Author + information
- Received October 1, 2013
- Revision received January 23, 2014
- Accepted January 30, 2014
- Published online August 1, 2014.
- Alexander J. Javois, MD∗,†∗ (, )
- Jonathan J. Rome, MD‡,
- Thomas K. Jones, MD§,
- Evan M. Zahn, MD‖,
- Craig E. Fleishman, MD¶,
- Ricardo H. Pignatelli, MD#,
- Larry A. Latson, MD∗∗,
- Gore HELEX Continued Access Study Group
- ∗Advocate Children’s Hospital, Oak Lawn, Illinois
- †University of Illinois Medical College, Chicago, Illinois
- ‡Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania
- §Seattle Children’s Hospital, Seattle, Washington
- ‖Heart Institute and Department of Pediatrics at Cedars-Sinai Medical Center, Los Angeles, California
- ¶Arnold Palmer Hospital for Children, Orlando, Florida
- #Texas Children’s Hospital, Houston, Texas
- ∗∗Joe DiMaggio Children’s Hospital, Hollywood, Florida
- ↵∗Reprint requests and correspondence:
Dr. Alexander J. Javois, Pediatric Cardiac Cath Lab, Advocate Hope Children’s Hospital, 4440 West 95th Street, Oak Lawn, Illinois 60453.
Objectives This report describes the immediate, 1-, and 5-year follow-up results of the U.S. Food and Drug Administration Continued Access clinical trial of the GORE HELEX Septal Occluder (W. L. Gore & Associates, Inc., Flagstaff, Arizona) for closure of secundum atrial septal defect.
Background 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 hydrophilic coating on the expanded polytetrafluoroethylene to improve echocardiographic visualization were first used in this trial.
Methods A total of 137 devices were implanted in 137 patients at 13 US institutions. 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.
Results Twelve-month follow-up was completed on 122 of 126 patients with implantations, and 5-year follow-up on 83 of 95 patients who agreed to the trial extension. The overall clinical success rate was 96.7%, and the major adverse event rate 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 an erosion or sudden catastrophic event.
Conclusions 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 defect.
Drs. Javois, Pignatelli, and Fleishman are consultants for W.L. Gore and Associates, Inc. Dr. Jones has received research grant support from and is a consultant for W.L. Gore and Associates, Inc. Dr. Latson has received research grant support from and is consultant for W.L. Gore and Associates, Inc. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received October 1, 2013.
- Revision received January 23, 2014.
- Accepted January 30, 2014.
- American College of Cardiology Foundation