Use Of Vascular Closure Devices Research Articles

Prolonged femoral compression post percutaneous coronary intervention leading to deep vein thrombosis

Deep vein thrombosis is an uncommon yet significant complication of percutaneous coronary interventions. Prolonged manual compression at the access site, a common practice for achieving hemostasis, can inadvertently exacerbate thrombosis risks, including venous stasis and endothelial injury. We present the case of an 84-year-old female with coronary artery disease who underwent staged percutaneous coronary intervention with stent placement in the left circumflex and left anterior descending arteries. After the procedure, manual pressure was applied to the femoral access site for over 30 minutes, after which the patient developed hypotension and leg pain. Point-of-care ultrasound revealed a large deep vein thrombosis in the right femoral vein, extending into the profunda and saphenous veins. The patient was treated with a heparin drip and monitored without surgical intervention. Her condition improved, and follow-up imaging confirmed resolution of the deep vein thrombosis. This case underscores the risks associated with extended manual compression and highlights the importance of adhering to guidelines for post percutaneous coronary intervention care. The use of vascular closure devices may reduce the likelihood of such complications. Additionally, early recognition and management of deep vein thrombosis is critical in preventing further thromboembolic events and improving patient outcomes.

Impact of Sex on Outcomes With Femoral Artery Closure Devices Versus Manual Compression in Patients Undergoing Percutaneous Coronary Intervention.

Femoral artery access is widely used despite recent increase in radial access for percutaneous coronary interventions (PCI). Femoral artery closure devices are used to shorten vascular closure time and reduce bleeding. We sought to examine sex-based outcomes of femoral artery vascular closure devices (VCD) in patients undergoing PCI. We identified patients who had undergone PCI (n = 11,415) in the Indiana University Health Multicenter Cardiac Cath registry using femoral artery access. Clinical outcomes were compared between VCD and manual compression and analyzed according to sex. Patients with cardiogenic shock and left ventricular support devices were excluded. The use of any vascular closure device as compared to femoral artery manual compression was associated with a reduction in 72-h bleeding events (adjusted odds ratio [OR]: 0.64; 95% confidence interval [CI]: 0.46-0.87). With manual compression, women had higher rates of 72-h bleeding as compared to men (4.5% vs. 1.6%, p < 0.001). Women demonstrated greater absolute risk reduction in 72-h bleeding events with use of VCD as compared to men (2.8% vs. 0.8%, p < 0.001). For women, VCD were associated with lower risk of access site bleeding (OR: 0.43; 95% CI: 0.24-0.8), hematoma (OR: 0.36; 95% CI: 0.2-0.63), and vascular complications (OR: 0.25, 95% CI: 0.09-0.72). Use of VCD was associated with lower risk of in-hospital death (adjusted OR: 0.4; 95% CI: 0.28-0.58; p < 0.001) in multivariable regression analysis. Women derive more benefit from use of femoral artery VCD during PCI than men with greater reduction in bleeding rates, access site hematoma, and vascular complications.

Advancements in Vascular Closure Devices for Effective Hemostasis in Femoral Artery Interventions.

With medical technology development, endovascular intervention has been widely used in clinical practice, and the establishment of surgical access through the femoral artery, where most vascular interventions are performed, is a common method. Postoperative hemostasis at the femoral artery puncture site is a key part of interventional procedures and is particularly important to ensure the safety and effectiveness of hemostasis. Some patients undergoing interventional therapy also use anticoagulant and antiplatelet drugs preoperatively and undergo systemic heparin session intraoperatively, which leads to abnormal coagulation, thus increasing the difficulty of hemostasis at the puncture point postoperatively. Certain patients with specific conditions, such as combined vascular calcification, obesity, diabetes mellitus, and renal impairment, present more challenging cases for postoperative puncture point hemostasis. Femoral artery puncture site hemostasis methods include manual compression, arterial compression devices, and vascular closure devices, which are a kind of equipment that helps interventional doctors stop bleeding quickly at the femoral artery puncture site. From the 1990s to the present, vascular occluders with many different concepts and mechanisms have emerged. Based on different hemostatic principles and materials, the mechanisms and principles of action are varied and include sealant occlusion, collagen patch embolization, polyester suture closure, absorbable polyethanol embolic agents, nickel-titanium alloy clips, polydiethanol sealant embolization, and suture bioabsorbable patches. Many studies have compared the hemostatic effect of vascular closure devices with those of manual compression. In this article, we review the hemostatic effects of the 2 modalities and the advances in the use of vascular closure devices in vascular intervention.

