Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli: The TAVI-SMALL Registry
The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli. Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aort...
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| Veröffentlicht in: | JACC. Cardiovascular interventions 2020-01, Vol.13 (2), p.196-206 |
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| creator | Regazzoli, Damiano Chiarito, Mauro Cannata, Francesco Pagnesi, Matteo Miura, Mizuki Ziviello, Francesca Picci, Andrea Reifart, Jörg De Marco, Federico Bedogni, Francesco Adamo, Marianna Curello, Salvatore Teles, Rui Taramasso, Maurizio Barbanti, Marco Tamburino, Corrado Stefanini, Giulio G Mangieri, Antonio Giannini, Francesco Pagnotta, Paolo A Maisano, Francesco Kim, Won-Keun Van Mieghem, Nicolas M Colombo, Antonio Reimers, Bernhard Latib, Azeem |
| description | The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli.
Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli.
TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter |
| doi_str_mv | 10.1016/j.jcin.2019.08.041 |
| format | Article |
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Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli.
TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm
on computed tomography) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedural mean aortic gradient, indexed effective orifice area, and rate of severe prosthesis-patient mismatch.
Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p < 0.001). Mean indexed effective orifice area was 1.04 cm
/m
(95% CI: 1.01 to 1.08 cm
/m
) with a trend toward lower values with the Portico. No significant differences were reported in terms of severe prosthesis-patient mismatch (overall rate 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups.
Transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials.</description><identifier>EISSN: 1876-7605</identifier><identifier>DOI: 10.1016/j.jcin.2019.08.041</identifier><identifier>PMID: 31883714</identifier><language>eng</language><publisher>United States</publisher><ispartof>JACC. Cardiovascular interventions, 2020-01, Vol.13 (2), p.196-206</ispartof><rights>Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31883714$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Regazzoli, Damiano</creatorcontrib><creatorcontrib>Chiarito, Mauro</creatorcontrib><creatorcontrib>Cannata, Francesco</creatorcontrib><creatorcontrib>Pagnesi, Matteo</creatorcontrib><creatorcontrib>Miura, Mizuki</creatorcontrib><creatorcontrib>Ziviello, Francesca</creatorcontrib><creatorcontrib>Picci, Andrea</creatorcontrib><creatorcontrib>Reifart, Jörg</creatorcontrib><creatorcontrib>De Marco, Federico</creatorcontrib><creatorcontrib>Bedogni, Francesco</creatorcontrib><creatorcontrib>Adamo, Marianna</creatorcontrib><creatorcontrib>Curello, Salvatore</creatorcontrib><creatorcontrib>Teles, Rui</creatorcontrib><creatorcontrib>Taramasso, Maurizio</creatorcontrib><creatorcontrib>Barbanti, Marco</creatorcontrib><creatorcontrib>Tamburino, Corrado</creatorcontrib><creatorcontrib>Stefanini, Giulio G</creatorcontrib><creatorcontrib>Mangieri, Antonio</creatorcontrib><creatorcontrib>Giannini, Francesco</creatorcontrib><creatorcontrib>Pagnotta, Paolo A</creatorcontrib><creatorcontrib>Maisano, Francesco</creatorcontrib><creatorcontrib>Kim, Won-Keun</creatorcontrib><creatorcontrib>Van Mieghem, Nicolas M</creatorcontrib><creatorcontrib>Colombo, Antonio</creatorcontrib><creatorcontrib>Reimers, Bernhard</creatorcontrib><creatorcontrib>Latib, Azeem</creatorcontrib><creatorcontrib>TAVI-SMALL Investigators</creatorcontrib><title>Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli: The TAVI-SMALL Registry</title><title>JACC. Cardiovascular interventions</title><addtitle>JACC Cardiovasc Interv</addtitle><description>The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli.
Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli.
TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm
on computed tomography) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedural mean aortic gradient, indexed effective orifice area, and rate of severe prosthesis-patient mismatch.
Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p < 0.001). Mean indexed effective orifice area was 1.04 cm
/m
(95% CI: 1.01 to 1.08 cm
/m
) with a trend toward lower values with the Portico. No significant differences were reported in terms of severe prosthesis-patient mismatch (overall rate 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups.
Transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials.</description><issn>1876-7605</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNo1kN9KwzAchYMgbk5fwAvJpTetSdM2qXdl-GcwEWzdbUnTX11GmtYmFfc2PotP5sB5dS7OxwfnIHRFSUgJTW934U5pG0aEZiERIYnpCZpTwdOApySZoXPndoSkJOPRGZoxKgTjNJ6jqRyldUr6LXgYcQGmDe6_BmkbWRvAG2k-Aa-6wUjrpde9xW0_4rwfvVa48GB7px3WFhedNObn-9jk1k5G3-FyC7jMN6ugeM7Xa_wK79r5cX-BTltpHFwec4HeHu7L5VOwfnlcLfN1MESU-kCJLFKCcN60SaqYBEJlxqgkQkLatG0SizrOOE1qEkPTioY1jVKx4iCJhCxhC3Tz5x3G_mMC56tOOwXmsAb6yVURYzRmEUvEAb0-olPdQVMNo-7kuK_-r2K_AnBsOQ</recordid><startdate>20200127</startdate><enddate>20200127</enddate><creator>Regazzoli, Damiano</creator><creator>Chiarito, Mauro</creator><creator>Cannata, Francesco</creator><creator>Pagnesi, Matteo</creator><creator>Miura, Mizuki</creator><creator>Ziviello, Francesca</creator><creator>Picci, Andrea</creator><creator>Reifart, Jörg</creator><creator>De Marco, Federico</creator><creator>Bedogni, Francesco</creator><creator>Adamo, Marianna</creator><creator>Curello, Salvatore</creator><creator>Teles, Rui</creator><creator>Taramasso, Maurizio</creator><creator>Barbanti, Marco</creator><creator>Tamburino, Corrado</creator><creator>Stefanini, Giulio G</creator><creator>Mangieri, Antonio</creator><creator>Giannini, Francesco</creator><creator>Pagnotta, Paolo A</creator><creator>Maisano, Francesco</creator><creator>Kim, Won-Keun</creator><creator>Van Mieghem, Nicolas M</creator><creator>Colombo, Antonio</creator><creator>Reimers, Bernhard</creator><creator>Latib, Azeem</creator><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20200127</creationdate><title>Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli: The TAVI-SMALL Registry</title><author>Regazzoli, Damiano ; Chiarito, Mauro ; Cannata, Francesco ; Pagnesi, Matteo ; Miura, Mizuki ; Ziviello, Francesca ; Picci, Andrea ; Reifart, Jörg ; De Marco, Federico ; Bedogni, Francesco ; Adamo, Marianna ; Curello, Salvatore ; Teles, Rui ; Taramasso, Maurizio ; Barbanti, Marco ; Tamburino, Corrado ; Stefanini, Giulio G ; Mangieri, Antonio ; Giannini, Francesco ; Pagnotta, Paolo A ; Maisano, Francesco ; Kim, Won-Keun ; Van Mieghem, Nicolas M ; Colombo, Antonio ; Reimers, Bernhard ; Latib, Azeem</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p211t-c892c8077df56c3ae01a931a08ae6dff548b49715b04edf8d3ddcc4c7ea0ae953</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Regazzoli, Damiano</creatorcontrib><creatorcontrib>Chiarito, Mauro</creatorcontrib><creatorcontrib>Cannata, Francesco</creatorcontrib><creatorcontrib>Pagnesi, Matteo</creatorcontrib><creatorcontrib>Miura, Mizuki</creatorcontrib><creatorcontrib>Ziviello, Francesca</creatorcontrib><creatorcontrib>Picci, Andrea</creatorcontrib><creatorcontrib>Reifart, Jörg</creatorcontrib><creatorcontrib>De Marco, Federico</creatorcontrib><creatorcontrib>Bedogni, Francesco</creatorcontrib><creatorcontrib>Adamo, Marianna</creatorcontrib><creatorcontrib>Curello, Salvatore</creatorcontrib><creatorcontrib>Teles, Rui</creatorcontrib><creatorcontrib>Taramasso, Maurizio</creatorcontrib><creatorcontrib>Barbanti, Marco</creatorcontrib><creatorcontrib>Tamburino, Corrado</creatorcontrib><creatorcontrib>Stefanini, Giulio G</creatorcontrib><creatorcontrib>Mangieri, Antonio</creatorcontrib><creatorcontrib>Giannini, Francesco</creatorcontrib><creatorcontrib>Pagnotta, Paolo A</creatorcontrib><creatorcontrib>Maisano, Francesco</creatorcontrib><creatorcontrib>Kim, Won-Keun</creatorcontrib><creatorcontrib>Van Mieghem, Nicolas M</creatorcontrib><creatorcontrib>Colombo, Antonio</creatorcontrib><creatorcontrib>Reimers, Bernhard</creatorcontrib><creatorcontrib>Latib, Azeem</creatorcontrib><creatorcontrib>TAVI-SMALL Investigators</creatorcontrib><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>JACC. Cardiovascular