Objective To explore the effect of pulmonary arterial hypertension on the children with functional single ventricle in the early period after Fontan operation. Methods Forty-three children with pulmonary arterial hypertension after Fontan operation were enrolled in our department between January 2015 and December 2016. There were 24 males and 19 females at a median age of 4.3 years ranging from 2.5 to 4.8 years. The pulmonary arterial pressure was evaluated by cardiac catheterization. There were 23 children diagnosed without pulmonary hypertension (a non-PAH group) including 16 males and 7 females, while 20 patients were diagnosed with pulmonary hypertension (a PAH group) including 8 males and 12 females. Postoperative parameters related to outcomes were compared between the two groups. Results There was no death in the non-PAH group, but the mortality of children in the PAH group was 20.0% (4/20, χ2=5.34, P=0.02). The central venous pressure (t=–2.50, P=0.02), N-terminal prohormone of brain natriuretic peptide (NT-proBNP, Z=–3.50, P<0.01), peritoneal dialysis rate (χ2=5.40, P=0.02), incidence of arrhythmia (χ2=4.40, P=0.03) in the PAH group were significantly higher than those of the non-PAH group. The early postoperative utilization rate of pulmonary vascular targeting agents in the PAH group was significantly higher than that in the non-PAH group (χ2=6.30, P=0.04). Conclusion Pulmonary arterial hypertension is one of the most important factors which influence the early postoperative prognosis of children with functional single ventricle after Fontan operation.
Digital health technology implementation has grown rapidly in recent years. To standardize the quality of digital health implementation research and increase the transparency and integrity of reporting, Perrin published iCHECK-DH: guidelines and checklist for the reporting on digital health implementations in 2023. This article interprets the contents of the list with a view to improving the reporting quality of digital implementation studies to develop more effective digital health interventions and achieve better health outcomes.
Objective To developapatient-reported outcomes scale of chronic obstructive pulmonary disease used for Chinese, thus offering tools for clinical efficacy assessment. Methods According to the development standard of International Patient-Reported Outcomes, the item pool was established and the preliminary scale was prepared. Then, 100 patients with chronic obstructive pulmonary disease and 50 healthy subjects were face-to-face interviewed with preliminary scale by well-trained investigators.Those copies were collected, surveys were analyzed and items were selected with 5 methods including measure of discrete tendency method, factor analysis, correlation coefficient method, Cronbach’s alpha coefficient method and item response Theory. Finally, the final scale was gained. Results The eventual scale contains 4 areas(physiological dimain, psychological dimension, social dimension, treatment), 11 dimensions(specific symptoms, general symptoms, individual, anxiety, depression, disease cognization, disease influence on social pctivity, social support, compliance, drug adverse reaction, satisfactory), and 52 items. Conclusion The ultimate scale coincides with the theoretical framework and reflects the connotation of the quality of life of patients with chronic obstructive pulmonary disease.
Objective To observe the clinical outcomes of Hangman fracture treated by anterior cervical discectomy and fusion. Methods A total of 41 patients with Hangman fracture were retrospectively analyzed, who underwent anterior cervical discectomy and fusion from May 2010 to May 2016. Intervertebral bone graft fusion was observed through postoperative radiographic images, and improvement of symptoms was evaluated by Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Modified Japanese Orthopaedic Association Scale (m-JOA). Surgical complications were evaluated as well. Results No severe complications occurred after surgery, but 5 patients had a transient dysphagia, which relieved spontaneously. Thirty-five patients had a fusion of intervertebral bone graft 3 months after surgery, and the remaining 6 patients did at the last follow-up. The VAS score was improved from 4.5±1.6 pre-operatively to 2.4±1.7 immediately post-operatively (P>0.05), and was further improved to 0.7±0.9 at the last follow-up (P<0.05). The NDI score was improved from 29.3±10.9 pre-operatively to 13.2±5.4 immediately post-operatively (P<0.05), and was further improved to 4.6±3.1 at the last follow-up (P<0.05). The m-JOA score was improved from 8.4±2.3 pre-operatively to 11.6±3.5 immediately post-operatively (P<0.05), and was further improved to 14.3±2.0 at the last follow-up (P<0.05). Conclusion Anterior cervical discectomy and fusion can be used in Hangman fracture, which is safe and reliable.
