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Cost–utility of cardiac contractility modulation in patients with heart failure with reduced ejection fraction in Italy
Aims Cardiac contractility modulation (CCM) is a device therapy for heart failure, based on the delivery of high‐voltage biphasic impulses to the right ventricular septum during the myocardial absolute refractory period. This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical...
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Published in: | ESC Heart Failure 2024-02, Vol.11 (1), p.229-239 |
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description | Aims
Cardiac contractility modulation (CCM) is a device therapy for heart failure, based on the delivery of high‐voltage biphasic impulses to the right ventricular septum during the myocardial absolute refractory period. This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical therapy (OMT) vs. OMT alone in patients with heart failure with reduced ejection fraction.
Methods and results
A Markov model with a lifespan time horizon was developed to assess the cost–utility using the FIX trials as main data sources. A deterministic sensitivity analysis and a probabilistic sensitivity analysis were run to analyse the decision uncertainty in the model through cost‐effectiveness acceptability curve (CEAC) and cost‐effectiveness acceptability frontier (CEAF). Value of information analysis was also conducted computing the expected value of perfect information (EVPI) and the expected value of partial perfect information. The base case results showed that the CCM plus OMT option was highly cost‐effective compared with OMT alone with an incremental cost–utility ratio of €7034/quality‐adjusted life year (QALY). The CEAC and CEAF illustrated that for all willingness to pay levels above €5600/QALY, tested up to €50 000/QALY, CCM plus OMT alternative had the highest probability of being cost‐effective. The EVPI per patient was estimated to be €124 412 on a willingness to pay threshold of €30 000/QALY.
Conclusions
For patients with heart failure with reduced ejection fraction, CCM therapy could be cost‐effective when taking a lifetime horizon. Further long‐term, post‐approval clinical studies are needed to verify these results in a real‐world context, particularly concerning the effect of CCM therapy on mortality. |
doi_str_mv | 10.1002/ehf2.14538 |
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fullrecord | <record><control><sourceid>proquest_doaj_</sourceid><recordid>TN_cdi_doaj_primary_oai_doaj_org_article_6be13cf7c9cb47828f38b2bc4b78b94f</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><doaj_id>oai_doaj_org_article_6be13cf7c9cb47828f38b2bc4b78b94f</doaj_id><sourcerecordid>2917457204</sourcerecordid><originalsourceid>FETCH-LOGICAL-c5418-9a6299ad59a0abb0b55df15e95f8660ec71664c62978804804d39e9872739f303</originalsourceid><addsrcrecordid>eNp9ks2KFDEQgBtR3GXdiw8gDV5EmDW_neQkMuzPwIIXPYd0urKTIdMZ02mXvvkOvqFPspnpcdn1IAQSqr76qBRVVW8xusAIkU-wduQCM07li-qUIM4XXBLy8sn7pDofhg1CCPMGc8JeVydUKEaJFKfVtIxD_vPr95h98Hmqo6utSZ03traxz8nYY2IbuzGY7GNf-77elRf0eajvfV7XazAp1874MCaYQwm60UJXwwbsocgdVHP1KpswvaleORMGOD_eZ9X3q8tvy5vF7dfr1fLL7cJyhuVCmYYoZTquDDJti1rOO4c5KO5k0yCwAjcNswUSUiJWTkcVKCmIoMpRRM-q1eztotnoXfJbkyYdjdeHQEx3unTvbQDdtICpdcIq2zIhiXRUtqS1rBWyVcwV1-fZtRvbLXQW9hMKz6TPM71f67v4U2NUGsOcFsOHoyHFHyMMWW_9YCEE00McB01k-QXliKiCvv8H3cQx9WVWmigsGBcEsUJ9nCmb4jAkcI_dYKT3G6L3G6IPG1Lgd0_7f0T_7kMB8Azc-wDTf1T68uaKzNIHY5THqg</addsrcrecordid><sourcetype>Open Website</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2917457204</pqid></control><display><type>article</type><title>Cost–utility of cardiac contractility modulation in patients with heart failure with reduced ejection fraction in Italy</title><source>PubMed Central (Open Access)</source><source>Publicly Available Content Database (Proquest) (PQ_SDU_P3)</source><source>Open Access: Wiley-Blackwell Open Access Journals</source><creator>Narducci, Maria Lucia ; Nurchis, Mario Cesare ; Ballacci, Federico ; Giordano, Federica ; Calabrò, Giovanna Elisa ; Massetti, Massimo ; Crea, Filippo ; Aspromonte, Nadia ; Damiani, Gianfranco</creator><creatorcontrib>Narducci, Maria Lucia ; Nurchis, Mario Cesare ; Ballacci, Federico ; Giordano, Federica ; Calabrò, Giovanna Elisa ; Massetti, Massimo ; Crea, Filippo ; Aspromonte, Nadia ; Damiani, Gianfranco</creatorcontrib><description>Aims
Cardiac contractility modulation (CCM) is a device therapy for heart failure, based on the delivery of high‐voltage biphasic impulses to the right ventricular septum during the myocardial absolute refractory period. This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical therapy (OMT) vs. OMT alone in patients with heart failure with reduced ejection fraction.
Methods and results
A Markov model with a lifespan time horizon was developed to assess the cost–utility using the FIX trials as main data sources. A deterministic sensitivity analysis and a probabilistic sensitivity analysis were run to analyse the decision uncertainty in the model through cost‐effectiveness acceptability curve (CEAC) and cost‐effectiveness acceptability frontier (CEAF). Value of information analysis was also conducted computing the expected value of perfect information (EVPI) and the expected value of partial perfect information. The base case results showed that the CCM plus OMT option was highly cost‐effective compared with OMT alone with an incremental cost–utility ratio of €7034/quality‐adjusted life year (QALY). The CEAC and CEAF illustrated that for all willingness to pay levels above €5600/QALY, tested up to €50 000/QALY, CCM plus OMT alternative had the highest probability of being cost‐effective. The EVPI per patient was estimated to be €124 412 on a willingness to pay threshold of €30 000/QALY.
Conclusions
For patients with heart failure with reduced ejection fraction, CCM therapy could be cost‐effective when taking a lifetime horizon. Further long‐term, post‐approval clinical studies are needed to verify these results in a real‐world context, particularly concerning the effect of CCM therapy on mortality.</description><identifier>ISSN: 2055-5822</identifier><identifier>EISSN: 2055-5822</identifier><identifier>DOI: 10.1002/ehf2.14538</identifier><identifier>PMID: 37943287</identifier><language>eng</language><publisher>England: John Wiley & Sons, Inc</publisher><subject>Adenosine triphosphatase ; Cardiac contractility modulation ; Cardiotonic Agents ; Clinical trials ; Cost analysis ; Costs ; Device therapy ; Economic evaluation ; Ejection fraction ; Health services ; Heart Failure ; Humans ; Italy - epidemiology ; Markov chains ; Original ; Patients ; Questionnaires ; Sensitivity analysis ; Stroke Volume</subject><ispartof>ESC Heart Failure, 2024-02, Vol.11 (1), p.229-239</ispartof><rights>2023 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.</rights><rights>2024. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c5418-9a6299ad59a0abb0b55df15e95f8660ec71664c62978804804d39e9872739f303</cites><orcidid>0000-0002-0341-1142</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2917457204/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2917457204?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,11562,25753,27924,27925,37012,37013,44590,46052,46476,53791,53793,75126</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37943287$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Narducci, Maria Lucia</creatorcontrib><creatorcontrib>Nurchis, Mario Cesare</creatorcontrib><creatorcontrib>Ballacci, Federico</creatorcontrib><creatorcontrib>Giordano, Federica</creatorcontrib><creatorcontrib>Calabrò, Giovanna Elisa</creatorcontrib><creatorcontrib>Massetti, Massimo</creatorcontrib><creatorcontrib>Crea, Filippo</creatorcontrib><creatorcontrib>Aspromonte, Nadia</creatorcontrib><creatorcontrib>Damiani, Gianfranco</creatorcontrib><title>Cost–utility of cardiac contractility modulation in patients with heart failure with reduced ejection fraction in Italy</title><title>ESC Heart Failure</title><addtitle>ESC Heart Fail</addtitle><description>Aims
Cardiac contractility modulation (CCM) is a device therapy for heart failure, based on the delivery of high‐voltage biphasic impulses to the right ventricular septum during the myocardial absolute refractory period. This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical therapy (OMT) vs. OMT alone in patients with heart failure with reduced ejection fraction.