interventions</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Regazzoli, Damiano</au><au>Chiarito, Mauro</au><au>Cannata, Francesco</au><au>Pagnesi, Matteo</au><au>Miura, Mizuki</au><au>Ziviello, Francesca</au><au>Picci, Andrea</au><au>Reifart, Jörg</au><au>De Marco, Federico</au><au>Bedogni, Francesco</au><au>Adamo, Marianna</au><au>Curello, Salvatore</au><au>Teles, Rui</au><au>Taramasso, Maurizio</au><au>Barbanti, Marco</au><au>Tamburino, Corrado</au><au>Stefanini, Giulio G</au><au>Mangieri, Antonio</au><au>Giannini, Francesco</au><au>Pagnotta, Paolo A</au><au>Maisano, Francesco</au><au>Kim, Won-Keun</au><au>Van Mieghem, Nicolas M</au><au>Colombo, Antonio</au><au>Reimers, Bernhard</au><au>Latib, Azeem</au><aucorp>TAVI-SMALL Investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli: The TAVI-SMALL Registry</atitle><jtitle>JACC. Cardiovascular interventions</jtitle><addtitle>JACC Cardiovasc Interv</addtitle><date>2020-01-27</date><risdate>2020</risdate><volume>13</volume><issue>2</issue><spage>196</spage><epage>206</epage><pages>196-206</pages><eissn>1876-7605</eissn><abstract>The aim of this study was to evaluate and compare the outcomes of transcatheter self-expandable prostheses in patients with small annuli.
Transcatheter aortic heart valves appear to have better performance than surgical valves in terms of prosthesis-patient mismatch, especially in patients with aortic stenosis with small aortic annuli.
TAVI-SMALL (International Multicenter Registry to Evaluate the Performance of Self-Expandable Valves in Small Aortic Annuli) is a retrospective registry of patients with severe aortic stenosis and small annuli (annular perimeter <72 mm or area <400 mm
on computed tomography) treated with transcatheter self-expandable valves (n = 859; Evolut R, n = 397; Evolut PRO, n = 84; ACURATE, n = 201; Portico, n = 177). Primary endpoints were post-procedural mean aortic gradient, indexed effective orifice area, and rate of severe prosthesis-patient mismatch.
Pre-discharge gradients were consistently low in every group, with a slight benefit with the Evolut R (8.1 mm Hg; 95% confidence interval [CI]: 7.7 to 8.5 mm Hg) and Evolut PRO (6.9 mm Hg; 95% CI: 6.3 to 7.6 mm Hg) compared with the ACURATE (9.6 mm Hg; 95% CI: 8.9 to 10.2 mm Hg) and Portico (8.9 mm Hg; 95% CI: 8.2 to 9.6 mm Hg) groups (p < 0.001). Mean indexed effective orifice area was 1.04 cm
/m
(95% CI: 1.01 to 1.08 cm
/m
) with a trend toward lower values with the Portico. No significant differences were reported in terms of severe prosthesis-patient mismatch (overall rate 9.4%; p = 0.134), permanent pacemaker implantation (15.6%), and periprocedural and 1-year adverse events. Pre-discharge more than mild paravalvular leaks were significantly more common with the Portico (19.2%) and less common with the Evolut PRO (3.6%) compared with the Evolut R (11.8%) and ACURATE (9%) groups.
Transcatheter self-expandable valves showed optimal clinical and echocardiographic results in patients with small aortic annuli, although supra-annular functioning transcatheter heart valves seemed to slightly outperform intra-annular functioning ones. The role of transcatheter aortic valve replacement with self-expandable valves for the treatment of aortic stenosis in patients with small annuli needs to be confirmed in larger trials.</abstract><cop>United States</cop><pmid>31883714</pmid><doi>10.1016/j.jcin.2019.08.041</doi><tpages>11</tpages></addata></record> |
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| title | Transcatheter Self-Expandable Valve Implantation for Aortic Stenosis in Small Aortic Annuli: The TAVI-SMALL Registry |
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