The immediate release patch in the correction of experimental atrial septal defects

Objectives : The purpose of this study was to evaluate the safety and efficacy of the Immediate Release Patch (IRP) in the occlusion of experimental Atrial Septal Defects (ASDs). Background : The IRP consists of a polyurethane foam patch, supported by a balloon catheter which incorporates a detaching mechanism. This mechanism allows for withdrawal of the catheter from the balloon/patch complex. After release, the device is held in position using a bioabsorbable safety thread, which is sutured subcutaneously at the groin. Methods : Experimental ASDs, 10–14 mm in diameter, were created in ten piglets. The ASDs were then corrected using IRPs 12–16 mm in diameter, under fluoroscopy and echocardiography. The animals were followed for one to four months, and were then euthanized and autopsied. A RAST test, which detects the presence of IgE antibodies for latex, was performed in seven animals. Results : All procedures, except for one, resulted in full occlusion of the defects, without serious complications. No devices embolized, and in less than two months, the balloons had deflated and the area of the device had decreased significantly. The autopsies revealed complete endothelialization as well as no thrombus formation on the device or the thread. The thread was absorbed after one month. In a single case, infection was detected on the right side of the device. Latex antibodies were not detected. Conclusion : The IRP was effective and safe in the animal model of an ASD. There was evidence of bio‐absorption of the complete device over time, without adverse reaction to latex. Clinical application is justified. © 2010 Wiley‐Liss, Inc.     

Staged percutaneous atrial septal defect closure and pulmonic balloon valvuloplasty in an adult with congenital heart disease

Combined atrial septal defect and pulmonic stenosis, while a common occurrence in children, is relatively uncommon in adults. There is no widely accepted order in which the defects should be corrected. We report a case that highlights the hemodynamics and the technical dilemma of deciding which lesion to correct first. © 2008 Wiley‐Liss, Inc.     

Iatrogenic atrial septal defect, erosion of the septum primum after device closure of a patent foramen ovale as a new medical entity.

Iatrogenic atrial septal defects are described in 2 patients. They occurred after implantation of Amplatzer occluders to close a patent foramen ovale. While device erosions to the extra-atrial space have been described, erosion induced atrial septal defects are a new medical entity. They may be fairly common in the situation of an atrial septal aneurysm whipping the rim of the device incessantly. They are clinically silent and benign and require echocardiography for detection. A second device solved the problem in the cases described.     

Iatrogenic erosion of the septum primum resulting in an atrial septal defect with left‐to‐right shunt: A rare pitfall of patent foramen ovale percutaneous closure

Iatrogenic erosion of the septum primum after foramen ovale closure is an anecdotal event. We report the case of a 39‐year‐old woman admitted to our institution for multifocal cryptogenic cerebral ischemia and a patent foramen ovale (PFO) associated with an aneurysm of the septum primum. The patient underwent percutaneous closure of the PFO with an Amplatzer PFO Occluder device. At the 6‐months follow up, the device was in the right position, but a jagged defect of the septum primum and evidence of significant left‐to‐right shunting was detected. The atrial septal defect was then repaired by a surgical approach. Although this event is not life‐threatening, it should be considered as a therapeutic pitfall, resulting in a risk of paradoxical embolism recurrences and long‐term hemodynamic impairment. © 2013 Wiley Periodicals, Inc.     

Utility of on‐line three‐dimensional transesophageal echocardiography during percutaneous atrial septal defect closure

Key echocardiographic assessments during percutaneous atrial septal defect (ASD) closure are the maximal defect diameter, the presence or absence of tissue rims, and the spatial relationships between the implanted device and cardiac structures. These assessments drive device selection and may help identify situations that may place a patient at risk for device erosion or other complications. On‐line three‐dimensional (3D) transesophageal echocardiography (TEE) enables the rendering of nearly unlimited tissue planes within an acquired pyramidal‐shaped volume with minimal image post‐processing. We present several cases of percutaneous ASD closure guided by on‐line 3D TEE imaging that highlight the potential advantages of this new imaging technology. © 2009 Wiley‐Liss, Inc.     

Late free atrial wall rupture after percutaneous atrial septal defect closure and transvenous pacemaker implantation

We report a remarkable case of right atrial rupture, 3 years after transcatheter closure of a secundum atrial septal defect, and 7 months after permanent transvenous two‐chamber pacemaker implantation. The etiology of the rupture remains unclear, but the presence of the two intracardiac devices is probably not coincidental. © 2008 Wiley‐Liss, Inc.     

Feasibility of transcatheter closure in unselected patients with secundum atrial septal defect,using amplatzer devices and a modified sizing balloon technique

Objectives: We aimed to assess (1) the role of surgical versus transcatheter closure techniques and (2) the impact of a modified implantation technique to optimize closure of secundum septal defects with the Amplatzer device. Background: Despite several comparative studies, the respective roles of surgical and transcatheter closure are not clarified. Additionally, the impact of modified method of implantation on device closure remains unknown. Methods: Fifty‐seven unselected patients were referred for secundum atrial septal defect closure in 2009, at a median age and weight of 27.5 (0.8–88) years and 40.6 (5.6–97) kg, respectively. Transcatheter closure was attempted in 53 cases under transesophagal echocardiography guidance in children (n = 28) and intracardiac echocardiography guidance in adults. If standard closure failed, a sizing balloon catheter inflated in the left atrium was used as a support to secure the position of the device upon deployment. Results: Fifty of the 57 cases (88%) were successfully closed with a median Amplatzer Septal Occluder size of 20 (10–40) mm, using the sizing balloon technique in eight (16%) cases. No major complication occurred. A trivial residual shunt remained in two patients (4%) whereas a mild mitral regurgitation appeared in one. By univariate analysis, a deficient superior–posterior rim and a large defect (>15 mm²/m²) were associated with the use of the sizing balloon technique (P = 0.04 and 0.03, respectively). A deficient superior–posterior rim and pulmonary hypertension were associated with failure to close the defect (P = 0.02 and 0.03, respectively). Conclusion: The majority of secundum atrial septal defect is amenable to transcatheter closure, using a modified implantation technique in 16% of cases. © 2011 Wiley‐Liss, Inc.     

PFO closure complications from the AGA registry

Objectives: To evaluate all complications that occurred during or after cardiac catheterizations for Amplatzer PFO device closure of patent foramen ovale (PFO), determine the cause of the complications and recommend techniques to minimize complications in the future. Background: Rare complications were reported to the manufacturer of the Amplatzer PFO occluder since the introduction of the device. Methods: A panel of independent physicians reviewed all complications reported to the manufacturer to determine whether the complication was related to the device or related to the cardiac catheterization procedure. Demographic data, echocardiograms, operative reports, and time to occurrence of complications were reviewed. Results: A total of 11 events were reported. Only two patients had device related complications (erosion), an incidence of 0.018%. Two patients were found to have additional atrial septal defect after PFO closure. Two patients were thought to have an inflammatory reaction without any serious sequelae. Five complications were related to the cardiac catheterization procedure (atrial appendage perforation). Conclusions: Device related complications after Amplatzer PFO occluder placement are extremely rare. Cardiac catheterization related complications appear to be the most common cause of the hemodynamic compromise. Careful manipulation of catheters and wires, recognition of the location of the catheter by fluoroscopy and echocardiography will decrease the risk of such complications. © 2008 Wiley‐Liss, Inc.     

A novel technique using a steerable guide catheter to successfully deliver an Amplatzer septal occluder to close an atrial septal defect

Correct positioning of an Amplatzer ASD occluder can be difficult in vertical hearts or in those with diminutive or missing septal rims. In this report we describe the use of a steerable sheath to position the device in the plane of the ASD to achieve success. © 2008 Wiley‐Liss, Inc.     

Management of residual shunts after initial percutaneous patent foramen ovale closure: A single center experience with immediate and long‐term follow‐up

Background: Moderate‐to‐large residual shunts following percutaneous patent foramen ovale (PFO) closure are clinically important and associated with recurrent neuroembolic events. However, their management has not been clearly established in clinical practice. We report our experience in patients of these patients with a prior history of cryptogenic stroke and/or transient ischemic attack (TIA). Methods: All patients undergoing percutaneous PFO closure were routinely screened at six‐months for residual shunts using transthoracic 2D echocardiography with antecubital administration of agitated saline contrast and color flow Doppler. Patients with evidence of moderate‐to‐large residual shunts were selected to undergo reintervention with shunt closure. Postreintervention follow‐up was performed at 24‐hr, 30 days, and every six months thereafter. Clinical predictors of the moderate‐to‐large residual shunts, and the feasibility, safety and long‐term efficacy of percutaneous residual shunt closure using a second device implant were examined. Results: Between 1995 and 2007, a total of 424 patients underwent PFO closure. Of these, 5% (21/424) had moderate‐to‐large residual shunts. Baseline characteristics among patients with moderate‐to‐large residual shunts and those with only none or small defects (n = 403) were similar. Multivariate analysis identified the 24‐hr postprocedure shunt as the only independent predictor of residual shunting at six months. Of the 21 study patients with moderate‐to‐large residual shunt (mean age, 47 ± 14), one underwent successful elective surgical repair, while the remaining 20 underwent transcatheter closure using a second device. The technique was successful in 95% (19/20), and all but one patient had complete shunt closure at six months of their percutaneous reintervention. We report no deaths, recurrent strokes or TIAs during the long‐term mean follow‐up period of 2.9 years. Conclusions: Our study suggests that in patients with moderate‐to‐large residual PFO shunts, percutaneous reintervention using a second device implant is safe and effective. © 2010 Wiley‐Liss, Inc.     

Experience using the new GORE® septal occluder at the margins

Complex atrial anatomy continues to challenge transcatheter device closure of septal defects. Devices and technology continue to evolve. We report three cases from our institution where the new Gore^® Septal Occluder was utilized for the closure of a lateral tunnel fenestration, a moderate‐sized secundum atrial septal defect and a long tunnel patent foramen ovale. Each case highlights the successful use of this new generation device in challenging circumstances. © 2013 Wiley Periodicals, Inc.     

Tips and tricks to prevent prolapse of the Amplatzer septal occluder through large atrial septal defects

We report on a new technique "using a partially inflated balloon through the atrial septal defect" to prevent prolapse of the left atrial disk of the Amplatzer septal occulder in large atrial septal defects (ASDs). Two patients underwent successful closure of their ASDs using this new technique.