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Late Results After Percutaneous Closure of Patent Foramen Ovale for Secondary Prevention of Paradoxical Embolism Using the Amplatzer PFO Occluder Without Intraprocedural Echocardiography

Effect of Device Size

Andreas Wahl, MD^_*, Tony Tai, MD^_*, Fabien Praz, MD^_*, Markus Schwerzmann, MD^_*, Christian Seiler, MD^_*, Krassen Nedeltchev, MD, Stephan Windecker, MD^_*, Heinrich P. Mattle, MD, Bernhard Meier, MD^_*,_*

^_* Department of Cardiology, University Hospital, Bern, Switzerland
Department of Neurology, University Hospital, Bern, Switzerland

^_* Reprint requests and correspondence: Prof. Bernhard Meier, Swiss Cardiovascular Center Bern, University Hospital, 3010 Bern, Switzerland (Email: bernhard.meier{at}insel.ch).

Objectives: We sought to assess the safety and clinical efficacy of patent foramen ovale (PFO) closure under fluoroscopic guidance only, without intraprocedural echocardiography.

Background: Percutaneous PFO closure has been shown to be safe and feasible using several devices. It is generally performed using simultaneously fluoroscopic and transesophageal or intracardiac echocardiographic guidance. Transesophageal echocardiography requires sedation or general anesthesia and intubation to avoid aspiration. Intracardiac echocardiography is costly and has inherent risks. Both lengthen the procedure. The Amplatzer PFO Occluder (AGA Medical Corporation, Golden Valley, Minnesota) can be safely implanted without echocardiographic guidance.

Methods: A total of 620 patients (51 ± 12 years; 66% male) underwent PFO closure using the Amplatzer PFO Occluder for secondary prevention of presumed paradoxical embolism. Based on size and mobility of the PFO and the interatrial septum, an 18-mm device was used in 50 patients, a 25-mm device in 492, and a 35-mm device in 78.

Results: All procedures were successful, with 5 procedural complications (0.8%): 4 arteriovenous fistulae requiring elective surgical correction, and 1 transient ischemic attack. Contrast transesophageal echocardiography at 6 months showed complete closure in 91% of patients, whereas a minimal, moderate, or large residual shunt persisted in 6%, 2%, and 1%, respectively. During a mean follow-up period of 3.0 ± 1.9 years (median: 2.6 years; total patient-years: 1,871), 5 ischemic strokes, 8 transient ischemic attacks, and no peripheral emboli were reported. Freedom from recurrent ischemic stroke, transient ischemic attack, or peripheral embolism was 99% at 1 year, 99% at 2 years, and 97% at 5 years.

Conclusions: The Amplatzer PFO Occluder affords excellent safety and long-term clinical efficacy of percutaneous PFO closure without intraprocedural echocardiography.

Key Words: atrial septal aneurysm • patent foramen ovale • cerebral ischemia • embolism • secondary stroke prevention

Abbreviations and Acronyms   APFO = Amplatzer PFO Occluder   ASA = atrial septal aneurysm   CI = confidence interval   ICE = intracardiac echocardiography   OR = odds ratio   PFO = patent foramen ovale   TEE = transesophageal echocardiography   TIA = transient ischemic attack

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J. Am. Coll. Cardiol. Intv. 2009 2: 124-126. [Full Text] [PDF]

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