Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation
Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. This retrospective study aimed to evaluate the “off-label” use of transcatheter heart valves (THV) for the treatment of NAVR. A total of 254 high surgical risk patients with NAVR (age 74...
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| Veröffentlicht in: | The American journal of cardiology 2018-09, Vol.122 (6), p.1028-1035 |
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| creator | De Backer, Ole Pilgrim, Thomas Simonato, Matheus Mackensen, G. Burkhard Fiorina, Claudia Veulemanns, Verena Cerillo, Alfredo Schofer, Joachim Amabile, Nicolas Achkouty, Guy Schäfer, Ulrich Deutsch, Marcus-André Sinning, Jan-Malte Rahman, Mohammed S. Sawaya, Fadi J. Hildick-Smith, David Hernandez, Jose Maria Kim, Won-Keun Lefevre, Thierry Seiffert, Moritz Bleiziffer, Sabine Petronio, Anna Sonia Van Mieghem, Nicolas Taramasso, Maurizio Søndergaard, Lars Windecker, Stephan Latib, Azeem Dvir, Danny |
| description | Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. This retrospective study aimed to evaluate the “off-label” use of transcatheter heart valves (THV) for the treatment of NAVR. A total of 254 high surgical risk patients with NAVR (age 74 ± 12 years, Society of Thoracic Surgeons risk score 6.6 ± 6.2%) underwent transcatheter aortic valve implantation (TAVI) with early generation (43%) or newer generation (57%) devices at 46 different sites. Device success was significantly higher in patients treated with newer as compared with early generation THV (82% vs 47%, p |
| doi_str_mv | 10.1016/j.amjcard.2018.05.044 |
| format | Article |
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Burkhard ; Fiorina, Claudia ; Veulemanns, Verena ; Cerillo, Alfredo ; Schofer, Joachim ; Amabile, Nicolas ; Achkouty, Guy ; Schäfer, Ulrich ; Deutsch, Marcus-André ; Sinning, Jan-Malte ; Rahman, Mohammed S. ; Sawaya, Fadi J. ; Hildick-Smith, David ; Hernandez, Jose Maria ; Kim, Won-Keun ; Lefevre, Thierry ; Seiffert, Moritz ; Bleiziffer, Sabine ; Petronio, Anna Sonia ; Van Mieghem, Nicolas ; Taramasso, Maurizio ; Søndergaard, Lars ; Windecker, Stephan ; Latib, Azeem ; Dvir, Danny</creator><creatorcontrib>De Backer, Ole ; Pilgrim, Thomas ; Simonato, Matheus ; Mackensen, G. Burkhard ; Fiorina, Claudia ; Veulemanns, Verena ; Cerillo, Alfredo ; Schofer, Joachim ; Amabile, Nicolas ; Achkouty, Guy ; Schäfer, Ulrich ; Deutsch, Marcus-André ; Sinning, Jan-Malte ; Rahman, Mohammed S. ; Sawaya, Fadi J. ; Hildick-Smith, David ; Hernandez, Jose Maria ; Kim, Won-Keun ; Lefevre, Thierry ; Seiffert, Moritz ; Bleiziffer, Sabine ; Petronio, Anna Sonia ; Van Mieghem, Nicolas ; Taramasso, Maurizio ; Søndergaard, Lars ; Windecker, Stephan ; Latib, Azeem ; Dvir, Danny</creatorcontrib><description>Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. This retrospective study aimed to evaluate the “off-label” use of transcatheter heart valves (THV) for the treatment of NAVR. A total of 254 high surgical risk patients with NAVR (age 74 ± 12 years, Society of Thoracic Surgeons risk score 6.6 ± 6.2%) underwent transcatheter aortic valve implantation (TAVI) with early generation (43%) or newer generation (57%) devices at 46 different sites. Device success was significantly higher in patients treated with newer as compared with early generation THV (82% vs 47%, p <0.001). The difference was driven by lower rates of device malpositioning (9% vs 33%) and aortic regurgitation (AR) ≥ moderate (4% vs 31%) and translated into higher clinical efficacy at 30 days in patients treated with newer as compared with early generation THV (72% vs 56%, p = 0.041). Both THV under- and oversizing were associated with an increased risk of THV malpositioning. In conclusion, TAVI is a feasible treatment strategy in selected high-risk patients with NAVR but is associated with a considerable risk of THV malpositioning and residual AR. Although newer-generation THV are associated with better outcomes, novel devices for the treatment of NAVR are warranted.</description><identifier>ISSN: 0002-9149</identifier><identifier>EISSN: 1879-1913</identifier><identifier>DOI: 10.1016/j.amjcard.2018.05.044</identifier><identifier>PMID: 30072124</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>Aortic valve ; Clinical outcomes ; Consortia ; Endocarditis ; Heart valves ; Implantation ; Medical personnel ; Mortality ; Patients ; Regurgitation ; Risk ; Risk groups ; Stroke ; Success ; Surgery ; Thorax ; Transplants & implants</subject><ispartof>The American journal of cardiology, 2018-09, Vol.122 (6), p.1028-1035</ispartof><rights>2018</rights><rights>Copyright © 2018. Published by Elsevier Inc.</rights><rights>Copyright Elsevier Limited Sep 15, 2018</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c393t-ffee61403b32ea55a020b627b33010576cd612f3822e30efdf315ee35eb7c2533</citedby><cites>FETCH-LOGICAL-c393t-ffee61403b32ea55a020b627b33010576cd612f3822e30efdf315ee35eb7c2533</cites><orcidid>0000-0003-4266-860X ; 0000-0001-8721-4068 ; 0000-0001-9035-343X ; 0000-0002-0799-7478 ; 0000-0002-7101-5686 ; 0000-0002-9684-320X ; 0000-0003-1369-6425 ; 0000-0001-9361-9782</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S000291491831244X$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30072124$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>De Backer, Ole</creatorcontrib><creatorcontrib>Pilgrim, Thomas</creatorcontrib><creatorcontrib>Simonato, Matheus</creatorcontrib><creatorcontrib>Mackensen, G. Burkhard</creatorcontrib><creatorcontrib>Fiorina, Claudia</creatorcontrib><creatorcontrib>Veulemanns, Verena</creatorcontrib><creatorcontrib>Cerillo, Alfredo</creatorcontrib><creatorcontrib>Schofer, Joachim</creatorcontrib><creatorcontrib>Amabile, Nicolas</creatorcontrib><creatorcontrib>Achkouty, Guy</creatorcontrib><creatorcontrib>Schäfer, Ulrich</creatorcontrib><creatorcontrib>Deutsch, Marcus-André</creatorcontrib><creatorcontrib>Sinning, Jan-Malte</creatorcontrib><creatorcontrib>Rahman, Mohammed S.</creatorcontrib><creatorcontrib>Sawaya, Fadi J.</creatorcontrib><creatorcontrib>Hildick-Smith, David</creatorcontrib><creatorcontrib>Hernandez, Jose Maria</creatorcontrib><creatorcontrib>Kim, Won-Keun</creatorcontrib><creatorcontrib>Lefevre, Thierry</creatorcontrib><creatorcontrib>Seiffert, Moritz</creatorcontrib><creatorcontrib>Bleiziffer, Sabine</creatorcontrib><creatorcontrib>Petronio, Anna Sonia</creatorcontrib><creatorcontrib>Van Mieghem, Nicolas</creatorcontrib><creatorcontrib>Taramasso, Maurizio</creatorcontrib><creatorcontrib>Søndergaard, Lars</creatorcontrib><creatorcontrib>Windecker, Stephan</creatorcontrib><creatorcontrib>Latib, Azeem</creatorcontrib><creatorcontrib>Dvir, Danny</creatorcontrib><title>Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation</title><title>The American journal of cardiology</title><addtitle>Am J Cardiol</addtitle><description>Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. This retrospective study aimed to evaluate the “off-label” use of transcatheter heart valves (THV) for the treatment of NAVR. A total of 254 high surgical risk patients with NAVR (age 74 ± 12 years, Society of Thoracic Surgeons risk score 6.6 ± 6.2%) underwent transcatheter aortic valve implantation (TAVI) with early generation (43%) or newer generation (57%) devices at 46 different sites. Device success was significantly higher in patients treated with newer as compared with early generation THV (82% vs 47%, p <0.001). The difference was driven by lower rates of device malpositioning (9% vs 33%) and aortic regurgitation (AR) ≥ moderate (4% vs 31%) and translated into higher clinical efficacy at 30 days in patients treated with newer as compared with early generation THV (72% vs 56%, p = 0.041). Both THV under- and oversizing were associated with an increased risk of THV malpositioning. In conclusion, TAVI is a feasible treatment strategy in selected high-risk patients with NAVR but is associated with a considerable risk of THV malpositioning and residual AR. Although newer-generation THV are associated with better outcomes, novel devices for the treatment of NAVR are warranted.