Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry
Objectives To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self‐expanding and balloon‐expandable transcatheter heart valves (THVs) in patients with a small aortic annulus. Background Few studies have directly compared TAVR outcomes us...
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| Veröffentlicht in: | Catheterization and cardiovascular interventions 2021-05, Vol.97 (6), p.E875-E886 |
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| creator | Hase, Hiromu Yoshijima, Nobuhiro Yanagisawa, Ryo Tanaka, Makoto Tsuruta, Hikaru Shimizu, Hideyuki Fukuda, Keiichi Naganuma, Toru Mizutani, Kazuki Yamawaki, Masahiro Tada, Norio Yamanaka, Futoshi Shirai, Shinichi Tabata, Minoru Ueno, Hiroshi Takagi, Kensuke Watanabe, Yusuke Yamamoto, Masanori Hayashida, Kentaro |
| description | Objectives
To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self‐expanding and balloon‐expandable transcatheter heart valves (THVs) in patients with a small aortic annulus.
Background
Few studies have directly compared TAVR outcomes using third‐generation THVs, focusing on patients with small aortic annuli.
Methods
In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third‐generation THVs. Propensity score matching was used to adjust baseline clinical characteristics.
Results
The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0–11.9] vs. 12.0 [IQR: 9.9–16.3] mmHg, p |
| doi_str_mv | 10.1002/ccd.29259 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2442841419</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2442841419</sourcerecordid><originalsourceid>FETCH-LOGICAL-c2689-994d4be61be1093e604491abf005e31ce37fd7a919f00d354c43ce209672c2ca3</originalsourceid><addsrcrecordid>eNp1kUtOHDEQhq0oKDySBRdAlrKBxYDtdnfj7EbN8BICCSZRdlaNuybTyP3Adg-aHUfgjJwEQw9ZRMrKVumrr-z6Cdnl7JAzJo6MKQ-FEqn6RLZ4KsQoF9nvz-s7VzLbJNve3zPGVCbUF7KZRDpLU7FFnqcOGm8gLDCgo9C6UBm6BLtE6rCzYLDGJtDHKizoZNnaPtBbukTne0_voKuwoQmtGnoJHTTokXYQYjH4oQWor8HaDzE0TW97_4NOF0hvisn4-uXpeTr-dRGH_al8cKuvZGMO1uO39blDfp5OpsX56Orm7KIYX42MyI7VSClZyhlmfIacqQQzJqXiMJszlmLCDSb5vMxBcRUrZZJKIxODIi4gF0YYSHbI_uDtXPvQow-6rrxBa-Mv2t5rIaU4llxyFdHv_6D3be-a-DotUhHHpjlnkToYKONa7x3OdeeqGtxKc6bfYtIxJv0eU2T31sZ-VmP5l_zIJQJHA_BYWVz936SL4mRQvgLs1Zza</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2524915710</pqid></control><display><type>article</type><title>Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry</title><source>Wiley Online Library All Journals</source><creator>Hase, Hiromu ; Yoshijima, Nobuhiro ; Yanagisawa, Ryo ; Tanaka, Makoto ; Tsuruta, Hikaru ; Shimizu, Hideyuki ; Fukuda, Keiichi ; Naganuma, Toru ; Mizutani, Kazuki ; Yamawaki, Masahiro ; Tada, Norio ; Yamanaka, Futoshi ; Shirai, Shinichi ; Tabata, Minoru ; Ueno, Hiroshi ; Takagi, Kensuke ; Watanabe, Yusuke ; Yamamoto, Masanori ; Hayashida, Kentaro</creator><creatorcontrib>Hase, Hiromu ; Yoshijima, Nobuhiro ; Yanagisawa, Ryo ; Tanaka, Makoto ; Tsuruta, Hikaru ; Shimizu, Hideyuki ; Fukuda, Keiichi ; Naganuma, Toru ; Mizutani, Kazuki ; Yamawaki, Masahiro ; Tada, Norio ; Yamanaka, Futoshi ; Shirai, Shinichi ; Tabata, Minoru ; Ueno, Hiroshi ; Takagi, Kensuke ; Watanabe, Yusuke ; Yamamoto, Masanori ; Hayashida, Kentaro ; OCEAN-TAVI Investigators ; OCEAN‐TAVI Investigators</creatorcontrib><description>Objectives
To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self‐expanding and balloon‐expandable transcatheter heart valves (THVs) in patients with a small aortic annulus.
Background
Few studies have directly compared TAVR outcomes using third‐generation THVs, focusing on patients with small aortic annuli.
Methods
In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third‐generation THVs. Propensity score matching was used to adjust baseline clinical characteristics.
Results
The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0–11.9] vs. 12.0 [IQR: 9.9–16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01–1.46] vs. 1.08 [IQR: 0.90–1.28] cm2/m2, p < .001}. However, no significant differences were reported in the incidence of severe prosthesis‐patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all‐cause mortality (log‐lank test, p = .81).
Conclusions
TAVR for patients with a small annulus using third‐generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all‐cause mortality at 1 year was similar between both groups.</description><identifier>ISSN: 1522-1946</identifier><identifier>EISSN: 1522-726X</identifier><identifier>DOI: 10.1002/ccd.29259</identifier><identifier>PMID: 32926552</identifier><language>eng</language><publisher>Hoboken, USA: John Wiley & Sons, Inc</publisher><subject>Aortic valve ; Balloon treatment ; Hemodynamics ; indexed effective orifice area ; Mortality ; prosthesis‐patient mismatch ; Regurgitation ; transcatheter heart valves ; valve‐in‐valve</subject><ispartof>Catheterization and cardiovascular interventions, 2021-05, Vol.97 (6), p.E875-E886</ispartof><rights>2020 Wiley Periodicals LLC.</rights><rights>2021 Wiley Periodicals LLC.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c2689-994d4be61be1093e604491abf005e31ce37fd7a919f00d354c43ce209672c2ca3</citedby><cites>FETCH-LOGICAL-c2689-994d4be61be1093e604491abf005e31ce37fd7a919f00d354c43ce209672c2ca3</cites><orcidid>0000-0001-5343-0352 ; 0000-0002-1304-5836 ; 0000-0003-3999-8536 ; 0000-0001-5210-6382 ; 0000-0003-1219-1193 ; 0000-0002-1750-1982 ; 0000-0003-2297-5303 ; 0000-0002-5849-4627 ; 0000-0002-4501-1358</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fccd.29259$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fccd.29259$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1416,27915,27916,45565,45566</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32926552$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hase, Hiromu</creatorcontrib><creatorcontrib>Yoshijima, Nobuhiro</creatorcontrib><creatorcontrib>Yanagisawa, Ryo</creatorcontrib><creatorcontrib>Tanaka, Makoto</creatorcontrib><creatorcontrib>Tsuruta, Hikaru</creatorcontrib><creatorcontrib>Shimizu, Hideyuki</creatorcontrib><creatorcontrib>Fukuda, Keiichi</creatorcontrib><creatorcontrib>Naganuma, Toru</creatorcontrib><creatorcontrib>Mizutani, Kazuki</creatorcontrib><creatorcontrib>Yamawaki, Masahiro</creatorcontrib><creatorcontrib>Tada, Norio</creatorcontrib><creatorcontrib>Yamanaka, Futoshi</creatorcontrib><creatorcontrib>Shirai, Shinichi</creatorcontrib><creatorcontrib>Tabata, Minoru</creatorcontrib><creatorcontrib>Ueno, Hiroshi</creatorcontrib><creatorcontrib>Takagi, Kensuke</creatorcontrib><creatorcontrib>Watanabe, Yusuke</creatorcontrib><creatorcontrib>Yamamoto, Masanori</creatorcontrib><creatorcontrib>Hayashida, Kentaro</creatorcontrib><creatorcontrib>OCEAN-TAVI Investigators</creatorcontrib><creatorcontrib>OCEAN‐TAVI Investigators</creatorcontrib><title>Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry</title><title>Catheterization and cardiovascular interventions</title><addtitle>Catheter Cardiovasc Interv</addtitle><description>Objectives
To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self‐expanding and balloon‐expandable transcatheter heart valves (THVs) in patients with a small aortic annulus.
Background
Few studies have directly compared TAVR outcomes using third‐generation THVs, focusing on patients with small aortic annuli.
Methods
In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third‐generation THVs. Propensity score matching was used to adjust baseline clinical characteristics.
Results
The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0–11.9] vs. 12.0 [IQR: 9.9–16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01–1.46] vs. 1.08 [IQR: 0.90–1.28] cm2/m2, p < .001}. However, no significant differences were reported in the incidence of severe prosthesis‐patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all‐cause mortality (log‐lank test, p = .81).
