Purpose: To review the initial clinical outcomes of patent ductus arteriosus (PDA) closure using the new Nit-Occlud PDA-R device (NOPDA-R).
Materials and methods: The NOPDA-R is a self-expandable, nitinol-made, premounted and cone-shaped device with two distinctive features: reverse reconfiguration of the distal disc and a peculiar "snare-like" release mechanism. From May to December 2010, 20 consecutive patients were included.
Results: Median age was 4.7 years (range, 6 months to 21 years) and weight was 16.4 kg (range, 6-49 kg). Mean PDA diameter at its narrowest point, usually the pulmonary end, was 2.92 ± 0.61 mm (range, 2.1-4.5 mm), length was 7.05 ± 1.17 mm (range, 4.7-9.2 mm) and diameter of the aortic ampulla was 9.52 ± 1.62 mm (range, 6-13 mm). Pulmonary artery mean pressure was 20.6 ± 4.49 mmHg (range, 14-28 mmHg) and Qp/Qs ratio was 2.0 ± 0.29 (range, 1.6- 2.5). Implantation success rate was 100%. The median cylinder diameter of the device was 6.53 ± 1.05 mm (range, 5.5-8.5 mm) leading to a final selected device 124% larger (cylinder diameter) than the narrowest PDA diameter. Assessed by transthoracic color-Doppler echocardiography at 24 hours, 1 month, and 3 months after implantation, complete closure was achieved in 60%, 90%, and 95% of patients, respectively. There were no complications and all patients were discharged home the next day.
Conclusion: Percutaneous PDA closure using the new NOPDA-R device was feasible, safe, and effective. Longer follow-up time and a larger number of patients are required to assess long-term performance.