Clinical Evaluation And Critical Pathway Study Of Totally Thoracoscopic Closure Of Secundum Atrial Septal Defect

[Background and Objective]Atrial septal defect(ASD)is the third most common type of congenital heart disease,with an estimated incidence of 56 per 100 000 livebirths.Approximately 65-70%of patients have a secundum defect,of whom the ratio of females to males is approximately(2-3):1.Although traditional thoracotomy is safe and effective in the treatment of ASD,problems such as severe pain and large wounds are also obvious and have a great impact on the mental health of patients(especially female patients).On the basis of previous technical experience,in 2000,our hospital took the lead in carrying out the totally thoracoscopic closure of secundum ASD which cannot be treated through the transcatheter closure.Compared with traditional sternotomy,totally thoracoscopic closure has the advantages of avoiding the use of a steel wire,with less postoperative drainage and bleeding,less invasive incisions(the total length of the operation incisions was approximately 6-7 cm)and faster recovery,so that the quality of patients’ life is obviously improved.Up to now,there are less reports with large-scale and long-term follow-up outcomes for totally thoracoscopic closure of secundum ASD,and the least are the clinical studies focusing on children with difficult operation and cardiopulmonary bypass catheterization.In addition,there is still a lack of standard treatment procedure for totally thoracoscopic closure of ASD,which hinders the popularization of the treatment.The aim of this study was to evaluate the safety and efficacy of totally thoracoscopic closure of secundum ASD by analyzing single-center clinical data,combining survival analysis and cardiac outcome analysis,and to analyze the learning curve of this therapeutic modality through 15-year continuous sample data.What’s more,to establish the critical pathway of totally thoracoscopic ASD treatment with our center’s experience,and to analyze the current situation of the CHD critical pathway in China.[Methods]1)The therapeutic modality is totally thoracoscopic closure of secundum ASD,which can be combined by other cardiac procedures.2)Collect the data of patients undergoing surgery retrospectively.Through the establishment of strict inclusion,exclusion criteria,screening data that meet the requirements of the study3)All patients were followed up until May 2019.Data analysis was carried out by combining the telephone follow-up results with the doctor workstation results.Collect clinical data for each follow-up time point to complete the database4)Adverse events were ascertained at each assessment on the basis of clinical evaluation,and events were classified into major or minor adverse events.5)Categorical variables were analyzed with the χ2 test or Fisher’s exact test,and variance analysis was used for continuous variables.6)Freedom from adverse events was assessed by the Kaplan-Meier method.7)The CUSUM method was used for the learning curve.The curve is divided into three stages according to the slope change,and further analyzed will be discussed.8)Develop standard treatment process and critical pathway form of totally thoracoscopic ASD closure through reference to the existing ASD treatment critical pathway and clinical experience.[Results](Part 1)Inclusion of children patients aged 3 to 12 from 2000 to 2015(n=583)1)The cardiopulmonary bypass and aortic cross-clamp times were 65.2±32.7 min and 22.2±17.1 min,respectively.The length of stay in the intensive care unit was 24.4 ±14.2 h.2)The mean follow-up period was 52.5±40.0 months,and the incidence of major adverse events was 0.69%3)In terms of the learning curve,the first 86 cases represented the ascending part,and the cases after 302 constituted the descending part.After reaching the proficiency stage,several perioperative indicators were reduced by more than 50%.(Part 2)Inclusion of adult patients greater than or equal to 18 years of age from 2014 to 2015(n=152)1)All procedures were performed successfully.The cardiopulmonary bypass and aortic cross-clamp time was 77.66±40.65 and 25.89±17.64 minutes,respectively.The length of stay in the intensive care unit was 25.58±17.57 hours.2)The mean follow-up period was 47.11±3.59 months,and the incidence of major adverse events was 1.97%.3)The cardiac function grade(NYHA)decreased in 105 patients,accounting for 69.08%4)Standard treatment process and critical pathway form of totally thoracoscopic ASD closure were established.[Conclusions]1)Totally thoracoscopic closure was safe and effective in treating secundum ASD,whose benefits overweighed the risks.2)With the accumulation of experience,the perioperative indicators improved significantly and tended to be stable.The first 86 cases constitute the learning stage.3)There are still many problems in CHD critical pathway in China,which should be optimized from the aspects of digitalization,evaluation system,multi-disciplinary cooperation,variation management and so on.