A comparison of the in vivo neoendothelialization and wound healing processes of three atrial septal defect occluders used during childhood in a nonrandomized prospective trial.

OBJECTIVE

We prospectively investigated the neoendothelialization of transcatheter secundum atrial septal defect (ASD) closure in children receiving one of three different occluders.

METHODS

Transcatheter ASD closure was performed for 44 children. The patients were divided into three groups: group I: Amplatzer, group II: Lifetech CeraFlex, and group III: Occlutech Figulla Flex II septal occluder. The data were prospectively analyzed. Markers of the three phases of wound healing were studied in all patients before and on the 1st and 10th days and 1st month post intervention.

RESULTS

The mean age of children was 7.08±3.51 years, and the mean weight was 26.07±15.07 kg. The mean ASD diameter was 12.65±3.50 mm. Groups I, II, and III comprised 34.1%, 31.8%, and 34.1% patients, respectively. No significant differences were observed between the groups regarding patient number, age, defect size, device diameter, or total septum/device ratio (p>0.05). Inflammatory and proliferative phase marker levels increased following the procedure (p<0.05). However, scar formation markers did not change after 1 month. No significant differences in neoendothelializaton were observed among the different occluders (p>0.05).

CONCLUSION

All three devices were composed of nitinol with different surface coating techniques. Although the different manufacturing features were claimed to facilitate of neoendothelialization, no differences were observed among the three devices 1 month following the procedure.