Amplatzer Septal Occluder Research Articles

Evaluating cost-effectiveness of PFO management strategies: closure with Cardioform vs. Amplatzer, and treatment with medical therapy alone, for secondary stroke prevention

Aim The aim of this study was to evaluate the cost-effectiveness of patent foramen ovale (PFO) closure using CARDIOFORM Septal Occluders versus AMPLATZER Septal Occluders, as well as compared to Medical Therapy Alone, from a payor perspective in the United States. Methods An economic evaluation compared the value of CARDIOFORM, AMPLATZER, and Medical Therapy Alone. A Markov model simulated a cohort of 1,000 individuals with PFO and a history of cryptogenic stroke, with baseline demographic and clinical characteristics reflecting individuals enrolled in the REDUCE and RESPECT trials over a five-year time horizon. The costs and health consequences associated with complications and adverse events, including recurrent stroke, were compared over a time horizon of 5 years. Results PFO closure using CARDIOFORM was economically dominant, providing both cost-savings and improved effectiveness compared to closure with AMPLATZER. It resulted in an estimated savings of over $1.3 million, an additional 24.8 quality-adjusted life-years (QALYs) gained, and 28 strokes avoided in a cohort of 1,000 patients. When compared to Medical Therapy Alone, closure with CARDIOFORM was found to be cost-effective, with an incremental cost-effectiveness ratio (ICER) of $36,697 per QALY gained. Sensitivity and scenario analysis showed the model findings to be highly robust across reasonable changes to baseline input values and assumptions. Conclusions The results of this analysis suggest that PFO closure using the CARDIOFORM Septal Occluder is the most cost-effective treatment strategy for patients with a PFO-associated stroke, particularly compared to AMPLATZER where it resulted in both cost-saving and improved patient outcomes.

Resolution of Severe Ulcerative Colitis Secondary to Nickel Allergy Following Explantation of Amplatzer Septal Occluder Device: A Delayed Presentation.

Nickel is a component of nitinol, an alloy used in several medical devices. Allergy to nickel may place patients at a high risk for severe hypersensitivity reactions. We report a rare case of a patient who developed severe ulcerative colitis ten years following closure of an atrial septal defect with the Amplatzer Septal Occluder device.

Initial Experience With an Amplatzer Cribriform Occluder in Patients With Atrial Septal Defects in Pakistan.

Background Due to their delayed onset of symptoms, atrial septal defects (ASDs) are common congenital cardiac defects that are frequently identified in adulthood. In cases of complicated ASD morphology, transcatheter closure employing devices such as the Amplatzer septal occluder (ASO) presents with difficulties. While the Amplatzer cribriform occluder (ACO) has gained popularity as a specialized option, little is known about its initial use or results, especially in older patients. Objective The goal of this study was to describe the early experience with ACO in patients aged 18 to 38 years who had ASDs at a tertiary care hospital in Pakistan, with a focus on the device's efficacy, safety, and viability. Methods A total of six cases with ASD who underwent ASD closure with the ACO were retrospectively reviewed at Lady Reading Hospital-Medical Teaching Institution (LRH-MTI), Peshawar, Pakistan. All the required data were obtained from the hospital management information system (HMIS), including patient demographics, defect features, procedure specifics, complications, and outcomes. Results Of all patients, 83.3% (n=5) were females and 16.7% (n=1) were males, and the mean age of the group was 27.7 ± 7.9 years. The results of echocardiography showed variation, with a mean fenestrated septum size of 22.4 mm (SD ± 5.4) and a range of device sizes between 18 and 35 mm. The ideal access method for device deployment in every situation was the right femoral vein. There were very few complications; in one instance, a residual shunt necessitated replacing the device. During the six-month follow-up, no complications were found, and all patients were discharged without any problems. Conclusion In conclusion, our study indicates that the ACO is a good choice for young adult patients' ASD closure, showing good safety and efficacy. To verify these results and evaluate the long-term functioning of the device, more prospective trials with larger cohorts are required.

Assessment of right heart size in children after percutaneous closure of secundum atrial septal defect with amplatzer septal occluder

Assessment of right heart size in children after percutaneous closure of secundum atrial septal defect with amplatzer septal occluder

Hybrid Closure of Postinfarction Apical Ventricular Septal Defect Using Septal Occluder Device and Right Ventricular Free Wall: The Apical BASSINET Concept.

