title: Percutaneous closure of patent foramen ovale: head-to-head comparison of two different devices.
abstract: Percutaneous closure of patent foramen ovale (PFO) has been proposed as the treatment of choice for young high-risk patients who suffered cryptogenic stroke and/or peripheral paradoxical embolism. We sought to compare prospectively two different devices used for percutaneous PFO closure.Prospective data were collected on 40 high risk patients (females: 38%, mean age : 44 +/- 11 years, interatrial septal aneurysm >10 mm: 68%) who underwent percutaneous PFO closure after cryptogenic stroke (n = 38) or peripheral paradoxical embolism (n = 2). Chronologically, 20 patients were first treated by a PFO-Star (Cardia, Burnsville, MI) device. Then, 20 other patients received a Starflex occluder (NMT, Boston, MA). The primary endpoint was complete PFO closure at 6 months as assessed by transthoracic contrast echocardiography. Secondary endpoints were major peri- or post procedural complications and clinical recurrence at 1 year follow-up.Baseline clinical and anatomical characteristics were comparable for both groups. Complete PFO closure was observed in 50% (PFO-Star) and 90% (Starflex) of patients (p=0.001) respectively. Major peri-procedural complications occurred in the PFO-star group only: right-sided device thrombus (1 patient) and aorto-right atrial fistula (1 patient). At 1 year follow-up, no clinical recurrence occurred.In conclusion, despite the absence of clinical recurrence in this high-risk population with presumed paradoxical embolism, complete PFO closure at 6 months follow-up was significantly related to the type of closure device used.
authors.affiliation: Cardiology Service, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Meier
authors.forename: Alexandre
authors.initials: A
authors.lastname: Berger
authors.forename: Alain
authors.initials: A
authors.lastname: Delabays
authors.forename: Grégoire
authors.initials: G
authors.lastname: Girod
authors.forename: Denis
authors.initials: D
authors.lastname: Graf
authors.forename: Xavier
authors.initials: X
authors.lastname: Lyon
authors.forename: Christan
authors.initials: C
authors.lastname: Roguelov
authors.forename: Pierre
authors.initials: P
authors.lastname: Vogt
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Stauffer
authors.forename: Eric
authors.initials: E
authors.lastname: Eeckhout