Left Atrial Appendage Occlusion Using the Amplatzer Amulet Device in High-Risk Patients With Atrial Fibrillation Undergoing Transcatheter Aortic Valve Intervention: A Randomized Pilot Study - Jakob, P.; Heinz, P.; Gong, Y.; Chen, M.; Binder, R. K.; Held, U.; Taramasso, M.; Paneni, F.; Schuetz, P.; Haager, P. K.; Kasel, M.; Pedrazzini, G.; et al. (2025)
BACKGROUND: Patients with severe aortic stenosis and atrial fibrillation (AF) undergoing transcatheter aortic valve intervention (TAVI) are at increased risk of bleeding and cerebrovascular events. This investigator-initiated, randomized, multicenter, open-label pilot study assessed left atrial appendage occlusion (LAAO) in patients with AF undergoing TAVI. METHODS: Patients were randomly assigned to LAAO (TAVI + LAAO) or standard medical therapy (SMT) (TAVI + SMT). The primary endpoint was a composite of cerebrovascular events, peripheral embolism, life-threatening/disabling/major bleeding, or cardiovascular mortality at 1 year. A sensitivity analysis was performed in the per-protocol population. RESULTS: Eighty-one patients (Society of Thoracic Surgeons score: 9.0% +/- 5.4%) were enrolled. The primary endpoint occurred in 13 patients (33%) in the TAVI + LAAO group and in 15 patients (37%) in the TAVI + SMT group (adjusted odds ratio [OR], 0.87; 95% CI: 0.32-2.29, p = 0.77). Bleeding rates were comparable between TAVI + LAAO (13%) and TAVI + SMT (17%), with absent nonprocedural bleeding in the TAVI + LAAO group and 5 gastrointestinal bleedings in TAVI + SMT, and cerebrovascular events did not significantly differ between groups (10% in TAVI + LAAO vs. 2.4% in TAVI + SMT). In the per-protocol analysis, occurrence of the primary endpoint was comparable between groups (adjusted OR, 0.55; 95% CI: 0.18-1.56, p = 0.27) with cerebrovascular events in 5.6% and 2.4%, and bleeding events in 8.3% and 17% for TAVI + LAAO and TAVI + SMT, respectively. CONCLUSIONS: This pilot study suggests that among high-risk patients with AF undergoing TAVI, a strategy of a combined procedure with LAAO and early cessation of oral anticoagulation overall showed similar rates of the primary end point as compared to a single TAVI procedure (NCT03088098).
Keywords: journalArticle; Abiomed, Alnylam, Amicus Therapeutics, Amgen, AstraZeneca, Bayer, B.Braun,; Abiomed, Edwards Lifesciences, EnCarda Inc, Medtronic, Novartis, Sinomed with; Antithrombotic therapy; Aortic valve stenosis; Atrial fibrillation; Bioanalytica, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers; Edwards Lifesciences, Abbott, Medtronic, Biosensors, and Highlife. F. Paneni; Edwards Lifesciences, Boston Scientific, and Abbott; Edwards Lifesciences, Fumedica, GE Healthcare, Guerbet, IACULIS, Inari Medical,; Foundation and research or travel grants to the institution without personal; Foundation, the Mach-Gaensslen Foundation, and the Monsol Foundation. Research,; Haager is a proctor for Abbott. M.A. Kasel is a consultant and proctor for; Ingelheim, Daichi Sankyo, Ely Lilly, Novartis, Novo Nordisk, Roche Diagnostics,; Iten-Kohaut Foundation, Boston Scientific, and Edwards Lifesciences; Janssen AI, Johnson & Johnson, Medalliance, Medtronic, MSD Merck Sharp & Dohme,; Left atrial appendage occlusion; Lifesciences and Boston Scientific and consultancy fees from Jenscare Scientific; Lifesciences. The other authors had no conflicts to declare; Luscher does no longer accept any honoraria from industry but has received; MedAlliance. F. Nietlispach received consultancy fees from Abbott and Edwards; Medtronic, Edwards Lifesciences, Boston Scientific, Shenqi Medical, CoreQuest,; Neovii Pharmaceutica, Neutromedics AG, Novartis, Novo Nordisk, OM Pharma,; OneCrea Medical, Cardiovalve, CoreMedic, PiCardia, HiD Imaging, and Simulands. T; Optimapharm, Orchestra BioMed, Pfizer, Philips AG, Sanofi-Aventis, Servier,; Pilgrim reports research grants from the Swiss National Science Foundation, the; R.K. Binder received speaker fees and grants from Pfizer, Daiichi Sankyo, Abbott,; Sanofi, and Vifor. B.E. Stahli and her research has been supported by a donation; Shockwave Medical, Siemens Healthcare, Sinomed, SMT Sahajanand Medical; Squibb, Cordis Medical, CorFlow Therapeutics, CSL Behring, Daiichi Sankyo,; Swiss Heart Foundation, the Swiss Polar Institute, the Bangerter-Rhyner; Switzerland, and research grants to the institution from the OPO Foundation, the; Technologies, Vascular Medical, V-Wave; Transcatheter aortic valve intervention; and Boston Scientific. M. Taramasso received consultancy fees from Abbott,; and consultancy fees to the institution from Biotronik, Boston Scientific,; and received grants to the; consulting and speaker fees from Boston Scientific, Abbott Vascular, Abiomed, and; educational grants to the institution from Abbott, Amgen, AstraZeneca, Boehringer; from Biotronik, Boston Scientific, Edwards Lifesciences, and ATSens; has outside this work received research and; has received; institution from Edwards Lifesciences and Boston Scientific. S. Windecker reports; is also member of the; member of the steering/executive group of trials funded by Abbott, Amgen,; of H.H. Sheikh Khalifa bin Hamad Al-Thani to the University of Zurich,; payments to the institution but no personal payments; receive funding by industry without impact on his personal remuneration. T.F.; remuneration from Bayer and Sanofi-Aventis. M. Chen received grants from Edwards; reports receiving fees for serving on advisory boards from Novo Nordisk. P.K.; research and educational grants; research, travel, and/or educational grants to the institution from Abbott,; serves as advisory board member and/or; speaker fees; steering/executive committee group of several investigator-initiated trials that; travel, or educational grants to the institution without personal remuneration