Experience with various occluder types for endovascular hemodynamic isolation of the left atrium appendage in patients with non-valvular atrial fibrillation

The aim of our study was to evaluate implantation efficacy and safety across various occluder types and to identify factors determining device selection.

Methods. This single-site prospective observational study included patients above the age of 40 years with non-valvular atrial fibrillation (AF) and high thromboembolic risk, undergoing endovascular isolation of the left atrium appendage (LAA) with Watchman or Amplatzer Cardiac Plug/Amulet devices. Occluders were implanted to patients without either had contraindications to anticoagulant therapy (ACT) or refused ACT. We evaluated technical aspects of device implantation, short- and long-term outcomes of the intervention over 3 years of follow-up.

Results. 90 patients were enrolled in the study (62 into the Watchman arm and 28 into the Amplatzer arm). Interventions were technically successful in 89 cases. In 1 patient (1/90, 1.1%) technical success was not achieved due to device migration (Amplatzer Amulet). The incidence of early (occurring within˂ 24 hours) implantation complications was 0% in the Watchman arm, and 3.6% in the Amplatzer arm (1/28) (р=0.135) (device migration). The cumulative incidence of all in-hospital complications was 11.3% and 14.3%, respectively (р=0.734). No significant differences between arms were found in the incidence of device thrombosis within 90 days post-implantation (3.3% in the Watchman’s arm and 8.3% in the Amplatzer arm, р=0.316). During the observation period, there were no significant differences in comparison groups in the incidence of net clinical efficacy endpoint events (р=0.58). The bleeding rate was 17.7% and 14.3%, respectively, р=0.769. No factors influencing the choice of the device could be identified reliably; however, there was a trend towards Watchman preference for appendage anatomic variants such as broccoli and cactus. Amplatzer was preferred in patients with contraindications to ACT.

Conclusion. Implantation of Watchman and Amplatzer Amulet occluders is equally effective and safe in preventing thromboembolism in patients with AF not receiving ACT for various reasons. The individual choice of a device may be influenced by appendage anatomy and indications to occluder implantation.

1. Singh IM, Holmes DR Jr. Left atrial appendage closure. Current Cardiology Reports. 2010;12(5): 413-21. https://doi.org/10.1007/s11886-010-0122-9.

2. Chugh SS, Havmoeller R, Narayanan K, et al. Worldwide epidemiology of atrial fibrillation: a Global Burden of Disease 2010 Study. Circulation.2014;25:129(8): 837-47. https://doi.org/10.1161/CIRCULATIONAHA.113.005119.

3. Stewart S, Hart C, Hole DJ, et al. Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart. 2001;86(5): 516-21. https://doi.org/10.1136/heart.86.5.516.

4. Glikson M, Wolff R, Hindricks G, et al. ESC Scientific Document Group. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion - an update. Europace. 2019;22(2): 1-184. https://doi.org/10.1093/europace/euz258.

5. David A. Cesario, G. William Dec. Implantable Cardioverter Defibrillator Therapy in Clinical Practice. Journal of the American College of Cardiology. 2005;46(9): 1729-36. https://doi.org/10.1016/j.jacc.2005.06.077.

6. Kirchhof P, Ammentorp B, Darius H, et al. Management of atrial fibrillation in seven European countries after the publication of the 2010 ESC Guidelines on atrial fibrillation: primary results of the PREvention oF thromboemolic events-European Registry in Atrial Fibrillation (PREFER in AF). Europace. 2014;16(1): 6-14. https://doi.org/10.1093/europace/eut263.

7. Gregory Y H Lip , Jean-Phillippe Collet, et al. 2018 Joint European consensus document on the management of antithrombotic therapy in atrial fibrillation patients presenting with acute coronary syndrome and/or undergoing percutaneous cardiovascular interventions: a joint consensus document of the European Heart Rhythm Association (EHRA), European Society of Cardiology Working Group on Thrombosis, European Association of Percutaneous Cardiovascular Interventions (EAPCI), and European Association of Acute Cardiac Care (ACCA) endorsed by the Heart Rhythm Society (HRS), Asia-Pacific Heart Rhythm Society (APHRS), Latin America Heart Rhythm Society (LAHRS), and Cardiac Arrhythmia Society of Southern Africa (CASSA). Europace. 2014;16(10): 1397-416. https://doi.org/10.1093/europace/euu174.

