Percutaneous transcatheter closure of patent foramen ovale in patients with paradoxical embolism.
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.


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.
Cardiac Unit, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston 02114, USA.
Francisco
F
Martín
Pedro L
PL
Sánchez
Elizabeth
E
Doherty
Pedro J
PJ
Colon-Hernandez
Gabriel
G
Delgado
Ignacio
I
Inglessis
Nandita
N
Scott
Judy
J
Hung
Mary Etta E
ME
King
Ferdinando
F
Buonanno
Zareh
Z
Demirjian
Michael
M
de Moor
Igor F
IF
Palacios
D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D006348:Cardiac Surgical Procedures / Q000009:adverse effects; D002305:Cardiac Tamponade / Q000209:etiology / Q000601:surgery; D019320:Embolism, Paradoxical / Q000209:etiology / Q000517:prevention & control*; D005260:Female; D005500:Follow-Up Studies; D005548:Foreign-Body Migration / Q000209:etiology; D006344:Heart Septal Defects, Atrial / Q000150:complications / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000009:adverse effects; D019736:Prostheses and Implants / Q000009:adverse effects; D018570:Risk Assessment; D055502:Secondary Prevention; D016896:Treatment Outcome