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DOI: 10.1148/radiol.2332031707
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(Radiology 2004;233:471-476.)
© RSNA, 2004

Pediatric Imaging

Amplatzer Atrial Septal Defect Occluder for Pediatric Patients: Radiographic Appearance1

Edward Y. Lee, MD, MPH, Marilyn J. Siegel, MD, Celeste M. Chu, MD, Fernando R. Gutierrez, MD and Henry W. Kort, MD

1 From the Mallinckrodt Institute of Radiology, Washington University School of Medicine, 510 S Kingshighway Blvd, St Louis, MO 63110 (E.Y.L., M.J.S., C.M.C., F.R.G.); and Division of Pediatric Cardiology, Department of Pediatrics, St Louis Children’s Hospital, St Louis, Mo (H.W.K.). Received October 22, 2003; revision requested January 8, 2004; revision received February 2; accepted March 2. Address correspondence to M.J.S. (e-mail: siegelm@mir.wustl.edu).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
PURPOSE: To describe the chest radiographic appearance of the Amplatzer septal occluder (ASO) (AGA Medical Corporation, Golden Valley, Minn) for atrial septal defects (ASDs) in pediatric patients.

MATERIALS AND METHODS: Two radiologists independently reviewed frontal and lateral chest radiographs obtained in young patients 24 hours after transcatheter ASD closure with the ASO. The appearance (flat disks or dots) and location of the ASO were recorded. The location was related to that of a thoracic vertebral body on frontal and lateral chest radiographs and to a line drawn between the anterior margin of the right hilum and the posterior margin of the inferior vena cava (hilar-caval line) on lateral radiographs; this line corresponded to the expected position of the interatrial septum. The relationship between ASO appearance and patient age was assessed with logistic regression and cumulative probability plots.

RESULTS: Sixty-eight pediatric patients (age range, 1 month to 18 years; mean age, 4.2 years; 24 boys and 44 girls) were included. On frontal radiographs, the ASO center projected between T7 and T9, either to the right of or over the spinous processes of the vertebral body. On lateral radiographs, the ASO projected over (n = 66) or anterior to (n = 2) the hilar-caval line. On frontal radiographs, it appeared as one or two flat disks (n = 61) or as two metallic dots (n = 7). On lateral radiographs, it appeared as two flat disks (n = 54) or as two metallic dots (n = 14). The relationship between increasing patient age and the metallic dot appearance on frontal and lateral radiographs and on the combination of frontal and lateral radiographs was highly significant in each case (P < .001, likelihood ratio {chi}2 test), with r2 values of 0.35, 0.20, and 0.28, respectively. ASDs were successfully occluded with the ASO in all patients except one, in whom trivial shunting was seen at 12-month follow-up.

CONCLUSION: The ASO in pediatric patients has a characteristic radiographic appearance when properly positioned.

© RSNA, 2004

Index terms: Atrial septal defect, 514.1268, 514.141 • Children, cardiovascular system, 514.141 • Stents and prostheses, 514.4619 • Thorax, radiography, 58.11


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
The secundum type of atrial septal defect (ASD) is one of the most common congenital heart lesions (1). For several decades, surgical closure has been considered the standard method of repairing a secundum ASD (2). Surgical closure has a high success rate, with low morbidity and good long-term outcome, but it requires median sternotomy and cardiopulmonary bypass, which may result in a variety of complications (3–5). More recently, transcatheter closure of the secundum ASD has become an alternative to surgical procedures. ASD device placement has been shown to be as effective as surgery in the repair of secundum ASD, involves a shorter hospital stay, results in less discomfort and better cosmesis, and costs less than surgical closure (3,6–7).

In 1976, King et al (8) reported the first transcatheter closures of secundum ASDs in humans. The original technology did not gain widespread acceptance because the delivery systems required very large (14–18-F) introducing catheters. This limited implantation of occluder devices in small children. In addition, once deployed, the devices could not be repositioned or removed without surgical intervention (9). Since the early 1990s, the design of these devices has been refined, and most delivery catheters are now smaller and the closure devices are retrievable if necessary (9). These improvements have meant that transcatheter device closure of secundum ASD is now possible in children.

