BACKGROUND:Cardiopulmonary bypass has adverse effects on patient physiology. A prospective randomized trial was undertaken to evaluate closure of atrial septal defects with or without cardiopulmonary bypass. METHODS:Between August 1997 and March 2000, 150 patients with ostium secundum atrial septal defects were enrolled. Patients were randomized for repair without cardiopulmonary bypass (ie, the sandwich operation; n = 74) as a study group or with cardiopulmonary bypass (n = 76) as a control group. In the sandwich group the sandwich patch was passed into the right atrium and placed at the defect during transesophageal echocardiography. The patch was secured with external transfixing sutures and endoscopic staples. Clinical outcomes were compared. Outcome variables included perioperative morbidity, mortality, length of stay in the intensive care unit, hospital length of stay from operation to discharge, residual shunt, reoperation, hematologic profile, transfusion requirement, and hospital fee. The follow-up duration ranged from 1 to 29 months (mean, 8.7 +/- 7.5 months). RESULTS: There was no operative mortality. The success rate of the sandwich operation was 68 (92%) of 74 patients. Patients in the sandwich group had shorter operative times and lengths of stay in the intensive care unit, fewer requirements of transfusion, and lower hospital fees. The differences in postoperative drainage, arrhythmias, and hematologic profiles could be due to chance. Two patients in the sandwich group required reoperation for residual shunt. The risk factor for residual shunt was earlier date of repair. Mitral and tricuspid valve function was not adversely affected by the operation. CONCLUSIONS: Closure of atrial septal defects without cardiopulmonary bypass can be done effectively. Adverse effects of cardiopulmonary bypass can be avoided, as shown by improvements of postoperative parameters with the sandwich operation.
RCT Entities:
BACKGROUND: Cardiopulmonary bypass has adverse effects on patient physiology. A prospective randomized trial was undertaken to evaluate closure of atrial septal defects with or without cardiopulmonary bypass. METHODS: Between August 1997 and March 2000, 150 patients with ostium secundum atrial septal defects were enrolled. Patients were randomized for repair without cardiopulmonary bypass (ie, the sandwich operation; n = 74) as a study group or with cardiopulmonary bypass (n = 76) as a control group. In the sandwich group the sandwich patch was passed into the right atrium and placed at the defect during transesophageal echocardiography. The patch was secured with external transfixing sutures and endoscopic staples. Clinical outcomes were compared. Outcome variables included perioperative morbidity, mortality, length of stay in the intensive care unit, hospital length of stay from operation to discharge, residual shunt, reoperation, hematologic profile, transfusion requirement, and hospital fee. The follow-up duration ranged from 1 to 29 months (mean, 8.7 +/- 7.5 months). RESULTS: There was no operative mortality. The success rate of the sandwich operation was 68 (92%) of 74 patients. Patients in the sandwich group had shorter operative times and lengths of stay in the intensive care unit, fewer requirements of transfusion, and lower hospital fees. The differences in postoperative drainage, arrhythmias, and hematologic profiles could be due to chance. Two patients in the sandwich group required reoperation for residual shunt. The risk factor for residual shunt was earlier date of repair. Mitral and tricuspid valve function was not adversely affected by the operation. CONCLUSIONS: Closure of atrial septal defects without cardiopulmonary bypass can be done effectively. Adverse effects of cardiopulmonary bypass can be avoided, as shown by improvements of postoperative parameters with the sandwich operation.