Interventional occlusion of left atrial appendage in patients with atrial fibrillation. Acute and long-term outcome of occluder implantation in the LAARGE Registry

Abstract

Background

Left atrial appendage occluder (LAAO) implantation is an alternative method for stroke prevention in atrial fibrillation (AF) patients who are not eligible for long-term oral anticoagulation. The present paper describes the acute and 1-year follow-up outcome data of the prospective, multicenter German left atrial appendage occlusion registry (LAARGE).

Methods

LAARGE enrolled 641 patients who were scheduled for LAAO implantation. The data collected included demographics, clinical characteristics, procedure indication, details of implantation, and outcome; patients were followed at 1-year post-implant. Efficacy and safety during follow-up are assessed by the occurrence of thrombembolic and bleeding events, respectively.

Results

A total of 641 consecutive patients (mean age: 75.9 ± 8.0) were enrolled from July 2014 to January 2016 in 38 hospitals in Germany. Patient demographics represent a critically-ill population with a calculated mean CHA2DS2-VASc score and HASBLED score of 4.5 and 3.9, respectively, with bleeding events as the main indication for LAAO implantation (79.4%). One-year all-cause mortality post-procedure was 11.5% with a non-fatal stroke/TIA rate of 1.3% (8 patients) and a rate of major bleeding of 1.6% (10 patients). The anticoagulation regimen after 1 year consisted of oral anticoagulation in 5.5% of patients and an antiplatelet therapy (APT) rate of 84.1% (majority single APT with ASS (74.5%), dual APT in 6.7%).

Conclusions

LAARGE, a prospective multicenter real-world and all-comer registry, is unique in its concept, as it is non-manufacturer sponsored and includes all commercially available devices. LAAO implantation is mainly performed in elderly, critically-ill patients with a history of bleeding. LAARGE demonstrates a favorable outcome at 1-year follow-up in terms of stroke/TIA (1.3%) and major bleeding (1.6%) while using a single APT in the vast majority of patients.

This is a preview of subscription content, access via your institution.

Fig. 1
Fig. 2

Abbreviations

LAAO:

left atrial appendage occluder

AF :

atrial fibrillation

OAC:

oral anticoagulation

LAARGE :

Left Atrial Appendage Occlusion Registry Germany

CAD :

coronary artery disease

CKD :

chronic kidney disease

References

  1. 1.

    Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the anticogulation and risk factors in atrial fibrillation (ATRIA) study. JAMA. 2001;285:2370–5.

    CAS  Article  Google Scholar 

  2. 2.

    Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham study. Stroke. 1991;22:983–8.

    CAS  Article  Google Scholar 

  3. 3.

    Gladstone DJ, Bui E, Fang J, Laupacis A, Lindsay MP, Tu JV, et al. Potentially preventable strokes in high-risk patients with atrial fibrillation who are not adequately anticoagulated. Stroke. 2009;40:235–40.

    CAS  Article  Google Scholar 

  4. 4.

    Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, et al. 2016 ESC Guidelines for the Management of Atrial Fibrillation Developed in Collaboration with EACTS. Eur Heart J. 2016.

  5. 5.

    Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2011;365:981-992

  6. 6.

    Madden JL. Resection of the left auricular appendix; a prophylaxis for recurrent arterial emboli. J Am Med Assoc. 1949;140:769–72.

    CAS  Article  Google Scholar 

  7. 7.

    Holmes DR, Reddy VY, Turi ZG, Doshi SK, Sievert H, Buchbinder M, 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.

    CAS  Article  Google Scholar 

  8. 8.

    Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, et al. Holmes D; PROTECT AF Investigators. Percutaneous left atrial appendage closure for stroke prophylaxis in patients with atrial fibrillation: 2.3-year follow-up of the PROTECT AF (Watchman Left Atrial Appendage System for Embolic Protection in Patients with Atrial Fibrillation) trial. Circulation. 2013;127:720–9.

    Article  Google Scholar 

  9. 9.

    Reddy VY, Holmes D, Doshi SK, Neuzil P, Kar S. Safety of percuatenous left atrial appendage closure: results from the Watchmann 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  Google Scholar 

  10. 10.

    Boersma LV, Schmidt B, Betts TR, Sievert H, Tamburino C, Teiger E, Pokushalov E, Kische S, Schmitz T, Stein KM, Bergmann MW; EWOLUTION investigators. Implant success and safety of left atrial appendage closure with the WATCHMAN device: peri-procedural outcomes from the EWOLUTION registry. Eur Heart J 2016;37:2465-2474.

  11. 11.

    Reddy VY, Möbius-Winkler S, Miller MA, Neuzil P, Schuler G, Wiebe J, et al. Left atrial appendage closure with the Watchman device in patients with a contraindication for oral anticoagulation: the ASAP study (ASA Plavix Feasibility Study With Watchman Left Atrial Appendage Closure Technology). J Am Coll Cardiol. 2013;61:2551–6.

    Article  Google Scholar 

  12. 12.

    Tzikas A, Holmes DR Jr, Gafoor S, Ruiz CE, Blomström-Lundqvist C, Diener HC, et al. Percutaneous left atrial appendage occlusion: the Munich consensus document on definitions, endpoints, and data collection requirements for clinical studies. Europace. 2017;19(1):4–15.

    PubMed  Google Scholar 

  13. 13.

    Boersma LV, Ince H, Kische S, et al. EWOLUTION Investigators. Efficacy and safety of left atrial appendage closure with WATCHMAN in patients with or without contraindication to oral anticoagulation: 1-Year follow-up outcome data of the EWOLUTION trial. Heart Rhythm. 2017;14(9):1302–8.

    Article  Google Scholar 

  14. 14.

    Tzikas A, Shakir S, Gafoor S, Omran H, Berti S, Santoro G, et al. Left atrial appendage occlusion for stroke prevention in atrial fibrillation: multicentre experience with the AMPLATZER Cardiac Plug. EuroIntervention. 2016;11(10):1170–9.

    Article  Google Scholar 

Download references

Author information

Affiliations

Authors

Corresponding author

Correspondence to Thorsten Lewalter.

Ethics declarations

Conflict of interest

T.L., J.B., and H.S. have received moderate speaker honoraria from Boston Scientific and Abbott, no conflict of interest for the remaining authors

Ethical approval

The LAARGE registry received ethical approval in April 2014 from the State Chamber of Medicine of Rhineland-Palatinate. All aspects of the registry comply with the principles of Good Clinical Practice (GCP) and the Declaration of Helsinki.

Informed consent

All enrolled patients provided written informed consent to be included in the registry and to participate in the follow-up.

Additional information

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

ESM 1

(DOC 929 kb)

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Brachmann, J., Lewalter, T., Akin, I. et al. Interventional occlusion of left atrial appendage in patients with atrial fibrillation. Acute and long-term outcome of occluder implantation in the LAARGE Registry. J Interv Card Electrophysiol 58, 273–280 (2020). https://doi.org/10.1007/s10840-019-00635-7

Download citation

Keywords

  • Atrial fibrillation
  • Left atrial appendage occluder
  • Stroke