Efficacy and Safety of Axiostat® Hemostatic Dressing in Aiding Manual Compression Closure of the Femoral Arterial Access Site in Patients Undergoing Endovascular Treatments: A Preliminary Clinical Experience in Two Centers.

BACKGROUND: Hemostasis of the femoral arterial access site by manual compression or a vascular closure device is critical to the safe completion of any endovascular procedure. Previous investigations evaluated the hemostatic efficacy at the radial access site of some chitosan-based hemostatic pads. This study aims to assess the efficacy and safety of a new chitosan-based hemostatic dressing, namely Axiostat®, in aiding manual compression closure of the femoral arterial access site in patients undergoing endovascular treatments. Furthermore, the outcomes were compared with evidence on manual compression alone and vascular closure devices. METHODS: This investigation is a two-center retrospective analysis of 120 consecutive patients who had undergone, from July 2022 to February 2023, manual compression closure of the femoral arterial access site aided by the Axiostat® hemostatic dressing. Endovascular procedures performed with introducer sheaths ranging from 4 Fr to 8 Fr were evaluated. RESULTS: Primary technical success was achieved in 110 (91.7%) patients, with adequate hemostasis obtained in all cases of prolonged manual compression requirements. The mean time-to-hemostasis and time-to-ambulation were 8.9 (±3.9) and 462 (±199) minutes, respectively. Clinical success was achieved in 113 (94.2%) patients, with bleeding-related complications noted in 7 (5.8%) patients. CONCLUSIONS: Manual compression aided by the Axiostat® hemostatic dressing is effective and safe in achieving hemostasis of the femoral arterial access site in patients undergoing endovascular treatment with a 4-8 Fr introducer sheath.

Manual superficial temporal artery compression using a circular plastic material for embolization of meningioma: illustrative case.

BACKGROUND: In meningiomas that occur in the high-convexity region, the superficial temporal artery (STA) frequently feeds the tumor, and when embolizing from the middle meningeal artery (MMA), the embolic material may not reach the tumor vessels because of the pressure gradient resulting from the STA blood flow, resulting in inadequate embolization. In this case, a circular plastic material was used to apply circumferential pressure around the parietal foramen to control blood flow to the tumor. OBSERVATIONS: A 45-year-old male underwent head magnetic resonance imaging that revealed a 2.2-cm meningioma in the right high-convexity region. Preoperative embolization was performed. When N-butyl-2-cyanoacrylate was injected from the right MMA while using a circular plastic material to compress the skin around the parietal foramen through which the bilateral STAs (the tumor feeders) flow, it was able to fully penetrate the tumor vessel and occlude the other feeders in a retrograde manner. The patient underwent tumor removal after embolization uneventfully. LESSONS: Manual compression of the STA using a circular plastic material is useful when the tumor is fed by the STA through the parietal foramen and is also applicable to transarterial embolization of dural arteriovenous fistulas fed by the STA or occipital artery.

Safety and efficacy of the Mynx Control vascular closure device in peripheral arterial procedures: A prospective study.

OBJECTIVES: This article aims to present a prospective study investigating the safety and efficacy of the Mynx Control extravascular closure device (Cordis Corporation, FL, USA), for femoral arterial closure in patients undergoing peripheral arterial procedures. METHODS: Between January 2020 and February 2021, 100 Mynx Control devices were deployed in 91 consecutive patients (mean age: 67.5 ± 16.9 years) who underwent peripheral arterial procedures. We used ultrasound and/or fluoroscopy during Mynx Control deployment and ultrasound post-procedure to detect complications. Femoral artery punctures included 62 (62%) antegrade and 38 (38%) retrograde punctures. The mean activated clotting time at time of device deployment was 221s. The primary endpoints were technical success, device failure, and complication rates up to 30 days. RESULTS: A 5F vascular sheath was used in 43 cases (43%) (36 (36%) 6F and 21 (21%) 7F). The majority of our cases had antegrade access (62%). Overall technical success rate was 97% in both antegrade and retrograde cases. In total, there were 4 minor complications: 3 (3%) cases of pseudoaneurysm and 1 (1%) case of haematoma. No major complications were recorded post-procedure or 30 days post index procedure. CONCLUSION: The Mynx Control vascular closure device is safe and effective in achieving haemostasis in patients undergoing antegrade and retrograde peripheral angioplasty procedures.