Hematological Complications From Transcatheter Aortic Valve Replacement (TAVR): Recognition and Treatment.

Transcatheter aortic valve replacement (TAVR) has emerged as a pivotal intervention for patients with severe aortic stenosis who are at high or prohibitive surgical risk. Although TAVR is a minimally invasive procedure, it is linked to serious hematological problems, most notably thrombosis and bleeding. Numerous factors, such as procedural features, patient comorbidities, and anticoagulation management techniques, contribute to these complications. Bleeding complications can be major, minor, or life-threatening. They can be caused by problems with the vascular access site, anticoagulation medication, or coexisting conditions like renal dysfunction and frailty. Hemoglobin drop, overt bleeding, and hematoma signs must all be closely watched to identify bleeding. Careful selection and modification of anticoagulation medication, the use of vascular closure devices, and timely attention to bleeding sites are examples of management techniques. Thrombotic consequences, which include cerebrovascular accidents and valve thrombosis, are caused by endothelial injury, stent implantation, and patient hypercoagulability. Imaging modalities such as computed tomography and transesophageal echocardiography are used in the crucial process of detection. The goal of preventive care is to maximize anticoagulation regimens that are customized to each patient's risk profile, frequently striking a balance between the risk of thrombosis and bleeding. A multidisciplinary strategy that integrates surgical, hematological, and cardiology expertise is necessary for the effective management of these hematological complications. To improve patient outcomes, ongoing research attempts to improve risk stratification and create safer anticoagulation protocols. This review emphasizes how critical it is to identify bleeding and thrombotic events as soon as possible and treat them promptly to reduce the risk of negative outcomes for TAVR patients.

ESR Essentials: arterial vascular access and closure devices-practice recommendations by the Cardiovascular and Interventional Radiological Society of Europe.

Vascular access is the initial, very important, step of endovascular procedures. Various access sites include the common femoral artery, brachial artery, radial artery, popliteal artery, and distal tibial vessels (pedal arteries). Successful arterial access requires advanced knowledge of anatomy, as well as proper training and experience. Today, vascular access should be obtained using real-time, ultrasound guidance to reduce access time, patient discomfort, and puncture-related complications including dissection, arteriovenous communication, and bleeding. Nevertheless, high-level evidence to support this recommendation in peripheral procedures is limited and level A data are mainly derived from randomized cardiac trials investigating only radial and femoral access. Vascular closure devices (VCDs) for femoral access can be broadly categorized as active closure devices, compression assist devices, and external/topical hemostasis devices. There is high-level evidence demonstrating that their use is related to less time for ambulation and increased patient satisfaction. However, available data failed to clearly demonstrate a benefit in complications compared to standard manual compression in peripheral endovascular arterial procedures, and thrombotic and infectious complications reported following VCD use remain an issue. Heterogeneity noted in the literature, caused by the vast variety of devices, access sites, sheath sizes, clinical scenarios, and procedures, poses difficulties in data analysis and future study design. As a result, an individualized VCD use is currently suggested for ≥ 5 Fr femoral artery access not only to reduce time to hemostasis and ambulation and to improve patient comfort, but also to reduce bleeding complications in cases of femoral access with increased bleeding risk, deranged coagulation, and large-bore access, though a high level of evidence to support this later recommendation is limited. KEY POINTS: US guidance is strongly recommended for femoral access and is mandatory to obtain more challenging access. The use of VCDs for femoral hemostasis is generally safe, effective, and currently supported by level I evidence. Proper training and correct VCD choice, based on the patient's individual characteristics, are imperative to optimize outcomes.

Vascular access complications after catheter ablation of ventricular arrhythmias: Impact of vascular closure devices