The Amplatzer septal occluder (ASO) (AGA Medical Corporation, Golden Valley, Minn) is one of the commonly used devices (10–18). Clinical and echocardiographic findings associated with transcatheter closure of secundum ASD with the ASO have been described (5,10–17). However, to our knowledge, there have been only a few reports regarding the radiographic features of this device, particularly in a large series of children (8,18,19). Thus, the purpose of our study was to describe the chest radiographic appearance of the ASO for ASDs in pediatric patients.


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
DISCUSSION
 REFERENCES
 
The institutional review board of St Louis Children’s Hospital approved our review of medical records and results of imaging examinations. Parental informed consent was not required.

Patient Population
Study inclusion criteria included the following: Patients had to be 18 years of age or younger, frontal and lateral chest radiography had to have been performed 24 hours after implantation, and transesophageal echocardiography (TEE) with color Doppler imaging and clinical examination had to have been performed 24 hours and 1, 6, and 12 months after the procedure. This is the standard protocol at our institution for evaluating patients for the presence of residual shunting or complications associated with transcatheter occlusion. Additional imaging is performed if results of the TEE examination suggest a residual or recurrent murmur. Implantation of an ASO device was performed by one of two experienced cardiologists. One cardiologist (H.W.K.) had 5 years of experience with device implantation, and the other cardiologist had more than 10 years of experience.

Clinical Review
The patients’ medical records were evaluated for the clinical indications for device implantation, the success of closure, and the presence or absence of residual shunting and complications. The clinical indications for using the ASO at our center are as follows: (a) the presence of a secundum ASD with a diameter of less than 40 mm as measured with echocardiography, (b) the presence of a left-to-right shunt exceeding 1.7:1 or signs of right ventricular overload (defined as a dilated right atrium and right ventricle at echocardiography), or (c) clinical symptoms such as frequent respiratory infection (more than six events per year) or failure to thrive.

The success of shunt closure was based on the results of TEE with color Doppler imaging. Patients were considered to have undergone successful ASD closure if they had (a) no left-to-right flow across the atrial septum, (b) trivial flow (jet width, <1 mm), or (c) a small (jet width, ≥1 but <2 mm) residual shunt at color Doppler TEE. Patients were considered to have undergone a failed procedure if moderate (jet width, 2–4 mm) or large (jet width, >4 mm) residual shunts were present.

Most complications are related to the procedure for transcatheter closure (5–17). Therefore, a brief description of this procedure is presented before the complications are defined. Implantation is performed with general anesthesia and fluoroscopic and echocardiographic guidance. Contrast material–enhanced angiography and device delivery are accomplished through a catheterized right femoral vein. Contrast material is injected into the right atrium and right superior pulmonary vein to define the anatomy of the ASD and to confirm that it is a secundum defect.

A 7- or 8-F catheter is then placed in either the left superior or the left inferior pulmonary vein, and a 0.0035-inch wire is exchanged for the catheter. A sizing balloon is introduced over the guidewire to measure the "stretched" diameter of the defect. Because the unstretched diameter determined at echocardiography often represents an underestimation of the stretched diameter of the ASD, the defect is balloon stretched to determine the size of the rim of tissue within which the device is to be deployed. The method of sizing is the "pulling technique," in which the balloon is inflated in the left atrial cavity and pulled across the septum into the right atrial cavity. The device is then "oversized" by 2 mm to ensure that it is self-centered and fits the defect snugly. The sizing balloon is then exchanged for a long delivery sheath, and the left disk of the device is first deployed by withdrawing the sheath. The device is pulled through the ASD into the right atrium, and the right disk is deployed after further withdrawal of the sheath so that the waist of the device occludes the ASD (Fig 1).



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  		Figure 1a. Angiographic images of ASO placement in 9-year-old girl. (a) Steep cranial and left anterior oblique angulation view during device placement demonstrates tip of 8-F catheter (curved arrow) in right superior pulmonary vein. The catheter was placed with a right femoral vein approach across the ASD into the right superior pulmonary vein. Contrast material is seen in the left atrium (LA), and there is immediate left-to-right shunting across the ASD (arrows), with opacification of the right atrium (RA). (b) View in same plane as a after device deployment. The catheter is now positioned in the main pulmonary vein since the catheter can no longer enter the left atrium because of the placement of the ASO. Contrast material is seen in the left atrium (LA) but there is no opacification of the right atrium (RA); this appearance confirms the proper position of the ASO.

