Closure of Long-Tunnel PFOs With the Coherex Flatstent EF - A Tailored Approach.
OBJECTIVE
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.


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).


CONCLUSIONS
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.
Charitè Berlin, Campus Benjamin Franklin, Department of Cardiology, Hindenburgdamm 30, 12200 Berlin, Germany. markus.reinthaler@gmx.at.
Markus
M
Reinthaler
Suneil K
SK
Aggarwal
Aral
A
Mert
Santi
S
Lim
Carsten
C
Skurk
Ulf
U
Landmesser
Michael J
MJ
Mullen
D000328:Adult; D006328:Cardiac Catheterization / Q000379:methods; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D054092:Foramen Ovale, Patent / Q000601:surgery*; D006801:Humans; D000069451:Long Term Adverse Effects / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000175:diagnosis / Q000209:etiology / Q000601:surgery*; D012086:Reoperation / Q000295:instrumentation / Q000379:methods; D055989:Septal Occluder Device / Q000009:adverse effects*; D016896:Treatment Outcome