Improved clinical outcomes associated with the Impella 5.5 compared to the Impella 5.0 in contemporary cardiogenic shock and heart failure patients
A redesigned surgically implanted heart pump incorporates several design changes from the prior device generation, but no published comparative data demonstrate if these changes translate to improved outcomes. We retrospectively compared clinical characteristics and outcomes, drawn from an FDA-manda...
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Veröffentlicht in: | The Journal of heart and lung transplantation 2023-05, Vol.42 (5), p.553-557 |
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creator | Ramzy, Danny Soltesz, Edward G. Silvestry, Scott Daneshmand, Mani Kanwar, Manreet D'Alessandro, David A. |
description | A redesigned surgically implanted heart pump incorporates several design changes from the prior device generation, but no published comparative data demonstrate if these changes translate to improved outcomes. We retrospectively compared clinical characteristics and outcomes, drawn from an FDA-mandated QA database, for contemporary patients treated with the Impella 5.5 or Impella 5.0 for acute myocardial infarction complicated by cardiogenic shock (AMICS), cardiomyopathy, or postcardiotomy cardiogenic shock (PCCS). A total of 1238 patients at 290 US sites were included for analysis. Patients receiving the Impella 5.5 had significantly higher survival through explant (i.e., successfully weaned or bridged to heart replacement therapy) than those receiving the Impella 5.0 in all 3 settings: AMICS (70.5% vs 56.8%; p = 0.005), cardiomyopathy (88.1% vs 76.9%; p = 0.001), and PCCS (76.1% vs 55.7%; p = 0.003). Duration of support was significantly longer for Impella 5.5 patients with AMICS (9.2 vs 6.1 days; p = 0.008) and cardiomyopathy (10.7 vs 8.1 days; p < 0.001). |
doi_str_mv | 10.1016/j.healun.2023.01.011 |
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We retrospectively compared clinical characteristics and outcomes, drawn from an FDA-mandated QA database, for contemporary patients treated with the Impella 5.5 or Impella 5.0 for acute myocardial infarction complicated by cardiogenic shock (AMICS), cardiomyopathy, or postcardiotomy cardiogenic shock (PCCS). A total of 1238 patients at 290 US sites were included for analysis. Patients receiving the Impella 5.5 had significantly higher survival through explant (i.e., successfully weaned or bridged to heart replacement therapy) than those receiving the Impella 5.0 in all 3 settings: AMICS (70.5% vs 56.8%; p = 0.005), cardiomyopathy (88.1% vs 76.9%; p = 0.001), and PCCS (76.1% vs 55.7%; p = 0.003). Duration of support was significantly longer for Impella 5.5 patients with AMICS (9.2 vs 6.1 days; p = 0.008) and cardiomyopathy (10.7 vs 8.1 days; p < 0.001).</description><identifier>ISSN: 1053-2498</identifier><identifier>EISSN: 1557-3117</identifier><identifier>DOI: 10.1016/j.healun.2023.01.011</identifier><identifier>PMID: 36841643</identifier><language>eng</language><publisher>United States: Elsevier Inc</publisher><subject>cardiogenic shock ; Cardiotonic Agents ; heart failure ; Heart Failure - complications ; Heart Failure - surgery ; Heart-Assist Devices - adverse effects ; Humans ; Impella ; mechanical circulatory support ; Myocardial Infarction ; Retrospective Studies ; Shock, Cardiogenic - etiology ; Shock, Cardiogenic - surgery ; temporary MCS ; Treatment Outcome</subject><ispartof>The Journal of heart and lung transplantation, 2023-05, Vol.42 (5), p.553-557</ispartof><rights>2023 The Authors</rights><rights>Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c408t-9cb8de0dfb9bffc8f93c56e8fba990873e2d79084380a02356681ae1048f1a073</citedby><cites>FETCH-LOGICAL-c408t-9cb8de0dfb9bffc8f93c56e8fba990873e2d79084380a02356681ae1048f1a073</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1053249823000323$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>314,776,780,3537,27901,27902,65534</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36841643$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ramzy, Danny</creatorcontrib><creatorcontrib>Soltesz, Edward G.</creatorcontrib><creatorcontrib>Silvestry, Scott</creatorcontrib><creatorcontrib>Daneshmand, Mani</creatorcontrib><creatorcontrib>Kanwar, Manreet</creatorcontrib><creatorcontrib>D'Alessandro, David A.</creatorcontrib><title>Improved clinical outcomes associated with the Impella 5.5 compared to the Impella 5.0 in contemporary cardiogenic shock and heart failure patients</title><title>The Journal of heart and lung transplantation</title><addtitle>J Heart Lung Transplant</addtitle><description>A redesigned surgically implanted heart pump incorporates several design changes from the prior device generation, but no published comparative data demonstrate if these changes translate to improved outcomes. We retrospectively compared clinical characteristics and outcomes, drawn from an FDA-mandated QA database, for contemporary patients treated with the Impella 5.5 or Impella 5.0 for acute myocardial infarction complicated by cardiogenic shock (AMICS), cardiomyopathy, or postcardiotomy cardiogenic shock (PCCS). A total of 1238 patients at 290 US sites were included for analysis. Patients receiving the Impella 5.5 had significantly higher survival through explant (i.e., successfully weaned or bridged to heart replacement therapy) than those receiving the Impella 5.0 in all 3 settings: AMICS (70.5% vs 56.8%; p = 0.005), cardiomyopathy (88.1% vs 76.9%; p = 0.001), and PCCS (76.1% vs 55.7%; p = 0.003). Duration of support was significantly longer for Impella 5.5 patients with AMICS (9.2 vs 6.1 days; p = 0.008) and cardiomyopathy (10.7 vs 8.1 days; p < 0.001).