Transcatheter aortic valve replacement with the self-expanding ACURATE Neo2 in patients with horizontal aorta: Insights from the ITAL-neo registry
Horizontal aorta (HA), defined by an aortic angulation (AA) ≥48°, is associated with worse outcomes particularly after self-expanding (SE) trans-catheter heart valve (THV) implantation. Although the SE ACURATE Neo THV demonstrated favorable procedural success rates in patients with HA, it remains as...
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| Veröffentlicht in: | International journal of cardiology 2023-10, Vol.389, p.131236-131236, Article 131236 |
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| creator | Barki, Monica Ielasi, Alfonso Buono, Andrea Maffeo, Diego Montonati, Carolina Pellegrini, Dario Pellicano, Mariano Gorla, Riccardo Costa, Giuliano Cozzi, Ottavia Ancona, Marco Soriano, Francesco De Carlo, Marco Ferrara, Erica Giannini, Francesco Massussi, Mauro Fovino, Luca Nai Messina, Antonio Sgroi, Carmelo Gallo, Francesco Nerla, Roberto Saccocci, Matteo D'Ascenzo, Fabrizio Conrotto, Federico Bettari, Luca Fiorina, Claudia Castriota, Fausto Poli, Arnaldo Petronio, Anna Sonia Oreglia, Jacopo Montorfano, Matteo Regazzoli, Damiano Reimers, Bernhard Barbanti, Marco Tamburino, Corrado Bedogni, Francesco Tarantini, Giuseppe Tespili, Maurizio |
| description | Horizontal aorta (HA), defined by an aortic angulation (AA) ≥48°, is associated with worse outcomes particularly after self-expanding (SE) trans-catheter heart valve (THV) implantation. Although the SE ACURATE Neo THV demonstrated favorable procedural success rates in patients with HA, it remains associated with a non-negligible rate of moderate or greater paravalvular leak (PVL).
Aim of the study was to assess the performance of ACURATE Neo2 in the setting of HA.
We performed a multicenter cohort analysis on patients with severe aortic valve stenosis and HA undergoing transcatheter aortic valve replacement (TAVR) with the Neo or Neo2 THV enrolled in the ITAL-neo registry. The primary endpoint was a composite of early safety and clinical efficacy at 30 days according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included the occurrence of moderate or severe PVL and 90-day clinical outcomes.
Among 900 patients included in the ITAL-neo registry, 407 exhibited HA; of these, 300 received a Neo THV and 107 a Neo2 THV. HA, irrespective of the THV implanted, emerged as an independent risk factor for developing ≥ moderate PVL. Technical and device success at 30-day follow-up was comparable between groups. However, Neo2 was associated with a significantly lower rate of ≥moderate PVL vs. Neo: (5% vs. 15%; p |
| doi_str_mv | 10.1016/j.ijcard.2023.131236 |
| format | Article |
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Aim of the study was to assess the performance of ACURATE Neo2 in the setting of HA.
We performed a multicenter cohort analysis on patients with severe aortic valve stenosis and HA undergoing transcatheter aortic valve replacement (TAVR) with the Neo or Neo2 THV enrolled in the ITAL-neo registry. The primary endpoint was a composite of early safety and clinical efficacy at 30 days according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included the occurrence of moderate or severe PVL and 90-day clinical outcomes.
Among 900 patients included in the ITAL-neo registry, 407 exhibited HA; of these, 300 received a Neo THV and 107 a Neo2 THV. HA, irrespective of the THV implanted, emerged as an independent risk factor for developing ≥ moderate PVL. Technical and device success at 30-day follow-up was comparable between groups. However, Neo2 was associated with a significantly lower rate of ≥moderate PVL vs. Neo: (5% vs. 15%; p < 0.001), which was confirmed also at 90-day follow-up. Additionally, no correlation was found between ≥moderate PVL and AA in the Neo2 group, while PVL degree increased proportionally to the AA in the Neo cohort.
In patients with HA, the new generation Acurate Neo2 THV was associated with a comparable device success rate and a significantly lower rate of ≥moderate PVL, when compared with its predecessor.
