Development of PR & Restenosis after Percutaneous Balloon Pulmonary Valvuloplasty

ABSTRACT

Background: Pulmonary stenosis is not an uncommon congenital heart disease in our population. Various age groups present with severe pulmonary stenosis require intervention either surgical or percutaneous catheter-based. Often lifesaving surgical intervention is not feasible considering procedural risk, the patient’s physical condition, and young age. Percutaneous balloon pulmonary valvuloplasty is safe, effective, almost painless, economical, and less hospital stay in any age group with immediate and long-term success. This study aimed to analyze the rate of development of (Pulmonary Regurgitation) PR & restenosis after Percutaneous Balloon Pulmonary Valvuloplasty (PBPV). Material & Methods: This hospital-based prospective observational study was conducted in the Department of Paediatric Cardiology Combined Military Hospital (CMH), Dhaka from January to December 2021. 0-18 years aged 50 population with PS who were referred to the Paediatric Cardiology Department of CMH Dhaka during the study period were selected as study subjects as per inclusion criteria. The purposive Sampling technique was used in this study. Data were collected with a predesigned standard data collection sheet. Statistical significance was set as a 95% confidence level at a 5% acceptable error level. Categorical variables were expressed as frequency and percentages. Mean, standard deviation, and/or medians with interquartile ranges were used to express the continuous variables. Paired t-test was performed in categorical comparison. A p-value of <0.05 was considered statistically significant. Collected data were analyzed using SPSS Version 24. Written informed consent was taken from every parent. Ethical clearance was taken from the Ethics Review Committee of CMH Dhaka for conducting the study. Results: 50(6.39%) had isolated valvular PS. The international standard for the prevalence of isolated PS is 8-10% which is very close to this study’s result. In this study, male predominance was found with the male-female ratio of 32 though there was no gender dominance found in other studies. Out of 50 cases, 3(6%) are neonates,7(14%) are infants, 27 (54%) are 1-5 years aged, and 13(26%) are more than 5 years aged. A total of 13(26%) cases developed PR, and all 13 patients developed trivial PR on D1 echo, out of them 1 patient developed mild PR on D30 Echo but in D90 and D180 Echo patients persisted the same mild PR. Out of 50 cases, 46(92%) were successful and 4 cases were procedure failed. None of the successful cases developed restenosis. Out of 4 procedure failed cases 1 patient developed restenosis on D30 follow up and 2 patients develop restenosis on the D90 follow-up. At D180 follow up none of the patients developed restenosis. All the restenosis cases had dysplastic pulmonary valves. One patient’s PS gradient persisted at 30-50 mm of Hg throughout the follow-up period. Overall restenosis in 180-day follow-up is 3(6%) and the remaining 47(94%) cases lead a healthy life in 6 months follow-up. Reballooning was done immediately after diagnosis of restenosis in stenosed cases. Conclusion: Immediate and intermediate-term (6 months) follow-up with Doppler echocardiography showed excellent outcomes in all cases except 3 (6.0%) restenosis cases and 13 (26.0%) insignificant PR cases. The baby who all had restenosis, had the risk factor, like- dysplastic PV. It may be concluded that balloon valvuloplasty is the procedure of choice for moderate, severe, and critical pulmonary valve stenosis.