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Ann Thorac Surg 2004;77:1435-1437
© 2004 The Society of Thoracic Surgeons

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Case report

Late cardiac perforation following transcatheter atrial septal defect closure

^a Department of Cardiovascular and Thoracic Surgery, Bronx, NY, USA
^b Department of Cardiology/Medicine, Bronx, NY, USA
^c Department of Anesthesia, Albert Einstein College of Medicine-Montefiore Medical Center, Bronx, New York, USA

Accepted for publication May 20, 2003.

^* Address reprint requests to Dr Gold, Department of Cardiovascular and Thoracic Surgery, Montefiore Medical Center, 3400 Bainbridge Ave, Suite 5B, Bronx, NY 10467, USA.
e-mail: jgold{at}montefiore.org

	Abstract

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Transcatheter closure of secundum atrial septal defect (ASD) has become an alternative to surgery. We present a patient with hemodynamic collapse secondary to cardiac perforation occurring 6-months after the placement of an Amplatzer Septal Occluder and discuss the utilization/complications of this device.

	Introduction

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Percutaneous transcatheter closure of atrial septal defects (ASD) has been performed with a variety of devices since 1976, as an alternative to conventional open surgical repair. The Amplatzer Septal Occluder (AGA Medical, Golden Valley, MN) is one such device (Fig 1), which has recently received FDA approved (December 2001) and is being widely applied in children and adults with secundum ASD. Reported closure rates have been good. However, transcatheter closure of ASD can be associated with catastrophic procedure complications that may require immediate surgical intervention. These complications are uncommon and seem primarily to be a function of operator experience. Reported early complications of Amplatzer use include residual shunt, systemic and pulmonary embolization, and device impingement on superior vena cava, on the right upper pulmonary vein, and on the mitral and tricuspid valves. All of these may require conversion to an immediate surgical repair. Late cardiac erosion/perforation of the device through the atrial wall, associated with pericardial tamponade, is a rare life-threatening complication. We present one patient with perforation of the dome of the left atrium 6-months after placement of the Amplatzer Septal Occluder.

View larger version (121K): [in this window] [in a new window]   Fig 1. In vitro model of the deployed Amplatzer atrial septal defect occlusion device (Amplatzer Septal Occluder; AGA Medical, Golden Valley, MN) demonstrating the exposed wire mesh.

On arrival to the ED, the patient was pale, diaphoretic, and hypotensive. Her extremities were cold and mottled with no palpable peripheral pulses. She was anuric and unarousable. Resuscitation with intravenous fluids and inotropic agents including "straight-line" norepinephrine and dopamine was attempted. She had a systolic blood pressure of 65 mm Hg with pulsus paradoxicus (>20 mm Hg respiratory variation in systolic pressure) and a central venous pressure of 24 mm Hg. The patient was intubated because of progressive somnolence, hypoxemia, and metabolic acidosis (pH = 7.05). A bedside echocardiogram demonstrated a significant pericardial effusion (2 cm) and biatrial/right ventricular collapse consistent with pericardial tamponade. The Amplatzer Septal Occluder was imaged within the atrial septum (Fig 2).

View larger version (85K): [in this window] [in a new window]   Fig 2. Apical transthoracic echocardiogram frame illustrating the Amplatzer Septal Occluder (thin arrow; AGA Medical, Golden Valley, MN) and deep biatrial compression (heavy arrows) due to the tamponade physiology.

A small amount of bright red blood was seen oozing from the dome of the left atrium between the superior vena cava and the root of the aorta. The metallic rim of the Amplatzer Septal Occluder could be easily seen protruding through the left atrial wall. At this point, given the patient's long period of shock and uncertain neurologic status the decision was made not to place her on cardiopulmonary bypass to remove the device or further explore the heart, but to simply drain the pericardium, repair the perforation, and close. Multiple interrupted Prolene (Ethicon, Inc, Somerville, NJ) sutures were placed into this region imprecating normal atrial tissue over the exposed metallic edge of the device. The bleeding was easily controlled as the mattress sutures were sequentially tied.

The pericardium was loosely reapproximated. Chest tubes were placed and the sternal incision was closed in the usual fashion. At the conclusion of the operation, transesophageal echocardiography confirmed normal biventricular function. The ASD closure device could be easily seen, stable in the interatrial septum. Color-flow mapping failed to identify any residual left-to-right shunt, and bubble contrast injection did not exhibit any evidence of right-to-left shunting.

Postoperatively, the patient remained hemodynamically stable and was extubated the next morning, with no neurologic or other organ system deficit. Metabolic and respiratory measurements rapidly normalized. The patient was discharged home 3 days postoperatively with a transthoracic echo demonstrating complete resolution of the effusion, normal cardiac function, and intact placement of the ASD closure device.

Before discharge, following lengthy discussions with the device manufacturer, interventional cardiologist, the patient, and her family, the decision was made to follow the patient closely, but not to reoperate to remove the device at this time.

