Use Of Closure Device Research Articles

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.

Over-the-scope clip for closure of persistent gastrocutaneous fistula after gastrostomy tube removal: a multicenter pediatric experience

BackgroundPercutaneous endoscopic gastrostomy is commonly used for enteral nutritional access, but gastrocutaneous fistulae (GCF) may persist after tube removal, posing clinical challenges. The use of endoscopic closure devices, including over-the-scope clips (OTSC), has shown promise in managing non-healing fistulae, although data in the pediatric population are limited.MethodsA retrospective multicenter study analyzed pediatric patients who underwent GCF closure following gastrostomy tube removal. Data from seven centers across multiple countries were collected, including patient demographics, procedural details, complications, and outcomes. Closure techniques were compared between OTSC and surgical closure.ResultsOf 67 pediatric patients included, 21 underwent OTSC closure and 46 had surgical closure. Surgical closure demonstrated a higher success rate (100%) compared to OTSC closure (61.9%, P < 0.001). While procedural duration was shorter for OTSC closure (25 vs. 40 min, P = 0.002), complications, and scar quality were comparable between techniques. A subsequent sub-analysis did not reveal differences based on center experience.ConclusionOTSC closure is feasible and safe in pediatric patients, but surgical closure remains superior in achieving sustained GCF closure, although OTSC offers benefits, such as shorter procedural duration, potentially reducing the duration of general anesthesia exposure. Non-operative approaches, including OTSC, may be a valuable alternative to surgical closure.Graphical abstract

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.

Comparison of percutaneous decannulation and open surgical repair for large-bore arterial access sites of extracorporeal membrane oxygenation.

Following weaning of peripheral venoarterial extracorporeal membrane oxygenation (ECMO) support, removal of cannulas and repair of large-bore arterial sites is traditionally by open surgical repair (OSR). The use of a percutaneous vascular closure device (VCD) offers a minimally invasive alternative to OSR with potential for reduced operative complications, reduced hospital length of stay and in-hospital mortality. A systematic review of Medline and Embase databases was conducted for studies comparing VCD-assisted decannulation with OSR following decannulation of peripheral ECMO. The primary endpoint was rate of post-procedural complications, namely wound infection and limb ischaemia. The secondary endpoint was in-hospital mortality. Eight studies, with a total of 685 patients, met inclusion criteria. Forty-eight percent (n = 328) of patients underwent VCD-assisted decannulation with the remainder decannulated by OSR. Pooled analysis demonstrated that patients undergoing VCD-assisted decannulation are at significantly lower risk of overall complications than surgical repair (OR 4.34; 95% CI 2.19-8.57; p < .001). Specifically, there was a substantial decrease in groin infections (OR 6.77; 95% CI 3.07-14.97; p < .001) without notable differences in limb ischaemia or pseudoaneurysm occurrence between the VCD and OSR cohorts. There was a lower incidence of intra-operative bleeding and haematoma in the VCD cohort (p < .001 and p = .002, respectively). Vascular closure device-assisted decannulation of peripheral ECMO offers a significantly reduced risk of complications, particularly groin infections and bleeding. Future research should encompass larger cohorts, randomised controlled trials, cost-benefit analyses, and the training of surgeons, cardiologists and intensivists in VCD-assisted decannulation, potentially through the integration of simulation-based training.

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.

Suture-Based Vascular Closure Versus Surgical Closure of Large Bore Arteriotomies: A Real-World Experience.

