Heart Rhythm TV Update: 2025 LAAO State of the Evidence and Debate

In this Breaking News #HRStv episode focused on LAAO 2025, host Daniel Alyesh, MD, FHRS is joined by John M. Mandrola, MD, and Luigi Di Biase, MD, PhD, FHRS to explore the evolving evidence behind left atrial appendage occlusion (LAAO).

The experts review key clinical trials—including PROTECT, PREVAIL, and OPTION—alongside insights from the NCDR registry, weighing the data on both efficacy and safety. Presented in a debate-style format, this engaging discussion concludes with a forward-looking preview of the highly anticipated CHAMPION-AF trial, set to be presented at ACC 2026.

#AFib #LAAO #anticoagulation #watchman #amulet

Additional Resources
Reddy VY, Doshi SK, Sievert H, Buchbinder M, Neuzil P, Huber K, Halperin JL, 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 Feb 12;127(6):720-9. doi: 10.1161/CIRCULATIONAHA.112.114389. Epub 2013 Jan 16. PMID: 23325525.

Holmes DR Jr, Kar S, Price MJ, Whisenant B, Sievert H, Doshi SK, Huber K, Reddy VY. 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 Jul 8;64(1):1-12. doi: 10.1016/j.jacc.2014.04.029. Erratum in: J Am Coll Cardiol. 2014 Sep 16;64(11):1186. PMID: 24998121.

Kar S, Doshi SK, Sadhu A, Horton R, Osorio J, Ellis C, Stone J Jr, Shah M, Dukkipati SR, Adler S, Nair DG, Kim J, Wazni O, Price MJ, Asch FM, Holmes DR Jr, Shipley RD, Gordon NT, Allocco DJ, Reddy VY; PINNACLE FLX Investigators. Primary Outcome Evaluation of a Next-Generation Left Atrial Appendage Closure Device: Results From the PINNACLE FLX Trial. Circulation. 2021 May 4;143(18):1754-1762. doi: 10.1161/CIRCULATIONAHA.120.050117. Epub 2021 Apr 6. PMID: 33820423.

Price MJ, Ellis CR, Nielsen-Kudsk JE, Thaler D, Gupta N, Koulogiannis K, Anderson JA, Gage R, Lakkireddy D. Peridevice Leak After Transcatheter Left Atrial Appendage Occlusion: An Analysis of the Amulet IDE Trial. JACC Cardiovasc Interv. 2022 Nov 14;15(21):2127-2138. doi: 10.1016/j.jcin.2022.09.001. PMID: 36357016.

Freeman JV, et al. J Am Coll Cardiol. 2020 Apr 7;75(13):1503-1518.

Alkhouli M, Du C, Killu A, Simard T, Noseworthy PA, Friedman PA, Curtis JP, Freeman JV, Holmes DR. Clinical Impact of Residual Leaks Following Left Atrial Appendage Occlusion: Insights From the NCDR LAAO Registry. JACC Clin Electrophysiol. 2022 Jun;8(6):766-778. doi: 10.1016/j.jacep.2022.03.001. Epub 2022 Apr 3. PMID: 35387751; PMCID: PMC9233062.

Alkhouli M, Alarouri H, Kramer A, Korsholm K, Collins J, De Backer O, Hatoum H, Nielsen-Kudsk JE. Device-Related Thrombus After Left Atrial Appendage Occlusion: Clinical Impact, Predictors, Classification, and Management. JACC Cardiovasc Interv. 2023 Nov 27;16(22):2695-2707. doi: 10.1016/j.jcin.2023.10.046. PMID: 38030357.

Maarse M, Seiffge DJ, Werring DJ, Boersma LVA; RAF, RAF-DOAC, CROMIS-2, SAMURAI, NOACISP, Erlangen Registry, and Verona Registry; STR-OAC LAAO Group; Aarnink EW, Fierro N, Mazzone P, Beneduce A, Tondo C, Gasperetti A, Pracon R, Demkow M, Zielinski K, de Backer O, Korsholm K, Nielsen-Kudsk JE, Estévez-Loureiro R, Caneiro-Queija B, Benito-González T, de Prado AP, Nombela-Franco L, Salinas P, Holmes D, Almakadma AH, Berti S, Romeo MR, Alvarez XM, Arzamendi D, Alla VM, Agarwal H, Eitel I, Paitazoglou C, Freixa X, Cepas-Guillén P, Chothia R, Badejoko SO, Bergmann MW, Spoon DB, Maddux JT, El-Chami M, Ram P, Branca L, Adamo M, Suradi HS, van Dijk VF, Rensing BJWM, Zietz A, Paciaroni M, Caso V, Koga M, Toyoda K, Kallmünzer B, Cappellari M, Wilson D, Engelter S, Swaans MJ; STR-OAC LAAO Group. Left Atrial Appendage Occlusion vs Standard of Care After Ischemic Stroke Despite Anticoagulation. JAMA Neurol. 2024 Sep 23;81(11):1150–8. doi: 10.1001/jamaneurol.2024.2882. Epub ahead of print. PMID: 39374446; PMCID: PMC11420820.

Galea R, De Marco F, Meneveau N, Aminian A, Anselme F, Gräni C, Huber AT, Teiger E, Iriart X, Babongo Bosombo F, Heg D, Franzone A, Vranckx P, Fischer U, Pedrazzini G, Bedogni F, Räber L, Valgimigli M. Amulet or Watchman Device for Percutaneous Left Atrial Appendage Closure: Primary Results of the SWISS-APERO Randomized Clinical Trial. Circulation. 2022 Mar 8;145(10):724-738. doi: 10.1161/CIRCULATIONAHA.121.057859. Epub 2021 Nov 6. PMID: 34747186.