Clinical Study On Effect Of Domestic And Imported Cardiovascular Expanding Balloon Catheter In Treatment Of Children With Pulmonary Valve Stenosis

Objective: To evaluate the efficacy and safety of domesticcardiovascular expanding balloon catheter on treatment of children withpulmonary valve stenosis.Method: From February2012to February2013,12inpatients of theChildren’s Hospital of Chongqing Medical University plannig to get theirfirst PVPBs were divided into2groups: the domestic Test group (n=6,5boys,1girl, mean age4.51±5.06) and the imported Control group (n=6,2boys,4girl, mean age3.01±2.13) according to single blind controlledgrouping method. Tatal of them get the PBPVs after the informed consentswere signed. Through the whole more than6-month research process, wecollected and kept records of such details of every patient as: the immediateeffect of each PBPV, the pre-operation as well as early and6monthsfollow-up datas including the clinic symptoms, electrocardiogram, cardiaccolor ultrasound, chest radiography and adverse events or complications.All data get analyzed with SPSS20.0statistic software. Continuousvariables were presented as mean±standard deviation, categorical variables were presented as values or percentages. It would be consideredstatistically significant when P<0.05.Results: There is no significant difference in the pre-operation PTG,patients’s age, weight, height and so on between the two groups (P>0.05).It’s4patients needing a repair of atrial septal defect(1in Test group,3inContrast group). During operation, no significant difference happenedbetween both group’s pulmonary valve annulus, balloon type, ratio ofballoon to pulmonary artery annulus and operation time(P>0.05). After thevalve dilation, the pulmonary artery systolic pressure rise from (24.17±4.40)mmHg to (26.00±4.73) mmHg in Test group and (23.00±3.46) mmHg to(23.33±2.25) mmHg in Control group; the right ventricle systolic pressure,RVSP decreases from (92.00±45.07) mmHg to (52.00±22.32) mmHg inTest group and (71.67±24.73) mmHg to (36.33±6.86) mmHg in Controlgroup; PTG decreases from (67.83±43.92) mmHg to (26.00±22.88) mmHgin Test group and (48.67±24.38) mmHg to (13.0±5.18) mmHg in Controlgroup accordingly. There were1confirmed and4suspicious reactive rightventricular outflow tract obstruction patients in Test group while1suspicious case in Control group right after the operation who needed totake propranolol in proper dose for6months. All patients were performedby phone and clinic follow-up with good remissions of clinic symptomsand cardiac murmurs as the same as less defect in height and weight to thenormal children. The PTG kept falling after the operation in both groups (P<0.05).Despite some diversity of the downtrend, there came to be littledifference between the two groups’ descending PTGs determined from thepatients1day and1,3,6months after the PBPV (P>0.1). The trend came amost same in the right ventricular internal dimension as the PTG but a littlerecovery at the last time test in6-months postoperation. The valveregurgitations in the two groups both got little worse1day right after thePBPV, but came better later with a obvious improvement in3-monthpostoperation inspection (P>0.1). Tough he cardiothoracic ratioin in thechest radiography showed little improvement in the Test group while greatone in the Control, both groups found no pulmonary oligaemia6monthsafter the PBPV.Conclusion：The domestic cardiovascular expanding balloon catheteris safe and effective on children with PS, and have cheaper price and moretypes for choice, so the domestic balloon could get better used in ourcountry in the future.