With the introduction of transcatheter aortic valve implantation (TAVI), endovascular abdominal aortic aneurysm repair (EVAR), thoracic endovascular aortic aneurysm repair (TEVAR), and frequent use ofleft ventricular assist devices in complicated percutaneous coronary interventions, the use of large bore arterial access has become a necessity. In the index study, we compared the percutaneous closure of large arteriotomies with open surgical (OS) closure. It was a prospective study in which we compared the technical success and vascular complication rate associated with the use of a suture-based vascular closure device (VCD): Perclose ProGlide(PP) with that of OS closure. The study was carried out at Command Hospital Air Force,Bengaluru, India, from January 1, 2016, toDecember 31, 2020. The inclusion criteria were any percutaneous intervention involving large bore arterial access (≥12 French (F) sheath). The exclusion criteria were any condition where a persistent need for vascular access at the end of the procedure was required. We noted the baseline characteristicsand type of anesthesia for all patients. The primary outcome was technical success and major vascular complications, which included major local site bleeding: Bleeding Academic Research Consortium (BARC) 3 or more, failed hemostasis requiring a second intervention, and acute vessel occlusion. Total time taken for the procedure (TTP), time to ambulation (TTA), and time to discharge post-procedure (TTD) were noted for each patient. The secondary outcomes were any bleeding other than major, local hematoma sized >5 cm at 24 hours, pseudo aneurysm formation at 30 days, and acute limb ischemia at 30 days. A total of 120 patients (PP: 60 (males: 54, females: 6), OS: 60 (males: 50, females: 10)) were included in this study.The mean age of patients was comparable in both groups (PP: 71.8 ± 9.62 years and OS: 71.0 ± 7.76 years, p-value: 0.63). Total large arteriotomies (mean size: 18.03F ± 3.34) closed were 184 (PP: 90, OS: 94). The procedures performed were EVAR: 64 (PP: 30, OS: 34), TAVI: 38 (PP: 21, OS: 17), and TEVAR: 18 (PP: 9, OS: 9). All patients in PP group received dual ProGlide with preclose technique. All TEVAR procedures (total arteriotomies: 18) required a vascular sheath of ≥ 24F.There was no statistical difference between the mean size of sheaths used in the two groups. The technical success (PP: 95.55%, OS: 97.87%, 95% CI: -5.78%-10.98%, p-value: 0.48) and rate of major complications were similar in both groups. Three patients in the PP group who had failed hemostasis with two ProGlides were successfully managed with one additional Angioseal (6F) each.The occurrence of hematoma sized larger than 5 cm was significantly more in the PP group compared to the OS group (PP: 7 (7.78%), OS: 0 (0%), p-value: 0.006). While GA was used for all patients who underwent vascular closure with OS, only eight patients (13.33%) in the PP group required GA. The TTP, TTA, and TTD were significantly lower in the PP group as compared to the OS group. The percutaneous closure of large bore arteriotomies with suture-based VCDs is equally effective and is not associated with increased major vascular complications. In fact, the TTP, TTA, and TTD are significantly lower in the PP group which can translate to better patient comfort and lower costs.

The use of percutaneous left atrial appendage occluder device in a patient with prior surgical ligation with incomplete exclusion: a case report

Abstract Background Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and the most common cause of cardioembolic stroke. The left atrial appendage (LAA) is the main source of thrombus formation in patients with AF. Therapies include use of percutaneous LAA closure devices, or surgical LAA occlusion (LAAO). Despite these options, complete closure of the LAA is not always achieved, and residual communication between the LAA and atrium may result in increased thrombus formation. Although studies have analysed the use of percutaneous measures such as coils, plugs, or second occluder device deployment in LAA with peri-device leak (PDL), use of percutaneous occlude devices in surgically occluded LAA is far less studied. Case summary We present a case of a 79-year-old female patient who underwent LAAO device deployment within a surgically occluded LAA with PDL. She underwent 27 mm LAAO device (WATCHMANTM) deployment and all the P.A.S.S. (Position, Anchor, Size, and Seal) criteria were satisfied. Only 1.4 mm PDL was present. She was continued on apixaban and aspirin post-operatively. Post-operative transoesophageal echocardiogram at 6 weeks demonstrated trivial PDL measuring 1.49 mm. Patient was continued on aspirin and clopidogrel, with discontinuation of apixaban. Discussion Percutaneous LAAO device deployment in previously surgically ligated LAA with incomplete exclusion is a potential therapeutic option for patients with AF and a high bleeding risk seeking a minimally invasive strategy, in an attempt to de-escalate anticoagulation therapy.

