3,055 results on '"Septal occluder device"'
Search Results
2. Percutaneous Transcatheter Closure of Post Myocardial Infarct Ventricular Septal Rupture After Surgical Patch Dehiscence.
- Author
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Varma P, Ferrari C, Gennari M, and De Marco F
- Subjects
- Humans, Treatment Outcome, Male, Intra-Aortic Balloon Pumping, Septal Occluder Device, Surgical Wound Dehiscence etiology, Surgical Wound Dehiscence diagnostic imaging, Aged, Myocardial Infarction etiology, Myocardial Infarction diagnostic imaging, Myocardial Infarction therapy, Cardiac Surgical Procedures adverse effects, Ventricular Septal Rupture etiology, Ventricular Septal Rupture diagnostic imaging, Ventricular Septal Rupture surgery, Ventricular Septal Rupture therapy, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects
- Abstract
Post myocardial infarction ventricular septal rupture (MI-VSR) is a dreaded complication, closure of which is extremely challenging. We here describe a case which was surgically closed after 10 days but had a failure needing continuous intra-aortic balloon pump (IABP) support and was subsequently closed percutaneously with a Post MI-VSR device., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)
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- 2025
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3. Atrial septal defect closure via a partial lower ministernotomy.
- Author
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Konstantinov IE, Bocchetta N, and Fricke TA
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- Humans, Minimally Invasive Surgical Procedures methods, Female, Cardiac Surgical Procedures methods, Septal Occluder Device, Treatment Outcome, Male, Adult, Heart Septal Defects, Atrial surgery, Sternotomy methods
- Abstract
Patients with secundum atrial septal defects preferentially undergo device closure; however, this procedure is not always feasible. Instead, patients can safely undergo surgical closure. At a time when minimally invasive surgery can now be utilized with improved cosmetic results and the same excellent outcomes as a conventional sternotomy for an atrial septal defect closure, we propose the partial lower ministernotomy as the new standard for surgical atrial septal defect closure. We present a surgical case demonstrating this technique., (© The Author 2025. Published by MMCTS on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)
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- 2025
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4. Enhanced Endothelialization Using Resveratrol-Loaded Polylactic Acid-Coated Left Atrial Appendage Occluders in a Canine Model.
- Author
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Hu L, Zhang K, Zhang H, Dong X, Ding L, Qi Y, and Tang M
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- Animals, Dogs, Materials Testing, Particle Size, Male, Coated Materials, Biocompatible chemistry, Coated Materials, Biocompatible pharmacology, Septal Occluder Device, Atrial Fibrillation drug therapy, Resveratrol pharmacology, Resveratrol chemistry, Resveratrol administration & dosage, Atrial Appendage diagnostic imaging, Polyesters chemistry
- Abstract
Left atrial appendage occlusion (LAAO) is a well-established alternative to anticoagulation therapy for patients with atrial fibrillation who have a high bleeding risk. After occluder implantation, anticoagulation therapy is still required for at least 45 days until complete LAAO is achieved by neoendocardial coverage of the device. We applied a polylactic acid-resveratrol coating to the LAAO membrane to enhance endothelialization with the goal of shortening the anticoagulation therapy duration. Eighteen dogs were randomly divided into the experimental group (coated occluders) or the control group (noncoated occluders). The dogs were sacrificed in cohorts at days 14, 28, and 90 for anatomical and pathological examination to evaluate endothelialization and thrombus formation. Transesophageal echocardiography (TEE) was performed before sacrifice to evaluate device-related adverse events. According to the anatomical and pathological examinations, all except one LAAO cover exhibited larger or thicker tissue or neoendocardial coverage in the experimental group compared with the control group at the same sacrifice time points. All connection hubs were densely covered by endothelial cells at 90 days and completely covered at 28 days in the experimental group, while all connection hubs were thinly covered at 90 days and two connection hubs were exposed at 28 days in the control group. Pathological examination revealed no thrombus formation in the experimental group, while a small amount of thrombus was observed in one dog at 90 days and in two dogs at 28 days in the control group. Finally, TEE showed no peri-device leakage (PDL) in the experimental group, whereas a small amount of PDL was detected in one dog (3.2 mm) at 28 days and in one dog (3.7 mm) at 14 days in the control group. The resveratrol-loaded polylactic acid-covered LAAO device enhanced endothelialization and reduced thrombus formation and PDL. This effect could possibly reduce the anticoagulation therapy duration.
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- 2025
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5. Surgery for chronic pyothorax after failed amplatzer closure of bronchopleural fistula.
- Author
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Vincent Y, Lenzini A, Hanna A, Leymarie N, Le Picault B, and Fadel E
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- Humans, Adult, Male, Chronic Disease, Treatment Failure, Thoracostomy methods, Bronchial Fistula surgery, Bronchial Fistula etiology, Pleural Diseases surgery, Pleural Diseases etiology, Pneumonectomy adverse effects, Empyema, Pleural surgery, Septal Occluder Device
- Abstract
Background: Post-pneumonectomy bronchopleural fistula (BPF) is a life-threatening event whose treatment is not standardized., Case Presentation: We report the management of a 28-year-old patient with a 3-year history of BPF complicating right pneumonectomy for congenital emphysema. Despite closure by an Amplatzer device, the patient had chronic pyothorax and severely deteriorated general health and quality of life. An attempt at Amplatzer device removal through an open window thoracostomy failed. A median sternotomy was performed, the carina was resected, and the left main bronchus was anastomosed to the trachea. The thoracostomy was closed using fasciocutaneous pedicled flaps. At 9 months, the patient was doing well., Conclusion: The utilisation of an Amplatzer device to close a broncho-pleural fistula can have adverse effects and potentially result in fatal sepsis in those cases where it is unsuccessful. The endoscopic treatment of BPF should be reserved for expert centers, considering the location, size, and stability of the fistula when choosing the treatment strategy. The surgical management of failed Amplatzer closure may be extremely complex, requiring a highly experienced team., Competing Interests: Declarations. Ethics approval and consent to participate: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. The study was conducted in accordance with the Declaration of Helsinki (as revised in 2013). Because this is an observational work, institutional review board approval was not necessary. Written patient consent for this retrospective analysis was obtained to include their information in this publication. Consent for publication: Written patient consent for this retrospective analysis was obtained to include their information in this publication. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)
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- 2025
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6. Secundum atrial septal defect closure in adults in the UK.
- Author
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English KM, Espuny-Pujol F, Franklin RC, Crowe S, and Pagel C
- Subjects
- Humans, Female, Male, Adult, Middle Aged, Retrospective Studies, England epidemiology, Wales epidemiology, Treatment Outcome, Cardiac Surgical Procedures methods, Hospital Mortality trends, Follow-Up Studies, Septal Occluder Device, Survival Rate trends, Risk Factors, Registries, Heart Septal Defects, Atrial surgery, Heart Septal Defects, Atrial epidemiology, Cardiac Catheterization
- Abstract
Aims: To examine determinants of access to treatment, outcomes, and hospital utilization in patients undergoing secundum atrial septal defect (ASD) closure in adulthood in England and Wales., Methods and Results: Large retrospective cohort study of all adult patients undergoing secundum ASD closures in England and Wales between 2000/01 and 2016/17. Data were from population-based official data sets covering congenital heart disease procedures, hospital episodes, and death registries. Out of 6541 index closures, 79.4% were transcatheter [median age 47 years, interquartile range (IQR) 34-61] and 20.6% were surgical (40 years, 28-52). The study cohort was predominantly female (66%), with socioethnic profile similar to the general population. Mortality in hospital was 0.2% and at 1 year 1.0% [95% confidence interval (CI) 0.8-1.2%]. Risk of death was lower for transcatheter repairs, adjusting for age, sex, year of procedure, comorbidities, and cardiac risk factors [in-hospital adjusted odds ratio 0.09, 95% CI 0.02-0.46; 1-year adjusted hazard ratio 0.5, 95% CI 0.3-0.9]. There was excess mortality 1 year after ASD closure compared with matched population data. Median (IQR) peri-procedural length of stay was 1.8 (1.4-2.5) and 7.3 (6.2-9.2) days for transcatheter and surgical closures, respectively. Hospital resource use for cardiac reasons started the year before repair (median two inpatient and two outpatient-only days) and decreased post-repair (zero inpatient and one outpatient days during the first 2 years)., Conclusion: This national study confirms that ASD closure in adults, by surgical or transcatheter methods, is provided independently of ethnic or socioeconomic differences, it is low (but not no) risk, and appears to reduce future cardiac hospitalization even in older ages., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)
- Published
- 2025
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7. Percutaneous Patent Ductus Arteriosus Closure in a Conjoined Twin: Case Report.
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Calamita PC, Lombardi JG, Barreto MRP, Barbosa OC, Prudente ML, Hamu ZC, and Gardenghi G
- Subjects
- Humans, Infant, Newborn, Treatment Outcome, Cardiac Catheterization methods, Female, Male, Ductus Arteriosus, Patent surgery, Ductus Arteriosus, Patent diagnostic imaging, Twins, Conjoined surgery, Septal Occluder Device
- Abstract
Conjoined twin patients with patent ductus arteriosus and hemodynamic repercussions have a worse prognosis. In the present case report, we demonstrate the first successful percutaneous closure of the ductus arteriosus with the Piccolo© device (Abbot Structural Heart, Plymouth, MN, USA) in this type of clinical situation.
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- 2025
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8. WATCHMAN versus LACbes® device for percutaneous left atrial appendage closure: a single-center, propensity-matched study.
- Author
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Zhang S, Xiong S, Zhang S, Chen K, Wang H, Li K, Xu X, Zhao X, Zhu N, Huang X, Qin Y, Guo Z, and Bai Y
- Subjects
- Humans, Female, Male, Aged, Treatment Outcome, Time Factors, Retrospective Studies, Risk Factors, Aged, 80 and over, Risk Assessment, Ischemic Stroke prevention & control, Ischemic Stroke etiology, Middle Aged, Septal Occluder Device, Stroke prevention & control, Stroke etiology, Left Atrial Appendage Closure, Atrial Appendage physiopathology, Atrial Appendage surgery, Atrial Fibrillation diagnosis, Atrial Fibrillation physiopathology, Atrial Fibrillation therapy, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Propensity Score, Prosthesis Design
- Abstract
Background: Different left atrial appendage closure (LAAC) devices have been introduced into the clinical setting. A new dual-seal mechanism LACbes® occluder with isogenous barbs for LAAC has been designed to facilitate easier delivery and improve safety. The purpose of this study is to compare the clinical outcomes of the WATCHMAN with those of the LACbes® device for LAAC., Methods: Consecutive patients with atrial fibrillation (AF) who had undergone LAAC performed using a WATCHMAN or LACbes® device from June 2016 to February 2022 were included. The primary efficacy endpoint included ischemic stroke, cardiovascular/unexplained death and device-related thrombus, while the primary safety endpoint included major peri-procedural complications and major bleeding events during clinical follow-ups. 1:1 propensity score matching (PSM) was performed., Results: After PSM, 184 patients were included in each group. The mean CHA
2 DS2 -VASc score was 3.1 ± 1.5 (LACbes®) vs. 3.1 ± 1.4 (WATCHMAN), and the HAS-BLED score was 2.7 ± 1.1 vs. 2.7 ± 1.0. At a mean follow-up of 2.5 ± 1.5 vs. 2.4 ± 0.9 years, the defined three endpoints were comparable between the two groups. The occurrence of all-cause stroke was lower in 5/452 (1.8%) with LACbes® vs. 16/433 (3.7%) with WATCHMAN occluders (HR, 0.40, 95% confidence interval (CI), 0.18-0.89, P = 0.023), and the incidence of any bleeding was higher in the WATCHMAN group (41/433, 9.5% vs. 8/452, 1.8%; HR, 0.19, 95% CI, 0.11-0.33)., Conclusion: The LACbes® occluder exhibited comparable safety and efficacy of stroke prevention for AF when compared with the WATCHMAN device., Competing Interests: Declarations. Ethics approval and consent to participate: This analysis was approved by the institutional review board (Changhai Hospital) and adheres to the relevant guidelines of the Declaration of Helsinki. We also received informed and signed consent from the included participants. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)- Published
- 2025
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9. Evaluation of endothelialization of an occluder device with cardiac computed tomography and assessment of the pathological validation.
- Author
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Liu A, Duan X, Wang K, Fan H, Li L, and Yan C
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- Humans, Female, Male, Middle Aged, Retrospective Studies, Adult, Septal Occluder Device, Coronary Angiography, Contrast Media, Tomography, X-Ray Computed methods, Computed Tomography Angiography methods
- Abstract
Background: Assessing the endothelialization of occlusive devices noninvasively remains a challenge. Cardiac computed tomography angiography (CTA) can be employed to evaluate device endothelialization based on contrast uptake within the occluder., Objective: This study examined device endothelialization using cardiac CTA and investigated the pathological associations., Methods: From January 2010 to May 2022, we retrospectively analyzed 25 patients (age: 50.00 [17.00, 52.00] years; 12 Female) who underwent surgical device removal within 1 month after cardiac CTA examination (implantation period: 29.00[0.50, 108.00] months). The contrast uptake within the occluder was determined using cardiac CTA. The relationship between contrast uptake within the occluder and the endothelialization status with pathology was analyzed., Results: Contrast uptake within the occluder was identified in 76.00% of patients. Pathological examination confirmed incomplete coverage of fibrotic tissue and superposed neoendothelium on the surface of all devices exhibiting contrast uptake. This included no coverage in 47.37% of patients and partial coverage in the remaining cases. On the surface of all devices without contrast uptake, a complete range of fibrotic tissue was observed, with an incomplete range of superposed neoendothelium in 66.67% of patients. On the surface of devices with an implantation period > 6 months, 71.43% of patients had incomplete coverage of fibrotic tissue and superposed neoendothelium on the left disc, 42.86% of patients occurred the same on the right disc., Conclusions: Contrast uptake within the occluder indicated incomplete endothelialization, as confirmed by pathological validation. Late endothelialization of the device occurs frequently, and further research is required to investigate related mechanisms., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2025 Liu et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2025
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10. Delayed occluder displacement following patent ductus arteriosus closure successfully managed with thoracic endovascular aortic repair: a case report and literature review.
- Author
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Pan D, Yu A, Li C, Chen L, Ni C, and Zhao H
- Subjects
- Humans, Female, Young Adult, Cardiac Catheterization methods, Endovascular Aneurysm Repair, Ductus Arteriosus, Patent surgery, Septal Occluder Device, Endovascular Procedures methods, Aorta, Thoracic surgery
- Abstract
Interventional occlusion of Patent ductus arteriosus (PDA) is generally efficacious and complications such as delayed occluder displacement are infrequent. Herein, we report a case of 24-year-old female with a history of unsuccessful PDA closures, who subsequently experienced delayed occluder displacement into the left main pulmonary artery. Despite numerous unsuccessful catheter-based interventions, thoracic endovascular aortic repair (TEVAR) was successfully executed. This procedure effectively resolved the PDA without any postprocedural complications. This case highlights the efficacy and safety of TEVAR as a viable alternative for managing complex PDA cases involving occluder displacement., Competing Interests: Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: none declared. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)
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- 2025
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11. Managing Congenital Heart Defects in Elderly: The Platypnea-Orthodeoxia Syndrome in Underestimated Patent Foramen Ovale.
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Verdoia M, Viola O, Marenna B, Marrara F, Bertola B, Brancati MF, Gioscia R, Soldà PL, and Rognoni A
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- Humans, Syndrome, Female, Aged, Treatment Outcome, Septal Occluder Device, Posture, Male, Cardiac Catheterization, Platypnea Orthodeoxia Syndrome, Foramen Ovale, Patent complications, Foramen Ovale, Patent diagnostic imaging, Dyspnea etiology, Hypoxia etiology, Hypoxia complications
- Abstract
The platypnea-orthodeoxia syndrome (POS) is a rare and often suboptimally managed condition with a complex diagnostic workup, conversely displaying an easy treatment and a good recovery of symptoms, especially if consequent to an intracardiac shunt. However, its identification is challenging, due to the several clinical manifestations, the multiple etiologies, representing often the delayed presentation of a congenital heart disease. We present a case report and review of available literature on patients with the POS secondary to a patent foramen ovale successfully treated with its closure., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2025
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12. Left atrial appendage occlusion devices vs direct oral anticoagulants for atrial fibrillation: An updated systematic review and meta-analysis.
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Fernandes JM, Pinheiro RPS, Serpa F, de Andrade NM, Pereira V, Sbardelotto ÂEE, and Gomes WF
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- Humans, Administration, Oral, Stroke prevention & control, Stroke etiology, Stroke epidemiology, Thromboembolism prevention & control, Thromboembolism etiology, Thromboembolism epidemiology, Hemorrhage chemically induced, Hemorrhage epidemiology, Septal Occluder Device, Atrial Fibrillation complications, Atrial Fibrillation drug therapy, Atrial Appendage surgery, Anticoagulants therapeutic use, Anticoagulants administration & dosage
- Abstract
Background: Direct Oral Anticoagulants (DOACs) are the first line anticoagulation for patients with non-valvular atrial fibrillation (NVAF). Percutaneous Left Atrial Appendage Occlusion (LAAO) has emerged as a new therapy and its safety and effectiveness compared with DOACs are still controversial., Methods: A systematic review of randomized controlled trials and observational studies was conducted, focusing on patients with NVAF. Outcomes analyzed included: (1) all-cause mortality; (2) cardiovascular (CV) mortality; (3) thromboembolic events; (4) stroke or transient ischemic attack (TIA); (5) bleeding events; and a (6) composite of death, hemorrhagic, and thromboembolic events. We performed a subgroup analysis of major bleeding according to different definitions: (1) Bleeding Academic Research Consortium (BARC); (2) International Society on Thrombosis and Haemostasis (ISTH); and (3) other definitions., Results: Ten studies involving 18,507 patients were included, with 42.35 % undergoing LAAO. In pooled analysis, LAAO was associated with lower rates of all-cause mortality (HR 0.63; 95 % CI 0.50-0.80), cardiovascular mortality (HR 0.56; 95 % CI 0.45-0.70), and of the composite outcome (HR 0.73; 95 % CI 0.58-0.92). A trend towards lower stroke/TIA events was observed but not statistically significant. Overall bleeding events did not significantly differ between groups; using the ISTH definition, LAAO showed significantly lower incidence of bleeding events (HR 0.63; 95 % CI 0.43-0.91). No difference was found in thromboembolic events., Conclusion: LAAO was associated with a significantly lower all-cause mortality and cardiovascular mortality, as well as the composite of death, hemorrhagic or thromboembolic events, as compared with DOACs., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2025
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13. Rescue Transcatheter Native Aortic Valve Closure to Treat Severe Aortic Regurgitation in a Patient With Single Ventricular Physiology and Decompensated Heart Failure.
- Author
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Kang SL, Deri A, Suliman M, and Bentham JR
- Subjects
- Humans, Treatment Outcome, Hypoplastic Left Heart Syndrome surgery, Hypoplastic Left Heart Syndrome physiopathology, Male, Recovery of Function, Prosthesis Design, Ventricular Function, Right, Ventricular Dysfunction, Right physiopathology, Ventricular Dysfunction, Right etiology, Ventricular Dysfunction, Right therapy, Ventricular Dysfunction, Right diagnostic imaging, Echocardiography, Doppler, Color, Hemodynamics, Aortic Valve Insufficiency physiopathology, Aortic Valve Insufficiency surgery, Aortic Valve Insufficiency diagnostic imaging, Aortic Valve Insufficiency etiology, Cardiac Catheterization instrumentation, Heart Failure physiopathology, Heart Failure therapy, Heart Failure diagnosis, Heart Failure etiology, Severity of Illness Index, Aortic Valve physiopathology, Aortic Valve surgery, Aortic Valve diagnostic imaging, Septal Occluder Device
- Abstract
Semilunar valve regurgitation in single ventricular physiology is rare but portends a poor prognosis. Medical therapy is often ineffective particularly in the context of structural valve abnormality, and surgical valve repair or replacement can be associated with poor outcomes. We report an innovative use of a highly occlusive and conformable Gore Septal Occluder for transcatheter treatment of severe native aortic regurgitation in a symptomatic patient with hypoplastic left heart syndrome and severe systemic right ventricular dysfunction, resulting in safe and complete occlusion of the aortic regurgitant orifice and clinical benefit., (© 2024 Wiley Periodicals LLC.)
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- 2025
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14. Device endothelialization and morphology assessments at 1 year using computed tomography angiography: comparison of traditional with novel puncturable atrial septal defect occluders.
- Author
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Fang Y, Hou K, Lin D, Zhou D, Pan W, and Ge J
- Subjects
- Humans, Female, Male, Time Factors, Treatment Outcome, Adult, Young Adult, China, Adolescent, Middle Aged, Septal Occluder Device, Heart Septal Defects, Atrial diagnostic imaging, Heart Septal Defects, Atrial therapy, Computed Tomography Angiography, Prosthesis Design, Predictive Value of Tests, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects
- Abstract
Background: Complete endothelialization is often not achieved within 6 months after implantation of an atrial septal defect (ASD) occluder, which may lead to microthrombus or thrombosis. This study aimed to assess the endothelialization and morphology of a novel puncturable ASD occluder (ReAces) compared with traditional occluders 1 year post-implantation using computed tomography angiography (CTA)., Methods: Fifteen patients from each group in a randomized controlled trial comparing ReAces with traditional occluders were included at the 1-year follow-up at Zhongshan Hospital, Fudan University. Baseline characteristics and procedural data were recorded. CTA was performed to assess the device morphology and degree of endothelialization. Independent samples t-test and Fisher's exact test were primarily used to compare the above data., Results: Each patient received a single device and had no residual shunts. There were no differences in defect size (15.3 ± 4.0 mm vs. 15.3 ± 4.7 mm, p = 1.00) or occluder size (21.2 ± 4.4 mm vs. 21.5 ± 5.3 mm, p = 0.882) between the two groups. At the 1-year follow-up CTA, the central region thickness (4.2 mm ± 0.9 mm vs. 7.8 mm ± 2.4 mm, p < 0.0001), left atrial device-occupied volume (1863.3 mm
2 ± 404.4 mm2 vs. 4764.4 mm2 ± 2321.2 mm2 , p < 0.001), and device compression rates (10.1 ± 4.8% vs. 17.5 ± 5.6%, p = 0.001) were significantly lower in the experimental group. All occluders in the experimental group achieved complete endothelialization, whereas in the control group, 7 patients did not (100% vs. 53.3%, p = 0.006)., Conclusions: Compared with traditional occluders, ReAces presented a significantly greater complete endothelialization rate, lower central region thickness, lower left atrial device-occupied volume, and lower device compression rates at 1 year post-implantation by CTA., Trial Registration: Trial registry: ClinicalTrials.gov. Unique identifying number: NCT05371366. Date of registration: 04/05/2022., Competing Interests: Declarations. Ethics approval and consent to participate: This study was approved by the Ethics Committee of Zhongshan Hospital, Fudan University (No. B2021-339R) and adhered to the principles of the Declaration of Helsinki. Written informed consent was obtained from all the patients or their relatives before any study procedures were initiated. Consent for publication: Not applicable. Competing interests: This study was supported by Hanyu Medical Technology. W.P and D.Z. were consultants of Hanyu Medical Technology. All the other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (© 2024. The Author(s).)- Published
- 2024
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15. [Application of modified percutaneous closure in the treatment of ventricular septal rupture after acute myocardial infarction].
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Sun ZR, Han Y, Liu YH, Jiang JC, Han Y, Ben LL, Zhang J, and Gao CY
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- Humans, Male, Retrospective Studies, Female, Aged, Treatment Outcome, Septal Occluder Device, Cardiac Tamponade etiology, Cardiac Tamponade surgery, Cardiac Tamponade therapy, Cardiac Catheterization methods, Ventricular Fibrillation, Operative Time, Ventricular Septal Rupture etiology, Ventricular Septal Rupture surgery, Myocardial Infarction complications, Myocardial Infarction surgery
- Abstract
Objective: To investigate the effect of modified percutaneous closure in the treatment of ventricular septal rupture. Methods: This study is a retrospective cohort study. Forty-four patients with ventricular septal rupture who underwent percutaneous closure at the Fuwai Central China Cardiovascular Hospital from December 2017 to October 2023 were included. According to the closure method, patients were divided into the modified group (11 cases) and the traditional group (33 cases). Surgical success was defined as successful placement of the occluder. The operation time, X-ray intake, sheath bending rate, incidence of ventricular fibrillation and pericardial tamponade, and postoperative residual shunt were compared between the two groups. Results: The age of the patients was (75.0±5.7) years, with 20 (45%) males. There were 3 cases of operation failure in the traditional group, while all patients in the modified group were successfully occluded. The procedure time in the modified group was shorter than that in the traditional group (40 (35, 45) min vs. 60 (50, 65)min, P <0.001); X-ray dose intake was lower ((442.43±73.26)mGy vs. (784.45±247.78)mGy, P <0.001). There was no occurrence of sheath bending in the modified group, while the incidence of sheath bending in the traditional surgery group was 46% (15/33), and the difference was statistically significant ( P =0.017). Intraoperative ventricular fibrillation and pericardial tamponade occurred in 7 cases (21%) and 2 cases (6%) in the traditional group respectively, while none occurred in the modified group, but the differences between the groups were not statistically significant (both P >0.05). There was no significant difference in residual shunt between the two groups (3.6 (2.5, 4.3) mm vs. 4.0 (3.5, 4.5) mm, P =0.506). Conclusion: The procedure of modified ventricular septal rupture closure is more simplified, with a lower incidence ofventricular fibrillation and pericardial tamponade.
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- 2024
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16. Complete percutaneous repair of Tetralogy of Fallot in adult: a case report.
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Das A, Lakhani G, Kar D, Mishra L, Mollah NN, and Tewary S
- Subjects
- Humans, Male, Adolescent, Septal Occluder Device, Cardiac Surgical Procedures methods, Balloon Valvuloplasty methods, Tetralogy of Fallot surgery, Cardiac Catheterization methods
- Abstract
Tetralogy of Fallot (TOF) is the most common congenital cyanotic heart disease and is characterized by an antero-superior deviation of the infundibular septum with a consequent large malaligned ventricular septal defect (VSD) and a pulmonary and sub-pulmonary (infundibular) stenosis. Surgical repair has been the cornerstone of treatment that is electively performed early in their lives between 3 and 6 months of age. With advancements in transcatheter interventions, the complete percutaneous repair of TOF, a complex disease with multiple treatable lesions, is becoming a conceivable possibility. Here, we report the case of total transcatheter correction of an 18-year-old boy with TOF, performed in two stages. The first stage involved addressing the right ventricular outflow tract (RVOT) obstruction with balloon pulmonary valvuloplasty (BPV) and occluding the conal artery using absolute alcohol and a coil. In the second stage, the VSD was closed with a Multifunctional Occluder (MFO) Konar device 14 -12 mm (Lifetech, China). While surgical treatment remains the gold standard for total correction of TOF, the transcatheter approach can also be considered for selected group of patients who are surgically turned-down., Competing Interests: Declarations. Disclosure: We have nothing to disclose. Competing interests: The authors declare no competing interests., (© 2024. The Author(s).)
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- 2024
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17. A Challenging Interventional Procedure: Transcatheter Closure of Tubular Patent Ductus Arteriosus in Patients with Pulmonary Hypertension.
- Author
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Yucel IK, Epcacan S, Bulut MO, Demir IH, Surucu M, Yilmaz EH, Kardas M, Kanlioglu P, and Celebi A
- Subjects
- Humans, Female, Male, Infant, Child, Preschool, Retrospective Studies, Treatment Outcome, Child, Ductus Arteriosus, Patent surgery, Cardiac Catheterization methods, Septal Occluder Device, Hypertension, Pulmonary surgery
- Abstract
Transcatheter closure of the tubular ducts remains the most challenging procedure, with higher complication rates than other types. This study evaluates the characteristics of transcatheter closure of tubular ducts with pulmonary hypertension. 73 patients with tubular ducts who underwent cardiac catheterization for transcatheter PDA closure were analyzed. The mean age and weight were 1.93 ± 2.68 years and 8.83 ± 6.14 kg, respectively. Transcatheter closure was attempted in 72 patients. Four cases (5.5%) were referred to surgery, while the procedure was completed in the remaining (94.5%). Amplatzer duct occluder (ADO) I or Cardiofix duct occluder (CDO) was the most commonly used devices. However, the use of Amplatzer vascular plug (AVP) II raised in recent years. The most common concern was aortic protrusion/stenosis in ADO I/CDO devices, but most regressed during follow-up. Iatrogenic coarctation of the aorta was observed in two with ADO I/CDO. Embolization of the device to the pulmonary artery was observed in three with CDO, AVP II, and AVP I. Significant left pulmonary artery stenosis requiring stenting developed in one after closure with an MVSDO device. Tubular ducts are highly associated with pulmonary arterial hypertension, and transcatheter closure of them is still challenging despite the developing device armamentarium. Although ADO I or similar devices are widely used, off-label devices are usually needed at increasing rates. The AVP II device is unsuitable for short tubular ducts but seems the best option for long ones., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2024
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18. Kissing-catheter technique in percutaneous transcatheter closure of patent ductus arteriosus: a snare-free approach.
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Zhang C, Chen L, and Gu H
- Subjects
- Humans, Female, Male, Retrospective Studies, Treatment Outcome, Child, Child, Preschool, Adult, Adolescent, Pulmonary Artery surgery, Pulmonary Artery diagnostic imaging, Ductus Arteriosus, Patent surgery, Ductus Arteriosus, Patent therapy, Cardiac Catheterization methods, Septal Occluder Device
- Abstract
Objectives: For percutaneous closure of the patent ductus arteriosus (PDA) with a mushroom-shaped occluder, the establishment of a guidewire rail with the antegrade venous approach may be difficult in some cases. The retrograde technique can be used instead; however, the use of a snare system may bring extra costs and risks. The aim of the study was to report on a new method that fulfills the retrograde technique without the use of a snare system in transcatheter closure of PDA., Methods: From May 2019 to January 2023, we attempted transcatheter closure using the kissing-catheter technique after failure of the conventional antegrade venous approach on 22 consecutive patients with PDA. This technique involves docking the distal ends of the antegrade catheter and retrograde catheter in the main pulmonary artery, and sending an exchange guidewire from one catheter, through the docking junction, and externalized from the proximal end of the other. Then an artery-PDA-vein guidewire loop was established for the delivery of the occluder. The results and operation time of this method were analyzed., Results: Successful establishment of the guidewire rail was achieved in all patients. The average time from attempting to dock the 2 catheters to successfully passing the guidewire was 26 ± 15 seconds. There were no complications during or after the procedures., Conclusions: The snare-free kissing-catheter technique is an efficient and reliable method for transcatheter closure of PDA in cases where the antegrade approach is difficult.
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- 2024
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19. Transcatheter closure of a right pulmonary artery to left atrium fistula using multi-modality image fusion guidance.
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Soszyn N, Gill EA, Zablah JE, and Morgan GJ
- Subjects
- Humans, Female, Middle Aged, Fistula surgery, Fistula diagnostic imaging, Fistula diagnosis, Septal Occluder Device, Multimodal Imaging, Echocardiography, Transesophageal methods, Vascular Fistula surgery, Vascular Fistula diagnostic imaging, Vascular Fistula diagnosis, Echocardiography, Pulmonary Artery abnormalities, Pulmonary Artery diagnostic imaging, Pulmonary Artery surgery, Heart Atria diagnostic imaging, Heart Atria abnormalities, Cardiac Catheterization methods
- Abstract
We present the case of 53-year-old woman with a late diagnosis of an right pulmonary artery-left atrium fistula who underwent transcatheter device closure using multi-modality imaging for pre-procedural planning and procedural guidance.
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- 2024
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20. Incomplete cor triatriatum dexter and percutaneous closure of atrial septal defects, a single-centre experience.
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Martín DG, Sánchez-Rubio Lezcano J, Fuertes Ferre G, Álvarez Roy L, López Ramón M, and Diarte De Miguel JA
- Subjects
- Humans, Middle Aged, Female, Male, Cardiac Catheterization methods, Foramen Ovale, Patent surgery, Foramen Ovale, Patent diagnosis, Foramen Ovale, Patent complications, Foramen Ovale, Patent diagnostic imaging, Echocardiography, Three-Dimensional methods, Treatment Outcome, Fluoroscopy, Cor Triatriatum diagnosis, Cor Triatriatum surgery, Echocardiography, Transesophageal methods, Septal Occluder Device, Heart Septal Defects, Atrial surgery, Heart Septal Defects, Atrial diagnosis
- Abstract
Cor Triatriatum Dexter (CTD) is a rare congenital heart malformation, with an estimated incidence of 0.025%, characterised by a membrane dividing the right atrium (RA) into two chambers. A variant, incomplete CTD (CTDi), occurs when the right membrane extends partially into the interatrial septum without fully dividing the RA. CTDi can be associated with interatrial septal defects, found in 5% of patients with atrial septal defects or a patent foramen ovale (PFO). The study reports three adult patients (46-53 years old) with CTDi and a PFO, all presenting cryptogenic stroke and referred for PFO closure. Two cases underwent percutaneous closure with guidance from fluoroscopy and 2D/3D transesophageal echocardiography (TEE), and the last one utilised intracardiac echocardiography (ICE) for device placement. In patients referred for PFO closure, CTDi is common and can complicate visualisation, prolong procedure times, and reduce success rates. Difficulties in device deployment and the risk of residual shunt or embolisation have been reported. The authors highlight that using oversizing techniques, traction manoeuvres during device deployment, and preoperative planning with advanced imaging (such as ICE or 3D TEE) are crucial for successful percutaneous closure in cases with CTDi and PFO.
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- 2024
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21. Discordance between the European and the United States guideline criteria for atrial septal defect closure in adult patients with pulmonary hypertension and its clinical impact.
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Tangcharoen T, Ngernsritrakul T, Chandavimol M, Kamsorn C, Apakuppakul S, and Yamwong S
- Subjects
- Humans, Female, Male, Retrospective Studies, Middle Aged, United States epidemiology, Adult, Europe epidemiology, Echocardiography methods, Treatment Outcome, Aged, Septal Occluder Device, Heart Septal Defects, Atrial surgery, Heart Septal Defects, Atrial complications, Heart Septal Defects, Atrial diagnosis, Hypertension, Pulmonary diagnosis, Practice Guidelines as Topic, Cardiac Catheterization methods
- Abstract
Background: The criteria for ASD closure in patients with PAH are different between the AHA/ACC and the ESC guidelines. We aimed to study the prevalence of patients with different guideline criteria for ASD closure and its impact on the clinical outcome after closure., Methods and Results: A retrospective cohort study recruiting patients who underwent ASD closure from 2011-2020 was conducted in a single university hospital. Patients were grouped into ASD closure recommended (class I, class IIa, and class IIb) and ASD closure not recommended groups (class III). The primary outcome was the prevalence of patients with discordant criteria and the clinical outcomes and echocardiographic parameters after ASD closure. A total of 17 of 66 ASD patients (25.8 %) were diagnosed with ASD with pulmonary hypertension. Two patients were excluded due to incomplete right heart catheterization data. 13 patients (86.7 %) were classified as ASD-closure recommended group by both guidelines. Two patients, classified as class IIb by ACC/AHA guidelines, were unsuitable for ASD closure by ESC guidelines. After ASD closure, all 15 patients reported functional class improvement and no significant difference in the echocardiography parameters. However, the number of patients with a low probability of PHT was higher in patients with ESC guideline-recommended closure., Conclusions: Most patients (86.7 %) are in concordant classification regarding ASD closure recommendations. The ESC guidelines are more restrictive than the AHA/ACC guidelines, allowing fewer patients for ASD closure. However, the clinical outcomes after ASD closure are not significantly different between these guidelines., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)
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- 2024
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22. Comparison of Embolization Coils and Patent Ductus Arteriosus Occluders for Coronary Artery Fistula Transcatheter Closure: A Single Centre Experience.
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Wei P, Li Y, Xu L, Wan J, Zhang F, Tse G, Chan JSK, Wang S, Ouyang W, Zhang G, Fang F, and Pan X
- Abstract
Background and Objectives: There is no dedicated occlusive device for closing coronary artery fistulas (CAFs), and specific efficacy and safety data of various off-label occlusive devices for CAFs closure are scarce., Methods: Patients undergoing transcatheter closure of CAFs from January 2011 to December 2022 were included in the single-center retrospective study. The study population was divided into 2 groups: coils group (n=35) and patent ductus arteriosus (PDA) occluders group (n=66)., Results: No significant intergroup differences were observed in demographic characteristics except age. The presence of multiple CAF origins (54.3% vs. 4.5%, p<0.001) and multiple draining sites (51.4% vs. 3.0%, p<0.001) were more common in the coils group. In contrast, the presence of aneurysm (72.7% vs. 14.3%, p<0.001), and large fistula (75.8% vs. 37.1%, p<0.001) were more prevalent in the PDA occluders group. The acute procedural success rate of the PDA occluders group was higher compared to that of the coils group (87.9% vs. 62.9%, adjusted odds ratio [OR], 7.20; 95% confidence interval, 1.59-32.64; p=0.01). In addition, no significant intergroup differences were noted in both the recanalization rate (7.8% vs. 20%, p=0.107) and the reintervention rate (3.1% vs. 8.6%, p=0.342)., Conclusions: Transcatheter closure of CAFs using PDA occluders was associated with significantly higher acute procedural success rates compared to coil embolization with comparable late outcomes., Competing Interests: The authors have no financial conflicts of interest., (Copyright © 2025. The Korean Society of Cardiology.)
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- 2024
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23. Device closure via minimally invasive left intercostal incision in children with perimembranous ventricular septal defect.
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Xu F, Zeng X, Xie L, Huang Q, Shen Y, Liao Z, Liao D, and Fan CJ
- Subjects
- Humans, Female, Male, Child, Preschool, Retrospective Studies, Child, Infant, Treatment Outcome, Length of Stay, Septal Occluder Device, Adolescent, Operative Time, Heart Septal Defects, Ventricular surgery, Minimally Invasive Surgical Procedures methods, Thoracotomy methods
- Abstract
When treating perimembranous ventricular septal defect, median sternotomy leads to unsightly scar, right subaxillary thoracotomy requires cardiopulmonary bypass, and transcatheter device closure constrained by vascular condition. Using small left intercostal incision, we employed transthoracic device closure to get around these issues. During this study, right subaxillary thoracotomy was used for surgical repair in 117 patients (Surgical group), whereas small left intercostal incision was used for transthoracic device closure in 131 patients (Device group). Retrospective data collection and analysis were conducted. The success rate was comparable (117/117 vs. 130/131, P = 1.000). The device group experienced notably reduced operating time, mechanical ventilation duration, ICU stay, and postoperative hospital stay (All P < 0.001). Given that the device group's incision was much smaller than the surgical group's (1.1 ± 0.3 vs. 6.8 ± 1.6 cm, P < 0.001), blood transfusion or drainage tube was not needed. The device group observed a lower frequency of complications, with the exception of small residual shunt. It is feasible and safe to perform transthoracic device closure in children with perimembranous ventricular septal defects via small left intercostal incision. It can be a good minimally invasive substitute for surgical closure when utilized properly., (© 2024. The Author(s).)
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- 2024
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24. Fenestrated closure of an atrial septal defect for left ventricular diastolic dysfunction in an early infant with hypertrophic cardiomyopathy.
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Hayashi K, Hasegawa T, and Tanaka T
- Subjects
- Humans, Infant, Male, Diastole, Echocardiography, Septal Occluder Device, Cardiomyopathy, Hypertrophic complications, Cardiomyopathy, Hypertrophic surgery, Heart Septal Defects, Atrial surgery, Heart Septal Defects, Atrial complications, Ventricular Dysfunction, Left etiology, Ventricular Dysfunction, Left physiopathology
- Abstract
Left ventricular diastolic dysfunction is associated with poor prognosis in patients with hypertrophic cardiomyopathy and CHD. We report the case of an infant concomitant with hypertrophic cardiomyopathy, an atrial septal defect, and left ventricular diastolic dysfunction, who was successfully managed with fenestrated closure of the atrial septal defect.
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- 2024
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25. Practical Aspects of Patent Foramen Ovale Closure: Ultrasound and Fluoroscopic Guidance.
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Piayda K, Bertog S, Mbai M, Sharma A, Veulemans V, and Sievert H
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- Humans, Fluoroscopy methods, Septal Occluder Device, Stroke prevention & control, Stroke etiology, Foramen Ovale, Patent surgery, Foramen Ovale, Patent diagnostic imaging, Foramen Ovale, Patent complications, Echocardiography, Transesophageal methods, Cardiac Catheterization methods, Ultrasonography, Interventional methods
- Abstract
Percutaneous PFO closure is a well-established medical procedure to mitigate paradoxic embolism and the future risk of stroke in a well-selected patient clientele. When it comes to procedural guidance during PFO closure, various modalities exist, each with its own advantages and disadvantages. Guidance by transesophageal echocardiography (in combination with fluoroscopy) offers high-resolution 2D/3D imaging, however, it requires the presence of a peri-interventional imager and conscious sedation (or endotracheal intubation). Intracardiac echocardiography and fluoroscopy guidance can be performed by a single operator and omits the need for conscious sedation (or endotracheal intubation)., Competing Interests: Disclosure H. Sievert has received study honoraria to institution, travel expenses and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Adona Medical, Akura Medical, Ancora Heart, Append Medical, Axon, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Cardiac Dimensions, Cardiac Success, Cardimed, Cardionovum, Celonova, Contego, Coramaze, Croivalve, CSL Behring LLC, CVRx, Dinova, Edwards, Endobar, Endologix, Endomatic, Esperion Therapeutics, Inc, Hangzhou Nuomao Medtech, Holistick Medical, Intershunt, Intervene, K2, Laminar, Lifetech, Magenta, Maquet Getinge Group, Metavention, Mitralix, Mokita, Neurotronic, NXT Biomedical, Occlutech, Recor, Renal Guard, Shifamed, Terumo, Trisol, Vascular Dynamics, Vectorious Medtech, Venus, Venock, Vivasure Medical, Vvital Biomed, and Whiteswell., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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26. Safety and feasibility of transcatheter closure of atrial septal defects in small children weighing less than 10 kg.
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Puthiyedath T, Sagar P, and Sivakumar K
- Subjects
- Humans, Female, Male, Child, Preschool, Infant, Echocardiography, Echocardiography, Transesophageal, Treatment Outcome, Retrospective Studies, Heart Septal Defects, Atrial surgery, Cardiac Catheterization methods, Feasibility Studies, Septal Occluder Device, Body Weight
- Abstract
Background: When young patients with an oval fossa defect present early with symptoms of heart failure and pulmonary hypertension, surgical treatment is recommended in small bodyweight rather than transcatheter closure., Methods: Outcomes of device closure in consecutive symptomatic children weighing under 10 kg were compared with young children aged below 4 years but weighing above 10 kg. Transthoracic echocardiography under conscious sedation guided the procedure in all without need for balloon sizing, transesophageal echocardiogram, and intubation anaesthesia. Symptoms, anthropometry, shunt ratio, pulmonary pressures, defect and device size, percentage oversizing, device/body weight ratio, complications, and post-procedural growth spurt were compared., Results: Ninety-six patients weighing under 10 kg were compared with 160 patients weighing above 10 kg. In total, 83.3% of patients in the study group and 25% of controls were severely malnourished. The median indexed defect size was 35.2 mm/sq.m and 27.4 mm/sq.m, and the device was oversized by 8.7% and 14.2% in the study group and controls, respectively. The device/body weight ratio was 1.93 in study group and 1.4 in controls. Procedure was successful in all except one patient weighing under 10 kg who had a device embolisation. Both groups showed significant growth spurts and proportion, with severe malnutrition reduced to 42% and 11% in the two groups., Conclusions: Device closure was feasible and safe in patients under 10 kg. Transthoracic echocardiographic imaging on conscious sedation provided adequate guidance. Symptoms and growth significantly improved after intervention. Despite a larger defect size, smaller patients had comparable outcomes. In symptomatic children under 10 kg needing early closure, transcatheter intervention should not be deferred.
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- 2024
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27. Retrograde closure of post-infarct ventricular septal rupture to avoid moderator band entanglement.
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Ho CB, Wong I, Chiang MCS, Chui ASF, Chan AKC, Wong CY, Chan KT, and Lee MKY
- Subjects
- Humans, Male, Middle Aged, Treatment Outcome, Cardiac Catheterization methods, Septal Occluder Device, Coronary Angiography methods, Respiratory Insufficiency etiology, Respiratory Insufficiency therapy, Respiratory Insufficiency diagnosis, Electrocardiography, Ventricular Septal Rupture etiology, Ventricular Septal Rupture diagnosis, Ventricular Septal Rupture therapy, Ventricular Septal Rupture surgery, ST Elevation Myocardial Infarction diagnosis, ST Elevation Myocardial Infarction etiology, Shock, Cardiogenic etiology, Shock, Cardiogenic therapy, Shock, Cardiogenic diagnosis
- Abstract
A 63-year-old man presented with delayed inferior ST-elevation myocardial infarction complicated with ventricular septal rupture (VSR). He developed cardiogenic shock and respiratory failure requiring intubation and Impella (Abiomed) support.
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- 2024
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28. Safety and Efficacy of Mini-Invasive Left Atrial Appendage Closure: A Propensity-Score Analysis.
