To present the short-term clinical trial outcome of the Med-Zenith pulmonary valve in treating postoperative pulmonary regurgitation in children with congenital heart disease.

Between January 2021 and March 2023, prospective screening of children with moderate to severe pulmonary regurgitation in Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University. The anatomy of right ventricular outflow tract, left and right ventricular volumes and pulmonary regurgitation fraction were evaluated by cardiac tomography angiography and cardiac magnetic resonance imaging (MRI). For patients who met the inclusion criteria, Med-Zenith pulmonary valve was implanted. During acute and short-term follow-up, the function of the Med-Zenith pulmonary valve, ventricular volume and complications were assessed. Inclusion criteria: ①Age ≥ 10 years or weight ≥ 25 kg. ②New York Heart Association (NYHA) functional class Ⅱ or above, accompanied by moderate to severe pulmonary regurgitation measured by echocardiography or a pulmonary regurgitation fraction ≥30% measured by magnetic resonance imaging.

A total of 13 patients with severe pulmonary regurgitation postoperative underwent successful implantation of Med-Zenith pulmonary valve. Among these patients, boys accounted for 61.5% (8/13). Mean age and mean weight at implantation were (14.5±2.1) years and (50.3±7.9) kg, respectively. After a median follow-up of 12.0 (12.0,24.0) months, all patients were clinically stable. All patients showed trivial or mild pulmonary regurgitation by echocardiography, and no paravalvular leakage was observed. Mean peak systolic pulmonary artery gradient was not significantly different from that before operation [(15.7±8.3) mmHg vs. (13.8±5.6) mmHg, P=0.429]. Mean right ventricular end-diastolic volume index, mean right ventricular end-systolic volume index and mean pulmonary artery regurgitation fraction by MRI were significantly decreased [(129.7±24.1) ml/m² vs. (197.7±18.9) ml/m², P<0.001; (129.7±24.1) ml/m² vs.(197.7±18.9) ml/m²,P<0.001;(6.4±6.0) % vs. (54.8±8.3) %, P<0.001]. Mean left ventricular end-diastolic volume index, the left ventricular end-systolic volume index was significantly increased [ (94.8±14.2 ml/m² vs. (88.4±9.6) ml/m², P=0.046; (49.2±18.5) ml/m² vs. (39.7±9.2) ml/m², P=0.025]. X-ray examination showed no fracture, displacement or deformation of the device. There was no serious device-related adverse event.

Med-Zenith pulmonary valve is safe and easy to treat pulmonary artery regurgitation after surgery in children with congenital heart disease. At a median follow-up of 1 year, 100% of the patients had mild or less valvular regurgitation, and no paravalvular leak was observed. The cadiac function of patients improved and the left and right ventricular volume indexes also significantly improved.

To evaluate the efficacy and safety of combining targeted pulmonary hypertension drugs with subsequent defect closure (Treat and Repair strategy) in clinical application.

Patients with severe pulmonary hypertension associated with congenital heart disease (CHD-PAH) who had completed right cardiac catheterization (RHC) were retrospectively enrolled in Affiliated Hospital of Xuzhou Medical University from January 2017 to October 2022. All patients were treated with targeted drugs ,and were divided into surgical groups and non-surgical groups according to whether the defect was closed after treatment. Heart function [World Health Organization (WHO)], 6-minite walking distance (6MWD), N-terminal pro-brain natriuretic peptide (NT-proBNP), right atrial diameter, pulmonary artery systolic pressure (echocardiography measurement, PASP_E), pulmonary vascular resistance (PVR), pulmonary artery systolic pressure (RHC measurement, PASP_c), pulmonary flow to systemic flow ratio (Qp/Qs) and other relevant indicators were compared between the two groups, and before and after targeted drug therapy. Logistic regression analysis was used to analyze the related factors affecting whether the patients could close the defect safely. The receiver operating characteristic (ROC) curve was used to analyze the value of each index in predicting whether the patient could safely close the defect.

A total of 41 patients were included, including 16 patients in the surgical group and 25 patients in the non-surgical group. At initial diagnosis, the mean pulmonary artery pressure (mPAP) and PVR in the surgery group were lower than those in the non-surgery group (P=0.011, P<0.001,respectively), and Qp/Qs was higher than that in the non-surgery (P=0.011). After targeted drug therapy, compared with before treatment, there was no statistically significant difference in right ventricular diameter between the two groups (P>0.05). Heart function (WHO) was improved, 6MWD was higher than before treatment, NT-proBNP, right atrial diameter and PASP_E were lower than before treatment (P<0.05). Compared with the initial diagnosis, PVR decreased in the operation group (5.52 WU vs. 4.03 WU, P<0.05) and PVR in the non-operation group (12.80 WU vs. 11.59 WU, P<0.05). Multivariate Logistic regression analysis showed that PVR was an independent predictor of closure after "Treat and Repair"strategy (OR=0.557, 95%CI 0.339-0.914, P=0.020). ROC curve analysis showed that PVR had the largest area under the curve (AUC=0.872, 95%CI 0.762-0.983, P<0.001), truncation value was 7.09, corresponding sensitivity was 75.0%, specificity was 92.1%.

