Results of the U.S. Food and Drug Administration Continued Access Clinical Trial of the GORE HELEX Septal Occluder for Secundum Atrial Septal Defect

Study Questions:

What are the immediate, 1-, and 5-year results for patients undergoing closure of secundum atrial septal defect (ASD) with the GORE HELEX Septal Occluder?

Methods:

Results of the U.S. Food and Drug Administration Continued Access clinical trial of the GORE HELEX Septal Occluder are reported in this manuscript. The devices were modified with a hydrophilic coating to improve echocardiographic visualization of the device. In the continued access trial, a total of 137 devices were implanted at 13 US institutions. Patients underwent evaluation with history and physical, electrocardiogram, and echocardiogram prior to hospital discharge and at 1, 6, 12, 36, 48, and 60 months. Device fluoroscopy was performed at 6, 12, and 60 months to assess for wire frame fracture.

Results:

Twelve-month follow-up was available for 122 of 126 patients, and 60-month follow-up was available for 83 of 95 patients who agreed to the trial extension. The clinical success rate was 96.7%, with a major adverse event rate of 3.6%. Wire frame fracture occurred in 11.7% of patients with no apparent clinical consequences. A clinically insignificant leak was seen or could not be ruled out in 26.6% of patients at the 5-year evaluation. No device erosions or sudden catastrophic events were reported.

Conclusions:

The authors concluded that the GORE HELEX Septal Occluder is a safe and effective transcatheter occluder for repair of secundum ASD.

Perspective:

This study reports immediate to 5-year outcomes of secundum ASD closure with the HELEX device in a selected patient population. Although clinically significant leak was rare, clinically insignificant residual leak was relatively common, occurring in about one-quarter of patients. Wire frame fracture also appeared to be relatively common, although these fractures do not appear to have been clinically significant. Both residual shunting and wire frame fracture increased in frequency with increasing device size. The soon-to-be available GORE Septal Occluder may also become an alternative to the Amplatzer septal occluder. Although the authors report no device erosions, the small sample size of this study should be noted, particularly in light of the reported erosion rate of 1-3 per device placements with the Amplatzer septal occluder.

Clinical Topics: Congenital Heart Disease and Pediatric Cardiology, Noninvasive Imaging, Congenital Heart Disease, CHD & Pediatrics and Imaging, Nuclear Imaging

Keywords: Fluoroscopy, United States Food and Drug Administration, Heart Septal Defects, Atrial, Electrocardiography, Septal Occluder Device


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