Methods and results
A Markov model with a lifespan time horizon was developed to assess the cost–utility using the FIX trials as main data sources. A deterministic sensitivity analysis and a probabilistic sensitivity analysis were run to analyse the decision uncertainty in the model through cost‐effectiveness acceptability curve (CEAC) and cost‐effectiveness acceptability frontier (CEAF). Value of information analysis was also conducted computing the expected value of perfect information (EVPI) and the expected value of partial perfect information. The base case results showed that the CCM plus OMT option was highly cost‐effective compared with OMT alone with an incremental cost–utility ratio of €7034/quality‐adjusted life year (QALY). The CEAC and CEAF illustrated that for all willingness to pay levels above €5600/QALY, tested up to €50 000/QALY, CCM plus OMT alternative had the highest probability of being cost‐effective. The EVPI per patient was estimated to be €124 412 on a willingness to pay threshold of €30 000/QALY.
Conclusions
For patients with heart failure with reduced ejection fraction, CCM therapy could be cost‐effective when taking a lifetime horizon. Further long‐term, post‐approval clinical studies are needed to verify these results in a real‐world context, particularly concerning the effect of CCM therapy on mortality.</description><subject>Adenosine triphosphatase</subject><subject>Cardiac contractility modulation</subject><subject>Cardiotonic Agents</subject><subject>Clinical trials</subject><subject>Cost analysis</subject><subject>Costs</subject><subject>Device therapy</subject><subject>Economic evaluation</subject><subject>Ejection fraction</subject><subject>Health services</subject><subject>Heart Failure</subject><subject>Humans</subject><subject>Italy - epidemiology</subject><subject>Markov chains</subject><subject>Original</subject><subject>Patients</subject><subject>Questionnaires</subject><subject>Sensitivity analysis</subject><subject>Stroke Volume</subject><issn>2055-5822</issn><issn>2055-5822</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>PIMPY</sourceid><sourceid>DOA</sourceid><recordid>eNp9ks2KFDEQgBtR3GXdiw8gDV5EmDW_neQkMuzPwIIXPYd0urKTIdMZ02mXvvkOvqFPspnpcdn1IAQSqr76qBRVVW8xusAIkU-wduQCM07li-qUIM4XXBLy8sn7pDofhg1CCPMGc8JeVydUKEaJFKfVtIxD_vPr95h98Hmqo6utSZ03traxz8nYY2IbuzGY7GNf-77elRf0eajvfV7XazAp1874MCaYQwm60UJXwwbsocgdVHP1KpswvaleORMGOD_eZ9X3q8tvy5vF7dfr1fLL7cJyhuVCmYYoZTquDDJti1rOO4c5KO5k0yCwAjcNswUSUiJWTkcVKCmIoMpRRM-q1eztotnoXfJbkyYdjdeHQEx3unTvbQDdtICpdcIq2zIhiXRUtqS1rBWyVcwV1-fZtRvbLXQW9hMKz6TPM71f67v4U2NUGsOcFsOHoyHFHyMMWW_9YCEE00McB01k-QXliKiCvv8H3cQx9WVWmigsGBcEsUJ9nCmb4jAkcI_dYKT3G6L3G6IPG1Lgd0_7f0T_7kMB8Azc-wDTf1T68uaKzNIHY5THqg</recordid><startdate>202402</startdate><enddate>202402</enddate><creator>Narducci, Maria Lucia</creator><creator>Nurchis, Mario Cesare</creator><creator>Ballacci, Federico</creator><creator>Giordano, Federica</creator><creator>Calabrò, Giovanna Elisa</creator><creator>Massetti, Massimo</creator><creator>Crea, Filippo</creator><creator>Aspromonte, Nadia</creator><creator>Damiani, Gianfranco</creator><general>John Wiley & Sons, Inc</general><general>John Wiley and Sons Inc</general><general>Wiley</general><scope>24P</scope><scope>WIN</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>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-0341-1142</orcidid></search><sort><creationdate>202402</creationdate><title>Cost–utility of cardiac contractility modulation in patients with heart failure with reduced ejection fraction in Italy</title><author>Narducci, Maria Lucia ; Nurchis, Mario Cesare ; Ballacci, Federico ; Giordano, Federica ; Calabrò, Giovanna Elisa ; Massetti, Massimo ; Crea, Filippo ; Aspromonte, Nadia ; Damiani, Gianfranco</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5418-9a6299ad59a0abb0b55df15e95f8660ec71664c62978804804d39e9872739f303</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adenosine triphosphatase</topic><topic>Cardiac contractility modulation</topic><topic>Cardiotonic Agents</topic><topic>Clinical trials</topic><topic>Cost analysis</topic><topic>Costs</topic><topic>Device therapy</topic><topic>Economic evaluation</topic><topic>Ejection fraction</topic><topic>Health services</topic><topic>Heart Failure</topic><topic>Humans</topic><topic>Italy - epidemiology</topic><topic>Markov