Ignacio Cruz-González1, Rocío González-Ferreiro2, Xavier Freixa3, Sameer Gafoor4, Samera Shakir5, Heyder Omran6, Sergio Berti7, Gennaro Santoro8, Joelle Kefer9, Ulf Landmesser10, Jens Erik Nielsen-Kudsk11, Prapa Kanagaratnam12, Fabian Nietlispach13, Steffen Gloekler5, Adel Aminian14, Paolo Danna15, Marco Rezzaghi7, Friederike Stock6, Miroslava Stolcova8, Luis Paiva16, Marco Costa16, Xavier Millán17, Reda Ibrahim18, Tobias Tichelbäcker19, Wolfgang Schillinger19, Jai-Wun Park20, Horst Sievert4, Bernhard Meier5, Apostolos Tzikas21. 1. Servicio de Cardiología, Hospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), CIBERCV, Salamanca, Spain. Electronic address: cruzgonzalez.ignacio@gmail.com. 2. Servicio de Cardiología, Hospital Universitario de Salamanca, Instituto de Investigación Biomédica de Salamanca (IBSAL), CIBERCV, Salamanca, Spain. 3. Servicio de Cardiologia, Hospital Clínico, Universidad de Barcelona, Barcelona, Spain. 4. Department of Cardiology, CardioVascular Center Frankfurt, Frankfurt, Germany. 5. Department of Cardiology, University Hospital of Bern, Bern, Switzerland. 6. Department of Cardiology, University Hospital of Bonn, Bonn, Germany. 7. Department of Cardiology, Fondazione Toscana Gabriele Monasterio, Massa, Italy. 8. Department of Cardiology, Ospedale Careggi di Firenze, Florence, Italy. 9. Department of Cardiology, St-Luc University Hospital, Brussels, Belgium. 10. Department of Cardiology, University Hospital of Zurich, Zurich, Switzerland. 11. Department of Cardiology, Aarhus University Hospital, Skejby, Denmark. 12. Department of Cardiology, Imperial College Healthcare NHS Trust, London, United Kingdom. 13. Department of Cardiology, University Hospital of Bern, Bern, Switzerland; Department of Cardiology, University Hospital of Zurich, Zurich, Switzerland. 14. Department of Cardiology, Centre Hospitalier Universitaire de Charleroi, Charleroi, Belgium. 15. Department of Cardiology Ospedale Luigi Sacco, Milan, Italy. 16. Department of Cardiology, Coimbra University Hospital Centre, Coimbra, Portugal. 17. Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 18. Department of Cardiology, Montreal Heart Institute, Montreal, Canada. 19. Department of Cardiology, University of Cologne, Faculty of Medicine and University Hospital Cologne, Heart Center Cologne, Cologne, Germany. 20. Department of Cardiology, Coburg Hospital, Coburg, Germany. 21. Department of Cardiology, AHEPA University Hospital, Thessaloniki, Greece.
Abstract
INTRODUCTION AND OBJECTIVES: Despite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment. METHODS: We analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO. Patientes with previous stroke on OAC therapy as indication for LAAO were identified and compared with patients with other indications. RESULTS: A total of 115 patients (11%) with RS were identified. The CHA2DS2-VASc and the HAS-BLED score were significantly higher in the RS group (respectively 5.5±1.5 vs 4.3±1.6; P <.001; 3.9±1.3 vs 3.1±1.2; P <.001). No significant differences were observed in periprocedural major safety events (7.8 vs 4.5%; P=.1). With a mean clinical follow-up of 16.2±12.2 months, the observed annual stroke/transient ischemic attack rate for the RS group was 2.6% (65% risk reduction) and the observed annual major bleeding rate was 0% (100% risk reduction). CONCLUSIONS: Patients with RS undergoing LAAO showed similar safety outcomes to patients without RS, with a significant reduction in stroke/transient ischemic attack and major bleeding events during follow-up. Adequately powered controlled trials are needed to further investigate the use of LAAO in RS patients.
INTRODUCTION AND OBJECTIVES: Despite the efficacy of oral anticoagulant (OAC) therapy, some patients continue to have a high residual risk and develop a stroke on OAC therapy (resistant stroke [RS]), and there is a lack of evidence on the management of these patients. The aim of this study was to analyze the safety and efficacy of left atrial appendage occlusion (LAAO) as secondary prevention in patients with nonvalvular atrial fibrillation who have experienced a stroke/transient ischemic attack despite OAC treatment. METHODS: We analyzed data from the Amplatzer Cardiac Plug multicenter registry on 1047 consecutive patients with nonvalvular atrial fibrillation undergoing LAAO. Patientes with previous stroke on OAC therapy as indication for LAAO were identified and compared with patients with other indications. RESULTS: A total of 115 patients (11%) with RS were identified. The CHA2DS2-VASc and the HAS-BLED score were significantly higher in the RS group (respectively 5.5±1.5 vs 4.3±1.6; P <.001; 3.9±1.3 vs 3.1±1.2; P <.001). No significant differences were observed in periprocedural major safety events (7.8 vs 4.5%; P=.1). With a mean clinical follow-up of 16.2±12.2 months, the observed annual stroke/transient ischemic attack rate for the RS group was 2.6% (65% risk reduction) and the observed annual major bleeding rate was 0% (100% risk reduction). CONCLUSIONS:Patients with RS undergoing LAAO showed similar safety outcomes to patients without RS, with a significant reduction in stroke/transient ischemic attack and major bleeding events during follow-up. Adequately powered controlled trials are needed to further investigate the use of LAAO in RS patients.