Objectives: The presence of a patent foramen ovale (PFO) has been associated with recurrent cryptogenic cerebrovascular event (CVE). The BioSTAR is a partly biodegradeable atrial septal repair implant. We investigated the feasibility and efficacy of the BioSTAR PFO-occluder.
Design: From October 2007 to December 2008, 59 consecutive patients underwent PFO closure at our institution with a history of at least one cryptogenic CVE defined by a neurologist. During the study period, all patients, who fulfilled our institutional criteria for PFO closure, were included. No patients were lost to follow-up.
Results: Of the 59 patients treated, a BioSTAR device could be implanted in 30 and in 29 patients another device, almost exclusively an Amplatzer, had to be used. No serious complications were observed during implantation of either. Four of 30 patients suffered a recurrent CVE after BioSTAR implantation as compared to 2/29 in the comparison group. At long-term follow-up 29/30 patients in the BioSTAR group had complete closure of their PFO as compared to 23 of 29 in the comparison group.
Conclusions: The BioSTAR device could be selected for use in small shunts less than 10 mm while the Amplatzer may be chosen for larger defects or more complicated anatomy.