failure occurred. Clinical and technical success were, respectively, of 95% and 100%. One small pseudoaneurysm was observed at 48 hr treated medically. No CFA access reintervention was required., Conclusions: The technique of ultrasound-guided PG deployment in aortic surgery is a safe and effective method for achieving hemostasis. It effectively prevents PG failures at a lower cost., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Introduction: Our retrospective study aimed at assessing safety of vascular closure devices (VCDs) used in a large single-centre Interventional Radiology (IR) department. Complication and deployment failure rates using collagen-based (Angio-seal) and suture-based (ProGlide) devices for common femoral artery haemostasis were compared., Materials and Methods: Data from VCDs deployed over a 6-year period were retrospectively analysed for patient age, procedure indication, puncture mode (antegrade/retrograde), sheath size, deployment failure and complications (haematoma, pseudoaneurysm formation, limb occlusion). Numerical and statistical analysis was undertaken., Results: Overall, 1321 common femoral artery punctures in 1217 patients were closed using VCDs. Failure rate using ProGlide was significantly higher when compared with Angio-seal ( P =<0.001) in sheath sizes ≤8 Fr. Heparin was not administered in embolisation procedures compared with angioplasty with or without stenting. Therefore, haematoma tended to occur more frequently following angioplasty without stenting ( P = 0.003) and angioplasty with stenting ( P = 0.001), when compared with embolisation. Deployment failure occurred more frequently when heparin was used during the procedure ( P = 0.005)., Conclusion: Although complications relating to sheath size are well established in the literature, there remains a paucity of data assessing the impact of procedure specific factors when comparing VCDs. Our study challenges that size is the sole determinant of VCD success and invites a more holistic view of VCD deployment strategies. This study advocates continued research into the nuances of other potential confounding variables to optimise patient outcomes., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Peripherally inserted central catheters (PICCs) are vital in delivering intravenous therapy. Despite their advantages, PICCs can lead to complications such as catheter exit site bleeding, which can cause patient distress and increase infection risk. This study evaluated the efficacy of StatSeal, a topical haemostatic device, in managing PICC exit site bleeding. StatSeal uses a hydrophilic polymer and potassium ferrate to form a seal, reducing access site bleeding and minimising dressing changes. For this study, Patients were recruited at Frimley Health NHS Foundation Trust; the trial involved 177 patients with StatSeal, and shows that 99% did not require additional dressing changes within the standard 7-day period. The findings demonstrate StatSeal's effectiveness in improving patient outcomes by reducing exit site bleeding and associated complications, enhancing the efficiency of vascular access maintenance and potentially lowering associated healthcare costs. The trial emphasises the importance of innovative solutions such as StatSeal to advance PICC care and improve patient experience.

Background: The trans femoral ipsilateral approach is often adopted for endovascular treatment (EVT) for better steerability of guidewires or better device deliverability. However, contrary to the trans femoral contralateral approach, ipsilateral antegrade puncture sometimes causes peculiar bleeding complications., Case Presentation: A 76-year-old female underwent EVT for chronic occlusion of the left superficial femoral artery (SFA) via the ipsilateral antegrade approach. After guidewire passage, we inflated the drug-coated balloons, but angiography showed blood flow stasis at the mid segment of the SFA. We also ensured prolonged balloon inflation, which resulted in favorable blood flow. While trying to ensure hemostasis, the blood pressure remained decreased, but neither bleeding nor superficial hematoma were observed at the puncture site. After hemostasis was achieved, we removed the surgical drape and noticed a swelling in the mid-portion of the thigh, distant from the puncture point. We then approached the left common femoral artery (CFA) contralaterally. Angiography showed continuous bleeding from a little bit distally to the sheath insertion point that was spreading through an intramuscular space. We stopped the bleeding with balloon tamponade inside the CFA. Angiography after hemostasis demonstrated blood flow stasis at the mid-segment of the SFA, similarly as that seen before. We confirmed compression of the SFA by a large hematoma using both intra- and extra- vascular ultrasound. Therefore, we deployed a self-expandable stent at the compressed SFA position. Finally, we achieved favorable blood flow on angiography., Conclusion: We encountered a case that latent bleeding unrecognized in the surgical field persisted while prolonged inflation of DCB was conducted at just proximal SFA. We could have avoided bailout stenting by noticing the bleeding incident in a timely manner. Prediction and prevention are essential for all kinds of procedural complications in EVT., (© 2024. The Author(s).)

Background: An increasing number of interventional procedures require large-sheath technology (>12F) with a favorable outcome with endovascular rather than open surgical access. However, vascular complications are a limitation for the management of these patients. This trial aimed to determine the effectiveness and safety of the Cross-Seal suture-mediated vascular closure device in obtaining hemostasis at the target limb access site following interventional procedures using 8F to 18F procedural sheaths., Methods: The Cross-Seal IDE trial (Investigational Device Exemption) was a prospective, single-arm, multicenter study in subjects undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheaths. The primary efficacy end point was time to hemostasis at the target limb access site. The primary safety end point was freedom from major complications of the target limb access site within 30 days post procedure., Results: A total of 147 subjects were enrolled between August 9, 2019, and March 12, 2020. Transcatheter aortic valve replacement was performed in 53.7% (79/147) and percutaneous endovascular abdominal/thoracic aortic aneurysm repair in 46.3% (68/147) of subjects. The mean sheath ID was 15.5±1.8 mm. The primary effectiveness end point of time to hemostasis was 0.4±1.4 minutes. An adjunctive intervention was required in 9.2% (13/142) of subjects, of which 2.1% (3/142) were surgical and 5.6% (8/142) endovascular. Technical success was achieved in 92.3% (131/142) of subjects. Freedom from major complications of the target limb access site was 94.3% (83/88)., Conclusions: In selected patients undergoing percutaneous endovascular procedures utilizing 8F to 18F ID procedural sheath, Cross-Seal suture-mediated vascular closure device achieved favorable effectiveness and safety in the closure of the large-bore arteriotomy., Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03756558., Competing Interests: Disclosures Dr Krishnan has served as a consultant to Abbott and Medtronic. Dr Nazif reports consulting fees or honoraria from Terumo Medical, Boston Scientific, Medtronic, Edwards Lifesciences, Teleflex, Opsens Medical, Encompass Technologies, and Columbia University Irving Medical Center. The other authors report no conflicts.

Background: Despite the use of two crossed Perclose ProGlide™ (Abbott Vascular Devices) is the most widespread technique to close the main arterial access in transfemoral transcatheter aortic valve implantation (TF-TAVI), the safest and most effective strategy still remains much debated., Aims: The aim of the present study was to evaluate the performance of a single Perclose ProGlide suture-mediated closure device to obtain femoral hemostasis after sheathless implantation of self-expanding transcatheter heart valves through their 14 F-equivalent fix delivery systems., Methods: This prospective observational study included 439 patients undergoing TF-TAVI at the "Montevergine" Clinic of Mercogliano, Italy. All patients underwent hemostasis of the large-bore access using a single Perclose ProGlide with preclose technique, after sheathless implantation of self-expanding transcatheter heart valves through 14 F-equivalent fix delivery systems. A multidetector computed tomography analysis of size, tortuosity, atherosclerotic, and calcification burdens of the ilio-femoral access route was made by a dedicated corelab. Vascular complications (VCs), percutaneous closure device (PCD) failure, and bleedings were adjudicated by a clinical events committee., Results: A total of 81 different VCs were observed in 60 patients (13.7%); among these, 41 (5% of patients) were categorized as major. PCD failure occurred in 14 patients (3.2%). At the logistic regression analysis, no predictors of PCD failure have been identified., Conclusion: This registry suggests that the use of a single suture-mediated closure device could be considered a safe and efficient technique to achieve access site hemostasis in patients undergoing TF-TAVI through 14 F-equivalent fix delivery systems., (© 2024 Wiley Periodicals LLC.)