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Denis C, Clerfond G, Chalard A, Riocreux C, Pereira B, Lamallem O, Guizani T, Catalan PA, Boudias A, Jean F, Bouchant-Pioche M, Abu-Alrub S, Combaret N, Souteyrand G, Motreff P, Jabaudon M, Futier E, Massoullie G, and Eschalier R
- Subjects
- Humans, Female, Male, Aged, Stroke prevention & control, Stroke etiology, Stroke epidemiology, Treatment Outcome, Retrospective Studies, Septal Occluder Device, Minimally Invasive Surgical Procedures methods, Cardiac Catheterization methods, Echocardiography, Three-Dimensional methods, Follow-Up Studies, Aged, 80 and over, Left Atrial Appendage Closure, Atrial Appendage surgery, Atrial Appendage diagnostic imaging, Atrial Fibrillation surgery, Atrial Fibrillation complications, Echocardiography, Transesophageal methods, Propensity Score
- Abstract
Background: Left atrial appendage closure (LAAC) for prevention of stroke is validated in patients with nonvalvular atrial fibrillation (NVAF) contraindicated to oral anticoagulation. General anaesthesia (GA) is often used for procedural guidance by transesophageal echocardiography (TEE); however, its use may be challenging in some patients. The aim of the study was to evaluate the safety and the midterm efficacy of a mini-invasive LAAC strategy using micro-TEE under procedural sedation., Methods: Comparison by propensity score of 2 cohorts of consecutive patients who underwent LAAC: standard TEE-guided LAAC (3-dimensional [3D] TEE under GA) and mini-invasive LAAC strategy (micro-TEE under procedural sedation). The primary endpoint was a composite of embolic or bleeding events, significant per procedural complication, and cardiovascular deaths within 3 months after LAAC., Results: In total, 432 patients were included (78.7 ± 8 years old, 32.4% of women, CHA
2 DS2 VASC score: 4.9 ± 1.1); 127 patients underwent mini-invasive LAAC strategy and were compared with 305 patients standard TEE-guided LAAC. The mini-invasive strategy was achieved in 122 of 127 (96.1%) planned patients. The primary endpoint occurred in 11.2% of patients from the mini-invasive LAAC strategy group and in 10.3% of patients from the standard TEE group (absolute difference = 0.9% [-6.4; 4.5], hazard ratio = 1.11 [0.56; 2.19], P = 0.76). Procedural times, fluoroscopy duration, and hospital stays were shorter in the mini-invasive LAAC strategy group (P < 0.001)., Conclusions: The mini-invasive LAAC strategy is safe and effective compared with the standard TEE-guided LAAC strategy. A mini-invasive LAAC strategy may also be an important tool to help physicians to treat more patients as LAAC indications evolve in the future., (Copyright © 2024 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)- Published
- 2024
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29. Migration of the left atrial appendage closure device to the aorta.
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González-Suárez S, Barbosa JCS, Siliato Robles MS, and Paguay Fernández MM
- Subjects
- Humans, Treatment Outcome, Aortic Valve Insufficiency diagnostic imaging, Aortic Valve Insufficiency surgery, Aortic Valve Insufficiency physiopathology, Aortic Valve Insufficiency etiology, Atrial Fibrillation physiopathology, Atrial Fibrillation surgery, Atrial Fibrillation diagnostic imaging, Echocardiography, Transesophageal, Septal Occluder Device, Male, Aged, Aortography, Severity of Illness Index, Female, Left Atrial Appendage Closure, Atrial Appendage diagnostic imaging, Atrial Appendage physiopathology, Atrial Appendage surgery, Foreign-Body Migration etiology, Foreign-Body Migration diagnostic imaging, Foreign-Body Migration surgery, Foreign-Body Migration therapy, Device Removal, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects
- Abstract
Percutaneous closure of the left atrial appendage may be indicated in patients with contraindications to anticoagulation therapy, for example, after recurrent gastrointestinal bleeding. It is an effective and safe procedure but is not without complications. We present a patient who presented with severe aortic insufficiency due to migration of the left atrial appendage closure device, which required urgent cardiac surgery for its removal., Competing Interests: Declarations Competing interests The authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)
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- 2024
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30. Closure of small fenestrations without optimal rims with a PDA coil far from primary atrial septal defects: a new approach.
- Author
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Sánchez González SK, Colín Ortiz JL, Flores Arizmendi A, Bobadilla Aguirre A, and Corona Villalobos CA
- Subjects
- Humans, Female, Male, Echocardiography, Transesophageal, Cardiac Surgical Procedures methods, Treatment Outcome, Heart Septal Defects, Atrial surgery, Septal Occluder Device, Ductus Arteriosus, Patent surgery, Cardiac Catheterization methods
- Abstract
An ostium secundum atrial septal defect (ASD) is a CHD that can be treated percutaneously since 1974, mostly cases with only one main defect. In cases with fenestrations close to the main defect, a single occluder can be used for treatment because the discs extend beyond the waist of the device. In some cases where the defects are far from each other, they may require either more than one device or surgical closure. We present two patients in whom we observed fenestrations far from the primary defect. Initially, the main ASDs were closed with an ASD occluder, and then the fenestrations were closed with a patent ductus arteriosus (PDA) coil, resulting in complete closure of both defects. This shows that closing small fenestrations that are far away from the primary interatrial defect without rims and using other devices instead, such as a PDA coil, is feasible and can avoid the need for an open-heart surgical procedure; moreover, it is important to note that leaving these fenestrations open can have the same physiology as a patent foramen oval.
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- 2024
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31. Infective endocarditis associated with left atrial appendage occlusion device: a contemporary systematic review.
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Sanchez-Nadales A, Iddrisu M, Wardak R, Arriola GM, Baez-Escudero J, and Xu B
- Subjects
- Humans, Atrial Fibrillation surgery, Septal Occluder Device, Prosthesis-Related Infections etiology, Prosthesis-Related Infections diagnostic imaging, Prosthesis-Related Infections therapy, Endocarditis, Staphylococcal Infections, Endocarditis, Bacterial, Atrial Appendage diagnostic imaging, Atrial Appendage surgery
- Abstract
Background: Data are limited regarding infective endocarditis (IE) complicating left atrial appendage occlusion (LAAO) device procedures. This systematic review examines the etiology, diagnosis, and management of infective endocarditis (IE) following LAAO., Methods: A comprehensive search of six databases was performed between 2007 and 2022. In selecting studies, articles were included if they provided information about IE complicating LAAO, with relevant clinical and imaging details. Articles were excluded if they were editorials, study protocols, letters, or abstracts., Results: We identified seven cases of IE complicating LAAO published between 2007 and 2022, from the United States and Europe, highlighting the exceedingly rare reported incidence of the condition. Staphylococcus aureus is the predominant organism implicated in LAAO infections. Echocardiography is a key imaging modality for diagnosing LAAO IE. Both antibiotic therapy and surgical intervention in appropriate patients are important for managing LAAO device-related IE., Conclusions: The limited data in the current literature regarding LAAO IE underscores the need for prospective clinical trials to establish evidence-based guidelines for infection prophylaxis, diagnosis, and management. Our findings emphasize the importance of vigilance for device-related infections, especially as the use of LAAO devices continues to grow worldwide., Competing Interests: Declarations. Conflict of interest: The authors declare no competing interests., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)
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- 2024
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32. Peri-device leakage and delayed endothelialization of the Watchman device: a computed tomography study.
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Chen T, Lu X, Wang X, Chen Q, Zhao R, Zhang W, Song T, Guo J, and Chen Y
- Subjects
- Humans, Male, Female, Aged, Retrospective Studies, Risk Factors, Septal Occluder Device, Middle Aged, Postoperative Complications diagnostic imaging, Tomography, X-Ray Computed methods, Computed Tomography Angiography methods
- Abstract
Objectives: This study aimed to explore the endothelialization process and assess the potential association between endothelialization and peri-device leak (PDL) following Watchman implantation via a quantitative method., Methods: This is a single-center retrospective study of consecutive patients undergoing LAAO between December 2015 and November 2021. Device endothelialization, compared between PDL and non-PDL group, were quantitatively analyzed based on hypoattenuated thickening in cardiac computed tomography angiography (CCTA). Advancement in endothelialization over time were explored using the Cochran-Armitage test and generalized estimating equation approach. Potential risk factors of delayed endothelialization were analyzed using the Cox proportional-hazards model., Results: A total of 172 patients (mean age, 68 years ± 10 [standard deviation], 114 men) were finally included. The average endothelialization ratio of the study population was 89.8 ± 7.2 percent. In the follow-up period of postprocedural 3 months to more than 12 months, an incremental trend of endothelialization over time was observed with the ratio of 85.8 ± 8.0, 89.6 ± 7.6, 92.2 ± 4.5, 94.3 ± 2.9 percent, respectively (p < 0.0001). Notably, patients without PDL exhibited a swifter advancement in endothelialization compared to those with PDL, irrespective of device size. The multivariable Cox regression model showed that PDL (HR = 2.113, 95%CI: 1.300-3.435, p = 0.003), DSP (HR = 1.717, 95%CI: 1.113-2.647, p = 0.014) were independent risk factors of delayed endothelialization., Conclusion: CCTA holds promise as an effective means of quantitatively assessing device endothelialization. Endothelialization advanced gradually over time, with PDL potentially impeding device endothelialization., Clinical Relevance Statement: A comprehensive understanding of the correlation between endothelialization ratio, time, and residual shunt can establish a more dependable foundation for determining the appropriate anticoagulation treatment following left atrial appendage closure., Key Points: Current recommendations for postleft atrial appendage occlusion anti-platelet and anticoagulation therapy are based on animal studies. Cardiac computed tomography angiography (CCTA) combined with the UNet neural network model enables the quantitative assessment of device endothelialization. This technique will allow for additional studies to better understand device endothelialization to optimize treatments in this population., (© 2024. The Author(s), under exclusive licence to European Society of Radiology.)
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- 2024
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33. Feasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study.
- Author
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Makkar A, Alkhouli M, Ellis CR, Shah AP, Coylewright M, Freeman JV, Anderson JA, Gage R, and Lakkireddy D
- Subjects
- Humans, Male, Female, Aged, Treatment Failure, Prosthesis Design, Cardiac Catheterization methods, Follow-Up Studies, United States epidemiology, Atrial Appendage surgery, Atrial Fibrillation surgery, Atrial Fibrillation physiopathology, Septal Occluder Device, Feasibility Studies, Registries
- Abstract
Background: Although expertise in left atrial appendage occlusion (LAAO) has grown, certain intricate anatomies may pose challenges, rendering them unsuitable for LAAO with the selected device., Objective: This analysis aimed to characterize outcomes of patients with prior failed percutaneous LAAO procedures who underwent a subsequent attempt with an Amulet occluder in the EMERGE LAA postapproval study., Methods: Patients enrolled in the National Cardiovascular Data Registry LAAO Registry who had an Amulet occluder implantation attempt between Food and Drug Administration approval (August 14, 2021) and June 30, 2023, were evaluated. A safety end point through 7 days or hospital discharge (whichever was later) and major adverse events through 45 days were reported., Results: A total of 8591 patients underwent attempted Amulet occluder implantation, of whom 244 patients had prior failed LAAO. Implantation success was 88.9% and 96.2% in patients with prior failed LAAO and index LAAO, respectively (P < .001). The safety composite end point was low, occurring in 1.6% and 0.8% of patients with prior failed LAAO and index LAAO, respectively (P = .148). Any major adverse event through 45 days occurred in 7.4% and 6.3% of prior failed LAAO and index LAAO patient cohorts, respectively (P = .497); most adverse events were similar between the groups (P > .05). At 45 days, peridevice leak ≤3 mm was achieved in >90% of patients in either group., Conclusion: A high degree of implantation success with a low rate of adverse events can be achieved with the Amulet occluder. The findings imply that the dual occlusive mechanism Amulet occluder facilitates successful closure, even in challenging anatomic scenarios., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)
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- 2024
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34. Influence of procedural timing on the preventive yield of percutaneous patent foramen ovale closure.