Postinfarction ventricular septal defect (VSD) is a catastrophic complication of myocardial infarction. Surgical repair still has poor outcomes. This report describes clinical outcomes after a novel hybrid transcatheter/surgical repair in patients with apical VSD. Seven patients with postmyocardial infarction apical VSD underwent hybrid transcatheter repair via subxiphoid surgical access. A transcatheter occluder (Amplatzer Septal Occluder) with a trailing premounted suture was deployed through the right ventricular wall and through the ventricular septum into the left ventricular apex. The trailing suture was used to connect an anchor external to the right ventricular wall. Tension on the suture then collapses the right ventricular free wall against the septum and left ventricular occluder, thereby obliterating the VSD. Outcomes were compared with 9 patients who underwent surgical repair using either patch or primary suture closure. All patients had significant left-to-right shunt (Qp:Qs 2.5:1; interquartile range [IQR, 2.1-2.6] hybrid repair versus 2.0:1 [IQR, 2.0-2.5] surgical repair), and elevated right ventricular systolic pressure (62 [IQR, 46-71] versus 49 [IQR, 43-54] mm Hg, respectively). All had severely depressed stroke volume index (22 versus 21 mL/m2) with ≈45% in each group requiring mechanical support preprocedurally. The procedure was done 15 (IQR, 10-50) versus 24 (IQR, 10-134) days postmyocardial infarction, respectively. Both groups of patients underwent repair with technical success and without intraprocedural death. One patient in the hybrid group and 4 in the surgical group developed multiorgan failure. The hybrid group had a higher survival at discharge (86% versus 56%) and at 30 days (71% versus 56%), but similar at 1 year (57% versus 56%). During follow-up, 1 patient in each group required reintervention for residual VSD (hybrid: 9 months versus surgical: 5 days). Early intervention with a hybrid transcatheter/surgical repair may be a viable alternative to traditional surgery for postinfarction apical VSD.

Fenestration: Integrating Wings Into the Atrial Septal Occluder for Navigating a Challenging Terrain.

Background Atrial septal defect (ASD) closure with significant left-to-right shunt and concurrent comorbidities poses challenges for intervention. A fenestrated atrial septal defect (FASD) device is a viable option for patients who cannot undergo complete occlusion due to hemodynamic and medical reasons. This study explores the use of FASD occluders in patients with secundum ASD and associated comorbidities where complete occlusion is difficult. Methodology This retrospective study collected the details of patients recommended for FASD closure diagnosed with significant secundum ASD and who had additional comorbidities between July 2015 and July 2023 in a tertiary cardiac center in eastern India. Among this cohort, patients who underwent FASD device placement were subjected to a comprehensive analysis. Results In total, 16 patients diagnosed with secundum ASD, characterized by significant left-to-right shunt and concurrent comorbidities, were considered for FASD closure during the study period. Ultimately, 13 patients (first group) underwent fenestrated atrial septal occluder implantation. The average age was 45.07 years, with the majority being females (n = 9). Comorbidities among this cohort included substantial left ventricular diastolic dysfunction (n = 7), left ventricular diastolic dysfunction coupled with moderate pulmonary hypertension (n = 1), severe pulmonary hypertension (n = 1), severe pulmonary valvular stenosis with right ventricular diastolic dysfunction (n = 2), and systemic lupus erythematosus (SLE) (n = 2). From this cohort, three patients did not undergo the intervention. The second group consisted of an elderly patient with severe left ventricular diastolic dysfunction, a young adult with a history of left atrial arrhythmia, and achild with Duchenne muscular dystrophy (DMD). The average ASD size among patients who underwent the intervention was 26.38 mm, with a thick-to-thick dimension measuring 31.15 mm. The procedure was successful in all 13 patients, with the most frequently used device being a 34 mm occluder (range = 28-40 mm). All devices, excluding the initial one, were custom-made atrial septal occluders (Lifetech Scientific). Among the patients, 12 exhibited left-to-right fenestration flow, while one patient experienced fenestration constriction, likely due to occluder overcrowding. The first patient hada handmade 5 mm fenestration in a 40 mm Amplatzer septal occluder, which got closed off at the one-year follow-up. The procedure was well-tolerated hemodynamically in all patients, with no major complications during the peri-procedural period. Short-term follow-up indicated favorable patient progress. Conclusions FASD closure emerges as a pivotal alternative for intricate scenarios involving secundum ASD coupled with concurrent comorbidities, offeringindividualized tailored solutions. Alongside the conventional associated comorbidities, such as left ventricular diastolic dysfunction and pulmonary hypertension, FASD devices hold the potential to extend their benefits to patients grappling with other complexities, including severe pulmonary valvular stenosis, SLE, predisposition to left atrial arrhythmia, and conditions like DMD. Ensuring meticulous evaluation of patient suitability and providing ongoing vigilant care becomes paramount for achieving optimal outcomes. The validation of these findings and the broadening of the comprehension of this approach necessitate further comprehensive investigations.

