Closure Device Research Articles

Hepatic and splenic venous access tract closure using the VASCADE vascular closure system following percutaneous intervention in patients with CHD.

Hepatic and splenic venous access are specialised techniques used to perform diagnostic and interventional procedures in the cardiac catheterisation laboratory. Bleeding events are the most commonly reported complication following hepatic or splenic venous access. The VASCADE Vascular Closure System (Cardiva Medical Inc. Santa Barbara, CA) is an approved device for closure of femoral vascular access tracts in patients ≥18 years of age. We report our experience using VASCADE to close the hepatic or splenic venous access site in the cardiac catheterisation laboratory. This is a single centre retrospective review of all patients who had percutaneous hepatic or splenic venous access obtained in the cardiac catheterisation laboratory from March 1, 2022 through October 30, 2023 and underwent tract closure with VASCADE. Ten patients (six male) underwent 16 procedures (median age and weight 3.5 years and 12.5 kg) with 15 hepatic and two splenic veins accessed. Successful closure of the access tracts with VASCADE was performed in all patients. There were no major adverse events related to closure of the access sites with VASCADE. VASCADE can be used following transhepatic and trans-splenic venous access in the cardiac catheterisation laboratory to safely close the access tract and potentially reduce the risk of post-procedural bleeding complications. Further evaluation in a larger cohort of patients is needed to ensure VASCADE is safe for use and provides adequate haemostasis following hepatic or splenic venous access, particularly in children.

Preliminary Insights Into Early Ambulation and Hemostasis After Atrial Fibrillation Ablation Using the Perclose Vascular Closure Device.

The introduction of the Perclose vascular closure device (VCD) for atrial fibrillation (AF) ablation procedures in Japan is expected to facilitate early ambulation. The study population comprised 554 patients undergoing AF ablation, of whom 377 successfully underwent Perclose VCD deployment at the end of the procedure. At 4 h after the procedure, 94% (353/377 patients) achieved early hemostasis and 57% (213/377 patients) achieved early ambulation. Notably, 0.5% (2/377 patients) developed acute deep vein thrombosis. The Perclose VCD demonstrated promising efficacy in achieving early hemostasis, potentially facilitating early ambulation and discharge in appropriate patients.

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.

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

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.

Femoral Large Bore Sheath Management: How to Prevent Vascular Complications From Vessel Puncture to Sheath Removal.

Transfemoral access is nowadays required for an increasing number of percutaneous procedures, such as structural heart interventions, mechanical circulatory support, and interventional electrophysiology/pacing. Despite technological advancements and improved techniques, these devices necessitate large-bore (≥12 French) arterial/venous sheaths, posing a significant risk of bleeding and vascular complications, whose occurrence has been related to an increase in morbidity and mortality. Therefore, optimizing large-bore vascular access management is crucial in endovascular interventions. Technical options, including optimized preprocedural planning and proper selection and utilization of vascular closure devices, have been developed to increase safety. This review explores the comprehensive management of large-bore accesses, from optimal vascular puncture to sheath removal. It also discusses strategies for managing closure device failure, with the goal of minimizing vascular complications.

Anticoagulation Alone vs Anticoagulation Plus Aspirin or DAPT Following Left Atrial Appendage Occlusion

BackgroundThe prevalence of and outcomes associated with different antithrombotic strategies after left atrial appendage occlusion (LAAO) are not well described. ObjectivesThis study sought to evaluate patterns of antithrombotic medication strategies at discharge following LAAO with the Watchman FLX device in real-world practice and to compare the risk of adverse events among the different antithrombotic regimens. MethodsThe authors evaluated patients in the NCDR (National Cardiovascular Data Registry) LAAO Registry who underwent LAAO with the second-generation LAA closure device between 2020 and 2022. They grouped patients by mutually exclusive discharge antithrombotic strategies and compared the rates of adverse events at 45 days and 6 months using multivariable Cox proportional hazards regression. ResultsAmong 53,878 patients undergoing successful LAAO with the second-generation LAA closure device, the most common antithrombotic discharge regimens were direct oral anticoagulant (DOAC) plus aspirin (48.3%), DOAC alone (22.6%), dual antiplatelet therapy (8.1%), warfarin plus aspirin (7.7%), and DOAC plus P2Y12 inhibitor (4.9%). In multivariate analysis, DOAC alone had a lower rate of major adverse events and major bleeding at 45 days of follow-up compared with DOAC plus aspirin (major adverse events: HR: 0.78; 95% CI: 0.68-0.91; major bleeding: HR: 0.69; 95% CI: 0.60-0.80). These differences persisted at 6 months. Warfarin without aspirin also showed lower rates of major bleeding at both time points. No differences were seen in stroke/transient ischemic attack or device-related thrombus. ConclusionsIn real-world U.S. practice, discharge on DOAC alone or warfarin alone was associated with a lower rate of adverse events compared with DOAC plus aspirin.

