Objective:To evaluate the clinical efficacy of percutaneous balloon pulmonary valvuloplasty (PBPV) via antegrade venous-arterial loop in neonates with critical pulmonary stenosis with intact ventricular septum (CPS-IVS).Methods:A retrospective case review was conducted. Fifteen neonates with CPS-IVS who underwent PBPV via antegrade venous-arterial loop at the Women and Children′s Hospital, Qingdao University between September 2020 and September 2023 were included. Pre-and post-operative right ventricular functional parameters, surgical complications, and follow-up outcomes were analyzed. Paired-sample t-test was used to compare changes in right ventricular systolic pressure (RVSP), percutaneous oxygen saturation (SpO 2), and echocardiographic findings pre-and post-operatively, as well as during the follow-up period. Results:Among the 15 neonates (9 males and 6 females) with CPS-IVS, the surgical age was (3.6±0.5) d. All neonates underwent successful PBPV via antegrade venous-arterial loop under general anesthesia. The immediate post-operative trans-pulmonary valve pressure gradient was (35±6) mmHg (1 mmHg=0.133 kPa), with a significant reduction in RVSP from (96±16) mmHg to (59±14) mmHg ( t=6.70, P<0.001). SpO 2 (with an inspired oxygen concentration of 0.48) increased from 0.86±0.07 pre-operatively to 0.97±0.03 post-operatively ( t=4.81, P<0.001). One month postoperatively, SpO 2 (without oxygen supplementation) normalized in all patients, with a statistically significant difference compared to pre-operative values ( t=0.16, P<0.001). Immediately postoperative, mild to moderate diastolic pulmonary valve regurgitation was observed in 8 patients, with no cases of severe regurgitation. Additionally, the severity of tricuspid valve regurgitation decreased from severe to mild-to-moderate in 6 patients. Three months postoperatively, one patient underwent a second PBPV due to an increased trans-pulmonary valve pressure gradient of 74 mmHg, which decreased to 27 mmHg immediately after the procedure, with subsequent good recovery. Over a one-year follow-up period, all 15 patients demonstrated improvements in right ventricular indices. The Z-score of the tricuspid valve annulus significantly improved from -1.9±0.8 pre-operatively to -0.4±0.1 post-operatively ( t=6.88, P<0.001). At the last follow-up, mild to moderate pulmonary valve regurgitation was observed in 3 patients, and mild tricuspid regurgitation in 2 patients, with no cases of moderate or severe regurgitation. Conclusion:Intervention via antegrade venous-arterial loop for the treatment of CPS-IVS in neonates is safe and effective.

Objective:To investigate the feasibility of ductus arteriosus (DA) stent placement through femoral artery approach without guiding catheter.Methods:In this retrospective case study, the birth weight, intervention age, preoperative echocardiography, intraoperative angiography and other clinical data, as well as the follow-up status (Nakata index and final circulatory status, etc.) of 15 patients with congenital heart disease who are dependent on the DA for pulmonary circulation at Women and Children′s Hospital, Qingdao University between January 2018 to June 2023 were collected. All pediatric patients underwent placement of a DA stent without a guiding catheter, the efficacy and safety of this approach were analyzed.Results:Among all 15 cases, there were 9 males and 6 females, with the birth weight of (3.3±0.3) kg and the intervention age of (15.0±0.1) d. Of which, there were 9 cases of pulmonary atresia with intact ventricular septum (PA-IVS), and 6 cases of critical pulmonary stenosis (CPS) with intact ventricular septum. The tricuspid annulus diameter before intervention was (8.8±0.8) mm, and the tricuspid annulus Z-score was -0.7±0.9. There were 3 cases of mild right ventricular dysplasia, 9 cases of moderate dysplasia, and 3 cases of severe dysplasia. All patients successfully completed the intervention without major complications. The narrowest diameter of the DA was (2.2±0.1) mm, the diameter of the DA stent was (3.9±0.3) mm, the preoperative percutaneous oxygen saturation (SpO 2) was 0.83±0.03, and the postoperative SpO 2 was 0.96±0.02. The follow-up time was (7.0±0.5) months. The Nakata index was (163±30) mm 2/m 2 before intervention, and was (173±34) mm 2/m 2 at the last follow-up. Biventricular circulation was successfully achieved in 14 patients, and the other one patient currently under close observation. Conclusion:The placement of a ductus arteriosus stent through femoral artery retrogradely without guiding catheter could serve as an effective and safe plan for neonates with PA-IVS or CPS accompanied by hypoplastic right heart syndrome.