Long-term follow-up of percutaneous secundum-type atrial septal defect closure using Amplatzer Septal Occluder since 1995: a single-centre study.

The goal of this single-centre study was to evaluate long-term results of percutaneous closure of secundum-type atrial septal defect using Amplatzer Septal Occluder with the follow-up to 25 years. A retrospective analysis of patients who underwent percutaneous closure of secundum-type atrial septal defect between September 1995 and October 2012 in our institution was performed. All procedures were performed after fulfilling strict indication criteria. More than 5 years follow-up was reached in 651/803 patients (81%) with median follow-up time of 12 (5-25) years. The mean stretched defect diameter was 14,0 ± 5,2 mm. Early reintervention due to moderate or severe residual atrial septal defect had to be performed in 3/803 patients (0,03%). The incidence of long-term moderate or severe residual atrial septal defect was 0,0%. The complete closure rate at 10-year follow-up was 98,5%, as trivial residual shunts persisted in 8/508 patients (1,5%). A significant rate of the echocardiographic right ventricular end-diastolic diameter post-procedural normalisation (p < 0,05) was encountered. The rate of major complications was 0,5%. One device embolisation, one thrombus formation at the occluder surface, and one cardiac erosion in periprocedural or short post-procedural course were experienced. Only one late complication of infective endocarditis at the region of implanted occluder and the aortic valve was detected. The survival rate of all followed patients was 100%. Percutaneous closure of secundum-type atrial septal defect using Amplatzer Septal Occluder is a safe and effective procedure accounting for a very low incidence of major complications in the long-term follow-up.

Late erosion of Amplatzer septal occluder device 9 years after the implantation. A case report.

Cardiac erosion is a rare but life-threatening complication after the interventional closure of an atrial septal defect. We present the case of a patient who developed cardiac erosion 9 years after the placement of an Amplatzer Septal Occluder. The patient presented to our hospital with symptoms of tamponade. Surgical exploration revealed a tear in the roof of the left atrium. To our knowledge, this is one of the most delayed presentations reported. In these cases, diagnosis is difficult and a level of clinical suspicion is demanded.

ECG-Gated CCTA in the Assessment of Post-Procedural Complications.

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). 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. 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. 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.

Concomitant Percutaneous Atrial Septal Defect Closure With an Amplatzer Septal Occluder and HeartMate 3 Implantation for High-Risk Heart Failure Patients: A Novel Hybrid Strategy

Concomitant Percutaneous Atrial Septal Defect Closure With an Amplatzer Septal Occluder and HeartMate 3 Implantation for High-Risk Heart Failure Patients: A Novel Hybrid Strategy

Transcatheter closure of residual VSD related to surgical patch after Fallot pulmonary atresia repair using Amplatzer septal occluder (patient number 11 in Table S1). VSD, ventricular septal defect.

Transcatheter closure of residual VSD related to surgical patch after Fallot pulmonary atresia repair using Amplatzer septal occluder (patient number 11 in Table S1). VSD, ventricular septal defect.

Transcatheter closure of postsurgical aortic pseudoaneurysms guided by three-dimensional image reconstruction: asingle-centre experience.

Postsurgical thoracic aortic pseudoaneurysms (PTAPs) are apotentially lethal complication after cardiac or aortic surgery. Surgical management can pose achallenge with high in-hospital mortality rates. Transcatheter closure is aless-invasive alternative treatment option for selected patients, although current experience is limited. We aimed to evaluate procedural and imaging outcomes of our first 11cases of transcatheter PTAP closure with the use of closure devices. Patients with ahigh operative risk who underwent transcatheter PTAP closure at our centre from 2019 to 2021 were retrospectively included. Suitability was evaluated on preprocedural computed tomography (CT) scans and three-dimensional (3D) reconstructions. All procedures were performed in the catheterisation laboratory. Intraprocedural aortography and postprocedural CT scans with 3D reconstructions were used to evaluate PTAP occlusion. Eleven consecutive patients with ahigh operative risk and ahistory of cardiac/aortic surgery who underwent transcatheter PTAP closure were included. PTAPs were predominantly located at the proximal or distal anastomosis of asupracoronary ascending aortic vascular graft or Bentall prosthesis (82%). Implanted closure devices included Amplatzer Valvular PlugIII (82%), Amplatzer septal occluder (9%) and Occlutech atrial septal defect occluder (9%). No periprocedural complications occurred. After device deployment, residual flow was absent on aortography in 64% and minimal residual flow was present in 36% of patients. Subtotal or total occlusion of the PTAP on follow-up CT ranged between 45% and 73%. Although subtotal or total occlusion of the PTAP was found at follow-up in only 45-73% of cases, transcatheter PTAP closure guided by preprocedural 3D reconstructions can offer avaluable minimally invasive primary treatment option for patients who otherwise would face ahigh-risk reoperation.