According to previous indications, some patients with severe CHD-PAH who lost the opportunity for surgery could successfully close the defect by using the strategy of "Treat and Repair". Baseline PVR was an independent predictor of successful closure of the defect after "Treat and Repair". The cut-off value of baseline PVR was 7.09 WU. Targeted drugs can improve cardiac function and exercise tolerance in patients with severe CHD-PAH.

To evaluate the efficacy, safety, and prognostic regression of occlusion therapy for patent foramen ovale (PFO).

PFO patients who underwent interventional closure treatment in the Department of Cardiology, Xiangyang Central Hospital from July 2018 to September 2022 were included. Preoperative evaluations included transthoracic echocardiography (TTE), contrast transthoracic echocaidiography of right heart (cTTErr), transesophageal echocardiography (TEE), and transcranial Doppler ultrasound bubble test (c-TCD). Follow-up evaluations were conducted at 1, 3, 6, and 12 months postoperatively using TTE, with additional c-TCD if necessary. Migraine patients recorded headache symptoms and the Headache Impact Test-6 scores before surgery and at 1, 3, 6, and 12 months after surgery.

A total of 783 PFO patients with age of (55.5±21.3) years, and 30.0% (235/783) male were involved. Seven hundred and twenty patients were successfully occluded with a success rate of 92.0% (720/783). Of these, 608 (77.7%, 608/783) patients were passed through the PFO using the conventional approach, and 112 (14.3%, 112/783) using the SWARTZ sheath. Intraoperative cardiac perforation occurred in 8 (1.0%, 8/783) patients, acute pericardiocentesis in 2 patients, and a small amount of pericardial effusion was left untreated in 6 patients. Postoperatively, 3 patients coughed up blood, including 1 case with a large amount of blood and the other 2 patients with a small amount of blood, all of which improved after 2 days. Postoperative follow-up was (33.8±3.6) months. During the follow-up, 633 (77.7%, 633/783) patients were found to have reached the cure standard, 14 (1.8%, 14/783) significantly relieved, and 32 (4.1%, 32/783) ineffective, with an overall effective rate of 89.9% (647/783). Among them, 18 (4.1%, 18/439) patients with migraine were ineffective, 4 (4.8%, 4/83) with syncope were ineffective, and 10 (9.4%, 10/106) with nonspecific symptoms were ineffective. There were no complications such as blocker dislodgement, severe arrhythmia, femoral arteriovenous fistula, etc. during the perioperative period and up to 5-year follow-up. Forty eight patients had no relief or partial relief of their original symptoms after 6 months of follow-up. Their cTTErr was reviewed, and they still had residual right to left shunt. Tracing the patients' preoperative TTE or TEE suggested that the patients had thin peripheral margins of the foramen ovale (peripheral periphery of the foramen ovale was not visualized in the subxiphoid biatrial view) or combined with atrial septal aneurysm.

Patients with PFO undergoing occlusion therapy have fewer serious complications and a high rate of surgical success. Standardized preoperative evaluation is of utmost importance to improve the degree of symptomatic improvement and reduce complications in patients. There is a need to develop new types of patent foramen ovale occluders to improve the effectiveness of occlusion.

To identify various pacing modalities of different interventricular septum and evaluate their electrophysiological characteristics using continuous pacing and recording technique.

All of the patients with symptomatic bradycardia were consecutively enrolled from April 2021 to September 2023, and attempted to do left bundle branch (LBB) pacing (LBBP) in Ningbo No.2 Hospital using continuous pacing and recording technique. In the standard 12-lead electrocardiogram and intracardiac electrocardiogram, stimulus to V₆ R wave peak time (Stim-V6RWPT), stimulus to V₁ R wave peak time, stimulus to QRS end duration (Stim-QRSd), and V₆-V₁ interpeak were documented and compared during implantation, which was divided into right ventricular septal pacing (RVSP), intraventricular septal pacing (IVSP1 and IVSP2), left ventricular septal pacing (LVSP), non-selective LBBP (NSLBBP), and selective LBBP (SLBBP).

Eighty-three point four percent (201/241) patients with six pacing modality transitions were included, (74.1±9.7) years old, and 115 (57.2%, 115/201) of them were male. The Stim-V6RWPT of NSLBBP and SLBBP were significantly shorter than RVSP, IVSP1 and IVSP2 [(68.8 ± 8.7) ms vs. (68.3 ± 8.8) ms vs. (104.5±10.3) ms, vs. (90.6±13.0) ms, vs. (82.2 ± 10.3) ms, P＜0.001]. Stim-QRSd was the narrowest in IVSP2 [(134.3 ± 14.8) ms] instead of NSLBBP [(137.4 ± 16.4) ms].

It is feasible to distinguish various pacing modalities at different interventricular septum using uninterrupted pacing technique. Electrophysiological evidence from our study shows that the characteristics of these six pacing modalities are different, especially LBBP and LVSP. Therefore, LBBP and LVSP should not be brought under the LBB area pacing umbrella.