Abstract: 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).
Tags: Abiomed, Alnylam, Amicus Therapeutics, Amgen, AstraZeneca, Bayer, B.Braun,, Abiomed, Edwards Lifesciences, EnCarda Inc, Medtronic, Novartis, Sinomed with, 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, Antithrombotic therapy, Aortic valve stenosis, Atrial fibrillation, Bioanalytica, Biotronik, Boehringer Ingelheim, Boston Scientific, Bristol Myers, consulting and speaker fees from Boston Scientific, Abbott Vascular, Abiomed, and, educational grants to the institution from Abbott, Amgen, AstraZeneca, Boehringer, 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,, from Biotronik, Boston Scientific, Edwards Lifesciences, and ATSens, Haager is a proctor for Abbott. M.A. Kasel is a consultant and proctor for, has outside this work received research and, has received, Ingelheim, Daichi Sankyo, Ely Lilly, Novartis, Novo Nordisk, Roche Diagnostics,, institution from Edwards Lifesciences and Boston Scientific. S. Windecker reports, is also member of the, 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,, member of the steering/executive group of trials funded by Abbott, Amgen,, Neovii Pharmaceutica, Neutromedics AG, Novartis, Novo Nordisk, OM Pharma,, of H.H. Sheikh Khalifa bin Hamad Al-Thani to the University of Zurich,, OneCrea Medical, Cardiovalve, CoreMedic, PiCardia, HiD Imaging, and Simulands. T., Optimapharm, Orchestra BioMed, Pfizer, Philips AG, Sanofi-Aventis, Servier,, payments to the institution but no personal payments, Pilgrim reports research grants from the Swiss National Science Foundation, the, R.K. Binder received speaker fees and grants from Pfizer, Daiichi Sankyo, Abbott,, 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,, Sanofi, and Vifor. B.E. Stahli and her research has been supported by a donation, serves as advisory board member and/or, Shockwave Medical, Siemens Healthcare, Sinomed, SMT Sahajanand Medical, speaker fees, Squibb, Cordis Medical, CorFlow Therapeutics, CSL Behring, Daiichi Sankyo,, steering/executive committee group of several investigator-initiated trials that, 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, travel, or educational grants to the institution without personal remuneration.
RSS 2.0