Therapeutic Effects Of Absorbable Occluder On Atrial Septal Defect In Children

Objective:To investigate the therapeutic safety and efficacy of absorbable occluder on atrial septal defect（ASD）in children.Method:All clinical data were collected from children patients with ASD subject to absorbable occluders treatments and those underwent nitinol occluders treatments during the period from March 20th 2019 to June 28th 2019,including general data,preoperative tests（ECG,UCG,routine blood,routine urine,liver and kidney function,myocardial markers,etc.）,intraoperative ASD measurements and the size of the selected occluders,surgically related information（whether the surgery was successful,time of operation）,postoperative follow-up UCG and ECG,etc.Results:A total of 20 ASD children patients subject to the treatment of absorbable occluders was enrolled in the absorbable group,with a median age of 50（41.25～69.0）months,10 males and 10 females,a median weight of 14.75（14.00～17.00）Kg and a median body surface area of 0.62（0.59～0.70）m²,the size of the ASD defect was（11.03±3.60）mm and the size of the plug was（15.30±4.22）mm,all of them successfully underwent closure（100%）.Meanwhile,another 20 cases subject to nitinol occluders treatments were also selected into the nitinol group,with a median age of52.50（47.50-66.75）months,7 males and 13 females,a median weight of16.50（15.0-19.75）Kg and a median body surface area of 0.68（0.63-0.77）m^2,the size of the ASD defect was（8.59±5.37）mm and the size of the plug was（11.60±4.80）mm.The size of ASD defect and the diameter of intraoperative occluder in the absorbable group were both larger than those in the Nitinol alloy group（P<0.05）.There was no significant difference between the two groups of children patient in gender ratio,age,weight and body surface area（P>0.05）.All the patients in both groups successfully underwent closure,and there was no significant difference in immediate closure rate and surgical success rate（P>0.05）.There was a statistically significant difference in the time of operative between the two groups（P<0.05）,with a median operative time of 37.50（30.00-60.00）min in the absorbable group and 17.00（15.00-20.00）min in the nitinol group.No blood was transfused intraoperatively in both groups,nor PICU monitoring was provided postoperatively.During the postoperative follow-up,20 cases in the absorbable group completed the 1-year postoperative follow-up and16 cases completed the 2-year follow-up,while 20 cases in the nitinol group completed the 1-year and 9 cases completed the 2-year follow-up,respectively.Serious complications such as serious arrhythmia,detachment,displacement,thrombosis,or death did not occur in both groups.Routine blood tests,liver and kidney function,cardiac functional enzymes,chest X-ray,ECG and UCG were completed postoperatively in cases of the absorbable group;while only ECG and UCG were completed in the nitinol group according to clinical practice.The 24-hour postoperative blood tests of patients in the absorbable group showed an increase in WBC compared with the preoperative period（P<0.05）,and there was no significant difference in the postoperative follow-up at 3,6,12 and 24 months compared with the preoperative period（P>0.05）.PLT was lower than preoperative period at 24 hours,3,6,and 12 months follow-up（P<0.05）,and there was no significant difference at 24 months postoperative follow-up compared with preoperative period（P>0.05）;Hb was not significantly different at 24 hours,3,6,and 12 months postoperative follow-up compared with preoperative period（P>0.05）,and was higher at24 months postoperative follow-up（P<0.05）;N%was higher at 24 hours and 24 months follow-up than preoperative period（P<0.05）,and the rest were not significantly different than preoperative values（P>0.05）.The postoperative liver and kidney function tests at 3,6,12 and 24 months showed that ALT and BUN were not significantly different from those before surgery（P>0.05）,and Scr was higher than preoperative value（P<0.05）;AST was higher than that before surgery at postoperative 3 and 6months（P<0.05）,and returned to the preoperative level at 12 and 24months after surgery（P>0.05）.The postoperative reexamination of cardiac functional enzymes indicated the CK-MB（P<0.05）at 3 mouths after surgery was higher than that before surgery,and there was no significant difference in CK-MB at the remaining periods（P>0.05）.There was no significant difference in the Tn I during postoperative follow-up（P>0.05）.There were no significant differences in urine routine and chest X-ray examination in the absorbable group compared with those before surgery（P>0.05）.During the 12-month postoperative ECG follow-up,there were10 ECG abnormalities in the absorbable group and 4 cases in the nitinol group,and there was no statistically significant difference in the incidence of ECG abnormalities between the two groups（P>0.05）.During the12-month postoperative ECG follow-up,the overall incidence of residual shunts was statistically different（P<0.05）,with postoperative residual shunts occurred in 9 cases（0.45）of the absorbable group and a small amount of residual shunts still presented in 7 cases（0.35）at the 12-month follow-up,of which 4 cases（0.57）completed the 18-month postoperative follow-up with residual shunts still presented.16 cases（0.80）completed the24-month postoperative UCG follow-up,in which 6 cases experienced residual shunts and 1 case underwent a small amount of residual shunt,in the absorbable group,the size of ASD defect before surgery was（11.70±3.51）mm and（9.86±3.54）mm in 10 patients with postoperative residual shunt and（14.80±4.02）mm in 10 patients without residual shunt,and the size of intraoperative occultor was（15.80±4.57）mm and（14.80±4.02）mm,respectively.There was no statistical difference（P>0.05）.In the nitinol group,there were 2 cases（0.10）with postoperative residual shunts,which disappeared at the 12-month follow-up,and 9 cases（0.45）completed the 24-month postoperative UCG follow-up,without residual shunts.Among them,the preoperative ASD defect sizes of 2 patients with postoperative residual shunt and 18 patients without residual shunt in the Nitinol alloy group were（9.70±2.40）mm and（8.46±5.64）mm,respectively,and the sizes of intraoperative ocapsulers were（10.00±0.00）mm and（11.78±5.04）mm,respectively.There was no statistical difference（P>0.05）.Conclusion:Absorbable occluders are safe and effective in the treatment of ASD.