Key result
PFO closure reduces annual mortality by an absolute ~0.7% vs medical therapy.
Why the study?
Proof that percutaneous closure of patent foramen ovale is superior to medical treatment remains incomplete due to rarity of paradoxical embolism and limited trial size and follow-up.
Absolute Event Rate: 0.4% vs 1.1%
p-value: p=<0.03
Supports observational mortality benefit of PFO closure; hypothesis-generating and requires validation in long-term RCTs.
Proof that percutaneous closure of the patent foramen ovale (PFO) is superior to medical treatment is still incomplete. Paradoxical embolism is a rare event occurring over decades rather than years. None of the 4 randomized trials published carried enough patients or was followed up for long enough to reach superiority endpoints. All data, however, point to a benefit of PFO closure. Free wall erosion (exceedingly rare) and triggering of atrial fibrillation (in about 1% of patients) are the only noteworthy complications. They are outweighed by the supposedly prevented events of paradoxical embolisms, such as stroke, transient ischemic attacks, myocardial infarctions, or other systemic embolisms. Medical treatment with perhaps the exception of lifelong oral anticoagulation provides less protection. During a 10-year follow-up of a comparative study the annual mortality was significantly lower in the patients with PFO closure (0.4%) than in those with medical treatment (1.1%, P < 0.03). PFO closure can be accomplished in less than 1 hour with immediate resumption of physical activity. It represents thus a kind of mechanical vaccination.
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Bernhard Meier (2014) conducted a review in Patent foramen ovale with previous neurological event (n=308). Percutaneous PFO closure vs. Medical treatment (antiplatelets or oral anticoagulation) was evaluated on Annual mortality (p=<0.03). Percutaneous closure of a patent foramen ovale significantly reduced annual mortality compared to medical therapy (0.4% vs 1.1% per year) in patients with prior neurological events over a 10-year follow-up.
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