Objective:To evaluate the clinical characteristics and prognosis of transcatheter closure of secundum atrial septal defect (ASD) in infants.Methods:A retrospective analysis was conducted on 83 cases with secundum ASD who underwent transcatheter closure at the Women and Children′s Hospital of Qingdao University from January 2010 to December 2021. The clinical data included general information, pre- and post-operative echocardiography and electrocardiography, surgery records, and follow-up outcomes. The children who underwent successful occlusion were divided into two groups based on the presence or absence of pulmonary hypertension: the normal group and the pulmonary hypertension group. Differences between the two groups in terms of age, weight, right ventricular end-diastolic diameter, maximum ASD diameter, occluder size, and pulmonary-to-systemic flow ratio (Qp/Qs) were compared. Intergroup comparisons were performed using the Wilcoxon test.Results:Among the 83 infants with secundum ASD, 12 were males and 71 were females, with the age of (10.8±1.6) months. There were 29 cases (35%) with weight-for-age below the median level (less than the 25th percentile), 19 cases (23%) with recurrent or refractory pulmonary infections, and 40 cases (48%) with pulmonary hypertension. In this study, 81 cases (97%) successfully completed the procedure, while 2 cases failed due to soft defect margins. Postoperative arrhythmias occurred in 12 cases, of which 11 were transient arrhythmia; one case of atrioventricular block returned to normal rhythm after surgical removal of the occluder. The 81 infants who underwent successful occlusion were divided into normal group (41 cases) and pulmonary hypertension group (40 cases). The pulmonary artery systolic pressure, maximum diameter of ASD, the size of the occluder, and the cardiothoracic ratio were higher in the pulmonary hypertension group compared to those in the normal group, while the Qp/Qs value was lower (all P<0.05). Follow-up results indicated that infants with ASD who underwent transcatheter closure had no new arrhythmias, residual shunts, or intervention-related mortality. Within one year postoperatively, all infants exhibited normalization of right ventricular dimensions and pulmonary artery pressure. During a 3-year follow-up, all 29 cases that originally had a weight-for-age below the median level exhibited catch-up growth, reaching above the median level. Conclusions:Transcatheter closure for secundum ASD in infants is safe and feasible. Follow-up indicates that early transcatheter closure may be necessary for larger ASD diameters combined with pulmonary hypertension, with significant clinical improvement postoperatively.

Objective:To evaluate the efficacy of transnasal high-flow humidified oxygen therapy in preventing hypoxemia in pediatric patients undergoing gastroscopy.Methods:In this prospective randomized controlled study, 226 pediatric patients, aged 6-12 yr, with a body mass index of 18-25 kg/m 2, of American Society of Anesthesiologists Physical Status classification Ⅰ or Ⅱ, undergoing painless gastroscopy at Women and Children′s Hospital of Qingdao University from February 2022 to August 2023, were selected and divided into 2 groups ( n=113 each) using the simple randomization method: normal nasal cannula oxygen therapy group (group N) and transnasal high-flow humidified oxygen therapy group (group H). Anesthesia was induced with intravenous nalbuphine hydrochloride 0.1 mg/kg and propofol 2 mg/kg, and gastroscopy was performed when the Modified Observer′s Assessment of Alertness/Sedation score reached 1. During the operation, group N inhaled oxygen 5 L/min through the nasal catheter; group H inhaled a mixture of air and oxygen through a transnasal high-flow humidified oxygen therapy system at 2 L·kg -1·min -1 (not exceeding 40 L/min), with FiO 2 of 40%. Primary outcomes were the occurrence of hypoxemia and the lowest SpO 2. Secondary outcomes included the requirement for airway interventions (jaw thrust, mask ventilation, endotracheal intubation) and incidence of adverse events (nasal dryness, laryngospasm, apnea, upper airway obstruction, abdominal distension, nausea and vomiting) and endoscopist′s satisfaction with the procedure. Results:A total of 214 patients finally completed the trial, with 106 in group N and 108 in group H. Compared with group N, the incidence of hypoxemia was significantly decreased (17.9% [19/106] versus 2.8% [3/108]), the lowest SpO 2 was increased, the requirement for jaw lifting interventions was reduced, the incidence of nasal dryness was decreased, and the degree of endoscopist′s satisfaction with the procedure was increased ( P<0.05), and no significant change was found in the other outcomes in group H ( P>0.05). Conclusions:Transnasal high-flow humidified oxygen therapy can effectively prevent hypoxemia and raise the safety of pediatric patients during the gastroscopy.

Objective:To evaluate the efficacy of transnasal high-flow humidified oxygen therapy in preventing hypoxemia in pediatric patients undergoing gastroscopy.Methods:In this prospective randomized controlled study, 226 pediatric patients, aged 6-12 yr, with a body mass index of 18-25 kg/m 2, of American Society of Anesthesiologists Physical Status classification Ⅰ or Ⅱ, undergoing painless gastroscopy at Women and Children′s Hospital of Qingdao University from February 2022 to August 2023, were selected and divided into 2 groups ( n=113 each) using the simple randomization method: normal nasal cannula oxygen therapy group (group N) and transnasal high-flow humidified oxygen therapy group (group H). Anesthesia was induced with intravenous nalbuphine hydrochloride 0.1 mg/kg and propofol 2 mg/kg, and gastroscopy was performed when the Modified Observer′s Assessment of Alertness/Sedation score reached 1. During the operation, group N inhaled oxygen 5 L/min through the nasal catheter; group H inhaled a mixture of air and oxygen through a transnasal high-flow humidified oxygen therapy system at 2 L·kg -1·min -1 (not exceeding 40 L/min), with FiO 2 of 40%. Primary outcomes were the occurrence of hypoxemia and the lowest SpO 2. Secondary outcomes included the requirement for airway interventions (jaw thrust, mask ventilation, endotracheal intubation) and incidence of adverse events (nasal dryness, laryngospasm, apnea, upper airway obstruction, abdominal distension, nausea and vomiting) and endoscopist′s satisfaction with the procedure. Results:A total of 214 patients finally completed the trial, with 106 in group N and 108 in group H. Compared with group N, the incidence of hypoxemia was significantly decreased (17.9% [19/106] versus 2.8% [3/108]), the lowest SpO 2 was increased, the requirement for jaw lifting interventions was reduced, the incidence of nasal dryness was decreased, and the degree of endoscopist′s satisfaction with the procedure was increased ( P<0.05), and no significant change was found in the other outcomes in group H ( P>0.05). Conclusions:Transnasal high-flow humidified oxygen therapy can effectively prevent hypoxemia and raise the safety of pediatric patients during the gastroscopy.

Objective:To evaluate the clinical efficacy of percutaneous balloon pulmonary valvuloplasty (PBPV) via antegrade venous-arterial loop in neonates with critical pulmonary stenosis with intact ventricular septum (CPS-IVS).Methods:A retrospective case review was conducted. Fifteen neonates with CPS-IVS who underwent PBPV via antegrade venous-arterial loop at the Women and Children′s Hospital, Qingdao University between September 2020 and September 2023 were included. Pre-and post-operative right ventricular functional parameters, surgical complications, and follow-up outcomes were analyzed. Paired-sample t-test was used to compare changes in right ventricular systolic pressure (RVSP), percutaneous oxygen saturation (SpO 2), and echocardiographic findings pre-and post-operatively, as well as during the follow-up period. Results:Among the 15 neonates (9 males and 6 females) with CPS-IVS, the surgical age was (3.6±0.5) d. All neonates underwent successful PBPV via antegrade venous-arterial loop under general anesthesia. The immediate post-operative trans-pulmonary valve pressure gradient was (35±6) mmHg (1 mmHg=0.133 kPa), with a significant reduction in RVSP from (96±16) mmHg to (59±14) mmHg ( t=6.70, P<0.001). SpO 2 (with an inspired oxygen concentration of 0.48) increased from 0.86±0.07 pre-operatively to 0.97±0.03 post-operatively ( t=4.81, P<0.001). One month postoperatively, SpO 2 (without oxygen supplementation) normalized in all patients, with a statistically significant difference compared to pre-operative values ( t=0.16, P<0.001). Immediately postoperative, mild to moderate diastolic pulmonary valve regurgitation was observed in 8 patients, with no cases of severe regurgitation. Additionally, the severity of tricuspid valve regurgitation decreased from severe to mild-to-moderate in 6 patients. Three months postoperatively, one patient underwent a second PBPV due to an increased trans-pulmonary valve pressure gradient of 74 mmHg, which decreased to 27 mmHg immediately after the procedure, with subsequent good recovery. Over a one-year follow-up period, all 15 patients demonstrated improvements in right ventricular indices. The Z-score of the tricuspid valve annulus significantly improved from -1.9±0.8 pre-operatively to -0.4±0.1 post-operatively ( t=6.88, P<0.001). At the last follow-up, mild to moderate pulmonary valve regurgitation was observed in 3 patients, and mild tricuspid regurgitation in 2 patients, with no cases of moderate or severe regurgitation. Conclusion:Intervention via antegrade venous-arterial loop for the treatment of CPS-IVS in neonates is safe and effective.

