Atrial Septal Defect Occluder Device Research Articles

Assessment of Nit-Occlud atrial septal defect occluder device healing process using micro-computed tomography imaging.

After percutaneous implantation of a cardiac occluder, a complex healing process leads to the device coverage within several months. An incomplete device coverage increases the risk of device related complications such as thrombosis or endocarditis. We aimed to assess the device coverage process of atrial septal defect (ASD) occluders in a chronic sheep model using micro-computed tomography (micro-CT). After percutaneous creation of an ASD, 8 ewes were implanted with a 16-mm Nit-Occlud ASD-R occluder (PFM medical, Cologne, Germany) and were followed for 1 month (N = 3) and 3 months (N = 5). After heart explant, the device coverage was assessed using micro-CT (resolution of 41.7 μm) and was compared to histological analysis. The micro-CT image reconstruction was performed in 2D and 3D allowing measurement of the coverage thickness and surface for each device. Macroscopic assessment of devices showed that the coverage was complete for the left-side disk in all cases. Yet incomplete coverage of the right-side disk was observed in 5 of the 8 cases. 2D and 3D micro-CT analysis allowed an accurate evaluation of device coverage of each disk and was overall well correlated to histology sections. Surface calculation from micro-CT images of the 8 cases showed that the median surface of coverage was 93±8% for the left-side disk and 55±31% for the right-side disk. The assessment of tissue reactions, including endothelialisation, after implantation of an ASD occluder can rely on in vitro micro-CT analysis. The translation to clinical practice is challenging but the potential for individual follow-up is shown, to avoid thrombotic or infective complications.

Atrial septal defect occluder device embolization: Experience of a tertiary care cardiac center.

Percutaneous device closure of atrial septal defect (ASD) has become an increasingly popular procedure as it offers several advantages. However, it is associated with infrequent, but life-threatening complications such as device embolization. To analyze the risk factors, common sites of embolization, associated complications, timing of embolization, and the treatment executed. A retrospective study was performed at a tertiary referral center for cardiac services. Pre-procedure, intra-procedure, and post-procedure data of patients whose ASD device embolized was collected retrospectively and analyzed for risk factors, common sites of embolization, associated complications, timing of embolization, and the treatment executed. Results: Thirty devices were embolized, out of which 13 were retrieved percutaneously in the Catheter laboratory, whereas 17 patients underwent surgery. Fourteen patients had an unfavorable septal morphology for device closure. Ten devices were embolized in the catheter laboratory, five in the intensive care unit, and two in the ward. The devices were embolized to almost all chambers of the heart and great vessels. One patient had an inferior vena cava rim tear while attempting percutaneous retrieval. One patient required a short period of total circulatory arrest (TCA) for retrieval of the device from ascending aorta, while another required a lateral position for retrieval from descending aorta. One patient required re-exploration for bleeding, while another had an air embolism and succumbed. Once embolization occurs, the risks associated increase manifold. Most of the surgical extractions are uneventful; however, there could be certain complications that may need repair of valvular apparatus, the institution of TCA, or the need for the lateral position. Air embolization though very rare can occur which could be fatal.

Abstract 15146: A Flying Saucer- Asymptomatic Migration of an Atrial Septal Defect Occluder Device to the Aortic Arch - No Good Deed Goes Unpunished!

Introduction: Though safe, the transcatheter closure with an atrial septal defect for secundum atrial septal defect (ASD) is associated with complications, such as device dislodgement. Case report: A 51-year-old female with a complex fenestrated secundum ASD (16mm superior defect and 14mm inferior defect with insufficient aortic rim) with hemodynamically significant shunt causing right heart dysfunction underwent placement of two atrial septal defect occluder devices (Amplatzer). While there was no shunting noted on immediate post-procedure transthoracic echocardiogram (TTE), a follow-up TTE after a year showed residual left to right shunting across the ASD. Transesophageal echocardiogram (TEE) showed a single occluder device (inferior) in place and a second device (superior) lodged in the distal aortic arch at the level of the left common carotid and left subclavian artery with mild local flow acceleration (aortic velocity 2.6 ms/s) and no superimposed device thrombus. Her only complaint was recurrent headaches, which pre-dated the procedure and were attributed to ocular migraine by her neurologist. The patient underwent a transcatheter procedure to attempt the retrieval of the dislodged device. The proximal end of the device was found adherent to the aortic wall. Aortogram revealed excellent flow around the device. The procedure was aborted due to the risk of dissection. Since the device did not cause any adverse effects and would likely continue to endothelialization. Conclusion: Atrial septal occluder device dislodgement can occur several months after implantation. Careful monitoring is required particularly when the ASD rim is insufficient. In cases of migration and adherence to the aortic wall without hemodynamic consequences, the device can likely be safely left in place to endothelialize. Despite a faster recovery with percutaneous procedures, a surgical approach should be considered in younger patients to avoid such complications.

