Transcatheter closure of atrial septal defect and interatrial communications with a new self expanding nitinol double disc device (Amplatzer septal occluder): multicentre UK experience
K C Chana, M J Godmanb, K Walshc, N Wilsond, A Redingtone, J L Gibbsf
a Glenfield
Hospital, Groby Road, Leicester LE3 9QP, UK, b Royal Hospital for Sick Children, Edinburgh EH9
1LF, UK, c Alder Hey Children's
Hospital, Liverpool L12 2AP, UK, d Royal
Hospital for Sick Children, Glasgow G3 8SL, UK, e Brompton Hospital, Sydney Street, London SW3
6NP, UK, f Yorkshire Heart
Institute, Leeds LS1 3EX, UK
Correspondence to: Dr Chan. email: chen.chan{at}glenfield-tr.trent.nhs.uk
Accepted for publication 11 January 1999
OBJECTIVE
To review
the safety and efficacy of the Amplatzer septal occluder for
transcatheter closure of interatrial communications (atrial septal
defects (ASD), fenestrated Fontan (FF), patent foramen ovale (PFO)).
DESIGN
Prospective
study following a common protocol for patient selection and technique
of deployment in all participating centres.
SETTING
Multicentre
study representing total United Kingdom experience.
PATIENTS
First 100 consecutive patients in whom an Amplatzer septal occluder was used to
close a clinically significant ASD or interatrial communication.
INTERVENTIONS
All
procedures performed under general anaesthesia with
transoesophageal echocardiographic guidance. Interatrial
communications were assessed by transoesophageal echocardiography with
reference to size, position in the interatrial septum, proximity to
surrounding structures, and adequacy of septal rim. Stretched diameter
of the interatrial communications was determined by balloon sizing. Device selection was based on and matched to the stretched diameter of
the communication.
MAIN OUTCOME
MEASURES
Success defined as deployment of device
in a stable position to occlude the interatrial communication without
inducing functional abnormality or anatomical obstruction. Occlusion
status determined by transoesophageal echocardiography during
procedure and by transthoracic echocardiography on follow up. Clinical
status and occlusion rates assessed at 24 hours, one month, and three months.
RESULTS
101 procedures
were performed in 100 patients (86 ASD, 7 FF, 7 PFO), age 1.7 to 64.3 years (mean (SD), 13.3 (13.9)), weight 9.2 to 100.0 kg (mean 32.5 (23.5)). Procedure time ranged from 30 to 180 minutes (mean 92.4 (29.0)) and fluoroscopy time from 6.0 to 49.0 minutes (mean 16.1 (8.0)). There were seven failures, all occurring in patients with ASD,
and one embolisation requiring surgical removal. Immediate total
occlusion rate was 20.4%, rising to 84.9% after 24 hours. Total
occlusion rates at the one and three month follow up were 92.5% and
98.9%, respectively. Complications were: transient ST elevation (1),
transient atrioventricular block (1), presumed deep vein thrombosis
(1), presumed transient ischaemic attack (1).
CONCLUSIONS
It appears
feasible to close interatrial communications and atrial septal defects
up to 26 mm stretched diameter safely with the Amplatzer septal
occluder. Short term results confirm an early high occlusion rate with
no major complications. Careful selection of cases based on the
echocardiographic morphology of the ASD and accurate assessment of
their stretched diameter is of utmost importance. Further experience
with the larger devices and longer term results are required before a
firm conclusion regarding its use can be made.
Keywords: interatrial communications; atrial septal defect; Amplatzer septal occluder; congenital heart defects
© 1999 by Heart
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