Septal Occluder Device Research Articles

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.

Same-day discharge after percutaneous closure of persistent foramen ovale using intracardiac echocardiography and the Gore Septal Occluder.

Periprocedural and postinterventional care of patients undergoing closure of patent foramen ovale (PFO) varies significantly across care providers. Same-day discharge (SDD) after transcatheter interventions is an evolving concept. This study aimed to assess the same-day discharge rate and incidence of complications in patients undergoing PFO closure with intracardiac echocardiography (ICE) using the Gore®Cardioform Septal Occluder (GSO) device. The secondary aim was to analyse the efficacy of femoral vein closure with Perclose ProGlide. Patients who underwent PFO closure with the GSO device at a university hospital in Stockholm, Sweden, were retrospectively included between March 1, 2017, and June 30, 2020, all with cryptogenic stroke as the indication for the procedure. All patients underwent PFO closure with conscious sedation and local anaesthesia. The indication for all patients was a cryptogenic stroke. Periprocedural imaging was performed using ICE and fluoroscopy in all patients. Patient characteristics and periprocedural data were collected from patient charts. Patients were kept on bed rest for 4-6 h post-intervention. Transthoracic echocardiography and clinical examination, including groin status, were performed before discharge. No clinical routine follow-up was performed the day following the intervention. Clinical follow-up was done by phone call two weeks after the procedure, and echocardiographic follow-up was done after 12 months. Data were analysed using linear and logistic regression models. In total, 262 patients were included, of which 246 (94%) had SDD. 166 patients (63%) received the ProGlide™ system for femoral vein access closure. Post-procedural arrhythmias occurred in 17 (6%) patients, and vascular complications in 9 patients (3%). The overall closure rate at follow-up was 98.5%. 25 out of 264 patients (9.5%) had to be readmitted within the first eight weeks after PFO closure, 16 due to atrial fibrillation warranting electric cardioversion, one due to an arteriovenous fistula that was operated, four due to chest pain/pain at the access site, and four patients developed fever. There was no difference in SDD among patients who received ProGlide™ vs. patients who did not receive ProGlide™. SDD appears safe after transcatheter PFO closure with the GSO device with high procedural success rates. Low rates of complications and readmissions make the intervention suitable for this patient-friendly and cost-effective concept.

Effectiveness and safety of a ventricular septal occluder device for the treatment of Gastro-tracheal fistula

Gastro-tracheal fistula (GTF) is one of the most serious complications after esophagogastrostomy and radiotherapy, with very high disability and mortality rates. To evaluate the effectiveness and safety of ventricular septal occluder devices (VSOD) for the treatment of Gastro-tracheal fistula (GTF). From January 2020 to May 2022, 14 patients with GTF underwent VSOD under real-time fluoroscopy. The technical success, complications, quality of life (QoL), Eastern Cooperative Oncology Group (ECOG) score, Karnofsky score, and median overall survival (mOS) were recorded and analyzed. Technical success, and major complication rates were 71.4%, and 14.3%, respectively. Both the ECOG and the Karnofsky score showed significant improvement at the 2-month evaluation compared with the pretreatment value (p<0.05). For QoL, general health, physical function, vitality, role physical, and social function all improved at the 2-month evaluation (p<0.05), but bodily pain, role emotion, and mental health showed no significant difference (P>0.05). During the mean follow-up of 9.6 months, eight patients were alive, and the mOS was 11.4 months (95% CI, 8.5-14.3). VSOD is a simple and safe technique for GTF treatment, but long-term observation is needed at multiple centers to confirm our findings.

Percutaneous closure of the left atrial appendage after failed surgical closure using a septal occluder device guided by real-time 4-dimensional intracardiac echocardiography.

Percutaneous closure of the left atrial appendage after failed surgical closure using a septal occluder device guided by real-time 4-dimensional intracardiac echocardiography.

Endoscopic Repair of Refractory Tracheoesophageal Fistula with a Cardiac Septal Occluder Device in a 12 Years-Old Patient

Purpose: Esophageal atresia (EA) and tracheoesophageal fistula (TEF) are rare anomalies in neonates that must be surgically repaired by esophageal reconstruction with or without ligation of the fistula. Recurrent tracheoesophageal fistula (rTEF) occurs in 3-15% of primary surgical repairs in esophageal atresia; it is associated with recurrent hospital admissions and up to 27% short term mortality. Dependable reparation very often proves difficult by standard surgical techniques. Using oesophageal fully covered self-expandable metal stents in adult patients yields a &amp;lt;50% efficacy and other endoscopic techniques such as occlusion by clips or glue show no better results. A minimally invasive alternative is the use of vascular plug septal occluders. We report the efficacy of endoscopic placement of a cardiac septal occluder (CSO) in a paediatric patient. Clinical case: A 12-year-old female with recurrent (rTEF) and refractory tracheoesophageal fistula (refTEF) was subjected to an refTEF closure procedure via endoscopic placement of a cardiac septal occlusion device. Conclusion: Debate regarding the gold standard of rTEF treatment closure a hot debate but flexible endoscopy is an accepted alternative. This report describes the successful fixing of a refTEF using a cardiac septal occluder. After four weeks follow up, no re-incidence of the tracheoesophageal fistula was detected. The results advocate for the endoscopic closure of refractory tracheoesophageal fistula with cardiac occluders in children thus establishing a promising therapeutical alternative in refTEF in paediatric population patients.

