Data Support Gore Helex Septal Occluder for Secundum Atrial Septal Defect

August 18, 2014—Alexander J. Javois, MD, et al published the immediate, 1-, and 5-year follow-up results of the US Food and Drug Administration Continued Access clinical trial of the Gore Helex septal occluder (Gore & Associates) for closure of secundum atrial septal defects in the Journal of the American College of Cardiology: Cardiovascular Interventions (2014;7:905–912). 

The investigators noted that the trial was conducted between May 2003 and August 2006 to allow continued enrollment in a trial of the investigational device during review of data from the pivotal trial. Devices with a hydrophilic coating on expanded polytetrafluoroethylene were first used in this trial to improve echocardiographic visualization.

As summarized in the Journal of the American College of Cardiology: Cardiovascular Interventions, a total of 137 devices were implanted in 137 patients at 13 institutions in the United States. Evaluations were scheduled at 1, 6, and 12 months for the initial trial and at 36 and 60 months for a later extension of the trial in those who consented to longer-term evaluations. Twelve-month follow-up was completed for 122 of 126 patients with implantations, and 5-year follow-up was completed for 83 of 95 patients who agreed to the trial extension. 

The investigators reported that the overall clinical success rate was 96.7%, and the major adverse event rate was 3.6%. Wire frame fractures were seen in 11.7% of patients with no clinical symptoms. A trivial, clinically insignificant leak was seen, or could not be ruled out, in 26.6% of patients at the 5-year evaluation, but no clinically significant leaks were seen. No patient experienced erosion or a sudden catastrophic event.

The immediate, 1-, and 5-year follow-up outcomes of the Continued Access clinical trial continue to demonstrate that the Gore Helex septal occluder is a safe and effective transcatheter occluder for repair of ostium secundum atrial septal defects, concluded the investigators in the Journal of the American College of Cardiology: Cardiovascular Interventions.