Atrial Septal Defect Occluder Research Articles

Abstract 4138310: Successful Endovascular Closure of Ascending Aortic Pseudoaneurysm Using Atrial Septal Defect Occluder

Introduction: Ascending aortic pseudoaneurysms are mostly related to either surgery or non-surgical trauma. Any pseudoaneurysm arising from graft anastomoses, regardless of size or location, must be repaired due to the potential for catastrophic rupture. Traditional surgical intervention has a high mortality rate, but percutaneous treatment has emerged as an alternative. We present such a case of pseudoaneurysm treated by percutaneous intervention using a 6-mm Amplatzer device. Case: A 77-year-old female with a history of type A aortic dissection s/p emergent repair with a 32 mm tube graft one year ago presented with chest pain radiating to her back. Initial vital signs showed a BP of 185/105, SaO2 98% on RA, 98.3 F, HR 98 bpm, and RR 24/min. A chest CT scan suggested a pseudoaneurysm at the proximal anastomotic site of the aortic graft (Figs. 1A and B). Serial troponin and EKGs were unremarkable for acute ischemia. Multiple quaternary centers declined intervention due to the high risk of redo sternotomy for open repair and patient frailty. After multidisciplinary discussions, it was felt that percutaneous closure with an Amplatzer device was possible without coronary obstruction. In the catheterization lab, a TEE probe was placed to visualize the pseudoaneurysm of the ascending aorta (Fig. 1C). Angiography showed the aneurysm coming off the posterior aorta just above the noncoronary cusp, with the neck measuring ~6 mm (Fig. 1D). The aneurysm was successfully engaged using an 8-French sheath and an 8-French AL1. Based on measurements from the TEE and the angiogram, a 6 mm ASO device was used. After device deployment and release, aortograms showed that the pseudoaneurysm was excluded (Fig. 1H). Assessment with TEE and CTA showed no residual flow in the pseudoaneurysm (Fig. 1 E–G). Conclusion: Using an atrial septal occluder, endovascular intervention may be a safe and effective alternative to surgery for treating the ascending aortic pseudoaneurysm, especially in patients with a high prohibitive surgical risk. Longitudinal follow-ups are needed to comment on long-term mortality benefits for these individuals.

Successful treatment of atrial flutter post-radiofrequency ablation for atrial fibrillation following atrial septal defect occlusion: a case report of pulsed field ablation

Abstract Background Atrial flutter (AFL) is a common arrhythmia following radiofrequency ablation (RFA) for atrial fibrillation (AF), with varying incidence depending on the ablation strategy. Patients with prior atrial septal defect (ASD) occlusion pose challenges for ablation, particularly when the lesions are located near the occluder. Pulsed field ablation (PFA) has emerged as a promising alternative to RFA for the treatment of AF or AFL; however, its use in patients with ASD occlusion remains unexplored. Case summary We present the case of a 46-year-old female with a history of ASD occlusion and subsequent RFA for AF. Despite the initial success, she developed symptomatic AFL 3 months post-procedure. Intracardiac echocardiography (ICE)–guided transseptal puncture guided by ICE revealed an AFL originating from the slow conduction area around the ASD occluder. Pulsed field ablation was successfully performed, and AFL was terminated without complications. Post-procedural follow-up demonstrated maintenance of sinus rhythm. Discussion Patients with ASD occlusion present unique challenges for ablation, including difficulties in transseptal puncture and risk of injury to the occluder. Pulsed field ablation offers a potential solution, with studies showing fewer reconnected pulmonary veins and larger lesion creation compared with traditional methods. In our case, PFA effectively terminated the refractory AFL, highlighting its utility in this patient population. Moreover, the use of the Jinjiang PFA catheter with pulse circuit self-checking technology ensured procedural safety, particularly near the occluder.

Transcatheter intervention treatment secondary septal pouch and patent foramen ovale with an atrial septal defect occluder.

Transcatheter intervention treatment secondary septal pouch and patent foramen ovale with an atrial septal defect occluder.

Closure of small fenestrations without optimal rims with a PDA coil far from primary atrial septal defects: a new approach.

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.

