ASSESSMENT OF SEPTAL CLOSURE DEVICE
Early and Late Cardiac Perforation by Amplatzer Atrial Septal Defect and Patent Foramen Ovale Devices Emma Ivens, FRACP, Christian Hamilton-Craig, FRACP, Constantine Aroney, FRACP, Andrew Clarke, FRACS, Homayoun Jalali, FRACS, and Darryl J. Burstow, FRACP, Brisbane, Australia
Cardiac perforation and device erosion are infrequent but potentially lethal complications of percutaneous occluder device insertion. Transthoracic and transesophageal echocardiography (TEE) and gated cardiac computed tomography are useful in detecting this complication. In particular, TEE can detect characteristic features to confirm the diagnosis before rapid surgical correction. Deficient superior-anterior rim and encroachment of the occluder device on the posterior atrial wall are risk factors for device erosion. TEE performed before device insertion with awareness of manufacturer’s guidelines for atrial geometry and device sizing may reduce the occurrence of this serious complication. (J Am Soc Echocardiogr 2009;22:1067-70.) Keywords: Echocardiography, Erosion, Heart septal defects, Imaging, Perforation
No animals were used during this study.
sinus adjacent to the device posteriorly (Figure 1F). At operation, device perforation of the free wall of the right atrium and rupture of the noncoronary sinus of the aortic root were confirmed. The device was visualized to seal the aortic defect with minimal clot surrounding it. Hemopericardium was present, implying intermittent leakage. The occluder device was excised, and an autologous pericardial patch and aortic root repair were performed. A 54-year-old woman presented with breathlessness and hypotension to a regional hospital. She had a history of paradoxical embolism and right middle cerebral artery stroke due to a patent foramen ovale (PFO), with a percutaneous Amplatzer PFO 25/18-mm occluder device insertion at another institution 18 months before presentation. Pericardial tamponade was diagnosed by transthoracic echocardiography, and she was transferred to our quaternary institution after needle pericardiocentesis. Echocardiography revealed a trivial residual pericardial effusion (Figure 2A). Twelve hours later she experienced further breathlessness and was hypotensive. Repeat echocardiography showed rapid increase in pericardial fluid to 1.6 cm with right atrial collapse and Doppler evidence of tamponade physiology (Figure 2B). A pericardial pigtail catheter was inserted, and 300 mL of bloodstained fluid was drained. TEE, using a matrix array transducer, revealed erosion through the atrial wall by the anterosuperior portion of the right atrial occluder disc and thickening of the atrial wall at the posterior disc margin (Figure 2C-D; Videos 7 and 8). Pericardial fluid was seen in the transverse sinus between the disc and the aorta, consistent with device perforation. A bolus-tracked arterial phase gated cardiac computed tomogram of the chest (64-detector dual-source Siemens scanner; Siemens Corp, New York, NY) demonstrated the occluder discs buried into the anterior atrial wall and protruding toward the aortic root (Figure 2 G). At operation, fresh blood was found in the transverse sinus, and the occluder device was confirmed to have ruptured the atrial wall both anteriorly and posteriorly. The device was excised, and a bovine pericardial patch repair was performed without complication.
Reprint requests: Emma Ivens, FRACP, Department of Echocardiography, Cardiac Investigations Unit, Prince Charles Hospital, Chermside 4032, Australia (E-mail:
[email protected]).
DISCUSSION
Cardiac perforation and device erosion are infrequent but potentially lethal complications of percutaneous occluder device insertion.1-4 Diagnosis has, to date, been difficult to make, with no established imaging criteria. We present characteristic clinical and imaging findings of early and late cardiac perforation diagnosed in patients at The Prince Charles Hospital, before surgical correction.
