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  <front>
    <journal-meta>
      <journal-id journal-id-type="nlm-ta">Arq Bras Cardiol</journal-id>
      <journal-id journal-id-type="publisher-id">abc</journal-id>
      <journal-title-group>
        <journal-title>Arquivos Brasileiros de Cardiologia</journal-title>
        <abbrev-journal-title abbrev-type="publisher">Arq. Bras. Cardiol.</abbrev-journal-title>
      </journal-title-group>
      <issn pub-type="ppub">0066-782X</issn>
      <issn pub-type="epub">1678-4170</issn>
      <publisher>
        <publisher-name>Sociedade Brasileira de Cardiologia - SBC</publisher-name>
      </publisher>
    </journal-meta>
    <article-meta>
      <article-id specific-use="scielo-v3" pub-id-type="publisher-id">Cv5ZDSThyhqTtV4t9xqBxMc</article-id>
      <article-id specific-use="scielo-v2" pub-id-type="publisher-id">S0066-782X2024001000501</article-id>
      <article-id pub-id-type="other">00501</article-id>
      <article-id pub-id-type="doi">10.36660/abc.20240201</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Carta Cient&#237;fica</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>Primeira Realiza&#231;&#227;o de Implante Transcateter de Valva Tric&#250;spide Via Transjugular com o Sistema Lux-Valve Plus Na Am&#233;rica Latina. Um Relato de Caso</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0003-1152-8946</contrib-id>
          <name>
            <surname>Esteves</surname>
            <given-names>Vinicius</given-names>
          </name>
          <role>Concep&#231;&#227;o e desenho da pesquisa</role>
          <role>Obten&#231;&#227;o de dados</role>
          <role>An&#225;lise e interpreta&#231;&#227;o dos dados</role>
          <role>Reda&#231;&#227;o do manuscrito</role>
          <xref ref-type="aff" rid="aff1">
            <sup>1</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0003-3511-7375</contrib-id>
          <name>
            <surname>Andrade</surname>
            <given-names>Pedro Beraldo de</given-names>
          </name>
          <role>An&#225;lise e interpreta&#231;&#227;o dos dados</role>
          <role>Reda&#231;&#227;o do manuscrito</role>
          <xref ref-type="aff" rid="aff2">
            <sup>2</sup>
          </xref>
          <xref ref-type="corresp" rid="c1"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Kreimer</surname>
            <given-names>Sergio</given-names>
          </name>
          <role>Obten&#231;&#227;o de dados</role>
          <role>Revis&#227;o cr&#237;tica do manuscrito quanto ao conte&#250;do</role>
          <xref ref-type="aff" rid="aff3">
            <sup>3</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Esteves</surname>
            <given-names>Fernanda Almeida</given-names>
          </name>
          <role>Obten&#231;&#227;o de dados</role>
          <role>Revis&#227;o cr&#237;tica do manuscrito quanto ao conte&#250;do</role>
          <xref ref-type="aff" rid="aff1">
            <sup>1</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Magalh&#227;es</surname>
            <given-names>Francisco Monteiro de Almeida</given-names>
          </name>
          <role>Obten&#231;&#227;o de dados</role>
          <role>Revis&#227;o cr&#237;tica do manuscrito quanto ao conte&#250;do</role>
          <xref ref-type="aff" rid="aff4">
            <sup>4</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Modine</surname>
            <given-names>Thomas</given-names>
          </name>
          <role>Concep&#231;&#227;o e desenho da pesquisa</role>
          <role>An&#225;lise e interpreta&#231;&#227;o dos dados</role>
          <role>Revis&#227;o cr&#237;tica do manuscrito quanto ao conte&#250;do</role>
          <xref ref-type="aff" rid="aff5">
            <sup>5</sup>
          </xref>
        </contrib>
        <aff id="aff1">
          <label>1</label>
          <institution content-type="orgname">Rede D'Or Sao Luiz</institution>
          <addr-line>
            <named-content content-type="city">S&#227;o Paulo</named-content>
            <named-content content-type="state">SP</named-content>
          </addr-line>
          <country country="BR">Brasil</country>
          <institution content-type="original">Rede D'Or Sao Luiz, S&#227;o Paulo, SP &#8211; Brasil</institution>