•This study provides pivotal evidence on Horizontal Aorta (HA) and on the management of patients with HA affected by severe aortic valve stenosis undergoing transcatheter aortic valve replacement (TAVR).•Our results showed that HA is common and is an independent risk factor for developing paravalvular leak (PVL).•Additionally, we demonstrated that the Acurate family, in particular Neo2 THV, is associated with a negligible rate of PVL in subjects with increased aortic angulation.</description><identifier>ISSN: 0167-5273</identifier><identifier>EISSN: 1874-1754</identifier><identifier>DOI: 10.1016/j.ijcard.2023.131236</identifier><identifier>PMID: 37532153</identifier><language>eng</language><publisher>Netherlands: Elsevier B.V</publisher><subject>Horizontal aorta (HA) ; Paravalvular leak (PVL) ; Self-expanding Acurate Neo2 ; Transcatheter aortic valve replacement (TAVR) ; Transcatheter heart valve (THV)</subject><ispartof>International journal of cardiology, 2023-10, Vol.389, p.131236-131236, Article 131236</ispartof><rights>2023 Elsevier B.V.</rights><rights>Copyright © 2023 Elsevier B.V. All rights reserved.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c362t-eecacfb360c208e655c1784b062ae96bdf914be04c76363b1259aca1bcc0df8a3</citedby><cites>FETCH-LOGICAL-c362t-eecacfb360c208e655c1784b062ae96bdf914be04c76363b1259aca1bcc0df8a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S0167527323010793$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37532153$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Barki, Monica</creatorcontrib><creatorcontrib>Ielasi, Alfonso</creatorcontrib><creatorcontrib>Buono, Andrea</creatorcontrib><creatorcontrib>Maffeo, Diego</creatorcontrib><creatorcontrib>Montonati, Carolina</creatorcontrib><creatorcontrib>Pellegrini, Dario</creatorcontrib><creatorcontrib>Pellicano, Mariano</creatorcontrib><creatorcontrib>Gorla, Riccardo</creatorcontrib><creatorcontrib>Costa, Giuliano</creatorcontrib><creatorcontrib>Cozzi, Ottavia</creatorcontrib><creatorcontrib>Ancona, Marco</creatorcontrib><creatorcontrib>Soriano, Francesco</creatorcontrib><creatorcontrib>De Carlo, Marco</creatorcontrib><creatorcontrib>Ferrara, Erica</creatorcontrib><creatorcontrib>Giannini, Francesco</creatorcontrib><creatorcontrib>Massussi, Mauro</creatorcontrib><creatorcontrib>Fovino, Luca Nai</creatorcontrib><creatorcontrib>Messina, Antonio</creatorcontrib><creatorcontrib>Sgroi, Carmelo</creatorcontrib><creatorcontrib>Gallo, Francesco</creatorcontrib><creatorcontrib>Nerla, Roberto</creatorcontrib><creatorcontrib>Saccocci, Matteo</creatorcontrib><creatorcontrib>D'Ascenzo, Fabrizio</creatorcontrib><creatorcontrib>Conrotto, Federico</creatorcontrib><creatorcontrib>Bettari, Luca</creatorcontrib><creatorcontrib>Fiorina, Claudia</creatorcontrib><creatorcontrib>Castriota, Fausto</creatorcontrib><creatorcontrib>Poli, Arnaldo</creatorcontrib><creatorcontrib>Petronio, Anna Sonia</creatorcontrib><creatorcontrib>Oreglia, Jacopo</creatorcontrib><creatorcontrib>Montorfano, Matteo</creatorcontrib><creatorcontrib>Regazzoli, Damiano</creatorcontrib><creatorcontrib>Reimers, Bernhard</creatorcontrib><creatorcontrib>Barbanti, Marco</creatorcontrib><creatorcontrib>Tamburino, Corrado</creatorcontrib><creatorcontrib>Bedogni, Francesco</creatorcontrib><creatorcontrib>Tarantini, Giuseppe</creatorcontrib><creatorcontrib>Tespili, Maurizio</creatorcontrib><title>Transcatheter aortic valve replacement with the self-expanding ACURATE Neo2 in patients with horizontal aorta: Insights from the ITAL-neo registry</title><title>International journal of cardiology</title><addtitle>Int J Cardiol</addtitle><description>Horizontal aorta (HA), defined by an aortic angulation (AA) ≥48°, is associated with worse outcomes particularly after self-expanding (SE) trans-catheter heart valve (THV) implantation. Although the SE ACURATE Neo THV demonstrated favorable procedural success rates in patients with HA, it remains associated with a non-negligible rate of moderate or greater paravalvular leak (PVL).