Objective To investigate the clinical efficacy of minimally invasive mitral valvuloplasty (MVP) in the treatment of infective endocarditis (IE) with mitral regurgitation (MR). Methods A retrospective analysis was conducted on the clinical data of patients who underwent MVP for IE with MR in the Department of Cardiovascular Surgery at Zhongshan Hospital, Fudan University from January 2016 to December 2020. Patients were divided into two groups based on the surgical incision: those with a right mini-thoracotomy were classified as a minimally invasive surgery (MIS) group, and those with a median sternotomy were classified as a median sternotomy (MS) group. All patients had isolated mitral valve involvement. Perioperative data were analyzed, and mid- to long-term outcomes were compared between the two groups. Results A total of 86 patients were included, with 40 in the MIS group (22 males and 18 females, with a mean age of 39±15 years ranging from 8 to 71 years) and 46 in the MS group (27 males and 19 females, with a mean age of 49±16 years ranging from 14 to 71 years). The patients in the MIS group were relatively younger (P=0.004) with better preoperative cardiac function (P=0.004). There was no statistical difference in preoperative fever, gender, or comorbidities between the two groups (P>0.05). The MIS group had shorter postoperative ventilation times, less postoperative 24-hour drainage, less blood transfusion, and shorter total hospital stays compared to the MS group (P=0.001, 0.018, 0.005, 0.005). There was no statistical difference in cardiopulmonary bypass times or ICU stays between the two groups (P>0.05). The perioperative complication rates and mortality rates were not significantly different between the two groups (P>0.05). Follow-up was conducted for 11-92 months, with a mean duration of 49±19 months and an overall follow-up rate of 91.6%. During the follow-up, 3 patients in each group required reoperation for mitral valve issues, with no statistical difference in incidence (7.5% vs. 6.5%, P=0.691). There were no warfarin-related complications, recurrences, or deaths in either group during follow-up. Multivariate regression analysis identified age, preoperative cardiac function, and surgeon experience as influencing factors for the choice of surgical approach. Conclusion Minimally invasive MVP for IE with MR is relatively safe in the perioperative period and shows significant efficacy, with clear mid- to long-term outcomes. It is recommended for younger patients with better preoperative cardiac function and when performed by surgeons with extensive experience in mitral valvuloplasty.
ObjectiveTo evaluate the quality of protocols and reports on the core outcome set of traditional Chinese medicine (COS-TCM), and to provide some evidence for COS-TCM developers to carry out studies and improve the reporting quality and methodological quality during their studies. MethodsLiterature databases in Chinese and English were searched to collect COS-TCM protocols or study reports from inception to April 18, 2023. The Core Outcome Set-STAndards for Reporting (COS-STAR), Core Outcome Set-STAndards for Development (COS-STAD), and Core Outcome Set-STAndardised Protocol Items (COS-STAP) were used to evaluate their reporting and methodological quality. Additionally, the consistency of studies with both published protocols and results was evaluated. ResultsA total of 14 protocols and 14 reports (involving 23 COS-TCM studies) were included. The evaluation of COS-TCM protocols according to the COS-STAP found that the reporting rates of "Stakeholders" (71.4%) and "Missing data" (42.9%) were relatively low. For the reports of COS-TCM, the evaluation based on the COS-STAD found that the reporting rates of "the population (s) covered by the COS" (35.7%) and "care was taken to avoid ambiguity of language used in the list of outcomes" (28.6%) were relatively low. Based on the COS-STAR, the items with low reporting rates were "Protocol Deviation" (7.1%), "Participants" (21.4%), and "Conflicts of interest" (28.6%). Additionally, the consistency evaluation found that there were inconsistencies between protocols and their results, such as the types of research included in the systematic review, the methods of qualitative research, the way of holding consensus meetings, scoring methods, etc. Moreover, only one study reported protocol deviation and reasons for change. ConclusionCOS-TCM studies need to improve their methodological quality and report transparency. When developing COS-TCM, we should pay attention to the characteristics of TCM while basing on international standards. The quality evaluation guidelines and standards of reporting for COS-TCM study need to be developed in the future.
