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

Abstract

The BioSTAR implant can achieve comparable closure rates to the ASO in small- to moderate-atrial septal defects with only a minimal skeleton of foreign material remaining after 6 months. Longer fluoroscopy and procedure times were a drawback; however, these should improve with familiarity with the implant and deployment system.

Historical developments of atrial septal defect closure devices: what we learn from the past

“…Closure rates at 1 and 6 months were 92% and 96%, respectively, as assessed by contrast TTE. Similar closure rates of 97-100% at 6-8 months have been reported in other studies [73,77]. It is still unknown whether defect sealing remained intact on the long term.…”

“…Limitations included concerns regarding efficacy in larger defects, the need for 11-F delivery sheaths with potential risks of vascular injury, fewer size options compared with ASO devices, and longer procedural time [77]. Dislocation of the device's residual framework had been reported more than 6 months post-procedurally, which led to aortic root perforation [78,79].…”

Platelet Activation Through the Efficacy of Aspirin in Congenital Heart Disease Patients Undergoing Transcatheter Closure of Atrial Septal Defects or Ventricular Septal Defects

“…This result may possibly be correlated with longer operative time and severe endangium injury of VSD occlusion, whereas patients treated with VSD occlusion need multiple radiography and so on (Li et al, 2008;Morgan et al, 2010). In our study, the GMP-140 serum level was increased after ASD and VSD occlusion, suggesting that patients who underwent these surgeries need antiplatelet therapy, which is the basis of oral anticoagulation and aspirin after VSD or ASD occlusion (Majunke et al, 2009).…”

Comparison Between the New Gore Septal and Amplatzer Devices For Transcatheter Closure of Patent Foramen Ovale

“…15 GSO devices were easily implanted. The procedural and fluoroscopy times compare favorably with those of most commonly used devices 16 and are lower than those of the Helex device registered in our previously published series of patients 6 despite being in the "learning curve" of new device implantation. GSO was successfully deployed in all patients.…”