Left atrial appendage occlusion for ischemic stroke prevention in patients with non-valvular atrial fibrillation: clinical expert opinion and consensus statement for the Asian-Pacific region

Abstract

Purpose

To develop a consensus statement for left atrial appendage occlusion (LAAO) in Asian-Pacific patients with non-valvular atrial fibrillation (NVAF) at risk of ischemic stroke. The need for such a region-specific consensus was indicated by the relative paucity of clinical evidence for LAAO and oral anticoagulation therapy obtained in Asian-Pacific populations and the specific stroke and bleeding characteristics of this population.

Methods

Consensus was developed by discussion and evaluation of available evidence and expert opinions during a 2-day meeting attended by clinical experts from the Asian-Pacific regions.

Results

The consensus statement arrived at provides recommendations based on available evidence and expert opinions regarding LAAO in Asian-Pacific patients. Gaps in the evidence and other areas requiring further research were identified.

Conclusion

LAAO is an alternative device-based therapy in carefully selected patients with NVAF at risk of ischemic stroke. However, evidence for LAAO is primarily obtained from Caucasian populations, and data on LAAO in Asian-Pacific patients are scarce. While the present consensus statement addresses several therapy-related aspects based on careful interpretation of available evidence and expert opinions, other areas require additional evidence derived from Asian-Pacific populations.

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References

  1. 1.

    Ezekowitz MD, Bridgers SL, James KE, Carliner NH, Colling CL, Gornick CC, et al. Warfarin in the prevention of stroke associated with nonrheumatic atrial fibrillation. Veterans affairs stroke prevention in nonrheumatic atrial fibrillation investigators. N Engl J Med. 1992;327:1406–12.

    CAS  PubMed  Google Scholar 

  2. 2.

    Singer DE, Hughes RA, Gress DR, Sheehan MA, Oertel LB, Maraventano SW, et al. The effect of low-dose warfarin on the risk of stroke in patients with nonrheumatic atrial fibrillation. N Engl J Med. 1990;323:1505–11.

    PubMed  Google Scholar 

  3. 3.

    The stroke prevention in atrial fibrillation investigators. Stroke prevention in atrial fibrillation study. Final results. Circulation. 1991;84:527–39.

  4. 4.

    Hylek EM, Evans-Molina C, Shea C, Henault LE, Regan S. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation. 2007;115:2689–96.

    CAS  PubMed  Google Scholar 

  5. 5.

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

    CAS  PubMed  Google Scholar 

  6. 6.

    Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883–91.

    CAS  PubMed  Google Scholar 

  7. 7.

    Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, et al. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011;365:981–92.

    CAS  PubMed  Google Scholar 

  8. 8.

    Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013;369:2093–104.

    CAS  PubMed  Google Scholar 

  9. 9.

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

    CAS  PubMed  Google Scholar 

  10. 10.

    Cresti A, García-Fernández MA, Sievert H, Mazzone P, Baratta P, Solari M, et al. Prevalence of extra-appendage thrombosis in non-valvular atrial fibrillation and atrial flutter in patients undergoing cardioversion: a large transoesophageal echo study. EuroIntervention. 2019;15:e225–30.

    PubMed  Google Scholar 

  11. 11.

    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  PubMed  Google Scholar 

  12. 12.

    Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, et al. Prospective randomized evaluation of the Watchman left atrial appendage closure device in patients with atrial fibrillation versus long-term warfarin therapy: the PREVAIL trial. J Am Coll Cardiol. 2014;64:1–12.

    PubMed  Google Scholar 

  13. 13.

    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;11:1170–9.

    PubMed  Google Scholar 

  14. 14.

    Landmesser U, Tondo C, Camm J, Diener HC, Paul V, Schmidt B, et al. Left atrial appendage occlusion with the AMPLATZER amulet device: one-year follow-up from the prospective global amulet observational registry. EuroIntervention. 2018;14:e590–e7.

    PubMed  Google Scholar 

  15. 15.

    Boersma LV, Ince H, Kische S, Pokushalov E, Schmitz T, Schmidt B, et al. 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;14:1302–8.

    PubMed  Google Scholar 

  16. 16.

    Holmes DR, Reddy VY, Buchbinder M, Stein K, Elletson M, Bergmann MW, et al. The assessment of the Watchman device in patients unsuitable for oral anticoagulation (ASAP-TOO) trial. Am Heart J. 2017;189:68–74.

    PubMed  Google Scholar 

  17. 17.

    Mas JL, Derumeaux G, Guillon B, Massardier E, Hosseini H, Mechtouff L, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017;377:1011–21.

    CAS  PubMed  Google Scholar 

  18. 18.

