Abstract
BACKGROUND: To evaluate the long-term safety and efficacy of using perventricular device closure in treating selected patient with doubly committed sub-arterial ventricular septal defect (VSD) METHODS: During July 2007 and April 2011, 86 patients with doubly committed subarterial VSD who met the inclusion criteria were enrolled in this study. Perventricular closure was attempted using a unique design eccentric device under the guidance of transesophageal echocardiography. Complications such as residual shunt, arrhythmia, valve regurgitation were all recorded in postoperative period and during follow-up. Multiple logistic regression analysis was performed to study risk factors for procedure failure and complications. RESULT: Perventricular device closure was successfully done in 75 patients (87.2 %) with mean age 7.0 ± 7.0 years old, VSD size 4.8 ± 1.5 mm and device size 6.7 ± 1.7 mm. Complete closure rate was achieved in 94.7 % at discharge and 96 % during follow-up. No severe complications such as device embolism, significant arrhythmia, left ventricular outflow tract obstruction as well as obvious valve regurgitation were noted during follow-up (Mean 4.5 ± 1.5 years). Procedure induced trivial-mild grade aortic valve regurgitation (AR) was noted in 16 (21.3 %) patients at discharge while 8 of them resolved during follow-up. Multivariable analysis revealed that procedure-induced AR was associated device diameter to patients' weight (OR=12.3 95 % CI 1.5- 99.2). Perventricular device closure was failed in 11 patients, preoperative aortic valve prolapse was the major risk factor for failure of the procedure (OR=65 95 % CI 7.5- 564.1). CONCLUSION: Perventricular closure of doubly committed subarterial VSDs appears to be a safe and effective minimally invasive treatment option in selected patients with good long-term outcomes. CLINICAL TRIAL REGISTRATION: Unique Identifier: ChiCTR-TNC-00000203 .