Clinical comparison between interventional and surgical treatment of congenital heart disease

  The incidence of congenital heart disease (congenital heart disease) is 6‰-8‰, and about 150,000 newborns with congenital heart disease are born each year in China, and surgery used to be the main treatment method. Since 1966, Rushkind and Miller proposed the application of balloon catheter to perform atrial septal stoma for palliative treatment of complete transposition of the great arteries, interventional therapy began to enter the field of pediatric precocious heart disease. 1997, the Amplatzer blocker was widely used in clinical practice, bringing the interventional treatment of left-to-right shunt type of precocious heart disease into a new stage. It has good safety, easy operation, controllability and few complications. The main objectives of this study were to compare the similarities and differences between interventional and surgical treatment in terms of efficacy, cost, complications, blood transfusion and hospitalization time; to compare the effects of the two treatments on patients’ hemodynamics and cardiac function by echocardiography; and to compare the effects of the two treatments on reducing cardiac volume load by measuring cardiac natriuretic peptide (ANP).  Materials and methods Patients with a single left-to-right shunt type of precordial ventricular septal defect (VSD) or atrial septal defect (ASD) treated in our department from May to December 2004, with cardiac function grade I-II, no more than mild pulmonary hypertension, and no preoperative pneumonia or heart failure were selected. The patients were divided into interventional and surgical treatment groups according to the treatment method.  The inclusion criteria for the control group were gender- and age-matched children with no preexisting heart disease, no pneumonia and heart failure, no heart enlargement, and no infection during the same period.  The ASD diameter in the intervention group ranged from 9.0 to 27.0 mm, with a mean of (15.0±5.27) mm were all of type II hole; the ASD diameter in the surgical group ranged from 7.0 to 35.0 mm, with a mean of (22.85±8.77) mm (P<0.05) had 8 cases of type II hole, 4 cases of upper chamber type, and 1 case of lower chamber type; the VSD diameter in the intervention group ranged from 2.7 to 5.0 mm, with a mean of (4.43± In the interventional group, the VSD diameters ranged from 2.7 to 5.0 mm, with a mean of (4.43±0.88) mm for the membranes; in the surgical group, the VSD diameters ranged from 3.6 to 11.0 mm, with a mean of (7.25±2.77 mm) (P<0.01), with 15 cases of the membranes and perimembranes, 4 cases of the subdry type, and 3 cases of the subcrural type.  Main reagents: ANP kits were provided by Beijing Beifu Dongya Biotechnology Research Institute. Blood samples were collected preoperatively and 24 h postoperatively, respectively, and the determination of ANP: 2 mL of venous blood was routinely collected and anticoagulated with EDTA + peptidase, and the supernatant was stored at -20°C after centrifugation at 3,000 rpm within 30 min at 4°C. The determination was performed by radioimmunoassay (equilibrium method). Ultrasound instrumentation was HP7500 (SONO7500 from PHILIPS) with conventional sectioning.  Treatment: All interventional groups were treated with standard Amplatzer occlusion with local anesthesia for children, basic anesthesia for children <10 years old, and general anesthesia if intraoperative esophageal ultrasound was applied; the surgical group was treated with direct intracardiac surgery under general anesthesia with extracorporeal circulation to repair ASD or VSD. Statistical methods: SPSS11.5 software package was used for statistical processing. The data were compared with the surgical group by the t-test for two independent samples, the paired t-test for the comparison before and after treatment, the ANOVA for the comparison between the intervention group and the surgical group and the control group, and the χ2 test for the count data.  The success rate was 100% in 25 cases in the interventional group, and the success rate was 100% in 35 cases in the surgical group, all of whom underwent direct intracardiac surgery under extracorporeal circulation.  In the interventional group, one patient (4%) with ASD had a small residual shunt after blocking, and the color Doppler showed that the shunt bundle was 1 mm wide; in the surgical group, two patients (5.7%) with VSD had a small residual shunt after blocking, and the right atrial right ventricular internal diameter and left ventricular diastolic diameter (LVDD) were significantly reduced after treatment with both methods. Peak flow velocity was higher than before. In patients with VSD, the LVDD decreased and the E and A peak flow velocities and E/A decreased after treatment with both methods. The difference between interventional and surgical treatment groups was not significant (P>0.05).  No postoperative arrhythmias were found in the intervention group, while 2 cases of perioperative junctional tachycardia and 3 cases of right bundle branch block were found in the surgery group; there were no infectious complications in the intervention group and no incisional or systemic infections in the surgery group; no complications such as hemolysis or embolism occurred in either group. No blood was transfused in the intervention group and all blood was transfused in the surgery group, and the amount of blood transfused was 3.00±1.08 units of suspended red blood cells (each unit of suspended red blood cells was equivalent to the amount of red blood cells in 200 mL of whole blood) There was a significant difference between the 2 groups (P<0.01).  The postoperative hospital stay was significant in the interventional group (5.1±1.3) d and in the surgical group (7.5±1.2) d (P<0.01). The cost of treatment was significantly higher in the interventional group (45,235±10,204) and in the surgical group (21,010±1,907) (P<0.01); the cost of interventional treatment was significantly higher than that of surgery (P<0.01).  