Aims: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]., Methods and Results: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group., Conclusion: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications., Competing Interests: Conflict of interest: R.R.T. is a consultant for Boston Scientific, Biotronik, Biosense Webster, and Abbott Medical, and he received speaker’s honoraria from Boston Scientific, Biotronik, Biosense Webster, Abbott Medical, and Lifetech and research grants from Abbott, Biosense Webster, and Lifetech. C.-H.H. received travel grants and research grants from Abbott Medical, Boston Scientific, Medtronic, Lifetech, Biosense Webster, and CardioFocus. He is a consultant for Boston Scientific, Biosense Webster, and Lifetech and received speaker honoraria from Abbott Medical, Boston Scientific, Medtronic, Biosense Webster, CardioFocus, Pfizer, BMS, C.T.I. GmbH, and Doctrina Med. K.-H.K. reports grants and personal fees from Abbott Vascular, Medtronic, and Biosense Webster outside the submitted work. C.E. received travel grants and research grants from Abbott, Boston Scientific, and Biosense Webster and speaker honoraria from Abbott, Boston Scientific, Biosense Webster, C.T.I. GmbH, and Doctrina Med. S.S.P. received travel grants and congress grants from Lifetech and an Educational Grant and speaker honoraria from Abbott Medical. J.V. received honoraria for lectures / talks: Abbott, Astra Zeneca, Pfizer, Boston Scientific, C.T.I., Doctrina Med, Medtronic and travel grants: Medtronic, Boston Scientific, Abbott, and is proctor for Boston Scientific. P.S. is Member of Advisory Board of Abbott, Biosense Webster, Boston Scientific and Medtronic. All other authors have no relevant disclosures., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Purpose: Mechanical circulatory support (MCS) using a venoarterial extracorporeal membrane oxygenation (VA-ECMO) device or a catheter-type heart pump (Impella) is critical for the rescue of patients with severe cardiogenic shock. However, these MCS devices require large-bore cannula access (14-Fr and larger) at the femoral artery or vein, which often requires surgical decannulation., Methods: In this retrospective study, we evaluated post-closure method using a percutaneous suture-mediated vascular closure system, Perclose ProGlide/ProStyle (Abbott Vascular, Lake Bluff, IL, Perclose), as an alternative procedure for MCS decannulation. Closure of 83 Impella access sites and 68 VA-ECMO access sites performed using Perclose or surgical method between January 2018 and March 2023 were evaluated., Results: MCS decannulation using Perclose was successfully completed in all access sites without surgical hemostasis. The procedure time of ProGlide was shorter than surgical decannulation for both Impella and VA-ECMO (13 min vs. 50 min; p < 0.001, 21 min vs. 65 min; p < 0.001, respectively). There were no significant differences in the 30-day survival rate and major adverse events by decannulation including arterial dissection requiring endovascular treatment, hemorrhage requiring a large amount of red blood cell transfusion, and access site infection., Conclusion: Our results suggest that the post-closure technique using the percutaneous suture-mediated closure system appears to be a safe and effective method for large-bore MCS decannulation., Competing Interests: Declaration of competing interest Keita Saku received research funding from Omron Healthcare Co., Abiomed Japan K.K., NTT Research, Inc., Asahi Kasei ZOLL Medical Corporation, Neuroceuticals Inc., and Zeon Medical Inc., and honoraria from Abiomed Japan K.K., Ono Pharmaceutical Co., Ltd., and Mallinckrodt Japan Co. Ltd. The other authors declare no conflict of interest., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: Patent hemostasis (PH) is essential for preventing radial artery occlusion (RAO) after trans-radial procedures; however, it remains unclear how it should be obtained. The aim of this multicenter randomized study was to evaluate whether the use of an adjustable device (AD), inflated with a pre-determined amount of air (AoA), was more effective than a non-adjustable device (non-AD) for achieving PH, thereby reducing the incidence of RAO., Methods: We enrolled a total of 480 patients undergoing transradial procedure at 3 Italian institutions. Before the procedure, a modified Reverse Barbeau Test (mRBT) was performed in all patients to evaluate the AoA to be eventually inflated in the AD. After the procedure, patients were randomized into 2 groups: (1) AD Group, using TR-Band (Terumo) inflated with the pre-determined AoA; and 2) non-AD Group, using RadiStop (Abbott). An RBT was performed during compression to demonstrate the achievement of PH, as well as 24 hours later to evaluate the occurrence of RAO., Results: PH was more often obtained in the AD Group compared with the non-AD Group (90% vs 64%, respectively, P less than .001), with no difference in terms of bleedings. RAO occurred more often in the non-AD Group compared with the AD Group (10% vs 3%, respectively, P less than .001). Of note, mRBT was effective at guiding AD inflation and identifying high-risk patients in whom PH was more difficult to obtain., Conclusions: The use of AD, filled with a predetermined AoA, allowed PH significantly more often compared with non-AD, providing a significantly reduced incidence of RAO.

Background: Mortality for pelvic fracture patients presenting with hemorrhagic shock ranges from 21% to 57%. The objective of this study was to develop a lethal and clinically relevant pelvic hemorrhage animal model with and without bony fracture for evaluating therapeutic interventions. ResQFoam is a self-expanding foam that has previously been described to significantly decrease mortality in large-animal models of abdominal exsanguination. We hypothesized that administration of ResQFoam into the preperitoneal space could decrease mortality in exsanguinating pelvic hemorrhage., Methods: Two pelvic hemorrhage models were developed using noncoagulopathic swine. Pelvic hemorrhage model 1: bilateral, closed-cavity, major vascular retroperitoneal hemorrhage without bony pelvic fracture. After injury, animals received no treatment (control, n = 10), underwent preperitoneal packing using laparotomy pads (n = 11), or received ResQFoam (n = 10) injected into the preperitoneal space. Pelvic hemorrhage model 2: unilateral, closed-cavity, retroperitoneal hemorrhage injury (with intraperitoneal communication) combined with complex pelvic fracture. After injury, animals received resuscitation (control, n = 12), resuscitation with preperitoneal packing (n = 10) or with ResQFoam injection (n = 10) into the preperitoneal space., Results: For model 1, only ResQFoam provided a significant survival benefit. The median survival times were 50 minutes and 67 minutes for preperitoneal packing and ResQFoam, compared with 6 minutes with controls ( p = 0.002 and 0.057, respectively). Foam treatment facilitated hemodynamic stabilization and resulted in significantly less hemorrhage (21.5 ± 5.3 g/kg) relative to controls (31.6 ± 5.0 g/kg, p < 0.001) and preperitoneal packing (32.7 ± 5.4 g/kg, p < 0.001). For model 2, both ResQFoam and preperitoneal packing resulted in significant survival benefit compared with controls. The median survival times were 119 minutes and 124 minutes for the preperitoneal packing and ResQFoam groups, compared with 4 minutes with controls ( p = 0.004 and 0.013, respectively)., Conclusion: Percutaneous injection of ResQFoam into the preperitoneal space improved survival relative to controls, and similar survival benefit was achieved compared with standard preperitoneal pelvic packing. The technology has potential to augment the armamentarium of tools to treat pelvic hemorrhage., (Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.)