The Prevalence of and Predisposing Factors for Late Atrial Arrhythmias after Transcatheter Closure of Secundum Atrial Septal Defects in Children.

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. 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. 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. 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.

Outcomes of Patent Foramen Ovale Transcatheter Closure: Should a Short Aortic Rim Preclude Closure?

BackgroundThe risk of erosion of an atrial septal closure device, in particular the Amplatzer Septal Occluder, has been described as higher in patients with a short aortic rim. Similar concern has been applied to patent foramen ovale (PFO) closure devices, but there are only rare reported cases of erosion. It may be that smaller devices are chosen due to fear of device erosion in PFO patients when this is not necessarily an issue. ObjectivesThe authors aimed to assess outcomes after PFO closure with the Amplatzer PFO device in patients with a short (<9 mm) aortic rim. MethodsWe performed a retrospective analysis of PFO closure for any indication, between 2006 and 2017 at a quaternary center. Preprocedural transesophageal echocardiographic parameters including the aortic rim were remeasured. Long-term outcomes were obtained by linkage to provincial administrative databases. ResultsOver the study period, 324 patients underwent PFO closure with the Amplatzer PFO device, with a mean age of 49.8 years; 61% had a short aortic rim (<9 mm). The most common indication was cryptogenic stroke (72%); those with longer aortic distance were more likely to have a non-stroke indication for closure, diabetes (15% vs 6.5%, P = 0.04), and heart failure (15.7% vs 4%, P < 0.001). Over a median 7 years of follow-up, there were no cases of device erosion or embolization requiring cardiac surgery. ConclusionsIn a large cohort with long-term administrative follow-up (1,394 patient-years), implantation of an Amplatzer PFO device was performed safely even in patients with a short aortic rim.

Temporary balloon occlusion test can overestimate the risk of acute pulmonary edema after transcatheter atrial septal defect closure.

Atrial septal defect (ASD) closure can cause acute pulmonary edema. Before transcatheter closure is performed, temporary balloon occlusion test (BOT) is recommended in patients with left ventricular dysfunction to predict the risk of pulmonary edema. However, the accuracy of BOT has not been verified. This study aimed to compare hemodynamic differences between BOT and transcatheter closure. A total of 42 patients with a single ASD over age 18 years who underwent BOT before transcatheter ASD closure between October 2010 and May 2020 were analyzed. Pulmonary capillary wedge pressure (PCWP) was measured using a Swan-Ganz catheter placed in the pulmonary artery at baseline, after 10 min of BOT, and after transcatheter closure. Amplatzer septal occluder was used for all transcatheter closures. Mean patient age was 64 ± 18 years (range, 18-78). Mean ASD diameter and pulmonary to systemic flow ratio were 18 ± 5and 2.8 ± 1.0 mm, respectively. Mean PCWP at baseline, during BOT, and after transcatheter closure was 8.9 ± 2.9, 13.5 ± 4.2, and 9.5 ± 2.6 mmHg, respectively. The difference between BOT and after transcatheter closure values was significant (p < 0.001). During BOT, PCWP increased ≥18 mmHg in 7patients, whereas after ASD closure, PCWP was <18 mmHg in all 7and none developed acute pulmonary edema. Temporary balloon occlusion of an ASD and transcatheter ASD closure result in different hemodynamic change. BOT overestimates increase of PCWP after transcatheter ASD closure and requires careful interpretation. Well-designed, larger studies in higher-risk patients are warranted to verify the clinical implications of BOT in more detail.

