Transcatheter patent foramen ovale closure for secondary prevention of paradoxical embolic events: Acute results from the FORECAST registry

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Abstract
Patients with patent foramen ovale (PFO) and paradoxical embolism are at increased risk for recurrent events. Percutaneous PFO closure is a new treatment modality aimed at secondary prevention. We report the multicenter experience of interventional closure of PFO using two different devices in 272 patients. The mean age was 51 +/- 14.2 years and 52.9% were males. The implantation procedure resulted in an initial complete shunt closure rate of 74.3% with a periprocedural complication rate of 6.6%. There were no deaths or pericardial tamponade. The mean procedure time was less than 44 min under either conscious sedation, local or general anesthesia. This is the largest report to date demonstrating the procedural safety, reliability, and feasibility of the transcatheter PFO closure technique with the STARFlex and CardioSEAL septal implants. Randomized clinical trials are currently in progress to identify patients most likely to benefit from this intervention.