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Embolization of Patent Foramen Ovale Closure Devices: Incidence,Role of Imaging in Identification,Potential Causes,and Management
Authors:Sachin S. Goel  Olcay Aksoy  E. Murat Tuzcu  Richard A. Krasuski  Samir R. Kapadia
Affiliation:Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, Ohio 44195
Abstract:Transcatheter patent foramen ovale (PFO) closure is an alternative to antiplatelet or anticoagulative therapy in patients with cryptogenic stroke, and it is associated with a small incidence of periprocedural sequelae. Because embolization of PFO closure devices is a very rare procedural complication, data on its frequency, causes, and management are sparse. We sought to review the medical literature and the cases of PFO closure-device embolization at our institution with the aim of identifying likely problems and reporting potential solutions. Out of 310 adult patients who underwent transcatheter PFO closure from June 2002 through April 2011, there were 2 cases (0.6%) of PFO closure-device embolization. In both patients, hypermobile septum primum and thick septum secundum were present. In one patient, failure to use a sizing balloon might have resulted in an underestimation of the PFO''s size. In both patients, device embolization was identified in a timely fashion, the embolized device was safely retrieved, and the PFO was percutaneously closed with success.The incidence of PFO closure-device embolization is very low. The cases described here underscore the importance of imaging in the identification of morphologic predispositions to closure-device malpositioning, in the recognition of impending embolization, and in the timely management of embolization.Key words: Contrast media/diagnostic use, device removal/methods, echocardiography, transesophageal, fluoroscopy, foramen ovale, patent/radiography/therapy/ultrasonography, foreign body migration, ischemic attack, transient/prevention & control, prosthesis implantation/adverse effects, septal occluder device/adverse effects, stroke/prevention & controlSeveral studies1–3 have shown the feasibility of transcatheter patent foramen ovale (PFO) closure as an adjunct or alternative to antiplatelet or anticoagulative therapy in patients with cryptogenic stroke. Procedural sequelae are rare. In a meta-analysis of 10 studies consisting of more than 1,350 patients with transcatheter PFO closure,4 major sequelae (death, tamponade, hemorrhage requiring blood transfusion, fatal pulmonary embolism, and need for surgical intervention) occurred in 1.5% of patients, and minor sequelae (device embolization with percutaneous retrieval, arrhythmias, device fracture, asymptomatic device thrombosis, symptomatic air embolism, and groin sequelae) occurred in 7.9% of patients. Data exist on the predisposing factors for embolization of atrial-septal-defect closure devices (inadequate rim and undersized device)5–8; but PFO closure-device embolization is such a rare complication that data on its frequency, causes, and management are sparse.1,9,10We sought to review the literature on PFO closure-device embolization and to describe such cases at our institution with the aim of identifying likely problems and reporting potential solutions. Open in a separate window
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