title: Initial experience with the novel patent foramen ovale occlusion device Nit-Occlud® in patients with stroke or transient ischemic attack.
abstract: BACKGROUND
  Patent foramen ovale (PFO) is associated with cryptogenic strokes and transient ischemic attacks (TIAs). This study examined the initial experience with a new PFO occluder, the Nit-Occlud® PFO Occlusion Device.
  
  
  METHODS
  Sixty-three patients with history of cryptogenic stroke or TIA and PFO underwent percutaneous closure of the defect with the Nit-Occlud® PFO Occlusion Device. The primary endpoint was successful implantation without recurrent event, device malfunction, embolization, or the need for a replacement device over 6 ± 2 weeks. All patients underwent transesophageal echocardiography (TEE) at 6-weeks, and 42 patients had repeat TEE at 6-months. Clinical follow-up at 18.7 ± 7.4 months was also performed.
  
  
  RESULTS
  The device was successfully implanted in 62 (98.4%) patients with no relevant procedural complications. At 6-week follow-up, 60 (95.2%) patients met the primary endpoint. A residual shunt at rest and with Valsalva was noted in 8 (12.7%) and 31 (49.2%) patients respectively at 6-week TEE. At 6-months, 1 of 42 (2.4%) and 9 of 42 (21.4%) patients had a residual shunt at rest and with Valsava, respectively. At 18 months, 5/63 patients had recurrent events (3 TIAs, 2 strokes). No device-related complications occurred. One patient developed atrial fibrillation.
  
  
  CONCLUSIONS
  In patients with cryptogenic stroke or TIA and a PFO, the Nit-Occlud® PFO Occlusion Device appears to be both a safe and effective means to occlude the PFO. It is associated with high procedural success and favorable rates of complete closure.
authors.affiliation: Medical University of South Carolina, Charleston, South Carolina.
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Steinberg
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Stefan C
authors.initials: SC
authors.lastname: Bertog
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Julia
authors.initials: J
authors.lastname: Momberger
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Franke
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Ilona
authors.initials: I
authors.lastname: Hofmann
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Kristina
authors.initials: K
authors.lastname: Renkhoff
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Sonya
authors.initials: S
authors.lastname: Joy
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Laura
authors.initials: L
authors.lastname: Vaskelyte
authors.affiliation: CardioVascular Center Frankfurt, Frankfurt, Germany.
authors.forename: Horst
authors.initials: H
authors.lastname: Sievert
mesh_terms: D000328:Adult; D006328:Cardiac Catheterization / Q000295:instrumentation*; D017548:Echocardiography, Transesophageal; D005240:Feasibility Studies; D005260:Female; D054092:Foramen Ovale, Patent / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D005858:Germany; D006801:Humans; D002546:Ischemic Attack, Transient / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D011474:Prosthesis Design; D011475:Prosthesis Failure; D012008:Recurrence; D055502:Secondary Prevention / Q000295:instrumentation*; D055989:Septal Occluder Device; D020521:Stroke / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D013997:Time Factors; D016896:Treatment Outcome
keywords: ASD/PDA/PFO; closure; interventional devices/innovation; structural heart disease intervention