H Yang1, B J Bouma2, K Dimopoulos3, P Khairy4, M Ladouceur5, K Niwa6, M Greutmann7, M Schwerzmann8, A Egbe9, G Scognamiglio10, W Budts11, G Veldtman12, A R Opotowsky13, C S Broberg14, L Gumbiene15, F J Meijboom16, T Rutz17, M C Post18, T Moe19, M Lipczyńska20, S F Tsai21, S Chakrabarti22, D Tobler23, W Davidson24, M Morissens25, A van Dijk26, J Buber27, J Bouchardy28, K Skoglund29, C Christersson30, T Kronvall31, T C Konings32, R Alonso-Gonzalez3, A Mizuno6, G Webb12, M Laukyte15, G T J Sieswerda16, K Shafer13, J Aboulhosn33, B J M Mulder34. 1. Department of Cardiology, Academic Medical Centre, Amsterdam, the Netherlands; Interuniversity Cardiology Institute of the Netherlands, Netherlands Heart Institute, Utrecht, the Netherlands. 2. Department of Cardiology, Academic Medical Centre, Amsterdam, the Netherlands. 3. Adult Congenital Heart Disease Center, Royal Brompton Hospital, London, United Kingdom. 4. Electrophysiology Service and Adult Congenital Heart Disease Centre, Montreal Heart Institute, Université de Montréal, Montreal, Canada. 5. Adult Congenital Heart Disease Unit, Centre de Référence M3C, Hôpital Européen Georges Pompidou, Université Paris Descartes, Paris, France. 6. Department of Cardiology, St. Luke's International Hospital, Tokyo, Japan. 7. Department of Cardiology, University Hospital Zurich, Zurich, Switzerland. 8. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 9. Department of Cardiology, Mayo Clinic, Rochester, United States of America. 10. Department of Cardiology, Vincenzo Monaldi Hospital, Naples, Italy. 11. Department of Cardiology, University Hospitals Leuven, Leuven, Belgium. 12. Department of Cardiology, Cincinnati Children's Hospital Medical Centre, Cincinnati, United States of America. 13. Department of Cardiology, Boston Children's Hospital, Boston, United States of America; Department of Medicine, Brigham and Women's Hospital, Boston, United States of America. 14. Department of Cardiology, Oregon Health & Science University Hospital, Portland, United States of America. 15. Vilnius University Faculty of Medicine, Vilnius, Lithuania. 16. Department of Cardiology, University Medical Centre Utrecht, Cardiology, Utrecht, the Netherlands. 17. Department of Cardiology, University Hospital Centre Vaudois (CHUV), Lausanne, Switzerland. 18. Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands. 19. Department of Cardiology, Phoenix Children's Heart Centre, Phoenix, United States of America. 20. Adult Congenital Heart Center, Cardinal Wyszynski National Institute of Cardiology, Warsaw, Poland. 21. Department of Cardiology, University of Nebraska Medical Centre, NE, United States of America. 22. Department of Cardiology, St Paul's Hospital University of British Columbia, Vancouver, Canada. 23. Department of Cardiology, University Hospital Basel, Basel, Switzerland. 24. Department of Cardiology, Milton S. Hershey Medical Center, Hershey, United States of America. 25. Department of Cardiology, Brugmann University Hospital, Brussels, Belgium. 26. Department of Cardiology, Radboud University Nijmegen Medical Centre, Nijmegen, the Netherlands. 27. Department of Cardiology, Sheba Medical Center, Ramat Gan, Israel. 28. Department of Cardiology, University Hospital Geneva, Genève, Switzerland. 29. Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden. 30. Department of Cardiology, Uppsala University Hospital, Uppsala, Sweden. 31. Department of Cardiology, Örebro University Hospital, Örebro, Sweden. 32. Department of Cardiology, VU University Medical Centre, Amsterdam, the Netherlands. 33. Department of Cardiology, Ronald Reagan UCLA Medical Centre, Los Angeles, United States of America. 34. Department of Cardiology, Academic Medical Centre, Amsterdam, the Netherlands; Interuniversity Cardiology Institute of the Netherlands, Netherlands Heart Institute, Utrecht, the Netherlands. Electronic address: b.j.mulder@amc.uva.nl.
