Key result
Cardioseal/Starflex ASD closure devices are linked to a ~15% failure rate vs Amplatzer or ASDOS.
Why the study?
Does the type of device used for percutaneous closure of a secundum ASD in adults affect the rate of device failure and complications?
Cohort (n=65)
No
Does the type of device used for percutaneous closure of a secundum ASD in adults affect the rate of device failure and complications?
While percutaneous ASD closure is generally safe and effective, the use of larger Cardioseal/Starflex devices is associated with a higher risk of device dislocation and embolization requiring surgical intervention.
Answers are grounded in this paper and cite their sources.
May warrant caution with Cardioseal/Starflex in adult ASD closure; leaves open need for randomized device comparisons.
The objective of this study was to find differences in outcome and complications using three different types of devices for percutaneous atrial septal defect (ASD) closure in adults. Percutaneous closure of a secundum-type ASD is increasingly performed in adult patients. All adult patients who underwent a percutaneous closure of a secundum-type ASD in our center between November 1996 and November 2004 were included. Failure was defined as dislocation or embolization of the device, which required surgical intervention. Periprocedural and mid-term complications were registered. Sixty-five patients, mean age 45.7+/-18.1 years (18 men, 47 women), underwent a percutaneous closure of an ASD with an ASDOS in 3, an Amplatzer in 36, and a Cardioseal/Starflex closure device in 26 patients. During an overall median follow-up of 1.2 years (range, 0.1-6.7 years), the failure occurred in four patients, all Cardioseal/Starflex (P=0.04). Within the Cardioseal/Starflex subgroup, the ASD and device diameters were significantly higher in those patients in whom the primary endpoint occurred compared to the others, 18.8+/-3.8 vs. 13.0+/-3.8 mm for ASD diameter (P=0.01) and 40 (range, 40-43) vs. 33 mm (range, 20-40) for device diameter (P=0.008). Overall complications were transient arrhythmias in 15.4%, pericardial effusion in 1.5%, and transient ischemic attack in 1.5%. Complete closure 6 months after the procedure occurred in 79.6%, without difference between the devices. Percutaneous ASD closure seems to be a relatively safe and effective procedure. However, using the larger Cardioseal/Starflex devices for closure seems to be related to a higher rate of device dislocation and embolization.
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Post et al. (2006) conducted a cohort in secundum atrial septal defect (n=65). Cardioseal/Starflex closure device vs. Amplatzer or ASDOS closure devices was evaluated on Failure (dislocation or embolization of the device requiring surgical intervention) (p=0.04). Among adults undergoing percutaneous ASD closure, the Cardioseal/Starflex device was associated with a higher rate of device failure compared to Amplatzer or ASDOS devices.
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