Competing Interests: Funding Support and Author Disclosures Dr B. O’Neill is a consultant for Abbott, Edwards Lifesciences, and Medtronic; and has received research support from Edwards Lifesciences assigned to employer Henry Ford Health. Dr Wang is a consultant for Abbott, Boston Scientific, and Edwards Lifesciences; and has received research grant support from Boston Scientific assigned to her employer Henry Ford Health. Dr Frisoli is a clinical proctor for Edwards Lifesciences, Abbott, Boston Scientific, and Medtronic. Dr W. O’Neill is a consultant for Abiomed, Medtronic, and Boston Scientific. Dr Villablanca is a consultant for Edwards Lifesciences and Teleflex. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Objectives: The aim was to identify the factors related to inadequate hemostasis with five minutes of manual compression using the EXOSEAL vascular closure device (VCD), and to evaluate the optimal time to hemostasis (TTH)., Methods: A total of 119 consecutive patients who underwent neuro-endovascular therapy via common femoral arterial puncture between February 2019 and August 2021 were included. These patients underwent hemostasis using an EXOSEAL with manual compression for five minutes. In this retrospective study, the 119 patients were divided into two groups: (1) achieved hemostasis with five minutes (n = 76); and (2) required more than five minutes to achieve hemostasis (n = 43, Add group). In both groups, patient's characteristics, endovascular procedures, and closure procedures were assessed., Results: On univariable analysis, activated clotting time (ACT), multiple antiplatelets, closure with an under-sized EXOSEAL VCD (U-VCD), endovascular procedure, and use of a 7Fr. VCD were significantly associated with additional compression ( p  < 0.05). On multivariate logistic regression analysis, the following three factors were found to be associated with additional compression: pre-closure ACT (adjusted OR, 0.136; 95% CI, 1.017-1.056; p  < 0.001); multiple antithrombotics (adjusted OR, 12.843; 95% CI, 3.458-47.693; p  < 0.001); and closure with a U-VCD (adjusted OR, 5.653; 95% CI, 1.751-18.151; p  = 0.004). On the receiver-operating characteristic curve analysis for prediction of the need for additional compression, the cutoff point for pre-closure ACT was calculated to be 268 s. In the Add group, mean TTH was 9.8 ± 1.5 min., Conclusion: Multiple antiplatelets and closure with a U-VCD may increase the risk of insufficient hemostasis with five-minutes compression using an EXOSEAL VCD for femoral puncture sites if the pre-closure ACT is greater than 268 s. In these patients, mean TTH was 9.8 ± 1.5 min., Competing Interests: Declaration of conflicting interestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Large bore accesses refer to accesses with a diameter of 10 French or greater and are necessary for various medical devices, including those used in transcatheter aortic valve replacement, endovascular aneurysm repair stent-grafts, and percutaneous mechanical support devices. Notably, the utilization of these devices via femoral access is steadily increasing due to advancements in technology and implantation techniques, which are expanding the pool of patients suitable for percutaneous procedures. However, procedures involving large bore devices carry a high risk of bleeding and vascular complications (VCs), impacting both morbidity and long-term mortality. In this review article, we will first discuss the incidence, determinants, and prognostic impact of VCs in patients undergoing large bore access procedures. Subsequently, we will explore the strategies developed in recent years to minimize VCs, including techniques for optimizing vascular puncture through femoral cannulation, such as the use of echo-guided access cannulation and fluoroscopic guidance. Additionally, we will evaluate existing vascular closure devices designed for large bore devices. Finally, we will consider new pharmacological strategies aimed at reducing the risk of periprocedural access-related bleeding., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

Background: A total percutaneous approach for management of aortic pathologies with endovascular grafts requires the use of large size delivery-systems. The diameter of these delivery systems usually exceeds the recommended sizes for most of the currently available percutaneous closure devices. A safe, effective and simple vascular access site closure device is desirable for success for percutaneous procedures for aortic pathologies. Hence, we aim to study safety and effectiveness of the use of a single suture based vascular access closure device (ProGlide) using a technique involving serial up and downsizing of the sheath size to achieve access site hemostasis in patients undergoing endovascular graft placement using femoral artery approach., Materials and Methods: We studied all consecutive patients who underwent endovascular grafting from January 2018 to December 2019. It is a retrospective observational study comparing procedural and short-term outcomes between single ProGlide use and surgical cut-down for femoral access site closure. We excluded patients with femoral artery minimal luminal diameter less than 5 mm, the presence of an aneurysm of the femoral artery, ≥180 degrees of calcium present at femoral/ external iliac artery and history of any vascular closure device use in the last six months., Results: We included 30 patients in single ProGlide group and 30 patients in the surgical cut-down group. One-third of the procedures were urgent procedures in the single Proglide group. Single ProGlide was successful in 93.34% patients and failure (6.66%) was seen due to hematoma and pseudoaneurysm in one patient each detected before discharge. The primary end-point defined by the success of procedure did not differ between the two groups. There were higher complications in the surgical group till 30 days as evidenced by infection, hematoma and neuronal injury. The secondary end-point, defined by the composite of complication events after discharge till 30 days was significantly higher in the surgical group (P-0.005) CONCLUSION: In patients with suitable femoral artery anatomy who undergo endovascular graft placement, effective hemostasis can be achieved safely using up and downsizing of the sheath with a single suture-based technique (Proglide). The results of the study could be considered hypothesis generating and needs to be confirmed in a randomized controlled trial before being adopted in clinical practice., (Copyright © 2021. Published by Elsevier Inc.)

Introduction: To evaluate the feasibility and safety of the Mynx vascular closure device (VCD) for arteriotomy closure after stent placement near the common femoral artery (CFA) access site., Methods: A total of 88 patients (73 men; mean age, 72 ± 9.2 years; 136 procedures) who underwent closure of CFA arteriotomy using the Mynx VCD after stent placement in proximal superficial femoral artery (SFA) with antegrade approach, or in common or external iliac artery with retrograde approach were retrospectively studied. Technical success and access site complication were evaluated. Body mass index (BMI), platelet count, international normalized ratio, prior history of ipsilateral CFA access, access direction, degree of CFA calcification, stent location and diameter, total procedure time, and sheath size were analyzed to evaluate their relationship with technical failure and development of bleeding complications., Results: Technical success was achieved in 94.9% (129/136) patients. The mean time to hemostasis was 0.7 ± 1.8 min. Technical failure was significantly associated with low BMI ( p = 0.001). Other variables presented no significant relationship with technical failure and development of complications. Ultrasonography on the day after the procedure revealed that 8 (5.9%) patients had hematoma., Conclusions: Mynx VCD for arteriotomy closure is feasible and provides hemostatic safety after stent placement near antegrade or retrograde CFA access. However, Mynx VCD may have a poor technical success rate among patients with low BMI.