8. Paulus Kirchhof, Stefano Benussi, Dipak Kotecha, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. European Heart Journal. 2016;37(38): 2893-2962. https://doi.org/10.1093/eurheartj/ehw210.

9. Methodological Recommendation of Ministry of Health «Atrial fibrillation and flutter in adults», 2020. Available from: http://cr.rosminzdrav.ru/#!/recomend/888. (In Russ.).

10. Glikson M, Wolff R, Hindricks G, et al. EHRA/ EAPCI expert consensus statement on catheter-based left atrial appendage occlusion - an update. EuroIntervention. 2020;15(13): 1133-1180. https://doi.org/10.4244/EIJY19M08_01.

11. Holmes DR Jr, Kar S, Price MJ,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. Journal of the American College of Cardiology. 2014;64(1): 1-12. https://doi.org/10.1016/j.jacc.2014.04.029.

12. 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): 1302-1308. https://doi.org/10.1016/j.hrthm.2017.05.038.

13. Osmancik P, Herman D, Neuzil P, et al. PRAGUE-17 Trial Investigators. Left Atrial Appendage Closure Versus Direct Oral Anticoagulants in High-Risk Patients With Atrial Fibrillation. Journal of the American College of Cardiology. 2020;75(25): 3122-3135. https://doi. org/10.1016/j.jacc.2020.04.067.

14. Landmesser U, Schmidt B, Nielsen-Kudsk JE, et al. Left atrial appendage occlusion with the AMPLATZER Amulet device: periprocedural and early clinical/echocardiographic data from a global prospective observational study. EuroIntervention. 2017;13(7): 867-876. https://doi. org/10.4244/EIJ-D-17-00493.

15. Basu Ray I, Khanra D, Shah S, et al. Meta-Analysis Comparing WatchmanTM and Amplatzer Devices for Stroke Prevention in Atrial Fibrillation. Front Cardiovasc Med. 2020;7: 89. https://doi.org/10.3389/ fcvm.2020.00089.

16. Ledwoch J, Franke J, Akin I, et al. WATCHMAN versus ACP or Amulet devices for left atrial appendage occlusion: a sub-analysis of the multicentre LAARGE registry. EuroIntervention. 2020;16(11): e942-e949. https://doi. org/10.4244/EIJ-D-19-01027.

17. Davtyan K, Simonyan G, Topchyan A, et al. Comparative Safety and Efficacy of Left Atrial Appendage Occlusion with the Watchman Device and Amplatzer Cardiac Plug: Results of the Russian National Registry. BioMed Research International. 2020;2020: 2352648. https://doi. org/10.1155/2020/2352648.

18. Lakkireddy D, Windecker S, Thaler D, et al. Rationale and design for AMPLATZER Amulet Left Atrial Appendage Occluder IDE randomized controlled trial (Amulet IDE Trial). American Heart Journal. 2019;211: 45-53. https://doi.org/10.1016/j.ahj.2018.12.010.

19. Glikson M, Wolff R, Hindricks G, et al. EHRA/EAPCI expert consensus statement on catheter-based left atrial appendage occlusion - an update. EuroIntervetion. 2020;15 (13): 1-89. https://doi.org/10.4244/EIJY19M08_01.

20. Freeman JV, Varosy P, Price MJ, et al. The NCDR Left Atrial Appendage Occlusion Registry. Journal of the American College of Cardiology. 2020;75(13): 1503-1518. https://doi.org/10.1016/j.jacc.2019.12.040.

21. Galea R, De Marco F, Aminian A, et al. Design and Rationale of the Swiss-Apero Randomized Clinical Trial: Comparison of Amplatzer Amulet vs Watchman Device in Patients Undergoing Left Atrial Appendage Closure. Journal of Cardiovascular Translational Research. 2021;1-11/ https://doi.org/10.1007/s12265-020-10095-4.

22. Kar S, Doshi SK, Sadhu A, et al. PINNACLE FLX Investigators. Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. Circulation. 2021;143(18): 1754-1762. https://doi.org/10.1161/CIRCULATIONAHA.120.050117.