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Jerónimo A, Nombela-Franco L, Simal P, Freixa X, Cerrato E, Cruz-Gonzalez I, Dueñas G, Veiga-Fernandez G, Goncalves-Ramirez LR, Garcia-Blas S, Fernández-Revuelta A, Cepas-Guillén P, Tomassini F, Lopez-Tejero S, Gonzalez-Manzanares R, De la Torre Hernandez JM, Perez de Prado A, Valero E, Gabani R, Travieso A, de Agustín JA, Tirado G, Jimenez-Quevedo P, and Salinas P
- Subjects
- Humans, Male, Female, Retrospective Studies, Middle Aged, Time Factors, Treatment Outcome, Septal Occluder Device, Time-to-Treatment, Aged, Risk Factors, Follow-Up Studies, Adult, Foramen Ovale, Patent complications, Foramen Ovale, Patent therapy, Foramen Ovale, Patent surgery, Cardiac Catheterization methods, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Recurrence, Secondary Prevention methods
- Abstract
Background: The benefit of patent foramen ovale closure (PFOC) ≤9 months after a cryptogenic stroke has been demonstrated in several randomised clinical trials. There is, however, insufficient data to support PFOC in non-recent cryptogenic strokes., Aims: The objective of the study was to evaluate the effectiveness of PFOC in relation to the time since the patient's most recent cryptogenic cerebrovascular event (CVE) or systemic embolism (SE)., Methods: We conducted a multicentre, retrospective cohort study with international participation, to assess the results of an early closure (EC, <9 months) for secondary prevention versus a delayed closure (DC, ≥9 months). Recurrence of CVE/SE following PFOC was evaluated as the primary endpoint., Results: 496 patients were included (65% in the EC and 35% in the DC group). With the exception of a larger defect size in the DC group (tunnel width 6 (4-14) vs 12 (6-16) mm, p=0.005), similar clinical and echocardiographic baseline features were observed between the groups. No differences were observed regarding the type of devices used for PFOC, procedural success rate (99.4 in EC vs 98.8% DC group) and periprocedural complications (2.1% vs 0.8%). Median follow-up was 2.0 (1.2-4.2) years in the whole study population. Recurrence of CVE/SE (3.9% vs 2.6%, p=0.443), death (1.4% vs 1.0%, p=0.697), residual shunt 12 months after PFOC, or antithrombotic treatment strategy were comparable in both groups during follow-up. A subanalysis comparing very delayed PFOC (≥24 months) also showed no differences in recurrence (4.2% in the <24-month vs 3.4% in the ≥24-month group, p=0.770)., Conclusion: Patients undergoing PFOC before and after 9 months after the index event had a comparable recurrence rate of CVE/SE. These findings suggest that PFOC might be recommended in cryptogenic CVE/SE which are more remote than 9 months., Competing Interests: Competing interests: PS declares speaker fees from Abbott and Gore., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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35. Long-Term Results of the Atrial Septal Defect Occluder ASSURED Trial for Combined Pivotal/Continued Access Cohorts.
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Qureshi AM, Sommer RJ, Morgan G, Paolillo JA, Gray RG, Love B, Goldstein BH, Sugeng L, and Gillespie MJ
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- Adolescent, Adult, Child, Child, Preschool, Female, Humans, Male, Middle Aged, Young Adult, Arrhythmias, Cardiac therapy, Arrhythmias, Cardiac physiopathology, Europe, Prospective Studies, Prosthesis Design, Risk Factors, Time Factors, Treatment Outcome, United States, Cohort Studies, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects, Heart Septal Defects, Atrial therapy, Heart Septal Defects, Atrial diagnostic imaging, Septal Occluder Device
- Abstract
Background: The GORE CARDIOFORM ASD Occluder (GCA, W. L. Gore & Associates) was approved in 2019 for ostium secundum atrial septal defect (ASD) closure., Objectives: This study sought to report the combined pivotal and continued access cohorts of the ASSURED (Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs) trial results through 36 months., Methods: This prospective, multicenter, single-arm trial evaluated procedural and clinical outcomes of ASD closure with the GCA. The primary endpoints were 6-month closure success following device implantation and composite clinical success (deployment/retention of device, safety, and closure). Technical and procedure success, safety, clinically significant new arrhythmia (CSNA) secondary endpoints, and wire frame fracture (WFF, with fluoroscopy) at 6 and 36 months were evaluated., Results: Of 569 patients (median age of 10.4 years and median weight of 35.0 kg) who underwent attempted secundum ASD closure, 526 were technical successes. The mean stop-flow ASD diameter was 17.6 ± 5.3 mm. All 478 patients with 6-month imaging achieved closure success. Composite clinical success at 6 and 36 months was achieved in 87.6% (468/534) and 84.0% (351/418) of patients, respectively. Technical failure occurred in 8.1% (43/548), 30-day device- or procedure-related serious adverse event in 3.9% (21/534), and 6-month device events in 2.8% (15/534) of patients. At 30 days, 21 of 569 patients (3.7%) had CSNA. At 6 months, 138 of 436 (31.7%) patients had WFFs and 105 of 185 (56.8%) at 36 months (without sequelae)., Conclusions: In this large congenital ASD device trial, the GCA had acceptable results. WFFs, although common, did not result in any clinical sequelae. The unique features, size range, and safety profile expand the options for secundum ASD closure. (Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs [ASSURED]; NCT02985684)., Competing Interests: Funding Support and Author Disclosures This study was sponsored by W. L. Gore & Associates. Dr Qureshi is a consultant for W. L. Gore & Associates, Medtronic, and B. Braun. Dr Sommer has received institutional funding from W. L. Gore & Associates for working on their national PFO and ASD trials; and serves on the Advisory Board for Conformal Medical. Dr Morgan is a consultant/proctor for W. L. Gore & Associates. Dr Paolillo is a consultant, proctor, and preceptor for W. L. Gore & Associates. Dr Goldstein is a consultant for Medtronic, W. L. Gore & Associates, Edwards Lifesciences, and Mezzion Pharmaceuticals. Dr Sugeng serves on the Speakers Bureau for Philips Healthcare; and is a consultant for Siemens Healthineers and Yale Echo Corelab YCRG. Dr Gillespie is a consultant for W. L. Gore & Associates and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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36. Echocardiography-guided percutaneous closure of oval-shaped secundum atrial septal defects.
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Siagian SN, Tandayu KMH Jr, Reno P, Mendel B, Christianto C, and Prakoso R
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- Humans, Male, Retrospective Studies, Female, Treatment Outcome, Child, Adolescent, Young Adult, Adult, Child, Preschool, Echocardiography, Transesophageal, Middle Aged, Prosthesis Design, Predictive Value of Tests, Time Factors, Heart Septal Defects, Atrial diagnostic imaging, Heart Septal Defects, Atrial therapy, Heart Septal Defects, Atrial surgery, Cardiac Catheterization instrumentation, Cardiac Catheterization adverse effects, Septal Occluder Device, Ultrasonography, Interventional
- Abstract
Background: An atrial septal defect (ASD) is considered oval-shaped when its shortest diameter is less than 75% of the longest diameter. Research on percutaneous closure of oval-shaped ASDs is limited, with no known reports of non-fluoroscopic closure for this population., Objective: To assess the effectiveness of non-fluoroscopic percutaneous closure for oval-shaped ASDs., Methods: This single-center retrospective study evaluates patients undergoing non-fluoroscopic percutaneous closure of oval-shaped ASDs, defined by the shortest to longest diameter ratio < 0.75, a circular index of 1.33, or ultrasound visualization of an oval shape. Device size was chosen to be 0-4 mm larger than the defect's longest diameter, based on transthoracic and transesophageal ultrasound measurements., Results: We identified 78 patients (33.3% children, 20.5% males) with a mean age of 27.4 ± 16.3 years and a mean weight of 46.8 ± 19.8 kg. The mean longest diameter and mean shortest diameter of ASDs were 23.3 ± 6.8 mm and 15.8 ± 5 mm, respectively. The mean ratio of the shortest to longest diameter was 0.7 ± 0.1. Percutaneous closure was not attempted in 7/78 (9%) patients. Three out of 71 (4.2%) procedures were fluoroscopy-guided upfront due to technical difficulties, and 5/71 (7%) were converted to fluoroscopy-guided closure. Overall procedural success rate was 98.6% (70/71) including 63/71 (88.7%) performed with zero fluoroscopy. Mean device size was 26.5 ± 7.1 mm. Mean procedural time was 45.3 ± 22.6 min. Eleven intraprocedural complications occurred including 6 arrhythmias, 3 pericardial effusions, and 2 device dislodgements., Conclusion: Transcatheter closure of oval-shaped ASD is safe and feasible. Echocardiography is adequate for adequate operative guidance., (© 2024. The Author(s).)
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- 2024
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37. Delivery systems for transcatheter therapies of congenital heart disease.
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Holzer RJ and Hijazi ZM
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- Humans, Septal Occluder Device, Heart Defects, Congenital therapy, Heart Defects, Congenital surgery, Cardiac Catheterization instrumentation, Cardiac Catheterization methods
- Abstract
Introduction: Delivery systems are crucially important for the implantation of medical devices in patients with congenital heart disease. However, very little data is available comparing the advantages and disadvantages of the various delivery systems., Areas Covered: This article describes the delivery systems and methods used for delivery of atrial septal occluder devices, ventricular septal occluder devices, devices to occlude patent arterial ducts, and transcatheter pulmonary valves. Delivery systems are compared relating to prepping and loading, positioning of the delivery sheath/catheter, deployment, ability to recapture and reposition, as well as device release., Expert Opinion: For most ASD/VSD/PDA occluder devices, the basic delivery mechanism has changed very little over the preceding 20 years. Future modifications may focus on meaningful modifications to the cable systems that reduce stiffness and improve angulation at the connection to the device. Over the next 5-10 years, it is expected to see significant changes to delivery systems used for transcatheter pulmonary valve implantation, that result in improvements in the ability to recapture and reposition self-expandable transcatheter valves during the deployment process, combined with kink resistant sheaths that facilitate easy tracking across often complex right ventricular outflow tracts.
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- 2024
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38. Atrial flow regulator in transposition of the great arteries, ventricular septal defect, and pulmonary stenosis: a case report.
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Bichali S, Delarue A, and Houeijeh A
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- Humans, Female, Infant, Cardiac Catheterization methods, Septal Occluder Device, Abnormalities, Multiple, Transposition of Great Vessels surgery, Pulmonary Valve Stenosis surgery, Heart Septal Defects, Ventricular surgery
- Abstract
A 5-month-old girl with transposition of the great arteries, ventricular septal defect, and pulmonary stenosis underwent the implantation of a 6-mm M Atrial Flow Regulator (Occlutech) over an 8-French delivery sheath for significant cyanosis and progressive restriction of the atrial septal defect, without adverse event for 6 months. The Atrial Flow Regulator device could improve blood mixing as a bridge to surgery.
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- 2024
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39. Association between patent foramen ovale morphology and clinical outcomes following transcatheter closure.