The preoperative ANP level in ASD patients was significantly higher in both groups than in the control group (P<0.01), and higher in the surgical group than in the interventional group (P<0.05); after surgery, there was a significant decrease in the surgical group compared with the preoperative group (P<0.01), and there was a decreasing trend in the interventional group compared with the preoperative group, and the difference was not significant.  The preoperative ANP levels in VSD patients were higher in the surgical group than in the control group (P<0.05), and higher in the interventional group than in the control group, but the differences were not significant; postoperatively, the interventional group showed a significant decrease compared with the preoperative group (P<0.05), and the surgical group showed a decreasing trend compared with the preoperative group, but the differences were not significant.  Discussion Amplatzer blocker intervention has the characteristics of high success rate, high controllability and easy to master, which are widely used in clinical practice. The comparison of interventional treatment and surgical treatment has been reported at home and abroad, and this study mainly compared the 2 treatments from the perspectives of clinical aspects and ANP.  The incidence and severity of complications are important indicators to judge the safety of a treatment method. The success rates of surgical and interventional treatment were similar in foreign reports. In China, serious complications can occur after VSD occlusion, including high atrioventricular block (degree III AVB), hemolysis, and blocker displacement, of which the incidence of degree III AVB is 1%-3%, which is higher than that of traditional surgical open-heart surgery, and the complication of degree III AVB of perimembranous ventricular defect intervention can occur at 7 d after surgery, which is detected due to As syndrome, and still has intermittent AVB after 50 d of treatment, and requires a pacemaker, which is highly unpredictable. The surgical experience is mostly immediate when the heart resumes postoperatively and is treated to restore a normal rhythm. If the heart rhythm is normal at the time of resumption, third-degree AVB that occurs during the postoperative recovery period can basically be recovered with treatment. The absence of serious complications of intervention in this study may be related to the selection of cases and the timing of this work, but the problem of arrhythmias after perimembranous VSD intervention still deserves great attention.  The average length of stay for surgical treatment of ASD was 4-8 d and the average length of stay for interventional treatment was 1-3 d. In China, Yang Rong et al. reported that the average length of stay for surgical treatment of ASD was 9.9 d and the average length of stay for interventional treatment was 8.8 d. In this study, the average length of stay for the interventional group after ASD and VSD was less than that of the surgical group. In our department, ASD was discharged 3 d after conventional ASD intervention, and VSD was discharged 5 d after surgery due to the need to observe whether atrioventricular block was caused after blocker placement, but it was less traumatic and less painful because it was possible to move to the floor on the second day after surgery.  Kim and Hijazi reported $21,780 for surgical treatment of ASD and $11,541 for interventional treatment, while Formigari et al. reported €15,000 for surgical treatment of ASD and €13,000 for interventional treatment. The cost of interventional treatment in this study was significantly higher than that of surgical procedures, contrary to foreign reports. This difference is due to the fact that the Amplatzer blocker currently applied is mainly dependent on imports and is more expensive; on the other hand, it is related to the relatively low cost of surgical procedures and intensive care in China.  ANP is a peptide hormone composed of 28 amino acids produced and secreted by cardiac myocytes, which has powerful diuretic, natriuretic, vasodilator and blood pressure-lowering effects. The altered hemodynamics of precardiac disease affects atrial pressure and circulating blood volume, which in turn causes ANP to increase. Studies have shown that increased left ventricular volume load and increased right heart volume pressure load in precardiac disease can cause elevated ANP. ANP levels are an important indicator of cardiac function and are an indication of asymptomatic volume overload. In this study, the preoperative ANP levels were higher in the ASD patients than in the control group, and the preoperative ANP levels were higher in the surgical group of VSD patients than in the control group, indicating that left-to-right shunt type of precordial disease has varying degrees of increased blood flow in the pulmonary circulation, which can lead to dilatation or increased pressure load in the atria, and this volume and pressure load can stimulate the secretion of ANP. In this study, the preoperative ANP levels in patients with ASD were higher in the surgical group than in the interventional group, which may be related to the fact that the ASD defect was significantly larger in the surgical group than in the interventional group (P<0.05 compared with the interventional group), suggesting that the size of ASD is related to the ANP level. The postoperative ANP level decreased in both the interventional and surgical groups compared with the preoperative group, and the difference between the two groups was not significant; suggesting that neither interventional nor surgical treatment of ASD or VSD caused deterioration of cardiac function in the absence of extracorporeal circulation complications, and the two treatments had the same effect in reducing cardiac volume load.  The present study suggests that the effect of interventional treatment of ASD and VSD with a single left-to-right shunt is comparable to that of surgical procedures, and is less invasive, does not require blood transfusion, and has a shorter hospital stay. However, the intervention is more expensive and some complications are more serious, so strict selection of indications and standardized operation are still issues that should be noted in clinical practice.