Axillary compared to brachial access for endovascular procedures.

Limited knowledge exists regarding access site complication rates between trans-axillary and trans-brachial approaches with sheath sizes ≥6Fr. We retrospectively reviewed our institution experience with access site complications for percutaneous trans-axillary and trans-brachial arterial interventions using sheath sizes ranging from 6Fr to 10Fr. We examined 67 endovascular interventions performed over 18 months, restricted to sheath sizes of 6Fr to 10Fr. Procedures utilizing trans-brachial (41 cases) and trans-axillary (26 cases) approaches under sonographic guidance were included. Cases involving hemodialysis accesses and those requiring surgical cut-down were excluded. The primary outcome measure was the occurrence of major access site complications (SIR grade-II/III) within 30 days, with data collected on hemostasis method, sheath size, and complications. Statistical analysis involved ANCOVA and Fisher's exact tests, with significance set at p < .05. Successful percutaneous arterial access was achieved in all cases using either approach (trans-axillary or trans-brachial). Closure devices were employed in all axillary punctures and in 71% of brachial punctures. Major access site complications occurred in 7 out of 41 cases (17%) in the trans-brachial group and in 4 out of 26 cases (15%) in the trans-axillary group. However, there was no statistically significant difference in complication rates between the two groups, regardless of access site or sheath size. Trans-axillary access serves as a safe and effective upper limb access method for percutaneous endovascular procedures requiring sheath size of 7Fr or larger when compared to trans-brachial approach.

Congenital heart disease cardiac catheterization at Uganda Heart Institute, a 12-year retrospective study of immediate outcomes

BackgroundCardiac catheterization is an invasive diagnostic and treatment tool for congenital heart disease (CHD) with potential complications.ObjectiveTo describe the immediate outcomes of patients who underwent cardiac catheterization for CHD at the Uganda Heart Institute (UHI).MethodsThe study was a retrospective chart review of 857 patients who underwent cardiac catheterization for CHD at UHI from 1st February 2012 to 30th June 2023. Precardiac catheterization clinical data, procedure details, and post-procedure data were recorded. The statistical software SPSS was used for data analysis.ResultsWe studied 857 patients who underwent cardiac catheterization for CHD at UHI. Females comprised 62.8% (n = 528). The age range was 3 days to 64 years, with a mean of 5.1 years (SD 7.4). Advanced heart failure was present in 24(2.8%) of the study participants. The most common procedures were patent ductus arteriosus device closure (n = 500, 58.3%), diagnostic catheterization (n = 194, 22.5%), and balloon pulmonary valvuloplasty (n = 114, 13.0%). PDA device closure had 89.4% optimal results while BPV had 75.9% optimal performance outcome.Adverse events occurred in 52 out of 857 study participants (6.1%). Clinically meaningful adverse events (CMAES) occurred in 3.9%, (n = 33), high severity adverse events in 2.9% (n = 25) and mortality in 1.5% (n = 13).Advanced heart failure at the time of cardiac catheterization, was significantly associated with clinically meaningful adverse events (OR 52 p-value < 0.001) and mortality (OR 564, p value < 0.001).ConclusionMany patients with CHD have benefited from the cardiac catheterization program at UHI with high optimal procedure outcome results. Patients with advanced heart failure at the time of cardiac catheterization have less favorable outcomes emphasizing the need for early detection and early intervention.

Impact of a Multidisciplinary Service Line and Program for Transcatheter Device Closure of the Neonatal Ductus Arteriosus.

