Outcome after percutaneous closure of a patent foramen ovale using the Intrasept device: a multi-centre study.
OBJECTIVE
This multi-centre study reports safety and efficacy of percutaneous patent foramen ovale (PFO) closure, using the fourth generation Intrasept device.


BACKGROUND
PFO has been associated with paradoxical embolism and cryptogenic stroke. Percutaneous PFO closure seems to reduce the risk for recurrent paradoxical thrombo-embolism. Currently, different devices are used for PFO closure.


METHODS
Patients, who underwent a PFO closure with the Intrasept device (Cardia, Eagan, MN) between July 2002 and September 2006, were included in the study. The primary endpoint was defined as reoccurrence of stroke, transient ischemic attack (TIA), or peripheral thrombo-embolism. Peri-procedural and mid-term complications were reported.


RESULTS
Four-hundred thirty patients (mean age 50.7 +/- 13.0 years, 231 men) underwent closure. The indications were cryptogenic stroke (69.8%), TIA (23.5%), peripheral embolism (3.3%), and other (3.5%). The median follow-up time was 0.8 years, range 3.9 years. The primary endpoint occurred in 0.5% for stroke, in 2.5% for TIA, and in none for peripheral embolism. Peri-procedural complications were reported in 11.5% of cases, from which 0.2% was defined as major. No severe complications occurred during mid-term follow-up. A residual shunt was present in 12.5% of patients who did not suffer from a recurrent event, compared to 36.4% of patients who reached the primary endpoint (P = 0.04).


CONCLUSIONS
This multi-centre study suggests that percutaneous closure of a symptomatic PFO with the fourth generation Intrasept device is safe and might be effective to prevent the recurrence of paradoxical thrombo-embolic events.
Luermans
Justin G L M
JG
Department of Cardiology, University Hospital Gasthuisberg, Leuven, Belgium.
Post
Martijn C
MC
Schräder
Rainer
R
Sluysmans
Thierry
T
Vydt
Tom
T
Vermeersch
Paul
P
Chessa
Massimo
M
Onorato
Eustaquio
E
Goy
Jean-Jacques
JJ
Budts
Werner I H L
WI
D000328:Adult; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D003326:Coronary Circulation; D018572:Disease-Free Survival; D019320:Embolism, Paradoxical / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D004867:Equipment Design; D005060:Europe; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D020521:Stroke / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D013923:Thromboembolism / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome