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Keywords = Amplatzer Septal Occluder

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12 pages, 1026 KiB  
Article
Efficacy and Safety of Percutaneous ASD Closure in Adults: Comparative Outcomes of Occluder Devices in a Single-Center Cohort
by Elham Kayvanpour, Elena Matzeit, Christoph Reich, Ziya Kaya, Sven Pleger, Norbert Frey, Benjamin Meder and Farbod Sedaghat-Hamedani
J. Clin. Med. 2025, 14(6), 1867; https://doi.org/10.3390/jcm14061867 - 10 Mar 2025
Viewed by 903
Abstract
Background: Atrial septal defect (ASD) is a prevalent congenital heart condition, resulting in left-to-right shunting. Untreated ASDs may be associated with complications, including right-sided heart failure, pulmonary hypertension, and atrial arrhythmias. Percutaneous ASD closure, performed with various occluder devices, has become the preferred [...] Read more.
Background: Atrial septal defect (ASD) is a prevalent congenital heart condition, resulting in left-to-right shunting. Untreated ASDs may be associated with complications, including right-sided heart failure, pulmonary hypertension, and atrial arrhythmias. Percutaneous ASD closure, performed with various occluder devices, has become the preferred approach for symptomatic patients with suitable anatomy, yet data on device-specific efficacy and safety profiles remain limited. Methods: This study was a retrospective, single-center analysis involving patients who underwent percutaneous ASD closure between January 2000 and February 2023. Data on patient characteristics, indications for the procedure, procedural details, and clinical outcomes were extracted from electronic medical records. Endpoints included complications at the puncture site, pericardial effusion, atrial arrhythmias, device-related thrombus formation, and overall survival. Results: A total of 195 patients were included (mean age 53.6 ± 16.2 years; 60.5% female). Three different devices were used: Amplatzer ASD occluder (n = 111), Gore Septal Occluder (n = 67), and Occlutech ASD occluder (n = 17). Initial procedural success rate was 90.8%, with no significant differences observed between devices. Periprocedural complication rates were low and comparable across all devices. New-onset atrial fibrillation within the first month post-implantation occurred in 7.5% of patients with the Gore device, compared to 0.9% with the Amplatzer device (p = 0.03) and 0% with the Occlutech device. No statistically significant differences were observed among the devices regarding thrombus formation, late-onset pericardial effusion, device erosion, or stroke. Conclusions: Percutaneous ASD closure demonstrates high procedural success and low complication rates across different occluder devices, supporting its efficacy and safety as a treatment for adults. Although the Gore device showed a higher incidence of new-onset AF compared to the Amplatzer device, no significant differences were observed regarding thrombus formation, pericardial effusion, device erosion or stroke. Full article
(This article belongs to the Special Issue Adult Congenital Heart Disease: Latest Advances and Prospects)
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9 pages, 476 KiB  
Article
Comparative Effectiveness of Devices for Interventional Patent Foramen Ovale Closure: Insights from a 23-Year Monocentric Analysis
by Elham Kayvanpour, Elena Matzeit, Ziya Kaya, Sven Pleger, Anke Bahrmann, Christine Reichardt, Peter Arthur Ringleb, Norbert Frey, Benjamin Meder and Farbod Sedaghat-Hamedani
J. Clin. Med. 2024, 13(21), 6354; https://doi.org/10.3390/jcm13216354 - 23 Oct 2024
Cited by 2 | Viewed by 1693
Abstract
Background/Objectives: Patent foramen ovale (PFO) is a congenital heart defect affecting up to 25% of the population, associated with an increased risk of cryptogenic stroke. Percutaneous PFO closure is a minimally invasive procedure aimed at reducing stroke risk by eliminating the right-to-left shunt. [...] Read more.