 


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  		Figure 1b. Angiographic images of ASO placement in 9-year-old girl. (a) Steep cranial and left anterior oblique angulation view during device placement demonstrates tip of 8-F catheter (curved arrow) in right superior pulmonary vein. The catheter was placed with a right femoral vein approach across the ASD into the right superior pulmonary vein. Contrast material is seen in the left atrium (LA), and there is immediate left-to-right shunting across the ASD (arrows), with opacification of the right atrium (RA). (b) View in same plane as a after device deployment. The catheter is now positioned in the main pulmonary vein since the catheter can no longer enter the left atrium because of the placement of the ASO. Contrast material is seen in the left atrium (LA) but there is no opacification of the right atrium (RA); this appearance confirms the proper position of the ASO.

 
For the purpose of analysis, complications were defined as major or minor on the basis of established criteria (5,7). Major complications included death due to the procedure, device embolization requiring surgical intervention, cardiac perforation requiring immediate percutaneous or surgical drainage, and cardiac arrhythmia requiring permanent pacemaker placement or long-term medication. Minor complications were defined as events that were transient and resolved with specific treatment. These included device embolization with percutaneous retrieval, cardiac arrhythmia requiring short-term treatment, access site hematoma or other vascular access site complication, retroperitoneal hematoma, surgical wound infection, pericardial effusion requiring medical management, and device-associated thrombus formation without embolization.

Radiograph Review
Two radiologists (M.J.S. and F.R.G.) independently reviewed frontal and lateral chest radiographs obtained 24 hours after ASO placement. A consensus reading was performed if there was a discrepancy. Both reviewers had more than 20 years of experience in interpreting chest radiographs. As noted above, radiographs were not routinely obtained after patients were discharged from the hospital unless there was evidence of a residual or recurrent shunt. In this study, one patient underwent delayed radiography for this indication.

An understanding of the radiographic appearance of the ASO requires a brief review of the physical appearance of the device. The ASO is a self-centering device constructed from 0.004–0.00075-inch nitinol wires that are tightly woven into two flat disks with a connecting waist. Polyester mesh is sewn into each disk and into the waist to induce stasis and thrombosis. The waist is 3–4 mm in length and is available in 4–40-mm widths; the width dictates the device size (Fig 2) (15). The left atrial and right atrial disks are 12–16 mm larger and 8–10 mm larger than the waist diameter, respectively.



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  		Figure 2a. Appearance of ASO. (a) Frontal view of left atrial disk. Nitinol mesh wires support the polyester patches. (b) A 90° profile view of ASO shows left atrial disk (long arrows), right atrial disk (short arrows), and the delivery cable (arrowheads), which is connected to the right atrial disk.

 


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  		Figure 2b. Appearance of ASO. (a) Frontal view of left atrial disk. Nitinol mesh wires support the polyester patches. (b) A 90° profile view of ASO shows left atrial disk (long arrows), right atrial disk (short arrows), and the delivery cable (arrowheads), which is connected to the right atrial disk.

 
For each patient in this study, the appearance and the location of the device on frontal and lateral chest radiographs were recorded. The appearance was recorded as being that of one or two flat disks or two dots, the dots corresponding to the ends of the waist of the device. The location was related to the respective thoracic vertebral body on the frontal radiograph. On the lateral radiograph, location was related to the respective thoracic vertebral body, as well as to a line drawn between the anterior margin of the right hilum and the posterior margin of the inferior vena cava (hilar-caval line). This line corresponded to the expected position of the interatrial septum, and thus the waist of the device, on lateral chest radiographs (Fig 3).



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  		Figure 3. Lateral chest radiograph in 3-year-old boy with an ASO shows a line, which bisects the device, between the anterior margin of the right hilum (RH) and the inferior vena cava (IVC).

