Skip to main content

ACP and Amulet: Trials and Registries Results

  • Chapter
Left Atrial Appendage Closure

Part of the book series: Contemporary Cardiology ((CONCARD))

  • 983 Accesses

Abstract

Percutaneous left atrial appendage (LAA) closure is considered an alternative to anticoagulation in patients with non valvular atrial fibrilation (NVAF) at risk of stroke or peripheral embolization. Despite the relatively recent introduction of the technique, percutaneous LAA occlusion is growing rapidly in reference centers all over the world. The Amplatzer™ Cardiac Plug (ACP) and Amplatzer™ Amulet are a first- and second-generation device for percutaneous LAA occlusion, respectively. Although no randomized trials are available, a 5-year multicenter experience with the ACP and several published registries have shown a remarkable performance of the device in terms of feasibility and safety as well as efficacy for stroke/peripheral embolism prevention and hemorrhagic risk reduction at long-term follow-up. The Amplatzer Amulet device has been recently released (CE mark since January 2013). Although similar in design, several important modifications have been added to facilitate the implantation process and reduce the number of complications.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 159.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Blackshear JL, Odell JA. Appendage obliteration to reduce stroke in cardiac surgical patients with atrial fibrillation. Ann Thorac Surg. 1996;61:755–9.

    Article  CAS  PubMed  Google Scholar 

  2. Camm AJ, Lip GY, De Caterina R, et al. 2012 Focused update of the ESC guidelines for the management of atrial fibrillation: an update of the 2010 ESC guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012;33:2719–47.

    Article  PubMed  Google Scholar 

  3. Di Biase L, Santangeli P, Anselmino M, et al. Does the left atrial appendage morphology correlate with the risk of stroke in patients with atrial fibrillation? Results from a multicenter study. J Am Coll Cardiol. 2012;60:531–8.

    Article  PubMed  Google Scholar 

  4. Freixa X, Chan JL, Tzikas A, Garceau P, Basmadjian A, Ibrahim R. The Amplatzer cardiac plug 2 for left atrial appendage occlusion: novel features and first-in-man experience. EuroIntervention. 2013;8:1094–8.

    Article  PubMed  Google Scholar 

  5. Freixa X, Tzikas A, Sobrino A, Chan J, Basmadjian AJ, Ibrahim R. Left atrial appendage closure with the Amplatzer cardiac plug: impact of shape and device sizing on follow-up leaks. Int J Cardiol. 2013;168:1023–7.

    Article  PubMed  Google Scholar 

  6. Park JW, Bethencourt A, Sievert H, et al. Left atrial appendage closure with Amplatzer cardiac plug in atrial fibrillation: initial European experience. Catheter Cardiovasc Interv. 2011;77:700–6.

    Article  PubMed  Google Scholar 

  7. Lam YY, Yip GW, Yu CM, et al. Left atrial appendage closure with AMPLATZER cardiac plug for stroke prevention in atrial fibrillation: initial Asia-Pacific experience. Catheter Cardiovasc Interv. 2012;79:794–800.

    Article  PubMed  Google Scholar 

  8. Guerios EE, Schmid M, Gloekler S, et al. Left atrial appendage closure with the Amplatzer cardiac plug in patients with atrial fibrillation. Arq Bras Cardiol. 2012;98:528–36.

    Article  PubMed  Google Scholar 

  9. Lopez-Minguez JR, Eldoayen-Gragera J, Gonzalez-Fernandez R, et al. Immediate and one-year results in 35 consecutive patients after closure of left atrial appendage with the Amplatzer cardiac plug. Rev Esp Cardiol. 2013;66:90–7.

    Article  PubMed  Google Scholar 

  10. Walsh K. Left atrial appendage closure with the amplatzer cardiac plug: results of the European prospective observational study. In: EuroPCR 2012; 2012.

    Google Scholar 

  11. Santoro G. Amplatzer cardiac plug: Italian registry. In: Progress in clinical pacing, Rome; 2010.

    Google Scholar 

  12. Urena M, Rodes-Cabau J, Freixa X, et al. Percutaneous left atrial appendage closure with the AMPLATZER cardiac plug device in patients with nonvalvular atrial fibrillation and contraindications to anticoagulation therapy. J Am Coll Cardiol. 2013;62:96–102.

    Article  PubMed  Google Scholar 

  13. Meerkin D, Butnaru A, Dratva D, Bertrand OF, Tzivoni D. Early safety of the Amplatzer cardiac plug for left atrial appendage occlusion. Int J Cardiol. 2013;168:3920–5.

