Clinical Analysis And Follow-up Of 249 Children With Pulmonary Valve Stenosis Treated By Percutaneous Balloon Pulmonary Valvuloplasty

BackgroundPulmonary valve stenosis(PS)is a common.congenital heart disease(CHD),accounting for 8%?0%of the patients with congenital heart disease.The traditional therapy is surgical treatment,by which chest is needed to be opened with the shortcomings of large trauma,scar,and slow recovery and so on.Since 1982,when Khan et al performed the first successful percutaneous balloon pulmonary valvuloplasty for a child with PS,this technique has gradually become the first choice of treatment in patients with PS,due to the advantages of simple operation,less trauma,no operation scar,fast recovery and so on.Many studies have reported good immediate and short-term efficacy about this percutaneous technique,and have demonstrated its effectiveness and analyzed the restenosis?Neverthless,few large sample of long-term was studied about ?P,valvular regurgitation,stenosis,right ventricular size and other indicators of the evaluating the efficacy of PBPV.ObjectiveThe aim of this study was to explore the applicationand evaluation the safety and efficacy of PBPV,to report the long-term results of PBPV,to analyze its influencing factors and to determine the incidence of pulmonary regurgitation as a complication of the technique during follow-up.MethodStudy Population:a total of 249 children diagnosed with pulmonary valve stenosis that underwent percutaneous balloon pulmonary valvuloplasty between November 1987 and December 2016 at the Shandong Provincial Hospital affiliated to Shandong University.Study Method:we collected the clinical information,baseline demographic data during hospitalization,postoperative 1 month,3 months,half a year,and 1 year after every 1 to 2 years of follow-up data of outpatient service review and the data of right ventricular diameter in the same period of the same age in the outpatient department.Statistical analyses were performed using the IBM Statistical Package for Social Sciences version 21.0.Results1.In this study,among the 249 cases,134 were male and 115 were female.The median age was 3.20 years old,ranging from 4 months to 17 years,The weight ranged from 6 to 65kg,with an average of(17.96 ± 9.96)kg,and the follow-up time was 1 months to 30 years;Mild stenosis occurred in 80 cases,moderate stenosis in 148 cases,severe stenosis in 21 cases;30 cases were accompanied with varying degrees of right ventricular outflow tract stenosis,and 13 cases with mild pulmonary valve dysplasia;199 cases(80%)with different degree of right ventricular wall thickening or right ventricular enlargemen.2.The success rate of PBPV was 99%(247/249).2 cases transformed to cardiac surgery after cardiac angiography;The balloon/pulmonary valve annulus ratio(BAR)was 1.17 ± 0.11(1?1.40);Right heart catheterization assessed the right ventricular pressure,pulmonary artery pressure,the peak-to-peak pulmonary transvalvular gradient(AP)before balloon dilation were(78.16±32.99)mmHg,(23.52±6.10)mmHg,(54.77±33.04)mmHg,the right ventricular pressure,AP decreased significantly after balloon dilation(P<0.05);Operation time was(58.54±24.51)min;Time of X-ray exposure was(10.52 ±4.14)min,X-ray dose was(5-701)mGY.Hospitalization time was(6.12±1.54)days.3.In this study,11 cases of children with severe complications(4.5%),of which 2 cases of pericardial effusion,6 cases ofright ventricular outflow tract,in 1 cases of seizure spasm,1 cases of supraventricular tachycardia,lcase of upper gastrointestinal bleeding in patients with heart failure,1 cases were found pulmonary artery dissection,after given positive symptomatic treatment and surgical operation,there were no death cases.4.The echocardiographic measured value was little higher than the cardiac catheterization data when measured the pulmonary transvalvular gradient.Their pearson correlation coefficient was 0.78;There was no significant difference between the two methods in measuring the diameter of pulmonary valve annulus(P<0.05).The consistency between the echocardiographic data and cardiac catheterization data shows statistically significant consistency.The results showed that there was a good linear correlation between echocardiography and cardiac catheterization in the measurement of pulmonary transvalvular gradient and pulmonary valve annulus diameter.5.A total of 223(90.3%)patients were followed up.The follow-up period was 1 months to 30 years,an average of(7.68±4.77)years old.The preoperative and postoperative 24 hours,after half a year,1?2 years,5 years,10 