Use of Dynamic Tissue System Adhesive Skin Closure Device and Multi-Tissue Platform Porcine Xenograft to Achieve Primary Closure After Wide Local Excision of a Melanoma

Background. Wide local excision with sentinel lymph node biopsy has been the standard of care for melanoma with a Breslow depth greater than 1 mm. Wide local excision with 1- to 2-cm margins can result in large wounds that cannot be primarily closed. Traditionally, management has included reconstruction with autologous flaps and skin grafting. Case Report. The authors of this case report achieved successful closure of a large posterior calf wound after 2-cm–wide local excision of the melanoma biopsy site in a 61-year-old male. The dermal lesion was a Clark level IV superficial spreading malignant melanoma with Breslow depth of 1.1 mm. Wound closure was achieved with a DTS adhesive skin closure device coupled with MTP xenograft powder as a healing adjunct. Conclusion. The results of this patient's case indicate that DTS adhesive skin closure device should be considered as an additional option for the closure of large defects following wide local excision in the management of melanoma.

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.

Interventional Therapy and Surgical Management of Lumbar Disc Herniation in Spine Surgery: A Narrative Review.

Significant advancements in lumbar disc herniation (LDH) management have been made in interventional pain therapy, operative therapy, peri-operative management, and cost analysis of various procedures. The present review aims to provide a concise narrative of all these topics, current trends, and possible future directions in the management of LDH. Interventional pain management using intradiscal injections often serves as a minimally invasive non-surgical approach. Surgical modalities vary, including traditional open laminectomy, microdiscectomy, endoscopic discectomy, tubular discectomy, percutaneous laser disc decompression, and transforaminal foraminotomy. Prevention of infections during surgery is paramount and is often done via a single-dose preoperative antibiotic prophylaxis. Recurrence of LDH post-surgery is commonly observed and thus mitigative strategies for prevention have been proposed including the use of annular closure devices. Finally, all treatments are well-associated with clear as well as hidden costs to the health system and society as described by billing codes and loss of patients' quality-adjusted life-years. Our summary of recent literature regarding LDH may allow physicians to employ up-to-date evidence-based practice in clinical settings and can help drive future advancements in LDH management. Future longitudinal and comprehensive studies elucidating how each type of treatments fare against different types of herniations are warranted.

Computed tomography defined femoral artery plaque composition predicts vascular complications during transcatheter aortic valve implantation.

Vascular and bleeding complications after transcatheter aortic valve implantation (TAVI) are common and lead to increased morbidity and mortality. Analysis of plaque at the arterial access site may improve prediction of complications. We investigated the association between demographic and procedural risk factors for Valve Academic Research Consortium (VARC-3) vascular complications in patients undergoing transfemoral TAVI with use of a vascular closure device (ProGlide® or MANTA®) in this retrospective cohort study. The ability of pre-procedure femoral CT angiography to predict complications was investigated including a novel method of quantifying plaque composition of the common femoral artery using plaque maps created with patient specific X-ray attenuation cut-offs. 23 vascular complications occurred in the 299 patients in the study group (7.7%). There were no demographic risk factors associated with vascular complications and no statistical difference between use of closure device (ProGlide® vs MANTA®) and vascular complications. Vascular complications after TAVI were associated with sheath size (OR 1.36, 95% CI 1.08-1.76, P 0.01) and strongly associated with CT-derived necrotic core volume in the common femoral artery of the procedural side (OR 17.49, 95% CI 1.21-226.60, P 0.03). Plaque map analysis of the common femoral artery by CT angiography reveals patients with greater necrotic core are at increased risk of VARC-3 vascular complications. The novel measurement of necrotic core volume in the common femoral artery on the procedural side by CT analysis was associated with post-TAVI vascular complications, which can be used to highlight increased risk.