chains</topic><topic>Original</topic><topic>Patients</topic><topic>Questionnaires</topic><topic>Sensitivity analysis</topic><topic>Stroke Volume</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Narducci, Maria Lucia</creatorcontrib><creatorcontrib>Nurchis, Mario Cesare</creatorcontrib><creatorcontrib>Ballacci, Federico</creatorcontrib><creatorcontrib>Giordano, Federica</creatorcontrib><creatorcontrib>Calabrò, Giovanna Elisa</creatorcontrib><creatorcontrib>Massetti, Massimo</creatorcontrib><creatorcontrib>Crea, Filippo</creatorcontrib><creatorcontrib>Aspromonte, Nadia</creatorcontrib><creatorcontrib>Damiani, Gianfranco</creatorcontrib><collection>Open Access: Wiley-Blackwell Open Access Journals</collection><collection>Wiley-Blackwell Open Access Backfiles (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>ProQuest Central (Corporate)</collection><collection>ProQuest Health and Medical</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>ProQuest Central Essentials</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Publicly Available Content Database (Proquest) (PQ_SDU_P3)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>ESC Heart Failure</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Narducci, Maria Lucia</au><au>Nurchis, Mario Cesare</au><au>Ballacci, Federico</au><au>Giordano, Federica</au><au>Calabrò, Giovanna Elisa</au><au>Massetti, Massimo</au><au>Crea, Filippo</au><au>Aspromonte, Nadia</au><au>Damiani, Gianfranco</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cost–utility of cardiac contractility modulation in patients with heart failure with reduced ejection fraction in Italy</atitle><jtitle>ESC Heart Failure</jtitle><addtitle>ESC Heart Fail</addtitle><date>2024-02</date><risdate>2024</risdate><volume>11</volume><issue>1</issue><spage>229</spage><epage>239</epage><pages>229-239</pages><issn>2055-5822</issn><eissn>2055-5822</eissn><abstract>Aims
Cardiac contractility modulation (CCM) is a device therapy for heart failure, based on the delivery of high‐voltage biphasic impulses to the right ventricular septum during the myocardial absolute refractory period. This study evaluated the cost‐effectiveness of CCM therapy plus optimal medical therapy (OMT) vs. OMT alone in patients with heart failure with reduced ejection fraction.
Methods and results
A Markov model with a lifespan time horizon was developed to assess the cost–utility using the FIX trials as main data sources. A deterministic sensitivity analysis and a probabilistic sensitivity analysis were run to analyse the decision uncertainty in the model through cost‐effectiveness acceptability curve (CEAC) and cost‐effectiveness acceptability frontier (CEAF). Value of information analysis was also conducted computing the expected value of perfect information (EVPI) and the expected value of partial perfect information. The base case results showed that the CCM plus OMT option was highly cost‐effective compared with OMT alone with an incremental cost–utility ratio of €7034/quality‐adjusted life year (QALY). The CEAC and CEAF illustrated that for all willingness to pay levels above €5600/QALY, tested up to €50 000/QALY, CCM plus OMT alternative had the highest probability of being cost‐effective. The EVPI per patient was estimated to be €124 412 on a willingness to pay threshold of €30 000/QALY.
Conclusions
For patients with heart failure with reduced ejection fraction, CCM therapy could be cost‐effective when taking a lifetime horizon. Further long‐term, post‐approval clinical studies are needed to verify these results in a real‐world context, particularly concerning the effect of CCM therapy on mortality.</abstract><cop>England</cop><pub>John Wiley & Sons, Inc</pub><pmid>37943287</pmid><doi>10.1002/ehf2.14538</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0002-0341-1142</orcidid><oa>free_for_read</oa></addata></record> |
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subjects | Adenosine triphosphatase Cardiac contractility modulation Cardiotonic Agents Clinical trials Cost analysis Costs Device therapy Economic evaluation Ejection fraction Health services Heart Failure Humans Italy - epidemiology Markov chains Original Patients Questionnaires Sensitivity analysis Stroke Volume |
title | Cost–utility of cardiac contractility modulation in patients with heart failure with reduced ejection fraction in Italy |
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