Successful treatment of a brachial artery pseudoaneurysm in a brachiobasilic arteriovenous fistula using ultrasound-guided manual compression.

Pseudoaneurysm is a well-recognized complication seen in arteriovenous fistula (AVF) which usually involves the venous segments. Ultrasound-guided manual compression (UGMC) is a non-invasive and effective treatment for the management of pseudoaneurysms involving the venous segment. Pseudoaneurysm of the arterial segment of AVF is rare complication which usually needs surgical intervention. We report the first successful treatment case of a brachial artery pseudoaneurysm in a brachiobasilic arteriovenous fistula using ultrasound-guided manual compression. The patient presented with a 30 × 30 mm pulsatile swelling below the cubital fossa after second session of hemodialysis using an AVF created 8 weeks earlier. Ultrasound doppler demonstrated a brachial artery pseudoaneurysm in the non-transposed brachiobasilic fistula. Complete occlusion of the cavity with thrombus formation was accomplished after 55 min of compression and the psuedoaneurysm did not recur. UGMC can be an alternative treatment option for select cases of arterial segment pseudoaneurysm in AVF.

Comparison of Vascular Complications after Arterial Sheath Removal using Manual Compression Method and ClampEase Method in Patients Undergoing Coronary Angiography.

Introduction: Angiography stands as the paramount and definitive diagnostic method for coronary artery disease. However, akin to various other invasive procedures, it may carry a multitude of complications. This study sought to assess the incidence of vascular complications post-arterial sheath removal, comparing the use of a ClampEase device against manual compression. Methods: This quasi-experimental clinical trial involved patients undergoing angiography at the post-angiography ward in Isfahan, Iran. A total of 91 patients were selected through convenience sampling and randomly assigned to either the manual compression or ClampEase device groups. Monitoring common vascular complications like hemorrhage, hematomas, and ecchymosis occurred up to 24 hours post-arterial sheath removal. Data were collected using a digital scale model DM3, a transparent flexible ruler, and a questionnaire named 'vascular complications after angiography.' Analysis was performed using SPSS software version 13. Results: Statistical analysis revealed that, when compared to the manual method, compression with the ClampEase device led to fewer vascular complications in patients and a quicker return to homeostasis. Conclusion: The findings underscore that the ClampEase method is a safer alternative with fewer vascular complications than the manual compression method. This discovery has implications for reducing hospital costs and length of stay. The ClampEase device is associated with a swifter time to hemostasis, contributing to enhanced patient comfort and acceptance.

Utility of manual venous compression during transvenous Onyx injection for a scalp arteriovenous fistula: illustrative case.

BACKGROUND: When performing transvenous liquid embolization for scalp arteriovenous fistulas, multiple networks of venous drainage could limit effective retrograde penetration of embolic agents into feeding arteries, resulting in incomplete obliteration. A salvage technique to achieve effective Onyx penetration with manual venous compression during transvenous embolization is demonstrated. OBSERVATIONS: A 43-year-old man presented with a progressively enlarging mass on his left temporal scalp that was first noticed approximately 20 years earlier. External carotid artery injection showed two scalp arteriovenous fistulas (AVFs). The patient received endovascular embolization. After successful transarterial obliteration of one AVF, transvenous Onyx embolization was performed for another AVF located in the subcutaneous layer. To avoid unnecessary Onyx migration into multiple venous networks, several coils were put in a venous pouch as a scaffold for the Onyx, and feeding arteries were temporarily occluded. Despite these adjunctive techniques, the Onyx migrated into multiple veins and even toward the orbit without complete fistula obliteration. Thereafter, Onyx was injected under manual compression of venous outlets from the pouch, resulting in complete obliteration. LESSONS: Manual compression of venous outlets can be used as a salvage procedure during transvenous Onyx embolization for a scalp AVF. A surgeon's radiation exposure can be reduced by step-by-step adjunctive procedures.

Microvascular tissue perfusion after postcatheterization pseudoaneurysm treatment.

BACKGROUND: Femoral pseudoaneurysm (PSA) is a severe complication after endovascular procedures. Ultrasound-guided manual compression (MC) and percutaneous thrombin injection (TI) are frequently used treatments. MC is less effective, TI may cause thromboembolic events. OBJECTIVE: Up to date, there is no data regarding impairment of microvascular tissue perfusion after PSA treatment. METHODS: In this single-center, prospective study 22 patients with PSA were included. We compared macro- and microcirculatory perfusion in the treated and untreated leg at baseline before, after and one day after treatment. Leg perfusion was assessed with ultrasound and ankle-brachial index (ABI). Microcirculatory perfusion of the feet was measured with a near-infrared spectroscopy (NIRS) camera generating StO2-tissue-maps. RESULTS: Successful PSA thrombosis was achieved in 16 (100%) patients in TI group and in 4 (66.7%) patients in MC group. There was no evidence of arterial thrombi on ultrasound and the ABI did not differ between groups. NIRS StO2-tissue-maps of the feet showed no significant difference in both groups concerning the treated (p = 0.121) or the untreated (p = 0.198) leg during follow up. CONCLUSIONS: In this small exploratory study, there was no evidence of micro- and macrovascular tissue perfusion impairment after treatment of postcatheterization femoral pseudoaneurysm with thrombin injection underscoring the safety of this approach.

New approaches to achieving hemostasis after venous access in cardiovascular patients.

Recent decades have seen a series of advances in percutaneous transvenous procedures for cardiac arrhythmias, including the implantation of leadless pacemakers. Many of these procedures require the insertion of large caliber sheaths in large veins, usually the femoral vein. Securing hemostasis efficiently and reliably at the access site is a key step to improving a procedure's safety profile. Traditionally, hemostasis was achieved by manual compression of venous access sites, but the trend toward larger sheaths and the increased use of uninterrupted anticoagulation has pushed the limits of this method. Achieving hemostasis by compression alone in these circumstances requires more attention and longer duration, leading to greater patient discomfort and prolonged immobility. In turn, manual compression may be more time-consuming for medical professionals and increase the number of occupied hospital beds. New approaches have been developed to facilitate early ambulation, decrease patient discomfort, and address the risk of access site complications. These approaches include vascular closure devices and subcutaneous suture techniques including figureof- eight and purse-string sutures. This article reviews the new approaches applied to achieve venous access site hemostasis in patients undergoing transvenous procedures for cardiac arrhythmias.

Access site complications are uncommon with vascular closure devices or manual compression after lower extremity revascularization.

OBJECTIVE: Vascular closure devices (VCDs) and manual compression (MC) are used to achieve hemostasis after peripheral vascular interventions (PVIs). We sought to compare perioperative outcomes between MC and four VCDs after PVI in a multicenter setting. METHODS: The Vascular Quality Initiative was queried for all lower extremity PVIs with common femoral artery access performed from 2010 to 2020. The VCDs included were MynxGrip (Cordis, Santa Clara, CA), StarClose SE (Abbott Vascular, Redwood City, CA), Angio-Seal (Terumo, Somerset, NJ), and Perclose ProGlide (Abbott Vascular). In a blinded fashion, these four VCDs (labeled A, B, C, and D) were compared to MC for baseline characteristics, procedural details, and outcomes (access site hematoma and stenosis/occlusion). Those with a sheath size >8F were excluded. Propensity score matching (1:1) was performed. Univariable and multivariable analyses were completed for unmatched and matched data. RESULTS: A total of 84,172 lower extremity PVIs were identified. Of these, 32,013 (38%) had used MC and 52,159 (62%) had used VCDs (A, 12,675; B, 6224; C, 19,872; D, 13,388). The average age was 68.7 years, and 60.4% of the patients were men. The most common indications for intervention were claudication (43.8%) and tissue loss (40.1%). Compared with MC, VCDs were used more often for patients with obesity, diabetes, and end-stage renal disease (P < .001 for all). VCDs were used less often for patients with hypertension, chronic obstructive pulmonary disease, coronary artery disease, prior percutaneous coronary and extremity interventions, and major amputation (P < .001 for all). VCD use was more common than MC during femoropopliteal (73% vs 63.8%) and tibial (33.8% vs 22.3%) interventions but less common with iliac interventions (20.6% vs 34.7%; P < .001 for all). Protamine was used less often with VCDs (19.1% vs 25.6%; P < .001). Overall, 2003 hematomas had developed (2.4%), of which 278 (13.9%) had required thrombin or surgical intervention. Compared with MC, the use of any VCD had resulted in fewer hematomas (1.7% vs 3.6%; P < .001) and fewer hematomas requiring intervention (0.2% vs 0.5%; P < .001). When divided by hemostatic technique, the rate of the development of any hematoma was as follows: MC, 3.6%; VCD A, 1.4%; VCD B, 1.2%; VCD C, 2.3%; and VCD D, 1.1% (P < .001). The rate of hematomas requiring intervention was as follows: MC, 0.5%; VCD A, 0.2%; VCD B, 0.2%; VCD C, 0.3%; and VCD D, 0.1% (P < .001). Access site stenosis/occlusion was similar between the MC and any VCD groups (0.2% vs 0.2%; P = .12). Multivariable analysis demonstrated that any VCD use and the use of the individual VCDs compared with MC were independently associated with the development of fewer hematomas. The incidence of access site stenosis/occlusion was similar between the use of any VCD and MC. The matched analysis revealed similar findings. CONCLUSIONS: Although the overall rates of hematomas requiring intervention were low regardless of hemostatic technique, VCD use, irrespective of type, compared favorably with MC, with significantly fewer access site complications after PVI.

Vascular Closure: the ABC's.

PURPOSE OF REVIEW: Vascular access and closure is a key part of endovascular procedures, and access site-related complications are an independent predictor of adverse procedural outcomes. The purpose of this review is to discuss the methods of vascular closure including manual compression, vascular closure devices (VCDs) for both arterial and venous arteriotomies, their mechanisms, and access site-related complications. RECENT FINDINGS: Various VCDs have been approved over the last three decades. These devices have different mechanisms to achieve hemostasis and are generally categorized into active and passive approximators. Studies have largely found that they are non-inferior to manual compression. Uncomplicated vascular closure is pertinent to avoid adverse procedure-related outcomes. The emergence of VCDs has reduced time to hemostasis, facilitating early ambulation and discharge and reducing hospitalization cost with comparable complication rate to manual compression. Nonetheless, they should be used in favorable vascular anatomy and are not intended to reduce complications.

AbsorbaSeal™ 5.6.7F vascular closure device: A good laboratory practice chronic study evaluating safety and efficacy in a healthy porcine model.

OBJECTIVES: Vascular closure devices (VCDs) are widely used for arteriotomy closure after percutaneous catheter-based procedures. In comparison to manual compression, VCDs have been associated with shorter time to hemostasis, shorter time to ambulation, and also decreased length of stay. Complexity of deployment, lack of immediate hemostasis, and residual deformity of the arterial wall remain as limitations of current VCDs. The aim of this study was to investigate the AbsorbaSeal™ 5.6.7F vascular closure device, a novel, completely bioabsorbable, intuitive, and easy to use VCD which uses a compressive, "sandwich"-type design comprising a low profile intravascular distal seal and gasket and an extravascular floating foot and proximal seal, in an open infrarenal aortic swine model. METHODS: Eight fully heparinized swine at a good laboratory practices facility underwent AbsorbaSeal™ 5.6.7F VCD closure of three 6F arteriotomies each in the proximal, mid, and distal infrarenal aorta. Two swine underwent harvest at each of four time cohorts: 30, 60, 90, and 120 days. Acute and chronic procedural safety and efficacy, as well as target site vascular remodeling over time, were the primary outcomes evaluated. Secondary outcome measures included local and systemic inflammatory responses, end-organ tissue analysis, and device-related complications through the follow-up periods. Histopathological evaluation was performed by a blinded pathologist. Standard statistical methods were used. RESULTS: In deployment of 24 AbsorbaSeal™ 5.6.7F VCDs, there were no device-related complications or mortalities. All deployments resulted in rapid arteriotomy seal (100% deployment success), with a mean time to hemostasis (cessation of arterial flow) of 21.5 s (median: 6.5 s) across a mean activated clotting time (ACT) of 356 s. Twenty of the 24 implant sites (83%) attained complete hemostasis within 20 s. Immediate post-implant and pre-termination angiographies at all time points were performed of all swine which demonstrated normal aortic appearance and tissue structure and normal downstream vascular beds. At 30 days, each implant's intravascular distal seal and gasket were removed from the circulation and completely covered with a smooth neointimal layer. Minimal inflammation and no intimal or luminal thrombus were observed at any site at every time point. CONCLUSIONS: AbsorbaSeal™ 5.6.7F is a safe, effective, and secure VCD that demonstrates rapid hemostasis in a fully heparinized open aortic porcine model. Removal from circulation and complete coverage of the intravascular distal seal and gasket with neointima occurred within 30 days post-implant. Natural transmural vessel healing from the arteriotomy itself with minimal inflammation was noted for each implant at every time point.