Outline a quality initiative establishing an institutional service line for neonatal transcatheter device closure of the patent ductus arteriosus (TDC-PDA). A retrospective descriptive observational study surrounds programmatic approach to TDC-PDA in premature neonates with process measure spanning education, implementation, referral, and post-procedural care. Metrics tracked pre- and post-program creation with statistical analyses performed. Neonatal TDC-PDA referrals increased exponentially since program inception (n = 13 in year prior; n = 42year 1; n = 74year 2), especially in patients weighing less than 1.3kg (12.5%; 55%; 50%), and were associated with an increased procedural success rate (81%; 95%; 99%). Procedural checklist creation decreased procedural "out of isolette" time (median 93min; 59; 52), and procedural-related complication or clinical sequelae (19%; 12%; 4%). A multidisciplinary service line and program dedicated to neonatal TDC-PDA can result in a significant increase in referrals as well as procedural efficacy and safety for this medically fragile population.

Guideline Updates Needed: Closure Devices to Prevent Recurrent Stroke in Patients With Patent Foramen Ovale.

Guideline Updates Needed: Closure Devices to Prevent Recurrent Stroke in Patients With Patent Foramen Ovale.

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

Compare efficacy and safety of autologous blood clot injection with C-clamp vascular closure device in treatment of iatrogenic pseudoaneurysm after femoral artery puncture.

Iatrogenic femoral artery pseudoaneurysm (FAP) is a complication following femoral artery puncture, with an incidence rate of 0.2%-5.5% post-cardiac catheterization procedures. Management typically involves observation or interventional treatments such as ultrasound-guided compression (UGC) or ultrasound-guided thrombin injections. This study compares the efficacy and safety of ultrasound-guided autologous blood clot injection (UGCI) with C-clamp vascular closure device-assisted UGC in treating FAP. Conducted at a high-volume training and research center, this prospective study enrolled patients with iatrogenic FAP post-femoral artery puncture. Patients were randomized into two treatments: UGC with a C-clamp device or UGCI. Primary endpoints were thrombosis induction within 24 h, average procedure time, and length of hospital stay (LOS). The study included 105 patients with 51 undergoing UGCI and 54 undergoing UGC. UGCI achieved a primary success rate of 96% versus 63% for UGC. The mean procedure duration for UGCI was significantly shorter (22 min) compared with UGC (49 min, p ⩽ 0.0001). LOS was also reduced in the UGCI group (1.5 days) compared to the UGC group (4.5 days). Complication rates were low for both procedures, with one deep vein thrombosis and one infection observed in the UGC group. UGCI demonstrated to be a safe, efficient, and faster alternative for treating iatrogenic FAPs with a higher success rate, reduced LOS, and similar low complication rates compared to UGC. This study suggests that UGCI could be considered a preferred method for the management of FAP post-femoral artery catheterization.

Closure methods for large defects after gastrointestinal endoscopic submucosal dissection.

Nowadays, endoscopic submucosal dissection (ESD) is commonly performed for the removal of large gastrointestinal lesions. Endoscopic mucosal defect closure after ESD is vital to avoid adverse events. In recent years, many innovative instruments have emerged and proved to be beneficial. In this paper, we conducted a thorough literature review and summarized the closure methods for large-size post-ESD mucosal defects over decades. We separated these methods into five categories based on the operational principle: "side closure" method, "ring closure" method, "layered closure" method, "hand suturing closure" method, and "specially designed device closure" method. Side closure with clips assisted by instruments such as threads or loops is applicable for each segment of the gastrointestinal tract to prevent postoperative bleeding. If the defect tension is too large to close with the traditional side closure methods, zigzag closure and ring closure could be applied to gather the bilateral defect edges together and achieve continuous closure. In the stomach and rectum with a high risk of submucosal dead space between the submucosa and muscular layers, side closure methods with muscle layer grasping clip or layered closure methods could enable the involvement of the deep submucosa and muscle layers. The ring closure method and specially designed devices including over-the-scope clip, Overstitch, and X-tack could resolve perforation effectively. Individual closure method requires endoscope reinsertion or sophisticated operation, which may be limited by the deep location and the narrow lumen, respectively. Although specially designed devices are expected to offer promising prospectives, the cost-effectiveness remains to be a problem.

