This retrospective study was reviewed and approved by Human Research Ethics Committee of Sichuan Provincial People’s Hospital (No. 2021216) and conducted in accordance with the relevant guidelines and regulations of Declaration of Helsinki. The patients who were diagnosed as mitral valve disease or secundum ASD/PFO between May 2013 and May 2021 in Sichuan Provincial People’s Hospital were reviewed and informed consent was waived. All the included patients were above 18 years old and covered by Sichuan registration medical insurance. The etiologies on mitral valve of the selected cases included congenital, rheumatic and degenerative. However, if concomitant with more complex procedures such as other anomalies rectification, tumor removal, aortic valve or artery procedure, surgical atrial fibrillation radiofrequency ablation, coronary artery bypass grafting or emergency condition, the cases were screened out. The occlusion procedure was completed by transjugular transcatheter intervention using homemade device only under the surveillance of transesophageal echocardiography (TEE). The cases were also excluded out if the closure procedure failed and then converted to open repair. Other exclusion criteria included the conditions which have an impact on systemic inflammation, such as infection disease (infective endocarditis, active rheumatism), immunological disease (Behcet's disease, Takayasu's arteritis).
The subjects were classified into three groups based on the ratio of the medical insurance imbursement to the total hospitalized medical expenses for mitral valve procedure: group A-low coverage, less than 30%, typically covered by off-site new rural cooperative medical insurance with high out-of-pocket payments; group B-medium coverage, less than 60% but more than 30%, usually represented by urban population and government employee medical insurance, and group C-high coverage, more than 60%, additionally commercial health insurance based on group A or group B. It is important to note that the occlusion device was not covered by any insurance type, which usually accounted for about 3/4 of total hospital expenses. Therefore, these patients correspond to low coverage (less than 30%) but with low expenses.
Anesthetic and operation scheme
All the included peoples received the homogeneous treatment and nursing care according to disease type. Anaesthesia was induced with midazolam, propofol, sufentanil, cisatracurium by endotracheal intubation and maintenance with propofol and sufentanil for mitral valve procedure. While, remifentanil replaced sufentanil for ASD occlusion procedure due to short half-time, if necessarily, with a low concentration of sevoflurane inhalation.
If necessarily, with a low concentration of sevoflurane inhalation, or remifentanil for ASD occlusion. All the patients receiving mitral valve procedure were conventionally transferred into intensive care unit (ICU) and then to general ward after surgical procedure. TEE-guided transcatheter ASD/PFO closure was completed via right jugular vein with dumbbell-shaped occlude device (Lifetech company, Beijing, China). These patients were extubated endotracheal tube after restoring to self-consciousness and transferred back to the surgical ward.
Systemic inflammatory reaction indexes and other biomarkers
Blood samples were regularly drawn at the next dawn after the admission date, 12, 24, and 48 h after procedure for monitoring the postoperative conditions, from which the level of highly sensitive C-reactive protein (hs-CRP) was acquired, and the neutrophil–lymphocyte ratio (NLR) was calculated by dividing the absolute value of peripheral neutrophil by lymphocyte from complete blood count tests . The troponin I (TnI) protein level was also collected at the same time-points. The artery blood gas was conventionally analyzed at the average interval of 8 h in the first 24 h postoperatively. The data on the lactate level was acquired from blood gas analysis record. The monitoring management for TnI was not requisite for ASD occlusion because severe coronary artery stenosis was excluded preoperatively out by coronary artery angiography if suspected. The detection results of the serum level of lactate after ASD occlusion was sporadic and almost of all were in normal limits.
Clinical outcome measurements
Information on basic medical reimbursement status was collected from the final updated version in medical software system after the patient was discharged from the hospital. The additional insurance condition was enquired on the interviews at least one month after the hospitalization to ensure additional reimbursement results clear, including telephone conversation, internet consultation and conference participation .
The clinical data were collected from historical medical records, such as the durations of cardiopulmonary bypass (CPB), aortic cross-clamping (ACC) and the procedure administration, mechanical ventilation time, thoracic drainage volume, and the length of ICU and hospital stay .
All statistical tests were two-tailed and associations were considered statistically significant if p ≤ 0.05 with SPSS software (version 17.0; SPSS Inc., Chicago, IL, USA). The distribution of data was assessed graphically (i.e., histograms), depending of normality, continuous variables were compared using the repeated measures ANOVA with post hoc comparisons to evaluate any significant effect of group or any significant interaction, differences between categorical variables were assessed using cross tabulation with chi-square analyses or the Fisher’s exact test. If there was no more than one piece of record missing in each item, a trend value was filled.