Why the study?
Does percutaneous patent foramen ovale closure increase the incidence of atrial fibrillation compared to medical treatment in patients with cryptogenic stroke?
Does percutaneous patent foramen ovale closure increase the incidence of atrial fibrillation compared to medical treatment in patients with cryptogenic stroke?
Percutaneous PFO closure does not appear to increase the risk of atrial fibrillation compared to medical therapy in patients with cryptogenic stroke, with large PFO size being the only significant predictor of AF.
AF incidence appears comparable after PFO closure or medical therapy; leaves open need for randomized confirmation of long-term safety.
OBJECTIVE: The occurrence of atrial fibrillation after percutaneous closure of a patent foramen ovale for cryptogenic stroke has been reported in a variable percentage of patients. However, its precise incidence and mechanism are presently unclear and remain to be elucidated. DESIGN: Prospective follow-up study. PATIENTS: Ninety-two patients undergoing a percutaneous patent foramen ovale closure procedure (closure group) for cryptogenic stroke were compared with a similar group of 51 patients, who were medically treated. METHODS: A systematic arrhythmia follow-up protocol to assess the incidence of AF was performed including a 7-day event-loop recording at day 1, after 6 and 12 months in patients of the closure group and compared with those of the medically treated group. RESULTS: The incidence of AF was similar in both study groups during a follow-up of 12 months, including 7.6% (95% CI: 3.1-15.0%) in the closure and 7.8% (95% CI: 2.18-18.9%) in the medically treated group (P=1.0). The presence of a large patent foramen ovale was the only significant risk factor for the occurrence of AF as demonstrated by a multivariate Cox regression analysis (95% CI, 1.275-20.018; P=0.021). CONCLUSIONS: Our findings indicate that patients with cryptogenic stroke and patent foramen ovale have a rather high incidence of AF during a follow-up of 12 months. Atrial fibrillation occurred with a similar frequency whether the patent foramen ovale/atrial septal defect was successfully percutaneously closed or was medically managed. The presence of a large patent foramen ovale was the only significant predictor of AF occurrence during follow-up.
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Bonvini et al. (2010) studied this question.
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