Background/Objectives: Patent foramen ovale (PFO) is a congenital heart defect affecting up to 25% of the population, associated with an increased risk of cryptogenic stroke. Percutaneous PFO closure is a minimally invasive procedure aimed at reducing stroke risk by eliminating the right-to-left shunt. Methods: This monocentric, retrospective study analyzed 716 patients who underwent PFO closure between January 2000 and February 2023. Data collected included demographics, indications for closure, procedural details, and outcomes. Key endpoints were complications at the puncture site, pericardial effusion, recurrent stroke or transient ischemic attack (TIA), thrombi on the device, new-onset atrial fibrillation, and death. Results: The cohort had a mean age of 50.6 ± 12.6 years, with 60.8% female. Four devices were used: Occlutech PFO occluder (n = 106), Amplatzer PFO occluder (n = 227), Gore septal occluder (n = 296), and Cardia PFO-Star (n = 87). The initial procedural success rate was 98.9%, with no significant differences between devices. Complication rates were low across all devices. Residual shunt incidence decreased from 17.9% in 1 month to 3.4% in 12 months. Device-specific complications included late-onset pericardial effusion (p = 0.01), erosions (Cardia PFO-Star), and device thrombus formation (Gore septal occluder). Conclusions: PFO closure is a safe and effective method for preventing recurrent strokes, with high success rates and varying specific complication profiles, depending on the device. Further long-term studies are needed to evaluate newer devices and optimize patient outcomes. Full article
(This article belongs to the Special Issue Patent Foramen Ovale 2023: More Lights than Shadows)
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10 pages, 789 KiB  
Article
Clinical Performance of the Gore Septal Occluder in Patent Foramen Ovale Closure in Different Septal Anatomies: 1-Year Results from a Single-Center Experience
by Giuseppe Verolino, Dario Calderone, Mara Gavazzoni, Davide Sala and Paolo Sganzerla
J. Clin. Med. 2023, 12(18), 5936; https://doi.org/10.3390/jcm12185936 - 13 Sep 2023
Cited by 4 | Viewed by 1876
Abstract
Background: PFO (Patent foramen ovale) is a common defect that affects about 25% of the population. Although its presence is asymptomatic in the majority of the cases, the remaining part becomes overt with different symptoms, including cryptogenic stroke. PFO closure is currently a [...] Read more.
Background: PFO (Patent foramen ovale) is a common defect that affects about 25% of the population. Although its presence is asymptomatic in the majority of the cases, the remaining part becomes overt with different symptoms, including cryptogenic stroke. PFO closure is currently a widely available procedure in complex anatomy, with Amplatzer PFO Occluder (APO) being the most commonly used tool. However, the performance of another device, the GORE Septal Occluder (GSO), has not been completely explored with regard to different septal anatomies. Methods: From March 2012 to June 2020, 118 consecutive patients with an indication of PFO closure were treated using the GSO system, included in a prospective analysis, and followed. After 12 months, every patient underwent transcranial Doppler ultrasound to evaluate the effectiveness of treatment. Results: Of 111 patients evaluated, 107 showed effective PFO closure (96.4%), and 4 showed a residual shunt (3.6%). To better evaluate the device performance, the overall population was sorted into two clusters based on the echocardiographic characteristics. The main difference between groups was for PFO width (4.85 ± 1.8 vs. 2.9 ± 1 mm, p < 0.001) and PFO tunnel length (12.6 ± 3.8 vs. 7.2 ± 2, p < 0.001), allowing complex and simple anatomies to be identified, respectively. Regardless of the aforementioned cluster, the GSO performance required to reach an effective closure was independent of anatomy type and the chosen device size. Conclusion: The GSO device showed a high closure rate at 1-year follow-up in patients, with at least one anatomical factor of complexity of PFO irrespective of the level of complexity itself. Full article
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13 pages, 5998 KiB  
Article
ECG-Gated CCTA in the Assessment of Post-Procedural Complications
by Carlo Liguori, Giulia Lassandro, Giovanni Ferrandino, Stefano Giusto Picchi, Stefania Tamburrini, Gabriella Toro, Fabio Tamburro, Salvatore Masala and Mariano Scaglione
Diagnostics 2023, 13(15), 2500; https://doi.org/10.3390/diagnostics13152500 - 27 Jul 2023
Cited by 1 | Viewed by 1687
Abstract
Introduction: The aim of our study was to assess the role of ECG-gated coronary CT angiography (CCTA) in the diagnosis, imaging follow-up, and treatment guidance in post-procedural/surgical interventions in the heart and thoracic aorta (PTCA, TAVI, PMK/ICD placement, CABGs). Materials and Methods: We [...] Read more.