BackgroundVascular access site complications are the most frequent complications of percutaneous catheter ablation (CA) of ventricular arrhythmias (VAs). Whether arterial/venous vascular closure devices (VCDs) prevent vascular complications is unknown. ObjectiveWe investigated the benefit of VCDs in patients undergoing CA of VAs. MethodsConsecutive CA of VAs were included (2018–2022). Vascular accesses were obtained with ultrasound guidance. At the discretion of the operator, arterial and/or venous VCDs were used. Cases were divided into 3 groups: no use of VCDs for any arterial/venous accesses (manual compression [MC]), use of VCDs for some but not all accesses (Partial-VCDs), and use of VCDs for all accesses (Complete-VCDs). Vascular complications were classified as minor if they did not require intervention or major if they required intervention. ResultsA total of 1016 procedures were performed in 872 patients (mean age 62 ± 13 years; mean body mass index 30 ± 6 kg/m2; 27% female) during the study period. Femoral arterial access was obtained in 887 procedures (875 single access: 7.4 ± 1.5 F size; 12 two accesses: 7.3 ± 3 and 6.9 ± 1.8 F). Femoral venous access was obtained in 1014 procedures (unilateral in 17%; bilateral in 83%; mean number of access sites per patient 2.6 ± 0.7; mean size 8.4 ± 1.3 F). Hemostasis was achieved with MC in 192 procedures (19%), with Partial-VCD in 275 (27%), and with Complete-VCD in 549 (54%). A vascular complication occurred in 52 procedures (5.1%), including a minor hematoma in 3.9% and/or a major complication in 1.7%. The rate of vascular complications was 6.8% (5.2% minor and 1.6% major) in the MC group, 7.6% (5.1% minor and 3.3% major) in the Partial-VCD group, and 3.3% (2.9% minor and 0.9% major) in the Complete-VCD group (P = .014 for comparison). In multivariable analysis, Complete-VCD remained independently associated with a lower risk of vascular complications (odds ratio 0.69; 95% confidence interval 0.48–0.96; P = .036). ConclusionIn patients undergoing CA of VAs, Complete-VCD is associated with lower rates of vascular-related complications compared with MC or Partial-VCD.

Dual ProGlide vs ProGlide and Angio-Seal for Femoral Access Hemostasis After Transcatheter Aortic Valve Replacement: A Randomised Comparative Trial

BackgroundVascular complications increase morbidity and mortality after transcatheter aortic valve replacements (TAVR), often related to failures in vascular closure devices (VCDs). We intended to compare the dual Perclose ProGlide (PP) strategy and the hybrid combination of PP and Angio-Seal (AS) for femoral access hemostasis after TAVR. MethodsA randomised controlled trial with 257 patients comparing dual PP with 1 PP and 1 AS (AS+PP) for vascular closure after transfemoral TAVR was conducted. The primary end point was the composite of TAVR access site–related vascular complications and life-threatening type 2/3 or 1 bleeding according to the Valve Academic Research Consortium 3. Secondary end points included additional VCD use and significant peripheral ischemia related to arteriotomy closure within 1 year. Modified VCD failure, defined as failure to achieve hemostasis within 5 minutes or requiring additional endovascular manoeuvres, was also recorded. ResultsThe AS+PP combination yielded lower rates of the primary end point (18.2% vs 29.8%; P = 0.0381), vascular complication (18.2% vs 29.8%; P = 0.0381), additional VCD use (0.8% vs 19.0%; P < 0.0001), and modified VCD failure (9.9% vs 33.1%; P < 0.0001) than the dual PP. Bleeding complication rates were similar between the 2 groups. Three-month follow-up vascular duplex tests showed similar common femoral artery (CFA) diameters and peak systolic velocities (PSVs) between the 2 groups, but those with additional intervention had higher PSVs and smaller CFA diameters than those without. ConclusionsCombined PP+AS for large-bore femoral access hemostasis after TAVR promises to be more effective and safer than dual PP in terms of vascular complications. Moreover, additional intervention for vascular complications resulted in smaller CFA diameters. Clinical Trial RegistrationNCT05491070

Passive Approximator Vascular Closure Device Use in Patients with Shallow Femoral Artery Depth Increases Puncture-site Complications in Neuroendovascular Treatment

Puncture-site complications in interventional radiology sometimes cause severe conditions. Vascular closure devices play an important role in preventing puncture-site complications. Vascular closure devices are divided into 2 types, the directly suturing or clipping type (active approximators) and adherent sealant types (passive approximators). However, which types of vascular closure device are the safest and most effective for achieving hemostasis remains unclear. We analyzed the efficacy of each type of vascular closure device and risk factors for puncture-site complications. This study investigated 327 consecutive cases of neuroendovascular surgery using a transfemoral procedure during a 2-year study period. Passive approximators (Angioseal [St Jude Medical, Saint Paul, MN] and Exoseal [Cordis Corporation, Miami, FL]) were mainly used in the first half and active approximators (Perclose [Abbot Vascular, Santa Clara, CA]) in the second. We compared groups and estimated risk factors for puncture-site complications. All procedures were successful. Comparing groups with and without puncture-site complications, use of passive approximators and ≥3 antithrombotic medications tended to be more frequent and distance from skin to femoral artery and body mass index tended to be lower in the group with complications without significance. The cutoff for femoral artery depth calculated from a receiver operating characteristic curve was 16.43 mm. Multivariate analysis revealed ≥3 antithrombotic medications (P= 0.002, OR 15.29, 95% CI 2.76-85.76) and passive approximator use in patients with femoral artery depth <16.43 mm (P < 0.001, OR 17.08, 95% CI 2.95-57.80) were significantly higher in the group with puncture-site complications. Passive approximator use in patients with shallow femoral artery depth increases puncture-site complications in neuroendovascular treatment.

