Key result
The Nit-Occlud PFO Occlusion Device achieved successful implantation without recurrent events or device complications at 6 weeks in 95.2% of patients.
Why the study?
Does the Nit-Occlud PFO Occlusion Device safely and effectively close PFOs in patients with cryptogenic stroke or TIA?
Observational (n=63)
Does the Nit-Occlud PFO Occlusion Device safely and effectively close PFOs in patients with cryptogenic stroke or TIA?
The Nit-Occlud PFO Occlusion Device demonstrates high procedural success and favorable rates of complete closure in patients with cryptogenic stroke or TIA.
Does not support routine PFO closure with Nit-Occlud; leaves open comparative efficacy versus approved devices in cryptogenic stroke.
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.
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Steinberg et al. (2014) conducted an observational in Cryptogenic stroke or transient ischemic attack and patent foramen ovale (n=63). Nit-Occlud PFO Occlusion Device was evaluated on Successful implantation without recurrent event, device malfunction, embolization, or the need for a replacement device over 6 ± 2 weeks. The Nit-Occlud PFO Occlusion Device achieved successful implantation without recurrent events or device complications at 6 weeks in 95.2% of patients.
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