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left atrial appendage closure (Watchman device, Lariat device)

Watchman. FDA-approval March 2015. [4] Indications: - prevention of left atrial thromboembolism in patients with atrial fibrillation (see left atrial appendage) [1-8] - recurrent hemorrhage in patient anticoagulated for atrial fibrillation [16] - patients with atrial fibrillation undergoing cardiac surgery for another reason [9,14] * 5 year stroke prevention in non-valvular atrial fibrillation comparable to warfarin [7] * better outcomes than with warfarin [8] * 21-month outcomes non-inferior to direct oral anticoagulants [13] * lower risks for stroke or thromboembolism when performed in patients with atrial fibrillation undergoing surgery for another reason [14] - 4.4% vs 7.0% (RR=0.67) - NNT = 37 to prevent 1 stroke over 5 years [14] * does not control arrhythmia of atrial fibrillation [15] Procedure: - a device is introduced into the atrium transseptally via the femoral vein - Watchman device is FDA-approved [4] - Lariat device is used off-label [5] - procedural success is 90% Complications: - Watchman deployed in 93% of attempted procedures [12] - procedure-related ischemic stroke (1%) [8] - pericardial effusion (1%) [8] - thrombus formation on device (7%) increasing risk of embolic stroke (RR=4.4) [10] - device embolization (0.24%) - surgery required for effusion or device retrieval (0.5%) - early mortality (0.1%) [8]l; death 0.2% [12] - may be superior to warfarin for preventing stroke or cardiovascular death [3] Management: - oral anticoagulation

Related

ablation for atrial fibrillation; pulmonary vein isolation/ablation left atrial appendage; left atrial auricle (LAA)

General

cardiac surgery (heart surgery)

