Page 103 - Journal of Structural Heart Disease Volume 4, Issue 4

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Meeting Abstracts
Major consultants from all these centers are invited for their feedback on the subject and their experiences are compared.Total 50 world renowned centers are selected to analyse with consent of respective directors of the cath labs.
Conclusion: Asian paediatric cardiac centers are far more di erent in types of interventional procedures from euro- pian and American places.Industry has a lot of role to play in the di erences.Economics and Educational strategies are the major di erentiating features.Work load due to population is the limiting factor for the di erence.
169. 1-YEAR OUTCOMES FROM THE GORE® CARDIOFORM ASD OCCLUDER (GORE ASSURED) CLINICAL STUDY
Matthew Gillespie1, Robert Sommer2 on behalf of Gore ASSURED Trial Investigators
Children’s Hospital of Philadelphia1, Philadelphia; NY Presbyterian, Columbia University School of Medicine2, New York, USA
Background: The GORE® CARDIOFORM ASD Occluder is a permanently implanted occluder being tested for the indi- cation of percutaneous, transcatheter closure of ostium secundum atrial septal defects (ASDs). The occluder system consists of an implantable occluder and a delivery system. The occluder is comprised of a platinum- lled nickel-tita- nium (Nitinol) wire frame covered with expanded polytet- ra uoroethylene (ePTFE). The occluder con gurations are capable of treating defects between 8-35 mm. When fully deployed, the occluder assumes a con guration complete with a left atrial disc, a right atrial disc, and an intra-disc region between these discs that is intended to occupy the defect.
Methods: Patients were enrolled from 22 Pivotal U.S. sites in a prospective single arm trial. Follow-up was immedi- ately post procedure and at scheduled intervals through 6 months. Endpoints included successful device placement, immediate and late closure success and serious adverse events, including serious device-related events requiring intervention.
Results: Pivotal enrollment began March 10, 2017 and completed on September 5, 2017. Twenty-two (22) sites were initiated during the Pivotal phase. The study was comprised of 125 Pivotal subjects and 43 training cases. The rst two patients at each site were considered training cases. All subjects are being followed per the study proto- col. The median patient age was 14.3 years [5.5- 84.7]. The
mean “stop ow” stretched diameter was 18mm [9-34]. Multiple fenestrations were seen in 18.3% (19/104), and atrial septal aneurysm in 6.7% (7/104) of patients. The median retroaortic rim length was 5 mm [0.1-39].
A mid-term safety and e cacy analysis of 30-day data on the rst 104 patients (67 Pivotal subjects and 37 training case patients) was performed in September 2017. Technical Success rate was 93.3% (97/104) overall (94% (63/67) for the Pivotal cohort); Procedure success rate (Technical and Closure success): 93.3% overall (94% for the Pivotal cohort). No residual defects were noted at 30 days. Serious AEs occurred in 7.7% overall (6.0% for the Pivotal cohort). No subject deaths have been reported.
Conclusion: Initial results from this prospective trial of the new Gore Cardioform Atrial Septal Occluder revealed high procedural success, and favorable 30-day outcomes. 1-year follow up data, including echo and uoroscopic assessment, will be available for presentation at the time of the PICS meeting (September 2018). This G-CASO is a promising new technology for ASD closure.
170. EARLY RESULTS OF THE CLINICAL TRIAL USING THE BEIJING MED-ZENITH PULMONARY ARTERY STENT FOR PULMONARY ARTERY STENOSIS
John P Cheatham1, Gao Wei2, Zhouqing Liang3, Meng Jian3 1Nationwide Children’s Hospital, Columbus, OH, USA, 2Shanghai Children’s Medical Center, Pudong, Shanghai, China, 3Beijing Med-Zenith Medical Scienti c Co, Beijing, China
Background: Stent therapy for post operative pulmonary artery stenosis (PAS) is one of the most challenging inter- ventional procedures in complex congenital heart disease (CHD). Balloon angioplasty (BA) has been performed since 1983, but has the disadvantage of elastic recoil and limited acute and long term e cacy. Balloon expandable stents (BES) were introduced for PAS in 1988 with better results, but the stents were not speci cally designed for PAS and had limited applications. These BES were composed of 316L stainless steel and a closed cell (CC) design. Later, open cell (OC) stents were used in PAS with some advan- tages over CC stents.
Therefore, we designed a PAS stent (PASS) composed of cobalt chromium with a “hybrid” design, combining the advantages of both CC and OC. The recommended expanded diameters are: (S) 6-12mm, (M) 12-16mm, and (L) 18-22mm, and there are variable lengths from 15-40mm in increments of 5mm., and shortening of 0- 15%.
Hijazi, Z
21st Annual PICS/AICS Meeting