Atrial Septal Closure Device Research Articles

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.

Successful Usage of FlexCath Steerable Catheter in Case of Atrial Septal Closure Device Comes Perpendicular to Interatrial Septum.

Percutaneous closure of atrial septal defects is challenging in cases where the device is perpendicular to the septum during the procedure. Hence, different techniques, maneuvers, and auxiliary equipment may be required. We aimed to demonstrate the effectiveness of the FlexCath steerable catheter application in percutaneous closure of atrial septal defect cases in which the device was perpendicular to the septum. Patients with atrial septal defect who presented to our clinic between January 2017 and December 2020 and were deemed eligible for percutaneous closure were included in the study. Atrial septal defects of 101 patients out of 110 patients were successfully closed using standard methods. Nine patients in whom it was seen if the device was perpendicular to the interatrial septum were successfully closed with FlexCath steerable catheter support. There was no statistically significant difference between patients in terms of age, gender, floopy rim, and multiple defects. In the group that was treated with FlexCath steerable catheter support, the aortic rim was smaller, and the defect diameter and the size of the atrial septal defects device were larger. The success of the procedure was 100% while using the flexcath steerable catheter in patients with the device perpendicular to the interatrial septum. There were no complica tions during the procedure. Percutaneous closure with FlexCath steerable catheter support in difficult cases with atrial septal defects was effective in those with the atrial septal closure device being per pendicular to the interatrial septum and was performed easily without any safety issues.

Management of tracheo-oesophageal fistula in adults.

Tracheo-oesophageal fistula (TOF) is a pathological connection between the trachea and the oesophagus that is associated with various underlying conditions including malignancies, infections, inhalation injuries and traumatic damage. As the condition spans multiple organ systems with varying aetiologies and acuities, TOF poses unique diagnostic and management challenges to pulmonologists, gastroenterologists and thoracic surgeons alike. Although stents have been a cornerstone in the management of TOF, there exists a large gap in our understanding of their efficacy and precise methodology, making stenting procedure both art and science. TOFs relating to underlying oesophageal or tracheal malignancies require advanced understanding of the airway and digestive tract anatomy, dimensions of the fistula, stent characteristics and types, and the interplay between the oesophageal stent and the airway stent if dual stenting procedure is elected. In this review article, we review the most up-to-date data on risk factors, clinical manifestations, diagnostic approaches, management methods and prognosis. Consequently, this article serves to evaluate current therapeutic strategies and the future directions in the areas of 3D-printed stents, over-the-scope clipping systems, tissue matrices and atrial septal closure devices.

Standing on the ledge: Atrial fibrillation ablation in patients with atrial septal closure devices

Standing on the ledge: Atrial fibrillation ablation in patients with atrial septal closure devices

Safety and efficacy of catheter ablation for atrial fibrillation in patients with percutaneous atrial septal closure device: Electrophysiology Collaborative Consortium for Meta-analysis-ELECTRAM Investigators.

Transseptal puncture (TSP) is challenging in patients with prior percutaneous atrial septal defect (ASD) occluder. We aimed to perform a systematic review and meta-analysis of the safety and efficacy of catheter ablation for atrial fibrillation (AF) in patients with percutaneous ASD occluder. We searched PubMed, Medline, Embase, Ovid, and Cochrane for studies reporting results of AF ablation (freedom from AF, fluoroscopy/procedure time, and complications) in patients with percutaneous ASD occluders. Three studies with a total of 64 patients met inclusion criteria. The success rate of TSP was 100%. All patients (but one) underwent TSP under fluoroscopic and intracardiac echocardiography guidance. Freedom from AF was achieved in 77.7% (95% confidence interval [CI]: 65.7-86.3) patients. In the subgroup analysis, comparing septal versus device puncture, no significant difference in recurrence of AF was observed (23.07% vs. 16.66%; risk ratio: 1.18; 95% CI: 0.35-4.00; p = .79, respectively). The total fluoroscopy time was not significantly different in patients with TSP via native septum or device (43.50vs. 70.67 min; p = .44), total procedural time was significantly longer with TSP via the closure device (237.3vs. 180 min; p = .004) compared with the native septum. There were no device dislodgement or residual interatrial shunt during the follow-up period. Catheter ablation for AF in patients with prior percutaneous ASD closure device is feasible and safe with favorable long-term outcomes.

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.