    Hausler KG, Endres M, Landmesser U. Left atrial appendage occlusion in patients with nonvalvular atrial fibrillation : present evidence, ongoing studies, open questions. Med Klin-Intensivmed. 2018. https://doi.org/10.1007/s00063-018-0500-4.

  19. 19.

    Tilz RR, Potpara T, Chen J, Dobreanu D, Larsen TB, Haugaa KH, et al. Left atrial appendage occluder implantation in Europe: indications and anticoagulation post-implantation. Results of the European Heart Rhythm Association Survey. Europace. 2017;19:1737–42.

    PubMed  Google Scholar 

  20. 20.

    Schmidt B, Chun KR. Antithrombotic therapy after left atrial appendage closure. Expert Rev Cardiovasc Ther. 2015;13:105–9.

    CAS  PubMed  Google Scholar 

  21. 21.

    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;37:2893–962.

    PubMed  Google Scholar 

  22. 22.

    January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, et al. 2019 AHA/ACC/HRS focused update of the 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2019;74:104–32.

    PubMed  Google Scholar 

  23. 23.

    Glikson M, Wolff R, Hindricks G, Mandrola J, Camm AJ, Lip GYH, et al. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion - an update. EuroIntervention. 2020;15:1133–80.

    PubMed  Google Scholar 

  24. 24.

    Casu G, Gulizia MM, Molon G, Mazzone P, Audo A, Casolo G, et al. ANMCO/AIAC/SICI-GISE/SIC/SICCH consensus document: percutaneous occlusion of the left atrial appendage in non-valvular atrial fibrillation patients: indications, patient selection, staff skills, organisation, and training. Eur Heart J Suppl. 2017;19:D333–D53.

    PubMed  PubMed Central  Google Scholar 

  25. 25.

    Kavinsky CJ, Kusumoto FM, Bavry AA, Bailey SR, Ellenbogen KA, Hess PL, et al. SCAI/ACC/HRS institutional and operator requirements for left atrial appendage occlusion. J Am Coll Cardiol. 2016;67:2295–305.

    PubMed  Google Scholar 

  26. 26.

    Guo Y, Tian Y, Wang H, Si Q, Wang Y, Lip GYH. Prevalence, incidence, and lifetime risk of atrial fibrillation in China: new insights into the global burden of atrial fibrillation. Chest. 2015;147:109–19.

    PubMed  Google Scholar 

  27. 27.

    Phillips KP, Santoso T, Sanders P, Alison J, Chan JLK, Pak H-N, et al. Left atrial appendage closure with WATCHMAN in Asian patients: 2 year outcomes from the WASP registry. Int J Cardiol Heart Vasc. 2019;23:100358.

    PubMed  PubMed Central  Google Scholar 

  28. 28.

    Chiang CE, Wang KL, Lip GY. Stroke prevention in atrial fibrillation: an Asian perspective. Thromb Haemost. 2014;111:789–97.

    CAS  PubMed  Google Scholar 

  29. 29.

    Hori M, Connolly SJ, Zhu J, Liu LS, Lau CP, Pais P, et al. Dabigatran versus warfarin: effects on ischemic and hemorrhagic strokes and bleeding in Asians and non-Asians with atrial fibrillation. Stroke. 2013;44:1891–6.

    CAS  PubMed  Google Scholar 

  30. 30.

    Lip GY, Wang KL, Chiang CE. Non-vitamin K antagonist oral anticoagulants (NOACs) for stroke prevention in Asian patients with atrial fibrillation: time for a reappraisal. Int J Cardiol. 2015;180:246–54.

    PubMed  Google Scholar 

  31. 31.

    Chan YH, Lee HF, See LC, Tu HT, Chao TF, Yeh YH, et al. Effectiveness and safety of four direct oral anticoagulants in Asian patients with nonvalvular atrial fibrillation. Chest. 2019;156:529–43.

    PubMed  Google Scholar 

  32. 32.

    Zhang J, Tang J, Cui X, Wang B, Bu M, Bai Y, et al. Indirect comparison of novel oral anticoagulants among Asians with non-Valvular atrial fibrillation in the real world setting: a network meta-analysis. BMC Cardiovas Disord. 2019;19:182.

    Google Scholar 

  33. 33.

    Lee SR, Lee YS, Park JS, Cha MJ, Kim TH, Park J, et al. Label adherence for non-vitamin K antagonist oral anticoagulants in a prospective cohort of Asian patients with atrial fibrillation. Yonsei Med J. 2019;60:277–84.

    CAS  PubMed  PubMed Central  Google Scholar 

  34. 34.

    Yasaka M, Lip GY. Impact of non-vitamin K antagonist oral anticoagulants on intracranial bleeding in Asian patients with non-valvular atrial fibrillation. Circ J. 2014;78:2367–72.