Introduction: The aim of our study was to assess the role of ECG-gated coronary CT angiography (CCTA) in the diagnosis, imaging follow-up, and treatment guidance in post-procedural/surgical interventions in the heart and thoracic aorta (PTCA, TAVI, PMK/ICD placement, CABGs). Materials and Methods: We retrospectively evaluated 294 ECG-gated CCTA studies performed in our center from January 2020 to January 2023. CCTA studies were acquired to detect/exclude possible complications related to the endovascular or surgical procedure. Results: There were 27 cases (9.2%) of post-procedural complications. Patients enrolled in the study were 18 males and 9 females (male/female ratio: 2), with age ranging from 47 to 86 years (mean age, 68.3 years). Among percutaneous coronary intervention (PCI) complications, coronary intimal dissection with ascending aorta involvement was found to be the most frequent complication after PTCA (22.2%). Vascular wall pseudoaneurysm formation (11.1%) and coronary stent misalignment or displacement (14.8%) were complications less frequently encountered after PTCA. Right atrial or ventricular perforation with associated hemopericardium were the most common complications (18.5%) after pacemaker implantation. Complications encountered after aortic valve interventions were loosening and dislocation of the prosthesis associated with aortic root pseudoaneurysm (7.4%), para-valvular leak (11.1%), and hemopericardium (7.4%). In one patient who underwent transcatheter repair of patent foramen ovale (3.7%), CTTA detected the dislocation of the Amplatzer septal occluder. Conclusions: ECG-gated CCTA is a fundamental diagnostic tool for the detection of post-procedural endovascular/surgical complications to enable optimal patient management. Radiologists must be familiar with the use of cardiac synchronization in the course of CT and must be aware of all possible complications that can occur in the context of acute settings or routine follow-up studies. Full article
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9 pages, 245 KiB  
Article
The Prevalence of and Predisposing Factors for Late Atrial Arrhythmias after Transcatheter Closure of Secundum Atrial Septal Defects in Children
by Tariq Abu-Tair, Claudia Martin, Christiane M. Wiethoff and Christoph Kampmann
J. Clin. Med. 2023, 12(11), 3717; https://doi.org/10.3390/jcm12113717 - 28 May 2023
Cited by 2 | Viewed by 1746
Abstract
Background: A 24 h Holter study in children after transcatheter secundum ASD (ASD II) closure was conducted to detect the prevalence of defects and/or device-related late atrial arrhythmias (LAAs). ASD II closure with an Amplatzer septal occluder (ASO) is an established procedure. Little [...] Read more.
Background: A 24 h Holter study in children after transcatheter secundum ASD (ASD II) closure was conducted to detect the prevalence of defects and/or device-related late atrial arrhythmias (LAAs). ASD II closure with an Amplatzer septal occluder (ASO) is an established procedure. Little is known about LAAs after device implantation. Methods: The eligible participants were children who had undergone ASO implantation, with a follow-up of ≥5 years, as well as one pre- and at least one post-procedural Holter ECG. Results: In total, 161 patients (mean age: 6.2 ± 4.3 years), with a mean follow-up of 12.9 ± 3.1 years (range 5–19), were included. A median of four Holter ECGs per patient were available. LAAs occurred before intervention in four patients (2.5%), and it was peri-interventional in four patients (2.5%), sustained in three patients (1.9%), and developed in three patients (1.9%). In patients with pre- and peri-interventional LAAs, the Qp/Qs ratio was higher (6.4 ± 3.9 vs. non-AA: 2.0 ± 1.1 (p = 0.002)) and the IAS/ASO ratio was lower (1.18 ± 0.27 vs. non-AA: 1.7 ± 0.4 (p < 0.001)). The patients with LAAs differed from those without LAAs in their Qp/Qs (6.8 ± 3.5 vs. 2.0 ± 1.3; p < 0.0001) and IAS/ASO ratios (1.14 ± 0.19 vs. 1.73 ± 0.45; p < 0.001). The patients with LAAs had a Qp/Qs ratio ≥2.94:1, and those who developed LAAs had an IAS/ASO ratio <1.15. Conclusions: LAAs occurred in 1.9% of patients and were sustained in another 1.9% of patients but persisted in those with large shunt defects and large occluders in relation to the atrial septal length. The predisposing factors for LAAs after ASD closure were a high Qp/Qs ratio, pre-existing atrial arrhythmias, and a low IAS/ASO ratio. Full article
(This article belongs to the Special Issue Congenital Heart Disease: Clinical Practice, Prognosis and Outcome)
20 pages, 1359 KiB  
Article
Procedural Tools and Technics for Transcatheter Paravalvular Leak Closure: Lessons from a Decade of Experience
by Sébastien Hascoët, Grzegorz Smolka, Teoman Kilic, Reda Ibrahim, Eustaquio-Maria Onorato, Patrick A. Calvert, Didier Champagnac, Xavier Freixa-Rofastes, Aleksejus Zorinas, Juan Pablo Sandoval, Gregory Ducrocq, Frederic Bouisset, Alain Fraisse and Benoit Gerardin
J. Clin. Med. 2023, 12(1), 119; https://doi.org/10.3390/jcm12010119 - 23 Dec 2022
Cited by 7 | Viewed by 3877
Abstract
Prosthetic paravalvular leaks (PVLs) are associated with congestive heart failure and hemolysis. Surgical PVL closure carries high risks. Transcatheter implantation of occluding devices in PVL is a lower risk but challenging procedure. Of the available devices, only two have been specifically approved in [...] Read more.