Objective:To investigate the feasibility of ductus arteriosus (DA) stent placement through femoral artery approach without guiding catheter.Methods:In this retrospective case study, the birth weight, intervention age, preoperative echocardiography, intraoperative angiography and other clinical data, as well as the follow-up status (Nakata index and final circulatory status, etc.) of 15 patients with congenital heart disease who are dependent on the DA for pulmonary circulation at Women and Children′s Hospital, Qingdao University between January 2018 to June 2023 were collected. All pediatric patients underwent placement of a DA stent without a guiding catheter, the efficacy and safety of this approach were analyzed.Results:Among all 15 cases, there were 9 males and 6 females, with the birth weight of (3.3±0.3) kg and the intervention age of (15.0±0.1) d. Of which, there were 9 cases of pulmonary atresia with intact ventricular septum (PA-IVS), and 6 cases of critical pulmonary stenosis (CPS) with intact ventricular septum. The tricuspid annulus diameter before intervention was (8.8±0.8) mm, and the tricuspid annulus Z-score was -0.7±0.9. There were 3 cases of mild right ventricular dysplasia, 9 cases of moderate dysplasia, and 3 cases of severe dysplasia. All patients successfully completed the intervention without major complications. The narrowest diameter of the DA was (2.2±0.1) mm, the diameter of the DA stent was (3.9±0.3) mm, the preoperative percutaneous oxygen saturation (SpO 2) was 0.83±0.03, and the postoperative SpO 2 was 0.96±0.02. The follow-up time was (7.0±0.5) months. The Nakata index was (163±30) mm 2/m 2 before intervention, and was (173±34) mm 2/m 2 at the last follow-up. Biventricular circulation was successfully achieved in 14 patients, and the other one patient currently under close observation. Conclusion:The placement of a ductus arteriosus stent through femoral artery retrogradely without guiding catheter could serve as an effective and safe plan for neonates with PA-IVS or CPS accompanied by hypoplastic right heart syndrome.

Objective:To evaluate the clinical characteristics and prognosis of transcatheter closure of secundum atrial septal defect (ASD) in infants.Methods:A retrospective analysis was conducted on 83 cases with secundum ASD who underwent transcatheter closure at the Women and Children′s Hospital of Qingdao University from January 2010 to December 2021. The clinical data included general information, pre- and post-operative echocardiography and electrocardiography, surgery records, and follow-up outcomes. The children who underwent successful occlusion were divided into two groups based on the presence or absence of pulmonary hypertension: the normal group and the pulmonary hypertension group. Differences between the two groups in terms of age, weight, right ventricular end-diastolic diameter, maximum ASD diameter, occluder size, and pulmonary-to-systemic flow ratio (Qp/Qs) were compared. Intergroup comparisons were performed using the Wilcoxon test.Results:Among the 83 infants with secundum ASD, 12 were males and 71 were females, with the age of (10.8±1.6) months. There were 29 cases (35%) with weight-for-age below the median level (less than the 25th percentile), 19 cases (23%) with recurrent or refractory pulmonary infections, and 40 cases (48%) with pulmonary hypertension. In this study, 81 cases (97%) successfully completed the procedure, while 2 cases failed due to soft defect margins. Postoperative arrhythmias occurred in 12 cases, of which 11 were transient arrhythmia; one case of atrioventricular block returned to normal rhythm after surgical removal of the occluder. The 81 infants who underwent successful occlusion were divided into normal group (41 cases) and pulmonary hypertension group (40 cases). The pulmonary artery systolic pressure, maximum diameter of ASD, the size of the occluder, and the cardiothoracic ratio were higher in the pulmonary hypertension group compared to those in the normal group, while the Qp/Qs value was lower (all P<0.05). Follow-up results indicated that infants with ASD who underwent transcatheter closure had no new arrhythmias, residual shunts, or intervention-related mortality. Within one year postoperatively, all infants exhibited normalization of right ventricular dimensions and pulmonary artery pressure. During a 3-year follow-up, all 29 cases that originally had a weight-for-age below the median level exhibited catch-up growth, reaching above the median level. Conclusions:Transcatheter closure for secundum ASD in infants is safe and feasible. Follow-up indicates that early transcatheter closure may be necessary for larger ASD diameters combined with pulmonary hypertension, with significant clinical improvement postoperatively.

