Patrizio Lancellotti1,2, Julien Magne3, Raluca Dulgheru1, Marie-Annick Clavel4, Erwan Donal5, Mani A Vannan6, John Chambers7, Raphael Rosenhek8, Gilbert Habib9,10, Guy Lloyd11, Stefano Nistri12, Madalina Garbi13, Stella Marchetta1, Khalil Fattouch14,15, Augustin Coisne16, David Montaigne16, Thomas Modine16, Laurent Davin1, Olivier Gach1, Marc Radermecker1, Shizhen Liu6, Linda Gillam17, Andrea Rossi18, Elena Galli5, Federica Ilardi1, Lionel Tastet4, Romain Capoulade4, Robert Zilberszac8, E Mara Vollema19, Victoria Delgado19, Bernard Cosyns20, Stephane Lafitte21, Anne Bernard22,23, Luc A Pierard1, Jeroen J Bax19, Philippe Pibarot4, Cécile Oury1. 1. GIGA Cardiovascular Sciences, Department of Cardiology, Heart Valve Clinic, University of Liège Hospital, Centre Hospitalier Universitaire du Sart Tilman, Liège, Belgium. 2. Gruppo Villa Maria Care and Research, Anthea Hospital, Bari, Italy. 3. Cardiology Department, Centre Hospitalier Universitaire de Limoges, Hôpital Dupuytren, Pôle Coeur-Poumon-Rein, Limoges, France. 4. Québec Heart and Lung Institute, Institut Universitaire de Cardiologie et de Pneumologie de Québec, Laval University, Quebec City, Québec, Canada. 5. Cardiologie and LTSI INSERM U 1099, Centre Hospitalier Universitaire de Rennes, Université de Rennes 1, Rennes, France. 6. Marcus Heart Valve Center, Piedmont Heart Institute, Atlanta, Georgia. 7. Guy's and St Thomas Hospitals, London, United Kingdom. 8. Department of Cardiology, Medical University of Vienna, Vienna, Austria. 9. Aix-Marseille Université, Unité de Recherche sur les Maladies Infectieuses et Tropicales Emergentes, Marseille, France. 10. Assistance Publique-Hopitaux Marseille, La Timone Hospital, Cardiology Department, Marseille, France. 11. Barts Heart Centre Echo Lab, St Bartholomew's Hospital, London, United Kingdom. 12. Cardiology Service, CMSR Veneto Medica, Altavilla Vicentina, Italy. 13. King's Health Partners, King's College Hospital NHS Foundation Trust, London, United Kingdom. 14. Department of Cardiovascular Surgery, GVM Care and Research, Maria Eleonora Hospital, Palermo, Italy. 15. Department of Surgery and Cancer, University of Palermo, Palermo, Italy. 16. Centre Hospitalier Universitaire de Lille, Departments of Clinical Physiology and Echocardiography and Cardiovascular Surgery, Lille, France. 17. Morristown Medical Center, Morristown, New Jersey. 18. Section of Cardiology, Department of Medicine, University of Verona, Verona, Italy. 19. Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands. 20. Centrum voor Hart en Vaatziekten, Universitair Ziekenhuis Brussel and In Vivo Cellular and Molecular Imaging Laboratory, Brussels, Belgium. 21. Centre Hospitalier Universitaire de Bordeaux, Hôpital Cardiologique Haut-Lévêque, Pessac, France. 22. Cardiology Department, University of Tours Hospital, Tours, France. 23. University François Rabelais, Tours, France.