Mitral Valve Surgery in Patients With an Implanted Amplatzer Septal Occluder: A Review of 2 Cases

Surgical approaches for mitral valve exploration vary, with the preferred approach being via the interatrial groove. Data on whether the interatrial groove approach can be used for mitral valve surgery in patients with a previously implanted Amplatzer septal occluder (ASO) (St Jude Medical, an Abbott company) are extremely limited. The authors performed mitral valve surgery using the transatrial septal approach on 2 patients following explantation of an ASO, which significantly impedes the interatrial groove approach. Concomitant surgical procedures with mitral valve replacement, removal of the ASO, and closure of an atrial septal defect with a patch significantly prolonged the cross-clamp and cardiopulmonary bypass durations, which is the reason for intraoperative low cardiac output syndrome. An intra-aortic balloon pump and venoarterial extra-corporeal membrane oxygenation were used in these 2 patients because of low cardiac output syndrome. When planning mitral valve surgery in patients with a previously implanted ASO, the device precludes the interatrial groove approach and can produce an unpredictable clinical scenario.

Endovascular Closure of Secondary Septal Defect in Children with Low Body Weight

The aim. To assess the effectiveness and safety of transcatheter closure of a secondary atrial septal defect (ASD) using an occluder in symptomatic children weighing ≤10 kg.&#x0D; Materials and methods. In the period from November 2014 to June 2021, on the basis of the National Amosov Institute of Cardiovascular Surgery of the National Academy of Medical Sciences of Ukraine, closure of secondary ASD using an occluder was performed in 18 patients, among them 13 women (72.2%) and 5 men (27.8%). Th e mean age of the patients was 18.94±9.44 months (the youngest patient was 12 months, the oldest was 4 years). The mean weight was 9.294±1.170 kg (6.4 kg to 10 kg), the mean Z-score was -1.7±1.5 (-4.6 to 0.46), the mean height was 80 cm (71 cm to 88 cm). According to the measurements by transesophageal echocardiography (TEE), the average size of the defects was 13.7 mm±3.6mm (the largest 18.0 mm, the smallest 6.0 mm).&#x0D; Results and discussion. In our publication, the effectiveness of the method was 100% (18/18), while the world statistics show 94-95%. Th e frequency of complications was 5.6% (n=1). We suggest that this is associated with the use of a sizing balloon and careful selection of the device.&#x0D; When choosing treatment tactics for symptomatic children weighing ≤10 kg, the decisive factor was the determination of the presence of edges and the size of the defect. Defects were considered suitable for closure, according to TEE data, when all margins of the defect were ≥4 mm, except for the aortic margin. Although the total length of the interatrial membrane was taken into account, it was not of decisive importance, since for most occluders with the presence of all edges, the fields of the implant could not interfere with the work of the anatomical structures of the heart. To determine the real size of the defect, we recommend a measuring balloon under TEE control.&#x0D; The following devices were used to close the defect: MemoPart ASD occluder, Amplatzer Septal Occluder, LifeTech HeartR Occluder, LifeTech HeartR Multi-Fenestrated Atrial Septal Defect (MF-ASD) Occluder.&#x0D; &#x0D; Conclusion. After the study, we are convinced that the endovascular method of closing a hemodynamically significant secondary ASD for the treatment of children with a body weight of ≤10 kg has proven to be an effective method, with successful implantation of the occluder in 100% of cases.

Transcatheter Fontan Fenestration Closure: Sustained Improvements in Oxygen Saturation with Minimal Morbidity and Mortality.

Fontan fenestration decreases central venous pressure and preserves cardiac output while decreasing systemic oxygen saturation. Transcatheter fenestration closure increases oxygen saturation, though the persistence of this increase and the long-term incidence of adverse outcomes such as death and heart transplant remain unknown. We describe immediate and long-term clinical and adverse outcomes following fenestration closure. Catheterization, echocardiogram, and clinic reports were reviewed following transcatheter Fontan fenestration closure. Data were reported as n (%) and median (IQR). Continuous variables were compared using Wilcoxon ranked sum test. 51 patients had fenestration closure 0.9 (0.7-1.5) years following extracardiac Fontan operation. Most (84%) were closed with Amplatzer Septal Occluders. Systemic O2 saturation immediately increased from 87 (83-89) to 95 (94-97)%, P < 0.05. Cardiac index decreased from 4 (3-5) to 2.9 (2.6-3.5) L/min/m2. Fontan pressure and pulmonary vascular resistance were not significantly changed. Clinical follow-up duration for all patients was 7.3 (range 1.3-16) years. Oxygen saturation at last follow-up was 94.5 (92-97)% and did not decrease over time (P < 0.05). One patient (2%) developed protein losing enteropathy, 1 (2%) had heart transplant, and 1 (2%) patient died 9.4years following fenestration closure. No patient required fenestration re-creation following closure. Transcatheter Fontan fenestration closure leads to sustained increases in systemic oxygen saturation and a low incidence of adverse outcomes such as death and transplant. Further study comparing fenestration closure to non-closure and longer follow-up duration are required to determine if there is a survival benefit to fenestration closure.