 
Statistical Analysis
Logistic regression and cumulative probability plots were used to investigate the relationship between device appearance and patient age. Separate analyses were performed for frontal views, lateral views, and the combination of frontal and lateral views. The {alpha} value was set at .05. Analyses were performed with JMP statistical analysis software (SAS Institute, Cary, NC).


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Study Patients
Between August 2000 and April 2003, there were 101 patients with secundum ASD at our institution who ranged in age from 1 month to 18 years. Of these 101 patients, 81 (80%) underwent septal closure with the ASO device. Twenty of 101 patients were excluded from analysis. Reasons for exclusion included the following: The defect was too large for occlusion; there was severe pulmonary artery hypertension (pulmonary artery systolic pressure > 60 mm Hg); there was a distance of less than 4 mm from the rim of the ASD defect to the atrioventricular valves, coronary sinus, or right pulmonary veins at echocardiography; and/or the defect was a primum rather than a secundum ASD.

Thirteen of 81 patients were excluded from further analysis because radiographs were not available for review. Echocardiographic and clinical findings and both frontal and lateral chest radiographs obtained 24 hours after the procedure were available for review for 68 (84%) of the 81 patients. These patients formed the study population. They ranged in age from 1 month to 18 years, with a mean age of 4.2 years. There were 24 boys and 44 girls.

Clinical Indications
The indications for occluder placement were a left-to-right shunt exceeding 1.7:1 in 49 (72%) of the 68 patients, right-sided heart failure in 12 (18%) patients, and clinical symptoms in seven (10%) patients that included recurrent respiratory infections (n = 5) and failure to thrive (n = 2) (Table).


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  		Clinical Variables and Indications for Transcatheter ASD Closure in 68 Pediatric Patients

 
Closure Results
The average device size (ie, the diameter of the connecting waist) was 17 mm (range, 5–38 mm). At the time of the procedure, 34 (50%) of 68 patients had complete closure of their ASD (Table). At discharge (ie, with 24 hours of follow-up), 65 (96%) of 68 patients had complete closure. For the remaining three patients, the residual shunt was defined as trivial (jet width, <1 mm) in one patient and small (jet width, ≥1 but <2 mm) in two patients. Echocardiography at 1- and 6-month follow-up points revealed complete closure in all 68 patients (100%). At 12-month follow-up, 67 (99%) of 68 patients had complete septal closure. A trivial shunt was noted in one patient at 12-month follow-up.

Complications
There were no deaths, malpositioned ASO devices, or complications requiring surgical repair after ASO placement in this study. A minor complication of transient cardiac arrhythmia that did not require treatment was observed in one patient immediately after the procedure.

Radiographic Findings
On frontal radiographs, the ASOs appeared as two dots in seven patients (10%) and as one (n = 42) or two (n = 19) flat disks in 61 patients (90%). On lateral radiographs, the devices appeared as two dots in 14 patients (21%) and as two flat disks in 54 patients (79%) (Figs 4, 5).



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  		Figure 4a. ASO in 2-year-old boy. (a) On frontal radiograph, the ASO appears as a flat disk (arrows). (b) On lateral radiograph, two flat disks are noted. The left atrial disk (arrow) is larger than the right atrial disk (arrowhead).

 


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  		Figure 4b. ASO in 2-year-old boy. (a) On frontal radiograph, the ASO appears as a flat disk (arrows). (b) On lateral radiograph, two flat disks are noted. The left atrial disk (arrow) is larger than the right atrial disk (arrowhead).

 


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  		Figure 5a. ASO in 16-year-old girl. (a) On frontal radiograph, the ASO has a two-metallic-dot (arrows) appearance. (b) On lateral radiograph, metallic dots (arrows) are again noted.

 


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  		Figure 5b. ASO in 16-year-old girl. (a) On frontal radiograph, the ASO has a two-metallic-dot (arrows) appearance. (b) On lateral radiograph, metallic dots (arrows) are again noted.

 
In all patients, the center of the ASO was located to the right of or over the spinous process of the vertebral body on frontal chest radiographs; none of the centers of the devices projected to the left of the spinous process. On frontal and lateral chest radiographs, the ASO projected between T7 and T9 in all patients. On lateral radiographs, the waist of the ASO projected over the hilar-caval line corresponding to the atrial septum in 66 patients (97%); in two patients, who were 30 and 47 months old, the device was anterior to the line.