Abstract 9492: Transcatheter Amplatzer Occluder Device Closure of Post-Myocardial Infarct Pseudoaneurysm: A Case Report

Introduction: Left Ventricular Pseudoaneurysm (LVP) is defined as cardiac wall rupture leading to a formation of wall with thrombus, pericardial, or scar tissue functioning as a pouch for blood. A loculated pericardial effusion (LPE), and right ventricular pericardial fistula (RVPF) have never been reported in literature. Here, we report the first case of a 70 year old male who developed a LVP, LPE, and RVPF. Case Description: A 70 year old male with a past medical history of hypertension presented with inferior wall STEMI. Cardiac catheterization demonstrated left anterior descending (LAD) with 80% occlusion and right coronary artery (RCA) with 100% occlusion. Percutaneous intervention of RCA with aspiration thrombectomy and two drug eluting stents was performed. Echocardiogram the following day demonstrated a LVP. A transesophageal echocardiogram (TEE) demonstrated LVP near the mid-inferior interventricular septum draining into the pericardial space, and LPE from the apical inferior left ventricle (LV) extending to the apical cap of the right ventricle (RV). Computed tomography angiography (CTA) demonstrated a multiloculated collection at the inferior septal aspect of LV contained by the pericardial space. Patient was a high risk for surgery. LVP was closed via a 24 mm atrial septal defect (ASD) occluder device. Intraoperative TEE demonstrated an ASD occluder device at the mid inferior septum at the location of the LVP neck with minimal residual flow into the LPE and a fistula connecting the LPE space with RV. RVFP was managed conservatively. LAD was managed medically. Patient was discharged home safely on guideline directed medical therapy. Discussion: LVP rate is 0.0026% following myocardial injury. It is reported that untreated LVP have a rupture risk of about 30% and a mortality rate of 50%. Prompt treatment is required to prevent mortality. Surgical management is the standard of care. A multidisciplinary heart team deemed the patient a high risk. Therefore, transcatheter treatment was sought in the patient above. Conclusions: Surgical treatment is standard of care for LVP, but transcatheter wall closure with an ASD device is a promising technique not only for high-risk surgical candidates such as above, but as a gold standard of treatment for LVP.

Device Closure of a Postoperative Residual Atrial Septal Defect after Seven Years

Postoperative residual atrial septal defect (ASD) is well explained and is usually small and of no hemodynamic significance, but large residual atrial septal defects are to be closed. Here we report a case of postoperative residual ASD which was reported as a small residual ASD in the immediate postoperative period, later presented to us with hemodynamically significant large residual symptomatic ASD. The residual ASD was successfully closed with a Floret ASD occluder device.

Late Infective Endocarditis Associated with an Atrial Septal Defect Occluder Device.

The Amplatzer septal occluder is one of several percutaneous devices used for the closure of secundum atrial septal defects. The main complications are related to the procedure, with infection being the least common. We present the case of a 67-year-old woman with a secundum atrial septal defect, who, 3 years after repair with an Amplatzer occluder, was admitted with sepsis and bacteraemia following recent hospitalization in an intensive care unit. Transoesophageal echocardiography showed the presence of a mobile echogenic structure in the left atrium suggestive of a vegetation. Few cases of late endocarditis involving the Amplatzer device have been reported, even though partial endothelization is one of the risk factors. There are no guidelines for the prevention, diagnosis or management of this complication.LEARNING POINTSThe Amplatzer septal occluder is one of several alternatives for the closure of atrial septal defects and has few related complications, with infection being the least common.Device-related endocarditis presents either early (<6 months) or late (>6 months).In our case, transoesophageal echocardiography played a key role in the diagnosis of late endocarditis.

Cardiac solution for a vascular scenario!