S4102 Closing Paths: ASD Occluder Innovation in Gastropleural Fistula Closure

S4102 Closing Paths: ASD Occluder Innovation in Gastropleural Fistula Closure

In-Vitro Assessment of Atrial Septal Defect Occluder Deployment: A Crucial Step in Occluding Atrial Septal Defects and Restoring Cardiac Function

In-Vitro Assessment of Atrial Septal Defect Occluder Deployment: A Crucial Step in Occluding Atrial Septal Defects and Restoring Cardiac Function

Long-Term Results of the Atrial Septal Defect Occluder ASSURED Trial for Combined Pivotal/Continued Access Cohorts

BackgroundThe GORE CARDIOFORM ASD Occluder (GCA, W. L. Gore & Associates) was approved in 2019 for ostium secundum atrial septal defect (ASD) closure. ObjectivesThis 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. MethodsThis 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. ResultsOf 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). ConclusionsIn 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)

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

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

Occlusion of Iatrogenic Atrial Septal Defects After Mitral Valve-in-Valve Implantation With a Novel Bioresorbable Occlusion Device

Occlusion of Iatrogenic Atrial Septal Defects After Mitral Valve-in-Valve Implantation With a Novel Bioresorbable Occlusion Device

Unexpected right atrial disc expansion of atrial septal defect occluder: a rare complication of percutaneous occluder.

Unexpected right atrial disc expansion of atrial septal defect occluder: a rare complication of percutaneous occluder.

Managing a Challenge Case: Transesophageal Echocardiography-Guided Transcatheter Closure of a Large Secundum Atrial Septal Defect in a Pregnant Woman

Background: The management of complex cardiovascular conditions during pregnancy poses unique challenges, and in the case of a large secundum atrial septal defect (ASD), achieving successful closure through a transcatheter approach guided by transesophageal echocardiography (TEE) requires careful navigation and expertise. This study sought to present a case that exemplifies the contemporary approach of using TEE guidance for the closure of an ASD in pregnant women Case presentation: A 31-year-old woman with multigravida, diagnosed with secundum ASD and pulmonary hypertension, underwent TEE. The TEE examination revealed a significant ASD measuring 2.8-3.1 cm with inadequate surrounding rims. Subsequently, our intention was to employ a device to address this defect. TEE was utilized to guide the placement of a 14F delivery sheath into the left upper pulmonary vein and left atrium. Using a catheter, we successfully deployed a 40 mm ASD Occluder (MemoPart), concluding the intervention without any complications. Given the concerns regarding the potential risks of radiation exposure and teratogenic effects on fetal development, particularly in young patients and during pregnancy, it is crucial to prioritize TEE-guided closure of ASD for the safety of both the mother and the fetus. Conclusion: Closure of ASD with zero fluoroscopy proved to be a safe and effective procedure, demonstrating feasibility and significant benefits for pregnant women with ASD. Keyword: Atrial Septal Defect, Pregnant Woman, Transcatheter Closure, Transesophageal Echocardiography.

Shed Atrial Septal Occluder Removed by Gastric Biopsy Forceps: A Case Report

Atrial septal defect (ASD) is a common congenital heart disease, and can be treated with occluders. However, occluder detachment remains one of the most urgent complications to be resolved. This paper reported a case of ASD occluder detachment, which was successfully resolved with gastroscopic biopsy forceps. A 57-year-old woman complained chest distress for over one week, and was admitted to cardiovascular department of Sir Run Run Shaw Hospital. Based on echocardiography, the patient was diagnosed as ASD, mitral and tricuspid valve regurgitation. On the second day after percutaneous closure of residual ASD, routine chest radiographs showed the occluder detached into the abdominal aorta. After a thorough evaluation and examination, we decided to use gastric biopsy forceps to remove occluder. As a result, the patient recovered well and discharged from the hospital. For postoperative patients with ASD, when occlusion devices detached and conventional strategies could not extract the occluders, gastric biopsy forceps would be appliable. Compared to conventional strategies, gastric biopsy forceps have better grasping force, and provide secure fixing for disconnected or detached occlusion devices in cardiac interventional surgeries.

Right disc thrombosis of the new Gore Cardioform ASD Occluder.

The GCA is a well performing device in terms of efficacy despite complex anatomies (aortic rim <5 mm and ASD diameter >17 mm) with a good safety profile. To evaluate atrial septal defect (ASD) features impacting on right disc device thrombosis in patients who underwent Gore Cardioform ASD Occluder (GCA) implantation. A total of 44 consecutive patients undergoing percutaneous ASD with GCA device from January 2020 to September 2022 at our tertiary care Center were evaluated. The minimum follow-up was 6 months. The patients were stratified in two groups according to a cut-off value of ASD diameter equal to 20 mm at sizing balloon, derived from ROC analysis (AUC = 0.894; p = 0.024). Baseline characteristics were comparable between groups in terms of age, sex, weight, height, and interatrial septum dimensions. Patients with ASD > 20 mm (n = 9) had a higher ASD/device dimension ratio, both at echocardiography (p = 0.009) and at sizing balloon (p = 0.001), longer fluoroscopic time (p = 0.022), and higher incidence of device thrombosis (0.006). Right disc thrombosis was observed in three patients of the ASD > 20 mm group, always in the inferior portion of the right disc. On univariate analysis, ASD diameter at sizing balloon (OR 1.360; p = 0.036) was the only positive predictor of device thrombosis. Right disc thrombosis of the GCA device may be under-recognized at follow-up, hence deserving clinical attention, especially in those patients with larger ASD diameters.

