Incidence of thrombus formation on the CardioSEAL and the Amplatzer interatrial closure devices

doi:10.1016/j.amjcard.2003.10.036

The American Journal of Cardiology

Volume 93, Issue 4, 15 February 2004, Pages 426-431

https://doi.org/10.1016/j.amjcard.2003.10.036 Get rights and content

Abstract

Transcatheter closure for atrial septal defect (ASD) and patent foramen ovale (PFO) is a promising alternative to surgical closure or anticoagulant therapy. A potential complication is thrombus formation on the device after implantation. From February 2001 to June 2003, 66 patients with atrial communication were treated successfully with the Amplatzer device (16 septal and 20 PFO occluders) or the CardioSEAL device (30). Patients were discharged on antiplatelet medication (aspirin and clopidogrel) and/or anticoagulation. Fifty patients (76%) had transesophageal echocardiography (TEE) 1 month after device implantation (28 ± 10 days). No patient experienced a thromboembolic episode during follow-up. TEE revealed that thrombus formation occurred more frequently on the CardioSEAL device (5 of 23 patients; 22%) than on the Amplatzer device (0 of 27 patients; 0%) (p = 0.02). Although thrombus disappeared or markedly diminished after additional anticoagulation therapy in 3 patients, 1 patient had surgical explantation of the device due to progressive increase in the size of thrombus with hypermobility despite intensive anticoagulation therapy. There was no variable associated with the presence of thrombus formation on the occluder other than the use of the CardioSEAL device. One month after insertion, the CardioSEAL device is more likely to have thrombus present than the Amplatzer device.

Section snippets

Patient population

From February 2001 to June 2003, 66 consecutive adult patients underwent transcatheter closure of an interatrial communication using the CardioSEAL or the Amplatzer device. Indications for PFO closure included the presence of spontaneous or provokable (with Valsalva maneuver) right to left shunt confirmed by a contrast study using agitated saline during TEE, and (1) a history of ≥1 cryptogenic stroke or transient ischemic attack, or (2) the presence of systemic hypoxemia that was partially

Patient population

Sixty-six consecutive adult patients underwent transcatheter closure therapy of interatrial communications. The closure devices were successfully deployed in all 66 patients. Baseline demographics of the patients are shown in Table 1. Forty-four of the 66 patients (67%) were women; mean age was 47 ± 14 years (range 17 to 77). Most of the patients (n = 48) had a PFO alone (73%). There were morphologic variations of the ASD, including 5 fenestrated septums. An atrial septal aneurysm was found in

Discussion

Although results from recent reports are encouraging,12, 13, 14 there remain several possible complications related to transcatheter closure of interatrial communications. These include air embolism, device embolization, atrial perforation, device malposition, residual shunt, device arm fracture, arrhythmia, infection, and thrombus formation on the device. Although most of these complications are caused by technical problems and may be solved by refinements of the device and implantation

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Incidence of thrombus formation on the CardioSEAL and the Amplatzer interatrial closure devices

Abstract

Section snippets

Patient population

Patient population

Discussion

J Am Soc Echocardiogr

J Am Coll Cardiol

Mayo Clin Proc

Am J Cardiol

Am J Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

J Am Coll Cardiol

Summary and comparison of atrial septal defect closure devices

Curr Interv Cardiol Rep

Massive thromboembolism due to transcatheter ASD closure with ASDOS device

J Invasive Cardiol

Surgical removal of atrial septal defect occlusion system-devices

Eur J Cardiothorac Surg

Closure of secundum atrial septal defects with the Amplatzer septal occluder devicetechniques and problems

Cathet Cardiovasc Intervent

The CardioSEAL devicehistory, techniques, results

J Interven Cardiol

Catheter closure of atrial septal defects and patent foramen ovale in patients with an atrial septal aneurysm using different devices

J Interv Cardiol