Aims: Despite rapid progress in device technologies for patent foramen ovale (PFO) closure over the past decade, long-tunnel anatomies still constitute a challenge. The present study investigated the performance of a novel in-tunnel device (Flatstent EF; Coherex Medical) in long-tunnel PFOs.
Methods and results: Three different umbrella devices (n = 61) and the Coherex Flatstent (n = 27) were used for PFO closure. The Flatstent was the preferred device in long-tunnel anatomies. Seven patients with long PFO tunnels underwent "detunnelization" by stepwise inflation of a low-pressure balloon followed by implantation of an umbrella device. Complete occlusion or trivial residual shunting ("clinical" occlusion) was achieved in 93% of the Flatstent and 92% of the umbrella device procedures (P=.92). Device performance in long-tunnel anatomies was in favor of the Flatstent (n = 24) compared with conventional occluders (n = 7), with "clinical" occlusion of 96% vs 86% (P=.24) and procedure time of 44 ± 16 minutes vs 59 ± 21 minutes (P=.04). Furthermore, postprocedural arrhythmias were significantly less frequent after Flatstent implantations (0.0% vs 9.1%; P=.03).
Conclusion: In long-tunnel PFOs, the Flatstent device was quicker to deploy, was at least as equally efficacious as umbrella devices, and reduced the incidence of symptomatic arrhythmias following PFO closure.