Hostname: page-component-586b7cd67f-dsjbd Total loading time: 0 Render date: 2024-11-22T23:39:56.473Z Has data issue: false hasContentIssue false
  • English
  • Français

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: [email protected]
Get access Rights & Permissions [Opens in a new window]

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
Check for updates
Copyright
© Cambridge University Press 2017 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1. Hoffman, JI, Kaplan, S. The incidence of congenital heart disease. J Am Coll Cardiol 2002; 39: 1890–1900.Google Scholar
2. King, TD, Thompson, SL, Steiner, C, et al. Secundum atrial septal defect. Nonoperative closure during cardiac catheterization. JAMA 1976; 235: 2506–2509.Google Scholar
3. Roos-Hesselink, JW, Meijboom, FJ, Spitaels, SE, et al. Excellent survival and low incidence of arrhythmias, stroke and heart failure long-term after surgical ASD closure at young age. A prospective follow-up study of 21-33 years. Eur Heart J 2003; 24: 190–197.Google Scholar
4. Du, ZD, Hijazi, ZM, Kleinman, CS, et al. Comparison between transcatheter and surgical closure of secundum atrial septal defect in children and adults: results of a multicenter nonrandomized trial. J Am Coll Cardiol 2002; 39: 1836–1844.Google Scholar
5. Bialkowski, J, Karwot, B, Szkutnik, M, et al. Closure of atrial septal defects in children: surgery versus Amplatzer device implantation. Tex Heart Inst J 2004; 31: 220–223.Google Scholar
6. Berger, F, Vogel, M, Alexi-Meskishvili, V, et al. Comparison of results and complications of surgical and Amplatzer device closure of atrial septal defects. J Thorac Cardiovasc Surg 1999; 118: 674–678; discussion 78–80.Google Scholar
7. Romanelli, G, Harper, RW, Mottram, PM. Transcatheter closure of secundum atrial septal defects: results in patients with large and extreme defects. Heart Lung Circ 2014; 23: 127–131.CrossRefGoogle ScholarPubMed
8. Varma, C, Benson, LN, Silversides, C, et al. Outcomes and alternative techniques for device closure of the large secundum atrial septal defect. Catheter Cardiovasc Interv 2004; 61: 131–139.Google Scholar
9. Moore, J, Hegde, S, El-Said, H, et al. Transcatheter device closure of atrial septal defects: a safety review. JACC Cardiovasc Interv 2013; 6: 433–442.Google Scholar
10. Divekar, A, Gaamangwe, T, Shaikh, N, et al. Cardiac perforation after device closure of atrial septal defects with the Amplatzer septal occluder. J Am Coll Cardiol 2005; 45: 1213–1218.Google Scholar
11. DiBardino, DJ, McElhinney, DB, Kaza, AK, et al. Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience database for adverse events involving Amplatzer septal occluder devices and comparison with the Society of Thoracic Surgery congenital cardiac surgery database. J Thorac Cardiovasc Surg 2009; 137: 1334–1341.Google Scholar
12. Circulatory System Devices Advisory Panel. ed. FDA Executive Summary Memorandum. Transcatheter ASD Occluders: Clinical Update and Review of Events. Circulatory System Devices Advisory Panel; 2012 24 May 2012; Gaithersburg, MD. Center for Devices and Radiological Health. US Food and Drug Administration, Gaithersburg, Maryland.Google Scholar
13. El-Said, HG, Moore, JW. Erosion by the Amplatzer septal occluder: experienced operator opinions at odds with manufacturer recommendations? Catheter Cardiovasc Interv 2009; 73: 925–930.CrossRefGoogle ScholarPubMed
14. AGA Medical Corporation. AMPLATZER® Septal Occluder and Delivery System. Physician Manual. St Jude Medical, St Paul, Minnesota, 2001.Google Scholar
15. Everett, AD, Jennings, J, Sibinga, E, et al. Community use of the amplatzer atrial septal defect occluder: results of the multicenter MAGIC atrial septal defect study. Pediatr Cardiol 2009; 30: 240–247.Google Scholar
16. Haas, NA, Soetemann, DB, Ates, I, et al. Closure of secundum atrial septal defects by using the occlutech occluder devices in more than 1300 patients: The IRFACODE project: a retrospective case series. Catheter Cardiovasc Interv 2016; 88: 571–581.Google Scholar
17. Chessa, M, Carminati, M, Butera, G, et al. Early and late complications associated with transcatheter occlusion of secundum atrial septal defect. J Am Coll Cardiol 2002; 39: 1061–1065.Google Scholar
18. Levi, DS, Moore, JW. Embolization and retrieval of the Amplatzer septal occluder. Catheter Cardiovasc Interv 2004; 61: 543–547.Google Scholar
19. Johnson, JN, Marquardt, ML, Ackerman, MJ, et al. Electrocardiographic changes and arrhythmias following percutaneous atrial septal defect and patent foramen ovale device closure. Catheter Cardiovasc Interv 2011; 78: 254–261.Google Scholar
20. Amin, Z, Hijazi, ZM, Bass, JL, et al. Erosion of Amplatzer septal occluder device after closure of secundum atrial septal defects: review of registry of complications and recommendations to minimize future risk. Catheter Cardiovasc Interv 2004; 63: 496–502.CrossRefGoogle ScholarPubMed
21. McElhinney, DB, Quartermain, MD, Kenny, D, et al. Relative risk factors for cardiac erosion following transcatheter closure of Atrial septal defects: a case-control study. Circulation 2016; 133: 1738–1746.Google Scholar