Conclusions
TAVR for patients with a small annulus using third‐generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all‐cause mortality at 1 year was similar between both groups.</description><subject>Aortic valve</subject><subject>Balloon treatment</subject><subject>Hemodynamics</subject><subject>indexed effective orifice area</subject><subject>Mortality</subject><subject>prosthesis‐patient mismatch</subject><subject>Regurgitation</subject><subject>transcatheter heart valves</subject><subject>valve‐in‐valve</subject><issn>1522-1946</issn><issn>1522-726X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><recordid>eNp1kUtOHDEQhq0oKDySBRdAlrKBxYDtdnfj7EbN8BICCSZRdlaNuybTyP3Adg-aHUfgjJwEQw9ZRMrKVumrr-z6Cdnl7JAzJo6MKQ-FEqn6RLZ4KsQoF9nvz-s7VzLbJNve3zPGVCbUF7KZRDpLU7FFnqcOGm8gLDCgo9C6UBm6BLtE6rCzYLDGJtDHKizoZNnaPtBbukTne0_voKuwoQmtGnoJHTTokXYQYjH4oQWor8HaDzE0TW97_4NOF0hvisn4-uXpeTr-dRGH_al8cKuvZGMO1uO39blDfp5OpsX56Orm7KIYX42MyI7VSClZyhlmfIacqQQzJqXiMJszlmLCDSb5vMxBcRUrZZJKIxODIi4gF0YYSHbI_uDtXPvQow-6rrxBa-Mv2t5rIaU4llxyFdHv_6D3be-a-DotUhHHpjlnkToYKONa7x3OdeeqGtxKc6bfYtIxJv0eU2T31sZ-VmP5l_zIJQJHA_BYWVz936SL4mRQvgLs1Zza</recordid><startdate>20210501</startdate><enddate>20210501</enddate><creator>Hase, Hiromu</creator><creator>Yoshijima, Nobuhiro</creator><creator>Yanagisawa, Ryo</creator><creator>Tanaka, Makoto</creator><creator>Tsuruta, Hikaru</creator><creator>Shimizu, Hideyuki</creator><creator>Fukuda, Keiichi</creator><creator>Naganuma, Toru</creator><creator>Mizutani, Kazuki</creator><creator>Yamawaki, Masahiro</creator><creator>Tada, Norio</creator><creator>Yamanaka, Futoshi</creator><creator>Shirai, Shinichi</creator><creator>Tabata, Minoru</creator><creator>Ueno, Hiroshi</creator><creator>Takagi, Kensuke</creator><creator>Watanabe, Yusuke</creator><creator>Yamamoto, Masanori</creator><creator>Hayashida, Kentaro</creator><general>John Wiley & Sons, Inc</general><general>Wiley Subscription Services, Inc</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>K9.</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-5343-0352</orcidid><orcidid>https://orcid.org/0000-0002-1304-5836</orcidid><orcidid>https://orcid.org/0000-0003-3999-8536</orcidid><orcidid>https://orcid.org/0000-0001-5210-6382</orcidid><orcidid>https://orcid.org/0000-0003-1219-1193</orcidid><orcidid>https://orcid.org/0000-0002-1750-1982</orcidid><orcidid>https://orcid.org/0000-0003-2297-5303</orcidid><orcidid>https://orcid.org/0000-0002-5849-4627</orcidid><orcidid>https://orcid.org/0000-0002-4501-1358</orcidid></search><sort><creationdate>20210501</creationdate><title>Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry</title><author>Hase, Hiromu ; Yoshijima, Nobuhiro ; Yanagisawa, Ryo ; Tanaka, Makoto ; Tsuruta, Hikaru ; Shimizu, Hideyuki ; Fukuda, Keiichi ; Naganuma, Toru ; Mizutani, Kazuki ; Yamawaki, Masahiro ; Tada, Norio ; Yamanaka, Futoshi ; Shirai, Shinichi ; Tabata, Minoru ; Ueno, Hiroshi ; Takagi, Kensuke ; Watanabe, Yusuke ; Yamamoto, Masanori ; Hayashida, Kentaro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c2689-994d4be61be1093e604491abf005e31ce37fd7a919f00d354c43ce209672c2ca3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Aortic valve</topic><topic>Balloon treatment</topic><topic>Hemodynamics</topic><topic>indexed effective orifice area</topic><topic>Mortality</topic><topic>prosthesis‐patient mismatch</topic><topic>Regurgitation</topic><topic>transcatheter heart valves</topic><topic>valve‐in‐valve</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hase, Hiromu</creatorcontrib><creatorcontrib>Yoshijima, Nobuhiro</creatorcontrib><creatorcontrib>Yanagisawa, Ryo</creatorcontrib><creatorcontrib>Tanaka, Makoto</creatorcontrib><creatorcontrib>Tsuruta, Hikaru</creatorcontrib><creatorcontrib>Shimizu, Hideyuki</creatorcontrib><creatorcontrib>Fukuda, Keiichi</creatorcontrib><creatorcontrib>Naganuma, Toru</creatorcontrib><creatorcontrib>Mizutani, Kazuki</creatorcontrib><creatorcontrib>Yamawaki, Masahiro</creatorcontrib><creatorcontrib>Tada, Norio</creatorcontrib><creatorcontrib>Yamanaka, Futoshi</creatorcontrib><creatorcontrib>Shirai, Shinichi</creatorcontrib><creatorcontrib>Tabata, Minoru</creatorcontrib><creatorcontrib>Ueno, Hiroshi</creatorcontrib><creatorcontrib>Takagi, Kensuke</creatorcontrib><creatorcontrib>Watanabe, Yusuke</creatorcontrib><creatorcontrib>Yamamoto, Masanori</creatorcontrib><creatorcontrib>Hayashida, Kentaro</creatorcontrib><creatorcontrib>OCEAN-TAVI