Transcatheter closure of secundum atrial septal defects with the new self-centering Amplatzer Septal Occluder.

AIMS: The study was set up to find out whether a new self-centering prosthesis for transcatheter closure of secundum atrial septal defects could overcome the disadvantages of previously described devices. METHODS AND RESULTS: Fifty-two consecutive patients with a significant atrial septal defect were considered for transcatheter closure with the Amplatzer Septal Occluder. The device, made of a Nitinol and polyester fabric mesh, provides a different approach to defect occlusion by stenting the atrial septal defect up to a stretched diameter of 26 mm. Three infants whose large defects were demonstrated on a transthoracic echocardiogram were excluded from transcatheter treatment. On transoesophageal echocardiography, 49 defects ranged from 6-26 mm, in one adult the defect measured 28 mm and this patient was excluded from attempted transcatheter closure. At cardiac catheterization in five further patients, devices were not implanted, in two because the stretched diameter exceeded 26 mm and in three the device was withdrawn because it was unstable or compromised the mitral valve. Thus, device closure was performed in 43 patients. At follow-up after 3 months the complete closure rate was 97%. CONCLUSION: The self-centering Amplatzer Septal Occluder is very efficient and user-friendly and offers interventional closure in 83% of an unselected group of patients presented with an atrial septal defect.     

Transcatheter closure of defects within the oval fossa using the Amplatzer Septal Occluder

This study reviewed the short-term outcome of transcatheter closure of the defects within the oval fossa using an Amplatzer Septal Occluder. From January 1997 to December 2000, 210 patients with defects within the oval fossa underwent successful transcatheter closure. We reviewed a total of 190 patients with left-to-right shunts, assessing the patients for possible complications and the presence of residual shunts using transthoracic echocardiogram at 24 h, 1 month, 3 months and one year. Their median age was 10 years, with a range from 2 to 64 years, and their median weight was 23.9 kg, with a range from 8.9 to 79 kg. In 5 patients, a patent arterial duct was closed, and in 2 pulmonary balloon valvoplasty performed, at the same sitting. The median size of the Amplatzer device used was 20 mm, with a range from 9 to 36 mm. The median times for the procedure and fluoroscopy were 95 min, with a range from 30 to 210 min, and 18.4 min, with a range from 5 to 144 min, respectively. Mean follow-up was 20.8 +/- 12.4 months. Complete occlusion was obtained in 168 of 190 (88%) patients at 24 h, 128 of 133 (96.2%) at 3 months, and 103 of 104 (99%) at one year. Complications occurred in 4 (2.1%) patients. In one, the device became detached, in the second the device embolized into the right ventricular outflow tract, the lower end of the device straddled in the third, and the final patient had significant bleeding from the site of venupuncture. There were no major complications noted on follow-up. We conclude that transcatheter closure of defects within the oval fossa using the Amplatzer Septal Occluder is safe and effective. Long-term follow-up is required, nonetheless, before it is recommended as a standard procedure.     

Transcatheter closure of atrial septal defects in children & adults using the Amplatzer Septal Occluder

We are reporting the worldwide experience in closing atrial septal defects (ASDs) in children and adults using the Amplatzer Septal Occluder (ASO) as of July 2000. The outcome measures were safety and efficacy with special emphasis on: (1) immediate success of the ASD closure as measured by transesophageal echocardiography (TEE), (2) short- and medium-term follow-up at 24 hours and 1 and 3 months and long-term follow-up at 1, 2, and 3 years as assessed by transthoracic echocardiography (TTE); and (3) the incidence of complications. In all, 3580 procedures were performed in 3535 patients. In 75 patients, the device was not implanted for variety of reasons; 3460 patients received a single ASO device and 45 received two devices for multiple ASDs. The median age of the patients was 12.1 year, (range, 10 days-88 years, the median weight was 41.0 kg (range, 2.4-137 kg) and the median Qp/Qs ratio was 2 (range, 0.3-10). The median size of ASD by TEE was 14 mm (range, 1-38 mm) and the median stretched diameter was 18 mm (range, 4-44 mm). The median size of device implanted was 18 mm (range, 4-40 mm). The median fluoroscopy time was 17.1 minutes (range, 0.0-194.0 minutes). The immediate success rate including those patients with complete closure, trivial residual shunt, or with small residual shunt was 97.4%. This increased to 99.2% and 100% at 3 months and 3 years, respectively. Minor complications were encountered in 2.8% of procedures, while serious complications occurred in less than 0.3% of the cases. There were no device related deaths. We conclude that the ASO is a safe and effective device for catheter closure of small to large ASDs up to a stretched diameter of 40 mm in children and adults with very high short-, medium, and long-term success rates.     

Ventricular septal defect following cardiac trauma: closure with the Amplatzer Septal Occluder

Ventricular septal defect following cardiac trauma: percutaneous closure with the Amplatzer septal occluder. HISTORY AND CLINICAL FINDINGS: A 36-year old roofer fell 8 m and suffered a severe polytrauma. A complicating pericardial tamponade was relieved as an emergency and myocardial fissure of the left ventricle about 1 cm in length sutured. 2 weeks later, a severe mitral insufficiency due to rupture of the papillary muscle occurred, that was cared by the implantation of a bioprosthesis. 6 weeks later dyspnoea and restricted physical capability were clinically impressive. INVESTIGATIONS AND DIAGNOSIS: Echocardiography demonstrated a posttraumatic muscular ventricular septal defect. Doppler echocardiography and heart catheterization showed a ventricular septal defect still restrictive with a left-to-right shunt (pulmonary-to-systemic flow ratio Qp/Qs 1.8:1). Under exercise, there was a significant increase in mean pulmonary arterial pressure from 27 to 60 mmHg. TREATMENT AND COURSE: The patient who had already been operated twice before was treated by the percutaneous occlusion of the ventricular septal defect from arterio- to venofemoral, a guide catheter was inserted transseptally into the left ventricle. An Amplatzer Septal Occluder, a self-expandable, self-centering wire-mesh double disc with a connecting central stent part, was loaded and then implanted in the ventricular septal defect. The intervention was controlled by fluoroscopy and echocardiography. Post intervention, only a trivial residual shunt was seen. The pumping efficacy of the left ventricle increased, in particular of the septal and apical segments. Clinically, the patient was markedly more load-bearing, the exercise-induced dyspnoea reduced. CONCLUSIONS: Following a cardiac trauma, various complications may occur that can manifest themselves clinically at two or more times. A posttraumatic ventricular septal defect of a patient already operated was successfully occluded by an Amplatzer Septal Occluder. Alongside established surgical methods, the non-operative implantation of new occlusion systems could mean an effective treatment option for muscular ventricular septal defects.     

Complications Related to Transcatheter Occlusion of Atrial Septal Defect with Amplatzer Septal Occluder in Children

METHODSPatients From August 1998 to March 2004, a total of 289 children (mean age: 6.5 ±3.8 years) have undergone transcatheter occlusion of secundum type ASD with ASO. All cases performed transthoracic echocardio- graphy (TTE) evaluation before implantation and con- finned by balloon sizing in interventional procedure, partly confirmed by transoesophageal echocardiography(TEE). Patients with a residual rim of atrial septum <4mm, or diameter of ASD + 14mm > the maximal septal length…     

Transcatheter device closure of interatrial septal defects in patients with hypoxia

BACKGROUND: There has been growing interest in transcatheter closure of interatrial septal defects (IASDs) for a variety of indications, but reports are limited in patients with hypoxia from right-to-left shunting. METHODS: Between August 2000 and October 2004, 181 patients were referred to our institution for elective closure of a patent foramen ovale (PFO) or atrial septal defect (ASD). Among these patients, 10 (5.5%) underwent closure for hypoxia due to persistent or intermittent right-to-left shunting. Clinical evaluation, including echocardiography with color Doppler and agitated saline, was performed in all patients to determine the degree of right-to-left shunting. Defects were closed with Amplatzer (n = 4) or Cardioseal (n = 6) devices, under transesophageal (TEE) or intracardiac echocardiography (ICE) guidance. RESULTS: Mean age was 62.7 years (range: 31-88 years) with 70% female. Characteristics for closure included four patients with persistent hypoxia and six with intermittent hypoxia, including two with platypnea-orthodeoxia syndrome. All patients had echocardiography showing moderate (n = 6) or severe (n = 4) shunting. Patients had significant comorbidities, including chronic lung disease requiring supplemental oxygen (n = 5) and congestive heart failure (n = 2). TEE guidance was used in three patients, and ICE was performed in the remainder. Mean closure device diameter was 27 mm. Mean preprocedural arterial oxygen saturation of 86.7% improved to 95.9% immediately after closure, with color Doppler and agitated saline revealing the absence of (n = 5) or mild (n = 5) shunting. In-hospital major complications were limited to one patient with a transient ischemic attack after an initially unsuccessful closure attempt. CONCLUSIONS: Percutaneous closure of IASDs in a heterogeneous group of patients with hypoxia can be safely and effectively performed. The procedure results in immediate arterial saturation improvement and reduced right-to-left shunting.     

Transcatheter closure of coronary artery fistulae using the Amplatzer Duct Occluder.

OBJECTIVE: The aim of this study is to report our experience using the Amplatzer Duct Occluder (ADO) for occlusion of significant coronary artery fistulae (CAF). BACKGROUND: Transcatheter closure of CAF with coils is well described. Use of newer devices may offer advantages such as improved control of device placement, use of a single instead of multiple devices, and high rates of occlusion. METHODS: A retrospective review of all patients catheterized for CAF from July 2002 through August 2005 was performed. RESULTS: Thirteen patients with CAF underwent cardiac catheterization, of which a total of 6 patients had ADO placement in CAF (age, 21 days to 56 years; median age, 4.3 years and weight, 3.8 kg to 74.6 kg; median weight, 13.3 kg). An arteriovenous wire loop was used to advance a long sheath antegrade to deploy the ADO in the CAF. Immediate and short-term outcomes (follow-up, 3 months to 14 months; median follow-up, 8.5 months) demonstrated complete CAF occlusion in 5 patients and minimal residual shunt in 1 patient (who had resolution of right atrial and right ventricular enlargement). On follow-up clinical evaluation, all 6 patients had absence of fistula-related murmurs, and 2 previously symptomatic patients had resolution of congestive heart failure symptoms. Early complications included transient palpitations and atrial arrhythmia in the 2 oldest patients (52 and 56 years old). CONCLUSIONS: Use of the ADO is applicable for transcatheter closure of significant CAF. Advantages of using the ADO include the antegrade approach, use of a single device, and effective CAF occlusion.     

Transcatheter Closure of Secundum Atrial Septal Defects Using the Amplatzer Septal Occluder: Initial Experience in Taiwan

We assessed the safety and efficacy of closure of secundum-type atrial septal defects (ASDs) using the Amplatzer septal occluder (ASO) in a sample of Taiwanese patients. Between June 2000 and April 2002, 25 patients underwent transcatheter closure of their secundum-type atrial septal defect/s using the ASO device. The procedures were performed under general anesthesia with access through the femoral vein using guidance provided by transoesophageal echocardiography (TEE) and fluoroscopy. Twenty-two patients had larger defects with right cardiac dilatation and paradoxical interventricular septal motion, while family concerns were the primary indications for closure for the other three. Twenty-five ASO devices were successfully implanted in 24 patients, with a lone individual referred for surgery due to implantation failure. The mean age of the patients was 12.5 years. The male-female ratio was 12:13. The mean pulmonary-systemic blood flow ratio (Qp:Qs) was 2.5:1. The ASD size (mean 20.2 mm; range 8–28.5) was measured using transoesophageal echocardiography, with a balloon-stretched diameter of 8–29.5 mm (mean 20.5). The size of the implanted devices ranged from 9–36 mm (mean 23.1). Fluoroscopy duration ranged from 9.7–41.2 minutes (mean 23.5). A residual shunt, assessed not significant from transoesophageal echocardiography, was detected in one patient who had received two ASO devices for multiple ASDs. Follow-up intervals ranged from 0.1–2 years (median 1.0), with no late complications determined for any patient. Transcatheter closure of secundum ASDs using the Amplatzer septal occluder is a safe and effective alternative to the surgical analog. With careful selection of patients, secundum ASDs can be successfully closed, with minimal procedural morbidity and excellent early results. Long-term follow up is necessary for evaluation, however, if this procedure is to be as effective as surgery.     

Transcatheter Closure of Secundum Atrial Septal Defects Using the Amplatzer Septal Occluder: Clinical Experience and Technical Considerations

The Amplatzer septal occluder (AGA Medical Corporation, Golden Valley, MN) is designed to be an ideal device for the transcatheter closure of ostium secundum atrial septal defects. This device is user-friendly and has a complete closure rate of greater than 96% and few complications. It is easily retrievable and repositionable. It is also useful for closure of other types of shunts. Large atrial septal defects (ASDs) of up to 38 mm may now be closed. The use of the transesophageal echocardiogram (TEE) for evaluation of device placement is also reviewed.     

Amplatzer PFO Occluder for treatment of incomplete LAA closure with AtriClip

Herein, we describe the use of an Amplatzer PFO Occluder to treat incomplete LAA closure due to a malpositioned AtriClip.     

Short- and intermediate-term results of transcatheter closure of atrial septal defect with the Amplatzer Septal Occluder

Background

The Amplatzer Septal Occluder (ASO) (AGA Medical Corp, Golden Valley, Minn) has gained wide acceptance for transcatheter closure of atrial septal defect (ASD). We conducted this study to evaluate the short-and intermediate-term results of ASD closure with the ASO and to determine the impact of deficient rim on the results.

Methods

Between March 1999 and February 2003, 197 patients underwent attempted transcatheter closure of ASD with the ASO. The size of the selected device either equaled or was 1 to 2 mm larger than the stretched diameter of the defect. Transesophageal echocardiography was used to monitor the implantation procedure. One hundred and fourteen patients (58%) with a deficiency in 1 rim (<5 mm) were included as group I, and the remaining 83 patients with adequate rims comprised group II.

Results

The mean stretched diameter measured with the balloon catheter was 18.6 ± 6.7 mm (range 7.1-37.2 mm). Deployment of the ASO was successful in 191 (97%) patients and failed in 6. There was no significant difference between the 2 groups in the success rate for ASD closure (110/114 vs 81/83). Repositioning of the device was required in 28 patients: 21 in group I and 7 in group II (21/114 vs 7/83, P > .05) The mean stretched diameter of the defect in these 28 patients was significantly larger than that in those who did not require repositioning of the device (27.3 ± 5.7 vs 17.1 ± 5.5 mm, P < .01). Three patients experienced severe complications: 1 had transient complete atrioventricular block, 1 had tamponade requiring drainage, and 1 had dislodgement of the device requiring emergent operation. One had a distal embolism to a fingertip. Echocardiography at 1 day, 3 months, 6 months, 12 months, and 24 months after the procedure showed residual shunts in 37/191 (19%), 15/189 (8%), 11/176 (6%), 7/131 (5%), and 3/72 (4%) patients, respectively.

Conclusions

The ASO is a safe and effective device for the transcatheter closure of ASD. Deficiency in 1 rim, particularly the superior anterior rim, does not influence the success rate of ASD closure.     

Transcatheter closure of double atrial septal defects with a single Amplatzer device.

Transcatheter closure of single secundum atrial defects has become the standard of treatment. The purpose of our study was to analyze the results of using a single Amplatzer device for closure of double atrial septal defects. Such defects were diagnosed in 41 out of 363 patients with atrial septal defects (ASDs) closed by transcatheter method. In 39, a single Amplatzer device was used. The size of the larger defect ranged from 5 to 18 mm, the smaller defect from 2 to 7 mm, with the distance between the borders of the communications ranging from 2 to 12 mm. We performed sizing and closure of only the larger defect. The mean size of implanted devices was 16.5 +/- 5.5 mm, equal to the stretched diameter of the main defect or 1-4 mm larger. The closure rate assessed by color Doppler flow examination was 61% after 24 hr, 78% after 1 month, 83% after 3 months, 86% after 1 year, and 95% after 2 years. If the distance between the two defects exceeded 7 mm, residual leaks were observed but tended to decrease and disappear with time. Selected patients with double atrial septal defects can be effectively treated with implantation of a single Amplatzer device.     

Transcatheter closure of atrial septal defects in adults with the Amplatzer septal occluder

OBJECTIVE—To assess the efficacy and complications of device occlusion of atrial septal defects in adults, using the Amplatzer septal occluder (ASO).
DESIGN—A prospective interventional study.
SETTING—Paediatric cardiology departments in two European teaching hospitals.
PATIENTS—The first 20 patients accepted for atrial septal defect device occlusion, on the basis of transoesophageal echocardiography. Sixteen patients had larger defects with right heart dilatation, while the primary indication for closure in four was a history of early paradoxical embolism.
INTERVENTIONS—Transcatheter atrial septal defect occlusions performed under transoesophageal echocardiography and fluoroscopic guidance between December 1996 and June 1998.
OUTCOME MEASURES—Success of deployment of ASO devices, procedure and fluoroscopic times, complications, and symptoms.
RESULTS—The ASO device was successfully implanted in all 20 patients (14 female), median age 44.2 years, with no complications. Of the 16 patients with right heart dilatation, the median Qp:Qs was 2.5:1. Defects measured 11-22 mm (median 18) on transoesophageal echocardiography, with balloon sized diameter (and device size) of 13-28 mm (median 20). For all 20 patients, the procedure time ranged from 38-78 minutes (median 61), and fluoroscopy 8.4-24.7 minutes (median 15.2). There were residual shunts in three patients at the end of the procedure, which were trivial ( 1 mm) as assessed by transoesophageal echocardiography, and persisted for more than six months in only one patient. Follow up ranged from 0.1-1.5 years (median 0.7). There have been no late complications.
CONCLUSIONS—The ASO device can be used successfully to close selected oval fossa defects in adults, with minimal procedural morbidity and excellent early results.