Aim of the study was to assess the performance of ACURATE Neo2 in the setting of HA.
We performed a multicenter cohort analysis on patients with severe aortic valve stenosis and HA undergoing transcatheter aortic valve replacement (TAVR) with the Neo or Neo2 THV enrolled in the ITAL-neo registry. The primary endpoint was a composite of early safety and clinical efficacy at 30 days according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included the occurrence of moderate or severe PVL and 90-day clinical outcomes.
Among 900 patients included in the ITAL-neo registry, 407 exhibited HA; of these, 300 received a Neo THV and 107 a Neo2 THV. HA, irrespective of the THV implanted, emerged as an independent risk factor for developing ≥ moderate PVL. Technical and device success at 30-day follow-up was comparable between groups. However, Neo2 was associated with a significantly lower rate of ≥moderate PVL vs. Neo: (5% vs. 15%; p < 0.001), which was confirmed also at 90-day follow-up. Additionally, no correlation was found between ≥moderate PVL and AA in the Neo2 group, while PVL degree increased proportionally to the AA in the Neo cohort.
In patients with HA, the new generation Acurate Neo2 THV was associated with a comparable device success rate and a significantly lower rate of ≥moderate PVL, when compared with its predecessor.
•This study provides pivotal evidence on Horizontal Aorta (HA) and on the management of patients with HA affected by severe aortic valve stenosis undergoing transcatheter aortic valve replacement (TAVR).•Our results showed that HA is common and is an independent risk factor for developing paravalvular leak (PVL).•Additionally, we demonstrated that the Acurate family, in particular Neo2 THV, is associated with a negligible rate of PVL in subjects with increased aortic angulation.</description><subject>Horizontal aorta (HA)</subject><subject>Paravalvular leak (PVL)</subject><subject>Self-expanding Acurate Neo2</subject><subject>Transcatheter aortic valve replacement (TAVR)</subject><subject>Transcatheter heart valve 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Oreglia, Jacopo ; Montorfano, Matteo ; Regazzoli, Damiano ; Reimers, Bernhard ; Barbanti, Marco ; Tamburino, Corrado ; Bedogni, Francesco ; Tarantini, Giuseppe ; Tespili, Maurizio</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c362t-eecacfb360c208e655c1784b062ae96bdf914be04c76363b1259aca1bcc0df8a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Horizontal aorta (HA)</topic><topic>Paravalvular leak (PVL)</topic><topic>Self-expanding Acurate Neo2</topic><topic>Transcatheter aortic valve replacement (TAVR)</topic><topic>Transcatheter heart valve (THV)</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Barki, Monica</creatorcontrib><creatorcontrib>Ielasi, Alfonso</creatorcontrib><creatorcontrib>Buono, Andrea</creatorcontrib><creatorcontrib>Maffeo, Diego</creatorcontrib><creatorcontrib>Montonati, 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Alfonso</au><au>Buono, Andrea</au><au>Maffeo, Diego</au><au>Montonati, Carolina</au><au>Pellegrini, Dario</au><au>Pellicano, Mariano</au><au>Gorla, Riccardo</au><au>Costa, Giuliano</au><au>Cozzi, Ottavia</au><au>Ancona, Marco</au><au>Soriano, Francesco</au><au>De Carlo, Marco</au><au>Ferrara, Erica</au><au>Giannini, Francesco</au><au>Massussi, Mauro</au><au>Fovino, Luca Nai</au><au>Messina, Antonio</au><au>Sgroi, Carmelo</au><au>Gallo, Francesco</au><au>Nerla, Roberto</au><au>Saccocci, Matteo</au><au>D'Ascenzo, Fabrizio</au><au>Conrotto, Federico</au><au>Bettari, Luca</au><au>Fiorina, Claudia</au><au>Castriota, Fausto</au><au>Poli, Arnaldo</au><au>Petronio, Anna Sonia</au><au>Oreglia, Jacopo</au><au>Montorfano, Matteo</au><au>Regazzoli, Damiano</au><au>Reimers, Bernhard</au><au>Barbanti, Marco</au><au>Tamburino, Corrado</au><au>Bedogni, Francesco</au><au>Tarantini, Giuseppe</au><au>Tespili, Maurizio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Transcatheter aortic valve replacement with the self-expanding ACURATE Neo2 in patients with horizontal aorta: Insights from the ITAL-neo registry</atitle><jtitle>International journal of cardiology</jtitle><addtitle>Int J Cardiol</addtitle><date>2023-10-15</date><risdate>2023</risdate><volume>389</volume><spage>131236</spage><epage>131236</epage><pages>131236-131236</pages><artnum>131236</artnum><issn>0167-5273</issn><eissn>1874-1754</eissn><abstract>Horizontal aorta (HA), defined by an aortic angulation (AA) ≥48°, is associated with worse outcomes particularly after self-expanding (SE) trans-catheter heart valve (THV) implantation. Although the SE ACURATE Neo THV demonstrated favorable procedural success rates in patients with HA, it remains associated with a non-negligible rate of moderate or greater paravalvular leak (PVL).
