A propensity score-matched comparison between Cardia and Amplatzer PFO closure devices - insights from the SOLUTION registry (Swiss percutaneOus patent foramen ovale cLosUre in recurrent clinical events prevenTION).
OBJECTIVE
To compare clinical outcome of Amplatzer PFO (APFO) to Cardia PFO (CPFO) occluder. Percutaneous patent foramen ovale (PFO) closure prevents stroke recurrence in stroke due to paradoxical embolism.


RESULTS
The primary endpoint was a composite of stroke, TIA, or peripheral embolism at follow-up. The secondary endpoint was residual shunt. Outcome was compared among 934 (APFO: 712; CPFO: 222) patients, and in 297 propensity score-matched patients. The primary endpoint occurred in 29 patients (0.71/100 patient-years): four (2%) with the CPFO (0.31/100 patient-years), and 25 (4%) with the APFO (0.89/100 patient-years) (p=0.20). Residual shunt at six months was more frequent with the CPFO (31% versus 9%, p<0.001). No differences in residual shunts were seen at the last available echocardiographic follow-up (9±18 months): APFO 11%, CPFO 14%, p=0.22.


CONCLUSIONS
This study suggests that PFO closure with APFO or CPFO is equally effective for the prevention of recurrent events. Residual shunt was more frequent at six months with CPFO, but was similar to APFO at later follow-up.
The University Hospital Fribourg, Fribourg, Switzerland.
Serban
S
Puricel
Diego
D
Arroyo
Jean-Jacques
JJ
Goy
Fabien
F
Praz
Nuno
N
Palhais
Andreas
A
Wahl
Jean-Christophe
JC
Stauffer
Mario
M
Togni
Alexandre
A
Berger
Bernhard
B
Meier
Stéphane
S
Cook
D000328:Adult; D000368:Aged; D006328:Cardiac Catheterization / Q000295:instrumentation*; D019320:Embolism, Paradoxical / Q000517:prevention & control*; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000601:surgery*; D006801:Humans; D002546:Ischemic Attack, Transient / Q000517:prevention & control; D008297:Male; D008875:Middle Aged; D057216:Propensity Score; D012008:Recurrence; D012042:Registries; D055989:Septal Occluder Device; D020521:Stroke / Q000517:prevention & control*; D016896:Treatment Outcome