Accura balloon dilatation catheter for percutaneous balloon pulmonary valvuloplasty among adult patients-its protean use.

BACKGROUND: Percutaneous balloon pulmonary valvuloplasty (PBPV) is the treatment of choice for hemodynamically significant pulmonary stenosis (PS). Currently, the Tyshak balloon is preferred but requires multiple dilatations because of its instability across the valve leading to a watermelon seeding effect. Accura balloon (Vascular Concept, UK) offers an advantage in its self-positioning configuration, variable diameter, and rapid inflation-deflation sequence which shortens the procedural time and valve injury. METHOD: 43 patients with severe pulmonary valve stenosis underwent PBPV using an Accura balloon at LPS Institute of Cardiology, GSVM Medical College, Kanpur, UP, India from March 2018 to February 2022. The procedure was carried out using the standard technique but the metallic straightener was removed when the catheter reached the right atrium to facilitate its delivery across the pulmonary valve. Patients were followed up by 2D echo at 24 hours and 6 months. RESULT: Successful BPV was done in all 43 patients [with mean age 21.9 (range 18-41); 31 males and 12 females] among which 5 patients had dysplastic valves. The mean diameter of the annulus was 18.5 (range 15-21) mm. Immediate hemodynamic improvement was observed in 38 patients (88%) as peak systolic gradient reduced from 84±13 to 22±12 mmHg (P<0.005) while 5 patients (12%) had <50% reduction of resting gradient, though it came down significantly at 6 months. Fluoroscopy and procedural time were 5.2±1.9 min and 22.6±3.4 min respectively. Major complications (death, cardiac perforation, tamponade, tricuspid regurgitation, requirement of blood transfusion) were none. Minor complications (transient hypotension, ventricular premature contraction, transient bradycardia) were reported in all patients. Accura balloon being bulky were delivered over left atrial and super stiff Amplatz wire in 36 and 7 patients respectively. CONCLUSION: PBPV using Accura balloon is safe and effective for both stenosed and dysplastic valves. In a few patients, maximal effect will be observed over a period of 6 months.

Effect of Balloon Pulmonary Valvuloplasty on Growth of Pulmonary Annulus in Infants with Tetralogy of Fallot.

Percutaneous balloon pulmonary valvuloplasty (PBPV) is an alternative intervention in infants with Tetralogy of Fallot (TOF). It can not only improve hypoxia but also promote pulmonary annulus (PA) growth. In this study, we evaluated the effect of PBPV on PA growth in infants with TOF. To eliminate the effect of the systemic to pulmonary shunt (SPS) that may promote PA growth, we divided TOF infants into 2 groups: group A, patients who underwent PBPV with or without other SPS, and group B, patients who attempted SPS but without PBPV. Sixty patients were included, 28 patients in group A and 32 patients in group B. Age at the time of intervention in group A (range, 0.4-5.4; median 1.4 months) was lower than that in group B (range, 2.3-7.7; median 4.8 months), p-value 0.02. The body weight in group A (range, 3-5.5; median 3.7 kg) was also lower than that in group B (range 4.1-6.4; median 5.9 kg), p-value 0.02. Echocardiographic data at the mean follow-up period of 37.2 months (3-88 months) in group A and 39.6 months (6-95 months) in group B demonstrated an increase in mean PA diameter from 5.0 ± 1.3 mm to 10.2 ± 2.9 mm, p-value < 0.001 in group A; and from 6.2 ± 2 mm to 9.5 ± 2.9 mm, p-value < 0.001 in group B. The median PA z-score increased from - 3.4SD (- 3.9 to - 2.6SD) to - 1.8SD (- 2.5 to - 0.8SD), with the p-value of 0.002 in group A; and increased from - 2.9SD (- 4.5 to - 1.3SD) to - 2.7SD (- 3.6 to - 1.4SD), with the p-value of 0.73 in group B. By using the PA z-score as the absolute value, there was a statistically significant increase in the PA z-score during follow-up in group A, but not in group B. Balloon pulmonary valvuloplasty in infants with TOF can facilitate the growth of the pulmonic annulus even after eliminating the effect of the systemic to pulmonary shunt.