Objective To summarize and analyze the preliminary clinical outcomes of the KokaclipTM transcatheter edge-to-edge mitral valve repair system for severe degenerative mitral regurgitation (DMR). Methods This study was a single-arm, prospective, single-group target value clinical trial that enrolled patients who underwent the KokaclipTM transcatheter edge-to-edge repair (TEER) system for DMR in the Department of Heart Surgery of Guangdong Provincial People's Hospital, Guangdong Cardiovascular Institute from June 2022 to January 2023. Differences in the grade of mitral regurgitation (MR) during the perioperative and follow-up periods were compared, and the incidences of adverse events such as all-cause death, thoracotomy conversion, reoperation, and severe recurrence of MR during the study period were investigated. Results The enrolled patient population consisted of 14 (50.0%) females with a mean age of 70.9±5.4 years. Twenty-eight (100.0%) patients were preoperatively diagnosed with typeⅡ DMR, with a prolapse width of 12.5 (11.0, 16.1) mm, a degree of regurgitation 4+ leading to pulmonary venous reflux, and a New York Heart Association cardiac function class≥Ⅲ. All patients completed the TEER procedure successfully, with immediate postoperative improvement of MR to 0, 1+, and 2+ grade in 2 (7.1%), 21 (75.0%), and 5 (17.9%) patients, respectively. Mitral valve gradient was 2.5 (2.0, 3.0) mm Hg. Deaths, thoracotomy conversion, or device complications such as unileaflet clamping, clip dislodgement, or leaflet injury were negative. Twenty-eight (100.0%) patients completed at least 3-month postoperative follow-up with a median follow-up time of 5.9 (3.6, 6.8) months, during which patients had a mean MR grade of 1.0+ (1.0+, 2.0+) grade and a significant improvement from preoperative values (P<0.001). There was no recurrence of ≥3+ regurgitation, pulmonary venous reflux, reoperation, new-onset mitral stenosis, or major adverse cardiovascular events. Twenty-two (78.6%) patients’ cardiac function improved to classⅠorⅡ. Conclusion The domestic KokaclipTM TEER system has shown excellent preliminary clinical results in selected DMR patients with a high safety profile and significant improvement in MR. Additional large sample volume, prospective, multicenter studies, and long-term follow-up are expected to validate the effectiveness of this system in the future.
Objective To review recent advancement of the relationship between obesity and gastric cancer. Method We searched PubMed, Medline, EMBASE, Cochrane Library databases, CNKI, and WanFang database for recent clinical trials about the impact of obesity on occurrence, surgery outcomes, and prognosis of gastric cancer. Results Obesity significantly increased the risk of adenocarcinoma of esophagogastric junction (AEG), increased difficulty in radical operation of gastric cancer and complications of perioperative period, but it had no effect on the long-term operative outcomes. The association between obesity and the survival of gastric cancer was not clear. However, the better survival was observed in most researches of gastric cancer patients with excess body weight. Conclusions The relationship between obesity and gastric cancer is very complex, and there is no consistent conclusion. A reasonable body weight by a healthy lifestyle is expected to decline the incidence of AEG.
ObjectiveTo compare the efficacy and safety of mitral valvuloplasty via minimally invasive approach with those of mitral valvuloplasty via traditional median sternotomy.MethodsA total of 1 221 patients undergoing mitral valvuloplasty from January 2015 to August 2018 in Guangdong Provincial People's Hospital were analyzed retrospectively, including 721 males and 500 females, with an average age of 47.2±15.1 years. According to the different surgical methods, they were divided into a study group (n=654), who received mitral valvuloplasty via the totally thoracoscopic approach, and a control group (n=567), who received mitral valvuloplasty via traditional median sternotomy. Clinical data, surgical results, and perioperative outcomes of the two groups were compared.ResultsThere was no significant difference in preoperative general data between the two groups (P>0.05). Compared with the control group, the study group had longer cardiopulmonary bypass time and aortic cross-clamping time (146.7±42.4 min vs. 122.7±30.6 min, 96.2±32.7 min vs. 78.3±23.8 min, both P=0.000), and shorter total operation time (227.4±55.3 min vs. 238.1±56.4 min, P=0.001). There was no significant difference in the incidence of secondary cross-clamping and mitral valve replacement between the two groups (3.7% vs. 2.6%, P=0.312; 1.7% vs. 1.4%, P=0.690). The blood transfusion rate and the incidence of respiratory tract infection and postoperative poor wound healing were lower (13.0% vs. 24.5%, 2.1% vs. 18.0%, 1.5% vs. 5.3%, all P=0.000) and the postoperative hospital stay was shorter (6.2±4.4 d vs. 11.5±8.8 d, P=0.000) in the study group. There was no significant difference in hospitalization expense between the two groups (95 847.9±31 322.0 yuan vs. 99 673.1±47 930.3 yuan, P=0.149). Within 30 d after surgery, 1 patient died in the study group and 4 patients died in the control group. Before discharge, there were 4 and 5 patients with severe mitral valve regurgitation in the study group and the control group, respectively.ConclusionCompared with mitral valvuloplasty via traditional median sternotomy, minimally invasive mitral valvuloplasty is superior in shortening operation time and postoperative hospital stay, lowering blood transfusion rate, and reducing postoperative complications, which can achieve better clinical outcomes.
Sample size, mean and standard deviation are necessary when conducting meta-analysis for continuous outcomes. Advanced methods of data extraction were needed if the mean and the standard deviation couldn’t be obtained from a literature directly. Eight methods were introduced and two examples were given to illustrate how to apply the methods.