A retrospective risk-adjusted analysis was completed using data from the National Surgical Quality Improvement Program (NSQIP) to (1) compare the risks of post-operative hematoma for thyroid surgery using conventional cautery compared alternative energy devices (defined as LigaSure and Harmonic Scalpel), and (2) compare operative times for the same. The primary outcome variable was post-operative hematoma occurrence. The secondary outcome variable was operative time. The exposure variable was use of conventional or alternative sources of cautery. All adult patients who underwent a total thyroidectomy, subtotal thyroidectomy or completion thyroidectomy between 2016 and 2018 were included. Multivariable linear and logistic regression analyses were performed to control for potentially confounding variables. A total of 13,330 cases were analyzed; 4342 used conventional cautery, and 8988 used alternative sources. There was a statistically significant decrease in post-operative hematoma risk using alternative sources of cautery compared to conventional cautery (OR 0.75; 95% CI 0.58-0.98) (p = 0.04). Use of alternative sources of cautery added 4.95 min onto operative time (95% CI 2.45-7.45) which was statistically significant (p < 0.0001). After controlling for confounding variables, there was a statistically significant lower rate of post-operative hematoma in thyroidectomies performed using alternative sources of cautery compared to those performed with traditional hemostatic methods. Alternative sources of cautery increased operative time by 4.95 min., (© 2021. The Author(s).)

Recently, trans-radial intervention has gained popularity as a common procedure to reduce hemorrhagic complications. However, the cuff-type hemostatic device (TR Band) previously used at our institution required 6 h to achieve hemostasis. Since July 2016, we have been using the VasoSTAT, a new hemostatic device that could achieve hemostasis in 4 h. In a verification study, we found that prolonged activated clotting time (ACT) was related to transient hemorrhage occurrence after the hemostatic procedure. Therefore, we designed a hemostatic protocol based on ACT and evaluated its efficacy. In this retrospective and observational study, 78 and 111 patients used the VasoSTAT and TR Band, respectively, from July 2015 to May 2017. In the VasoSTAT group, the ACTs were significantly lower in the hemostasis success (246 ± 46 s) than in the failure group patients (327 ± 59 s) (P < 0.01). Therefore, we applied the hemostatic protocol to 271 patients from May 2017 to March 2020. The hemostasis success rate was 96% in the post-protocol applied group patients, which was significantly higher than the 82% success rate in the pre-protocol applied group patients (P < 0.01). VasoSTAT resulted in adequate hemostasis in 4 h. Further, ACT was predictive of adequate hemostasis., (© 2021. The Author(s).)

Emergent and long-term hemorrhage control is requisite and beneficial for reducing global mortality and postoperative complications (e.g., second bleeding and adverse tissue adhesion). Despite recent advance in injectable hydrogels for hemostasis, achieving rapid gelation, strong tissue-adhesive property and stable mechanical strength under fluid physiological environment is still challenging. Herein, we developed a novel chitosan hydrogel (CCS@gel) via dynamic Schiff base reaction and mussel-inspired catechol chemistry. The hydrogel possessed high gelation rate (<10 s), strong wet adhesiveness, excellent self-healing performance and biocompatibility. More importantly, the CCS@gel exhibited saline-induced contractile performance and mechanical enhancement, promoting its mechanical property in moist internal conditions. In vivo studies demonstrated its superior hemostatic efficacy for diverse anticoagulated visceral and carotid bleeding scenarios, compared to commercialized fibrin glue. The hydrogel-treated rats survived for 8 weeks with minimal inflammation and postoperative adhesion. These results revealed that the promising CCS@gel would be a facile, efficient and safe sealant for clinical hemorrhage control., (Copyright © 2021. Published by Elsevier Ltd.)

Objective: Although the use of closure devices (CD) for femoral artery antegrade access (AA) is not in the instructions for use (IFU) for many devices, AA has been reported to be associated with a lower incidence of access site complications compared to manual compression alone. We hypothesized that CD use for AA would not be associated with a clinically significant increased odds of access site complications compared to CD use for retrograde access (RA)., Methods: This was a retrospective review of the Vascular Quality Initiative from 2010 to 2019 for infrainguinal peripheral vascular interventions with common femoral artery access closed with a CD. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether access was antegrade or retrograde. Hierarchical multivariable logistic regressions controlling for hospital level variation were used to examine the independent association between AA and access site complications. The primary outcomes were access site hematoma, stenosis, or occlusion as defined in the VQI. The secondary outcome was the development of an access site hematoma requiring an intervention, which was defined as transfusion, thrombin injection, or surgery. Sensitivity analyses after coarsened exact matching were performed to reduce residual bias., Results: Overall, 72,463 cases were identified and 6,070 (8.4%) had AA. Patients with AA were less likely to be smokers (27.2% vs 33.0%) or obese (31.5% vs 35.6%; all P<0.05). Patients with AA were more likely to be on dialysis (12.8% vs 10.1%) and have ultrasound-guided access (76.4% vs 66.2%; P<0.05 for all). Compared to RA, patients with AA were more likely to develop any access site hematoma (2.5% vs 1.8%; P<0.01) and a hematoma requiring intervention (0.7% vs 0.5%; P=0.03), but had no difference in access site stenosis or occlusion (0.3% vs 0.2%; P=0.21). On multivariable analyses, AA had increased odds of developing any access site hematoma (OR=1.46; 95% CI=1.22-1.76) and a hematoma requiring intervention (OR=1.48; 95% CI=1.10-1.98). Sensitivity analyses after coarsened exact matching confirmed these findings., Conclusion: In this nationally representative sample, the use of CDs for femoral access was associated with an overall low rate of access site complications. However, there was an increased odds of access site hematomas with AA. Patient selection for AA remains important and ultrasound guided access should be the standard of care for this approach., (Copyright © 2021. Published by Elsevier Inc.)