Investigators</creatorcontrib><creatorcontrib>OCEAN‐TAVI Investigators</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>MEDLINE - Academic</collection><jtitle>Catheterization and cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hase, Hiromu</au><au>Yoshijima, Nobuhiro</au><au>Yanagisawa, Ryo</au><au>Tanaka, Makoto</au><au>Tsuruta, Hikaru</au><au>Shimizu, Hideyuki</au><au>Fukuda, Keiichi</au><au>Naganuma, Toru</au><au>Mizutani, Kazuki</au><au>Yamawaki, Masahiro</au><au>Tada, Norio</au><au>Yamanaka, Futoshi</au><au>Shirai, Shinichi</au><au>Tabata, Minoru</au><au>Ueno, Hiroshi</au><au>Takagi, Kensuke</au><au>Watanabe, Yusuke</au><au>Yamamoto, Masanori</au><au>Hayashida, Kentaro</au><aucorp>OCEAN-TAVI Investigators</aucorp><aucorp>OCEAN‐TAVI Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry</atitle><jtitle>Catheterization and cardiovascular interventions</jtitle><addtitle>Catheter Cardiovasc Interv</addtitle><date>2021-05-01</date><risdate>2021</risdate><volume>97</volume><issue>6</issue><spage>E875</spage><epage>E886</epage><pages>E875-E886</pages><issn>1522-1946</issn><eissn>1522-726X</eissn><abstract>Objectives
To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self‐expanding and balloon‐expandable transcatheter heart valves (THVs) in patients with a small aortic annulus.
Background
Few studies have directly compared TAVR outcomes using third‐generation THVs, focusing on patients with small aortic annuli.
Methods
In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third‐generation THVs. Propensity score matching was used to adjust baseline clinical characteristics.
Results
The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0–11.9] vs. 12.0 [IQR: 9.9–16.3] mmHg, p < .001; iEOA: 1.20 [IQR: 1.01–1.46] vs. 1.08 [IQR: 0.90–1.28] cm2/m2, p < .001}. However, no significant differences were reported in the incidence of severe prosthesis‐patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all‐cause mortality (log‐lank test, p = .81).
Conclusions
TAVR for patients with a small annulus using third‐generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all‐cause mortality at 1 year was similar between both groups.</abstract><cop>Hoboken, USA</cop><pub>John Wiley & Sons, Inc</pub><pmid>32926552</pmid><doi>10.1002/ccd.29259</doi><tpages>12</tpages><orcidid>https://orcid.org/0000-0001-5343-0352</orcidid><orcidid>https://orcid.org/0000-0002-1304-5836</orcidid><orcidid>https://orcid.org/0000-0003-3999-8536</orcidid><orcidid>https://orcid.org/0000-0001-5210-6382</orcidid><orcidid>https://orcid.org/0000-0003-1219-1193</orcidid><orcidid>https://orcid.org/0000-0002-1750-1982</orcidid><orcidid>https://orcid.org/0000-0003-2297-5303</orcidid><orcidid>https://orcid.org/0000-0002-5849-4627</orcidid><orcidid>https://orcid.org/0000-0002-4501-1358</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1522-1946 |
| ispartof | Catheterization and cardiovascular interventions, 2021-05, Vol.97 (6), p.E875-E886 |
| issn | 1522-1946 1522-726X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2442841419 |
| source | Wiley Online Library All Journals |
| subjects | Aortic valve Balloon treatment Hemodynamics indexed effective orifice area Mortality prosthesis‐patient mismatch Regurgitation transcatheter heart valves valve‐in‐valve |
| title | Transcatheter aortic valve replacement with Evolut R versus Sapien 3 in Japanese patients with a small aortic annulus: The OCEAN‐TAVI registry |
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