POSTER 1 7:10 – 7:17 Initial Clinical Experience with the GORE® CARDIOFORM ASD Occluder for Transcatheter Atrial Septal Defect Closure Presenter: Quentin de Hemptinne Authors: Quentin de Hemptinne, Eric Horlick, Mark Osten, Xavier Millán, Victor- Xavier Tadros, Michele Pighi, Francisco Gonzalez Barlatey, Sami alnasser, Joaquim Miró, Anita Asgar, Reda Ibrahim. Montreal Heart Institute, CHU Ste-Justine and Toronto General Hospital

Initial Clinical Experience with the GORE® CARDIOFORM ASD Occluder for Transcatheter Atrial Septal Defect Closure Initial Clinical Experience with the GORE® CARDIOFORM ASD Occluder for Transcatheter Atrial Septal Defect Closure Quentin de Hemptinne, MD a ; Eric M. Horlick, MD b ; Mark D. Osten, MD b ; Xavier Millán, MD a ; Victor-Xavier Tadros, MD, MSc a ; Michele Pighi, MD a ; Francisco Gonzalez Barlatey, MD c ; Sami M. Alnasser, MD b ; Joaquim Miró, MD c ; Anita W. Asgar, MD a ; Réda Ibrahim, MD a a Department of Medicine, Montreal Heart Institute. b Department of Cardiology, Toronto General Hospital. c Department of Cardiology, CHU Sainte-Justine.

Background Transcatheter closure has become the treatment of choice for secundum ASD A wide range of occluder devices are available Risk of cardiac erosion associated with rigid devices and future access to the left atrium FIM multicenter clinical experience with a novel device

GORE ® CARDIOFORM ASD Occluder (GCO)

Methods A retrospective chart review of adult and pediatric ASD patients treated with the GCO at three Canadian centers: o Montreal Heart Institute (Montreal, Quebec, Canada) o Sainte-Justine Hospital (Montreal, Quebec, Canada) o Toronto General Hospital (Toronto, Ontario, Canada)

Results Between February and December 2015, 26 patients (5 children and 21 adults) underwent transcatheter ASD closure with the GCO Pediatric (n=5)Adult (n=21) Median age (years)6 ( )55 (36-58) Females3 (60%)13 (62%) Indication for ASD closure Significant shunt with RV enlargement5 (100%)20 (95%) Stroke or thromboembolism03 (14%) Pulmonary hypertension1 (20%)6 (29%)

Procedural Results Pediatric (n=5)Adult (n=21) Procedural success 4 (80%)18 (86%) Stroke - TIA 00 Myocardial infarction 00 Cardiovascular death 00 Device embolization 00 Pericardial effusion 01 (5%) Tamponade 00

Procedural Results Procedural success achieved in 22/26 patients (85%)using the GCO Device closure was not achieved using the GCO in 4 patients : o 3 patients were successfully treated with a ASO device o 1 patient was treated surgically o In all cases there were deficient or absent aortic rims in the setting of a large defect (>27mm)

Follow-up data Pediatric (n=4)Adult (n=18) Median follow-up duration (days)277 ( )146 ( ) Functional class I at follow-up4 (100%)16 (89%) Closure success (absence of residual shunt) 4 (100%)18 (100%) Residual RV enlargement07 (38%) Pericardial effusion00 Supraventricular tachyarrhythmia Atrial fibrillation 02 (11%) Flutter 1 (20%)0 Stroke - TIA00 Cardiovascular death00 Non-cardiovascular death01 (6%)

Secondary Outcomes Wire frame fractures o Fluoroscopic imaging of the device was performed in 20 patients (91%) at 186 days (IQR: ) o Wire frame fracture was noted in 5 cases. o No clinical consequence or device dysfunction was observed in these patients.

Conclusions The GORE CARDIOFORM ASD Occluder was safe and effective for the transcatheter closure of atrial septal defects in both pediatric and adult patients in this initial first-in-man experience. Procedural success was 85% with no procedural complications There were NO cases of residual shunting at F/U