Combined Study Data Support Gore Helex for ASD Treatment

April 21, 2014—An investigation that sought to summarize the outcomes for all patients evaluated during a prospective clinical study in the United States with the Gore Helex septal occluder (Gore & Associates, Flagstaff, AZ) for transcatheter repair of secundum atrial septal defects (ASD) was published by John F. Rhodes, Jr., MD, and Jake Goble, PhD, in Catheterization and Cardiovascular Interventions (2014;83:944–952).

The investigators concluded that the clinical data presented in this report reaffirm the safety and efficacy of the Gore Helex septal occluder when used for secundum ASD repair, and noted that this combined clinical study cohort represents the largest prospective, controlled clinical trial data set available for the device.

The background of the investigation noted that no previous reports were available that summarized the combined clinical trial outcomes for the Gore Helex for repair of secundum ASD.

As summarized in Catheterization and Cardiovascular Interventions, 435 patients were enrolled through the feasibility, pivotal, continued access, and postapproval studies in the United States between 1999 and 2009. All patients enrolled through these studies were collectively reviewed as the “study cohort.” The clinical success, defined as a composite evaluation of safety and efficacy, was reported for these patients at the 12-month follow-up period.

The investigators reported that 412 of the 435 patients enrolled in the four clinical studies were eligible for follow-up. Device efficacy, as represented by clinical closure at 12 months, was achieved in 98.3% of subjects and in 99.5% of those receiving a device whose nominal diameter was greater than or equal to twice the balloon-sized defect diameter. Through 12 months after implantation, freedom from major adverse events was 95.2%. Together, these results yielded a 93% composite clinical success at 12 months after the index procedure.