</description><subject>cardiogenic shock</subject><subject>Cardiotonic Agents</subject><subject>heart failure</subject><subject>Heart Failure - complications</subject><subject>Heart Failure - surgery</subject><subject>Heart-Assist Devices - adverse effects</subject><subject>Humans</subject><subject>Impella</subject><subject>mechanical circulatory support</subject><subject>Myocardial Infarction</subject><subject>Retrospective Studies</subject><subject>Shock, Cardiogenic - etiology</subject><subject>Shock, Cardiogenic - surgery</subject><subject>temporary MCS</subject><subject>Treatment Outcome</subject><issn>1053-2498</issn><issn>1557-3117</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kc2KFTEQhYMozjj6BiJZuum20umf9EaQYdSBATe6Dumk4s21u9Mm6RGfwxe2Lnd04UIoSMH5KodTxdhLAbUA0b851gc0877WDTSyBkElHrFL0XVDJYUYHlMPnayadlQX7FnORwAiu-Ypu5C9akXfykv263bZUrxHx-0c1mDNzONebFwwc5NztMEUEn-EcuDlgJxwnGfDu7rjRG0mkVriPxrwsJK8Fly2mEz6ya1JLsSvSBY8H6L9xs3qOCVIhXsT5j0h30wJuJb8nD3xZs744uG9Yl_e33y-_ljdffpwe_3urrItqFKNdlIOwflpnLy3yo_Sdj0qP5lxBDVIbNxATSsVmFPyvlfCoIBWeWFgkFfs9flf2sD3HXPRS8j2FGHFuGfdDApAibaXhLZn1KaYc0KvtxQWCqYF6NM59FGfz6FP59AgqASNvXpw2KcF3d-hP_sn4O0ZQMp5HzDpbGkHFl1IaIt2Mfzf4TeTzp86</recordid><startdate>202305</startdate><enddate>202305</enddate><creator>Ramzy, Danny</creator><creator>Soltesz, Edward G.</creator><creator>Silvestry, Scott</creator><creator>Daneshmand, Mani</creator><creator>Kanwar, Manreet</creator><creator>D'Alessandro, David A.</creator><general>Elsevier Inc</general><scope>6I.</scope><scope>AAFTH</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>202305</creationdate><title>Improved clinical outcomes associated with the Impella 5.5 compared to the Impella 5.0 in contemporary cardiogenic shock and heart failure patients</title><author>Ramzy, Danny ; Soltesz, Edward G. ; Silvestry, Scott ; Daneshmand, Mani ; Kanwar, Manreet ; D'Alessandro, David A.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c408t-9cb8de0dfb9bffc8f93c56e8fba990873e2d79084380a02356681ae1048f1a073</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>cardiogenic shock</topic><topic>Cardiotonic Agents</topic><topic>heart failure</topic><topic>Heart Failure - complications</topic><topic>Heart Failure - surgery</topic><topic>Heart-Assist Devices - adverse effects</topic><topic>Humans</topic><topic>Impella</topic><topic>mechanical circulatory support</topic><topic>Myocardial Infarction</topic><topic>Retrospective Studies</topic><topic>Shock, Cardiogenic - etiology</topic><topic>Shock, Cardiogenic - surgery</topic><topic>temporary MCS</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ramzy, Danny</creatorcontrib><creatorcontrib>Soltesz, Edward G.</creatorcontrib><creatorcontrib>Silvestry, Scott</creatorcontrib><creatorcontrib>Daneshmand, Mani</creatorcontrib><creatorcontrib>Kanwar, Manreet</creatorcontrib><creatorcontrib>D'Alessandro, David A.</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><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>The Journal of heart and lung transplantation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ramzy, Danny</au><au>Soltesz, Edward G.</au><au>Silvestry, Scott</au><au>Daneshmand, Mani</au><au>Kanwar, Manreet</au><au>D'Alessandro, David A.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Improved clinical outcomes associated with the Impella 5.5 compared to the Impella 5.0 in contemporary cardiogenic shock and heart failure patients</atitle><jtitle>The Journal of heart and lung transplantation</jtitle><addtitle>J Heart Lung Transplant</addtitle><date>2023-05</date><risdate>2023</risdate><volume>42</volume><issue>5</issue><spage>553</spage><epage>557</epage><pages>553-557</pages><issn>1053-2498</issn><eissn>1557-3117</eissn><abstract>A redesigned surgically implanted heart pump incorporates several design changes from the prior device generation, but no published comparative data demonstrate if these changes translate to improved outcomes. We retrospectively compared clinical characteristics and outcomes, drawn from an FDA-mandated QA database, for contemporary patients treated with the Impella 5.5 or Impella 5.0 for acute myocardial infarction complicated by cardiogenic shock (AMICS), cardiomyopathy, or postcardiotomy cardiogenic shock (PCCS). A total of 1238 patients at 290 US sites were included for analysis. Patients receiving the Impella 5.5 had significantly higher survival through explant (i.e., successfully weaned or bridged to heart replacement therapy) than those receiving the Impella 5.0 in all 3 settings: AMICS (70.5% vs 56.8%; p = 0.005), cardiomyopathy (88.1% vs 76.9%; p = 0.001), and PCCS (76.1% vs 55.7%; p = 0.003). 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subjects | cardiogenic shock Cardiotonic Agents heart failure Heart Failure - complications Heart Failure - surgery Heart-Assist Devices - adverse effects Humans Impella mechanical circulatory support Myocardial Infarction Retrospective Studies Shock, Cardiogenic - etiology Shock, Cardiogenic - surgery temporary MCS Treatment Outcome |
title | Improved clinical outcomes associated with the Impella 5.5 compared to the Impella 5.0 in contemporary cardiogenic shock and heart failure patients |
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