Patent foramen ovale closure in patients with cryptogenic thrombo-embolic events using the Cardia PFO occluder.
OBJECTIVE
We report our experience with three generations of the Cardia patent foramen ovale (PFO) occluder in patients with cryptogenic thrombo-embolic events (TE).


RESULTS
Between 1998 and 2004, interventional PFO closure was attempted in 403 patients. Prior to PFO closure, 605 TE occurred, translating into an annual incidence of 3.1%. PFO closure was successful in all patients. Peri-procedural complications occurred in eight patients (2.0%). At 6 months follow-up, residual shunt was present in 10.8% of patients. Transient thrombi developed on 10 devices (predominantly generation II) and asymptomatic wire fractures were detected in 14 cases (generation I and II). The annual incidence of recurrent TE was 2.0% (n=13). Atrial septal aneurysm and prior device-related thrombus formation were identified as predictors of recurrent TE.


CONCLUSIONS
Owing to technical improvements and modified adjunctive pharmacotherapy, the rate of thrombus formation has declined and wire fractures are virtually absent in generation III devices. The overall rate of recurrent TE is reduced by transcatheter PFO closure with the Cardia PFO occluder, and seems comparable to recurrence rates reported for other devices used for this purpose.
Spies
Christian
C
Section of Cardiology, Rush University Medical Center, Chicago, IL, USA.
Strasheim
Roland
R
Timmermanns
Ines
I
Schraeder
Rainer
R
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D021721:Balloon Occlusion / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods*; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006344:Heart Septal Defects, Atrial / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D055502:Secondary Prevention; D013923:Thromboembolism / Q000517:prevention & control*; D016896:Treatment Outcome