	Comment

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Postmarket surveillance of the clinical experience with the Amplatzer Septal Occluder, and other such devices continues. Device malposition, residual shunts, hemolysis, embolization into the right ventricle and pulmonary arterial tree, peripheral embolization into the leg, partial occlusion of the superior vena cava, damage to the mitral or tricuspid valves, and sudden death after implantation of an Amplatzer device from 1 to 18 months later have been reported [1–12]. To date there have been 16 reported cases of hemopericardium following Amplatzer device implant, including the patient presented here [12]. This represents the results of more than 25,000 worldwide implantations of the device. Ten of these bleeding complications occurred within 72 hours of implantation. Seven were detected within 24 hours. The reported late erosions or perforations have occurred at 4 weeks, 5 weeks, 3 months, and 8 months after implant. All patients presented with chest pain, dyspnea, or sudden hemodynamic collapse. One previous patient was managed with pericardiocentesis alone, whereas the others underwent surgical exploration including subxiphoid exploration of the pericardium, closed surgical repair of the perforation, and open-heart surgery to repair the erosion and remove the device. There was one fatality. Four of the prior patients have been managed by leaving the device in place. Two patients had traumatic aorta-atrial fistulas at the perforation site. In 1 patient perforation occurred when the patient was involved in an automobile accident. In all patients it appears that the anterosuperior, or retroaortic portion of the atrial wall is affected, most commonly on the left atrial side of the septum. This may relate to the fact that the left atrial occluding disk is larger than the right atrial component in the Ampltzer Septal Occluder.

Surgery remains the standard of care for ASD repair with excellent long-term results since 1954, and low operative mortality and morbidity [13]. Transcatheter closure is growing rapidly, principally due to the patient's desire for a "less invasive procedure," and the reputed procedural efficacy and safety. New devices continue to reach clinical trials. Following FDA approval, postmarket surveillance of approved devices continue to define procedural and late complications of these newer procedures.

Just as interventional cardiologists and cardiothoracic surgeons have reached some consensus on the role(s) for percutaneous versus surgical revascularization in the treatment of coronary artery disease, with time, certain anatomic variants of ASD may be better approached with one technique or the other. Only with ongoing surveillance of the percutaneous devices to better define procedural and late complications of the procedure can such a consensus be achieved. Because more than 25,000 Amplatzer devices and tens of thousands of other devices have been implanted to close atrial level defects, familiarity with the devices and knowledge of their potential complications and surgical implications by the cardiothoracic surgical community is increasingly important.

	References

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1. Young D. Later results of closure of secundum atrial septal defects in children. Am J Cardiol 1973;31:16-22.
2. Aggoun Y., Gallet B., Acar P., et al. Perforation of the aorta after percutaneous closure of an atrial septal defect with an Amplatz prosthesis, presenting with acute severe hemolysis. Arch Mal Coeur Vaiss 2002;95:479-482.[Medline]
3. Acar P., Aggoun Y., Abdel-Massih T. Images in cardiology: thrombus after transcatheter closure of ASD with an Amplatzer septal occluder assessed by three dimensional echocardiographic reconstruction. Heart 2002;88:52.[Free Full Text]
4. Ebeid M.R. Percutaneous catheter closure of secundum atrial septal defects: a review. J Invasive Cardiol 2002;14:25-31.[Medline]
5. Cao Q.L., Du Z.D., Joseph A., et al. Immediate and six-month results of the profile of the Amplatzer septal occluder as assessed by transesophageal echocardiography. Am J Cardiol 2001;88:754-759.[Medline]
6. Agarwal S.K., Ghosh P.K., Mittal P.K. Failure of devices used for closure of atrial septal defects: mechanisms and management. J Cardiovasc Surg 1997;113:426-427.
7. Peuster M., Boekenkamp R., Kaulitz R., Fink C., Hausdorf G. Transcatheter retrieval and repositioning of an Amplatzer device embolized into the left atrium. Cathet Cardiovasc Interven 2000;51:297-300.
8. Lambert V, Belli E, Piot JD, Planche C, Losay J. [Hemolysis, a rare complication after percutaneous closure of an atrial septal defect] Arch Mal Coeur Vaiss 2000 May;93(5):623-5. French
9. Berdat P.A., Chatterjee J.P., Windecker S., Meier B., Carrel T. Surgical Management of Complications After Transcatheter Closure of an Atrial Septal Defect or Patent Foramen Ovale. J Thorac Cardiovasc Surg 2000;120:1034-1039.[Abstract/Free Full Text]
10. Berger F., Vogel M., Alexi-Meskishvili V., Lange P.E. Comparison of results and complications of surgical and Amplatzer device closure of atrial septal defects. J Thorac Cardiovasc Surg 1999;118:674-680.[Abstract/Free Full Text]
11. Chessa M., Carminati M., Butera G., et al. Early and late complications associated with transcatheter occlusion of secundum atrial septal defect. J Am Coll Cardiol 2002;39:1061-1065.[Abstract/Free Full Text]
12. Personal communication, CEO, AGA Medical, Golden Valley, MN; December 3, 2002
13. Murphy J.G., Gersh B.J., McGoon M.D., et al. Long term outcome after surgical repair of isolated atrial septal defect. N Engl J Med 1990;323:1645-1650.[Abstract]

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This Article Abstract Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to Personal Folders Download to citation manager Author home page(s): Ourania Preventza Jeffrey P. Gold Permission Requests Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Preventza, O. Articles by Gold, J. P. Search for Related Content PubMed PubMed Citation Articles by Preventza, O. Articles by Gold, J. P. Related Collections Congenital - acyanotic