Device-related thrombosis after transcatheter closure of atrial septal defect using the Gore Cardioform ASD occluder.

A previously healthy 60-year-old female was diagnosed with a secundum atrial septal defect measuring 23 x 12 mm on transesophageal echocardiogram.

Cerebral Embolism and MINOCA Secondary to Left Atrial Myxoma after Occlusion of Atrial Septal Defect by Amplatzer Occluder: A Case Report.

Primary heart tumors are rare, with atrial myxomas being the most common type. Atrial myxomas can lead to embolisms, heart obstruction, and systemic symptoms. Herein, we report a case of 72-year-old woman who presented with a left atrial myxoma at the atrial septal defect occluder, a new acute cerebral infarction, and MINOCA (myocardial infarction with no obstructive coronary atherosclerosis). Left atrial myxoma is a common primary cardiac tumor; however, left atrial myxomas arising after percutaneous atrial septal defect occlusion are rare. Additionally, the patient presented with a new case of multiple systemic emboli. The patient underwent surgical resection of a left atrial myxoma, occluder, and left atrium, and atrial septal repair, and was discharged with good recovery for outpatient follow-up. The possibility of a cardiac tumor, especially an atrial myxoma, which can lead to a series of complications, should be considered at the closure site after percutaneous atrial septal closure. Therefore, active surgical treatment and long-term follow-up are warranted in such cases.

The Importance of Weight-Based Protocols and Reduction of Frame Rates in ASD Percutaneous Closure

Introduction: In the context of interventional and diagnostic cardiology procedures, there is a growing effort to minimize exposure to ionizing radiation. Most modern angiography machines allow selection of exposure parameters based on the patient's weight. Our experience has led us to question whether the use of weight-based protocols is the right approach for pediatric interventional cardiology exams. Aim and Materials: The purpose of this research is to investigate the efficacy of techniques aimed at reducing radiation exposure during ASD percutaneous closure in pediatric patients. Since 2020, in all patients we used predefined acquisition parameters with a low exposure level (CARD &lt;6Kg) and reduced pulsations to 4p/s. Therefore, from 2020 we used the lowest possible radiological pediatric protocol regardless of patient weight. We compared this group of patients (B) with an historical group of patients (A) with an ASD, in which a radiological protocol based only on patient’s weight was applied. Results: Group A included 92 patients with ostium secundum atrial septal defect. Group B included 114 patients with ostium secundum atrial septal defect. In this group, 22 patients received a Gore Cardioform ASD occluder device with the need of a biplane imaging. The two groups were comparable in terms of age (p=0.1) and weight (p=0.2). The absorbed dose in group A was significantly higher than in group B. Median total air kerma was 6.55 mGy(1.2-255,6 mGy) in group A and 5.25 mGy(0.4-140.5 mGy) in group B (p 0.001). Dose area product (DAP) was 130,2 μGym²(24.25-5774 μGym²) in group A and 67.1 μGym²(8.6-3107 μGym²) in group B(p 0.001). Conclusion: Our strategy resulted in a significant reduction in radiation exposure to the patients while maintaining good radioscopic resolution. This significance was maintained despite the use of new devices in 2021 in addition to Amplatzer (GORE-Occlutech).

Infective Endocarditis After Percutaneous Device Closure of Atrial Septal Defects: Incidence, Diagnosis, and Treatment. Case Report and Literature Review.

Infective endocarditis (IE) on atrial septal defect (ASD) closure devices, while extremely rare, has been reported to be more frequent early after the procedure. We describe a case of late IE after percutaneous closure of patent foramen ovale (PFO). We also performed a literature review on this subject. We reviewed a total of 42,365 patients who were treated with percutaneous devices: 13,916 for ostium secundum (OS) (32%), 24,726 for PFO (58%) and 3,723 for OS+PFO (8%). Among these patients, we identified 50 cases of IE after atrial septal defect device closure (0.001%). In contrast to previous reports, nearly 66% of IE in this setting occurred late, after at least 6 months from the procedure (33/50 patients). A statistical analysis clearly showed that the mean time from the procedure to IE increased in the last five years, probably associated with a change in antiplatelet therapy after ASD closure. Management of IE on an ASD occluder should always be discussed in the setting of a multidisciplinary heart team that includes a cardiologist, cardiac surgeon, and anesthetist. While surgical strategies gave excellent results, conservative management might be considered in cases of small IE vegetations and for patients in good general condition. However, in these cases, the patient must be closely observed with repeated blood and instrumental tests.

