First experience With the biostar‐device for various applications in pediatric patients With congenital heart disease

Abstract

Background: Interventional closure of atrial septal defects (ASD) and surgical tunnel fenestrations in Fontan patients has become the procedure of choice for many years. Recently, the BioSTAR Occluder, a modification of the Starflex device with a resorbable matrix has become available. Patients: Ten Biostar devices were implanted in nine children with interatrial septal defects, one within a fontan baffle, eight with secundum atrial septal defects. The age of the patients ranged from 11 months to 17 years, the body weight ranged from 12.9–78 kg. Results: 10 BioSTAR devices were implanted in nine patients. In one patient, two BioSTAR devices were used to occlude multiple defects within the oval fossa. All defects were successfully and uneventfully occluded. Mean procedure time was 56 (range 28–125). Mean fluoroscopy time was 4.8 (range 1.1 to 13.0) min. None of the nine patients showed residual shunts after device implantation. After 30 days no shunt was seen in the control transthoracic echocardiography. No adverse effects like allergic reactions, tachyarrhythmia or thrombembolic events occurred in any of the patients. Conclusion: The BioSTAR closure device is a safe and effective device for the closure of a variety of interatrial shunts in children including multifenestrated interatrial defects and fontan fenestrations, however, possible long term consequences (e.g., fractures, recurrent shunts after scaffold degradation) remain to be studied. © 2009 Wiley‐Liss, Inc.

A biodegradable device (BioSTAR™) for atrial septal defect closure in children

“…The Bio-STAR implant has been available in Europe for patent oval foramen and atrial septal defect closure since 2006, and used in North America primarily for patent oval foramen closure for recurrent stroke prevention [22][23][24]. There is a limited pediatric experience and few studies assessing efficacy in secundum atrial septal defect closure [25]. The patient population in the BEST study [22] was exclusively adults and only 4 of the 58 patients included had an ASD with right heart dilation.…”

Development and preclinical evaluation of a biodegradable ventricular septal defect occluder

“…This would minimize the likelihood of long‐term complications related to a metal occluder. Although there are some published documents about BD ASD and patent foramen ovale occluders in animal experiments and clinical trials , a BD occluder for closure of VSD is absent. We report the results of implantation of a BD occluder in an acute canine VSD model, and evaluate the feasibility, effectiveness, and safety of the new device.…”

Double BioDisk: a new bioprosthetic device for transcatheter closure of atrial septal defects - a feasibility study in adult sheep

“…It showed accelerated healing with early endothelization and low immune response with fast ICL remodeling into connective cardiac tissue. Because of these positive results, the Biostar has already been applied successfully in treatment of ASD in children and adults 15,16,17…”