Objectives: To evaluate uterine tamponade devices' effectiveness for atonic refractory postpartum haemorrhage (PPH) after vaginal birth and the effect of including them in institutional protocols., Search Strategy: PubMed, EMBASE, CINAHL, LILACS, POPLINE, from inception to January 2021., Study Selection: Randomised and non-randomised comparative studies., Outcomes: Composite outcome including surgical interventions (artery ligations, compressive sutures or hysterectomy) or maternal death, and hysterectomy., Results: All included studies were at high risk of bias. The certainty of the evidence was rated as very low to low. One randomised study measured the effect of the condom-catheter balloon compared with standard care and found unclear results for the composite outcome (relative risk [RR] 2.33, 95% CI 0.76-7.14) and hysterectomy (RR 4.14, 95% CI 0.48-35.93). Three comparative studies assessed the effect of including uterine balloon tamponade in institutional protocols. A stepped wedge cluster randomised controlled trial suggested an increase in the composite outcome (RR 4.08, 95% CI 1.07-15.58) and unclear results for hysterectomy (RR 4.38, 95% CI 0.47-41.09) with the use of the condom-catheter or surgical glove balloon. One non-randomised study showed unclear effects on the composite outcome (RR 0.33, 95% CI 0.11-1.03) and hysterectomy (RR 0.49, 95% CI 0.04-5.38) after the inclusion of the Bakri balloon. The second non-randomised study found unclear effects on the composite outcome (RR 0.95, 95% CI 0.32-2.81) and hysterectomy (RR 1.84, 95% CI 0.44-7.69) after the inclusion of Ebb or Bakri balloon., Conclusions: The effect of uterine tamponade devices for the management of atonic refractory PPH after vaginal delivery is unclear, as is the role of the type of device and the setting., Tweetable Abstract: Unclear effects of uterine tamponade devices and their inclusion in institutional protocols for atonic refractory PPH after vaginal delivery., (© 2021 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Background: Management of coagulopathy during major oncologic surgery can be multifactorial and challenging. Viscoelastic assays (VEAs) can be useful in providing vital data about the mechanism of coagulopathy in these dynamic circumstances., Objectives: A prospective nonrandomized observational study with the aim of describing the coagulation parameters of patients undergoing major oncologic surgery using the Quantra® and TEG® 5000 systems. Our secondary objectives included the correlation between Quantra and TEG parameters, and the times to result for both technologies., Methods: This study included 74 adults undergoing oncologic surgery with an anticipated blood loss of more than 500 ml. For each subject, whole blood samples for each device were collected at multiple points perioperatively for comparison., Results: Correlation coefficients between Quantra and TEG parameters were 0.8 and above, indicating a very strong correlation (p < .001). Correlation coefficients between conventional laboratory tests and Quantra ranged from 0.74 to 0.83, indicating a moderate correlation (p < .001). The mean time to obtain results and total processing time was shorter for Quantra in comparison to TEG., Conclusions: Quantra parameters strongly correlated with TEG parameters; however, Quantra parameters were available in shorter amount of time as it is specifically designed as a closed point of care device., (© 2021 Wiley Periodicals LLC.)

Background:  We retrospectively evaluated vascular complications and wound infections after surgical or percutaneous transfemoral removal of temporary extracorporeal life support systems (ECLSs)., Methods:  A total of 83 patients were weaned from ECLS between August 2015 and September 2020. We analyzed for a composite endpoint of vascular complications and wound infections requiring negative-pressure wound therapy. Patients were divided into two groups: percutaneous group using the MANTA vascular occlusion system (VCD; Teleflex, Morrisville, North Carolina, United States) ( n  = 23) and surgical group ( n  = 60)., Results:  The median age in the entire cohort was 67 years. Vascular complications were seen in 20% ( n  = 12) in the surgical group and in 13% ( n  = 3) in the percutaneous group ( p  = 0.72). A total of 32% ( n  = 19) in the surgical group and 9% ( n  = 2) in the percutaneous group ( p  = 0.031) had wound infections. A composite endpoint of vascular complications and wound infections showed significantly more complications in the surgical group (52%, n  = 31) as compared with the percutaneous group (22%, n  = 5) ( p  = 0.020). The median duration in the intensive care unit was 13 days for the surgical group and 12 days for the percutaneous group without any significant difference in both groups ( p  = 0.93)., Conclusions:  Using the MANTA VCD for percutaneous removal of ECLS cannulas after weaning from ECLS is safe and reproducible. A composite endpoint of vascular complications and wound infections was significantly lower in the percutaneous removal group as compared with the surgical group., Competing Interests: The authors have no conflicts of interests to declare., (Thieme. All rights reserved.)

Developing an anti-infective shape-memory hemostatic sponge able to guide in situ tissue regeneration for noncompressible hemorrhages in civilian and battlefield settings remains a challenge. Here we engineer hemostatic chitosan sponges with highly interconnective microchannels by combining 3D printed microfiber leaching, freeze-drying, and superficial active modification. We demonstrate that the microchannelled alkylated chitosan sponge (MACS) exhibits the capacity for water and blood absorption, as well as rapid shape recovery. We show that compared to clinically used gauze, gelatin sponge, CELOX™, and CELOX™-gauze, the MACS provides higher pro-coagulant and hemostatic capacities in lethally normal and heparinized rat and pig liver perforation wound models. We demonstrate its anti-infective activity against S. aureus and E. coli and its promotion of liver parenchymal cell infiltration, vascularization, and tissue integration in a rat liver defect model. Overall, the MACS demonstrates promising clinical translational potential in treating lethal noncompressible hemorrhage and facilitating wound healing., (© 2021. The Author(s).)

Background:  To more minimize the minimally invasive valve surgeries, percutaneous vascular access and closure has been used for the establishment of extracorporeal circulation. This study investigates early clinical outcomes of patients who received MANTA for femoral artery closure as first experiences in minimally invasive valve surgery., Methods:  Between January 2019 and July 2019, 103 consecutive patients (mean age: 58 ± 11 years) underwent video-assisted minimally invasive valve surgery through right anterior minithoracotomy at two cardiac surgery referral centers in Germany. Percutaneous cannulation for cardiopulmonary bypass and femoral artery closure with MANTA were performed in all patients: 18-F and 14-F MANTA were used in 88 (85.4%) and 15 (14.6%) patient, respectively. Mitral, aortic, tricuspid, and double valve surgeries were performed in 51 (49.5%), 39 (37.9%), 7 (6.8%), and 6 (5.8%), patients, respectively. Clinical data were prospectively entered into our institutional database., Results:  Cardiopulmonary bypass time and cross-clamping time were 69 ± 23 and 38 ± 14 minutes, respectively. Except for two patients with late pseudoaneurysm on 15th and 23th postoperative day, neither major nor minor vascular complications nor vascular closure device failure according to the Valve Academic Research Consortium-2 definition criteria was observed. Additionally, no wound healing disorders or conversion to surgical closure was observed., Conclusions:  MANTA as percutaneous femoral artery closure after decannulation of cardiopulmonary bypass is a safe, feasible, and effective approach and yields excellent early outcomes. Larger size studies are needed to evaluate more the efficacy and safety of MANTA., Competing Interests: None declared., (Thieme. All rights reserved.)

Background: Recent trends in prehospital tourniquet use remain underreported. In addition, the impact of prehospital tourniquet use on patient survival has not been evaluated in a population-level study. We hypothesized that prehospital tourniquets were used more frequently in Los Angeles County and their use was associated with improved patient survival., Study Design: This is a retrospective cohort study using a database maintained by the Los Angeles County Emergency Medical Services Agency. We included patients who sustained extremity vascular injuries between October 2015 and July 2019. Patients were divided into the following study groups: prehospital tourniquet and no-tourniquet group. Our primary end point was in-hospital mortality. The secondary outcomes included 4- and 24-hour transfusion requirements and delayed amputation., Results: A total of 944 patients met our inclusion criteria. Of those, 97 patients (10.3%) had prehospital tourniquets placed. The rate of tourniquet use increased linearly throughout our study period (goodness of fit, p = 0.014). In multivariable analysis, prehospital tourniquet use was significantly associated with improved mortality (adjusted odds ratio 0.32; 95% CI, 0.16 to 0.85; p = 0.032). Similarly, transfusion requirements were significantly lower within 4 hours (regression coefficient -547.76; 95% CI, -762.73 to -283.49; p < 0.001) and 24 hours (regression coefficient -1,389.82; 95% CI, -1,824.88 to -920.97; p < 0.001). There was no significant difference in delayed amputation rates (adjusted odds ratio 1.07; 95% CI, 0.21 to 10.88; p < 0.097)., Conclusions: Prehospital tourniquet use has been on the rise in Los Angeles County. Our results suggest that the use of prehospital tourniquets for extremity vascular injuries is associated with improved patient survival and decreased blood transfusion requirements, without an increase in delayed amputations., (Copyright © 2021 American College of Surgeons. Published by Elsevier Inc. All rights reserved.)