References

  1. Holmes DR 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 The Lancet, Volume 374, Issue 9689, Pages 534 - 542, 15 August 2009 PMID: 19683639 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2809%2961343-X/fulltext - McCabe DJH et al Left atrial appendage occlusion in non-valvular atrial fibrillation The Lancet, Volume 374, Issue 9689, Pages 504 - 506, 15 August 2009 PMID: 19683627 http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2809%2961468-9/fulltext
  2. Physician's First Watch, Dec 13, 2013 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org - Reuters. December 11, 2013 U.S. FDA panel backs use of Boston Scientific anti-stroke device. http://news.yahoo.com/u-fda-panel-backs-boston-scientific-anti-stroke-005321477--finance.html
  3. Reddy VY et al. Percutaneous left atrial appendage closure vs warfarin for atrial fibrillation: A randomized clinical trial. JAMA 2014 Nov 19; 312:1988 PMID: 25399274
  4. Boston Scientific Press Release. March 15, 2015 Boston Scientific Receives FDA Approval for WATCHMAN Left Atrial Appendage Closure Device. First-Of-Its-Kind Alternative to Long-Term Warfarin Therapy for Stroke Risk Reduction in Patients with Non-Valvular Atrial Fibrillation. http://news.bostonscientific.com/2015-03-13-Boston-Scientific-Receives-FDA-Approval-for-WATCHMAN-Left-Atrial-Appendage-Closure-Device
  5. Chatterjee S, Herrmann HC, Wilensky RL et al Safety and Procedural Success of Left Atrial Appendage Exclusion With the Lariat DeviceA Systematic Review of Published Reports and Analytic Review of the FDA MAUDE Database. JAMA Intern Med. Published online May 04, 2015 PMID: 25938303 http://archinte.jamanetwork.com/article.aspx
  6. Holmes DR Jr et al. Left atrial appendage closure as an alternative to warfarin for stroke prevention in atrial fibrillation: A patient-level meta-analysis. J Am Coll Cardiol 2015 Jun 23; 65:2614. PMID: 26088300 - Waks JW and Manning WJ. Left atrial appendage closure to reduce the risk of thromboembolic complications in atrial fibrillation: Pay now and possibly pay later? J Am Coll Cardiol 2015 Jun 23; 65:2624. PMID: 26088301
  7. Reddy VY et al. 5-Year outcomes after left atrial appendage closure: From the PREVAIL and PROTECT AF Trials. J Am Coll Cardiol 2017 Dec 19; 70:2964 PMID: 29103847 Free full text
  8. Reddy VY, Gibson DN, Kar S et al. Post-approval U.S. experience with left atrial appendage closure for stroke prevention in atrial fibrillation. J Am Coll Cardiol 2017 Jan 24; 69:253. PMID: 27816552 Free Article http://www.sciencedirect.com/science/article/pii/S0735109716366414 - Saw J, Price MJ. Assessing the safety of early U.S. commercial application of left atrial appendage closure. J Am Coll Cardiol 2017 Jan 24; 69:262. PMID: 27816551 http://www.sciencedirect.com/science/article/pii/S0735109716366955
  9. Friedman DJ, Piccini JP, Wang T et al Association Between Left Atrial Appendage Occlusion and Readmission for Thromboembolism Among Patients With Atrial Fibrillation Undergoing Concomitant Cardiac Surgery. JAMA. 2018;319(4):365-374 PMID: 29362794 https://jamanetwork.com/journals/jama/article-abstract/2670253 - Ferraris VA. Left Atrial Appendage Occlusion During Cardiac Operations for Prevention of Thromboembolic Events. JAMA. 2018;319(4):345-347. PMID: 29362774 https://jamanetwork.com/journals/jama/article-abstract/2670233
  10. Fauchier L, Cinaud A, Brigadeau F et al. Device-related thrombosis after percutaneous left atrial appendage occlusion for atrial fibrillation. J Am Coll Cardiol. 2018 Apr 10;71(14):1528-1536 PMID: 29622159 - Valderrabano M. Left Atrial Appendage Occlusion Device-Related Thrombus: Certainties and Uncertainties. J Am Coll Cardiol. 2018 Apr 10;71(14):1537-1539. PMID: 29622160
  11. Lowenstern A, Al-Khatib SM, Sharan L et al. Interventions for preventing thromboembolic events in patients with atrial fibrillation: A systematic review. Ann Intern Med 2018 Oct 30; PMID: 30383133
  12. Freeman JV, Varosy P, Price MJ et al. The NCDR Left Atrial Appendage Occlusion Registry. J Am Coll Cardiol 2020 Mar 29; PMID: 32238316 https://www.sciencedirect.com/science/article/pii/S0735109720300899 - Lakkireddy DR, Turagam MK. NCDR Left Atrial Appendage Occlusion Registry: The "Watch" man has arrived. J Am Coll Cardiol 2020 Mar 29; [e-pub] PMID: 32238317 https://www.sciencedirect.com/science/article/pii/S0735109720301686
  13. Osmancik P et al. Left atrial appendage closure versus direct oral anticoagulants in high-risk patients with atrial fibrillation. J Am Coll Cardiol 2020 Jun 30; 75:3122. PMID: 32586585 https://www.sciencedirect.com/science/article/abs/pii/S0735109720351755 - Price MJ, Saw J. Transcatheter left atrial appendage occlusion in the DOAC era. J Am Coll Cardiol 2020 Jun 30; 75:3136. PMID: 32586586 https://www.sciencedirect.com/science/article/abs/pii/S0735109720353079
  14. Whitlock RP, Belley-Cote EP, Paparella D et al Left atrial appendage occlusion during cardiac surgery to prevent stroke. N Engl J Med 2021 May 15; [e-pub] PMID: 33999547 https://www.nejm.org/doi/10.1056/NEJMoa2101897
  15. Medical Knowledge Self Assessment Program (MKSAP) 19 American College of Physicians, Philadelphia 2022
  16. NEJM Knowledge+ Complex Medical Care
  17. Maille B, Defaye P, Bentounes SA et al Outcomes Associated With Left Atrial Appendage Occlusion Via Implanted Device in Atrial Fibrillation. Mayo Clin Proc. 2024 May;99(5):754-765. PMID: 38180394 https://www.mayoclinicproceedings.org/article/S0025-6196(23)00304-X/abstract