years pulmonary transvalvular gradient respectively was(63.56±24.07)mmHg,(26.65±11.19)mmHg,(24.23±11.41)mmHg,(20.93±8.94)mmHg,(18.27±8.83)mmHg,(15.27±7.25)mmHg.Repeated measurement data analysis of variance found there was significant difference at different time points.Children with postoperative follow-up time period of the pulmonary transvalvular gradient were significantly lower than that before operation.The pulmonary transvalvular gradient of Postoperative long-term was significant decreased when compare with the time before operation and short term after operation.The results of logistic regression analysis show that valve dysplasia,with right ventricular outflow tract stenosis,and the immediate postoperative residual transvalvular gradient degree were the risk factors for long term curative effect of PBPV in children who could not reach the best standard.6.Of the 29 cases(14%)in whom the postvalvuloplasty gradient was greater than 36 mmHg after half a year follow-up,there are still 12 cases(6.5%)after one or two years follow-up,among them,3 cases were given operation again,3 cases gradually reduced to below 36 mmHg,2 cases were still more than 36 mmHg after the 10 years,and the other 3 cases were lost visit.During follow up,we found 1 cases that his immediately,the short-term effect reached the excellence standard,but the postoperative residual transvalvular gradient Increased gradually in long-term follow-up,10 years later reached to 41 mmHg.7.The total incidence of pulmonary regurgitation was 58%,68%,73%,76%,80%,and 83%at the time of preoperative,postoperative 24 h,six months,1-2 years,5 years and 10 years.There were 14 cases(21%)with moderate to severe pulmonary regurgitation in the follow-up time of more than 10 years.12 cases of moderate pulmonary regurgitation,2 cases of severe pulmonary regurgitation.Friedman M test showed that there was a significant difference among the preoperative 24 h,postoperative 24 h and ten years after operation in pulmonary regurgitation(P<0.05).Those patients whom were followed up more than 10 years,the total incidence of pulmonary regurgitation and the degree of regurgitation were significantly higher than those preoperative or short term after operation(P<0.05).With the prolongation of time,the incidence of pulmonary valve regurgitation and the degree of regurgitation increased gradually after PBPV.8.The right ventricular diastolic diameter was(19.27±3.03)in patients more than 10 years follow-up,when the same term and age healthy children's right ventricular diastolic diameter was(15.24±2.89)mm,right ventricular diastolic diameter is significantly higher than the control group(P<0.05).9.There were 43%(107/249)of the children with tricuspid regurgitation before operation,and the incidence of tricuspid regurgitation was 42%,41%,45%,43%and 44%at the points of postoperative 24h,six months,1-2 years,5 years and 10 years follow-up,there was no significant change in the total incidence of tricuspid regurgitation.However,among the 20 cases with moderate or above tricuspid regurgitation before the PBPV,the degree of regurgitation was gradually reduced or disappeared in 17 patients during the follow-up period.Only 1 case need to give pulmonary valve replacement.Friedman M test showed that there was a significant difference in the incidence of tricuspid regurgitation among the preoperative 24 h,postoperative 24 h and 10 years after the PBPV(P<0.05).The degree of tricuspid regurgitation degree was decreased in whom were followed up for more than 10 years after PBPV,when compared with preoperative and 24 hours postoperatively(P<0.05).Conclusions1.PBPV has a high success rate in the treatment of children with PS,and it has good medium-long-term curative effect,less complications and lower restenosis rate,which can be used as the first choice for PS.2.Valve dysplasia,with right ventricular outflow tract stenosis,the immediate postoperative residual transvalvular gradient degree were the risk factors for long term curative effect of PBPV in children who could not reach the best standard,yet the age,degree of stenosis before operation,balloon pulmonary valve annulus ratio,whether combined with other abnormal factorshad no significant effect on the long-term curative effect.3.The tricuspid regurgitation degree reduced during long-term follow-up,but pulmonary regurgitation incidence and degree increased,the right ventricular diastolic diameter was also larger than healthy people,few patients woluld be restenosis,which needed to pay attention to the long-term follow-up outside the hospital.