Keywords: atrial septal defect; interventional cardiac catheterisation; Amplatzer septal occluder     

Transcatheter closure of atrial septal defects with the Amplatzer septal occluder--a Japanese clinical trial.

This study reports the results of a Japanese clinical trial of transcatheter closure of atrial septal defects (ASD) using the Amplatzer septal occluder (ASO). Thirty-five patients with secundum ASD underwent transcatheter closure using the ASO at a median age of 12.9 years (range, 3.2-29.2 years) and a median weight of 39.2kg (range, 11.6-65.1 kg). The ASO was successfully implanted in 34 patients. The mean ASD diameter of the 34 patients measured by transesophageal echocardiography was 11.7 +/- 4.2mm (range, 5.0-20.8mm) and the mean balloon stretched diameter was 16.8 +/- 4.2 mm (range, 9-25 mm). The mean ASO size was 16.9 +/- 4.3 mm (range, 9-26mm). Complete closure rate at 1 day and 1 year after closure was 91% and 97%, respectively. One patient developed a transient second-degree atrioventricular block during the implantation procedure. No other complications occurred. Transcatheter closure of ASD using the ASO is effective and safe.     

Intraoperative imaging of hybrid procedure for muscular ventricular septal defects closure with Amplatzer Duct Occluder II

Hybrid approach becomes a promising conception of an alternative treatment for muscular ventricular septal defects (VSD) closure in infants. In this paper we report epicardial echocardiography imaging that enabled successful hybrid procedure performed in premature infant referred for surgical correction of a large perimembraneous VSD with simultaneous perventricular approach for concomitant muscular VSD.     

Occlusion of interatrial communications with the Amplatzer device: experience in 48 consecutive patients

Both secundum atrial septal defect (ASD) and patent foramen ovale (PFO) have been closed interventionally using several different occluding devices. At a single institution we strived for interventional occlusion of interatrial communications using the Amplatzer device exclusively. During a study period of 22 months, we studied 48 patients ranging in age from 1 to 48 years with an ASD (n = 45) or a PFO (n = 3). Successful implantation of an Amplatzer device was possible in 92% of the patients, and 95% of these patients had a complete early closure of their defect. There were no complications related to the procedure. We conclude that interventional closure of interatrial communications with the Amplatzer device is feasible and safe for selected patients.     

Retrograde transcatheter closure of ventricular septal defects in children using the Amplatzer Duct Occluder II

Objectives: To describe the technique and results of transcatheter closure of ventricular septal defects (VSDs) by a modified retrograde transarterial approach using the new Amplatzer Duct Occluder II (ADO II). Background: Transcatheter device closure of ventricular septal defects (VSDs) by antegrade method is well established, but a challenging procedure. We describe a retrograde technique that obviates the need for arteriovenous looping. Material and Methods: This is a prospective study from a single center. Between April 2009 and February 2010 13 children were identified for closure of various types of perimembranous and muscular VSDs using the ADO II device. All had met the criteria for surgical closure. Following left ventricular angiogram two were excluded as technically nonfeasible. The median age was 48 months (range 15–78). The median weight was 14 kg (range 7.5–20). The device was successfully deployed in the 11 selected children by the method described. The follow‐up evaluation included chest roentgenogram, ECG, and echocardiogram on day 1, at 6 weeks, at 3, 6, and 12 months. Results: The immediate and follow up complete closure rates were 73 and 82%, respectively. The median fluoroscopic time was 14 min (range 8.2–45). There were no procedure related complications. All patients were doing well at median follow up of 10 months; none showing any conduction abnormality. Conclusion: Transcatheter retrograde device closure of selected cases of Ventricular Septal Defects using the Amplatzer Duct Occluder II is simple and appears safe in the short term and can be completed within a short fluoroscopic time.© 2010 Wiley‐Liss, Inc.