    CAS  PubMed  Google Scholar 

  35. 35.

    Shen AY-J, Yao JF, Brar SS, Jorgensen MB, Chen W. Racial/ethnic differences in the risk of intracranial hemorrhage among patients with atrial fibrillation. J Am Coll Cardiol. 2007;50:309–15.

    PubMed  Google Scholar 

  36. 36.

    Bang OY, Hong K-S, Heo JH. Asian patients with stroke plus atrial fibrillation and the dose of non-vitamin K oral anticoagulants. J Stroke. 2016;18:169–78.

    PubMed  PubMed Central  Google Scholar 

  37. 37.

    Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener H-C, Dubner SJ, et al. The changing landscape for stroke prevention in AF: findings from the GLORIA-AF registry phase 2. J Am Coll Cardiol. 2017;69:777–85.

    PubMed  Google Scholar 

  38. 38.

    Chan YH, Kuo CT, Yeh YH, Chang SH, Wu LS, Lee HF, et al. Thromboembolic, bleeding, and mortality risks of rivaroxaban and dabigatran in Asians with nonvalvular atrial fibrillation. J Am Coll Cardiol. 2016;68:1389–401.

    CAS  PubMed  Google Scholar 

  39. 39.

    Cha MJ, Choi EK, Han KD, Lee SR, Lim WH, Oh S, et al. Effectiveness and safety of non-vitamin K antagonist oral anticoagulants in Asian patients with atrial fibrillation. Stroke. 2017;48:3040–8.

    CAS  PubMed  Google Scholar 

  40. 40.

    Steinberg BA, Shrader P, Thomas L, Ansell J, Fonarow GC, Gersh BJ, et al. Off-label dosing of non-vitamin K antagonist oral anticoagulants and adverse outcomes: the ORBIT-AF II registry. J Am Coll Cardiol. 2016;68:2597–604.

    CAS  PubMed  Google Scholar 

  41. 41.

    Chao T-F, Lip GYH, Liu C-J, Tuan T-C, Chen S-J, Wang K-L, et al. Validation of a modified CHA2DS2-VASc score for stroke risk stratification in Asian patients with atrial fibrillation: a nationwide cohort study. Stroke. 2016;47:2462–9.

    CAS  PubMed  Google Scholar 

  42. 42.

    DiBiase L, Mohanty S, Trivedi C, Romero J, Natale V, Briceno D, et al. Stroke risk in patients with atrial fibrillation undergoing electrical isolation of the left atrial appendage. J Am Coll Cardiol. 2019;74:1019–28.

    Google Scholar 

  43. 43.

    Tsai HH, Lin HW, Lu YH, Chen YL, Mahady GB. A review of potential harmful interactions between anticoagulant/antiplatelet agents and Chinese herbal medicines. PLoS One. 2013;8:e64255.

    CAS  PubMed  PubMed Central  Google Scholar 

  44. 44.

    Price MJ. Prevention and management of complications of left atrial appendage closure devices. Interv Cardiol Clin. 2014;3:301–11.

    PubMed  Google Scholar 

  45. 45.

    Du X, Chu H, Ye P, He B, Xu H, Jiang S, et al. Combination of left atrial appendage closure and catheter ablation in a single procedure for patients with atrial fibrillation: multicenter experience. J Formos Med Assoc. 2019;118:891–7.

    PubMed  Google Scholar 

  46. 46.

    Kuwata S, Taramasso M, Zuber M, Suetsch G, Attinger-Toller A, Wicki D, et al. Feasibility of concomitant MitraClip and left atrial appendage occlusion. EuroIntervention. 2017;12:1940–5.

    PubMed  Google Scholar 

  47. 47.

    Yu J, Liu X, Zhou J, Xue X, Muenzel M, Schulze PC, et al. Long-term safety and efficacy of combined percutaneous LAA and PFO/ASD closure: a single-center experience (LAAC combined PFO/ASD closure). Expert Rev Med Devices. 2019;16:429–35.

    CAS  PubMed  Google Scholar 

  48. 48.

    Khattab AA, Gloekler S, Sprecher B, Shakir S, Guerios E, Stortecky S, et al. Feasibility and outcomes of combined transcatheter aortic valve replacement with other structural heart interventions in a single session: a matched cohort study. Open Heart. 2014;1:e000014.

    PubMed  PubMed Central  Google Scholar 

  49. 49.

    Fauchier L, Cinaud A, Brigadeau F, Lepillier A, Pierre B, Abbey S, et al. Device-related thrombosis after percutaneous left atrial appendage occlusion for atrial fibrillation. J Am Coll Cardiol. 2018;71:1528–36.