Off-label use of muscular VSD device for closure of a rare congenital portosystemic shunt

BackgroundCongenital portosystemic shunt (CPSS) is a vascular malformation in which portal blood drains toward the systemic circulation, leading to pulmonary hypertension.Case presentationA 10-year-old patient was brought for evaluation because of dyspnea on exertion. Echocardiography revealed a pulmonary hypertension of 75 mmHg, and multi-slice CT angiography revealed the presence of a CPSS. Closure was finally implemented using a muscular ventricular septal defect device. Follow-up of the patient revealed a gradual decline in pulmonary hypertension.ConclusionsCPSS is an overlooked cause of reversible pulmonary hypertension (PH). Closure of such lesions and reversal pulmonary hypertension are possible via catheterization. The preferred device type depends largely on the intervening team. Plugs are the first choice for interventional radiologists, while ventricular and atrial septal occluder devices and duct occluders are preferred by pediatric cardiologists.

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

An unusual site of ablation for a ventricular tachycardia.

Scar-related ventricular tachycardia (VT) ablation involves localizing the critical isthmuses by overdrive pacing maneuvers and three-dimensional activation mapping. Implantable prosthetic devices have been known to complicate this by covering sites of potential isthmuses. We herein present a sentinel report of scar-VT ablation with a protected isthmus localized over an endothelialized post-myocardial infarction ventricular septal defect occluder device.

Abstract 15989: Gore Cardioform Device Complicated by Delayed Right Atrial Disk Expansion

This is a 31-year-old male with a recently discovered secundum atrial septal defect (ASD) with significant left-to-right shunt and associated right ventricular enlargement and dysfunction underwent an uncomplicated percutaneous ASD closure device placement earlier in 2023. Five weeks later, upon repeat transthoracic echocardiogram (TTE), the patient was found to have new onset atrial flutter and what was thought to be a large device-related thrombus abutting the right atrial disc. The patient was admitted to the hospital, started on systemic anticoagulation, and AV nodal blocker therapy. X-rays and a transesophageal echocardiogram (TEE) were performed and showed a Gore Cardioform ASD occluder device that was complicated with significant expansion of the right atrial disk and loosening of fabric likely in the setting of displacement of locking pin (Figure 1A-B). No clear thrombus was visualized. The patient underwent an uncomplicated ASD closure device removal, ASD repair with pericardial patch, right sided Maze, and left atrial appendage ligation in May of 2023 (Figure 1C). We report a case of extreme expansion of the right atrial disk of the Gore Cardioform septal occlusion device. Very few cases of right or left atrial disk expansion have been reported but only in the immediate post-implantation period. This is thought to be secondary to immediate post-operative increase in left atrial pressures. In our patient, intra-procedural TEE and immediate post-procedural TTE the day after showed a well-apposed device across the ASD with no residual shunt. Furthermore, the wedge pressure measured during the procedure was within normal limits. Extreme expansion of the right atrial disk five weeks after the implantation has not been reported. While we know that the pin unlocking caused the expansion of the atrial disk, it is currently unclear as to what initiated this series of events.

S2613 A Case of Endoscopic Repair of Tracheoesophageal Fistula With Septal Occluder Device

S2613 A Case of Endoscopic Repair of Tracheoesophageal Fistula With Septal Occluder Device

S3411 Endoscopic Closure of an Enterovaginal Fistula: Novel Use of a Cardiac Septal Occluder Device

S3411 Endoscopic Closure of an Enterovaginal Fistula: Novel Use of a Cardiac Septal Occluder Device

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.

Endoscopic closure of a recto-pelvic fistula with a cardiac septal occluder device

Video 1Endoscopic closure of a recto-pelvic fistula with a cardiac septal occluder device in a patient for whom other surgical and endoscopic interventions had failed.