    Article  PubMed  Google Scholar 

  14. Kefer J, Vermeersch P, Budts W, et al. Transcatheter left atrial appendage closure for stroke prevention in atrial fibrillation with Amplatzer cardiac plug: the Belgian Registry. Acta Cardiol. 2013;68:551–8.

    PubMed  Google Scholar 

  15. Streb W, Szymala M, Kukulski T, et al. Percutaneous closure of the left atrial appendage using the Amplatzer cardiac plug in patients with atrial fibrillation: evaluation of safety and feasibility. Kardiol Pol. 2013;71:8–16.

    PubMed  Google Scholar 

  16. Wiebe J, Bertog S, Franke J, et al. Safety of percutaneous left atrial appendage closure with the amplatzer cardiac plug in patients with atrial fibrillation and contraindications to anticoagulation. Catheter Cardiovasc Interv. 2014;83:796–802.

    Article  PubMed  Google Scholar 

  17. Holmes DR, Reddy VY, Turi ZG, et al. Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation: a randomised non-inferiority trial. Lancet. 2009;374:534–42.

    Article  CAS  PubMed  Google Scholar 

  18. Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percutaneous left atrial appendage closure: results from the Watchman left atrial appendage system for embolic protection in patients with AF (PROTECT AF) clinical trial and the continued access registry. Circulation. 2011;123:417–24.

    Article  PubMed  Google Scholar 

  19. Tzikas A, Shakir S, Gafoor S et al. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the Amplatzer cardiac plug. Eurointerventions 2015. Jan 22; 10(10)

    Google Scholar 

  20. Connolly SJ, Ezekowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139–51.

    Article  CAS  PubMed  Google Scholar 

  21. Connolly SJ, Eikelboom J, Joyner C, et al. Apixaban in patients with atrial fibrillation. N Engl J Med. 2011;364:806–17.

    Article  CAS  PubMed  Google Scholar 

  22. Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883–91.

    Article  CAS  PubMed  Google Scholar 

  23. Viles-Gonzalez JF, Kar S, Douglas P, et al. The clinical impact of incomplete left atrial appendage closure with the Watchman device in patients with atrial fibrillation: a PROTECT AF (Percutaneous closure of the left atrial appendage versus warfarin therapy for prevention of stroke in patients with atrial fibrillation) substudy. J Am Coll Cardiol. 2012;59:923–9.

    Article  PubMed  Google Scholar 

  24. Freixa X, Abualsaud A, Chan J, et al. Left atrial appendage occlusion: initial experience with the Amplatzer Amulet. Int J Cardiol. 2014;174(3):492–6.

    Article  PubMed  Google Scholar 

  25. Freixa X, Kwai Chan JL, Tzikas A, Garceau P, Basmadjian A, Ibrahim R. Percutaneous closure of a very large left atrial appendage using the Amplatzer Amulet. Can J Cardiol. 2013;29(10):1329.e9–11.

    Article  Google Scholar 

  26. Freixa X, Tzikas A, Basmadjian A, Garceau P, Ibrahim R. The chicken-wing morphology: an anatomical challenge for left atrial appendage occlusion. J Interv Cardiol. 2013;26:509–14.

    PubMed  Google Scholar 

  27. Lam SC, Bertog S, Sievert H. Incomplete left atrial appendage occlusion and thrombus formation after Watchman implantation treated with anticoagulation followed by further transcatheter closure with a second-generation Amplatzer cardiac plug (Amulet device). Catheter Cardiovasc Interv. 2015;85(2):321–7.

    Article  PubMed  Google Scholar 

  28. Gloekler S, Shakir S, Doblies J, et al. Early results of first versus second generation Amplatzer occluders for left atrial appendage closure in patients with atrial fibrillation. Clin Res Cardiol 2015 Mar 4.

    Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Apostolos Tzikas M.D., Ph.D. .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2016 Springer International Publishing Switzerland

About this chapter

Cite this chapter

Freixa, X., Tzikas, A., Ibrahim, R. (2016). ACP and Amulet: Trials and Registries Results. In: Saw, J., Kar, S., Price, M. (eds) Left Atrial Appendage Closure. Contemporary Cardiology. Humana Press, Cham. https://doi.org/10.1007/978-3-319-16280-5_13

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-16280-5_13

  • Publisher Name: Humana Press, Cham

  • Print ISBN: 978-3-319-16279-9

  • Online ISBN: 978-3-319-16280-5

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics