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Initial experience with the novel patent foramen ovale occlusion device N it‐ O cclud® in patients with stroke or transient ischemic attack
Author(s) -
Steinberg Daniel H.,
Bertog Stefan C.,
Momberger Julia,
Franke Jennifer,
Hofmann Ilona,
Renkhoff Kristina,
Joy Sonya,
Vaskelyte Laura,
Sievert Horst
Publication year - 2015
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.25580
Subject(s) - medicine , patent foramen ovale , occlusion , shunt (medical) , stroke (engine) , surgery , percutaneous , cardiology , atrial fibrillation , transesophageal echocardiogram , embolization , mechanical engineering , engineering
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. Conclusion 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. © 2015 Wiley Periodicals, Inc.