        </aff>
        <aff id="aff2">
          <label>2</label>
          <institution content-type="orgname">Santa Casa de Miseric&#243;rdia de Mar&#237;lia</institution>
          <addr-line>
            <named-content content-type="city">Mar&#237;lia</named-content>
            <named-content content-type="state">SP</named-content>
          </addr-line>
          <country country="BR">Brasil</country>
          <institution content-type="original">Santa Casa de Miseric&#243;rdia de Mar&#237;lia &#8211; Cardiologia Invasiva, Mar&#237;lia, SP &#8211; Brasil</institution>
        </aff>
        <aff id="aff3">
          <label>3</label>
          <institution content-type="orgname">Hospital e Maternidade Brasil</institution>
          <addr-line>
            <named-content content-type="city">Santo Andr&#233;</named-content>
            <named-content content-type="state">SP</named-content>
          </addr-line>
          <country country="BR">Brasil</country>
          <institution content-type="original">Hospital e Maternidade Brasil, Santo Andr&#233;, SP &#8211; Brasil</institution>
        </aff>
        <aff id="aff4">
          <label>4</label>
          <institution content-type="orgname">Hospital das Cl&#237;nicas da Faculdade de Medicina da Universidade de S&#227;o Paulo</institution>
          <institution content-type="orgdiv1">Instituto do Cora&#231;&#227;o</institution>
          <addr-line>
            <named-content content-type="city">S&#227;o Paulo</named-content>
            <named-content content-type="state">SP</named-content>
          </addr-line>
          <country country="BR">Brasil</country>
          <institution content-type="original">Instituto do Cora&#231;&#227;o do Hospital das Cl&#237;nicas da Faculdade de Medicina da Universidade de S&#227;o Paulo, S&#227;o Paulo, SP &#8211; Brasil</institution>
        </aff>
        <aff id="aff5">
          <label>5</label>
          <institution content-type="orgname">Centre Hospitalier Universitaire de Bordeaux</institution>
          <addr-line>
            <named-content content-type="city">Bordeaux</named-content>
          </addr-line>
          <country country="FR">Fran&#231;a</country>
          <institution content-type="original">Centre Hospitalier Universitaire de Bordeaux, Bordeaux, Nouvelle-Aquitaine &#8211; Fran&#231;a</institution>
        </aff>
      </contrib-group>
      <author-notes>
        <corresp id="c1"><label>Correspond&#234;ncia:</label><bold>Pedro Beraldo de Andrade</bold> &#8226; Santa Casa de Miseric&#243;rdia de Mar&#237;lia &#8211; Cardiologia Invasiva &#8211; Rua Vicente Ferreira, 828. CEP <postal-code>17515-900</postal-code>, Mar&#237;lia, SP &#8211; Brasil E-mail: <email>pedroberaldo@gmail.com</email> </corresp>
        <fn fn-type="conflict">
          <label>Potencial conflito de interesse</label>
          <p>N&#227;o h&#225; conflito com o presente artigo.</p>
        </fn>
        <fn fn-type="edited-by">
          <label>Editor respons&#225;vel pela revis&#227;o:</label>
          <p>Pedro Lemos</p>
        </fn>
      </author-notes>
      <pub-date date-type="pub" publication-format="electronic">
        <day>18</day>
        <month>10</month>
        <year>2024</year>
      </pub-date>
      <pub-date date-type="collection" publication-format="electronic">
        <year>2024</year>
      </pub-date>
      <volume>121</volume>
      <issue>10</issue>
      <elocation-id>e20240201</elocation-id>
      <history>
        <date date-type="received">
          <day>27</day>
          <month>03</month>
          <year>2024</year>
        </date>
        <date date-type="rev-recd">
          <day>31</day>
          <month>07</month>
          <year>2024</year>
        </date>
        <date date-type="accepted">
          <day>31</day>
          <month>07</month>
          <year>2024</year>
        </date>
      </history>
      <permissions>
        <license license-type="open-access" xlink:href="https://creativecommons.org/licenses/by/4.0/" xml:lang="en">
          <license-p>This is an open-access article distributed under the terms of the Creative Commons Attribution License</license-p>
        </license>
