Study Shows Continued Safety and Efficacy of the GORE HELEX Septal Occluder

In the early '90s the GORE HELEX Septal Occluder was developed for the closure of secundum atrial septal defects (ASDs). A study published Aug. 18 in the JACC Cardiovascular Interventions reported the short- and long-term safety and efficacy data for the Continued Access clinical trial of the GORE HELEX Septal Occluder, and showed that the immediate, one- and five-year follow-up outcomes continue to demonstrate that the device "is a safe and effective transcatheter occluder for repair of ostium secundum ASD."

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The U.S. Food and Drug Administration-approved trial was conducted between May 2003 and August 2006, at 13 U.S. medical centers. Looking at 137 devices implanted in 137 patients, with follow-up evaluations at one, six, and 12 months for the initial trial, and at 36 and 60 months for the later extension of the trial, results showed that the overall clinical success rate was 96.7 percent, with a major adverse event rate of 3.6 percent. The only adverse events seen were two early asymptomatic device embolizations treated by transcatheter retrieval and two elective removals of devices from the atrial septum (one possible device instability and one associated with additional defects). Further, in 11.7 percent of patients, wire frame fractures were seen with no clinical symptoms.

At the five-year evaluation, a trivial, clinically insignificant leak was seen in 26.6 percent of patients. The authors note that moving forward, "recommended changes for device size-to-defect size ratio and maximal ASD size will likely result in a lower incidence of such possible trivial leaks." However, no patients were subject to an erosion, perforation, allergic reaction, or arrhythmias requiring treatment.

Ultimately, the authors conclude that the device continues to be "a safe and effective alternative to the repair of an ostium secundum ASD."

"Dr. Javois' study demonstrates excellent short- and immediate-term outcomes for the GORE HELEX device," said Robert Beekman, III, MD, FACC, chair of the ACC's Adult Congenital and Pediatric Cardiology Section. "This study also underscores the importance of multi-center efforts and registries, as we strive to better understand the long-term outcomes of patient with CHD. CHD is a relatively uncommon condition – a fact that limits the ability of single centers to evaluate care and patient outcomes. Multicenter cooperation enables studies of this magnitude to be accomplished and improves our understanding of CHD outcomes."

Keywords: Registries, Follow-Up Studies, United States Food and Drug Administration, Pediatrics, Heart Septal Defects, Atrial, Hypersensitivity, Septal Occluder Device

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