Use of the MynxGrip vascular closure device in patients undergoing interventional diagnosis or treatment: The PANDA multicenter, open-label, randomized controlled trial.

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. 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. 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. 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.

Transcatheter closure of postsurgical aortic pseudoaneurysms guided by three-dimensional image reconstruction: asingle-centre experience.

Postsurgical thoracic aortic pseudoaneurysms (PTAPs) are apotentially lethal complication after cardiac or aortic surgery. Surgical management can pose achallenge with high in-hospital mortality rates. Transcatheter closure is aless-invasive alternative treatment option for selected patients, although current experience is limited. We aimed to evaluate procedural and imaging outcomes of our first 11cases of transcatheter PTAP closure with the use of closure devices. Patients with ahigh operative risk who underwent transcatheter PTAP closure at our centre from 2019 to 2021 were retrospectively included. Suitability was evaluated on preprocedural computed tomography (CT) scans and three-dimensional (3D) reconstructions. All procedures were performed in the catheterisation laboratory. Intraprocedural aortography and postprocedural CT scans with 3D reconstructions were used to evaluate PTAP occlusion. Eleven consecutive patients with ahigh operative risk and ahistory of cardiac/aortic surgery who underwent transcatheter PTAP closure were included. PTAPs were predominantly located at the proximal or distal anastomosis of asupracoronary ascending aortic vascular graft or Bentall prosthesis (82%). Implanted closure devices included Amplatzer Valvular PlugIII (82%), Amplatzer septal occluder (9%) and Occlutech atrial septal defect occluder (9%). No periprocedural complications occurred. After device deployment, residual flow was absent on aortography in 64% and minimal residual flow was present in 36% of patients. Subtotal or total occlusion of the PTAP on follow-up CT ranged between 45% and 73%. Although subtotal or total occlusion of the PTAP was found at follow-up in only 45-73% of cases, transcatheter PTAP closure guided by preprocedural 3D reconstructions can offer avaluable minimally invasive primary treatment option for patients who otherwise would face ahigh-risk reoperation.

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.

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.

Outcomes of Layered Closure and Adjunctive Adhesive Retention Suture Device Use Following Ankle Fracture Open Reduction and Internal Fixation: A Single Center, Retrospective Cohort Study

Introduction. Wound edge necrosis, dehiscence, infection, and need for reoperation can occur following ankle fracture ORIF. An assistive retention suture device has been developed to serve as an adjunct to skin closure to help mitigate the potential for wound dehiscence and subsequent complications. Objective. This single-center retrospective review compared early postoperative healing and functional outcomes following ankle fracture ORIF in 39 patients in which layered closure alone (n = 20) and layered closure with use of a DAC (n = 19) was performed. Results. Adjunctive assistive retention suture device use with layered closure following ankle fracture ORIF resulted in a 60% decrease in the time to healing, an 80% reduction in postoperative dehiscence, a 90% reduction in the need for reoperation, and a 53% reduction in the time in which use of an ambulatory assistive device, brace, or orthoses was required compared to layered closure alone. Conclusions. The results of this study suggest that use of this assistive retention suture device minimizes potential postoperative healing complications, decreases need for revisional surgery, and reduces time until return to activity.

1019 SAFETY OF PLUG-BASED AND SUTURE-BASED VASCULAR CLOSURE DEVICES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT: A MULTICENTER OBSERVATIONAL STUDY