Prosthetic paravalvular leaks (PVLs) are associated with congestive heart failure and hemolysis. Surgical PVL closure carries high risks. Transcatheter implantation of occluding devices in PVL is a lower risk but challenging procedure. Of the available devices, only two have been specifically approved in Europe for transcatheter PVL closure (tPVLc): the Occlutech® Paravalvular Leak Device (PLD) and Amplatzer™ ParaValvular Plug 3 (AVP 3). Here, we review the various tools and devices used for tPVLc, based on three observational registries including 748 tPVLc procedures performed in 2005–2021 at 33 centres in 11 countries. In this case, 12 registry investigators with over 20 tPVLc procedures each described their practical tips and tricks regarding imaging, approaches, delivery systems, and devices. They considered three-dimensional echocardiography to be the cornerstone of PVL assessment and procedure guidance. Anterograde trans-septal mitral valve and retrograde aortic approaches were used in most centres, although some investigators preferred the transapical approach. Hydrophilic-coated low-profile sheaths were used most often for device deployment. The AVP 3 and PLD devices were chosen for 89.0% of procedures. Further advances in design and materials are awaited. These complex procedures require considerable expertise, and experience accumulated over a decade has no doubt contributed to improve practices. Full article
(This article belongs to the Section Cardiology)
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17 pages, 3409 KiB  
Review
Advances in Percutaneous Patent Foramen Ovale Closure: From the Procedure to the Echocardiographic Guidance
by Simona Sperlongano, Mario Giordano, Giovanni Ciccarelli, Giuseppe Bassi, Marco Malvezzi Caracciolo D’Aquino, Carmen Del Giudice, Gianpiero Gaio, Antonello D’Andrea, Adriana Postolache, Maurizio Cappelli Bigazzi, Giancarlo Scognamiglio, Berardo Sarubbi, Maria Giovanna Russo, Paolo Golino and Patrizio Lancellotti
J. Clin. Med. 2022, 11(14), 4001; https://doi.org/10.3390/jcm11144001 - 11 Jul 2022
Cited by 14 | Viewed by 4378
Abstract
Percutaneous patent foramen ovale (PFO) closure by traditional, double disc occluder devices was shown to be safe for patients with PFO, and more effective than prolonged medical therapy in preventing recurrent thromboembolic events. The novel suture-mediated “deviceless” PFO closure system overcomes most of [...] Read more.
Percutaneous patent foramen ovale (PFO) closure by traditional, double disc occluder devices was shown to be safe for patients with PFO, and more effective than prolonged medical therapy in preventing recurrent thromboembolic events. The novel suture-mediated “deviceless” PFO closure system overcomes most of the risks and limitations associated with the traditional PFO occluders, appearing to be feasible in most interatrial septum anatomies, even if data about its long-term effectiveness and safety are still lacking. The aim of the present review was to provide to the reader the state of the art about the traditional and newer techniques of PFO closure, focusing both on the procedural aspects and on the pivotal role of transesophageal echocardiography (TEE) in patient’s selection, peri-procedural guidance, and post-interventional follow-up. Full article
(This article belongs to the Section Cardiology)
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37 pages, 73340 KiB  
Review
Role of Echocardiography in the Diagnosis and Interventional Management of Atrial Septal Defects
by P. Syamasundar Rao
Diagnostics 2022, 12(6), 1494; https://doi.org/10.3390/diagnostics12061494 - 18 Jun 2022
Cited by 8 | Viewed by 11699
Abstract
This review centers on the usefulness of echo-Doppler studies in the diagnosis of ostium secundum atrial septal defects (ASDs) and in their management, both in children and adults. Transthoracic echocardiography can easily identify the secundum ASDs and also differentiate secundum ASDs from other [...] Read more.
