Developing High Medical Technology, a Challenge for Developing Countries: The Percutaneous Closure of Atrial Septal Defects Using Nit-Occlud ASD-R: Early and Mid-term Results.

OBJECTIVE: To assess the efficacy and safety of the Nit-Occlud ASD-R (PFM S.R.L, La Paz, Bolivia) in the percutaneous closure of secundum atrial septal defects (ASD). PATIENTS AND METHODS: Fifty-three consecutive patients with median age of 11 years (range 3-67) and mean weight 27.1 kg (range 13-75 kg), treated in two cardiology centers between May 2007 and March 2011. RESULTS: Mean fluoroscopy time was 14 minutes (5-53), mean procedure time was 70 minutes (45-150), mean defect size, as measured by the stop-flow technique, was 17.8 mm (5.6-31), and mean stent size of the implanted device was 18 mm (6-28), which is 0.98 times the defect size. Successful closure of the ASD without major complications was achieved in 49 of 53 patients. In 71.4% of patients in whom device implantation was accomplished, there was no evidence of a persistent shunt at the completion of the procedure. This closure rate increased to 91.7% after 24 hours, with 95.8% closure after three months and 100% closure after six months. Device embolization occurred in one patient within 24 hours of implantation and required surgical device removal and ASD closure. There were no other major complications and no deaths during the period of follow-up (average 72 months; range 59-105 months). CONCLUSION: The Nit-Occlud ASD-R device is safe and effective with very good closure rates.

Transcatheter closure of large patent ductus arteriosus at high altitude with a novel nitinol device.

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.

Chronic hypobaric hypoxia, patent arterial duct and a new interventional technique to close it.

BACKGROUND: Interventional closure of patent arterial duct has become an accepted alternative to surgical closure. Clinical trial with "Nit-Occlud® PDA-R". METHODS AND RESULTS: To assess the safety and efficacy of the device, we performed a prospective clinical study between June, 2009 and December, 2010 in La Paz, Bolivia. In all, 29 - 22 female patients and 7 male patients - out of 59 patients were selected on the basis of inclusion criteria. The procedures were performed under sedation at an age and weight of 5.7 years and 22.7 kilograms, respectively, with 4-6 French arterial sheaths and 5-7 French venous sheaths. The minimal diameter of the duct was 3.5 millimetres. The procedure, fluoroscopy, and hospitalisation times were 96.4 minutes (55 to 145), 13.1 minutes (3 to 25.2), and 24 hours, respectively. The "Nit-Occlud® PDA-R" was successfully deployed in all patients. Immediate, 24-hour, 1-, 3-, and 6-month closure rates were 65.5%, 79.3%, 96.5%, and 100%, respectively. The systolic pulmonary pressure diminished from 37 millimetres of mercury (21 to 57) before the intervention to 31 millimetres of mercury (21 to 45) after the intervention. No early or late embolisation, haemolysis, left pulmonary artery, or descending aorta obstruction occurred. CONCLUSIONS: We conclude that the "Nit-Occlud® PDA-R" device is safe and effective in closing patent arterial duct up to a diameter of 8 millimetres.