BackgroundAscending aortic pseudoaneurysms (AAPs) constitute a rare, albeit potentially dangerous, condition that occurs in up to 13% of patients after cardiac or aortic surgeries. For patients with a history of cardiac surgery, repeat thoracotomy poses additive risks. The high morbidity and mortality rates associated with the surgical management of AAPs have led to the development of transcatheter approaches.Case reportWe report a case of AAP percutaneous closure at the site of aortic cannulation with an ASO device in a post-CABG 65-year-old man, who refused surgery.ConclusionThe use of the Amplatzer Atrial Septal Defect Occluder (ASO) device represents an acceptable alternative to surgery in treatment of Ascending aortic pseudoaneurysms.

Percutaneous Closure of Atrial Septal Defects with the MemoPart Atrial Septal Occluder: The Early-Term Results of a Multicenter Study.

Atrial septal defect (ASD) is a common congenital heart disease with left-to-right shunt that may lead to pulmonary hypertension over time. Secundum ASD closure with transcatheter technique is currently the preferred method. The aim of this study was to evaluate the clinical experience and early-term outcomes of patients treated with a MemoPart ASD occluder device between June 2013 and June 2019. Fifty-six patients (35 females) with a mean age of 9.4 ± 6.6years (range: 2-44years) were included in the study. The diameters of the devices used to close the ASDs were 7-28mm. The ratio of the device/defect diameter was 1.14:1. Atrial septal defect closure was applied successfully in all patients. The MemoPart septal occluder is a safe and effective device for ASD closure. In wide ASDs and cases with more than one deficient rim, weak rims, or wide and complicated cases, it can be used carefully with sufficient experience.

Nit-Occlud atrial septal defect occluder device: Histological characterisation of the healing process.

We describe the healing process following transcatheter implantation of the Nit-Occlud ASD-R occluder (PFM medical, Cologne, Germany) for atrial septal defect closure in a sheep model with histological confirmation of neotissue formation covering the device.

Non-invasive assessment of cardiac percutaneous occluders healing process using computed tomography imaging: a proof of concept study

Abstract Funding Acknowledgements Type of funding sources: Other. Main funding source(s): National Research Agency (ANR) French Federation of Cardiology : “Aide à la recherche par équipe 2018, Cardiopathies de l’enfant” Introduction After percutaneous implantation of an atrial septal defect (ASD) occluder device, a complex healing process leads to the device coverage within several months. However, an unexplained incomplete device coverage is at risk of complications such as thrombosis or infectious endocarditis. Purpose The aim of the study was to assess the device coverage process of ASD occluder devices in a chronic sheep model using micro-CT technology. Methods After percutaneous creation of an ASD by catheterization, 8 ewes (mean age 5.4 ± 0.7 yo and mean weight 55.6 ± 7.9 kg) were implanted with a 16-mm Nit-Occlud ASD-R occluder (PFM medical, Cologne, Germany) and were followed for 1 month (N = 3) and 3 months (N =5). After heart explantation, a iodine contrast agent was used to enhance the tissue signal. The device coverage was then assessed by micro-CT and the results were compared to histology, used as the gold standard for healing evaluation. The micro-CT image resolution was 41.7 µm. Reconstruction was performed in 2D and 3D with Amira® software, allowing to obtain images that were exploited by a code to measure the surface for each disk of the analyzed devices. Histological study was performed after resin embedding and Richardson blue staining was used. The pathologist was blinded to the duration of animals’ follow-up and micro-CT results. Results ASD creation and device closure was successful in 100% animals without complications. Following heart explantation, macroscopic assessment of devices showed that the coverage was complete for the left-side disk regardless of the duration of the follow-up and variable for the right-side disk, depending of the protrusion of this disk. 2D and 3D micro-CT analysis allowed an accurate evaluation of device coverage of each disk and was overall well correlated to histology slices (cf Figure). Surface calculation from micro-CT images showed that the median surface of coverage was 93 ± 8% for the left-side disk and 55 ± 31% for the right-side disk. Conclusion This preliminary study made the proof of concept that micro-CT is a reliable tool to assess the coverage of intra-cardiac occluders in vitro. The translation to clinical practice is challenging but would allow an individual follow-up, to avoid thrombotic or infective complications. Abstract Figure.

