Sung-Han Yoon1, Won-Keun Kim2, Abhijeet Dhoble3, Stephan Milhorini Pio4, Vasilis Babaliaros5, Hasan Jilaihawi6, Thomas Pilgrim7, Ole De Backer8, Sabine Bleiziffer9, Flavien Vincent10, Tobias Shmidt11, Christian Butter12, Norihiko Kamioka5, Lena Eschenbach13, Matthias Renker2, Masahiko Asami7, Mohamad Lazkani14, Buntaro Fujita15, Antoinette Birs16, Marco Barbanti17, Ashish Pershad18, Uri Landes19, Brad Oldemeyer14, Mitusnobu Kitamura11, Luke Oakley1, Tomoki Ochiai1, Tarun Chakravarty1, Mamoo Nakamura1, Philip Ruile20, Florian Deuschl21, Daniel Berman1, Thomas Modine22, Stephan Ensminger15, Ran Kornowski19, Rudiger Lange13, James M McCabe16, Mathew R Williams6, Brian Whisenant23, Victoria Delgado4, Stephan Windecker7, Eric Van Belle10, Lars Sondergaard8, Bernard Chevalier24, Michael Mack25, Jeroen J Bax4, Martin B Leon26, Raj R Makkar27. 1. Cedars-Sinai Medical Center, Smidt Cedars-Sinai Heart Institute, Los Angeles, California. 2. Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany. 3. University of Texas Health Science Center, Houston, Texas. 4. Leiden University Medical Center, Leiden, the Netherlands. 5. Emory University School of Medicine, Atlanta, Georgia. 6. Department of Cardiology and Cardiothoracic Surgery, NYU Langone Medical Center, New York, New York. 7. Bern University Hospital, Bern, Switzerland. 8. Heart Center, Rigshospitalet, Copenhagen, Denmark. 9. Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen, Germany. 10. Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases, CHU Lille Institut Cśur Poumon, Cardiology, Inserm U1011, Lille, France. 11. Asklepios Klink St. Georg, Hamburg, Germany. 12. Heart Center Brandenburg in Bernau & Brandenburg Medical School, Bernau, Germany. 13. German Heart Center Munich, Munich, Germany. 14. University of Colorado Health, Loveland, Colorado. 15. Ruhr University Bochum, Bad Oeynhausen, Germany; Department of Cardiac and Thoracic Vascular Surgery, University of Schleswig-Holstein, Lübeck Campus, Lübeck, Germany. 16. University of Washington, Seattle, Washington. 17. University of Catania, Catania, Italy. 18. Banner University Medical Center, Phoenix, Arizona. 19. Cardiology Department, Rabin Medical Center, Petah Tikva and Tel-Aviv University, Tel-Aviv, Israel. 20. Department of Cardiology Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany. 21. Structural Heart Division, University Heart Center, Hamburg, Hamburg, Germany. 22. Department of Interventional Cardiology for Coronary, Valves and Structural Heart Diseases, CHU Lille Institut Cśur Poumon, Cardiology, Inserm U1011, Lille, France; Bordeaux University Hospital, Bordeaux, France. 23. Intermountain Heart Institute, Salt Lake City, Utah. 24. Ramsay Generale de Sante Institute Cardiovasculaire Paris-Sud, Massy, France. 25. Baylor Scott and White Health Heart Hospital-Plano, Plano, Texas. 26. Columbia University Medical Center-New York Presbyterian Hospital, New York, New York. 27. Cedars-Sinai Medical Center, Smidt Cedars-Sinai Heart Institute, Los Angeles, California. Electronic address: makkarr@cshs.org.
Abstract
BACKGROUND: Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials. OBJECTIVES: This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. METHODS: Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications. RESULTS: A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). CONCLUSIONS: Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521).
BACKGROUND:Bicuspid aortic stenosis accounts for almost 50% of patients undergoing surgical aortic valve replacement in the younger patients. Expanding the indication of transcatheter aortic valve replacement (TAVR) toward lower-risk and younger populations will lead to increased use of TAVR for patients with bicuspid aortic valve (BAV) stenosis despite the exclusion of bicuspid anatomy in all pivotal clinical trials. OBJECTIVES: This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. METHODS:Patients with BAV confirmed by central core laboratory computed tomography (CT) analysis were included from the international multicenter BAV TAVR registry. BAV morphology including the number of raphe, calcification grade in raphe, and leaflet calcium volume were assessed with CT analysis in a masked fashion. Primary outcomes were all-cause mortality at 1 and 2 years, and secondary outcomes included 30-day major endpoints and procedural complications. RESULTS: A total of 1,034 CT-confirmed BAV patients with a mean age of 74.7 years and Society of Thoracic Surgeons score of 3.7% underwent TAVR with contemporary devices (n = 740 with Sapien 3; n = 188 with Evolut R/Pro; n = 106 with others). All-cause 30-day, 1-year, and 2-year mortality was 2.0%, 6.7%, and 12.5%, respectively. Multivariable analysis identified calcified raphe and excess leaflet calcification (defined as more than median calcium volume) as independent predictors of 2-year all-cause mortality. Both calcified raphe plus excess leaflet calcification were found in 269 patients (26.0%), and they had significantly higher 2-year all-cause mortality than those with 1 or none of these morphological features (25.7% vs. 9.5% vs. 5.9%; log-rank p < 0.001). Patients with both morphological features had higher rates of aortic root injury (p < 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). CONCLUSIONS: Outcomes of TAVR in bicuspid aortic stenosis depend on valve morphology. Calcified raphe and excess leaflet calcification were associated with increased risk of procedural complications and midterm mortality. (Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry; NCT03836521).
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