This review centers on the usefulness of echo-Doppler studies in the diagnosis of ostium secundum atrial septal defects (ASDs) and in their management, both in children and adults. Transthoracic echocardiography can easily identify the secundum ASDs and also differentiate secundum ASDs from other kinds of ASDs, such as ostium primum ASD, sinus venosus ASD and coronary sinus ASD, as well as patent foramen ovale. Preliminary selection of patients for device occlusion can be made by transthoracic echocardiograms while final selection is based on transesophageal (TEE) or intracardiac (ICE) echocardiographic studies with optional balloon sizing of ASDs. TEE and ICE are extremely valuable in guiding device implantation and in evaluating the position of the device following its implantation. Echo-Doppler evaluation during follow-up is also useful in documenting improvements in ventricular size and function, in assessing the device position, in detecting residual shunts, and in identifying rare device-related complications. Examples of echo images under each section are presented. The reasons why echo-Doppler is very valuable in diagnosing and managing ASDs are extensively discussed. Full article
(This article belongs to the Special Issue Diagnosis and Management of Congenital Heart Disease)
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8 pages, 382 KiB  
Article
Comparison of the Change in Diastolic Dysfunction after Transcatheter Atrial Septal Defect Closure between Asymptomatic Younger and Older Age Groups
by Lucy Youngmin Eun, Han Ki Park and Jae Young Choi
J. Clin. Med. 2020, 9(11), 3637; https://doi.org/10.3390/jcm9113637 - 12 Nov 2020
Cited by 2 | Viewed by 2326
Abstract
Transcatheter device closure of a secundum atrial septal defect (ASD) is followed by a noticeable change in the left atrium (LA) and left ventricle (LV) over a long-term follow-up. This study aimed to assess the remodeling of the atrial and ventricular myocardium with [...] Read more.
Transcatheter device closure of a secundum atrial septal defect (ASD) is followed by a noticeable change in the left atrium (LA) and left ventricle (LV) over a long-term follow-up. This study aimed to assess the remodeling of the atrial and ventricular myocardium with respect to diastolic function in adult ASD patients. Around 38 asymptomatic patients (age: 48.6 ± 17.1 years, range: 23–69 years) diagnosed with ASD during routine health check-up and who underwent ASD device closure with the Amplatzer septal occluder were included in this retrospective study, and their medical records (containing echocardiographic data) were reviewed. The defect size was 21.77 + 6.79 mm, while the balloon measurement of the defect was 24.29 ± 6.64 mm. The patients were divided into two groups, namely, Group I (with 18 patients aged <50 years [mean: 33.06 ± 9.43 years] and Group II (with 20 patients aged ≥50 years [mean: 62.55 ± 7.54 years]). Comparison of echocardiographic data collected before closure and at a follow-up 2 years later revealed significant differences between pre-closure and post-closure states in the left ventricular end-diastolic dimension (40.76 ± 3.28 vs. 43.39 ± 3.52), left ventricular mass (99.64 ± 28.81 vs. 116.57 ± 32.03), and right ventricular pressure (36.88 ± 12.20 vs. 31.81 ± 11.11). Tissue Doppler measurements were significantly decreased 2 years after closure, while the post-closure E/E’ was higher than the pre-closure E/E’ (11.58 ± 4.80 vs. 8.79 + 3.19, p < 0.005). In both groups, mitral A and tissue Doppler E’, A’, and S’ values decreased post-closure, while the E/E’ was higher in Group II than in Group I at both pre-closure and long-term follow-up measurements (pre-closure: 9.60 ± 5.15 vs. 7.41 ± 1.42, p < 0.003; post-closure: 13.03 + 4.05 vs. 10.49 ± 3.95, p < 0.02). The LA size and LV function exhibited recognizable remodeling after transcatheter ASD closure. Because the LV preload elevation (i.e., E/E’) after ASD closure can be pronounced in older patients, caution should be provided more in older patients than in younger patients. Hence, it may be beneficial to close the ASD at an earlier age in adults even after a late diagnosis; a relatively younger age may be more suited for adaptation to the remodeling process to protect the myocardial function. Careful consideration should be given to the previous underloaded left heart after long-term closure. Full article
(This article belongs to the Special Issue Adult Congenital Heart Disease: An Increasing and Ageing Population)
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23 pages, 54145 KiB  
Review
Outcomes of Device Closure of Atrial Septal Defects
by P. Syamasundar Rao
Children 2020, 7(9), 111; https://doi.org/10.3390/children7090111 - 25 Aug 2020
Cited by 7 | Viewed by 8882
Abstract
Several devices have been designed and tried over the years to percutaneously close atrial septal defects (ASDs). Most of the devices were first experimented in animal models with subsequent clinical testing in human subjects. Some devices were discontinued or withdrawn from further clinical [...] Read more.
Several devices have been designed and tried over the years to percutaneously close atrial septal defects (ASDs). Most of the devices were first experimented in animal models with subsequent clinical testing in human subjects. Some devices were discontinued or withdrawn from further clinical use for varied reasons and other devices received Food and Drug Administration (FDA) approval with consequent continued usage. The outcomes of both discontinued and currently used devices was presented in some detail. The results of device implantation are generally good when appropriate care and precautions are undertaken. At this time, Amplatzer Septal Occluder is most frequently utilized device for occlusion of secundum ASD around the world. Full article
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