PP-548 - Retrival of Embolized Atrial Septal Defekt Closure Device in the Left Iliac Artery

PP-548 - Retrival of Embolized Atrial Septal Defekt Closure Device in the Left Iliac Artery

Safe Surgical Retrieval of Embolized Atrial Septal Defect Closure Device

Surgical retrieval of atrial septal closure device is associated with significant morbidity. We present a technique for safer removal of such devices from the heart.

Transesophageal echocardiography guided transseptal puncture for atrial fibrillation ablation in a patient with a 30 mm atrial septal closure device.

Percutaneous device closure is a well-established treatment of atrial septal defects (ASD) and the method of stroke prevention in a selected group of patients with patent foramen ovale (PFO). However, in case of drug-refractory atrial fibrillation (AF), when catheter ablation of pulmonary veins (PV) is required, the access to the left atrium is more difficult due to the ASD/PFO closure device. We report a case of a 58-year-old man with PFO closure performed due to recurrent stroke (Nit-Occlud PFO device 30 mm in diameter). 3.8 years after the successful procedure the patient suffered from frequent, symptomatic episodes of drug-refractory AF. Before the pulmonary vein isolation (PVI) procedure a computed tomography scan was obtained to access the PV anatomy and to visualize the device position (Figure 1 A). Figure 1 A – Computed tomography scan merged with CARTO map of left atrium (LA) indicating relation of the device (green arrows) to the anatomical structures and ablation line (red dots). Projections shown in Figure 1: right anterior oblique (RAO) 46o ... During PVI four venous accesses were obtained: two in the right and two in the left femoral veins. Diagnostic catheters were placed in coronary sinus and His bundle position. Left atrial access was obtained with a double transseptal puncture under both fluoroscopic and transesophageal echocardiography (TEE) guidance (Vivid q). Two 8.5-Fr transseptal sheaths were advanced over a guide wire to the superior vena cava. Then a transseptal needle was introduced into the sheath, and the whole unit was withdrawn under the fluoroscopic antero-posterior view and TEE guidance. The typical “jump” of the needle could not be observed due to device presence. The optimal site of the transseptal puncture was determined mostly on TEE guidance. In the bicaval view the correct position in the vertical axis was fixed. In the short axis view the position of the puncture needle was corrected in the anterior-posterior (A-P) axis (Figure 1 B). The transseptal system was positioned in relation to the interatrial septum, visualized by TEE and directed to the thinner part of the septum, below and posterior to the occluder device. When the transseptal unit was placed in the desired location, the position was confirmed by the typical tenting of the septum caused by the transseptal unit, and the needle was advanced through the septum. Effectiveness of the puncture was confirmed by saline injection to the left atrium and assessed by TEE (Figure 1 C). Finally, the transseptal sheath was advanced over the wire to the left atrium. A second transseptal puncture was performed using a similar technique, slightly inferior to the first access. The ablation strategy consisted of PVI with two wide antral circumferential RF ablations around ipsilateral PV using an electroanatomical mapping system (CARTO 3), a 3.5-mm irrigated-tip catheter and a circular mapping catheter. All four PV were isolated with confirmed entrance and exit block (Figure 1 A). There were no procedure-related complications. More and more patients after device PFO/ASD closure will undergo procedures requiring transseptal access. As described in this case and several previous reports [1–4], transseptal access in a patient with an atrial septal occluder device can be performed successfully and allow pulmonary vein isolation. The TEE is an effective method to guide transseptal puncture in this group of patients.

Double Transseptal Puncture Adjacent to Multiple Amplatzer Atrial Septal Occluders: Case Report

Successful transseptal puncture adjacent to a single Amplatzer atrial septal closure device is well described. Rarely multiple Amplatzer devices may be required to close defects in the interatrial septum. We report on successful double transseptal puncture adjacent to multiple Amplatzer atrial septal occluder devices for the purposes of catheter ablation for atrial fibrillation.

Catheter Ablation of Atrial Fibrillation in Patients with Hardware in the Heart - Septal Closure Devices, Mechanical Valves and More.

Patients with mechanical "hardware" in the heart, such as those with mechanical cardiac valves or atrial septal closure devices, represent a population at high risk of developing AF. Catheter ablation of AF in these subjects might represent a challenge, due to the perceived higher risk of complications associated with the presence of intracardiac mechanical devices. Accordingly, such patients were excluded or poorly represented in major trials proving the benefit of catheter ablation for the rhythm-control of AF. However, recent evidence supports the concept that catheter ablation procedures might be equally effective in these patients, without a significant increase in the risk of procedural complications. This review will summarize the current state-of-the-art on catheter ablation of AF in patients with mechanical "hardware" in the heart.

Palliation of a Malignant Gastrocolic Fistula and Gastric Outlet Obstruction Using Combined Atrial Septal Closure Device and Duodenal Stent

Palliation of a Malignant Gastrocolic Fistula and Gastric Outlet Obstruction Using Combined Atrial Septal Closure Device and Duodenal Stent

Transseptal puncture through atrial septal closure devices

Ostium secundum defects involve the region of the fossa ovalis and represent 80% of all atrial septal defects (ASDs). They account for approximately 7% of all congenital malformations. 1 Warnes C.A. Liberthson R. Danielson G.K. et al. Task force 1: the changing profile of congenital heart disease in adult life. J Am Coll Cardiol. 2001; 37: 1170-1175 Abstract Full Text Full Text PDF PubMed Scopus (1054) Google Scholar Small defects (<1 cm) may be left alone, but some patients develop right heart dilation later in life due to increased left ventricular end-diastolic pressure (LVEDP) and left-to-right shunting. Considerable shunt (Qp/Qs >1.5), right atrial/right ventricular enlargement, and paradoxical embolism are the main indications for ASD closure. 2 Warnes C.A. Williams R.G. Bashore T.M. et al. ACC/AHA 2008 guidelines for the management of adults with congenital heart disease. J Am Coll Cardiol. 2008; 52: e1-e121 Abstract Full Text Full Text PDF PubMed Scopus (239) Google Scholar , 3 Baumgartner H. Bonhoeffer P. De Groot N.M. et al. ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). Eur Heart J. 2010; 31: 2915-2957 Crossref PubMed Scopus (1848) Google Scholar Recently, device closure has emerged as the treatment of choice for secundum ASD when the anatomy is suitable. 2 Warnes C.A. Williams R.G. Bashore T.M. et al. ACC/AHA 2008 guidelines for the management of adults with congenital heart disease. J Am Coll Cardiol. 2008; 52: e1-e121 Abstract Full Text Full Text PDF PubMed Scopus (239) Google Scholar , 3 Baumgartner H. Bonhoeffer P. De Groot N.M. et al. ESC Guidelines for the management of grown-up congenital heart disease (new version 2010). Eur Heart J. 2010; 31: 2915-2957 Crossref PubMed Scopus (1848) Google Scholar Transseptal access and atrial fibrillation ablation guided by intracardiac echocardiography in patients with atrial septal closure devicesHeart RhythmVol. 8Issue 11PreviewPercutaneous positioning of closure devices is a well-established treatment of atrial septal defects (ASDs). However, patients who have undergone the procedure are at increased risk for developing atrial fibrillation (AF), and treatment by catheter ablation is underutilized due to the perceived difficulty of obtaining transseptal access in the presence of the closure device. Full-Text PDF

Transseptal access and atrial fibrillation ablation guided by intracardiac echocardiography in patients with atrial septal closure devices

Percutaneous positioning of closure devices is a well-established treatment of atrial septal defects (ASDs). However, patients who have undergone the procedure are at increased risk for developing atrial fibrillation (AF), and treatment by catheter ablation is underutilized due to the perceived difficulty of obtaining transseptal access in the presence of the closure device. The purpose of this study was to report the acute and long-term results of radiofrequency catheter ablation of AF in patients with ASD closure devices. Thirty-nine patients (age 54 ± 6 years, 72% males) with drug-refractory AF (33% paroxysmal, 51% persistent, 16% long-standing persistent) and ASD closure devices (82% Amplatzer, 18% CardioSEAL) underwent radiofrequency catheter ablation. A double transseptal access guided by intracardiac echocardiography was obtained in all patients. In 35 of 39 patients (90%), the transseptal access was obtained in a portion of the native septum, whereas in 4 of 39 patients (10%), a direct access through the device was required. The latter group had a significantly longer time for achieving the double transseptal access (73.6 ± 1.1 minutes vs. 4.3 ± 0.4 minutes, P < .001), longer fluoroscopy time (122 ± 5 minutes vs. 80 ± 8 minutes, P < .001), and total procedural time (4.1 ± 0.2 hours vs. 3.1 ± 0.3 hours, P < .001). At follow-up of 14 ± 4, months the overall success rate was 77% (85% in paroxysmal AF, 73% in nonparoxysmal AF). Transthoracic contrast-enhanced echocardiography with the Valsalva maneuver, performed between 3 and 6 months after the procedure, failed to detect shunt in all patients. Radiofrequency catheter ablation of AF is feasible, safe, and effective in patients with ASD closure devices. Transseptal access can be obtained in portions of the native septum in the majority of cases. Direct transseptal puncture of the device is feasible and safe but requires longer time for each transseptal access.