      </permissions>
      <kwd-group xml:lang="pt">
        <title>Palavras-chave</title>
        <kwd>Insufici&#234;ncia da Valva Tric&#250;spide</kwd>
        <kwd>Insufici&#234;ncia Card&#237;aca</kwd>
        <kwd>Implante de Pr&#243;tese de Valva Card&#237;aca</kwd>
      </kwd-group>
      <counts>
        <fig-count count="4"/>
        <table-count count="0"/>
        <equation-count count="0"/>
        <ref-count count="10"/>
      </counts>
    </article-meta>
  </front>
  <body>
    <sec sec-type="intro">
      <title>Introdu&#231;&#227;o</title>
      <p>A preval&#234;ncia de regurgita&#231;&#227;o tric&#250;spide (RT) aumenta com a idade, doen&#231;a card&#237;aca esquerda concomitante e fibrila&#231;&#227;o atrial cr&#244;nica.<sup><xref ref-type="bibr" rid="B1">1</xref></sup> A RT moderada ou grave est&#225; associada a mortalidade excessiva e desfechos desfavor&#225;veis.<sup><xref ref-type="bibr" rid="B2">2</xref></sup> O tratamento de escolha &#233; o reparo da valva tric&#250;spide, com um anel prot&#233;tico capaz de reduzir o di&#226;metro do anel tric&#250;spide, melhorar a coapta&#231;&#227;o dos folhetos valvares e corrigir a regurgita&#231;&#227;o. A troca valvar &#233; reservada aos pacientes que n&#227;o apresentam condi&#231;&#245;es anat&#244;micas para reparo. Entretanto, a abordagem cir&#250;rgica isolada da valva tric&#250;spide continua raramente indicada e ainda n&#227;o h&#225; dados que demonstrem melhora da sobrevida apenas com o tratamento cir&#250;rgico da RT, tornando esta condi&#231;&#227;o subtratada na pr&#225;tica cl&#237;nica, apesar do aumento da taxa de mortalidade em pacientes com RT moderada a grave conduzidos clinicamente.<sup><xref ref-type="bibr" rid="B3">3</xref></sup></p>
      <p>Com base nestas observa&#231;&#245;es, recentemente o tratamento da RT vem transicionando de uma abordagem conservadora para uma abordagem mais intervencionista. Essa mudan&#231;a levou &#224;s primeiras tentativas em humanos de interven&#231;&#245;es transcateter na v&#225;lvula tric&#250;spide (ITVT). V&#225;rios dispositivos foram desenvolvidos, com estrat&#233;gias baseadas na redu&#231;&#227;o do anel valvar, na melhora da coapta&#231;&#227;o entre os folhetos ou na substitui&#231;&#227;o valvar.<sup><xref ref-type="bibr" rid="B4">4</xref></sup> Em um estudo com pareamento por escore de propens&#227;o, o ITVT foi associado a uma sobrevida 40% maior e &#224; aus&#234;ncia de reinterna&#231;&#227;o por insufici&#234;ncia card&#237;aca.<sup><xref ref-type="bibr" rid="B5">5</xref></sup></p>
      <p>A LuX-Valve (Jenscare Biotechnology Co., Ningbo, China) &#233; um dispositivo de substitui&#231;&#227;o de v&#225;lvula tric&#250;spide transcateter (SVTT) ortot&#243;pico autoexpans&#237;vel, cuja viabilidade e efic&#225;cia foram previamente relatadas.<sup><xref ref-type="bibr" rid="B6">6</xref>,<xref ref-type="bibr" rid="B7">7</xref></sup> O sistema LuX-Valve Plus &#233; a vers&#227;o de segunda gera&#231;&#227;o do dispositivo e pode ser implantado atrav&#233;s da veia jugular.<sup><xref ref-type="bibr" rid="B8">8</xref></sup> Apresentamos a primeira realiza&#231;&#227;o de SVTT transjugular com o sistema LuX-Valve Plus na Am&#233;rica Latina em uma paciente com RT sintom&#225;tica de alto risco cir&#250;rgico.</p>
    </sec>
    <sec sec-type="cases">
      <title>Relato de Caso</title>
      <p>Paciente do sexo feminino, 78 anos, portadora de hipertens&#227;o arterial sist&#234;mica, fibrila&#231;&#227;o atrial, diabetes mellitus, dislipidemia, doen&#231;a arterial obstrutiva perif&#233;rica e artrite reumatoide, apresentava sinais e sintomas de insufici&#234;ncia card&#237;aca direita cr&#244;nica, incluindo edema perif&#233;rico, ascite, intoler&#226;ncia ao exerc&#237;cio, dispneia e baixa capacidade funcional. Apesar da terapia cl&#237;nica otimizada, a paciente apresentou interna&#231;&#245;es hospitalares recorrentes por piora dos sintomas. O ecocardiograma revelou fun&#231;&#227;o biventricular preservada, sem sinais de hipertens&#227;o arterial pulmonar, aumento biatrial significativo (volume indexado de &#225;trio direito = 50mL/m<sup>2</sup> e volume indexado de &#225;trio esquerdo = 75mL/m<sup>2</sup>), RT grave (3+), com &#225;rea de orif&#237;cio regurgitante (ERO) efetivo = 0,4cm<sup>2</sup>, volume regurgitante = 42mL/batimento e di&#226;metro do anel tric&#250;spide = 46mm. Com base na idade avan&#231;ada, risco de mortalidade em 30 dias de 8,4% pelo escore da <italic>Society of Thoracic Surgeons</italic> (STS) e anatomia favor&#225;vel pela an&#225;lise da tomografia computadorizada, o <italic>Heart Team</italic> optou pela SVTT com sistema LuX-Valve Plus 30-50.</p>
