Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement

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...

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Veröffentlicht in:Journal of the American College of Cardiology 2020-09, Vol.76 (9), p.1018-1030
Hauptverfasser: 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.
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container_issue 9
container_start_page 1018
container_title Journal of the American College of Cardiology
container_volume 76
creator 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.
description 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. This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. 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. 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 
doi_str_mv 10.1016/j.jacc.2020.07.005
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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. This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. 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. 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 &lt; 0.001). Patients with both morphological features had higher rates of aortic root injury (p &lt; 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). 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) [Display omitted]</description><identifier>ISSN: 0735-1097</identifier><identifier>EISSN: 1558-3597</identifier><identifier>DOI: 10.1016/j.jacc.2020.07.005</identifier><identifier>PMID: 32854836</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aged ; Aged, 80 and over ; aortic stenosis ; bicuspid aortic valve ; Bicuspid Aortic Valve Disease - diagnostic imaging ; Bicuspid Aortic Valve Disease - mortality ; Bicuspid Aortic Valve Disease - surgery ; Female ; Follow-Up Studies ; Humans ; Internationality ; Male ; Mortality - trends ; Prospective Studies ; Registries ; Tomography, X-Ray Computed - mortality ; Tomography, X-Ray Computed - trends ; transcatheter aortic valve implantation ; Transcatheter Aortic Valve Replacement - mortality ; Transcatheter Aortic Valve Replacement - trends ; Treatment Outcome</subject><ispartof>Journal of the American College of Cardiology, 2020-09, Vol.76 (9), p.1018-1030</ispartof><rights>2020 American College of Cardiology Foundation</rights><rights>Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c400t-fcf1befaf577e15de7307cc73f3eabaca4da19413b312000fa49738c265a9e9d3</citedby><cites>FETCH-LOGICAL-c400t-fcf1befaf577e15de7307cc73f3eabaca4da19413b312000fa49738c265a9e9d3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.jacc.2020.07.005$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32854836$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yoon, Sung-Han</creatorcontrib><creatorcontrib>Kim, Won-Keun</creatorcontrib><creatorcontrib>Dhoble, Abhijeet</creatorcontrib><creatorcontrib>Milhorini Pio, Stephan</creatorcontrib><creatorcontrib>Babaliaros, Vasilis</creatorcontrib><creatorcontrib>Jilaihawi, Hasan</creatorcontrib><creatorcontrib>Pilgrim, Thomas</creatorcontrib><creatorcontrib>De Backer, Ole</creatorcontrib><creatorcontrib>Bleiziffer, Sabine</creatorcontrib><creatorcontrib>Vincent, Flavien</creatorcontrib><creatorcontrib>Shmidt, Tobias</creatorcontrib><creatorcontrib>Butter, Christian</creatorcontrib><creatorcontrib>Kamioka, Norihiko</creatorcontrib><creatorcontrib>Eschenbach, Lena</creatorcontrib><creatorcontrib>Renker, Matthias</creatorcontrib><creatorcontrib>Asami, Masahiko</creatorcontrib><creatorcontrib>Lazkani, Mohamad</creatorcontrib><creatorcontrib>Fujita, Buntaro</creatorcontrib><creatorcontrib>Birs, Antoinette</creatorcontrib><creatorcontrib>Barbanti, Marco</creatorcontrib><creatorcontrib>Pershad, Ashish</creatorcontrib><creatorcontrib>Landes, Uri</creatorcontrib><creatorcontrib>Oldemeyer, Brad</creatorcontrib><creatorcontrib>Kitamura, Mitusnobu</creatorcontrib><creatorcontrib>Oakley, Luke</creatorcontrib><creatorcontrib>Ochiai, Tomoki</creatorcontrib><creatorcontrib>Chakravarty, Tarun</creatorcontrib><creatorcontrib>Nakamura, Mamoo</creatorcontrib><creatorcontrib>Ruile, Philip</creatorcontrib><creatorcontrib>Deuschl, Florian</creatorcontrib><creatorcontrib>Berman, Daniel</creatorcontrib><creatorcontrib>Modine, Thomas</creatorcontrib><creatorcontrib>Ensminger, Stephan</creatorcontrib><creatorcontrib>Kornowski, Ran</creatorcontrib><creatorcontrib>Lange, Rudiger</creatorcontrib><creatorcontrib>McCabe, James M.</creatorcontrib><creatorcontrib>Williams, Mathew R.</creatorcontrib><creatorcontrib>Whisenant, Brian</creatorcontrib><creatorcontrib>Delgado, Victoria</creatorcontrib><creatorcontrib>Windecker, Stephan</creatorcontrib><creatorcontrib>Van Belle, Eric</creatorcontrib><creatorcontrib>Sondergaard, Lars</creatorcontrib><creatorcontrib>Chevalier, Bernard</creatorcontrib><creatorcontrib>Mack, Michael</creatorcontrib><creatorcontrib>Bax, Jeroen J.</creatorcontrib><creatorcontrib>Leon, Martin B.</creatorcontrib><creatorcontrib>Makkar, Raj R.</creatorcontrib><creatorcontrib>Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry Investigators</creatorcontrib><title>Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement</title><title>Journal of the American College of Cardiology</title><addtitle>J Am Coll Cardiol</addtitle><description>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. This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. 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. 