A prospective randomized trial was conducted to evaluate the complication rate and patient comfort using three different vascular closure strategies following coronary angiography

Background: The use of vascular closure devices is now common in clinical practice for femoral artery puncture, although manual compression remains the current gold standard. The development and use of vascular closure devices are aimed at improving patient comfort and avoiding complications such as hematoma, pseudoaneurysm formation, and the need for blood transfusion in the event of significant bleeding or surgical revision at the puncture site. Aims: The aim of this study is to evaluate the complication rate after femoral arterial puncture using different closure techniques. Furthermore, patient comfort will also be measured. Material and Methods: In this prospective, two-centre study, 142 patients were randomized into three groups: the Vascular Closure Device (VCD, Cordis), manual compression (MC) and External Compression Device (ECD, Maquet). The primary endpoint is combined with the evaluation of hematoma greater than 5 cm, pseudoaneurysm formation, the need for blood transfusion or relevant bleeding with a hemoglobin drop greater than 2 g/dl, the occurrence of retroperitoneal hematoma, pressure ulcers greater than grade 2, ischemia of the ipsilateral limb, or nerve damage. Follow-up visits are scheduled at 24 hours, 7 days, and 30 days. Results: The ratio of gender and pre-existing conditions within the randomized groups is almost equal. Medication before coronary angiography is comparable. Significantly more interventions are performed in the VCD group. Correspondingly, the procedure time is longer, and dual antiplatelet therapy is prescribed more often. Compression time and time to first hemostasis were significantly longer in the VCD group. The number of rebleeds after primary hemostasis is significantly higher in the ECD group. None of the enrolled patients suffered major bleeding or required a blood transfusion. No retroperitoneal hematoma was observed. Overall, there is one AV fistula in the MC group, two pseudoaneurysms in the VCD group, and one pseudoaneurysm in the ECD group. Pain was reported at significantly higher rates in the MC group than in either device group. The highest level of pain is reported within 48 hours in the MC group, and voiding dysfunction is significantly more frequent in the MC group. The same results are observed for sleep quality. Patients in the MC group reported significantly fewer hematomas greater than 5 cm at 7 days compared to patients who received a VCD. Conclusion: Our results show no significant difference in the achievement of the combined primary endpoint of all three groups. However, the rate of rebleeding after primary hemostasis is significantly lower in the VCD group, even with prolonged procedure time. There was no difference in the incidence of MACCE. Patient pain and voiding dysfunction within 24 hours are highest in the MC group. No difference is reported between 7 and 30 days.

Access site complications in thoracic endovascular aortic repair

BackgroundPercutaneous access and use of vascular closure devices facilitate thoracic endovascular aortic repair (TEVAR) procedures during local anesthesia and allow immediate detection of signs of spinal ischemia. However, the very large bore access (usually ≥22F sheath) associated with TEVAR increases the risk of vascular complications. In this study, we sought to define the safety and feasibility of two percutaneous femoral artery closure devices during TEVAR, in terms of access site vascular complications and major, life-threatening, or fatal bleeding (≥major) within 48 hours. Access site vascular complications were defined as technical failure of vascular closure or later formation of pseudoaneurysm. MethodsFrom March 2010 to December 2022, 199 transfemoral TEVAR were performed at Helsinki University Central Hospital, Finland. We retrospectively categorized these into three groups, based on surgeon preference for the access technique and femoral artery closure method: (1) surgical cut-down and vessel closure, n = 85 (42.7%), (2) percutaneous access and vascular closure with suture-based ProGlide, n = 56 (28.1%), or (3) percutaneous access and vascular closure with ultrasound-guided plug-based MANTA, n = 58 (29.1%). The primary outcome measure was technical success of vascular closure and access site vascular complications during index hospitalization. Secondary outcome measures were ≥major bleeding, early mortality, and hospital stay. ResultsThe technical success rate was 97.6% vs 91.1% vs 93.1% for surgical cut-down, ProGlide, and MANTA, respectively (P = .213). The rate of access site vascular complication was 3.5% vs 8.9% vs 10.3%, respectively (P = .290), with two pseudoaneurysms detected postoperatively and conservatively managed in the MANTA group. The vascular closure method was not associated with increased risk of ≥major bleeding, early mortality, or hospital stay on univariate analysis. Predictors for ≥major bleeding after TEVAR in multivariable analysis were urgent procedure (odds ratio: 2.8, 95% confidence interval: 1.4-5.5; P = .003) and simultaneous aortic branch revascularization (odds ratio: 2.7, 95% confidence interval: 1.3-5.4; P = .008). ConclusionsIn this study, the technical success rates of the percutaneous techniques demonstrated their feasibility during TEVAR. However, the number of access site complications for percutaneous techniques was higher compared with open approach, although the difference was not statistically significant. In the lack of evidence, the safety of the new MANTA plug-based vascular closure for TEVAR warrants further investigation.

Effectiveness and Safety of Different Vascular Closure Devices: Multicentre Prospective Observational study.

The aim of this prospective, multicentre, observational study was to compare the efficacy and safety of balloon-based and non-balloon-based vascular closure devices (VCDs). From March 2021 to May 2022, 2373 participants from 10 different centres were enrolled. Among them, 1672 patients with 5-7 Fr accesses were selected. Successful haemostasis, failure and safety were evaluated. Successful haemostasis was defined as the possibility to obtain complete haemostasis with the use of VCDs, without any complication. Failure management was defined as the need of manual compression. Safety was defined as the rate of complications. Cases of haematomas/pseudoaneurysms (PSA) and artero-venous fistula (AVF) were collected. VCDs mechanism of action is statistically significant associated with the outcome. Non-balloon-based VCDs demonstrated a statistically significant better outcome: successful haemostasis was obtained in 96.5% vs. 85.9%, of cases when compared to balloon occluders (p < 0.001). The incidence of AVF was statistically more frequent using non-balloon occluders devices (1.57% vs 0%, p: 0.007). No significant statistical difference was found in comparing haematoma and PSA occurrence. Thrombocytopenia, coagulation deficit, BMI, diabetes mellitus and anti-coagulation were demonstrated to be independent predictors of failure management. Our study suggests a better outcome with the same complication rate, except that for AVF incidence for non-balloon collagen plug device if compared to balloon occluders vascular closure devices.

PO-01-021 VASCULAR ACCESS COMPLICATIONS DURING CATHETER ABLATION OF VENTRICULAR ARRHYTHMIAS: IMPACT OF VASCULAR CLOSURE DEVICE

In patients (pts) with ventricular arrhythmias (VAs) undergoing catheter ablation (CA), the need for multiple vascular access points with large bore sheaths predisposes to vascular complications. Whether arterial/venous vascular closure devices prevent vascular complications is unknown. We investigated the benefit of vascular closure devices in pts undergoing CA of VAs. Consecutive pts undergoing CA of VAs between 2018-2020 were included. Vascular accesses were obtained with ultrasound guidance. At the discretion of the operator, arterial (Perclose or AngioSeal) and/or venous (Vascade or figure-of-eight suture) were used. Pts were divided into 3 groups: no use of vascular closure devices for any of the arterial/venous accesses (No-Closure), use of vascular closure devices for some but not the all of the arterial/venous accesses (Partial-Closure), use of vascular closure devices for all of the arterial/venous accesses (Complete-Closure). Vascular complications were defined minor if they didn’t require intervention or major if they required intervention (transfusion, percutaneous/surgical repair). 522 pts (62±13 years, BMI 30±6 kg/m2, 26% female) underwent ablation of VT (41%) or PVCs (59%) during the study period. 134 (34%) were on oral anticoagulation before the procedure (interrupted in 129, uninterrupted in 5). 477 arterial accesses were obtained in 471 (90%) pts (single access in 465 pts – 7.5±1.4 Fr size, two accesses in 6 – 7±1.5 Fr and 7±4 Fr). 1258 venous accesses were obtained in 520 (99.6%) pts (unilateral in 24%, bilateral in 75.6%, N. of accesses 2.4±0.7/pt, size 8.4±1.33 Fr). 142 (27%) pts received No-Closure, 201 (39%) Partial-Closure and 179 (34%) Complete-Closure. A vascular access-related complication occurred in 31 (5.9%) pts, including a minor hematoma in 4.6% and a major complication in 1.3%. The rate of vascular complications was 7% (5.6% minor and 1.4% major) in the No-Closure group, 6.9% (5% minor and 1.9% major) in the Partial-Closure group, and 3.9% (3.4% minor and 0.5% major, P=0.15 for comparison) in the Complete-Closure group. In pts undergoing CA of VAs, Complete-Closure using dedicated arterial/venous closure devices/sutures appeared associated with lower absolute rates of minor and major vascular-related complications compared to No-Closure or Partial-Closure. Although the differences did not reach statistical significance, they suggest a potential benefit of Complete-Closure and require further investigation in larger cohorts.

Costs and Budget Impact of Collagen-Based Vascular Closure Device Versus Manual Compression Following Peripheral Endovascular Procedures

To evaluate the annual costs and budget impact of using a vascular closure device to achieve haemostasis following femoral access endovascular procedures in England, compared with manual compression. A budget impact model was developed in Microsoft® Excel, based on the estimated number of peripheral endovascular procedures eligible for day-case management performed annually by the National Health Service in England. The clinical effectiveness of vascular closure devices was captured based on the requirement for inpatient stays and the incidence of complications. Data for endovascular procedures, time to haemostasis, length of hospital stay, and complications were collected from public sources and the published literature. There were no patients involved in this study. Model outcomes are reported as estimated number of bed days and annual costs to the National Health Service for all peripheral endovascular procedures in England, and the average cost per procedure. The robustness of the model was tested in a sensitivity analysis. The model estimated savings for the National Health Service of up to £4.5 million annually if vascular closure devices were used in every procedure instead of manual compression. The model estimated an average cost saving of £176 per procedure for vascular closure devices over manual compression, primarily due to fewer inpatient stays. The sensitivity analysis demonstrated that the proportion of day-case procedures for vascular closure devices and manual compression was a key driver of costs and savings. The use of vascular closure devices for achieving haemostasis after peripheral endovascular procedures may be associated with lower resource use and cost burden, compared with manual compression, based on shorter time to haemostasis and ambulation and an increased likelihood of a day-case procedure.

Post-closure With MANTA Fluoroscopic DOT Technique for Emergent Percutaneous Mechanical Circulatory Support and ‘Bail-out’ for Large Bore Arterial Hemostasis

BackgroundLarge bore arterial hemostasis for emergent MCS initiation in cardiogenic shock and during failures of suture mediated vascular closure devices (VCD) necessitates dry/post-closure technique for successful closure. Use of the alternative MANTA fluoroscopic DOT technique, without depth finder, as post closure and as ‘bail-out’ in this high-risk patient population is described. MethodsAll patients who underwent emergent percutaneous transfemoral MCS initiation, without use of upfront sutured-mediated pro-glide VCDs, and procedures where proglide-perclose technique (PPT) failed to achieve hemostasis were post-closed with the alternative MANTA fluoroscopic DOT technique (without depth finder) as primary method or as ‘bail-out’.Patient related factors, cardiovascular co-morbidities, clinical indication, distribution of 14F versus 18F MANTA, and types of procedures obtained. Primary outcomes of access site related acute flow-limiting limb ischemia or bleeding requiring intervention analyzed. Results27 patients met inclusion criteria; mean age 64 years, majority male 19 (70 %), more than half obese (56 %) with mean BMI 31.06 kg/m2. 22 (81 %) had emergent MCS initiation and 5 (19 %) PPT hemostasis failures. Types of percutaneous MCS support included; 11 (44 %) Impella CP, 2 (7 %) 15F arterial ECMO, 6 (22 %) 17F arterial ECMO, 4 (15 %) 19F ECMO. All achieved hemostasis utilizing alternative MANTA fluoroscopic DOT technique without vascular complications of bleeding or acute ischemic limb. ConclusionThe alternative MANTA fluoroscopic DOT technique (without depth finder) can be successfully applied as post-closure for emergent MCS support delayed hemostasis and as bail-out for per-close suture mediated VCD failures for large bore arterial hemostasis.

Percutaneous Suture - Closure Device Used for Iatrogenic Carotid Artery Injury Management: Case Report and Review of Literature.

Accidental carotid artery injury is an uncommon but serious central venous catheter insertion complication. Hemostasis might not be readily achieved by manual compression; therefore, surgery or endovascular treatment remains the mainstay for accidental carotid artery injury. However, not all patients are suitable candidates for surgery.Vascular closure devices are widely used in femoral arteries to achieve hemostasis and early ambulation. The use of vascular closure devices is occasionally reported in other vascular beds. Here we present a case of an iatrogenic left common carotid artery injury treated by vascular closure device, which is of help in the future management of this complication.