Atrial septal defect occluder devices and embolization – a case series

Introduction: Atrial Septal Defect (ASD) secundum is a commonly occurring congenital heart disease. Patients with unstable hemodynamic may require closure, which can be accomplished either percutaneous transcatheter of an atrial septal occluder (ASO) device or open surgery. Closure using an occluder carries the risk of device embolization (DE). Case Presentation: This case series presents two patients who had dislodgement after ASD closure using ASO. The demographic data, comorbidities, surgical details, and follow-up results are all summarized. A 9-year-old girl and a 12-year-old boy admitted to our centre. The girl echocardiography evaluation revealed dislodgment of ASD occluder in a large secundum ASD, right upper PV blockage, and a high chance of pulmonary hypertension (PH). While the boy showed the occluder device that was misplaced and positioned in the right ventricle. A secundum ASD with a left to right shunt and moderate TR with a peak pressure gradient of 21.5mmHg were also found. During the procedure, we discovered that the girl had an occluder in the superior rim of ASD II 3x2 cm, which was dislodged towards the lower right PV, above the mitral valve, and the posterior occluder leaflet was removed by replacing a section of the rim. We discovered a secundum ASD with a dimension of 2x1cm on the boy The occluder was found behind the anterior cusp of the tricuspid valve. The retrieved occluder device appeared intact, and the tricuspid valve was injured, but no rupture. Conclusion: The occurrence of ASO migration is uncommon, necessitating further surgery for device removal, closure of the remaining defect, and ensure there is no cardiac erosion or rupture. Surgery can also alleviate symptoms including shortness of breath and palpitations

Atrial septal defect occluder combined with stent graft for the management of post-dissection aortic aneurysm previously treated with unsuccessful coils: a case report

BackgroundAlthough the candy-plug technique has been reported to be useful for the treatment of post-dissection aortic aneurysm, the stent graft needs be to customized to accommodate the size of vascular occluders.Case presentationWe present a case of a persistent false lumen successfully treated with endovascular stent-graft and atrial septal defect occluder in a patient with Stanford Type B dissection. A covered stent graft was implanted into the false cavity through a distal rupture, and an atrial septal defect occluder was inserted into the covered stent to seal of the false cavity. Decreased aneurysmal diameter and false lumen thrombosis were noted by CT scan at 6-month follow-up.ConclusionsOur case showed that combined use of a stent graft and atrial septal defect occluder is safe, technically feasible and effective in sealing of the false lumen in post-dissection aortic aneurysm patients with previously failed false lumen thrombosis.

Impact of Gore Cardioform Atrial Septal Defect Occluder on Atrial and Ventricular Electromechanics in a Pediatric Population

Transcatheter closure is the first-line treatment for ostium secundum atrial septal defect (ASD). The GORE Cardioform ASD Occluder (GCA) is potentially innovative compared with other self-centering devices. This study aimed to compare the mechanic changes in atrial and ventricular properties before and after GCA implantation. All consecutive patients aged <18years who underwent isolated ASD closure with a single GCA device were enrolled from 2 centers. Echocardiography and electrocardiogram were performed the day before, 24hours, and 6months after ASD closure. Between January 2020 and February 2021, 70 pediatric patients with ASD were enrolled. The mean age was 7.9 ± 3.9years, and the mean defect diameter was 17.1 ± 4.5mm. Global longitudinal strain analysis showed no change in left ventricular longitudinal function (T0 -23.2 ± 2.8%, 24 hours -23.0 ± 2.8%, and 6months -23.5 ± 2.7%). An early and transient reduction in longitudinal strain was detected in the basal septal segments (T0 -19.8 ± 3.3%, 24 hours -18.7 ± 3.6%, and 6months -19.2 ± 3.4%), left atrium (T0 41.4 ± 15.3%, 29.2 ± 1.4%, and 39.0 ± 12.9%), and right ventricle (-27.6 ± 5.4%, -23.6 ± 5.0%, and -27.3 ± 4.6) 24hours after closure, secondary to hemodynamic changes because of flow redirection after ASD closure. Six months after the procedure, only the left atrium showed a mild global longitudinal strain reduction because of the presence of the device within the septum. GCA device had no impact on global and regional ventricular function. Atrial mechanics were preserved, except for the segments covered by the device. This is the first device demonstrating no impact on the left and right ventricular mechanics, irrespective of the device size.