    PubMed  Google Scholar 

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Acknowledgments

This expert opinion and consensus statement is based on discussions among clinical experts listed below during the Heart & Brain Summit in Bangkok, Thailand, July 13 and 14, 2019. All experts listed below reviewed and agreed with the final consensus manuscript.

T. Akagi, Okayama, Japan; J.L.K. Chan, Hong Kong; C.T. Chi, Vietnam; C-C. Chiu, Chang Hua, Taiwan; A.S.F. Chui, Hong Kong; K. Durongpisitkul, Bangkok, Thailand; E. Harmeiwaty, Jakarta, Indonesia; D. Firman, Jakarta, Indonesia; S. Haifeng, Beijing, China; P.K. Hazra, Kolkata, India; S. Komonchan, Bangkok, Thailand; P.X. Lanh, Ho Chi Minh City, Vietnam; M-C. Lin, Taichung, Taiwan; H.F. Liong, Kuala Lumpur, Malaysia; K. Meemook, Bangkok, Thailand; A.M. Muthuppalaniappan, Kuala Lumpur, Malaysia; N.H.T. My, Ho Chi Minh City, Vietnam; Y. Nakajima, Iwate, Japan; K. Oki, Tokyo, Japan; B. Paul, Kolkata, India; A.T. Prabhakar, Vellore, India; P. Puhl, Sydney, Australia; S. Pumprueg, Bangkok, Thailand; D.A. Quoc, Ho Chi Minh City, Vietnam; V. Samuel, Vellore, India; L. Sanders, Melbourne, Australia; V. Sharma, Singapore; J. Sharp, Sydney, Australia; R. Sharpe, Gold Coast, Australia; E. Tay, Singapore; N.B. Thang, Ho Chi Minh City, Vietnam; D. Wang, Sydney, Australia; A. Wong, Brisbane, Australia; X. Yingqi, Jilin, China; W. Zhanhang, Guangzhou, China.

Funding

Organization of the Heart & Brain Summit in Bangkok, Thailand, July 13 and 14, 2019, was logistically and financially supported by Abbott.

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Authors

Contributions

Development of this consensus was initiated following several indications from Asian-Pacific physicians regarding the paucity of clinical evidence for LAAO obtained from Asian-Pacific patients. The consensus presented in this manuscript is the result of discussions during a 2-day consensus meeting in which all contributors listed above participated and provided input to the arrived consensus. These participants were selected based on their expertise and experience in ischemic stroke prevention and LAAO. This manuscript was prepared by Dr. Albers in close collaboration with Dr. Diener and Dr. Lewalter and was reviewed by all authors and by all participants in the consensus meeting.

Corresponding author

Correspondence to Edgar Tay.

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Conflict of interest

Edgar Tay is a speaker and proctor and received an educational grant from Boston Scientific. Jason Sharp is a proctor for Abbott and Boston Scientific. Dennis Wang is a proctor for Abbott. Angus Shing Fung Chui is a proctor for Boston Scientific. Bert Albers received a honorarium from Abbott for preparing this manuscript. In the last 3 years, Hans-Christoph Diener (HCD) received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from Abbott, Bayer Vital, BMS, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Pfizer, Portola, Sanofi-Aventis, and WebMD Global. Financial support for research projects was provided by Boehringer Ingelheim. HCD received research grants from the German Research Council (DFG), German Ministry of Education and Research (BMBF), European Union, NIH, Bertelsmann Foundation, and Heinz-Nixdorf Foundation. HCD served as editor of Neurologie up2date, Info Neurologie & Psychiatrie, and Arzneimitteltherapie and is on the editorial board of Lancet Neurology. HCD chairs the Treatment Guidelines Committee of the German Society of Neurology and contributed to the EHRA and ESC guidelines for the treatment of AF. Thorsten Lewalter reported lectures and memberships of advisory boards with modest honoraria for Abbott, Boston Scientific, Lifetech, Bayer, Daiichi Sankyo, Pfizer, and Böhringer Ingelheim. Andrew Wong reports no disclosures or conflicts of interest.

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Societal endorsement: This paper is endorsed by the Asian Pacific Society of Interventional Cardiology (APSIC).

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Tay, E., Paul, B., Sharp, J. et al. Left atrial appendage occlusion for ischemic stroke prevention in patients with non-valvular atrial fibrillation: clinical expert opinion and consensus statement for the Asian-Pacific region. J Interv Card Electrophysiol (2020). https://doi.org/10.1007/s10840-020-00752-8

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Keywords

  • Left atrial appendage occlusion
  • Atrial fibrillation
  • Ischemic stroke prevention
  • Asian-Pacific region
  • Consensus