Incidence and predictors of vascular complications following transcatheter aortic valve implantation: A comparison of the MANTA and suture-based vascular closure devices.

Vascular complications post-transcatheter aortic valve implantation (TAVI) are common. Recent data regarding predictors of vascular complications are limited, particularly comparing newer plug-based devices versus traditional suture-based vascular closure devices (VCD). The primary objective was to identify characteristics that predict a higher risk of vascular complications in TAVI patients, as judged by the VARC-3 criteria, specifically comparing risk factors between suture-based vs MANTA device closure. Retrospective analysis of patients who underwent TAVI between December 2019 and September 2023 was performed. Logistic regression and propensity score matching was performed to ascertain risk factors for vascular complications post-TAVI. Of the 1763 patients, there were 106 vascular complications (6%). There was a nonsignificant increased complication rate in MANTA vs suture-based device closure (8.3% vs 5.3%, p = 0.064). Among these, the most common complications were VCD failure (23%), pseudoaneurysm (20%) and arterial dissection (19%). Obesity (p = 0.021), anemia (p = 0.039) and MANTA device use (p = 0.027) were predictors of vascular complications. Within the MANTA cohort, novel oral anticoagulant (NOAC) use was predictive of vascular complications (p = 0.002). Among suture-based devices, obesity (p = 0.037) and anaemia (p = 0.017) were significant predictors. A propensity matched analysis derived 90 pairs of patients matched for age, gender, diabetes, peripheral arterial disease, NOAC use, anemia and obesity, identifying an average treatment effect of 0.039 (p = 0.04) when MANTA device closure was performed. Vascular complications in TAVI remain common. Identifying predictors such as MANTA device closure, obesity, anemia, and baseline NOAC use will allow for improved risk stratification and appropriate VCD selection in patients undergoing TAVI.

Early and Mid-Term Follow-up Results of Device Closure of Secundum Atrial Septal Defects Using Transesophageal Echocardiogram Guidance: A Comparison of Percutaneous Versus Peratrial Approaches

Background: Percutaneous closure of secundum atrial septal defects (ASDs) under only transesophageal echocardiogram (TEE) guidance is less invasive and avoids exposure to radiation, but the treatment of choice is controversial. Methods: One hundred and forty-four patients with a secundum ASD were included in this study. The patients received percutaneous device closure (PCDC/TEE) (n = 74) or peratrial device closure (PDC/TEE) (n = 70). A double-disk ASD occluder was used in both groups. The treatment was performed under only TEE guidance in both groups. Physical exams, electrocardiography, and echocardiography were performed immediately after device release, and at discharge, 3, 6, 12 months, and at yearly intervals after the procedure. Results: In ASD with a maximum diameter less than 20 mm, the successful closure rate was 100% for all PCDC/TEE and PDC/TEE. When the ASD diameter was between 20 mm and 25 mm, the success rate was 84% for PCDC/TEE and 100% for PDC/TEE. The average intracardiac manipulation time was 19.4 ± 6.4 minutes for PCDC/TEE and 5.7 ± 7.0 minutes for PDC/TEE (p &lt; 0.001). The average procedure time was 23.1 ± 6.8 minutes for PCDC/TEE and 51.1 ± 8.2 minutes for PDC/TEE (p &lt; 0.001). The postoperative hospital stay was 3 ± 1 days for PCDC/TEE and 5 ± 1 days for PDC/TEE (p &lt; 0.001). For the mean follow-up of 520 ± 256 days, there no cardiac deaths or significant residual shunts were documented in either group. Conclusions: In patients with an ASD less than 25 mm, PCDC/TEE is a safe and effective method of ASD closure. Additionally, PCDC/TEE is less traumatic, provides better cosmetic results, and decreases hospital stays. However, when the ASD diameter is greater than 20 mm and the aortic rim of ASD is less than 3 mm, the peratrial approach may be a better choice.

Perioperative Assessment and Clinical Outcomes of Percutaneous Atrial Septal Defect Closure with Three-Dimensional Transesophageal Echocardiography.