CLINICAL CASES A 39-year-old man with dyspnea was found to have a secundum atrial septal defect (ASD) with a dilated right ventricle. The defect was situated anterosuperiorly, with a deficient superior-anterior rim and adequate rims elsewhere, measuring 15 mm in diameter, with a stretched diameter of 19 mm (Figure 1A, B; Videos 1 and 2). A 20-mm Amplatzer (AGA Medical Corp, Plymouth, MN) ASD occluder device was inserted percutaneously with no residual shunt. Two weeks later the patient presented with pericardial-type chest pain. Transthoracic echocardiography demonstrated a small pericardial effusion (Figure1C). Transesophageal echocardiography (TEE) revealed that the occluder device occupied 100% of the anterior-posterior atrial septal dimension, with erosion of the device toward the aortic root anteriorly and posteriorly involving the atrial wall (Figure 1D-E, Videos 3-6). Pericardial fluid was present in the oblique
From the Departments of Echocardiography (E.I., C.H-C., D.J.B.) and Cardiac Surgery (A.C., H.J.), The Prince Charles Hospital, Brisbane Australia; and Cardiac Services, Holy Spirit Northside Hospital, Brisbane Australia (E.I., C.A., A.C., H.J.). Dr Hamilton-Craig is supported by the National Heart Foundation of Australia. Disclosures: The authors report no conflicts of interest.
0894-7317/$36.00 Copyright 2009 by the American Society of Echocardiography. doi:10.1016/j.echo.2009.06.013
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Figure 1 (A), TEE: Bicaval view showing a secundum ASD (red arrow). (B), TEE: 0-degree view showing a deficient superoanterior rim (red arrow). (C), Transthoracic echocardiogram; Parasternal long-axis view showing a small pericardial effusion (red arrow). (D), TEE: 0-degree view showing the 20-mm Amplatzer (AGA Medical Corp, Plymouth, MN) atrial septal occluder device occupying the entire anteroposterior extent of the atrial septum superiorly (red arrow). (E), TEE: 50-degree view showing the RA disc of the Amplatzer device abutting anteriorly into the noncoronary sinus of the aortic root (red arrow). (F), TEE: 0-degree view showing the Amplatzer ASD device in contact with the atrial wall posteriorly in association with a small pericardial effusion localized to this area (red arrow). View video clips online. RA, Right atrium; LA, left atrium; AV, aortic valve.
after percutaneous ASD or PFO closure. Cardiac perforation by the closure device can cause intermittent symptoms and pericardial fluid accumulation because of intermittent occlusion of the puncture site by the device itself. Features supportive of device erosion are as follows:
new cardiac symptoms of pericardial pain, dyspnea, or tamponade; device size and geometry in relation to atrial size, particularly the device extending more than 90% across the atrial septum; relationship of device to aorta and posterior atrial wall, especially if the device is in contact with these structures; preimplantation deficient superior-anterior rim;
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presence of pericardial fluid adjacent to device, even if trivial, especially with confirmed hemopericardium; and TEE or computed tomography evidence of disc protrusion into or through the atrial/aortic wall.
According to device company implantation guidelines (AGA Medical Corp),4 the device should not make contact with the free atrial wall and rims should be adequate to stabilize the device ($5 mm for an ASD occluder device), although it has been generally accepted that the superior-anterior rim may be deficient during ASD closure.5,6 During PFO closure, the minimum distance between the device and the superior vena cava or aorta should be 9 mm.4 In addition, the ASD/PFO device ideally should not extend across more than 90% of the atrial septum. In the first case presented above, the superioranterior rim was deficient and the device occupied 100% of the septal length superiorly and made contact with the atrial free wall posteriorly. In the second case presented, the device was not inserted under transesophageal guidance, and once again the device occupied the full extent of the atrial septum, making contact with the atrial wall anteriorly and posteriorly. Divekar et al7 studied 29 patients with confirmed cardiac perforation secondary to percutaneous septal occluder devices, which occurred from as early as before discharge to as late as 3 years after insertion. In this series, 66% occurred late. Presenting symptoms were similar to the cases described above, with dyspnea, pericardial effusion, hemopericardium, and tamponade. In addition, there were 3 deaths after device erosion. Cardiac perforation occurred predominantly in the anterosuperior atrial walls or adjacent aorta, consistent with the imaging findings of the cases presented above. With detailed pre-procedural and intraoperative TEE, coupled with awareness and stringent application of imaging criteria for suitability, we may be able to reduce the risk of device perforation. Further study is required as to whether a deficient superior-anterior rim should be a relative contraindication to percutaneous ASD closure and whether other types of percutaneous devices or closure would be more appropriate in these cases.
