Published Online
on August 12, 2002

A more recent version of this article appeared on August 27, 2002

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Submitted on April 8, 2002
Revised on June 13, 2002
Accepted on June 13, 2002

Percutaneous Transcatheter Closure of Patent Foramen Ovale in Patients With Paradoxical Embolism

Francisco Martín MD, Pedro L. Sánchez MD, Elizabeth Doherty MD, Pedro J. Colon-Hernandez MD, Gabriel Delgado MD, Ignacio Inglessis MD, Nandita Scott MD, Judy Hung MD, Mary Etta E. King MD, Ferdinando Buonanno MD, Zareh Demirjian MD, Michael de Moor MD, and Igor F. Palacios MD^*

From the Cardiac Unit, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston.

^* To whom correspondence should be addressed. E-mail: palacios.igor{at}mgh.harvard.edu.

Background—Percutaneous transcatheter closure of patent foramen ovale (PFO) is used as an alternative to surgery or long-term anticoagulation for the treatment of patients with paradoxical embolism and PFO.

Methods and Results—We report the immediate and long-term clinical and echocardiographic outcome of 110 consecutive patients (58 males, mean age 47±14 years) who underwent transcatheter closure of PFO because of paradoxical embolism between 1995 and 2001. Procedural success, defined as successful deployment of the device and effective occlusion (no, or trivial, shunt after device placement), was achieved in all (100%) patients. There was no in-hospital mortality, 1 device migration requiring surgical intervention (0.9%), and 1 episode of cardiac tamponade (0.9%) requiring pericardiocentesis. A progressive increment in full occlusion was observed (44%, 51%, 66%, and 71% at 1 day, 6 months, and 1 and 2 years, respectively, after device placement). At a mean follow-up of 2.3 years, 2 patients experienced recurrent neurological events (1 fatal stroke and 1 transient ischemic attack), representing an annual risk of recurrence of 0.9%. In addition, 4 (3.6%) of the patients required reintervention for device malalignment or significant shunt. Kaplan-Meier analysis showed a freedom from recurrent embolic events and reintervention of 96% and 90% at 1 and 5 years, respectively.

Conclusions—Transcatheter closure of PFO is a safe and effective therapy for patients with paradoxical embolism and PFO. It is associated with a high success rate, low incidence of hospital complications, and low frequency of recurrent systemic embolic events.

Key words: heart septal defects • embolism • catheterization • stroke

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