Comparison of results of closure of secundum atrial septal defect by surgery versus Amplatzer septal occluder.

S repair remains the standard for closure of secundum atrial septal defect (ASD). Although satisfactory results have been reported for transcatheter occlusion of these defects with a number of devices,1–5 few studies have directly compared transcatheter occlusion with surgical repair.6,7 This study reports our experience with contemporary cohorts of patients from a single institution treated surgically or with the Amplatzer septal occluder (AGA Medical Corporation, Golden Valley, Minnesota). • • • We reviewed the records of all patients in whom surgical or catheter treatment with the Amplatzer septal occluder for isolated secundum ASD was undertaken at C. S. Mott Children’s Hospital, University of Michigan Health System, from March 1998 through May 2000. Amplatzer septal occluders were implanted under a protocol approved by the University of Michigan Medical School Institutional Review Board. Subjects were not eligible for attempted Amplatzer closure in the presence of severe pulmonary artery hypertension, weight ,8 kg, recent or ongoing serious infection, or the presence of contraindications to aspirin therapy. For the purposes of this study, surgical patients were limited to those without associated structural cardiac anomalies or systemic illnesses. Patients not accepted for the Amplatzer protocol and those referred for surgical repair in whom previous attempts at Amplatzer occlusion were unsuccessful were not included in the surgical cohort. Date of birth, sex, weight, date of intervention, duration of hospitalization, complications, and admission hemoglobin concentration were recorded. Postoperative hemoglobin concentration, need for blood products, duration of cardiopulmonary bypass and aortic crossclamping, and type of repair (primary vs patch) were recorded for the surgical group. Estimated blood loss, procedure time, and fluoroscopy time were recorded for the catheter group. Reports from echocardiograms were reviewed for the presence of residual shunts, significant atrioventricular valve insufficiency, pericardial effusion, and intracardiac thrombus. Residual shunts were graded as trivial (Doppler color jet ,1 mm), mild (jet 1 to 2 mm), or moderate (jet 2 to 4 mm) as previously reported.1 Cardiac catheterization was performed using general endotracheal anesthesia, systemic heparinization, and antimicrobial prophylaxis with intravenous cefazolin (25 mg/kg). Rightand left-sided cardiac catheterization was performed. The ASD was sized under standard biplane fluoroscopic and transesophageal echocardiographic guidance using a 27or 33-mm sizing balloon (Boston Scientific, Natick, Massachusetts). If the ASD was considered to be suitable for transcatheter closure, the appropriate delivery sheath was advanced into the left atrium and a device equal to or no more than 2 mm larger that the ASD diameter was delivered. After confirmation of device stability and position, the device was released and repeat rightsided cardiac catheterization performed. Patients recovered overnight in the hospital, and 2 additional doses of intravenous cefazolin (25 mg/kg) were given at 8-hour intervals. The following morning, a chest x-ray, electrocardiogram, and transthoracic echocardiogram were recorded before patient discharge. As dictated by the study protocol, aspirin (81 mg/day) was prescribed for 6 months. Routine follow-up evaluation was scheduled at 6 and 12 months after device implantation. Surgical repair by primary closure, pericardial patch, or Gore-Tex (W.L. Gore & Associates, Inc, Flagstaff, Arizona) patch was performed through a right atriotomy after institution of general endotracheal anesthesia, cardiopulmonary bypass, and anterograde cardioplegia. Patients recovered in the intensive care unit where they were extubated and then transferred to the general care unit for further convalescence when appropriate. Cefazolin (25 mg/kg) was administered intravenously every 8 hours prophylactically until chest tubes were removed. An echocardiogram, chest x-ray, and electrocardiogram were recorded before patient discharge. After discharge, outpatient evaluation was scheduled at 2 weeks with the surgeon and at 6 weeks with the cardiologist. Continuous data (reported as mean 6 SD) from the Amplatzer and surgical groups were compared by unpaired Student’s t tests. Categorical data were compared by Fisher’s exact test. In each instance a p value ,0.05 was considered significant. In all, 89 patients meeting the study criteria were identified. There were 45 patients who were taken to the catheterization laboratory for potential closure with the Amplatzer septal occluder and 44 patients who underwent surgical repair. There were significant differences between the groups in age, weight, and sex distribution (Table 1). The age and weight differences reflect the tendency of adult patients to be referred to From the University of Michigan Congenital Heart Center, Division of Pediatric Cardiology, Department of Pediatrics, and Section of Cardiac Surgery, Department of Surgery, University of Michigan, Ann Arbor, Michigan. Dr. Lloyd’s address is: L1242/0204, Women’s, 1500 East Medical Center Drive, Ann Arbor, Michigan 481090204. E-mail: lloydt@umich.edu. Manuscript received October 13, 2000; revised manuscript received and accepted April 2, 2001.