Clinical outcomes of MANTA vs suture-based vascular closure devices after transcatheter aortic valve replacement: An updated meta-analysis

ObjectiveA recently published randomized control trial showed different results with suture-based vascular closure device (VCD) than plug-based VCD in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The learning curve for MANTA device is steep, while the learning curve for suture based VCD is shallow as the devices are quite different. In this meta-analysis, we have compared suture-based (ProGlide and Prostar XL) vs plug-based VCDs (MANTA). MethodsWe performed a meta-analysis of all published studies (using PubMed/Medline and Cochrane databases) reporting the clinical outcome of plug-based vs suture-based VCDs in transfemoral TAVR patients. ResultsWe included nine studies with a total of 2865 patients (plug-based n = 1631, suture-based n = 1234). There was no significant difference in primary outcome of all bleeding when using plug-based as opposed to suture-based VCDs (RR 1.14 [0.62–2.06] I2 = 72%). There was no significant difference in the incidence of secondary outcomes between two groups including major life threatening bleeding (RR 1.16 [0.38–3.58] I2 = 65%), major vascular complications (RR 0.84 [0.35–2.00] I2 = 55%), minor vascular complications (RR 1.05 [0.56–1.95] I2 = 42%), pseudo aneurysm (RR 1.84 [0.11–29.98] I2 = 44%), stenosis-dissection (RR 0.98 [0.66–1.47] I2 = 0%), VCD failure (RR 1.71 [0.96–3.04] I2 = 0%), and blood transfusion (RR 1.01 [0.38–2.71], I2 = 61%). ConclusionLarge bore arteriotomy closure with plug-based VCD was not superior to suture-based VCDs in this transfemoral TAVR population. There was very frequent use of secondary VCDs in suture-based VCD group which is not practical when using MANTA. Additional high-powered studies are required to determine the safety and efficacy of MANTA device.

Vascular Closure Devices versus Manual Compression in Cardiac Interventional Procedures: Systematic Review and Meta-Analysis.

Backgrounds Manual compression (MC) and vascular closure device (VCD) are two methods of vascular access site hemostasis after cardiac interventional procedures. However, there is still controversial over the use of them and a lack of comprehensive and systematic meta-analysis on this issue. Methods Original articles comparing VCD and MC in cardiac interventional procedures were searched in PubMed, EMbase, Cochrane Library, and Web of Science through April 2022. Efficacy, safety, patient satisfaction, and other parameters were assessed between two groups. Heterogeneity among studies was evaluated by I2 index and the Cochran Q test, respectively. Publication bias was assessed using the funnel plot and Egger's test. Results A total of 32 studies were included after screening with inclusion and exclusion criteria (33481 patients). This meta-analysis found that VCD resulted in shorter time to hemostasis, ambulation, and discharge (p < 0.00001). In terms of vascular complication risks, VCD group might be associated with a lower risk of major complications (p = 0.0001), but the analysis limited to randomized controlled trials did not support this result (p = 0.68). There was no significant difference in total complication rates (p = 0.08) and bleeding-related complication rates (p = 0.05) between the two groups. Patient satisfaction was higher in VCD group (p = 0.002). Meta-regression analysis revealed no specific covariate as an influencing factor for above results (p > 0.05). Conclusions Compared with MC, the use of VCDs significantly shortens the time of hemostasis and allows earlier ambulation and discharge, meanwhile without increase in vascular complications. In addition, use of VCDs achieves higher patient satisfaction and leads cost savings for patients and institutions.

Quality care guidelines for uterine artery embolisation in women with symptomatic uterine fibroids in Australia and New Zealand: According to the AGREE-II checklist and endorsed by the Interventional Radiology Society of Australasia.

Quality care guidelines for uterine artery embolisation in women with symptomatic uterine fibroids in Australia and New Zealand: According to the AGREE-II checklist and endorsed by the Interventional Radiology Society of Australasia.

Comparison of Application Effects of Different Hemostasis Methods After Ischemic Cerebrovascular Intervention.