Purpose: Aquablation using the AquaBeam system combines real-time image guidance and robotics to enable precise and heat-free removal of prostatic tissue with a high velocity water jet. The aim of this study is to report the outcomes of Aquablation up to 1 year in a single centre within the UK employing an athermal approach to haemostasis., Methods: Fifty-five consecutive men underwent Aquablation between September 2017 and December 2018 (as part of OPEN WATER trial). Standard Aquablation was performed with the AquaBeam system (PROCEPT ® BioRobotics) with 2 passes of Aquablation followed by bladder washout with application of continuous bladder irrigation via a catheter on a continuous traction device. Patients were followed up at 3 and 12 months. The data were prospectively collected on patient demographics, uroflowmetry, prostate volume, International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) and International Index of Erectile Function (IIEF-15)., Results: The mean age was 64.1 ± 7.9 years. Operating time was 26.9 ± 9.2 min. Mean prostate volume decreased from 58.2 ± 23.9 cc to 33.2 ± 12.9 cc (p < 0.0001). There were significant improvements at the 12 month follow-up in maximum urinary flow rate (9.9 ± 5.1 ml/s vs. 23.9 ± 11.6 ml/s), IPSS (21.7 ± 7.4 vs. 6.1 ± 4.2) and quality of life score (4.8 ± 1.1 vs. 1.4 ± 1.4) (p < 0.0001). There was no significant change in IIEF-15 and MSHQ-EjD scores. There were 8 (14.5%) Clavien grade 2 or higher complications., Conclusion: Our single centre experience suggests Aquablation using an entirely athermal approach is a safe cavitating procedure resulting in significant LUTS improvement comparable to standard cavitating procedures with greater preservation of sexual function., (© 2021. Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Exsanguination due to extremity hemorrhage is a major cause of preventable traumatic deaths. Extremity tourniquet use has been shown to be safe and improve survival. The purpose of this study was to compare the efficacy, efficiency, and durability of the Generation 7 Combat Application Tourniquet (CAT; North American Rescue, Greer, SC), the Tactical Mechanical Tourniquet (TMT; Combat Medical Systems, Harrisburg, NC), and the SOF Tactical Tourniquet-Wide (SOFTT-W; Tactical Medical Solutions, Anderson, SC)., Methods: This study was a three-phase randomized, cross-over trial. In successive trials, subjects were timed during the application of each tourniquet to the upper and lower extremity. Following successful lower extremity application, subjects low crawled 25 ft and then were dragged 25 ft, after which effectiveness was reassessed, as defined by the cessation of distal pulses by Doppler ultrasound., Results: In arm application, both the CAT and TMT had significantly less failure rates than the SOFTT-W (5.56%, 19.44%, 58.33%), with the CAT being the fastest tourniquet when compared with TMT and SOFTT-W (37.8 seconds, 65.01 seconds, 63.07 seconds). In leg application, the CAT had significantly less rates of failure when compared with the SOFTT-W, but there was no other significant difference between the tourniquets (27.78%, 44.44%, 61.11%). In addition, the CAT was significantly faster than both the TMT and SOFTT-W when applied to the leg (8.33 seconds, 40.96 seconds, 34.5 seconds). There was no significant difference in tourniquet failure rates between the three tourniquets after subject maneuvers in phase 3 (34.29%, 42.86%, 45.45%)., Discussion: The CAT is as effective as the TMT and significantly more effective than the SOFTT-W. In addition, the CAT demonstrated shorter application times than either the TMT or SOFTT-W. However, there was no significant difference between the three tourniquets in their ability to maintain pulselessness after subject maneuvers., Level of Evidence: Care management, level II., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Partial resuscitative endovascular balloon occlusion of the aorta (pREBOA) is a technology that occludes aortic flow and allows for controlled deflation and restoration of varying distal perfusion. Carotid flow rates (CFRs) during partial deflation are unknown. Our aim was to measure CFR with the different pREBOA balloon volumes and correlate those to the proximal mean arterial pressure (PMAP) and a handheld pressure monitoring device (COMPASS; Mirador Biomedical, Seattle, WA)., Methods: Ten swine underwent a hemorrhagic injury model with carotid and iliac arterial pressures monitored via arterial lines. Carotid and aortic flow rates were monitored with Doppler flow probes. A COMPASS was placed to monitor proximal pressure. The pREBOA was inflated for 15 minutes then partially deflated for an aortic flow rate of 0.7 L/min for 45 minutes. It was then completely deflated. Proximal mean arterial pressures and CFR were measured, and correlation was evaluated. Correlation between CRF and COMPASS measurements was evaluated., Results: Carotid flow rate increased 240% with full inflation. Carotid flow rate was maintained at 100% to 150% of baseline across a wide range of partial deflation. After full deflation, CFR transiently decreased to 45% to 95% of baseline. There was strong positive correlation (r > 0.85) between CFR and PMAP after full inflation, and positive correlation with partial inflation (r > 0.7). Carotid flow rate had strong correlation with the COMPASS with full REBOA (r > 0.85) and positive correlation with pREBOA (r > 0.65)., Conclusion: Carotid flow rate is increased in a hemorrhagic model during full and partial inflation of the pREBOA and correlates well with PMAP. Carotid perfusion appears maintained across a wide range of pREBOA deflation and could be readily monitored with a handheld portable COMPASS device instead of a standard arterial line setup., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Background: Transcatheter aortic valve implantation (TAVI) procedures have revolutionized the treatment of aortic stenosis. However, due to large sheaths, improperly deployed closure devices, and the comorbidities and challenges innate to this population, vascular access complications can be devastating. The objective of this study is to evaluate vascular access complications in one of the largest TAVI sites in North America., Methods: This was a retrospective single center review between January 2014 and December 2018 of vascular access complications necessitating operative intervention by vascular surgery. Patient demographics and preoperative comorbidities were collected. Type of vascular access complication, types of repair, closure device used, and postoperative outcomes were analyzed., Results: A total of 37 cases out of a total of 985 TAVI procedures were identified. TAVI was carried out in the operating suite (70%) or the catheterization lab (30%). Consults to vascular surgery were requested intraoperatively (60%), immediately postoperative (14%), later in the day of the TAVI (20%), and on postoperative day 1 (6%). The location of injury included common femoral artery (49%), superficial femoral artery (11%) and external iliac artery (41%), with some cases injuring multiple vessels. Closure devices were found in the subcutaneous tissue (26%), anterior wall (37%), posterior wall (11%), intra-arterial (11%), closing the anterior to the posterior wall (16%), and in the inguinal ligament (5%). Injuries included tears (11%), dissections (38%), and vessel rupture (19%). The majority of repairs were done primarily (64%), with patch (28%) and bypass (8%) less frequently. Four patients died perioperatively (11%), 2 from hemorrhage, 1 from cardiac arrest, and 1 from progressive respiratory disease., Conclusions: Access complications during TAVI procedures predispose complex patients to increased risk of morbidity and mortality. Careful patient selection, proper access techniques, and performing high risk patients in the operating suite with vascular surgery are fundamental in minimizing complications., (Copyright © 2021 Elsevier Inc. All rights reserved.)