Aim of the study was to assess the performance of ACURATE Neo2 in the setting of HA.
We performed a multicenter cohort analysis on patients with severe aortic valve stenosis and HA undergoing transcatheter aortic valve replacement (TAVR) with the Neo or Neo2 THV enrolled in the ITAL-neo registry. The primary endpoint was a composite of early safety and clinical efficacy at 30 days according to the Valve Academic Research Consortium-3 (VARC-3). Secondary endpoints included the occurrence of moderate or severe PVL and 90-day clinical outcomes.
Among 900 patients included in the ITAL-neo registry, 407 exhibited HA; of these, 300 received a Neo THV and 107 a Neo2 THV. HA, irrespective of the THV implanted, emerged as an independent risk factor for developing ≥ moderate PVL. Technical and device success at 30-day follow-up was comparable between groups. However, Neo2 was associated with a significantly lower rate of ≥moderate PVL vs. Neo: (5% vs. 15%; p < 0.001), which was confirmed also at 90-day follow-up. Additionally, no correlation was found between ≥moderate PVL and AA in the Neo2 group, while PVL degree increased proportionally to the AA in the Neo cohort.
In patients with HA, the new generation Acurate Neo2 THV was associated with a comparable device success rate and a significantly lower rate of ≥moderate PVL, when compared with its predecessor.
•This study provides pivotal evidence on Horizontal Aorta (HA) and on the management of patients with HA affected by severe aortic valve stenosis undergoing transcatheter aortic valve replacement (TAVR).•Our results showed that HA is common and is an independent risk factor for developing paravalvular leak (PVL).•Additionally, we demonstrated that the Acurate family, in particular Neo2 THV, is associated with a negligible rate of PVL in subjects with increased aortic angulation.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>37532153</pmid><doi>10.1016/j.ijcard.2023.131236</doi><tpages>1</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0167-5273 |
| ispartof | International journal of cardiology, 2023-10, Vol.389, p.131236-131236, Article 131236 |
| issn | 0167-5273 1874-1754 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2845657509 |
| source | Elsevier ScienceDirect Journals Complete |
| subjects | Horizontal aorta (HA) Paravalvular leak (PVL) Self-expanding Acurate Neo2 Transcatheter aortic valve replacement (TAVR) Transcatheter heart valve (THV) |
| title | Transcatheter aortic valve replacement with the self-expanding ACURATE Neo2 in patients with horizontal aorta: Insights from the ITAL-neo registry |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-21T19%3A52%3A52IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Transcatheter%20aortic%20valve%20replacement%20with%20the%20self-expanding%20ACURATE%20Neo2%20in%20patients%20with%20horizontal%20aorta:%20Insights%20from%20the%20ITAL-neo%20registry&rft.jtitle=International%20journal%20of%20cardiology&rft.au=Barki,%20Monica&rft.date=2023-10-15&rft.volume=389&rft.spage=131236&rft.epage=131236&rft.pages=131236-131236&rft.artnum=131236&rft.issn=0167-5273&rft.eissn=1874-1754&rft_id=info:doi/10.1016/j.ijcard.2023.131236&rft_dat=%3Cproquest_cross%3E2845657509%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2845657509&rft_id=info:pmid/37532153&rft_els_id=S0167527323010793&rfr_iscdi=true |