ObjectiveTo explore the effects of two different hemostasis methods, namely, arterial compression devices and vascular closure devices, in the ischemic cerebrovascular intervention to provide a theoretical basis for clinical selection of hemostasis methods.MethodsA total of 302 patients who underwent ischemic cerebrovascular intervention in our hospital from January 2016 to December 2020 were selected as the research subjects and randomly divided into the control group (n = 151) and the observation group (n = 151). The patients in both groups underwent cerebrovascular intervention. The patients in the control group were treated with an artery compressor for hemostasis after the operation, while those in the observation group were treated with vascular closure devices for hemostasis. The hemostatic indexes and vascular parameters at the puncture site before and after the operation were compared between the two groups. The comfort level of the patients was assessed at 6, 12, and 24 h after the operation with the Kolcaba Comfort Scale score, and the postoperative complications were recorded.ResultsThere was no significant difference in the success rate of hemostasis between the two groups (p > 0.05). The hemostatic time and immobilization time of (2.69 ± 0.62) min and (4.82 ± 0.93) h in the observation group were lower than those in the control group with (16.24 ± 3.58) min and (7.94 ± 1.86) h (p < 0.05). The differences in the minimum inner diameter of the puncture site and its nearby vessels and the peak velocity of blood flow between the two groups before and after the operation were not statistically significant within or between groups (p > 0.05). The scores of the Kolcaba comfort scale in the observation group (80.16 ± 8.49) and (93.65 ± 9.26) at 6 and 12 h, respectively, after the operation, were higher than those in the control groups (72.08 ± 7.54) and (85.49 ± 8.63) (p < 0.05). The 24 h postoperative Kolcaba comfort scale score was (97.54 ± 9.86) in the observation group and (96.82 ± 9.64) in the control group, and the difference was not statistically significant (p > 0.05). In the control group, there were 7 cases of dysuria, 12 cases of low back pain, 14 cases of sleep disorder, 20 cases of mental stress, and 5 cases of wound bleeding, and the total incidence of complications was 38.41% (58/151). In the observation group, there were 4 cases of dysuria, 8 cases of low back pain, 10 cases of sleep disorder, 14 cases of mental stress, and 3 cases of wound bleeding, and the total incidence of complications was 25.83% (39/151). The total incidence of complications in the observation group was lower than that in the control group (p < 0.05).ConclusionFor patients with ischemic cerebrovascular disease undergoing femoral artery puncture intervention, the use of vascular closure devices can stop the bleeding quickly, which can significantly shorten the bleeding time, and the postoperative braking time of patients is short, with high comfort and fewer complications.

Vascular Accesses in Cardiac Stimulation and Electrophysiology: An Italian Survey Promoted by AIAC (Italian Association of Arrhythmias and Cardiac Pacing).

Simple SummaryBoth cardiac implantable electronic device (CIED) implantations and electrophysiology procedures require vascular access to reach the heart through vessels. Different types of access carry different rates of complications. Safety and ease of vascular access are the main targets of physicians; in fact, each complication causes morbidity and raises costs. To avoid complications, the use of ultrasound-guided vessel puncture and closure devices is increasing in frequency. We conducted a survey in Italian centers to outline common practice; an uneven pattern of habits emerged. Hopefully, recently published scientific society consensus statements will lead to an improvement in physicians’ practice. The survey highlights that there is an unmet need for dedicated courses, particularly for ultrasound-guided vessel puncture.Cardiac implantable electronic device (CIED) implants and electrophysiological procedures share a common step: vascular access. On behalf of the AIAC Ricerca Investigators’ Network, we conducted a survey to outline Italian common practice regarding vascular access in EP-lab. All Italian physicians with experience in CIED implantation and electrophysiology were invited to answer an online questionnaire (from May 2020 to November 2020) featuring 20 questions. In total, 103 cardiologists (from 92 Italian hospitals) answered the survey. Vascular access during CIED implants was considered the most complex step following lead placement by 54 (52.4%) respondents and the most complex for 35 (33.9%). In total, 54 (52.4%) and 49 (47.6%) respondents considered the cephalic and subclavian vein the first option, respectively (intrathoracic and extrathoracic subclavian/axillary vein by 22 and 27, respectively). In total, 45 (43.7%) respondents performed close arterial femoral accesses manually; only 12 (11.7%) respondents made extensive use of vascular closure devices. A total of 46 out of 103 respondents had experience in ultrasound-guided vascular accesses, but only 10 (22%) used it for more than 50% of the accesses. In total, 81 (78.6%) respondents wanted to increase their ultrasound-guided vascular access skills. Reducing complications is a goal to reach in cardiac stimulation and electrophysiological procedures. Our survey shows the heterogeneity of the vascular approaches used in Italian centres. Some vascular accesses were proved to be superior to others in terms of complications, with ultrasound-guided puncture as an emerging technique. More effort to produce the standardization of vascular accesses could be made by scientific societies.