</description><subject>Aortic valve</subject><subject>Clinical outcomes</subject><subject>Consortia</subject><subject>Endocarditis</subject><subject>Heart valves</subject><subject>Implantation</subject><subject>Medical personnel</subject><subject>Mortality</subject><subject>Patients</subject><subject>Regurgitation</subject><subject>Risk</subject><subject>Risk groups</subject><subject>Stroke</subject><subject>Success</subject><subject>Surgery</subject><subject>Thorax</subject><subject>Transplants & implants</subject><issn>0002-9149</issn><issn>1879-1913</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkV2L1TAQhoMo7nH1JygFb7xpnUmaflzJsqy6sKjIrrchTSdrStsck3TBf28O5yjojVdhyPPMJPMy9hKhQsDm7VTpZTI6jBUH7CqQFdT1I7bDru1L7FE8ZjsA4GWPdX_GnsU45RJRNk_ZmQBoOfJ6x5a7SHabV4qx8La4DXqNRqfvlCgUFz4kZ4pven6g4nrZz3pNOjm_FtaHzJJOC63pIH7ZAhWf8mUm_9K-0v0W7t3Re86eWD1HenE6z9nd-6vby4_lzecP15cXN6URvUiltUQN1iAGwUlLqYHD0PB2EAIQZNuYsUFuRcc5CSA7WoGSSEgaWsOlEOfszbHvPvgfG8WkFhcNzfkD5LeoOHSixYb3MqOv_0Env4U1v05xRIF9l_ebKXmkTPAxBrJqH9yiw0-FoA55qEmd8lCHPBRIlfPI3qtT921YaPxj_Q4gA--OAOV1PDgKKhpHq6HRBTJJjd79Z8Qv47KecQ</recordid><startdate>20180915</startdate><enddate>20180915</enddate><creator>De Backer, Ole</creator><creator>Pilgrim, Thomas</creator><creator>Simonato, Matheus</creator><creator>Mackensen, G. 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Burkhard ; Fiorina, Claudia ; Veulemanns, Verena ; Cerillo, Alfredo ; Schofer, Joachim ; Amabile, Nicolas ; Achkouty, Guy ; Schäfer, Ulrich ; Deutsch, Marcus-André ; Sinning, Jan-Malte ; Rahman, Mohammed S. ; Sawaya, Fadi J. ; Hildick-Smith, David ; Hernandez, Jose Maria ; Kim, Won-Keun ; Lefevre, Thierry ; Seiffert, Moritz ; Bleiziffer, Sabine ; Petronio, Anna Sonia ; Van Mieghem, Nicolas ; Taramasso, Maurizio ; Søndergaard, Lars ; Windecker, Stephan ; Latib, Azeem ; Dvir, Danny</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c393t-ffee61403b32ea55a020b627b33010576cd612f3822e30efdf315ee35eb7c2533</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2018</creationdate><topic>Aortic valve</topic><topic>Clinical outcomes</topic><topic>Consortia</topic><topic>Endocarditis</topic><topic>Heart valves</topic><topic>Implantation</topic><topic>Medical personnel</topic><topic>Mortality</topic><topic>Patients</topic><topic>Regurgitation</topic><topic>Risk</topic><topic>Risk groups</topic><topic>Stroke</topic><topic>Success</topic><topic>Surgery</topic><topic>Thorax</topic><topic>Transplants & implants</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>De Backer, Ole</creatorcontrib><creatorcontrib>Pilgrim, Thomas</creatorcontrib><creatorcontrib>Simonato, Matheus</creatorcontrib><creatorcontrib>Mackensen, G. 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Burkhard</au><au>Fiorina, Claudia</au><au>Veulemanns, Verena</au><au>Cerillo, Alfredo</au><au>Schofer, Joachim</au><au>Amabile, Nicolas</au><au>Achkouty, Guy</au><au>Schäfer, Ulrich</au><au>Deutsch, Marcus-André</au><au>Sinning, Jan-Malte</au><au>Rahman, Mohammed S.</au><au>Sawaya, Fadi J.</au><au>Hildick-Smith, David</au><au>Hernandez, Jose Maria</au><au>Kim, Won-Keun</au><au>Lefevre, Thierry</au><au>Seiffert, Moritz</au><au>Bleiziffer, Sabine</au><au>Petronio, Anna Sonia</au><au>Van Mieghem, Nicolas</au><au>Taramasso, Maurizio</au><au>Søndergaard, Lars</au><au>Windecker, Stephan</au><au>Latib, Azeem</au><au>Dvir, Danny</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation</atitle><jtitle>The American journal of cardiology</jtitle><addtitle>Am J Cardiol</addtitle><date>2018-09-15</date><risdate>2018</risdate><volume>122</volume><issue>6</issue><spage>1028</spage><epage>1035</epage><pages>1028-1035</pages><issn>0002-9149</issn><eissn>1879-1913</eissn><abstract>Patients with pure native aortic valve regurgitation (NAVR) and increased surgical risk are often denied surgery. 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| source | Elsevier ScienceDirect Journals |
| subjects | Aortic valve Clinical outcomes Consortia Endocarditis Heart valves Implantation Medical personnel Mortality Patients Regurgitation Risk Risk groups Stroke Success Surgery Thorax Transplants & implants |
| title | Usefulness of Transcatheter Aortic Valve Implantation for Treatment of Pure Native Aortic Valve Regurgitation |
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