Discussion to: Infarct exclusion repair of postmyocardial infarction ventricular septal rupture with a hybrid patch and septal occluder device compared with patch only

Discussion to: Infarct exclusion repair of postmyocardial infarction ventricular septal rupture with a hybrid patch and septal occluder device compared with patch only

Infarct exclusion repair of postmyocardial infarction ventricular septal rupture with a hybrid patch and septal occluder device compared with patch only

ObjectiveWe developed a hybrid technique for repairing post-myocardial infarction (MI) ventricular septal defect (VSD) that combines infarct exclusion with patch and a nitinol-mesh septal occluder device (SOD) to provide a scaffold to support the damaged septal wall. Here, we compare outcomes of patients with post-MI VSD repaired using patch only or hybrid patch/SOD. MethodsPatients undergoing post-MI VSD repair at our institution from 2013 to 2022 who received patch alone or patch/SOD repair were analyzed. Primary outcome was survival to hospital discharge. Clinical outcomes and echocardiograms were also analyzed. ResultsOver a 9-year period, 24 patients had post-MI VSD repair at our institution with either hybrid patch/SOD (n = 10) or patch only repair (n = 14). VSD size was 18 ± 5.8 mm for patch/SOD and 17 ± 4.6 mm for patch only. In the patch/SOD repair cohort, average size of SOD implant was 23.6 ± 5.6 mm. Mild left ventricular dysfunction was present prerepair and was unchanged postrepair in both groups; however, moderate-to-severe right ventricular (RV) dysfunction was common in both groups before repair. RV function worsened or persisted as severe in 10% of hybrid versus 54% of patch-only patients postrepair. Tricuspid annular systolic excursion and RV:left ventricle diameter ratio, quantitative metrics of RV function, improved after patch/SOD repair. No intraoperative mortality occurred in either group. Postoperative renal, hepatic, and respiratory failure requiring tracheostomy was common in both groups. Survival to hospital discharge in both cohorts was 70%. ConclusionsPost-MI VSD repair with patch/SOD has comparable short-term outcomes with patch alone. Addition of a SOD to patch repair provides a scaffold that may enhance the repair of post-MI VSD with patch exclusion.

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.

Case Report: Removal of septal occluder device and closure of atrial septal defect with pulmonary vein flow redirection

BACKGROUND: Atrial septal defect represents 10 to 15% of congenital heart disease and is more frequent in women with a 2:1 ratio. Sinus venosus atrial septal defect is usually associated with partial anomalous pulmonary venous drainage from the right superior pulmonary vein to the right atrium directly or indirectly through the superior vena cava. Rarer still, is the inferior sinus venosus, which may be associated with partial anomalous venous drainage from the right inferior pulmonary vein. CASE REPORT: 13-year-old patient with a history of intervention for interatrial defect closure with Amplatzer occluder at the age of six. He was brought to receive medical attention for fatigue and dyspnea that had been progressing for 2 years. Cardiac CT reported partial anomalous connection of pulmonary veins and echocardiogram reported a residual atrial septal defect of 10 mm and mild to moderate pulmonary hypertension. Based on the findings, surgical treatment was decided. EVOLUTION: In correction surgery, we observed Amplatzer occluder incorrectly positioned, the device was removed and flow was redirected from right pulmonary veins to left atrium with bovine pericardium patch. After the surgical intervention, the patient had a favorable evolution without no post-surgical complications. At follow-up, 15 days after medical discharge, the patient was asymptomatic, and a cardiac CT scan showed the corrected interatrial defect. CONCLUSION: The treatment of atrial septal defect should be individualized, since it will depend on the size of the defect, the age at the time of diagnosis, the magnitude of the shunt, the severity of the symptoms and the presence of other conditions. If the defect requires repair, it is important to weigh the benefits of choosing percutaneous closure vs. surgical intervention to avoid the need for reintervention, as in the present case. Closure and redirection of pulmonary vein flow with bovine patch is a safe and effective option.

Lost and found: late embolization of an atrial septal occluder device.

A 66-year-old male with a history of percutaneously closed atrial septal defect (ASD) with a Cera™ occluder four years earlier underwent transthoracic echocardiography. Device migration into the left ventricular outflow tract and moderate mitral regurgitation (MR) were found (Panel A). The previous follow-up 12 months echocardiogram was unremarkable. Periprocedural imaging showed a 30 × 17 mm ASD, a borderline anterior rim (5 mm), and a thin posterior rim, considered adequate according to current guidelines. The expanded balloon diameter was 31 mm and a 36 device was selected. During the procedure final device position was satisfactory and the device was stable after the tug test. After the heart team reviewed the case interventional retrieval of the device was attempted. Using a snare catheter and a double tool retrieval technique, the attempts were unsuccessful (Panel E). The patient was sent for cardiac surgery. Pre-operative transoesophageal echocardiogram showed entrapment of the device in the mitral subvalvular apparatus and chordae tendineae rupture causing eccentric severe MR (Panel B, C, and D). Surgical removal of the device (Panel F), ASD closure, and mitral valve replacement were performed.

Early Infective Endocarditis Associated with an Amplatzer Atrial Septal Occluder Device in a 14-Year-Old Male.

Infective endocarditis (IE) associated with an ASD device, particularly in the early post-procedure period, is extremely rare. We report a case of infective endocarditis presenting with embolic complications and vegetations on the device that were only seen on transesophageal echocardiography, necessitating device removal.

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.