From January 2019 to January 2020, 106 patients (age, 64.8 ± 14.1 years; male, 63.2%) were included to retrospectively investigate the feasibility and safety of ultrasound-guided deployment of ExoSeal after femoral artery access. Baseline characteristics were not different except for age (P = .022), body mass index (P = .009), and diameter (P < .001) between the calcified plaque or stenosis (CS) group (n = 49) and non-CS group (n = 57). The overall technical and clinical success rates were 96.2% and 100%, respectively. The technical (CS group, 48/49; non-CS group, 54/57) and clinical success rates (100%), time to hemostasis (CS group, 3.21 ± 0.54 min; non-CS group, 3.39 ± 0.71 min), and complication rates (CS group, 1/49; non-CS group, 0/57) were not different between the 2 groups. ExoSeal seems to be safe to use under ultrasound guidance in the femoral arteries with CS., (Copyright © 2021. Published by Elsevier Inc.)

Background: There is substantial investment in layperson and first responder training involving tourniquet use for hemorrhage control. Little is known however about prehospital tourniquet application, field conversion, or outcomes in the civilian setting. We describe the experience of a metropolitan region with prehospital tourniquet application., Methods: We conducted a retrospective cohort study characterizing prehospital tourniquet use treated by emergency medical services (EMS) in King County, Washington, from January 2018 to June 2019. Emergency medical services and hospital records were abstracted for demographics, injury mechanism, tourniquet details, clinical care, and outcomes. We evaluated the incidence of tourniquet application, who applied the device (EMS, law enforcement, or layperson), and subsequent course., Results: A total of 168 patients received tourniquet application, an incidence of 5.1 per 100,000 person-years and 3.48 per 1,000 EMS responses for trauma. Tourniquets were applied for penetrating trauma (64%), blunt trauma (30%), and bleeding ateriovenous fistulas (7%). A subset was critically ill: 13% had systolic blood pressures of <90 mm Hg, 8% had Glasgow Coma Scale score of <13, and 3% had cardiac arrest. Among initial applications, 48% were placed by law enforcement, 33% by laypersons, and 18% by EMS. Among tourniquets applied by layperson or law enforcement (n = 137), EMS relied solely on the original tourniquet in 45% (n = 61), placed a second tourniquet in 20% (n = 28), and removed the tourniquet without replacement in 35% (n = 48). Overall, 24% required massive transfusion, 59% underwent urgent surgery, and 21% required vascular surgery. Mortality was 3% (n = 4). At hospital discharge, the tourniquet limb was fully functional in 81%, partially functional in 10%, and nonfunctional in 9%; decreased function was not attributed to tourniquet application., Conclusion: The high rate of application, need for urgent hospital intervention in a subset, and low incidence of apparent complication suggest that efforts to increase access and early tourniquet use can provide public health benefit., Level of Evidence: Therapeutic, level IV., (Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.)

Purpose: Ambulatory peripheral vascular interventions have been steadily increasing. In ambulatory procedures, 4F devices might be particularly useful having the potential to reduce access-site complications; however, further evidence on their safety and efficacy is needed., Materials and Methods: BIO4AMB is a prospective, non-randomized mulitcentre, non-inferiority trial conducted in 35 centres in Europe and Australia comparing the use of 4F- and 6F-compatible devices. The main exclusion criteria included an American Society of Anaesthesiologists class ≥ 4, coagulation disorders, or social isolation. The primary endpoint was access-site complications within 30 days., Results: The 4F group enrolled 390 patients and the 6F group 404 patients. Baseline characteristics were similar between the groups. Vascular closure devices were used in 7.7% (4F group) and 87.6% (6F group) of patients. Patients with vascular closure device use in the 4F group were subsequently excluded from the primary analysis, resulting in 361 patients in the 4F group. Time to haemostasis was longer for the 4F group, but the total procedure time was shorter (13.2 ± 18.8 vs. 6.4 ± 8.9 min, p < 0.0001, and 39.1 ± 25.2 vs. 46.4 ± 27.6 min, p < 0.0001). Discharge on the day of the procedure was possible in 95.0% (4F group) and 94.6% (6F group) of patients. Access-site complications were similar between the groups (2.8% and 3.2%) and included predominantly groin haematomas and pseudoaneurysms. Major adverse events through 30 days occurred in 1.7% and 2.0%, respectively., Conclusions: Ambulatory peripheral vascular interventions are feasible and safe. The use of 4F devices resulted in similar outcomes compared to that of 6F devices.

Background: Percutaneous endovascular aneurysm repair (pEVAR) is commonly utilized and requires the use of suture-mediated closure (SMC) devices to ensure adequate femoral artery hemostasis. Despite the use of such devices, puncture-related complications remain relatively common. We introduced two new adjuncts (pledget reinforcement and tractional compression) along with SMC to reduce such puncture-related complications. The aim of the study was to assess the efficacy and safety of the new adjunct techniques., Methods: This retrospective observational cohort study examines the impact of two adjunctive techniques on puncture-related complications compared with the previous year data before this new introduction of adjunct techniques., Results: Sixty-one percutaneous femoral punctures (in 31 patients) utilizing adjunct techniques for closure (the adjunct group) were retrospectively compared with 89 punctures (in 46 patients) closed with standard SMC technique (the standard group). The use of adjunctive techniques led to a significant reduction in overall puncture-related complications (3/61 (4.9%) vs. 20/89 (22.5%), P = 0.0106) and the need for emergent surgical repair after failed hemostasis (2/61 (3.3%) vs. 13/89 (14.6%), P = 0.037)., Conclusions: These novel adjunctive techniques (pledget reinforcement and tractional compression) of SMC for pEVAR reduce puncture-related complications and increase the confidence to offer percutaneous techniques for more patients., (Crown Copyright © 2021. Published by Elsevier Inc. All rights reserved.)