S368 Chronic Tracheoesophageal Fistula Successfully Treated Using an Amplatzer Closure Device Under Endoscopic Visualization

Introduction: In tertiary care centers, where advanced endoscopic expertise is available, the placement of an Amplatzer septal occluder is practical and safe. This allows for potential fistula closure, especially in patients with severe comorbidities or in critical condition or those with chronic or recurrent tracheoesophageal fistulas (TEF). Case Description/Methods: A 72-year-old man with a history of gastroesophageal reflux disease (GERD) and well-differentiated esophageal adenocarcinoma who presented for dysphagia and cough. Social history was negative for smoking, smokeless tobacco, alcohol ingestion and illicit drug use. Home medications include famotidine. He had no known significant family history. The patient had undergone numerous esophagogastroduodenoscopies (EGD) since 2017 for recurrent strictures requiring TTS balloon dilations, intralesional triamcinolone acetonide injections and esophageal stenting complicated by formation of a tracheoesophageal fistula (TEF) at the anastomotic site. The TEF was initially treated with stenting 3 months prior to presentation. The patient underwent EGD and bronchoscopy with visualization of a 5 mm fistula. He was then evaluated by the surgery team for consideration of surgical repair, however the patient declined surgical intervention. Given the clinical condition of the patient with recurrent aspiration events, failed endoscopic management and refusal of surgical intervention, it was decided to remove the esophageal stent and attempt placement of an Amplatzer septal occluder. An 18 mm Amplatzer device (AD) was successfully placed with satisfactory closure of the TEF. Repeat endoscopy 5 months later, showed that the device had remained in the correct position and the patient remained asymptomatic following advancement of his diet. Discussion: Acquired TEF is a rare complication, the incidence in the US has yet to be reported. Amplatzer occluder devices, originally designed for transcatheter closure of cardiac defects, have shown promise in the treatment of TEFs. It is suggested that the placement of the AD induces granulation tissue formation around the device allowing for complete closure of the fistula without compromising airway patency. Upon review of current literature only one other case report was found where an AD was used for the management of refractory TEF. In the setting of large or difficult to manage TEFs and patients who are not surgical candidates, Amplatzer septal occluder devices can be used to successfully treat complicated TEFs. Watch the video at https://tinyurl.com/ACGAbstractS368Figure 1.: Amplatzer device deployed with successful tracheoesophageal fistula closure.

Transcatheter retrieval of atrial septal defect and patent ductus arteriosus occluder: a guidance for device retrieval based on comprehensive bench tests.

The aim of this study is to establish a guidance for device retrieval based on comprehensive bench tests. Device embolisation remains a major complication in transcatheter closure of atrial septal defect and patent ductus arteriosus. Although percutaneous retrieval is feasible in the majority of cases, surgical retrieval may be required in complicated circumstances. However, the methods of transcatheter device retrieval have not been completely established. Bench tests of device retrieval were performed to verify the appropriate retrieval method according to device type/size. The devices used for testing were Amplatzer Septal Occluder (Abbott, Chicago, IL, United States of America), Figulla Flex II (Occlutech GmbH, Jena, Germany), Amplatzer Duct Occluder-I (Abbott), Amplatzer Duct Occluder-II (Abbott), and Amplatzer Vascular Plug-II (Abbott). The retrieval equipment constituted diagnostic catheters (multipurpose catheter and right Judkins catheter, 4-Fr or 5-Fr, Gadelius Medical, Tokyo, Japan), delivery sheath and cables for each device, Amplatz goose neck snares (Medtronic, Minneapolis, MN, United States of America), OSYPKA CATCHER (Osypka ag, Rheinfelden-Herten, Germany), and OSYPKA LASSOS (Osypka). We investigated the retrieval equipment and sheath sizes required for a successful retrieval procedure for variously sized devices. For patent ductus arteriosus devices, the type of snare and the snaring position are considered important. For atrial septal defect devices, simple snare capture or a double-snare technique with a sufficiently large sheath is effective. Special care should be taken when using the OSYPKA CATCHER for device retrieval. The results of this study may assist in the selection of both capture devices and a retrieval sheath or a catheter for complete retrieval.