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Sun L, Fan Z, Gao J, Zhao T, Si J, Zhang H, Li Y, Sun J, Wang X, Liu Z, Yi M, Hua Y, Xing Y, Liu Z, and Li J
- Subjects
- Humans, Male, Female, Middle Aged, Adult, Prospective Studies, Treatment Outcome, Follow-Up Studies, Septal Occluder Device, Foramen Ovale, Patent surgery, Foramen Ovale, Patent complications, Foramen Ovale, Patent epidemiology, Cardiac Catheterization methods
- Abstract
Background: Anatomic variations of the patent foramen ovale (PFO) are commonly observed, yet limited research has investigated their impact on clinical outcomes following transcatheter closure. We aimed to explore the association between PFO morphology and clinical outcomes., Methods: Consecutive patients with cryptogenic stroke who underwent PFO closure were prospectively enrolled at a single center from September 2019 to April 2023. Patients were categorized into simple and complex groups based on PFO morphology. Composite events were compared between the two groups during a median follow-up of 24 months, including all-cause mortality, recurrent stroke, residual moderate or severe shunt, and symptomatic atrial fibrillation., Results: A total of 247 patients were enrolled, with a mean age of 41.9 ± 13.0 years and 45.3% males. Ninety-one (36.8%) patients had complex PFO. These individuals were older (45.4 ± 12.5 years vs. 39.9 ± 12.9 years; P = 0.001), more males (56.0% vs. 39.1%; P = 0.010), had longer procedure times (54 ± 32 min vs 46 ± 29 min; P = 0.044), and had a higher rate of using delivery sheath-assisted crossing of the PFO (22.0% vs 12.8%; P = 0.040) than those with simple PFO. The estimated event rates were 27.9% and 11.3% (P = 0.006) in the complex and simple PFO groups, respectively (12.9 events and 5.2 events per 100 person-years; P = 0.001). After adjusting for age, sex, hypertension, diabetes, smoking, device type, and left atrial diameters, complex PFO remained independently associated with composite events (HR 2.10, 95%CI 1.06-4.17, P = 0.034)., Conclusions: Patients with complex PFO may suffer from a higher risk of adverse events following transcatheter PFO closure., Competing Interests: Declaration of competing interest The authors report no relationships that could be construed as a conflict of interest., (Copyright © 2024 Elsevier B.V. All rights reserved.)
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- 2024
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40. Catheter based left atrial appendage closure in-hospital outcomes in Germany from 2016 to 2020.
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Maier A, Kaier K, Heidt T, Westermann D, von Zur Mühlen C, and Grundmann S
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- Humans, Germany epidemiology, Female, Male, Aged, Treatment Outcome, Retrospective Studies, Aged, 80 and over, Septal Occluder Device, Postoperative Complications epidemiology, Hospital Mortality trends, Left Atrial Appendage Closure, Atrial Appendage surgery, Cardiac Catheterization methods, Atrial Fibrillation surgery, Atrial Fibrillation epidemiology
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Background: New and refined catheter based left atrial appendage (LAA) closure devices have been introduced in the past decade. The procedure can be performed using either an endocardial occlusion device or an epicardial loop stitch. We aimed to analyzed recent procedural safety., Methods: Catheter based LAA closures were identified in a complete nationwide German dataset via ICD and OPS codes from 2016 to 2020., Results: From 2016 to 2020, 28,039 endocardial and 213 epicardial occlusions were performed. Numbers of endocardial procedures increased from 5259 in 2016 to 5917 in 2020 (p = 0.020) in 387 centers with shifting of patients' characteristics towards older age (β = 0.29, p < 0.001), more heart failure (β = 1.01, p < 0.001) and renal disease (β = 0.67, p = 0.001) and without a significant trend for in-hospital safety except more bleeding (β = 0.12, p = 0.05). In-hospital major adverse cardiac and cerebrovascular events (MACCE) or pericardial puncture were independent on center procedure numbers. The loop stitch procedure was performed in 15 centers. Patients were younger (76.17 ± 8.16 vs. 73.16 ± 8.99, p < 0.001) and had a lower comorbidity index (2.29 ± 1.93 vs. 1.92 ± 1.64, p = 0.005). Adjusted risk difference for pericardial effusion (8.04%; 95% CI 3.01-13.08%; p = 0.002) and pericardial puncture (6.60%; 95% CI 3.85-9.35%; p < 0.001) was higher for the loop stitch procedure, while risk of bleeding (- 1.85%; 95% CI - 3.01 to - 0.69%; p = 0.002), intracerebral bleeding (- 0.37%; 95% CI - 0.59 to - 0.15%; p = 0.001) and shock (- 1.41%; 95% CI - 2.44 to - 0.39%; p = 0.007) was lower. No significant difference was observed for in-hospital MACCE., Conclusions: Endocardial occlusion was the major catheter based LAA closure procedure in Germany without improvements in in-hospital safety from 2016 to 2020. In-hospital MACCE was independent on endocardial LAAC center volumes. Conclusions on the comparison between the two procedure types must be made cautious as the LAA loop stitch occlusion was utilized limited in a minor number of centers., (© 2023. The Author(s).)
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- 2024
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41. PERCUTANEOUS OCCLUSION OF MAJOR AORTOPULMONARY COLLATERALS IN TRANSPOSITION OF THE GREAT ARTERIES USING AMPLATZER PICCOLO OCCLUDERS: CASE REPORT.
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Khelashvili V, Shiryaev T, and Gogia O
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- Humans, Infant, Aorta, Thoracic surgery, Aorta, Thoracic diagnostic imaging, Aorta, Thoracic physiopathology, Embolization, Therapeutic methods, Septal Occluder Device, Collateral Circulation, Pulmonary Artery surgery, Pulmonary Artery diagnostic imaging, Pulmonary Artery physiopathology, Transposition of Great Vessels surgery, Transposition of Great Vessels diagnostic imaging, Transposition of Great Vessels physiopathology
- Abstract
Collateral vascular arteries from the descending aorta to the pulmonary arteries are uncommon after arterial switch operation. We describe a case of transposition of the great arteries (TGA) with significant aortopulmonary collateral vessels causing management difficulties after an arterial switch operation. Preoperatively, the presence of collaterals exacerbated aortic diastolic runoff and led to myocardial ischemia. Postoperatively, despite uneventful extubation, the infant developed clinical heart failure characterized by pericardial and pleural effusions and feeding difficulties, which promptly resolved with percutaneous embolization of collaterals. Major aortopulmonary collaterals (MAPCAs) are rarely associated with TGA, but if present they may cause important hemodynamic imbalance in infants with TGA.
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- 2024
42. Interventional closure of an iatrogenic LAA-perforation by means of a PFO-occluder.
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Genske F, Marquetand C, Schmidt T, Stiermaier T, and Eitel I
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- Humans, Aged, 80 and over, Treatment Outcome, Foramen Ovale, Patent therapy, Foramen Ovale, Patent diagnostic imaging, Foramen Ovale, Patent complications, Hemodynamics, Male, Heart Arrest etiology, Heart Arrest therapy, Heart Arrest diagnosis, Heart Arrest physiopathology, Cardiopulmonary Resuscitation, Echocardiography, Transesophageal, Female, Drainage instrumentation, Septal Occluder Device, Atrial Appendage diagnostic imaging, Atrial Appendage physiopathology, Cardiac Catheterization adverse effects, Cardiac Catheterization instrumentation, Iatrogenic Disease, Heart Injuries etiology, Heart Injuries therapy, Heart Injuries diagnostic imaging, Heart Injuries physiopathology, Heart Injuries prevention & control, Atrial Fibrillation therapy, Atrial Fibrillation physiopathology, Atrial Fibrillation diagnosis, Pericardial Effusion etiology, Pericardial Effusion therapy, Pericardial Effusion diagnostic imaging, Prosthesis Design
- Abstract
Atrial fibrillation (AF) is the most common rhythm disorder with a high risk for cardioembolic strokes. Interventional occlusion of the left atrial appendage (LAA) is an alternative to the widely established stroke prevention with oral anticoagulation. Complications through LAA closure (LAAC) are rare and usually occur periinterventional. We present a case of an 87-year-old patient who presents for elective LAAC. After placement of the LAA occluder (Amplatzer Amulet device 25 mm) in the LAA and partial resheathing, the patient developed a pericardial effusion (PE), became hemodynamically unstable and went into cardiac arrest with the need for cardiopulmonary resuscitation (CPR). After drainage of the PE, we closed the causative LAA-perforation using a persistent foramen ovale (PFO)-occluder device (Amplatzer Talisman, 25 mm). Thereby we were able to successfully seal the perforation and stabilize the patient. The patient was monitored at our intensive care unit for 2 days and left the hospital in good condition a few days after. Procedural complications during interventional LAAC are rare but can be serious. The most common complication, PE, requires percutaneous drainage and often cardiac surgery. We present a case in which a perforation and following PE with hemodynamic relevance and need for CPR was resolved with an interventional strategy through implantation of a PFO-occluder into the perforation. With this approach we were able to show that in the right setting even serious complications can be treated by interventional measures, thereby not only saving the patient's life, but also avoiding cardiac surgery., (© 2024 The Author(s). Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)
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- 2024
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43. Antithrombotic Therapy in Patients Undergoing Percutaneous Left Atrial Appendage Occlusion.
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Galea R and Räber L
- Subjects
- Humans, Cardiac Catheterization methods, Septal Occluder Device, Anticoagulants therapeutic use, Anticoagulants administration & dosage, Ischemic Stroke prevention & control, Thrombosis prevention & control, Thrombosis etiology, Atrial Appendage surgery, Atrial Fibrillation complications, Atrial Fibrillation surgery, Fibrinolytic Agents therapeutic use, Fibrinolytic Agents administration & dosage
- Abstract
Percutaneous left atrial appendage closure (LAAC) is a valid alternative to oral anticoagulation to prevent ischemic stroke in patients with atrial fibrillation.The devices approved in Europe and United States for percutaneous LAAC contain metal and temporary antithrombotic therapy is strongly recommended following implantation to prevent thrombus formation on the atrial device surface. There is still uncertainty regarding to the optimal antithrombotic drug regimen after device implantation for several reasons. Thus, this review aims at summarizing the available evidence and the remaining challenges related to the management of antithrombotic therapy in the context of LAAC procedure., Competing Interests: Disclosures R. Galea reports no relationships relevant to the contents of this paper to disclose. L. Raber reports research grants to institution by Abbott Vascular, United States, Boston-Scientific, Biotronik, Germany, InfraRedx, United States, HeartFlow, United States, Sanofi, United States, Regeneron and Swiss National Science Foundation. He reports speaker/consultation fees by Abbott-Vascular, Amgen, AstraZeneca, Canon, Novo Nordisk, Medtronic, Occlutech, Sanofi., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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44. Animal Experimental Study of Bioabsorbable Left Atrial Appendage Occluder.
