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

Abstract

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.