Apostolos Tzikas1, Xavier Freixa2, Laura Llull2, Sameer Gafoor3, Samera Shakir4, Heyder Omran5, George Giannakoulas6, Sergio Berti7, Gennaro Santoro8, Joelle Kefer9, Adel Aminian10, Steffen Gloekler4, Ulf Landmesser11, Jens Erik Nielsen-Kudsk12, Ignacio Cruz-Gonzalez13, Prapa Kanagaratnam14, Fabian Nietlispach15, Reda Ibrahim16, Horst Sievert3, Wolfgang Schillinger17, Jai-Wun Park18, Bernhard Meier4, Haralampos Karvounis6. 1. AHEPA University Hospital, Thessaloniki, Greece. Electronic address: aptzikas@yahoo.com. 2. Hospital Clinic of University of Barcelona, Barcelona, Spain. 3. CardioVascular Center Frankfurt, Frankfurt, Germany. 4. University Hospital of Bern, Bern, Switzerland. 5. University Hospital of Bonn, Bonn, Germany. 6. AHEPA University Hospital, Thessaloniki, Greece. 7. Fondazione Toscana Gabriele Monasterio, Massa, Italy. 8. Ospedale Careggi di Firenze, Florence, Italy. 9. St-Luc University Hospital, Brussels, Belgium. 10. Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium. 11. University Hospital of Zurich, Zurich, Switzerland. 12. Aarhus University Hospital, Skejby, Denmark. 13. University Hospital of Salamanca, Salamanca, Spain. 14. Imperial College Healthcare NHS Trust, London, United Kingdom. 15. University Hospital of Bern, Bern, Switzerland; University Hospital of Zurich, Zurich, Switzerland. 16. Montreal Heart Institute, Montreal, Canada. 17. Universitätsmedizin Göttingen, Göttingen, Germany. 18. Coburg Hospital, Coburg, Germany.
Abstract
BACKGROUND: In patients with non-valvular atrial fibrillation (NVAF), intracranial bleeding (ICB) constitutes a very challenging situation in which the rate of both ischemic and hemorrhagic events is increased. In these patients, left atrial appendage occlusion (LAAO) might represent a very valid alternative. OBJECTIVES: To investigate the procedural safety and long-term outcome of patients undergoing LAAO therapy due to previous ICB. METHODS: Data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients were analyzed. Patients with previous ICB as indication for LAAO were compared to patients with other indications. RESULTS: A total of 198 patients (18.9%) with previous ICB were identified. The CHA2DS2-VASc score was similar (4.5±1.5 vs. 4.4±1.6, p=0.687) and the HAS-BLED score was higher in patients with previous ICB compared to those without (3.5±1.1 vs. 3.1±1.2, p<0.001). No significant differences in peri-procedural major adverse events were observed (2.5 vs 5.4%, p=0.1). Patients with previous ICB were more frequently on single acetylsalicylic acid therapy after LAAO (42.4% vs. 28.3%; p<0.001). With an average follow-up of 1.3years, the observed annual stroke/TIA rate (procedure and follow-up) for patients with previous ICB was 1.4% (75% relative risk reduction). The observed annual major bleeding rate (procedure and follow-up) for patients with previous ICB was 0.7% (89% relative risk reduction). CONCLUSIONS: In patients with NVAF and previous ICB, LAAO seemed to be a safe procedure and was associated with a significant reduction in stroke/TIA and a remarkably low frequency of major bleeding during follow-up.
BACKGROUND: In patients with non-valvular atrial fibrillation (NVAF), intracranial bleeding (ICB) constitutes a very challenging situation in which the rate of both ischemic and hemorrhagic events is increased. In these patients, left atrial appendage occlusion (LAAO) might represent a very valid alternative. OBJECTIVES: To investigate the procedural safety and long-term outcome of patients undergoing LAAO therapy due to previous ICB. METHODS: Data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients were analyzed. Patients with previous ICB as indication for LAAO were compared to patients with other indications. RESULTS: A total of 198 patients (18.9%) with previous ICB were identified. The CHA2DS2-VASc score was similar (4.5±1.5 vs. 4.4±1.6, p=0.687) and the HAS-BLED score was higher in patients with previous ICB compared to those without (3.5±1.1 vs. 3.1±1.2, p<0.001). No significant differences in peri-procedural major adverse events were observed (2.5 vs 5.4%, p=0.1). Patients with previous ICB were more frequently on single acetylsalicylic acid therapy after LAAO (42.4% vs. 28.3%; p<0.001). With an average follow-up of 1.3years, the observed annual stroke/TIA rate (procedure and follow-up) for patients with previous ICB was 1.4% (75% relative risk reduction). The observed annual major bleeding rate (procedure and follow-up) for patients with previous ICB was 0.7% (89% relative risk reduction). CONCLUSIONS: In patients with NVAF and previous ICB, LAAO seemed to be a safe procedure and was associated with a significant reduction in stroke/TIA and a remarkably low frequency of major bleeding during follow-up.