A novel femoral artery compression device (butterfly compress) versus manual compression for hemostasis after femoral artery puncture: a randomized comparison.

OBJECTIVE: This study aimed to investigate the hemostatic efficacy of a novel femoral artery compression device in patients undergoing an interventional procedure through femoral artery puncture. MATERIAL AND METHODS: Patients enrolled in this trial were randomly assigned 1:1 to the novel femoral artery compression device (NFACD) or the manual compression (MC) group. The primary endpoints were time to hemostasis (TTH), time to ambulation (TTA), any other complications, such as the occurrence of hematoma, bleeding, pseudoaneurysm and arteriovenous fistula at the puncture site, and time to hospital discharge. RESULTS: A total of 617 patients were included in this study (NFACD, n = 308 versus MC, n = 309) from May 2017 to September 2019, and the baseline characteristics of the groups were similar. We found that the TTH and TTA were significantly shorter in the NFACD group than in the MC group (4.4 ± 11.6 min vs. 20.1 ± 22.5 min; p < 0.001; 8.9 ± 14.2 h vs. 16.3 ± 27.5 h; p = 0.002). There were few other complications in either group. In addition, there was no significant difference in time to hospital discharge between the NFACD group and the MC group. CONCLUSION: The novel femoral artery compression device is effective in achieving hemostasis in patients undergoing femoral artery puncture and is associated with a marked shortening of the TTH and TTA.

Comparative outcomes of vascular access closure methods following atrial fibrillation/flutter catheter ablation: insights from VAscular Closure for Cardiac Ablation Registry.

PURPOSE: This registry compared the safety and efficacy of vascular closure device Perclose (PC) with figure-of-eight stitch (Fo8) and manual compression (MC) following catheter ablation of atrial fibrillation/flutter. METHODS: VAscular Closure for Cardiac Ablation Registry (VACCAR) is a prospective, observational registry that assessed the time to hemostasis (TTH), time to ambulation (TTA), length of stay (LOS), complications, patient-reported outcomes, and pain medication use. RESULTS: A total of 434 patients (mean age 64.0±11.0 years; 38% female; 94.9% white) were enrolled between October 2017 and May 2019: 156 in MC, 203 in Fo8, and 75 in the PC group. Median TTH was significantly reduced in the PC and Fo8 group at 7 and 9 min respectively vs. the MC group at 20 min (p<0.001). Median TTA was significantly reduced in both the PC and Fo8 group at 2.2 h vs. the MC group at 6.5 h (p<0.001 for both). Median LOS for the PC group was significantly reduced at 27.5 h compared to the MC and Fo8 group at 29 h (p<0.01). A higher proportion of same-day discharges were noted in the PC and Fo8 groups at 14 (18.7%) and 25 (12.3%), respectively, compared to 5 (3.2%) in the MC group (p<0.01 for all). There was no significant difference in complications between the three groups. CONCLUSIONS: Both PC and Fo8 are safe with improved TTH, TTA, LOS, and a higher number of same-day discharges compared to MC.

Femoral artery access site closure with perclose suture mediated device in coronary interventions.

