Clinical Study Of Domestic Cardiovascular Expanding Balloon Catheter In Treatment Of Children With Pulmonary Valve Stenosis

Objective: Through the comparison of the domestic and importedcardiovascular expanding balloon catheter on treatment of children withpulmonary stenosis (PS), we can evaluate the efficacy and safety ofdomestic one to provide reference for clinical choose better material.Method: Select24hospitalized children receiving the treatment ofPBPV during February2012-February2014in our hospital. The24children were randomly assigned to the experimental group as well as thecontrol group, both12cases. The experimental group used thecardiovascular expanding balloon developed by Xuzhou Ya Tai Science&Technology Ltd. The control group used the CRISTAL BALLOONdeveloped by BALT EXTRUSION, Inc. which was imported from France.Observe and collect the clinical data (cardiac catheterization angiography,cardiac ultrasound examination, electrocardiogram, chest X-ray, signsand symptoms, complications, etc.) during the preoperative, intraoperativeand postoperative1day,1month,3months,6months period of both group.All the data use excel2003and SPSS17.0for statistical analysis, with P < 0.05for the difference was statistically significant.Result: All children’s average age is3.68±3.71years old，averageheight93.83±23.66cm，average weight18.44±16.95kg，and there is nosignificant difference between the two groups (P>0.05). NO significantdifference showed on pulmonary valve diameter, balloon diameter andoperation time in the two groups(P>0.05). After PBPV, the PAP rise from(24.50±5.21) mmHg to (24.67±6.47), right ventricular pressure decreasedfrom （83.08±36.23）mmHg to (40.67±19.56) and PTG decreased from（58.58±35.50） mmHg to (16.08±18.67） mmHg in test group. thepulmonary artery Pressure decreased from （22.58±5.79） mmHg to(21.67±3.92), right ventricular pressure decreased from （75.92±19.13）mmHg to(35.17±7.71) and PTG decreased from （53.33±19.11） mmHg to（15.17±7.12） mmHg in control group. There was1child showingreactive right ventricular outflow tract but returned to normal after3months(21.75mmHg).All children’s clinical symptoms and signs werealleviated. Both groups of the patients showed the descending PTGs in1day and1,3,6months after the PBPV(P <0.05). The difference betweentwo groups of PTG in each period was (P>0.05). The difference betweentwo groups of the right ventricular internal dimension in each period was（P>0.05）.The difference between two groups of Pulmonary valve andtricuspid regurgitation was （P>0.05）.In the normal range of EF, thedifference between two groups of EP was （P>0.05）. Two groups of children’s electrocardiogram QRS axis was descending comparedwith pre-operation, Electric axis right and right ventricular hypertrophywere back to normal, but the difference between two groups was（P>0.05）.The chest X-ray shows that the CRT is decend in both group, and the trendis consistent. There is no serious complications in both group.Conclusion: There is similar efficacy and safety to Domestic andimported balloon in the treatment of PS, and the domestic one is worthy ofpromotion.