Abstract Background Transcatheter aortic valve replacement (TAVR), is the treatment of choice for most patients with aortic stenosis. Transfemoral access remains the most widely used peripheral vascular approach for TAVR and dedicated plug-based or suture-based vascular closure devices are available to achieve femoral hemostasis. However, the comparative safety of such strategies is controversial in patients undergoing transfemoral TAVR. Objectives in this study, we aimed to evaluate the rates of vascular access complications according to the use of plug-based or suture-based vascular closure in patients undergoing TAVR. Methods Data were retrospectively collected from two high-volume TAVR centers from September 2009 to March 2022. Patients were categorized according to the use of plug-based or suture-based vascular closure devices. The plug-based platform used was MANTA (Teleflex), while the suture-based devices were the Perclose ProGlide™ or the Prostar™ Systems (Abbott Vascular). Baseline demographic, clinical, and echocardiographic variables were compared between these groups using an independent-sample Student's t-test for continuous variables, presented as mean±SD, and the chi-square test for categorical or binary variables, presented as number and percentage, as appropriate. The odds ratio (OR) for vascular complications was calculated using a multivariate logistic regression model including as dependent variables all relevant baseline and procedural characteristics. The closure device variable was included in the multivariate model using the Prostar™ XL device group as reference. Vascular complications were adjudicated according to the Valve Academic Research Consortium definitions 3. Results Out of 874 patients, hemostasis was achieved with Prostar™ XL PVS in 120 (13.7%) patients, with Perclose ProGlide™ in 525 (60.1%), and with MANTA 229 (26.2%). No differences in age and common cardiovascular risk factors were observed between the group except for the prevalence of peripheral arterial disease (30.6% vs. 17.0%, p&amp;lt;0.0001) and dyslipidemia (58.9% vs. 68.6%, p=0.01) as well as for the echo and procedural variables except for the Euroscore II that was lower in the plug-based group (6.0±5.6 vs. 5.1±4.68), and for the higher use of new generation devices (79.1% vs. 98.3%, p&amp;lt;0.0001). After adjustment for common cardiovascular risk factors and procedural features, no differences were observed for total vascular complications [OR: 0.68 (95% confidence interval (CI): 0.33 to 1.38) and OR: 0.60 (95% CI: 0.33 to 1.53), for Perclose ProGlide™ and MANTA groups, respectively]. Likewise, no substantial differences were observed for major and minor vascular complications. Conclusions Both suture-based and plug-based devices have comparable outcomes with regard to the risk of vascular complications. Further randomized clinical trials are warranted to confirm this observation in high-risk sub-group patients with for example heavily calcified access or obesity.

Percutaneous, Antegrade Access of the Superficial Femoral Artery can be Safely Used in Procedures for the Treatment of Lower Extremity Limb Ischemia

Recent studies have shown that antegrade access for treatment of infrainguinal peripheral vascular disease is associated with decreased radiation exposure and contrast use without a significant increase in access complication, although data is limited on antegrade superficial femoral artery (SFA) access for larger sheath sizes. We aim to describe a single institution's contemporary experience with percutaneous antegrade SFA access. A retrospective review of percutaneous, infrainguinal endovascular interventions for arterial occlusive disease at a major academic institution was conducted between 2018 and 2020. Antegrade, percutaneous, SFA access cases were included. Information on demographics, indication, sheath size, arteries treated, type of intervention, concurrent pedal access, closure devices, and complications was collected and analyzed. A total of 45 patients with an average BMI of 25.25 were identified. Indications for intervention included tissue loss (64.4%), rest pain (6.7%), claudication (13.3%), and acute limb ischemia (11.1%). 80.0% of patients had multilevel interventions. Angioplasty was performed in 68.8% of patients, stenting in 8.3%, atherectomy in 15.6% and thrombectomy in 7.3%. Nearly a quarter of cases involved concurrent pedal access. Maximum sheath size was 4Fr for 4.4% of patients, 5Fr for 28.9%, 6Fr for 46.7%, 7Fr for 11.1%, and 8Fr for 8.9%. Closure device was utilized in 75.6% of cases, with no closure device failures. In the entire cohort, there were no demonstrated access site complications. This study demonstrates percutaneous, antegrade SFA access for complex endovascular interventions for infrainguinal occlusive disease can be effectively utilized, even with larger sheath size. Moreover, routine use of closure devices is safe, improving patient comfort and expediting time to ambulation.