OBJECTIVE: To compare the outcome of suture mediated vascular closure device Perclose Proglide (PP) with manual compression (MC) following transfemoral access for coronary interventions (CI). METHODS: It is a retrospective, observational, single centre study from January 2018 to September 2019. Consecutive patients undergoing interventions through transfemoral access were divided into PP and MC groups. Those with less than 3 months follow up were excluded. Two groups were compared for baseline characteristics and various complications at 24 h and at 30 days. RESULTS: Out of 1743 patients studied, PP group included 1343 and MC group, 400 patients. Both groups were comparable in baseline characteristics, sheath size and use of antiplatelets and anticoagulation. PP group had significantly less minor bleeding (P = .01, CI 0.34-4.03) and hematoma (P = .0007, CI 0.95-5.10) at 24 h. At 30 days, minor bleeding (P < .0001, CI 0.97-4.25), hematoma (P = .0002, CI 1.05-4.93) and pseudo-aneurysm (P = .0095, CI 0.03-1.18) were also significantly less in PP group. Obesity (OR 3.5, CI 1.29-9.49) and hypertension (OR 2.41, CI 1.12-5.19) were associated with increased minor bleeding at 24 h. Device failure rate was 2.38%. CONCLUSIONS: PP device is safe, effective and is associated with fewer complications than MC in CI. Device failure rate is low. Obesity and hypertension are associated with increased minor bleeding in both groups.

Safety and efficacy study of the wound care 360° SiteSeal® vascular closure device in percutaneous cardiac catheterization procedures.

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.

Distal Embolic Protection by Manual Compression of the Vertebral Artery in Subclavian Artery Stenting.

Objective: There is no established method for preventing vertebral artery embolization in percutaneous transluminal angioplasty (PTA) for subclavian artery stenosis. We manually compressed the supraclavicular fossa outside the sternocleidomastoid muscle to disrupt vertebral artery blood flow and prevent embolism. We report the usefulness of this procedure. Case Presentations: Between April 2017 and July 2018, three patients with severe stenosis of the subclavian artery of 80% or higher were examined. For these patients, subclavian artery stenting was performed. The approach was via the left brachial artery in one patient and right femoral artery in two patients. After crossing the lesion, the vertebral artery was manually compressed and angiography confirmed that blood flow was blocked. In all patients, stent placement was successfully performed and good dilatation was confirmed by angiography. There were no neurological complications and no findings suggestive of acute cerebral infarction were found on magnetic resonance imaging (MRI). Conclusion: Prevention of distal embolism by manual compression is simple, does not require multiple catheters, and is useful for subclavian artery stenting.

Results from the prospective, multicenter AMBULATE-CAP trial: Reduced use of urinary catheters and protamine with hemostasis via the Mid-Bore Venous Vascular Closure System (VASCADE® MVP) following multi-access cardiac ablation procedures.

INTRODUCTION: Manual compression (MC), historically the most common method to achieve hemostasis after percutaneous vascular procedures, is time consuming, requires prolonged bedrest, and is uncomfortable for patients and clinicians. Recent studies demonstrate the efficacy and safety of vascular closure devices and suggest shorter times to hemostasis and patient ambulation compared with MC. The current study evaluated the feasibility of the VASCADE® venous vascular closure system (VVCS) while allowing for urinary catheter (UC) elimination, and elimination of protamine and/or same calendar day discharge (SCDD). METHODS AND RESULTS: In this prospective, multicenter trial, patients were enrolled and assigned to the following groups: no UC, no protamine, and/or SCDD (no co-enrollment in no protamine and SCDD). After completing the catheter-based cardiac procedure, access sites were closed using the VVCS. Outcomes included final hemostasis (all sites) without major access site-related complications at 30 days, rates of access site closure-related complications, device success, and study group success. All 168 patients had hemostasis without major access site-related complications through 30 days. In the no UC group, 160 out of 164 (97.6%) patients did not receive a UC. Additionally, 39 out of 41 (95.1%) patients received heparin without protamine reversal and no access site bleeding-related ambulation delays, and 18 out of 18 (100%) patients were discharged on the same day. There were no major access site closure-related complications, few minor complications, and adverse events were generally mild and well managed. CONCLUSION: The VVCS was effective for achieving hemostasis following catheter-based procedures; access site closure-related complications and adverse events were well managed.

