Efficacy and safety of transcatheter closure in adults with large or small atrial septal defects.
BACKGROUND
In most patients with secundum atrial septal defects (ASD), transcatheter closure is the preferred treatment strategy, but whether device size affects clinical outcomes is unknown. We sought to study the efficacy and safety of large closure devices compared to the use of smaller devices.


METHODS
Using a single-center, prospective registry of adult patients undergoing transcatheter ASD closure, patients receiving a large closure device (waist diameter ≥25 mm, n = 41) were compared to patients receiving smaller devices (waist diameter ≤24 mm, n = 66). We analyzed pre-interventional clinical, hemodynamic and echocardiographic data, interventional success and complication rates, and 6-month clinical and echocardiographic outcomes. The primary efficacy outcome was successful ASD closure achieved by a single procedure and confirmed by lack of a significant residual shunt at 6 months. The primary safety outcome was a composite of device embolization, major bleeding, and new-onset atrial arrhythmia occurring within 6 months.


RESULTS
Transcatheter ASD closure using large devices was successful in 90 % compared to 97 % of patients receiving smaller devices as defined by the primary efficacy outcome (p = 0.20). The primary safety outcome occurred in 4 patients of the large and 6 patients of the small device group, resulting in an event-free rate of 90 and 91 %, respectively (p = 0.89). Similar significant symptomatic improvement was observed in both treatment groups after 6 months, indicated by a 50 % increase in the fraction of patients in NYHA class I (p < 0.0001 vs. baseline).


CONCLUSIONS
Transcatheter closure in this cohort of patients with large or small ASD was effective with similar complication rates during short-term follow-up irrespective of the size of the implanted device.
Division of Cardiology, Department of Internal Medicine, Triemli City Hospital, Birmensdorferstrasse 497, 8063 Zurich, Switzerland.
Matthias R
MR
Meyer
Division of Cardiology, Department of Internal Medicine, Triemli City Hospital, Birmensdorferstrasse 497, 8063 Zurich, Switzerland.
David J
DJ
Kurz
Division of Cardiology, Department of Internal Medicine, Triemli City Hospital, Birmensdorferstrasse 497, 8063 Zurich, Switzerland.
Alain M
AM
Bernheim
Division of Pediatric Cardiology, Pediatric Heart Centre, University Children's Hospital, Zurich, Switzerland.
Oliver
O
Kretschmar
Division of Cardiology, Department of Internal Medicine, Triemli City Hospital, Birmensdorferstrasse 497, 8063 Zurich, Switzerland.
Franz R
FR
Eberli
Atrial septal defect; Congenital heart disease; Device size; Percutaneous transcatheter closure