Device closure of muscular ventricular septal defects using the Amplatzer muscular ventricular septal defect occluder: immediate and mid-term results of a U.S. registry.

OBJECTIVES We sought to report the results of a U.S. registry of device closure of congenital muscular ventricular septal defects (VSDs) using the new Amplatzer mVSD occluder (AGA Medical Corp., Golden Valley, Minnesota). BACKGROUND Muscular VSDs pose a significant surgical challenge with increased morbidity and mortality. METHODS Data were prospectively collected from 83 procedures involving 75 patients who underwent an attempt of percutaneous (70 [93.3%] of 75) and/or perventricular (surgical) (6 [8.0%] of 75) device closure of hemodynamically significant muscular VSDs. The patients' median age was 1.4 years (range 0.1 to 54.1 years). Outcome parameters were procedural success, evidence of residual shunts on echocardiography, and occurrence of procedure-related complications. The median follow-up was 211 days (range 1 to 859 days). RESULTS The median size of the primary VSD was 7 mm (range 3 to 16 mm) and in 34 of 78 (43.6%) procedures, patients had multiple VSDs (range 2 to 7). The device was implanted successfully in 72 of 83 (86.7%) procedures. In 17 of 83 (20.5%) procedures, multiple devices were implanted (range 2 to 3). Procedure-related major complications occurred in 8 of 75 (10.7%) patients. Device embolization occurred in two patients and cardiac perforation in one patient. There were two (2.7%) procedure-related deaths. The 24-h postprocedural complete closure rate was 47.2% (34 of 72 patients), increasing to 69.6% (32 of 46 patients) at 6 months and 92.3% (24 of 26 patients) at 12 months. Six patients underwent successful closure using the perventricular surgical (beating heart) approach, with complete closure at day 1 in three patients and trivial/small residual shunts in the remainder of the patients. CONCLUSIONS The Amplatzer mVSD device (AGA Medical Corp.) offers excellent closure rates and low mortality when used to close congenital muscular VSDs. The device appears to be safe and effective.