Percutaneous patent foramen ovale closure: the Paradoxical Cerebral Embolism Prevention Registry.
BACKGROUND
The natural history and therapeutic interventions for secondary prevention after a cerebrovascular event in patients with patent foramen ovale (PFO) are not yet established. This study aims to assess the safety and efficacy of percutaneous PFO closure in a population of patients with ischemic cerebrovascular disease of unknown etiology.


METHODS
This prospective observational study included patients with a history of cryptogenic transient ischemic attack (TIA) or stroke who underwent percutaneous PFO closure. The effectiveness of the device for the secondary prevention of TIA or stroke was assessed by comparing observed events in the sample with expected events for this clinical setting.


RESULTS
The sample included 193 cases of percutaneous PFO closure (age 46.4 ± 13.1 years, 62.2% female) with a mean follow-up of 4.3 ± 2.2 years, corresponding to a total exposure to ischemic events of 542 patient-years. The high-risk characteristics of the PFO were assessed prior to device implantation. There were seven primary endpoint events during follow-up (1.3 per 100 patient-years), corresponding to a relative risk reduction of 68.2% in recurrent TIA or stroke compared to medical therapy alone. The procedure was associated with a low rate of device- or intervention-related complications (1.5%).


CONCLUSIONS
In this long-term registry, percutaneous PFO closure was shown to be a safe and effective therapy for the secondary prevention of cryptogenic stroke or TIA.
Serviço de Cardiologia, Hospital Geral, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal. Electronic address: luisvpaiva@hotmail.com.
Luís
L
Paiva
Serviço de Cardiologia, Hospital Geral, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
Paulo
P
Dinis
Serviço de Cardiologia, Hospital Geral, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
Rui
R
Providência
Serviço de Cardiologia, Hospital Geral, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
Marco
M
Costa
Serviço de Cardiologia, Hospital Geral, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
Susana
S
Margalho
Serviço de Cardiologia, Hospital Geral, Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal.
Lino
L
Goncalves
D019320:Embolism, Paradoxical / Q000517:prevention & control*; D005260:Female; D054092:Foramen Ovale, Patent / Q000601:surgery*; D006801:Humans; D020766:Intracranial Embolism / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011174:Portugal; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D012042:Registries
Acidente vascular cerebral; Closure; Encerramento; Foramen ovale patente; Patent foramen ovale; Stroke