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 &lt; 0.001). Patients with both morphological features had higher rates of aortic root injury (p &lt; 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). 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) [Display omitted]</description><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>aortic stenosis</subject><subject>bicuspid aortic valve</subject><subject>Bicuspid Aortic Valve Disease - diagnostic imaging</subject><subject>Bicuspid Aortic Valve Disease - mortality</subject><subject>Bicuspid Aortic Valve Disease - surgery</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Humans</subject><subject>Internationality</subject><subject>Male</subject><subject>Mortality - trends</subject><subject>Prospective Studies</subject><subject>Registries</subject><subject>Tomography, X-Ray Computed - mortality</subject><subject>Tomography, X-Ray Computed - trends</subject><subject>transcatheter aortic valve implantation</subject><subject>Transcatheter Aortic Valve Replacement - mortality</subject><subject>Transcatheter Aortic Valve Replacement - 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Brad</creatorcontrib><creatorcontrib>Kitamura, Mitusnobu</creatorcontrib><creatorcontrib>Oakley, Luke</creatorcontrib><creatorcontrib>Ochiai, Tomoki</creatorcontrib><creatorcontrib>Chakravarty, Tarun</creatorcontrib><creatorcontrib>Nakamura, Mamoo</creatorcontrib><creatorcontrib>Ruile, Philip</creatorcontrib><creatorcontrib>Deuschl, Florian</creatorcontrib><creatorcontrib>Berman, Daniel</creatorcontrib><creatorcontrib>Modine, Thomas</creatorcontrib><creatorcontrib>Ensminger, Stephan</creatorcontrib><creatorcontrib>Kornowski, Ran</creatorcontrib><creatorcontrib>Lange, Rudiger</creatorcontrib><creatorcontrib>McCabe, James M.</creatorcontrib><creatorcontrib>Williams, Mathew R.</creatorcontrib><creatorcontrib>Whisenant, Brian</creatorcontrib><creatorcontrib>Delgado, Victoria</creatorcontrib><creatorcontrib>Windecker, Stephan</creatorcontrib><creatorcontrib>Van Belle, Eric</creatorcontrib><creatorcontrib>Sondergaard, Lars</creatorcontrib><creatorcontrib>Chevalier, Bernard</creatorcontrib><creatorcontrib>Mack, Michael</creatorcontrib><creatorcontrib>Bax, Jeroen J.</creatorcontrib><creatorcontrib>Leon, Martin B.</creatorcontrib><creatorcontrib>Makkar, Raj R.</creatorcontrib><creatorcontrib>Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry Investigators</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of the American College of Cardiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yoon, Sung-Han</au><au>Kim, Won-Keun</au><au>Dhoble, Abhijeet</au><au>Milhorini Pio, Stephan</au><au>Babaliaros, Vasilis</au><au>Jilaihawi, Hasan</au><au>Pilgrim, Thomas</au><au>De Backer, Ole</au><au>Bleiziffer, Sabine</au><au>Vincent, Flavien</au><au>Shmidt, Tobias</au><au>Butter, Christian</au><au>Kamioka, Norihiko</au><au>Eschenbach, Lena</au><au>Renker, Matthias</au><au>Asami, Masahiko</au><au>Lazkani, Mohamad</au><au>Fujita, Buntaro</au><au>Birs, Antoinette</au><au>Barbanti, Marco</au><au>Pershad, Ashish</au><au>Landes, Uri</au><au>Oldemeyer, Brad</au><au>Kitamura, Mitusnobu</au><au>Oakley, Luke</au><au>Ochiai, Tomoki</au><au>Chakravarty, Tarun</au><au>Nakamura, Mamoo</au><au>Ruile, Philip</au><au>Deuschl, Florian</au><au>Berman, Daniel</au><au>Modine, Thomas</au><au>Ensminger, Stephan</au><au>Kornowski, Ran</au><au>Lange, Rudiger</au><au>McCabe, James M.</au><au>Williams, Mathew R.</au><au>Whisenant, Brian</au><au>Delgado, Victoria</au><au>Windecker, Stephan</au><au>Van Belle, Eric</au><au>Sondergaard, Lars</au><au>Chevalier, Bernard</au><au>Mack, Michael</au><au>Bax, Jeroen J.</au><au>Leon, Martin B.</au><au>Makkar, Raj R.</au><aucorp>Bicuspid Aortic Valve Stenosis Transcatheter Aortic Valve Replacement Registry Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement</atitle><jtitle>Journal of the American College of Cardiology</jtitle><addtitle>J Am Coll Cardiol</addtitle><date>2020-09-01</date><risdate>2020</risdate><volume>76</volume><issue>9</issue><spage>1018</spage><epage>1030</epage><pages>1018-1030</pages><issn>0735-1097</issn><eissn>1558-3597</eissn><abstract>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. This study sought to evaluate the association of BAV morphology and outcomes of TAVR with the new-generation devices. 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. 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 &lt; 0.001). Patients with both morphological features had higher rates of aortic root injury (p &lt; 0.001), moderate-to-severe paravalvular regurgitation (p = 0.002), and 30-day mortality (p = 0.016). 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) [Display omitted]</abstract><cop>United States</cop><pub>Elsevier Inc</pub><pmid>32854836</pmid><doi>10.1016/j.jacc.2020.07.005</doi><tpages>13</tpages><oa>free_for_read</oa></addata></record>
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subjects Aged
Aged, 80 and over
aortic stenosis
bicuspid aortic valve
Bicuspid Aortic Valve Disease - diagnostic imaging
Bicuspid Aortic Valve Disease - mortality
Bicuspid Aortic Valve Disease - surgery
Female
Follow-Up Studies
Humans
Internationality
Male
Mortality - trends
Prospective Studies
Registries
Tomography, X-Ray Computed - mortality
Tomography, X-Ray Computed - trends
transcatheter aortic valve implantation
Transcatheter Aortic Valve Replacement - mortality
Transcatheter Aortic Valve Replacement - trends
Treatment Outcome
title Bicuspid Aortic Valve Morphology and Outcomes After Transcatheter Aortic Valve Replacement
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