Surgical explantation of atrial septal closure devices for refractory nickel allergy symptoms

ObjectivesSystemic allergic reactions to nickel alloys in percutaneous atrial septal defect occlusion devices have a poorly defined natural history. We describe our experience of surgical removal of the offending device in a series of patients with nickel allergy and refractory symptoms. MethodsPatients with atrial septal defect device explants for nickel allergy were reviewed. Administered questionnaires focused on symptoms, quality of life, and satisfaction along with the 36-Item Short Form Health Survey to measure physical and mental health postsurgery. ResultsAtrial septal defect devices were removed for nickel allergy in 58 patients during the past 10 years. The median age was 42 years (range, 24-71 years) and 95% were women. Explantation occurred at a median of 8 years (range, 6 months-18 years) after insertion. Symptoms included fatigue (82%), chest pain (78%), headache (73%), and palpitation (58%). Surveys were available for 45 patients: 58% rated their quality of life as poor and 69% were not at all satisfied with their device. Postexplant, all patients reported improvement in their symptoms, with 18 patients (42%) noting complete resolution. In 12 patients prospectively studied, the preoperative scores in physical and mental health domains were lower than the validation group, indicating significant disability. Similarly, there was marked improvement in each domain postremoval. ConclusionsPatients with nickel allergy and severe refractory symptoms after atrial septal defect device implantation experience profound resolution of symptoms and improved quality of life after removal. Nickel allergy should be considered before device insertion, and a low threshold should exist for surgical removal for refractory symptoms.

Percutaneous Edge-to-Edge Mitral Valve Repair (PMVR) in a Patient with Barlow’s Disease, an Implanted Atrial Septal Defect (ASD) Occluder Device, and a Left Ventricular Assist Device (LVAD)

Percutaneous Edge-to-Edge Mitral Valve Repair (PMVR) in a Patient with Barlow’s Disease, an Implanted Atrial Septal Defect (ASD) Occluder Device, and a Left Ventricular Assist Device (LVAD)

Surgical removal of atrial septal defect occlusion device and mitral valve replacement in a 39-year-old female patient with infective endocarditis

Дефекты межпредсердной перегородки - вторые по частоте после дефектов межжелудочковой перегородки среди врождённых пороков сердца. Эндоваскулярное закрытие дефекта межпредсердной перегородки выполняют по строгим показаниям у пациентов со значимым сбросом крови слева направо. Развитие инфекционного эндокардита после транскатетерной имплантации окклюдера бывает чрезвычайно редким осложнением. В данном клиническом наблюдении рассмотрен случай развития инфекционного эндокардита митрального клапана (с развитием выраженной недостаточности) через 13 лет после эндоваскулярного закрытия дефекта межпредсердной перегородки у пациентки 39 лет. Перед выполнением хирургического вмешательства проведена комплексная антибиотикотерапия. В ходе операции выполнены удаление окклюдера дефекта межпредсердной перегородки, протезирование митрального клапана, пластика дефекта межпредсердной перегородки и резекция ушка левого предсердия. Послеоперационный период протекал без особенностей.

A Case Report of Late Atrial Septal Defect Occlusion Device Erosion into the Aorta

A Case Report of Late Atrial Septal Defect Occlusion Device Erosion into the Aorta

Predictive Factors for Patients Undergoing ASD Device Occlusion Who "Crossover" to Surgery.

The aim of this study was to define characteristics of those patients who are referred for device closure of an Atrial septal defect (ASD), but identified to "crossover" surgery. All patients who underwent surgical and device (Amplatzer or Helex occluder) closures of secundum ASDs from 2001 to 2010 were reviewed and organized into three groups: surgical closure, device closure, and "crossover" group. 369 patients underwent ASD closure (265 device, 104 surgical). 42 of the 265 patients referred for device closure "crossed over" to the surgical group at various stages of the catheterization procedure. The device group had defect size measuring 14.2mm (mean) and an ASD index (Defect Size (mm)/BSA) of 14.0 compared to the corresponding values in the surgical group (20.1mm, ASD index 25.9) (P<0.001) and in the "crossover" group (20.7mm, 22.6 ASD index) (P<0.001). 79 patients in the device group had a deficient rim, and 86% were located in the retroaortic region. 33 patients in the "crossover" group had deficient rims with 70% deficiency in the posterior/inferior rim. The device group with deficient rims had an ASD index of 14.7 compared with the crossover group ASD index of 23.8 (P<0.001). Comparing the device and "crossover" groups, an ASD index greater than 23.7 had a 90% specificity in "crossing over" to surgery. The crossover and surgical groups had statistically larger ASD defect size indexes compared with the device group. Deficient rim in the posterior/inferior rim is associated with a large ASD size index which is a predictive factor for crossing over to surgery. Catheterization did not negatively impact surgical results in the "crossover" group.

