BACKGROUND: Patent ducti arteriosi (PDAs) are more frequent and larger at high altitude than at sea level. A novel PDA closure device, the Nitocclud PDA-R, is designed specifically for both large and medium size PDAs. The initial clinical experience with a new nitinol-based device in high altitude patients with large PDAs is described. METHODS: The Nitocclud PDA-R is a self-expandable, self-centering, repositionable occluder made of one nitinol wire without use of welding. It contains several polyester membranes, is delivered with a central guide wire and is released by retraction of the central wire into the delivery catheter. The efficacy of this device was evaluated at several high altitude centers. RESULTS: Fifty-one patients without other congenital cardiac defects underwent transcatheter closure of PDA. Complete occlusion of the PDA was achieved in 98% of the patients. Nearly 49% of the patients had no shunt immediately after device implantation. Echocardiography revealed a complete closure rate by Doppler interrogation of 69% after 24 hr, 96% after 6 months, and 98% after 1 year. In two cases, device embolization was observed after release, and in both cases the device was easily retrieved with standard interventional techniques. There have been no episodes of delayed device migration, endocarditis, hemolysis, wire fracture, device disruption, or death. CONCLUSIONS: The Nitocclud PDA-R device is safe and effective and can easily close very large PDAs. This device has a high rate of complete occlusion within 1 year and is easily retrieved if embolized.
BACKGROUND: Patent ducti arteriosi (PDAs) are more frequent and larger at high altitude than at sea level. A novel PDA closure device, the Nitocclud PDA-R, is designed specifically for both large and medium size PDAs. The initial clinical experience with a new nitinol-based device in high altitude patients with large PDAs is described. METHODS: The Nitocclud PDA-R is a self-expandable, self-centering, repositionable occluder made of one nitinol wire without use of welding. It contains several polyester membranes, is delivered with a central guide wire and is released by retraction of the central wire into the delivery catheter. The efficacy of this device was evaluated at several high altitude centers. RESULTS: Fifty-one patients without other congenital cardiac defects underwent transcatheter closure of PDA. Complete occlusion of the PDA was achieved in 98% of the patients. Nearly 49% of the patients had no shunt immediately after device implantation. Echocardiography revealed a complete closure rate by Doppler interrogation of 69% after 24 hr, 96% after 6 months, and 98% after 1 year. In two cases, device embolization was observed after release, and in both cases the device was easily retrieved with standard interventional techniques. There have been no episodes of delayed device migration, endocarditis, hemolysis, wire fracture, device disruption, or death. CONCLUSIONS: The Nitocclud PDA-R device is safe and effective and can easily close very large PDAs. This device has a high rate of complete occlusion within 1 year and is easily retrieved if embolized.