{"id":5420,"date":"2021-10-08T14:26:29","date_gmt":"2021-10-08T14:26:29","guid":{"rendered":"https:\/\/edwardseducation.com\/edwardsmasters\/?p=5420"},"modified":"2023-04-23T11:31:22","modified_gmt":"2023-04-23T11:31:22","slug":"durability-an-even-more-important-factor-in-valve-selection","status":"publish","type":"post","link":"https:\/\/edwardseducation.com\/edwardsmasters\/durability-an-even-more-important-factor-in-valve-selection\/","title":{"rendered":"Durability: An even more important factor in valve selection"},"content":{"rendered":"\t\t
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The 2021 update of the ESC\/EACTS Guidelines for the management of valvular heart disease, recommends treating patients with severe aortic stenosis younger than 75 years and low risk<\/strong> with surgical aortic valve replacement (SAVR)<\/strong>, simplifying the initial patient treatment pathway and preferred mode of intervention. The implication is that valve durability is now even more important<\/strong> because of younger patients\u2019 greater longevity.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Edwards Lifesciences has two ongoing trials, COMMENCE and EU Feasibility<\/a>, that are evaluating the longevity of a bioprosthetic valve with novel RESILIA tissue. Both trials have\u00a0demonstrated a favourable safety profile and good haemodynamic performance at 5 years, with additional follow-up to be conducted up to 10 years.1,2<\/sup><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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The COMMENCE trial<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Safety endpoints, probability event-free:<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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COMMENCE is an FDA pivotal trial designed to evaluate the safety and effectiveness of the INSPIRIS bioprosthetic aortic valve with the novel RESILIA tissue.1<\/sup> The 5-year data are now available:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/span><\/span>All-cause mortality 89.2%<\/span><\/b><\/p>

\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/span><\/span>Major paravalvular leak 99.5%<\/span><\/b><\/p>

\u00b7\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0 <\/span><\/span>Endocarditis 97.8%<\/span><\/b><\/p>

\u00a0<\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Improved haemodynamic performance from baseline<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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The absence of structural valve deterioration through 5 years* and the presence of stable gradients, plus freedom from regurgitation support durability over the observational period.<\/p>

*One case of structural valve deterioration was diagnosed at postoperative Day 1,848.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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At 5 years, COMMENCE results indicate a favourable safety profile and stable haemodynamic performance of a bioprosthetic valve with RESILIA tissue. Ten-year data in an extended follow-up cohort and the RESILIENCE trial with 11-year follow-up are forthcoming.<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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The RESILIA EU Feasibility study<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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The RESILIA EU Feasibility study has investigated the safety and performance in aortic valve replacement patients of the bioprosthesis with the novel RESILIA tissue at 5 years.2<\/sup> Here, we summarise the results at 5 years:<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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Stable haemodynamic performance:<\/p>

  • Mean gradient was 14.8 \u00b1 7.6 mmHg<\/p><\/li>

  • Average effective orifice area was 1.4 \u00b1 0.5 cm<\/span>2<\/sup><\/p><\/li><\/ul>

    Zero structural valve deterioration events and stable transvalvular gradients were observed at 5 years.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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    At 5-years, results from the EU Feasibility study represent the longest follow-up of aortic valve replacement patients with RESILIA tissue and demonstrate excellent haemodynamic performance and safety outcomes.1<\/sup><\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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    Recommended resources<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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    https:\/\/edwardseducation.com\/edwardsmasters\/the-latest-tissue-valve-technology-responding-to-the-unmet-needs-in-avr\/<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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    References<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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    1. Bavaria J, Griffith B, Heimansohn DA et al.<\/em> Five-year outcomes of the COMMENCE trial investigating aortic valve replacement with a novel tissue bioprosthesis. Presented at the Society of Thoracic Surgeons (STS) Annual Meeting, January 29-31, 2021.<\/p>

    2. Bartus K, Litwinowicz R, Bilewska A et al<\/em>. Final 5-year outcomes following aortic valve replacement with a RESILIA\u2122 tissue bioprosthesis. Eur J Cardiothorac Surg<\/em> 2020; 59:<\/strong> 434\u201341.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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    No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.<\/b><\/p>

    For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.edwards.com where applicable).<\/strong><\/p>

    Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93\/42\/EEC bear the CE marking of conformity.<\/strong><\/p>

    Edwards, Edwards Lifesciences, the stylized E logo, COMMENCE, INSPIRIS, INSPIRIS RESILIA, and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.<\/b><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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    \u00a9 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2948 v1.0<\/strong><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t

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    Edwards Lifesciences<\/strong>\u00a0\u2022 Route de l\u2019Etraz 70, 1260 Nyon, Switzerland \u2022 edwards.com<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

    The 2021 update of the ESC\/EACTS Guidelines […]<\/p>\n","protected":false},"author":26,"featured_media":7971,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"tags":[],"topic_interest":[450,442],"secondary_topic":[459,467,456,457,453,479],"article_tags":[532,585,613,628,1041,646,647,825,1042,1040],"anatomy":[],"topics":[],"course":[],"class_list":["post-5420","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry"],"acf":{"latestnews":false,"mostpopular":false,"views":"398","header__style":"default","header__alternative-title":"","footer-section__show":true,"footer-section__object":false,"slider__background-image":{"ID":7972,"id":7972,"title":"Big Size_Publications 01 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