Abstract
Importance: The natural history and the management of patients with asymptomatic aortic stenosis (AS) have not been fully examined in the current era. Objective: To determine the clinical outcomes of patients with asymptomatic AS using data from the Heart Valve Clinic International Database. Design, Setting, and Participants: This registry was assembled by merging data from prospectively gathered institutional databases from 10 heart valve clinics in Europe, Canada, and the United States. Asymptomatic patients with an aortic valve area of 1.5 cm2 or less and preserved left ventricular ejection fraction (LVEF) greater than 50% at entry were considered for the present analysis. Data were collected from January 2001 to December 2014, and data were analyzed from January 2017 to July 2018. Main Outcomes and Measures: Natural history, need for aortic valve replacement (AVR), and survival of asymptomatic patients with moderate or severe AS at entry followed up in a heart valve clinic. Indications for AVR were based on current guideline recommendations. Results: Of the 1375 patients included in this analysis, 834 (60.7%) were male, and the mean (SD) age was 71 (13) years. A total of 861 patients (62.6%) had severe AS (aortic valve area less than 1.0 cm2). The mean (SD) overall survival during medical management (mean [SD] follow up, 27 [24] months) was 93% (1%), 86% (2%), and 75% (4%) at 2, 4, and 8 years, respectively. A total of 104 patients (7.6%) died under observation, including 57 patients (54.8%) from cardiovascular causes. The crude rate of sudden death was 0.65% over the duration of the study. A total of 542 patients (39.4%) underwent AVR, including 388 patients (71.6%) with severe AS at study entry and 154 (28.4%) with moderate AS at entry who progressed to severe AS. Those with severe AS at entry who underwent AVR did so at a mean (SD) of 14.4 (16.6) months and a median of 8.7 months. The mean (SD) 2-year and 4-year AVR-free survival rates for asymptomatic patients with severe AS at baseline were 54% (2%) and 32% (3%), respectively. In those undergoing AVR, the 30-day postprocedural mortality was 0.9%. In patients with severe AS at entry, peak aortic jet velocity (greater than 5 m/s) and LVEF (less than 60%) were associated with all-cause and cardiovascular mortality without AVR; these factors were also associated with postprocedural mortality in those patients with severe AS at baseline who underwent AVR (surgical AVR in 310 patients; transcatheter AVR in 78 patients). Conclusions and Relevance: In patients with asymptomatic AS followed up in heart valve centers, the risk of sudden death is low, and rates of overall survival are similar to those reported from previous series. Patients with severe AS at baseline and peak aortic jet velocity of 5.0 m/s or greater or LVEF less than 60% have increased risks of all-cause and cardiovascular mortality even after AVR. The potential benefit of early intervention should be considered in these high-risk patients.
Importance: The natural history and the management of patients with asymptomatic aortic stenosis (AS) have not been fully examined in the current era. Objective: To determine the clinical outcomes of patients with asymptomatic AS using data from the Heart Valve Clinic International Database. Design, Setting, and Participants: This registry was assembled by merging data from prospectively gathered institutional databases from 10 heart valve clinics in Europe, Canada, and the United States. Asymptomatic patients with an aortic valve area of 1.5 cm2 or less and preserved left ventricular ejection fraction (LVEF) greater than 50% at entry were considered for the present analysis. Data were collected from January 2001 to December 2014, and data were analyzed from January 2017 to July 2018. Main Outcomes and Measures: Natural history, need for aortic valve replacement (AVR), and survival of asymptomatic patients with moderate or severe AS at entry followed up in a heart valve clinic. Indications for AVR were based on current guideline recommendations. Results: Of the 1375 patients included in this analysis, 834 (60.7%) were male, and the mean (SD) age was 71 (13) years. A total of 861 patients (62.6%) had severe AS (aortic valve area less than 1.0 cm2). The mean (SD) overall survival during medical management (mean [SD] follow up, 27 [24] months) was 93% (1%), 86% (2%), and 75% (4%) at 2, 4, and 8 years, respectively. A total of 104 patients (7.6%) died under observation, including 57 patients (54.8%) from cardiovascular causes. The crude rate of sudden death was 0.65% over the duration of the study. A total of 542 patients (39.4%) underwent AVR, including 388 patients (71.6%) with severe AS at study entry and 154 (28.4%) with moderate AS at entry who progressed to severe AS. Those with severe AS at entry who underwent AVR did so at a mean (SD) of 14.4 (16.6) months and a median of 8.7 months. The mean (SD) 2-year and 4-year AVR-free survival rates for asymptomatic patients with severe AS at baseline were 54% (2%) and 32% (3%), respectively. In those undergoing AVR, the 30-day postprocedural mortality was 0.9%. In patients with severe AS at entry, peak aortic jet velocity (greater than 5 m/s) and LVEF (less than 60%) were associated with all-cause and cardiovascular mortality without AVR; these factors were also associated with postprocedural mortality in those patients with severe AS at baseline who underwent AVR (surgical AVR in 310 patients; transcatheter AVR in 78 patients). Conclusions and Relevance: In patients with asymptomatic AS followed up in heart valve centers, the risk of sudden death is low, and rates of overall survival are similar to those reported from previous series. Patients with severe AS at baseline and peak aortic jet velocity of 5.0 m/s or greater or LVEF less than 60% have increased risks of all-cause and cardiovascular mortality even after AVR. The potential benefit of early intervention should be considered in these high-risk patients.
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