Objective:Postoperative venous obstruction (PVO) is the most severe complication of total anomalous pulmonary venous connection (TAPVC), and facing challenging re-intervention with high mortality. We aimed to review and analyze the follow-up and management of postoperative PVO in our center.Methods:We conducted a retrospective study of the patients with isolated TAPVC admitted in our center from October 2013 to October 2019. All available data and images of PVO patients were reviewed, such as the initial perioperative medical records, patients’ follow-up records, results of patients’ echo and CT angiography. Re-intervention including hybrid technique, sutureless technique, and patch augmentation, were carried out for postoperative PVO patients. The results were reviewed and analyzed to find the risk factors for adverse prognosis.Results:A series of 174 isolated TAPVC patients were admitted in our center and 169 received surgical treatment and 26 (26/169, 15.4%) had postoperative PVO. The diagnosis was made at a median time of 11.5 (0-77) weeks after initial operation and within 6 months of surgery in 22 (22/26, 84.6%) of the 26 patients. The subtype of TAPVC patients with postoperative PVO were: supracardiac 11 cases (11/26, 42.3%), cardiac 7 cases (7/26, 26.9%), infracardiac 5 cases (5/26, 19.2%), and mixed 3 cases (3/26, 11.5%). Bilateral obstruction and stenosis with diffusely small pulmonary veins were in 12 (12/26, 46.2%) and 3 cases (3/26, 11.5%) respectively. PVO progressed to worse condition in all the 26 cases during follow-up period. 8 (8/26, 30.8%) postoperative PVO patients underwent 10 re-interventions: one cases had 3 re-interventions. Five-year survival for patients with postoperative PVO was worse than those without postoperative PVO ( HR=6.46, 95% CI: 2.34-17.85, P<0.01). Risk factors for death or re-intervention in postoperative PVO patients were earlier presentation after TAPVC repair ( HR=0.85, 95% CI: 0.73-0.99, P=0.04) and an increased number of lung segments affected by obstruction ( HR=1.74, 95% CI: 1.01-2.99, P=0.04). Conclusion:Risk factors for death or re-intervention in postoperative PVO patients were earlier presentation after TAPVC repair and an increased number of lung segments affected, which should be focused on during strict follow-up period. Early re-intervention should be taken before irreversible secondary changes occur in these patients.

OBJECTIVE： To systematically evaluate therapeutic efficacy of modified Cangfu daotan decoction （MCDD） combined with chemical medicine versus chemical medicine alone in the treatment of polycystic ovarian syndrome （PCOS）， and to provide evidence-based reference for clinical decision. METHODS： Retrieved from PubMed， Embase， Cochrane Library， CJFD， Wanfang database， VIP and CBM， randomized controlled trials （RCTs） about MCDD combined with chemical medicine [ethynestradiol cycloprogesterone （Diane-35）， clomiphene， metformin] （trial group） versus chemical medicine alone （control group） in the treatment of PCOS were collected. After data extraction and quality evaluation with Cochrane 5.1.0 bias risk evaluation tool and Jadad scale， Meta-analysis was conducted for total response rate， serum hormone level （FSH， LH， LH/FSH， testosterone）， BMI， ovulation rate and physical signs （hirsutism， acne） by using Stata 14.0 software. Trial sequential analysis（TSA）was conducted by using TSA 0.9 software. RESULTS： A total of 20 RCTs were included， involving 1 484 patients. Results of Meta analysis showed that total response rate [RR＝1.13，95％CI （1.02，1.24），P＜0.05]， serum hormone level {FSH [WMD＝－0.59，95％CI（－0.98，－0.20），P＜0.05]，LH [WMD＝－0.95，95％CI（－1.41， －0.52），P＜0.05]，LH/FSH [WMD＝－1.04，95％CI（－1.78，－0.33），P＜0.05]，testosterone [WMD＝－0.93，95％CI（－1.38，－0.28），P＜0.05]}， BMI [SMD＝－1.01，95％CI  （－1.76，－0.27），P＜0.05]， ovulation rate [RR＝1.17，95％CI（1.02，1.34），P＜0.05] and physical signs {hirsutism [WMD＝－0.48，95％CI（－0.86， －0.10），P＜0.05]， acne [WMD＝－1.16，95％CI（－1.56，－0.75），P＜0.05]} of trial group were all better than those of control group， with statistical significance. TSA showed that there are reliable evidences for MCDD combined with chemical medicine in the treatment of PCOS. CONCLUSIONS： Versus chemical medicine alone in the treatment of PCOS， MCDD combined with chemical medicine can improve total response rate and ovulation rate， reduce serum hormone levels， BMI and physical signs.