Rainer Kozlik-Feldmann1, Avraham Lorber2, Horst Sievert3,4, Peter Ewert5, Christian Jux6, Götz C Müller7, Robert Dalla Pozza8, Mustafa Yigitbasi9, Dietmar Schranz6, Angelika Lindinger10, Omar Galal11, Thomas Meinertz12. 1. Department of Pediatric Cardiology, University Heart and Vascular Center, Hamburg, Germany. r.kozlik-feldmann@uke.de. 2. Department of Pediatric Cardiology and Adults With Congenital Heart Disease, Faculty of Medicine, Technion, Meyer Children's Hospital of Haifa, Rambam Medical Center, Haifa, Israel. 3. CardioVascular Center Frankfurt, Frankfurt, Germany. 4. Anglia Ruskin University, Chelmsford, UK. 5. Department of Pediatric Cardiology and Congenital Heart Defects, German Heart Center Munich, Munich, Germany. 6. Department of Pediatric Cardiology and Congenital Heart Defects, University Hospital Giessen and Marburg, Giessen, Germany. 7. Department of Pediatric Cardiology, University Heart and Vascular Center, Hamburg, Germany. 8. Department of Pediatric Cardiology and Pediatric Intensive Care, Grosshadern Medical Center, University of Munich, Munich, Germany. 9. Department of Congenital Heart Defects-Pediatric Cardiology, German Heart Center Berlin, Berlin, Germany. 10. Member of the Data Safety and Monitoring Board, Westpfalz-Klinikum, Pediatric Cardiology, Kaiserslautern, Germany. 11. Member of the Data Safety and Monitoring Board, King Faisal Specialist Hospital and RC, Pediatric Cardiology, Jeddah, Saudi Arabia. 12. Head of Clinical Trial and Member of the Data Safety and Monitoring Board, Cardiological-Internal Practice, Hamburg, Germany.
Abstract
OBJECTIVE: This study presents data from the admission trial to show the feasibility, safety and effectiveness of the Nit-Occlud® Lê VSD in the treatment of perimembranous ventricular septal defects with an aneurysmal configuration and a diameter up to 8 mm. BACKGROUND: The majority of ventricular septal defects (VSD) are still closed surgically, while a less invasive transcatheter treatment by closure devices is available. Device-based closure is reported to be associated with the risk of complete atrio-ventricular block, especially with double-disc devices in perimembranous defects. METHODS: In six tertiary centers in Germany and Israel, an interventional closure of a periembranous VSD was attempted in 88 patients using the Nit-Occlud® Lê VSD. RESULTS: The interventional VSD closure was performed in 85 patients. Patients had a median age of 8.0 (2-65) years and a median body weight of 26.7 (10-109) kg. A complete closure of the defects was achieved in 85.4% 2 weeks after device implantation, in 88.9% after three months and in 98.6% at the 5-year follow-up. There was no incidence of death during the study nor did any patient suffer of permanent atrio-ventricular block of higher degree. Serious adverse events, by definition, are potentially life-threatening or require surgery to correct, while major serious events require medical or transcatheter intervention to correct. The study results exhibit a serious adverse event rate of 3.5% (3/85 patients) and a major adverse event rate of 5.9% (5/85 patients). CONCLUSION: The Nit-Occlud® Lê VSD coil offers the possibility of an effective and safe approach in patients with aneurysmal perimembranous ventricular septal defects.
OBJECTIVE: This study presents data from the admission trial to show the feasibility, safety and effectiveness of the Nit-Occlud® Lê VSD in the treatment of perimembranous ventricular septal defects with an aneurysmal configuration and a diameter up to 8 mm. BACKGROUND: The majority of ventricular septal defects (VSD) are still closed surgically, while a less invasive transcatheter treatment by closure devices is available. Device-based closure is reported to be associated with the risk of complete atrio-ventricular block, especially with double-disc devices in perimembranous defects. METHODS: In six tertiary centers in Germany and Israel, an interventional closure of a periembranous VSD was attempted in 88 patients using the Nit-Occlud® Lê VSD. RESULTS: The interventional VSD closure was performed in 85 patients. Patients had a median age of 8.0 (2-65) years and a median body weight of 26.7 (10-109) kg. A complete closure of the defects was achieved in 85.4% 2 weeks after device implantation, in 88.9% after three months and in 98.6% at the 5-year follow-up. There was no incidence of death during the study nor did any patient suffer of permanent atrio-ventricular block of higher degree. Serious adverse events, by definition, are potentially life-threatening or require surgery to correct, while major serious events require medical or transcatheter intervention to correct. The study results exhibit a serious adverse event rate of 3.5% (3/85 patients) and a major adverse event rate of 5.9% (5/85 patients). CONCLUSION: The Nit-Occlud® Lê VSD coil offers the possibility of an effective and safe approach in patients with aneurysmal perimembranous ventricular septal defects.
Authors: Rudi Foth; Thomas Quentin; Ina Michel-Behnke; Manfred Vogt; Thomas Kriebel; Anne Kreischer; Wolfgang Ruschewski; Thomas Paul; Matthias Sigler Journal: Circ Cardiovasc Interv Date: 2009-02-20 Impact factor: 6.546