O-5
Outcomes of Secundum Atrial Septal Defect Closure with the new GORE Cardioform ASD Occluder- Results from the Continued Access GORE ASSURED Clinical Trial
Presenter
Athar M. Qureshi, M.D., FSCAI, Texas Children's Hospital, Houston, TX
Athar M. Qureshi, M.D., FSCAI, Texas Children's Hospital, Houston, TX, Robert J. Sommer, M.D., NewYork-Presbyterian Columbia University Irving Medical Center, New York, NY, Gareth J. Morgan, M.B.B.S., FSCAI, Children's Hospital Colorado, Aurora, CO, Robert G. Gray, M.D., The University of Utah, Salt Lake City, UT, Barry A. Love, M.D., Icahn School of Medicine at Mount Sinai, New York, NY, Bryan H. Goldstein, M.D., FSCAI, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, Lissa Sugeng, MD, Yale New Haven Hospital, New Haven, CT and Matthew J. Gillespie, M.D., FSCAI, Children's Hospital of Philadelphia, Philadelphia, PA
Keywords: Adult Congenital Heart Disease (ACHD), Atrial Septal Defect (ASD), Congenital Heart Disease (CHD) and Structural Heart Disease (SHD)
Background:
The GORE Cardioform ASD Occluder (W.L. GORE and Associates, Flagstaff, AZ) is a recently approved device for closure of secundum atrial septal defects (ASD). The purpose of this study is to report the results of the U.S. Food and Drug Administration (FDA) post market approval continued access GORE ASSURED clinical trial.
Methods:
This was a prospective, multicenter, single arm clinical trial comparing the GORE Cardioform ASD Occluder with existing benchmark data from other U.S. FDA approved devices. The study cohort included patients from 22 centers enrolled from 12/2017 - 7/2019. The primary end points were 6- month closure success after device implantation (complete closure or insignificant residual shunt) and 6- month composite clinical success (technical, safety and 6-month closure success). Secondary endpoints evaluated included safety outcomes, arrhythmias and device wire frame fracture (WFF) at 6 months.
Results:
A total of 444 patients age 18.2 + 18.3 years with a mean weight of 43.6 + 30.0 kg underwent attempted secundum ASD closure. The mean stop flow ASD diameter was 17.7 + 5.3 mm. The primary endpoint of closure success was met in 100% of patients (361 patients with complete data). The primary endpoint of composite clinical success (409 patients with complete data) was met in 85.8 % of patients (technical failure in 9.3%, 30-day serious adverse event in 4.6 % and device event in 3.2% of patients). No patient experienced a cardiac erosion. Clinically significant arrhythmias were observed in 19/444 (4.3%) of patients. WFF was noted in 99/328 (30%) patients (17.7%, 15%, 28.6%, 80% and 60% of patients with 27 mm, 32 mm, 37 mm, 44 mm and 48 mm devices, respectively). No clinical sequalae were observed in any patient with WFF. Serious device related adverse events were similar in patients with and without WFF [1/99 (1%) versus 6/229 (2.6%), p = 0.68].
Conclusions:
In this largest congenital ASD device trial to date, the GORE Cardioform ASD Occluder was found to have favorable results compared to other available U.S. FDA approved devices. Due to its unique features, size range and safety profile, the GORE Cardioform ASD Occluder expands the options for secundum ASD closure.