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Transcatheter closure of secundum atrial septal defects: has fear of device erosion altered outcomes?

Published online by Cambridge University Press:  12 January 2017

Bryan Mitchelson ,
Clare O’Donnell ,
Peter Ruygrok ,
John Wright ,
John Stirling  and
Nigel Wilson
Bryan Mitchelson
Affiliation:
Green Lane Paediatric and Congenital Cardiac Services, Starship Children’s Hospital, Auckland, New Zealand
Clare O’Donnell*
Affiliation:
Green Lane Paediatric and Congenital Cardiac Services, Starship Children’s Hospital, Auckland, New Zealand
Peter Ruygrok
Affiliation:
Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand
John Wright
Affiliation:
Green Lane Paediatric and Congenital Cardiac Services, Starship Children’s Hospital, Auckland, New Zealand
John Stirling
Affiliation:
Green Lane Paediatric and Congenital Cardiac Services, Starship Children’s Hospital, Auckland, New Zealand
Nigel Wilson
Affiliation:
Green Lane Paediatric and Congenital Cardiac Services, Starship Children’s Hospital, Auckland, New Zealand
*
Correspondence to: C. O’Donnell MBChB SM, FRACP, Paediatric/Congenital Cardiologist, Paediatric and Congenital Cardiac Service, Starship/Auckland City Hospitals, Starship Children’s Hospital Private Bag 92024, Victoria Street West, Auckland 1142, New Zealand. Tel: +64 9 307 4949, ext 23642/2361; Fax:+64 9 375 7026; E-mail: ClareOD@adhb.govt.nz
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Abstract

Background

Transcatheter device closure has become the established standard of care for suitable atrial septal defects. Device erosion has been a recent focus and has prompted changes in the Instructions for Users documentation released by device companies. We reviewed our entire local experience with atrial septal defect device closure, focussing on the evolution of this procedure in our centre and particularly on complications.

Methods

We carried out a retrospective review of 581 consecutive patients undergoing attempted transcatheter device closure of an atrial septal defect in Auckland from December 1997 to June 2014. We reviewed all complications recorded and compared our outcomes with the current literature. We sought to understand the impact of the evolution in recommendations and clinical practice on patient outcomes in our programme.

Results

There were a total of 24 complications (4.1%), including 10 device embolisations (1.7%), nine arrhythmias (1.5%), two significant vascular access-related complications (0.3%), one device erosion (0.2%), one malposed device (0.2%), and one probable wire perforation of the left atrial appendage (0.2%). There was one mortality related to device embolisation. All device embolisations occurred following the change in Instructions for Users after publication of the first device erosion report in 2004. This increase in embolisation rate was statistically significant (p-value 0.015).

Conclusions

In our series, the incidence of device embolisation was higher than that anticipated, with a significant increase following changes to the Instructions for Users. This highlights the need for ongoing data collection on complication incidence and for ongoing review of the impact of changes in clinical practice on complication rates.

Keywords

Atrial septal defectASD device closurecomplicationsembolisation
Type
Original Articles
Information
Cardiology in the Young , Volume 27 , Issue 6 , August 2017 , pp. 1153 - 1161
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Copyright
© Cambridge University Press 2017 

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