Outcomes of percutaneous balloon pulmonary valvuloplasty in congenital pulmonary valve stenosis.

Percutaneous balloon pulmonary valvuloplasty (PBPV) is the primary treatment for pulmonary valve stenosis (PVS). The study consisted of 228 children with PVS who underwent PBPV from January 2004 to October 2019 at a single center. The risk factors for ≥moderate pulmonary regurgitation (PR), residual stenosis, and restenosis were analyzed based on the baseline patient characteristics and measured value of corresponding inspection results. Among 228 patients, follow-up results were obtained in 193 patients. The univariate analysis demonstrated that young age, low weight, small pulmonary annulus diameter, higher initial RV-PA PSEG, increased RV/systemic pressure ratio, and severe PVS were associated with ≥moderate PR. The multivariate analysis demonstrated that higher initial RV-PA PSEG and low weight were independently associated with ≥moderate PR, while higher initial RV-PA PSEG was independently associated with residual stenosis and restenosis. PBPV is a preferred tre atment in PVS children with a higher success rate. Higher initial RV-PA PSEG was a significant factor for ≥moderate PR, residual stenosis, and restenosis.

Elabela: A Novel Biomarker for Right Ventricular Pressure Overload in Children With Pulmonary Stenosis or Pulmonary Atresia With Intact Ventricular Septum.

Background: Assessing right ventricular overload in children is challenging. We conducted this study involving children with pulmonary valvular stenosis (PS) or pulmonary atresia with intact ventricular septum (PA/IVS) to evaluate the potential of a new endogenous ligand of apelin receptor, Elabela (ELA), as a potential biomarker for right heart overload. Methods: In this prospective cohort study, a total of 118 congenital heart diseases patients with right ventricle outflow tract obstruction were recruited from 2018 to 2019. Among them, 44 isolated PS and 7 PA/IVS patients were selected. Their venous blood was collected, and all patients underwent an echocardiographic examination. Among them, post-operative blood was collected from 24 patients with PS after percutaneous balloon pulmonary valvuloplasty. The plasma ELA concentration was measured using enzyme-linked immunosorbent assay. Results: The ELA was significantly associated with the peak transvalvular pulmonary gradient (r = -0.62; p = 0.02), thus reflecting the severity of PS or PA/IVS. The ELA significantly increased at 3 days after intervention, when mechanical obstruction of the right outflow tract was relieved. Based on the receiver-operator characteristic curve results, ELA could be a risk factor for duct dependence in patients with critical PS or PA/IVS who are younger than 6 months (AUC: 0.82). Conclusion: ELA concentration and severity of PS or PA/IVS had a significant negative correlation, indicating that ELA might be a novel biomarker for right ventricular afterload and reflect the immediate pressure changes in the right heart. Furthermore, ELA could predict duct-dependency in PS and PA/IVS patients, as valuable as classical echocardiographic indexes.

Transcatheter interventional therapy for pulmonary stenosis in infants / 中国实用儿科杂志

OBJECTIVE: To summarize the experience of percutaneous balloon pulmonary valvuloplasty for pulmonary stenosis in infants,and to evaluate its necessity,safety and effectiveness. METHODS: From January 2009 to December2018,68 cases of pulmonary stenosis were treated by percutaneous balloon pulmonary valvuloplasty. The clinical data before and after operation were analyzed retrospectively. RESULTS: The mean age was(6.34±3.6)months. The mean operation weight was(7.81±2.11)kg. The preoperative body weight/age Z score was-0.80±1.38,and growth restriction was in 22 cases(32.4%),cyanosis in 15 cases(22.1%)and tachypnea in 23 cases(33.8%). The mean right ventricular/left ventricular length-diameter ratio was 0.56±0.73 by echocardiography,the mean cardiothoracic ratio was 0.56±0.43 by chest radiography,and the average value of preoperative oxygen saturation was 94.74 ± 6.10. The mean systolic pressure ratio of right ventricle/left ventricle before operation was 0.68±0.26. After balloon dilation,the mean pressure gradient of pulmonary valve decreased from(75.57 ± 18.61)mmHg to(22.37 ± 5.21)mmHg,and the mean systolic pressure of right ventricle decreased from(83.78±22.44)mmHg to(54.16±20.81)mmHg. The immediate success rate of operation was 100%. There were no serious arrhythmia,cardiac perforation,rupture of tendon chordae,vascular injury or other complications during the operation. The proportion of mild to moderate pulmonary regurgitation was 53.3% in early stage after operation,and there was no severe regurgitation. The restenosis rate was 2.94% during the follow-up period of 3 months to 10 years. The pulmonary valve regurgitation degree of 32 children who were followed up for more than 5 years did not further aggravate,and no specific management was carried out. No obvious right ventricular dysfunction was found in all patients. Compared with the toddlerhood infants undergoing PBPV in our center,the babyhood infants had obvious clinical symptoms and serious condition. The early and medium-long-term follow-up after operation was satisfactory. There was no significant difference in the effect of operation in the low-weight or low-age infants in babyhood. CONCLUSION: PBPV is necessary for the treatment of pulmonary stenosis in infants. The technique is safe and feasible,and the follow-up results are effective.

Long-term follow - up of percutaneous balloon pulmonary valvuloplasty in pulmonary valve stenosis in 230children / 中华实用儿科临床杂志

Objective To evaluate the safety and efficacy of percutaneous balloon pulmonary valvuloplasty (PBPV)in the treatment of the children with pulmonary stenosis (PS),and to observe the long - term prognosis and analyze the influencing factors. Methods The total of 230 children were collected,who had been diagnosed with pul-monary valve stenosis and had undergone percutaneous balloon pulmonary valvuloplasty between November 1987 and November 2015 in Shandong Provincial Hospital Affiliated to Shandong University. Their ages ranged from 4 months to 17 years,and the follow - up duration lasted from 1 month to 29 years. The data included clinical data and long - term follow - up data of hospitalized children,and the echocardiography data from the healthy peers in the same period. Then the data were analyzed statistically. Results In this study,228 cases of children were successfully performed PBPV, and the success rate was 99％(228 / 230 cases). The pulmonary transvalvular gradient (△P)of preoperation,24 hours postoperatively,half a year postoperatively,2 years postoperatively,5 years postoperatively,and 10 years postope-ratively was (63. 5 ± 23. 8)mmHg (1 mmHg = 0. 133 kPa),(26. 2 ± 11. 1)mmHg,(24. 8 ± 9. 8)mmHg,(20. 9 ± 8. 9)mmHg,(18. 1 ± 8. 7)mmHg,(15. 3 ± 7. 3)mmHg and (15. 3 ± 7. 3)mmHg,respectively. The immediate post-operative △P was significantly lower than that of preoperation (P < 0. 01),and the △P of the most children decreased in the long - term follow - up. The results of Logistic regression analysis showed that valve dysplasia with right ventricu-lar 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. The restenosis rate was 4. 6％(3 /65 cases)with children followed up for more than 10 years. The incidence of long - term follow - up pulmonary valve regurgitation (83％)was significantly higher than that before operation (58％)and short term (68％)after operation, and the degree of regurgitation also increased (P < 0. 05),while the degree of regurgitation of the tricuspid regurgitation decreased gradually during the follow - up (P < 0. 05);the right ventricular diastolic diameter of the patients at 10 years or more after the operation was measured as (19. 27 ± 3. 03)mm,which was significantly higher than that (15. 24 ± 2. 89)mm of the healthy children of at the same term healthy age (P < 0. 05). Conclusions The PBPV has a high success rate in the treatment of children with PS,and it has good medium - long - term curative effect,less com-plications and lower restenosis rate. Therefore,PBPV can be used as the first choice for PS. However,the incidence and degree of pulmonary regurgitation has an increasing trend after PBPV and the right ventricular diastolic diameter is still larger than that of the healthy children. Therefore,the long - term follow - up is necessary out of the hospital.

Progress of percutaneous balloon pulmonary valveplasty application in children with pulmonary valve stenosis / 中华实用儿科临床杂志

Pulmonary valve stenosis (PS) is a relatively common congenital heart disease,and there are 2 treatment methods of surgical operation and intervention.Percutaneous balloon pulmonary valvuloplasty (PBPV) was applied successfully in children with PS for the first time by Kan.For more than 30 years,with the update of intervention equipment,improvement of operation method and accumulation of clinical experience,the application of PBPV continuously has made new progress.Most of the previous reports of the PBPV were for the immediate and short-term efficacy,while long-term follow-up data and some special types of PS review research were less.Now,combined with PBPV clinical data and long-term follow-up study in recent years,an overview of the application progress of PBPV including indications,methods,curative effect and follow-up,prevention and cure of complications and some special type of PS are provided.

Evaluating the risk factors of reintervention of neonates with PA/IVS and CPS/IVS after PBPV as initial intervention method.

OBJECTIVES: To analyze the clinical features, immediate and short-term outcome of percutaneous balloon pulmonary valvuloplasty (PBPV) of neonates with pulmonary atresia with intact ventricular septum (PA/IVS) or critical pulmonary stenosis with intact ventricular septum (CPS/IVS) who underwent PBPV as initial intervention methods to evaluate the risk factors of reintervention. METHOD: Thirty-eight neonates with PA/IVS or CPS/IVS admitted to Shanghai Xinhua Hospital between June 2009 and November 2014 who underwent PBPV as initial procedures were respectively studied. We analyzed their clinical features, the immediate and short-term outcome of PBPV, and evaluated the risk factors for reintervention. RESULTS: Thirty-eight neonates with PA/IVS and CPS/IVS who underwent PBPV as initial procedures were included in our study with a mean age of 13±8 days. Among the 12 patients who underwent reintervention, 7 patients had PA/IVS (64%) and 5 had CPS/IVS (36%). Patients with PA/IVS (p=0.005), small pulmonary valve diameter (p=0.035), and bad pulmonary valve development were important risk factors. The immediate and short-term outcome of PBPV was better in patients who did not need reintervention, and the peak-to-peak pulmonary transvalvular gradient in the 1st month after PBPV had the best capability in predicting reintervention with help of receiver operating characteristic curve and the logistic regression analysis. Days of prostaglandin E1 (PGE1) infusion after PBPV >5 days was also found to be a risk factor for reintervention. CONCLUSION: The short- and mid-term outcome of pulmonary valve perforation and PBPV in neonates with PA/IVS and CPS/IVS was favorable. Risk factors include PA/IVS, small pulmonary valve, bad short-term pulmonary valve development, the peak-to-peak pulmonary transvalvular gradient in the 1st month after procedure >42mmHg, and PGE1 infusion >5 days.

The Comparison between the Echocardiographic Data to the Cardiac Catheterization Data on the Diagnosis, Treatment, and Follow-Up in Patients Diagnosed as Pulmonary Valve Stenosis.

