Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement
Sung-Han Yoon, Won-Keun Kim, Abhijeet Dhoble, Stephan Milhorini Pio, Vasilis Babaliaros, Hasan Jilaihawi, Thomas Pilgrim, Ole De Backer, Sabine Bleiziffer, Flavien Vincent, Tobias Shmidt, Christian Butter, Norihiko Kamioka, Lena Eschenbach, Matthias Renker, Masahiko Asami, Mohamad Lazkani, Buntaro Fujita, Antoinette Birs, Marco Barbanti, Ashish Pershad, Uri Landes, Brad Oldemeyer, Mitusnobu Kitamura, Luke Oakley, Tomoki Ochiai, Tarun Chakravarty, Mamoo Nakamura, Philip Ruile, Florian Deuschl, Daniel Berman, Thomas Modine, Stephan Ensminger, Ran Kornowski, Rudiger Lange, James M McCabe, Mathew R Williams, Brian Whisenant, Victoria Delgado, Stephan Windecker, Eric Van Belle, Lars Sondergaard, Bernard Chevalier, Michael Mack, Jeroen J Bax, Martin B Leon, Raj R Makkar, Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry Investigators, Sung-Han Yoon, Won-Keun Kim, Abhijeet Dhoble, Stephan Milhorini Pio, Vasilis Babaliaros, Hasan Jilaihawi, Thomas Pilgrim, Ole De Backer, Sabine Bleiziffer, Flavien Vincent, Tobias Shmidt, Christian Butter, Norihiko Kamioka, Lena Eschenbach, Matthias Renker, Masahiko Asami, Mohamad Lazkani, Buntaro Fujita, Antoinette Birs, Marco Barbanti, Ashish Pershad, Uri Landes, Brad Oldemeyer, Mitusnobu Kitamura, Luke Oakley, Tomoki Ochiai, Tarun Chakravarty, Mamoo Nakamura, Philip Ruile, Florian Deuschl, Daniel Berman, Thomas Modine, Stephan Ensminger, Ran Kornowski, Rudiger Lange, James M McCabe, Mathew R Williams, Brian Whisenant, Victoria Delgado, Stephan Windecker, Eric Van Belle, Lars Sondergaard, Bernard Chevalier, Michael Mack, Jeroen J Bax, Martin B Leon, Raj R Makkar, Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry Investigators
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).
Keywords: aortic stenosis; bicuspid aortic valve; transcatheter aortic valve implantation.
Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed