Heart 1998;80:517-521 ( November )
Percutaneous closure of secundum atrial septal defect with a new self centring device ("angel wings")
a Department of Paediatric Cardiology,
University Hospital Eppendorf, Hamburg, Germany, b Department of Cardiology,
University Hospital Eppendorf, c Department of Cardiology, Hospital
Bethanien, Frankfurt, Germany, d Department of Paediatric Cardiology, University
Hospital Gie
en, Germany, e Department of Paediatric Cardiology, University Hospital,
Münster, Germany, f Department of Paediatric Cardiology, Heart Center Munich,
Germany, g Department of
Cardiology, Heart Center Bad Oeynhausen, Germany, h Department of Cardiology, Charité Campus
Virchow Klinikum, Humboldt University of Berlin and German Heart
Institute Berlin, Germany
Correspondence to: Dr C Rickers, University Hospital Eppendorf, Department of Paediatric Cardiology, Martinistrasse 52 20246 Hamburg, Germany.
Accepted for publication 24 June 1998
Objective
To investigate the safety, efficacy, and
clinical application of a new self centring device ("angel wings")
for closure of secundum atrial septal defects (ASD II) and persistent
foramen ovale in all age groups.
DesignMulticentre, prospective, non-randomised study.
PatientsInclusion criteria: defects with an
occlusive diameter of 
20 mm and a surrounding rim of > 4 mm;
body weight > 10 kg; and an indication for surgical closure of
secundum atrial septal defect. Additionally, there were compassionate
indications for closure in patients with persistent foramen ovale.
InterventionsDefects were closed by a
transcatheter device consisting of two square frames made of
superelastic nitinol wire. The frames are covered by elastic polyester
fabric, which is sewn together at a central circle. All procedures,
except for three interventions that were carried out under sedation,
were performed under general anaesthesia using transoesophageal
echocardiography and fluoroscopy to monitor intervention.
ResultsClosure was attempted in 75 (71%) of 105 patients. An ASD II was present in 35 children and 15 adults. A
persistent foramen ovale was present in 25 adults with suspected
paradoxical embolism. Transcatheter closure was unsuccessful in three
children and crossover to surgery was required. Residual shunts were
found in 20 patients (27%) immediately after the procedure. A
transient atrioventricular third degree block occurred in three
patients (4%) and the right atrial disk was not fully deployed in
three. A minor shunt (< 3 mm) was present in only three (4%) of 72 patients during follow up of 1-17 months. Blood clots on the right
atrial disks in two patients (one required lysis) were seen during
follow up transoesophageal echocardiography. Serious complications
demanding surgical removal of the device occurred in three patients.
One patient had haemopericardial tamponade because of an aortic lesion.
Left atrial thrombus formation due to an unfolded right atrial disk was
found in a second patient and dislodgement of the left atrial disk
resulted in a large residual shunt in a third.
ConclusionsPercutaneous closure of a central ASD
with a diameter 20 mm in paediatric and adult patients is
feasible and effective with this new device. It is a promising
alternative to surgical closure. Modifications of the design, however,
seem to be mandatory as 4% of patients developed serious complications.
© 1998 by Heart
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