Initial experience with the novel patent foramen ovale occlusion device Nit-Occlud® in patients with stroke or transient ischemic attack.

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.

Transcatheter closure of multiple interatrial communications.

OBJECTIVES: We sought to examine acute and midterm results of closure of multiple interatrial communications with staged device deployment and to review the relevant literature. BACKGROUND: Information about percutaneous methods of closure for multiple defects is limited. METHODS: We treated 148 patients with multiple defects. Of these, 88 had a relevant left to right shunt ("LRS"), 52 had a presumed paradoxical embolism ("PPE"), five had both (LRS and PPE), and one patient, respectively, had migraine, decompression sickness, and a right to left shunt. After implantation of the first device, closure of additional septal defects was attempted only if indicated clinically. RESULTS: Ninety-four patients received a single device and 53 more than one. In four patients, surgical defect closure followed. At the end of follow-up (FU; mean 4.5 ± 3.4 years), complete closure of all defects occurred in 67.6% (62.1% for LRS, 76.5% for PPE). Clinical success (small or trivial residual shunt) was achieved in 86.9% (83.9% for LRS, 90.2% for PPE). Complications included pericardial effusions in 2.7%, recurrent thromboembolic events in 4.8%, and new onset of atrial fibrillation in 10.1%. In a significant number of patients with multiple defects, after single device implantation, the likelihood of complete closure increased with FU time (26% complete closure at 1 month vs. 78% at 24 months). CONCLUSION: Percutaneous closure of multiple interatrial communications is feasible and safe. Importantly, many residual defects close without further intervention at FU. Therefore, staged device delivery is an alternative to simultaneous device implantation, possibly requiring fewer and smaller second devices.