Damien Kenny1, Andreas Eicken2, Ingo Dähnert3, Younes Boudjemline4, Horst Sievert5, Martin Be Schneider6, Tommaso Gori7, Ziyad M Hijazi8. 1. Department of Cardiology, Our Lady's Children's Hospital, Dublin, Ireland. 2. German Heart Center, Munich, Germany. 3. Department of Pediatric Cardiology Heart Centre, University of Leipzig, Leipzig, Germany. 4. Department of Pediatric Cardiology, Centre de reference des Malformations Cardiaques Congénitales Complexes, Necker Hospital, Paris, France. 5. CardioVascular Center Frankfurt, Frankfurt, Germany & Anglia Ruskin University, Chelmsford, United Kingdom. 6. Department of Pediatric Cardiology, Charitè Medical Center, Humboldt University, Berlin, Germany. 7. Zentrum für Kardiologie, Kardiologie I, University Medical Center, and DZHK Standort Rhein-Main, Mainz, Germany. 8. Sidra Cardiovascular Center of Excellence, Weil Cornell Medical College, Doha, Qatar.
Abstract
AIMS: The aim of this study was to compare the efficacy and safety of the Occlutech Figulla Flex II Occluder (OFFII) with the Amplatzer Septal Occluder (ASO) in patients > 8kg undergoing transcatheter ASD closure. METHODS AND RESULTS: Randomized, controlled, multi-center prospective clinical trial with randomization 2:1 in favor of the OFFII. Primary efficacy endpoint was the rate of successful device placement and defect closure without major complications at hospital discharge. All data were assessed through a core laboratory. Interim analysis was performed when 70% of the patients were treated to evaluate for noninferiority. From a total of 176 randomized subjects, interim analysis was performed on the first 158 patients (65.2% female) (107 OFFII/51 ASO) undergoing device closure at a median weight of 42 kg (range 13-125 kg). Seventy-six percent (120 patients) completed 6-month follow-up. Successful device placement (first attempt) was achieved in 99.1% of the OFF group vs 90.2% of the ASO group (P < 0.05). Early efficacy success was achieved in 94.4% of the OFFII group vs 90.2% of the ASO group (P < 0.001). The incidence of major complications was 5.6% for the OFFII group compared to 9.8% for the ASO. CONCLUSIONS: The OFFII device was not inferior to the ASO with less complications and greater efficacy than the ASO.
RCT Entities:
AIMS: The aim of this study was to compare the efficacy and safety of the Occlutech Figulla Flex II Occluder (OFFII) with the Amplatzer Septal Occluder (ASO) in patients > 8kg undergoing transcatheter ASD closure. METHODS AND RESULTS: Randomized, controlled, multi-center prospective clinical trial with randomization 2:1 in favor of the OFFII. Primary efficacy endpoint was the rate of successful device placement and defect closure without major complications at hospital discharge. All data were assessed through a core laboratory. Interim analysis was performed when 70% of the patients were treated to evaluate for noninferiority. From a total of 176 randomized subjects, interim analysis was performed on the first 158 patients (65.2% female) (107 OFFII/51 ASO) undergoing device closure at a median weight of 42 kg (range 13-125 kg). Seventy-six percent (120 patients) completed 6-month follow-up. Successful device placement (first attempt) was achieved in 99.1% of the OFF group vs 90.2% of the ASO group (P < 0.05). Early efficacy success was achieved in 94.4% of the OFFII group vs 90.2% of the ASO group (P < 0.001). The incidence of major complications was 5.6% for the OFFII group compared to 9.8% for the ASO. CONCLUSIONS: The OFFII device was not inferior to the ASO with less complications and greater efficacy than the ASO.
Authors: Raymond N Haddad; Diala Khraiche; Damien Bonnet; Mathilde Meot; Sophie Malekzadeh-Milani Journal: Front Pediatr Date: 2021-03-11 Impact factor: 3.418
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