CONCLUSIONS
:
Erosion and cardiac perforation are infrequent but life-threatening complications of percutaneous occluder devices and can be difficult
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to diagnose.8 Echocardiography and cardiac computed tomography are useful in supporting, and in some cases confirming, the diagnosis. In particular, TEE can detect characteristic features that enable a diagnosis to be made before rapid surgical correction. TEE performed with the awareness of manufacturers’ guidelines for atrial geometry and device sizing may reduce the occurrence of this serious complication.
Supplementary data Supplementary data associated with this article can be found in the online version, at doi:10.1016/j.echo.2009.06.013.
REFERENCES 1. Delaney JW, Li JS, Rhodes JF. Major complications associated with transcatheter atrial septal occluder implantation: a review of the medical literature and the manufacturer and user facility device experience (MAUDE) database. Congenit Heart Dis 2007;2:256-64. 2. Luermans JG, Post MC, Plokker HWM, ten Berg JM, Suttorp MJ. Complications and mid-term outcome after percutaneous patent foramen ovale closure in patients with cryptogenic stroke. Neth Heart J 2008;16:332-6. 3. Varma C, Benson LN, Silversides C, Yip J, Warr MR, Webb G, et al. Outcomes and alternative techniques for device closure of the large secundum atrial septal defect. Catheter Cardiovasc Interv 2004;61:131-9. 4. AGA Medical Corporation Website; International Products. Available at: http://international.amplatzer.com/international_products/pfo_device/ new_article_1414/tabid/524/default.aspx. Accessed February 22, 2009. 5. Cooke J, Gelman J, Harper R. Echocardiologists’ role in the deployment of the Amplatzer atrial septal occluder device in adults. J Am Soc Echocardiogr 2001;14:588-94. 6. Podnar T, Martanovic P, Gavora P, Masura J. Morphological variations of secundum-type atrial septal defects: feasibility for percutaneous closure using Amplatzer septal occluders. Cathet Cardiovasc Intervent 2001;53: 386-91. 7. Divekar A, Gaamangwe T, Shaikh N, Raabe M, Ducas J. Cardiac perforation after device closure of atrial septal defects with the Amplatzer septal occluder. J Am Coll Cardiol 2005;45:1213-8. 8. Varma C, Benson LN, Warr MR, Yip J, Jaigobin C, Webb G, et al. Clinical outcomes of patent foramen ovale closure for paradoxical emboli without echocardiographic guidance. Catheter Cardiovasc Interv 2004;62:519-25.
Figure 2 (A), Transthoracic echocardiogram: Subcostal view showing a small pericardial effusion (red arrow). (B), Transthoracic echocardiogram: Subcostal view showing an increase in the size of the pericardial effusion 12 hours later (red arrow). (C), (D), TEE: 30- to 50-degree views showing a small localized pericardial effusion in the transverse sinus with the PFO occluder device protruding through the cardiac wall into this space (red arrow). (E), TEE 30-degree view showing the PFO device to occupy the entire anteroposterior extent of the atrial septum superiorly. In addition to the anterior cardiac perforation, the device appears to extend within the atrial wall posteriorly (red arrow). (F), Three-dimensional TEE showing the PFO occluder device. (G), Gated cardiac computed tomography scan (viewed in the same orientation as TEE images). The PFO occluder device is buried into the anterior atrial wall, protruding toward the aortic root (red arrow). (H), Postoperative TEE: The occluder device has been surgically removed, and the atrial View video clips online. wall has been repaired both anteriorly and posteriorly. In addition, the PFO was surgically closed.