Background: Percutaneous endovascular aneurysm repair (EVAR) and peripheral interventions using the Perclose Proglide suture mediated system has not been adequately studied in patients with synthetic grafts at access sites., Methods: We report the use of the Perclose Proglide in 10 patients in whom previously inserted synthetic grafts in the groin were punctured for arterial access (5 for peripheral interventions and 5 undergoing EVAR). In patients undergoing peripheral interventions a single device was used, while in patients undergoing EVAR 2 devices were employed per access site. The preclosing technique was used in every case., Results: Hemostasis was achieved in all patients. No complications were observed except for a small laceration and a localized hemodynamically nonsignificant stenosis, without any clinical sequel., Conclusions: This small case series indicates the feasibility of percutaneous access with the Perclose Proglide system to perform EVAR and peripheral endovascular interventions in the presence of synthetic grafts in the groin, with promising outcomes., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: While the percutaneous approach is increasingly preferred, suture-mediated closure devices have been put into clinical practice to close the femoral artery during procedures requiring a large-sized introducer. However, scar in the groin is considered a contraindication or an exclusion criterion for percutaneous procedures. The aim of our study was to investigate the outcomes and safety of Pro-Glide device as suture-mediated closure device in patients who underwent thoracic endovascular aortic repair with percutaneous femoral access ≥22 F who had previous groin intervention., Methods: A total of 73 patients who underwent endovascular repair with percutaneous femoral access were retrospectively included in the study. Previous groin intervention was defined as history of open surgical access or large sheath insertion (>18 F) to femoral artery because of endovascular or valvular intervention. Patients were divided into two groups as who had previous groin intervention PGI (+) and had not PGI (-)., Results: A total of 73 patients [60 male (82.2%)] were included in the study. Seventeen patients had PGI, and 56 did not. When groups were compared in terms of sheath sizes, a significantly higher sheath sizes were used in PGI (+) patients (24.5 ± 1.1 F vs. 23.8 ± 0.9 F, p  = 0.005). The overall success rate in the femoral approach with pre-close technique was statistically insignificant between two groups (94.1% vs. 96.4%, p  = 0.55). One patient in PGI (+) group and two patients in PGI (-) had technical failure for percutaneous femoral approach. One patient (5.9%) in PGI (+) group and one patient (1.8%) in PGI (-) group had femoral complications after the procedures; however, there was no significant difference between the groups in terms of complications (5.9% vs. 1.8%, p  = 0.13)., Conclusion: Pro-Glide device may be a safe and less invasive method for femoral access in patients with PGI and might not be considered as a contraindication for patients with history of PGI.

Objectives: Vascular access site complications after percutaneous transfemoral cardiovascular procedures remain a common cause of morbidity and mortality. We evaluated the SiteSeal® VCD for achieving hemostasis following diagnostic cardiac catheterization., Methods: We conducted a prospective case control single center study to assess the safety and efficacy of SiteSeal® VCD compared to standard manual compression following diagnostic cardiac catheterization. Forty patients were enrolled in study to receive either SiteSeal® device or manual compression (20 in each group)., Results: Patients in the SiteSeal® group achieved hemostasis in a significantly shorter time (4 ± 2.4 vs. 19 ± 2.4 min, P  < 0.001), had shorter time from hemostasis to ambulation (95 ± 44 vs. 388 ± 63 min, P  < 0.001) and significantly earlier device deployment to discharge time compared to the manual compression group (4.7 ± 1.1 vs. 8.9 ± 4.8 h, P  = 0.001). There was one non-major bleeding event in the SiteSeal® group which occurred >24 h after discharge from the hospital and was managed conservatively. In the remaining device patients, there was no clinical or Doppler ultrasound evidence of major or minor vascular complication with good overall patient comfort at discharge, 7 days and 30 days follow-up., Conclusions: In this first clinical experience, the SiteSeal® VCD achieved safe and efficient hemostasis, allowed for earlier ambulation and faster discharge compared to manual compression.

Most infectious human viruses are generally found in the bloodstream after being released by infected organs. Thus, hemorrhage in patients, whose blood contains infectious viruses might be a significant risk for secondary infections. In this work, a self-sealing hemostatic needle that causes no bleeding even after its removal is reported. The materials used for the self-sealing needles are inspired by mussel adhesive polysaccharide, chitosan-catechol, which shows a rapid phase transition from a solid phase (i.e., a thin film) to an adhesive gel upon coming into contact with blood. We found that the self-sealing time for the complete hemostasis depends on the oxidation pathway of the conjugated catechol. For high-temperature oxidation (i.e., 60 °C), Michael addition is a dominant oxidative coupling reaction, which weakens the chitosan-catechol attachment force on the needle surface. Thus, the film is easily transferred to the hemorrhaging sites, with the result that there is no bleeding even after a short injection time (<5 s). In contrast, during low-temperature oxidation (4 °C), Schiff base formation is dominant, which strengthens the film attachment force on the needle surface, resulting in continued bleeding owing to a dearth of tissue transfer after the injection.

Background: One of the most frequent life-threatening emergencies is extremity haemorrhage. In such cases, patient survival depends on a fast on-scene intervention. Thus, both the potential witnesses and medical emergency staff should have the ability to control haemorrhages. However, simulator-based courses do not fully reflect the structures and physiology of the human body. Therefore, invasive procedure training in trauma patients is limited. The present study aims to evaluate the effectiveness of cadavers as educational tools during a training course in extremity haemorrhage control with the use of the Combat Application Tourniquet (CAT)., Methods: This study was conducted among 31 paramedic students, who applied a tourniquet to the upper extremity of an unembalmed (fresh) human cadaver with simulated bleeding. Two time measurements were performed, the latter being preceded by a short CAT application training on a human cadaver., Results: The mean time needed to stop the simulated bleeding in the first attempt was 38.33 seconds (SD±35.14). After the training, the mean time decreased to 20.58 seconds (SD±5.77). A statistically significant difference was observed between these two values (p=0.004)., Conclusion: This study demonstrated that training conducted on human cadavers led to a significant improvement in the effectiveness of CAT use. Cadavers constitute a high-quality educational tool that, after adequate preparation, allows for practicing invasive medical procedures, such as extremity haemorrhage control.

Background: Tourniquets are a critical tool in the immediate response to life-threatening extremity hemorrhage; however, the optimal tourniquet type and effectiveness of noncommercial devices remain unclear. Our aim was to evaluate the efficacy of five tourniquets in a perfused-cadaver model., Methods: This prospective study used a perfused-cadaver model with standardized superficial femoral artery injury bleeding at 700 mL/min. Five tourniquets were tested: combat application tourniquet; rapid application tourniquet system; Stretch, Wrap, And Tuck Tourniquet; an improvised triangle bandage windlass; and a leather belt. Forty-eight medical students underwent a practical hands-on demonstration of each tourniquet. Using a random number generator, they placed the tourniquets on the bleeding cadaver in random order. Time to hemostasis, time to secure devices, estimated blood loss, and difficulty rating were assessed. A one-way repeated measures analysis of variance was used to compare efficacy between the tourniquets in achieving the outcomes., Results: The mean ± SD participant age was 25 ± 2.6 years, and 29 (60%) were male. All but one tourniquet was able to stop bleeding, but the rapid application tourniquet system had a 4% failure rate. Time to hemostasis and estimated blood loss did not differ significantly (p > 0.05). Stretch, Wrap, And Tuck Tourniquet required the longest time to be secured (47.8 ± 17.0 seconds), whereas the belt was the fastest (15.2 ± 6.5 seconds; p < 0.001). The improvised windlass was rated easiest to learn and apply, with 22 participants (46%) assigning a score of 1., Conclusion: Four of five tourniquets evaluated, including both noncommercial devices, effectively achieved hemostasis. A standard leather belt was the fastest to place and was able to stop the bleeding. However, it required continuous pressure to maintain hemostasis. The improvised windlass was as effective as the commercial devices and was the easiest to apply. In an emergency setting where commercial devices are not available, improvised tourniquets may be an effective bridge to definitive care., (Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved.)