TY - JOUR
T1 - Initial experience with the novel patent foramen ovale occlusion device Nit-Occlud® in patients with stroke or transient ischemic attack
AU - Steinberg, Daniel H.
AU - Bertog, Stefan C.
AU - Momberger, Julia
AU - Franke, Jennifer
AU - Hofmann, Ilona
AU - Renkhoff, Kristina
AU - Joy, Sonya
AU - Vaskelyte, Laura
AU - Sievert, Horst
N1 - Publisher Copyright:
© 2015 Wiley Periodicals, Inc.
PY - 2015/6/1
Y1 - 2015/6/1
N2 - 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.
AB - 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.
KW - ASD/PDA/PFO
KW - closure
KW - interventional devices/innovation
KW - structural heart disease intervention
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U2 - 10.1002/ccd.25580
DO - 10.1002/ccd.25580
M3 - Article
C2 - 24948394
AN - SCOPUS:84929711548
SN - 1522-1946
VL - 85
SP - 1262
EP - 1267
JO - Catheterization and Cardiovascular Interventions
JF - Catheterization and Cardiovascular Interventions
IS - 7
ER -