Mid-term outcomes of the Helex septal occluder for percutaneous closure of secundum atrial septal defects.

BACKGROUND: The HELEX Septal Occluder (HSO) was approved by the Food and Drug Administration for closure of secundum atrial septal defects (ASD) in 2006. However, little mid-term follow-up information is available. The object of this study was to examine mid-term outcomes after HSO implantation

METHODS: A retrospective chart review was performed on the first 74 patients who underwent ASD closure with the HSO between 4/00-10/04. Only patients who left the catheterization laboratory after successful implantation and had a minimum follow-up of 5 years were selected for analysis.

RESULTS: Thirty-three patients met entry criteria. At implantation the mean age was 10.9 years and the median ASD size was 15.1 mm. At a median follow-up of 88 months, 26 patients had complete ASD closure, 6 had trivial left-right shunts, and 1 had a significant residual shunt having a reintervention. Fluoroscopy, performed in 27 patients revealed a frame fracture in 3 patients (9%), all of whom were asymptomatic and had effective ASD closure. All 3 devices were 30 mm or 35 mm HSO and were left in place. One patient developed first-degree heart block and remained asymptomatic with no progression. There were no instances of late device embolization, cardiac perforation, erosion, or death.

CONCLUSIONS: Following successful implantation, HSO results in effective closure of secundum ASD in mid-term follow-up. Late complications appear to be rare with the exception of frame fracture, which in this series did not result in clinical sequelae.