All relationships between ASO appearance and patient age were highly significant for frontal views, lateral views, and the combination of frontal and lateral views (P < .001, likelihood ratio {chi}2 test), with r2 values of 0.35, 0.20, and 0.28, respectively. Cumulative probability plots of the relationships between ASO appearance and patient age are shown in Figure 6.



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  		Figure 6a. Cumulative probability plots of relationships between patient age and ASO appearance on (a) frontal radiographs, (b) lateral radiographs, and (c) frontal and lateral radiographs combined. The lines of fit partition the probability into the response categories. The probability of which appearance of the device will be seen can be read directly by viewing the vertical axis. As an example, for frontal views, at a patient age of approximately 100 months, the probability that an ASO will have a metallic dot appearance would be about 23%, and the probability of a disk appearance would be about 77% (100% – 23% = 77%).

 


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  		Figure 6b. Cumulative probability plots of relationships between patient age and ASO appearance on (a) frontal radiographs, (b) lateral radiographs, and (c) frontal and lateral radiographs combined. The lines of fit partition the probability into the response categories. The probability of which appearance of the device will be seen can be read directly by viewing the vertical axis. As an example, for frontal views, at a patient age of approximately 100 months, the probability that an ASO will have a metallic dot appearance would be about 23%, and the probability of a disk appearance would be about 77% (100% – 23% = 77%).

 


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  		Figure 6c. Cumulative probability plots of relationships between patient age and ASO appearance on (a) frontal radiographs, (b) lateral radiographs, and (c) frontal and lateral radiographs combined. The lines of fit partition the probability into the response categories. The probability of which appearance of the device will be seen can be read directly by viewing the vertical axis. As an example, for frontal views, at a patient age of approximately 100 months, the probability that an ASO will have a metallic dot appearance would be about 23%, and the probability of a disk appearance would be about 77% (100% – 23% = 77%).

 
There were no differences in the appearance or the location of the ASO between the patients with successful ASO deployment and the one patient with a trivial residual shunt.


   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
REFERENCES
 
Surgical closure has been the traditional method of treatment for ASD for several decades. Although perioperative mortality in most centers is near zero, residual postoperative shunting can occur in 2%–8% of patients, and minor morbidity occurs in about 18% of patients (10–17).

Transcatheter occlusion techniques are gaining widespread acceptance for closure of secundum ASDs (10–17). The effectiveness and cost efficiency of and the relatively low morbidity after transcatheter closure of ASDs make this technique an attractive alternative to surgical repair (3,6,7). Even patients once thought to need surgery for deficient rims of tissue near the ASD have been shown to have transcatheter closure rates similar to those of patients with sufficient rims of tissue (17).

The devices that have been previously evaluated in clinical trials include the ASO, the CardioSEAL occlusion system (National Medical Technologies, Boston, Mass), a buttoned device, and the Angel Wings and Guardian Angel devices (Microvena, White Bear Lake, Minn) (10–21). Among these devices, the ASO is currently the most commonly used in pediatric patients (10–17).

The radiographic features of the ASO reflect the features of the device itself. The two disks and narrow waist of the device can be seen as flat disks or metallic dots. The metallic dots represent the metallic ends of the central waist, which has a length of 3–4 mm. In our experience, the disk appearance was noted on 90% of frontal radiographs and on 79% of lateral radiographs, and it was substantially more common than the dot appearance. One flat disk was more common on frontal radiographs, while two disks were more common on lateral radiographs. One possible explanation for this difference is that one disk is more likely to be superimposed on the other on frontal radiographs. It is also possible that cardiac motion impairs the identification of two disks on frontal radiographs. Motion may also explain why two dots (ie, the waist of the device) rather than disks were seen in some patients. Patient size may also be a factor in whether one visualizes disks or dots. The soft tissues in larger patients may make it more difficult to detect the thin disks. In our series, disks were more often seen in younger patients than in older patients.