Abstract
BACKGROUND: Current guidelines consider vitamin K antagonists (VKA) the oral anticoagulant agents of choice in adults with atrial arrhythmias (AA) and moderate or complex forms of congenital heart disease, significant valvular lesions, or bioprosthetic valves, pending safety data on non-VKA oral anticoagulants (NOACs). Therefore, the international NOTE registry was initiated to assess safety, change in adherence and quality of life (QoL) associated with NOACs in adults with congenital heart disease (ACHD). METHODS: An international multicenter prospective study of NOACs in ACHD was established. Follow-up occurred at 6 months and yearly thereafter. Primary endpoints were thromboembolism and major bleeding. Secondary endpoints included minor bleeding, change in therapy adherence (≥80% medication refill rate, ≥6 out of 8 on Morisky-8 questionnaire) and QoL (SF-36 questionnaire). RESULTS: In total, 530 ACHD patients (mean age 47 SD 15 years; 55% male) with predominantly moderate or complex defects (85%), significant valvular lesions (46%) and/or bioprosthetic valves (11%) using NOACs (rivaroxaban 43%; apixaban 39%; dabigatran 12%; edoxaban 7%) were enrolled. The most common indication was AA (91%). Over a median follow-up of 1.0 [IQR 0.0-2.0] year, thromboembolic event rate was 1.0% [95%CI 0.4-2.0] (n = 6) per year, with 1.1% [95%CI 0.5-2.2] (n = 7) annualized rate of major bleeding and 6.3% [95%CI 4.5-8.5] (n = 37) annualized rate of minor bleeding. Adherence was sufficient during 2 years follow-up in 80-93% of patients. At 1-year follow-up, among the subset of previous VKA-users who completed the survey (n = 33), QoL improved in 6 out of 8 domains (p ≪ 0.05). CONCLUSIONS: Initial results from our worldwide prospective study suggest that NOACs are safe and may be effective for thromboembolic prevention in adults with heterogeneous forms of congenital heart disease.
BACKGROUND: Current guidelines consider vitamin K antagonists (VKA) the oral anticoagulant agents of choice in adults with atrial arrhythmias (AA) and moderate or complex forms of congenital heart disease, significant valvular lesions, or bioprosthetic valves, pending safety data on non-VKA oral anticoagulants (NOACs). Therefore, the international NOTE registry was initiated to assess safety, change in adherence and quality of life (QoL) associated with NOACs in adults with congenital heart disease (ACHD). METHODS: An international multicenter prospective study of NOACs in ACHD was established. Follow-up occurred at 6 months and yearly thereafter. Primary endpoints were thromboembolism and major bleeding. Secondary endpoints included minor bleeding, change in therapy adherence (≥80% medication refill rate, ≥6 out of 8 on Morisky-8 questionnaire) and QoL (SF-36 questionnaire). RESULTS: In total, 530 ACHD patients (mean age 47 SD 15 years; 55% male) with predominantly moderate or complex defects (85%), significant valvular lesions (46%) and/or bioprosthetic valves (11%) using NOACs (rivaroxaban 43%; apixaban 39%; dabigatran 12%; edoxaban 7%) were enrolled. The most common indication was AA (91%). Over a median follow-up of 1.0 [IQR 0.0-2.0] year, thromboembolic event rate was 1.0% [95%CI 0.4-2.0] (n = 6) per year, with 1.1% [95%CI 0.5-2.2] (n = 7) annualized rate of major bleeding and 6.3% [95%CI 4.5-8.5] (n = 37) annualized rate of minor bleeding. Adherence was sufficient during 2 years follow-up in 80-93% of patients. At 1-year follow-up, among the subset of previous VKA-users who completed the survey (n = 33), QoL improved in 6 out of 8 domains (p ≪ 0.05). CONCLUSIONS: Initial results from our worldwide prospective study suggest that NOACs are safe and may be effective for thromboembolic prevention in adults with heterogeneous forms of congenital heart disease.
Authors: Christoph Sinning; Elvin Zengin; Gerhard Diller; Paulus Kirchhof; Stefan Blankenberg; Carsten Rickers; Yskert von Kodolitsch Journal: Cardiovasc Diagn Ther Date: 2021-12
Authors: Cristina Chimenti; Carlo Lavalle; Michele Magnocavallo; Maria Alfarano; Marco Valerio Mariani; Federico Bernardini; Domenico Giovanni Della Rocca; Gioacchino Galardo; Paolo Severino; Luca Di Lullo; Fabio Miraldi; Francesco Fedele; Andrea Frustaci Journal: ESC Heart Fail Date: 2021-12-16
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