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Zhao T, Diao F, Zhang Z, Liu C, Chen Y, Bai Y, Guo Z, Huang S, Liu Z, Zhao X, Qin Y, Cao J, and Huang X
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- Animals, Dogs, Atrial Fibrillation surgery, Disease Models, Animal, Polyesters, Alloys, Polydioxanone, Absorbable Implants, Atrial Appendage surgery, Septal Occluder Device
- Abstract
Left atrial appendage (LAA) closure can prevent stroke in high-risk patients with atrial fibrillation.A bioabsorbable LAA occluder made of degradable polymer materials, such as polydioxanone (PDO) and poly-L-lactic acid (PLA), and nitinol wire was used. Occluders were successfully implanted in 18 Chinese rural dogs, 2 of which died within 48 hours after operation due to pericardial tamponade and hemorrhage, respectively. Follow-up observation was performed after transcatheter LAA closure. New tissue was found on the surface of the occluder 2 months after operation. No adjacent structures such as the mitral valve and the left superior pulmonary vein were affected by the occluder discs. Hematoxylin and eosin (HE) staining was performed at 3 months after operation, which showed intact intimal structure on the occluder surface, and unabsorbed PDO and PLA were observed. Scanning electron microscopy showed irregular arrangement of endothelial cells. New endothelial tissue was observed to completely cover the occluder at 6 months after operation. Most PDOs were replaced by fibrous connective tissue, and scanning electron microscopy showed regularly arranged endothelial cells. Pathological examination at 12 months showed only a small remnant of PDO. The gross specimens of the liver, spleen, and kidneys and pathological examination did not indicate thromboembolism.The bioabsorbable LAA occluder made of PDO, PLA, and nitinol wire was safe and effective for the occlusion of LAA in dogs. The surface of the occluder was endothelialized half a year after operation. The absorbable materials of the occluder were degraded after 1 year.
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- 2024
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45. Resolution of Migraine with Aura Post-PFO Closure in a Young Female: A Case Report.
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Stujanna EN, Pandhita G, and Prakoso R
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- Humans, Female, Adult, Migraine with Aura etiology, Foramen Ovale, Patent complications, Foramen Ovale, Patent surgery, Septal Occluder Device
- Abstract
BACKGROUND Migraine, a prevalent primary headache disorder, often disrupts daily life, particularly when accompanied by visual auras. While the etiology of migraines remains elusive, emerging evidence suggests a correlation with cardiovascular anomalies. CASE REPORT This case involves a 35-year-old woman experiencing migraine with aura. Imaging studies, including MRI/A, revealed small-vessel ischemic damage in the right frontal region and historical microbleeds in the right occipital area. The patient's RoPE score was a high 9 out of 10, and a grade 4 (severe) PFO was diagnosed following a TEE+bubble test. A transfemoral PFO closure was successfully performed using a 25-mm Amplatzer PFO occluder device via an antegrade transvenous approach without fluoroscopy. The patient was discharged in stable condition, with no migraine episodes reported at 5-month follow-up. The detection of PFO in young migraineurs, particularly those with aura, is crucial and warrants thorough investigation during their assessment and treatment. CONCLUSIONS This case underscores the importance of incorporating cardiac evaluations in the diagnostic regimen for young individuals presenting with migraine and aura to uncover and rectify potential contributory structural heart defects like PFO. After PFO closure, this patient's significant improvement, evidenced by the absence of migraine recurrence, highlights the potential therapeutic benefit of addressing cardiac anomalies in such patients. It is important to note that current evidence does not support PFO closure as a treatment for migraines unless there are findings suggestive of ischemic stroke.
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- 2024
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46. Impact of occluder device configurations in in-silico left atrial hemodynamics for the analysis of device-related thrombus.
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Albors C, Mill J, Olivares AL, Iriart X, Cochet H, and Camara O
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- Humans, Heart Atria physiopathology, Septal Occluder Device, Computational Biology, Thrombosis physiopathology, Computer Simulation, Atrial Fibrillation physiopathology, Hemodynamics physiology, Models, Cardiovascular, Atrial Appendage physiopathology
- Abstract
Left atrial appendage occlusion devices (LAAO) are a feasible alternative for non-valvular atrial fibrillation (AF) patients at high risk of thromboembolic stroke and contraindication to antithrombotic therapies. However, optimal LAAO device configurations (i.e., size, type, location) remain unstandardized due to the large anatomical variability of the left atrial appendage (LAA) morphology, leading to a 4-6% incidence of device-related thrombus (DRT). In-silico simulations have the potential to assess DRT risk and identify the key factors, such as suboptimal device positioning. This work presents fluid simulation results computed on 20 patient-specific left atrial geometries, analysing different commercially available LAAO occluders, including plug-type and pacifier-type devices. In addition, we explored two distinct device positions: 1) the real post-LAAO intervention configuration derived from follow-up imaging; and 2) one covering the pulmonary ridge if it was not achieved during the implantation (13 out of 20). In total, 33 different configurations were analysed. In-silico indices indicating high risk of DRT (e.g., low blood flow velocities and flow complexity around the device) were combined with particle deposition analysis based on a discrete phase model. The obtained results revealed that covering the pulmonary ridge with the LAAO device may be one of the key factors to prevent DRT, resulting in higher velocities and reduced flow recirculations (e.g., mean velocities of 0.183 ± 0.12 m/s and 0.236 ± 0.16 m/s for uncovered versus covered positions in DRT patients). Moreover, disk-based devices exhibited enhanced adaptability to various LAA morphologies and, generally, demonstrated a lower risk of abnormal events after LAAO implantation., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Albors et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2024
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47. Persistence of residual shunt at 6 and 12 months after transoesophageal echocardiography-guided percutaneous closure of a patent foramen ovale for cryptogenic stroke.
- Author
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Witte LS, El Bouziani A, Beijk MAM, Robbers-Visser D, Coutinho JM, Tijssen JGP, Straver B, Bouma BJ, and de Winter RJ
- Subjects
- Humans, Female, Male, Adult, Time Factors, Middle Aged, Treatment Outcome, Follow-Up Studies, Ischemic Stroke etiology, Ischemic Stroke prevention & control, Ischemic Stroke epidemiology, Retrospective Studies, Stroke etiology, Stroke prevention & control, Foramen Ovale, Patent complications, Foramen Ovale, Patent diagnostic imaging, Foramen Ovale, Patent surgery, Echocardiography, Transesophageal methods, Cardiac Catheterization methods, Septal Occluder Device
- Abstract
Background: Young patients suffering from cryptogenic stroke alongside a patent foramen ovale (PFO) are often considered for percutaneous device closure to reduce the risk of stroke recurrence. Residual right-to-left shunt after device closure may persist in approximately a quarter of the patients at 6 months, and some may close at a later time point. This study aimed to assess the prevalence and persistence of residual right-to-left shunt after percutaneous PFO closure., Methods: Consecutive patients undergoing transoesophageal echocardiography-guided PFO closure for cryptogenic stroke between 2006 and 2021, with echocardiographic follow-up including contrast bubble study and Valsalva manoeuvre, were enrolled. Follow-up transthoracic echocardiography was performed at 6 months and repeated at 12 months in case of residual right-to-left shunt. Primary outcomes included the prevalence and grade of residual right-to-left shunt at 6 and 12 months after percutaneous PFO closure., Results: 227 patients were included with a mean age of 43±11 years and 50.2% were women. At 6-month follow-up, 72.7% had no residual right-to-left shunt, 12.3% small residual right-to-left shunt, 6.6% moderate residual right-to-left shunt and 8.4% large residual right-to-left shunt. At 12-month follow-up, the presence of residual right-to-left shunt in all patients was 12.3%, of whom 6.6% had small residual right-to-left shunt, 2.6% had moderate residual right-to-left shunt and 3.1% had large residual right-to-left shunt., Conclusions: Residual right-to-left shunts are common at 6 months after percutaneous closure of PFO. However, the majority are small and two-thirds of residual right-to-left shunts achieve complete closure between 6 and 12 months., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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48. Guideline Updates Needed: Closure Devices to Prevent Recurrent Stroke in Patients With Patent Foramen Ovale.
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Saver JL
- Subjects
- Humans, Cardiac Catheterization instrumentation, Cardiac Catheterization methods, Foramen Ovale, Patent complications, Foramen Ovale, Patent surgery, Foramen Ovale, Patent therapy, Secondary Prevention methods, Stroke prevention & control, Stroke etiology, Septal Occluder Device, Practice Guidelines as Topic, Recurrence
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- 2024
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49. Left Atrial Appendage Closure in Patients With a Mechanical Mitral Valve Prosthesis: A Multicentre Italian Pilot Study.
- Author
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Preda A, Margonato D, Gaspardone C, Rizza V, Vella C, Rampa L, Marzi A, Guarracini F, Della Bella P, Agricola E, Gaspardone A, Montorfano M, and Mazzone P
- Subjects
- Humans, Female, Male, Aged, Retrospective Studies, Pilot Projects, Italy epidemiology, Mitral Valve surgery, Septal Occluder Device, Middle Aged, Follow-Up Studies, Thrombosis prevention & control, Thrombosis etiology, Thrombosis epidemiology, Cardiac Catheterization methods, Anticoagulants therapeutic use, Treatment Outcome, Thromboembolism prevention & control, Thromboembolism etiology, Thromboembolism epidemiology, Left Atrial Appendage Closure, Atrial Appendage surgery, Atrial Fibrillation complications, Atrial Fibrillation surgery, Atrial Fibrillation therapy, Heart Valve Prosthesis
- Abstract
Background: In patients with atrial fibrillation (AF) on vitamin K antagonist (VKA) therapy and therapeutic international normalized ratio (INR) range, the incidence of cardiac thromboembolism is not negligible, and the subgroup of patients who have a mechanical prosthetic mitral valve (PMV) has the highest risk. We aimed to assess the long-term effects of left atrial appendage closure (LAAC) in AF patients with a mechanical PMV who experienced a failure of VKA therapy., Methods: In this retrospective, multicentre study, patients underwent LAAC because of thrombotic events including transient ischemic attack and/or stroke, systemic embolism, and evidence of left atrial appendage thrombosis and/or sludge, despite VKA therapy, were enrolled. Patients with a mechanical PMV were included and compared with those affected by nonvalvular AF. The primary endpoint was the composite of all-cause death, major cardiovascular events, and major bleedings at follow-up. The feasibility and safety of LAAC also were assessed., Results: A total of 55 patients (42% female; mean age, 70 ± 9 years), including 12 with a mechanical PMV, were enrolled. The most-frequent indication to LAAC (71%) was LAA thrombosis or sludge. Procedural success was achieved in 96% of overall cases, and in 100% of patients with a PMV. In 35 patients, a cerebral protection device was used. During a median follow-up of 6.1 ± 4.3 years, 4 patients with a PMV, and 20 patients without a PMV, reported adverse events (hazard ratio 0.73 [95% confidence interval 0.25-2.16, P = 0.564])., Conclusions: LAAC seems to be a valuable alternative in patients with AF who have a mechanical PMV, with failure of VKA therapy. This off-label, real-world clinical practice indication deserves validation in further studies., (Copyright © 2024 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
- Full Text
- View/download PDF
50. Percutaneous closure of a sinus venosus defect with partial anomalous pulmonary venous return.
- Author
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Bienstock SW, Hopkins K, Love B, Zaidi A, LaRocca G, Dangas G, and Lerakis S
- Subjects
- Humans, Male, Aged, Heart Septal Defects, Atrial diagnosis, Heart Septal Defects, Atrial surgery, Heart Septal Defects, Atrial complications, Echocardiography methods, Scimitar Syndrome surgery, Scimitar Syndrome diagnosis, Scimitar Syndrome physiopathology, Septal Occluder Device, Treatment Outcome, Pulmonary Veins abnormalities, Pulmonary Veins surgery, Echocardiography, Transesophageal methods, Cardiac Catheterization methods
- Abstract
A 73-year-old man with a history of hypertension, hyperlipidemia, and obesity presented for cardiovascular evaluation. He was experiencing mild fatigue and dyspnea on exertion. Transthoracic echocardiogram (TTE) showed right ventricular dilation, which was otherwise unremarkable.
- Published
- 2024
- Full Text
- View/download PDF
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