A comparison of figure-of-8-suture versus manual compression for venous access closure after cardiac procedures: An updated meta-analysis.

BACKGROUND: Manual compression (MC) is the current standard to achieve postprocedural hemostasis in patients who need venous vascular access closure after cardiovascular procedures. Figure-of-8 (F8) suture for venous access closure has been reported to be a safe and efficacious alternative to MC. METHODS: A systematic search was done using PubMed, Google Scholar, EMBASE, SCOPUS, and ClinicalTrials.gov without language restriction up until April 15, 2020 for studies comparing F8 suture versus MC. Risk ratio (RR) and mean difference (MD) with 95% confidence interval (CI) were calculated using a random effects model. RESULTS: Time to achieve hemostasis was significantly reduced in the F8 arm [MD -21.04 min (95% CI: -35.66 to -6.42; P = .005)]. Access site bleeding was significantly lower in the F8 group [RR 0.35 (95% CI: 0.18 to 0.66; P = .001)] along with a lower incidence of hematoma formation [RR 0.42 (95% CI: 0.26 to 0.67; P = .0003)]. There was no significant difference in rates of fistula or pseudoaneurysm formation between the two groups. Overall access site complications were lower in the F8 arm [RR 0.38 (95% CI: 0.26 to 0.55; P < .00001)] and the effect was more pronounced for sheaths ≥10 Fr [RR 0.33 (95% CI: 0.18 to 0.60; P = .0003)]. There was lower postprocedural protamine use in the F8 group [RR 0.07 (95% CI: 0.01 to 0.36; P = .001)]. CONCLUSION: For large-bore venous access closure, the F8 suture results in a shortened time to achieve hemostasis along with a lower overall risk of access site complications and postprocedural protamine use.

A Stopped Pilot Study of the ProGlide Closure Device After Transbrachial Endovascular Interventions.

Purpose: To evaluate the feasibility and safety of the suture-mediated ProGlide device in closure of the brachial artery after endovascular interventions. Materials and Methods: From 2016 to 2017, a pilot study was performed using the ProGlide to achieve hemostasis after percutaneous access of distal brachial arteries >4 mm in diameter. In an interim analysis, the results were compared to a matched control group taken from a 60-patient historical cohort who underwent brachial artery access and manual compression to achieve hemostasis between 2014 and 2017. The primary outcome was access-related reintervention and the secondary outcome was the incidence of access-site complications. Results: Seven patients (mean age 67.9 years; 6 men) were enrolled in the study before it was stopped in 2017. Four patients experienced 6 access-site complications (neuropathy, hematoma, occlusion, and pseudoaneurysm). These resulted in 3 access-related reinterventions: surgical evacuation of a hematoma, thrombectomy of the occluded brachial artery, and surgical repair of the pseudoaneurysm. In the interim comparison to the 19 matched patients (mean age 61.9 years; 6 men), the ProGlide group had proportionally more patients experiencing access-related complications (57% vs 16% for manual compression, p=0.035) and resultant reinterventions (43% vs 11%, p=0.064). Based on this data the trial was stopped. Conclusion: Considering this experience, it is not advisable to use the ProGlide in transbrachial endovascular interventions due to the high incidence of complications and access-related reinterventions.

Experience of Manual Compression Hemostasis Under Endoscopic Observation for Acute Hemorrhagic Rectal Ulcer.

We experienced two cases in which manual compression hemostasis under endoscopic observation was used in patients with acute hemorrhagic rectal ulcer (AHRU). The patients experienced an episode of massive fresh hematochezia, requiring the blood transfusion. Emergent sigmoidoscopy revealed multiple ulcers with a large protuberant visible vessel or with gush-out hemorrhage on the lower rectum. Endoscopic hemostasis by hemoclips and hypertonic saline-epinephrine injection was attempted; however, mechanical mucosal injury induced by hemoclips and needles caused another gush-out hemorrhage. Thus, the site of bleeding was manually compressed by a forefinger under endoscopic observation. After 5 min, compression hemostasis was achieved, and the postoperative course was uneventful. Manual compression hemostasis under endoscopic observation is useful and worth attempting for AHRU.