CCI: BioSTAR ASD device could find home in certain pediatric patients
A bioabsorbable atrial septal defect (ASD) repair implant (BioSTAR, NMT Medical) has proved comparable to the Amplatzer Septal Occluder (ASO, AGA Medical) in children, but the BioSTAR was associated with longer procedure times, according to a study published in the July issue of Catheterization and Cardiovascular Interventions.
“Percutaneous closure of atrial defects has evolved as the treatment of choice for the majority of defects and for patent foramen ovale,” the authors wrote. However, even with use of this technique, concerns of complications and the device's ability to cause artifacts during MRI of the thorax and chronic foreign body reaction have been raised, but not resolved.
To address these concerns, Gareth Morgan, MB, BaO, of the University of Toronto School of Medicine, and colleagues investigated the partially resorbable implant in 10 children undergoing ASD closure between Nov. 1, 2007, and Nov. 30, 2008. Inclusion criteria was a balloon-stretched atrial defect with a diameter that was 16 mm or less.
The BioSTAR group was matched to patients undergoing ASD closure with an ASO implant.
The BioSTAR device is based on NMT’s STARflex device equipped with double umbrella stainless steel arms, a nitinol wire and two discs of acellular porcine collagen. The device is available in 23 mm, 28 mm and 33 mm diameters.
The BioStar arm received six 28 mm and four 33 mm devices, while the sizes in the ASO arm ranged from 5 to 22 mm.
Subsequent to the procedures, investigators followed up with transthoracic echocardiography within 24 hours, at 30 to 60 days and once after six months. The patients were also administered 3-5 mg/kg of acetylsalicylic acid per day.
Nine out of 10 BioSTAR implants were performed using intracardiac echo (ICE) guidance, while two of the 10 ASO implants were performed using ICE. Transesophageal guidance was used in the other cases.
All device implants were successful and 24-hour and six-month occlusion rates were 90 and 100 percent, respectively, for the BioSTAR arm and 100 percent at both times for the ASO arm.
One child did not achieve immediate complete occlusion due to a trivial leak related to prolapse of the superiorly oriented arm of the left-sided disc into the right atrium.
Procedural times differed significantly—52 minutes in the BioSTAR arm compared with 39.5 minutes in the ASO arm. Fluoroscopy times were 6.7 minutes and 6.1 minutes, respectively.
No vascular complications or thrombotic or bleeding complications were present in either group during the study and recovery time and hospital length of stay were similar in both study arms.
“Given the device’s unique biomechanical features, the procedural and early-term follow-up and the potential intrinsic benefits, the BioSTAR implant should be considered in cases of a small to moderate defect with the appropriate morphology,” the authors concluded.
However, "given the familiarity of most operators with the STARflex platform, the technical application in the clinical setting, i.e., the learning curve, may be steep."
“Percutaneous closure of atrial defects has evolved as the treatment of choice for the majority of defects and for patent foramen ovale,” the authors wrote. However, even with use of this technique, concerns of complications and the device's ability to cause artifacts during MRI of the thorax and chronic foreign body reaction have been raised, but not resolved.
To address these concerns, Gareth Morgan, MB, BaO, of the University of Toronto School of Medicine, and colleagues investigated the partially resorbable implant in 10 children undergoing ASD closure between Nov. 1, 2007, and Nov. 30, 2008. Inclusion criteria was a balloon-stretched atrial defect with a diameter that was 16 mm or less.
The BioSTAR group was matched to patients undergoing ASD closure with an ASO implant.
The BioSTAR device is based on NMT’s STARflex device equipped with double umbrella stainless steel arms, a nitinol wire and two discs of acellular porcine collagen. The device is available in 23 mm, 28 mm and 33 mm diameters.
The BioStar arm received six 28 mm and four 33 mm devices, while the sizes in the ASO arm ranged from 5 to 22 mm.
Subsequent to the procedures, investigators followed up with transthoracic echocardiography within 24 hours, at 30 to 60 days and once after six months. The patients were also administered 3-5 mg/kg of acetylsalicylic acid per day.
Nine out of 10 BioSTAR implants were performed using intracardiac echo (ICE) guidance, while two of the 10 ASO implants were performed using ICE. Transesophageal guidance was used in the other cases.
All device implants were successful and 24-hour and six-month occlusion rates were 90 and 100 percent, respectively, for the BioSTAR arm and 100 percent at both times for the ASO arm.
One child did not achieve immediate complete occlusion due to a trivial leak related to prolapse of the superiorly oriented arm of the left-sided disc into the right atrium.
Procedural times differed significantly—52 minutes in the BioSTAR arm compared with 39.5 minutes in the ASO arm. Fluoroscopy times were 6.7 minutes and 6.1 minutes, respectively.
No vascular complications or thrombotic or bleeding complications were present in either group during the study and recovery time and hospital length of stay were similar in both study arms.
“Given the device’s unique biomechanical features, the procedural and early-term follow-up and the potential intrinsic benefits, the BioSTAR implant should be considered in cases of a small to moderate defect with the appropriate morphology,” the authors concluded.
However, "given the familiarity of most operators with the STARflex platform, the technical application in the clinical setting, i.e., the learning curve, may be steep."