Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement.
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Yoon Sung-Han, Kim Won-Keun, Dhoble Abhijeet, Milhorini Pio Stephan, Babaliaros Vasilis, Jilaihawi Hasan, Pilgrim Thomas, De Backer Ole, Bleiziffer Sabine, Vincent Flavien, Shmidt Tobias, Butter Christian, Kamioka Norihiko, Eschenbach Lena, Renker Matthias, Asami Masahiko, Lazkani Mohamad, Fujita Buntaro, Birs Antoinette, Barbanti Marco, Pershad Ashish, Landes Uri, Oldemeyer Brad, Kitamura Mitusnobu, Oakley Luke, Ochiai Tomoki, Chakravarty Tarun, Nakamura Mamoo, Ruile Philip, Deuschl Florian, Berman Daniel, Modine Thomas, Ensminger Stephan, Kornowski Ran, Lange Rudiger, McCabe James M, Williams Mathew R, Whisenant Brian, Delgado Victoria, Windecker Stephan, Van Belle Eric, Sondergaard Lars, Chevalier Bernard, Mack Michael, Bax Jeroen J, Leon Martin B, Makkar Raj R, Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry Investigators
Аннотация
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).