To close the atrial septal defect (ASD) with the transcatheter method, correctly defining the defect and selecting the appropriate closure device size are the most critical steps for the procedure's success. Although ASD can be successfully closed under the guidance of three-dimensional (3D) transesophageal echocardiography (TEE) and two-dimensional (2D) TEE, measurement comparisons between different types of defects are still needed. Our study was designed retrospectively. Sixty-one patients who underwent transcatheter ASD closure with 2D TEE and 3D TEE between 2020 and 2024 were included. The patients were divided into three groups according to the defect shape: circular, oval, and complex; and the measurement results, perioperative process, and clinical outcomes were compared in each group. The average age of the patients was 35.05 ± 13.87 years, and 41 (67.2%) were women. The average follow-up period of the patients was 15.3 ± 9.18 months. No statistical significance was observed in the comparison of measurements obtained with 3D TEE and 2D TEE in the circular and oval defect groups. The differences between the minimum defect diameters of complex defects measured by 2D TEE and 3D TEE (p: 0.037), IVC rims (p < 0.001), aortic rims (p: 0.012), and the differences between implanted device dimensions and the maximum defect diameters measured by both methods were compared; statistical significance was observed (p: 0.025). In circular and non-complex oval defects, it has been observed that the size of the closure device selected with 2D TEE or 3D TEE is optimal, and the procedure is practical and feasible. While the closure of complex ASDs with 3D TEE provides reliable and optimal results, using only 2D TEE in complex ASDs may lead to selecting a smaller-sized device.

A Novel Suture-Based Vascular Closure Device to Achieve Hemostasis after Venous or Arterial Access While Leaving Nothing behind: A Review of the Technological Assessment and Early Clinical Outcomes.

Vascular hemostasis after venous and arterial access in cardiovascular procedures remains a challenge. As sheath size gets larger for structural heart and vascular procedures, no dedicated closure devices exist that can overcome all the challenges of achieving vascular hemostasis, in particular on the venous side. Efficiently and reliably ensuring hemostasis at the access point is crucial for enhancing the safety of a procedure. Historically, hemostasis relied on manually compressing venous access sites. However, the shift towards larger sheaths and the more frequent use of continuous anticoagulation has strained this approach. Achieving hemostasis solely through compression in these scenarios demands heightened vigilance and prolonged application, resulting in increased patient discomfort and extended immobility. Consequently, manual compression may consume more time for healthcare providers and contribute to bed occupancy in hospitals. This review article summarizes the development of the SiteSeal® Vascular Closure Device, a novel leave-nothing-behind approach to achieve hemostasis. The introduction of this technology has provided clinicians with a safer and more effective way to achieve immediate hemostasis, facilitate early ambulation, and enable earlier discharges with fewer access site complications compared with traditional manual compression.

Feasibility, safety, and efficacy of a novel external compression vascular closure device: The LockeT® study.

Hemostasis following large-bore femoral vein access remains a challenge. Manual compression has been the standard of care but requires bedside staff, prolonged bed rest, and longer length of stay. The LockeT is an external compression device that attempts to address these issues while achieving venous hemostasis. We evaluate postprocedural hemostasis and vascular closure outcomes after using LockeT following cardiac electrophysiologic procedures. We performed a single-center, observational study of patients who underwent vascular closure for electrophysiology procedures using LockeT. Postprocedural outcomes were subsequently analyzed. We studied 102 patients (N) for whom LockeT was used to close 182 separate vascular access sites (n). Common procedures were atrial fibrillation ablation (56.9%, N = 58) and left atrial appendage occlusion (28.4%, N = 29). Most often, 8-Fr [48.3% (n = 126)], 11-Fr [27.2% (n = 71)], and 8.5-Fr [16.9% (n = 44)] sheaths were used, with an average procedure time of 82.1 ± 29.4 min. Hemostasis was achieved in 97.8% (n = 187) of all LockeT cases. Time to ambulation and discharge were 3.93 ± 1.10 hand 8.1 ± 4.4 h, respectively. No major complications were noted. Postprocedurally, 52% (N = 53) of patients were discharged on the same day. There were no differences in hemostasis (p = .859) or ambulation times (p = .202) between procedure types. The LockeT can effectively close venous access sites with no major complications.