Feasibility of percutaneous closure of atrial septal defects in adults under transthoracic echocardiography guidance using the Figulla atrial septal defect occluder device

BackgroundClosure of atrial septal defect (ASD) among adults under transthoracic echocardiography (TTE) guidance using devices other than the Amplatzer Septal Occluder has not been extensively tested. Aim of workAssessment of the safety and efficiency of secundum ASD closure using the Occlutech Figulla ASD Occluder under TTE guidance in adult patients with hemodynamically significant secundum ASD. MethodsTwenty patients (mean age, 32.9±9.7, 75% of them females) were enrolled in the study. All patients underwent TTE and transoesophageal echocardiography (TEE) to assess the characteristics of the ASD prior to percutaneous closure. Procedures were performed using the Figulla Occluder device under both fluoroscopic and TTE guidance. Follow-up clinical and TTE examinations were done at 1, 3, and 6 months following the procedure. ResultsTTE estimated mean ASD size was 21.7±7.3 mm with adequate rims except for the aortic rim (deficient in one third of cases). Mean device size was 28.1±8.6 mm with mean procedure and fluoroscopic times of 46.2±16.4 and 15.7±5.4minutes respectively. ASD was successfully closed in all patients. Two patients showed a small residual shunt immediately after the device placement that disappeared by the end of the 2nd followup TTE examination. Transient complications were detected in 2 patients. All patients were asymptomatic during the follow-up period. ConclusionTranscatheter closure of secundum ASD in adults under TTE guidance using the Occlutech Figulla ASD occluder device is safe and effective when performed in a tertiary center and by expert echocardiographers and interventional cardiologists.

Percutaneous device closure of atrial septal defect with totally transthoracic echocardiography guide, without x-ray machine.

The present study investigated the feasibility of totally transthoracic echocardiography-guided percutaneous device occlusion of atrial septal defects (ASDs) without using x-ray equipment.Between September and December 2014, we performed totally transthoracic echocardiography-guided percutaneous device occlusion for 20 patients with secundum ASD without using x-ray equipment. We carried out percutaneous femoral vein puncture, used a specialized delivery sheath during operation, and closed the ASD by releasing an occluder.All 20 patients experienced successful occlusion and smoothly went through the perioperative period. The average procedure time ranged from 30 to 40 minutes (32.4 ± 3.5 minutes), and the size of the implanted occluder ranged from 20 to 38 mm (25.4 ± 5.8 mm). No occluder displacements, residual fistula, or thrombus-related complications after the procedure. There was no clinical death, no arrhythmia, no hemolysis, no infection, or embolism during patients’ hospitalization and the follow-up period.Totally transthoracic echocardiography-guided percutaneous device occlusion of ASDs without the use of x-ray equipment may be safe and feasible.

Nickel hypersensitivity reaction following Amplatzer atrial septal defect occluder device deployment successfully treated by explantation of the device

Nickel hypersensitivity reaction following Amplatzer atrial septal defect occluder device deployment successfully treated by explantation of the device

Successful thrombolytic treatment of a mobile thrombus on atrial septal defect occluder device

This case report presents a case with septal occluder device thrombosis which was successfully treated with low dose longer duration of thrombolytic application. Our case showed that the thrombolytic strategy with the lower dose and the longer duration might be a valuable alternative treatment option for the septal occluder thrombosis which is anticoagulation-resistant. This strategy might obviate the need for surgery.

Embolization of Atrial Septal Defect Occluder Device into the Left Ventricle- Emergency Surgical Removal

With the introduction of technological improvements, invasive cardiologic interventions have become increasingly used alternatives to surgery. Despite its numerous benefits, serious and potentially life-threatening complications of invasive cardiology interventions may occur. We presented a case of attempted percutaneous transcatheter closure of a large ASD in 6 years old boy, complicated by device embolization to the left ventricle necessitating emergency surgical retrieval in the department of cardiac surgery, National Institute of Cardiovascular Diseases (NICVD), Dhaka.University Heart Journal Vol. 10, No. 2, July 2014; 95-96