Midterm Follow‐Up of Percutaneous Closure of Secundum Atrial Septal Defect with Helex Septal Occluder

Abstract

The Helex Septal Occluder (HSO) is a relatively new device used in the percutaneous closure of atrial septal defects (ASDs). The immediate and short-term results of its deployment have been reported, but the medium-term results have not been described. The objective was to describe the midterm efficacy and safety of percutaneous closure of ASD with the HSO. The HSO was used in 33 children to close secundum ASDs between July 1999 and November 2000. Detailed data were collected at implantation and 31 children have been followed clinically and investigated with electrocardiogram (ECG) (n = 30), echocardiogram, and fluoroscopy (n = 30) at a mean of 63 (range 55-74) months after implantation. The ages and body weights at implantation ranged from 13 to 220 months and 7.6 to 57.6 kg. The ASD diameter ranged from 7 to 17 mm. All sizes of HSO were deployed. The range of device to defect ratio was 1.4 to 3.3. Of the 21 residual shunts noted early after implantation, only four persisted, all small, at latest follow-up. There were no new shunts. There were no new ECG abnormalities. There was a pronounced change in the configuration of one HSO without sequelae. In two patients in whom the locking loop missed the right atrial eyelet at deployment, there were no sequelae or residual shunts. There were no cases of frame fracture or explantation. There has been no death or long-term morbidity. At midterm follow-up the HSO is durable and effective, with a low incidence of adverse sequelae even in the small subgroup with imperfect configuration.