ObjectiveWe constructed a real-world evidence evaluation system to provide reference for obtaining high-quality evidence in evidence-based medicine.MethodsThrough the investigation and analysis of the key factors influencing the real-world research evidence, combined with domestic and foreign literature and evaluation tools, we preliminarily constructed the indicators of the real-world evidence evaluation system, then consulted experts in related fields by the Delphi method, modified and determined the final evaluation indicators. ResultsThe indicators of the final real-world evidence evaluation system included 40 items. The recovery efficiencies of the two rounds of expert consultation were 88.2% and 100%; The expert coordination coefficients were 0.174 (P<0.001) and 0.189 (P<0.001). After the second round of consultation, the mean of Likert scale in the range of 3.73~4.93, and the coefficient of variation varied in the range of 0.05~0.21. ConclusionThe real-world evidence evaluation system constructed in this study has certain reliability and scientificity, which can provide a basis and help for the transformation of real-world research into high-quality evidence.
Objective To investigate the effect and prognosis of patients with ventricular septal rupture after myocardial infarction treated by surgical repair combining an occluder and a patch. Methods Clinical data of 42 patients with myocardial infarction complicated with ventricular septal rupture admitted to the First Affiliated Hospital of Zhengzhou University from January 2010 to September 2021 were retrospectively analyzed. According to the surgical methods, 27 patients were divided into a traditional group, including 17 males and 10 females, with an average age of 62.81±6.81 years, who were repaired by patch only, and 15 patients were divided into a modified group, including 11 males and 4 females, with an average age of 64.27±9.24 years, who were repaired by surgery combining an occluder and a patch. Perioperative and follow-up data of the two groups were compared and analyzed.Results There were statistical differences between the two groups in preoperative Killip grading, rate of intra-aortic balloon pump use, interval from myocardial infarction to operation, and the number of culprit artery (P<0.05). There was no statistical difference in other preoperative data, the cardiopulmonary bypass time, aortic cross-clamping time, postoperative hospital stay or in-hospital death rate between the two groups (P＞0.05). No residual shunt occurred in the modified group, and the difference was statistically significant compared with the traditional group (P=0.038). There was no statistical difference in other complications between the two groups (P＞0.05). The median follow-up time was 4 years. Two patients in the traditional group and one in the modified group died during follow-up. The follow-up cardiac function grading of patients in the modified group was statistically different from that in the traditional group (P=0.023). Conclusion The perioperative mortality of ventricular septal rupture after myocardial infarction is high, but the long-term effect is satisfactory. Surgical repair combining an occluder and a patch is a safe and effective treatment for ventricular septal rupture, which can effectively reduce postoperative residual shunt.
Objective To preliminarily investigate the feasibility and clinical outcomes of percutaneous pulmonary valve implantation (PPVI) using a domestic self-expanding valve. Methods Patients with right ventricle outflow tract (RVOT) dysfunction after surgery for congenital heart disease who presented to Beijing Anzhen Hospital from March 2019 to July 2024 and were assessed to be suitable for PPVI via self-expanding valves were retrospectively analyzed. The patients underwent PPVI with either the PT-Valve or the Venus-P. Baseline, surgical, and imaging data were recorded and the patients were followed up. Results A total of 13 patients, including 4 males and 9 females, aged 14 to 55 years, were included. Initial congenital heart disease included tetralogy of Fallot (9 patients), right ventricular double outlet (1 patient), simple pulmonary stenosis (2 patients), and pulmonary atresia (1 patient). All patients underwent RVOT reconstruction with transannular patching. Indications for PPVI intervention included severe pulmonary stenosis with mild regurgitation (1 patient), severe regurgitation of the pulmonary valve (12 patients). PT-Valve was used in 9 patients, and Venus-P was used in 4. Valve implantation was successful in 13 patients, with no psevere erioperative complications. One patient with pulmonary stenosis was implanted with an overlay Cheatham-Platinum stent followed by PT-Valve valve implantation, and the postoperative result was satisfactory. Postoperative pulmonary and perivalvular regurgitation were mild or less, and the median peak flow velocity of the pulmonary valve was 1.32 m/s. At 3-month follow-up, the patient's NYHA classification improved significantly compared with the preoperative period, and the QRS wave width shortened compared with that of the preoperative period, the difference was statistically significant [(159.0±27.6) ms vs. (144.3±33.8) ms, P=0.005]. Ejection fraction and tricuspid annular plane systolic excursion increased, but the difference did not reach statistical significance. The patients had an increased postoperative left ventricular end-diastolic diameter, and the difference was statistically significant [(41.00±3.63) versus (44.77±5.12) mm, P=0.023]. Patients had a reduction in moderate or greater mitral regurgitation postoperatively, the difference was statistically significant. The difference in moderate or greater tricuspid regurgitation was not statistically significant. The follow-up time was (27.7±20.5) months, and no stent fracture or infective endocarditis occurred during the follow-up period; mild valve displacement occurred in one patient, and the remaining patients had good valve position. The patients' NYHA classification was class Ⅰ. Conclusion Domestic self-expanding valves for PPVI are feasible for the treatment of patients with RVOT dysfunction after surgery for congenital heart disease, and their safety and efficacy need to be further verified by studies with longer periods of time and larger sample sizes.