OBJECTIVES:Conventional surgical closure has been considered the gold standard for the treatment of perimembranous ventricular septal defects (PVSDs) in infants for many years, but it requires a cardiopulmonary bypass and midline sternotomy which can lead to both physical and psychological trauma in the future. An intraoperative device closure can be performed with the advantages of reduced invasion, faster recovery and so on. We evaluate the safety and feasibility of intraoperative device closure of PVSDs in infants in comparison with surgical closure. METHODS:One hundred eighty-six infants with a PVSD were enrolled in our study. Among them, 97 patients were treated by surgical closure and 89 were treated byintraoperative device closure. The success rates, complications, length of hospital stay and costs were measured. RESULTS: The success rate was similar (P = 0.228) in the two groups: 87/89 patients (97.8%) in the device group versus 97/97 patients (100%) in the surgical group. Complication needs management was required in one patient of the device group (1.1%) and in two patients of the surgical group (2.0%) (P = 1.000). Minor complications were observed in 7/87 patients (8.0%) of the device group versus 15/99 patients (15.2%) of the surgical group (P < 0.001). Both groups were similarly effective in reducing the left ventricular end-diastolic dimension, pulmonary arterial pressure and cardiothoracic rate. The procedure time, inpatient stay and intensive care unit stay are shorter in the device group; the total cost was similar for both groups. CONCLUSIONS:Intraoperative device closure of PVSDs under real-time transoesophageal echocardiography guidance is safe and feasible without CPB. Under the right conditions, intraoperative device closure can be a good alternative to surgical closure for the treatment of PVSDs in infants.
RCT Entities:
OBJECTIVES: Conventional surgical closure has been considered the gold standard for the treatment of perimembranous ventricular septal defects (PVSDs) in infants for many years, but it requires a cardiopulmonary bypass and midline sternotomy which can lead to both physical and psychological trauma in the future. An intraoperative device closure can be performed with the advantages of reduced invasion, faster recovery and so on. We evaluate the safety and feasibility of intraoperative device closure of PVSDs in infants in comparison with surgical closure. METHODS: One hundred eighty-six infants with a PVSD were enrolled in our study. Among them, 97 patients were treated by surgical closure and 89 were treated by intraoperative device closure. The success rates, complications, length of hospital stay and costs were measured. RESULTS: The success rate was similar (P = 0.228) in the two groups: 87/89 patients (97.8%) in the device group versus 97/97 patients (100%) in the surgical group. Complication needs management was required in one patient of the device group (1.1%) and in two patients of the surgical group (2.0%) (P = 1.000). Minor complications were observed in 7/87 patients (8.0%) of the device group versus 15/99 patients (15.2%) of the surgical group (P < 0.001). Both groups were similarly effective in reducing the left ventricular end-diastolic dimension, pulmonary arterial pressure and cardiothoracic rate. The procedure time, inpatient stay and intensive care unit stay are shorter in the device group; the total cost was similar for both groups. CONCLUSIONS: Intraoperative device closure of PVSDs under real-time transoesophageal echocardiography guidance is safe and feasible without CPB. Under the right conditions, intraoperative device closure can be a good alternative to surgical closure for the treatment of PVSDs in infants.