Author + information
- Received September 16, 2008
- Accepted September 29, 2008
- Published online February 1, 2009.
- 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† and
- Bernhard Meier, MD⁎,⁎ ()
- ↵⁎Reprint requests and correspondence:
Prof. Bernhard Meier, Swiss Cardiovascular Center Bern, University Hospital, 3010 Bern, Switzerland
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.
Prof. Meier receives a research grant from and serves on the Speakers' Bureau of AGA Medical, Golden Valley, Minnesota. Drs. Tai and Praz contributed equally to this paper.
- Received September 16, 2008.
- Accepted September 29, 2008.
- American College of Cardiology Foundation