The location of the occluder is dictated by the position of the secundum ASD. In our patient population, the center of the ASO projected between T7 and T9 on the frontal radiograph, either to the right of or over the spinous process of the vertebral body. In none of the patients did the center of the disk project to the left of the spinous process. On lateral radiographs, 97% of the devices projected over the hilar-caval line. In two patients, the devices projected anterior to the line.

Our present results differ from the results we previously reported regarding the appearance of ASO devices in 24 adult patients, 20 of whom had an ASD, two of whom had patent foramen ovale, and two of whom had ventricular septal defect (18). In that study, on frontal radiographs, the ASO appeared as metallic dots in 23 (96%) of 24 patients and as two disks with a central waist in one patient. On lateral radiographs, the device had a disk appearance in 20 (83%) of 24 patients and a dot appearance in four patients. On frontal radiographs, the ASO projected between T8 and T11 and was positioned over the right side of the spinous process in 18 (75%) of 24 patients and over the spinous process in four patients. The ASO projected to the left of the spine in patients with a ventricular septal defect. On lateral radiographs, the waist of the ASO projected over the pulmocaval line in 19 (79%) of 24 patients and projected anterior to the line in five patients—one patient with an ASD, the two patients with patent foramen ovale, and the two patients with ventricular septal defect.

We believe that the differences in ASO appearance at radiography between pediatric and adult patients may be explained by differences in body habitus. The depth of penetration of the photon beam, which should increase visualization of the ASO device, is greater in children than in adults. The explanation for the difference in location of the ASO among pediatric and adult patients is possibly related to differences in positioning. In children younger than 5 years, chest radiography is usually performed with the patient in a supine position, whereas it is standard practice to perform radiography in older children and adults with the patient in an erect position.

There were at least two limitations to our study. First, all patients had ASDs that were successfully occluded. Thus, comparisons of the appearance and location of successfully placed and unsuccessfully placed ASOs could not be made. Second, the 3-year period of our study may not have been of adequate duration to allow us to have ascertained whether there are any long-term complications from transcatheter ASD closure in pediatric patients.

Although we did not encounter complications in our series, some have been described in the literature. In a study involving a series of 417 patients, including children and adults, Chessa et al (7) noted 36 immediate complications in 34 patients (9.0%) after transcatheter ASD closure performed by using either an ASO or a CardioSEAL device. Embolization or malpositioning was the most common complication, occurring in 12 patients, and nearly always necessitated surgical retrieval.

In a study involving a series of 48 children who underwent closure with either an ASO or a CardioSEAL device, Butera et al (16) noted, immediately after deployment, two malpositioned devices that necessitated only percutaneous retrieval and implantation of larger devices. Reports of rare delayed complications of ASO implantation have included delayed embolization to the left ventricular outflow tract (22) and the development of an aorta-to–right atrium fistula (23).

In conclusion, percutaneous transcatheter closure is a safe and effective technique for treating ASDs in selected pediatric patients. Because proper positioning is evaluated with chest radiography along with echocardiography, it is crucial for radiologists to recognize the characteristic radiographic appearances of a properly positioned device. The ASO has a characteristic radiographic appearance when it is properly positioned. Familiarity with the appearance of the ASO will prevent confusing it with a foreign object in the esophagus or airway. Future studies are needed to determine the radiologic appearances of unsuccessfully placed ASOs in pediatric patients.


   ACKNOWLEDGMENTS
 
We thank Charles F. Hildebolt, DDS, PhD, for statistical analysis.


   FOOTNOTES
 
Abbreviations: ASD = atrial septal defect, ASO = Amplatzer septal occluder, TEE = transesophageal echocardiography

Authors stated no financial relationship to disclose.

Author contributions: Guarantors of integrity of entire study, all authors; study concepts and design, all authors; literature research, E.Y.L., M.J.S., C.M.C.; clinical studies, all authors; data acquisition and analysis/interpretation, all authors; statistical analysis, E.Y.L., M.J.S., C.M.C.; manuscript preparation, definition of intellectual content, revision/review, and final version approval, all authors; manuscript editing, E.Y.L., M.J.S., C.M.C., H.W.K.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 

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