BACKGROUND: Isolated pulmonary valve stenosis (PS) makes up 6-9% of all congenital heart defects among children. The initial gold standard for diagnosis, follow-up of PS is by echocardiography. However, the most accurate diagnosis still remains to be measurement of the pressure gradient through transcatheterization. The purpose of this study is to compare the difference between the echocardiographic data to the cardiac catheterization data on the diagnosis, treatment, and follow-up in patients diagnosed as PS, and to see what parameters should be closely monitored. METHODS: A total of 112 patients (Male : Female = 46 : 66) who underwent balloon pulmonary valvuloplasty (BPV) at Severance Cardiovascular Hospital, between December, 2002 to August, 2012 were retrospectively analyzed. The patients were all under 16 years of age and critical PS patients who underwent BPV were excluded from this study. RESULTS: The pre-BPV right ventricle (RV)-pulmonary artery (PA) systolic pressure gradient and post-BPV systolic pressure gradient showed statistically significant decrease. The pre-BPV RV-PA systolic pressure gradient and 3 month post-BPV systolic pressure gradient showed statistically significant decrease. The consistency between the echocardiographic data and cardiac catheterization data shows statistically significant consistency. The mean pressure gradient and systolic pressure gradient on the echocardiography shows high consistency when comparing with the cardiac catheterization data. CONCLUSION: Our study shows that BPV in PS is a safe and effective procedure in children and adolescent. The standard echocardiographic evaluation of PS, during diagnosis and follow-up, should include mean transpulmonic pressure gradient, as well as the peak systolic pressure gradient. The success of the procedure should be held off until at least 3 months, only if the patients do not show any symptoms.

The Comparison between the Echocardiographic Data to the Cardiac Catheterization Data on the Diagnosis, Treatment, and Follow-Up in Patients Diagnosed as Pulmonary Valve Stenosis

BACKGROUND: Isolated pulmonary valve stenosis (PS) makes up 6-9% of all congenital heart defects among children. The initial gold standard for diagnosis, follow-up of PS is by echocardiography. However, the most accurate diagnosis still remains to be measurement of the pressure gradient through transcatheterization. The purpose of this study is to compare the difference between the echocardiographic data to the cardiac catheterization data on the diagnosis, treatment, and follow-up in patients diagnosed as PS, and to see what parameters should be closely monitored. METHODS: A total of 112 patients (Male : Female = 46 : 66) who underwent balloon pulmonary valvuloplasty (BPV) at Severance Cardiovascular Hospital, between December, 2002 to August, 2012 were retrospectively analyzed. The patients were all under 16 years of age and critical PS patients who underwent BPV were excluded from this study. RESULTS: The pre-BPV right ventricle (RV)-pulmonary artery (PA) systolic pressure gradient and post-BPV systolic pressure gradient showed statistically significant decrease. The pre-BPV RV-PA systolic pressure gradient and 3 month post-BPV systolic pressure gradient showed statistically significant decrease. The consistency between the echocardiographic data and cardiac catheterization data shows statistically significant consistency. The mean pressure gradient and systolic pressure gradient on the echocardiography shows high consistency when comparing with the cardiac catheterization data. CONCLUSION: Our study shows that BPV in PS is a safe and effective procedure in children and adolescent. The standard echocardiographic evaluation of PS, during diagnosis and follow-up, should include mean transpulmonic pressure gradient, as well as the peak systolic pressure gradient. The success of the procedure should be held off until at least 3 months, only if the patients do not show any symptoms.

Prophylaxis and treatment for the complications of the percutaneous balloon pulmonary valvuloplasty in children with pulmonary valve stenosis / 国际儿科学杂志

Percutaneous balloon pulmonary valvuloplasty has replaced surgery as the first choice for pulmonary valve stenosis,especially for the isolated ones in children.However,there still happen to be some complications which could lead to a bad prognosis or even death,when the procedure has already been a recognized safe one.This paper reviews these complications with their causal factors as well as the ways to prevent and treat them.

Diagnosis and treatment of children with pulmonary stenosis / 国际儿科学杂志

Pulmonary valve stenosis is a common congenital heart disease,and its early diagnosis and treatment can improve growth and prognosis in children with pulmonary valve stenosis.With the development of the diagnostics and treatment,percutaneous balloon pulmonary valvuloplasty has replaced surgery as the first choice for isolated pulmonary valve stenosis.This paper reviews the recent progress in diagnosis and treatment of pulmonary valve stenosis.