Transseptal access for pulmonary vein isolation in a patient with atrial septal closure device: Use of electrocautery and atrial septostomy

Transseptal access for pulmonary vein isolation in a patient with atrial septal closure device: Use of electrocautery and atrial septostomy

Reduction of a previous atrial septostomy in a patient with end-stage pulmonary hypertension by a manually fenestrated device

A case of profound systemic oxygen desaturation after atrial septostomy in a patient with primitive pulmonary hypertension is reported. A new method to correct such severe complication of atrial septostomy is described, consisting in a graded reduction of the right to left atrial shunt by deployment of a manually perforated atrial septal closure device.

A Case of Bioabsorbable Atrial Septal Closure Device Fracture Diagnosed by Transesophageal Echocardiography Just after Deployment

(Echocardiography 2010;27:E55‐E56)

Use of Amplatzer device for endobronchial closure of bronchopleural fistulas

Postpneumonectomy bronchopleural fistulas (BPFs) remain difficult management problems associated with considerable morbidity and mortality. Traditional therapies have included primary repair or delayed closure with the creation of an Eloesser cavity and tissue flap reinforcement. New bronchoscopic modalities have included the use of bioglues, stents, and coils. We describe another additional, less invasive bronchoscopic modality - the use of an atrial septal closure device.

Patent Foramen Ovale Closure

Setting aside the controversial questions of whether closing a patent foramen ovale (PFO) is indicated or effective for the prevention of recurrent stroke or the treatment of migraine headaches, what is the physiological impact of implanting a transcatheter device in the atrial septum? In this issue of Circulation , Wohrle and his colleagues address 1 aspect of this question, reporting the results of a study in which they assessed atrioventricular and semilunar valve function in 102 patients before and after transcatheter PFO closure.1 The authors evaluated valvar competence before, the day following, and 12 months after PFO closure and found no significant change in aortic regurgitation (AR) or regurgitation of the other cardiac valves. On their own, these findings might be passed off as predictable and modestly novel. Viewed in the context of a recent article by Schoen et al in Heart , however, they are noteworthy.2 Accordingly, to appreciate the study by Wohrle et al fully, it should be read as a counterpoint to the report by Schoen et al, which was a surprise to many in its description of new or increased AR in 10% of 170 patients who underwent transcatheter closure of a PFO and 9% of 70 in whom a device was placed to close an atrial septal defect.2 Article see p 3002 Before simply accepting the apparently contradictory findings of these 2 studies, however, it is worth acknowledging several basic methodological differences. The first difference is the means by which valvar regurgitation was assessed. In contrast to Schoen et al, who evaluated valvar function with transesophageal echocardiography 3, 6, and 12 months after catheterization, Wohrle et al assessed the function of the aortic and other valves with cardiac magnetic resonance imaging. Schoen et al graded AR according to a standard ordinal scale, …

Transcathether occlusion of interatrial communications: postprocedural transoesophageal echocardiography allows timely detection and treatment of intracardiac thrombus formation

Thrombus formation leading to ischaemic stroke is a major concern after transcathether occlusion of interatrial communications. The aim of our study was to verify if postprocedural transoesophageal echocardiography (TEE) might improve timely detection and management of thrombus formation. We studied 65 patients with patent foramen ovale or atrial septal defect who received an atrial septal closure device. Transoesophageal echocardiography was used to guide the procedure, and was repeated <1 h after the end of the procedure, at 30 day and 6 month follow-up visits. Transoesophageal echocardiography <1 h after procedure revealed a left-sided thrombus attached to the device in three patients. All cases were successfully treated by thrombolytic therapy with full-dose tenecteplase (0.53 mg/kg in 5-10 s) with disappearance of thrombus in 15-60 min. No cerebrovascular event was recorded during a follow-up of 311 +/- 235 days. Thrombus formation on interatrial closure devices can occur soon after device implantation and can be timely detected by postprocedural TEE.