      <p>O sistema LuX-Valve Plus &#233; composto por quatro componentes: 1) v&#225;lvula prot&#233;tica de tr&#234;s folhetos de peric&#225;rdio bovino; 2) Stent valvular de nitinol autoexpans&#237;vel constitu&#237;do por um disco atrial; 3) uma &#226;ncora ventricular septal, e 4) dois clipes de ancoragem revestidos com politetrafluoretileno (<xref ref-type="fig" rid="f1">Figura 1</xref>). O procedimento foi realizado sob anestesia geral com orienta&#231;&#227;o ecocardiogr&#225;fica transesof&#225;gica e fluorosc&#243;pica. A veia jugular interna direita foi puncionada sob orienta&#231;&#227;o ultrassonogr&#225;fica, uma bainha introdutora de 30 Fr foi ent&#227;o posicionada na veia e, posteriormente, o sistema de libera&#231;&#227;o foi avan&#231;ado. A v&#225;lvula foi liberada e os clipes de preens&#227;o do folheto anterior foram expandidos. O sistema de entrega foi ent&#227;o retirado, permitindo a captura do folheto anterior pelos clipes. O disco atrial foi posteriormente implantado e a v&#225;lvula come&#231;ou a funcionar. O componente de ancoragem foi ent&#227;o posicionado e fixado pela &#226;ncora de nitinol de tr&#234;s pontas no septo ventricular. Por fim, a v&#225;lvula foi completamente liberada e o cateter introdutor foi retirado (<xref ref-type="fig" rid="f2">Figura 2</xref>). A hemostasia foi obtida com 2 Perclose ProGlide&#8482;.</p>
      <fig id="f1">
        <label>Figura 1</label>
        <caption>
          <title>Sistema LuX-Valve Plus.</title>
        </caption>
        <graphic xlink:href="1678-4170-abc-121-10-e20240201-40201-gf01.tif"/></fig>
      <fig id="f2">
        <label>Figura 2</label>
        <caption>
          <title>T&#233;cnica de implante do dispositivo LuX-Valve Plus. A) Acesso percut&#226;neo transjugular. B) Alinhamento e coaxializa&#231;&#227;o do sistema. C) Libera&#231;&#227;o ventricular. D) Libera&#231;&#227;o final.</title>
        </caption>
        <graphic xlink:href="1678-4170-abc-121-10-e20240201-40201-gf02.tif"/></fig>
      <p>O ecocardiograma na alta demonstrou redu&#231;&#227;o significativa da RT, com refluxo menor que leve em controle de 30 dias. A paciente referiu melhora significativa da classe funcional pela <italic>New York Heart Association</italic> (NYHA) aos 30 dias de acompanhamento.</p>
    </sec>
    <sec sec-type="discussion">
      <title>Discuss&#227;o</title>
      <p>O sistema LuX-Valve Plus &#233; um sistema de SVTT implantado pela veia jugular. O sistema de entrega tem as fun&#231;&#245;es de flex&#227;o, rota&#231;&#227;o e expans&#227;o, o que permite atender aos requisitos de posicionamento da v&#225;lvula e garantir que a v&#225;lvula possa ser coaxializada com a v&#225;lvula tric&#250;spide nativa. Os resultados de doze meses do implante do sistema LuX-Valve de primeira gera&#231;&#227;o em seis pacientes, atrav&#233;s de uma pequena incis&#227;o no t&#243;rax direito e no &#225;trio direito, confirmaram sua seguran&#231;a e efic&#225;cia, com melhora significativa no gradiente transvalvar m&#233;dio, na sobrecarga de c&#226;maras direitas, nos &#237;ndices de fun&#231;&#227;o ventricular e <italic>strain</italic> longitudinal global, na redu&#231;&#227;o da classe funcional pela NYHA e aus&#234;ncia de vazamento paravalvar significativo em todos os pacientes, exceto um, que faleceu tr&#234;s meses ap&#243;s a interven&#231;&#227;o devido a RT paravalvar moderada e n&#227;o recupera&#231;&#227;o da insufici&#234;ncia card&#237;aca direita.<sup><xref ref-type="bibr" rid="B7">7</xref></sup></p>
      <p>A primeira experi&#234;ncia em humanos com este dispositivo de segunda gera&#231;&#227;o demonstrou sucesso do procedimento em todos os dez casos realizados, sem mortalidade intraprocedimento ou convers&#227;o para cirurgia aberta. Diferentemente do nosso caso, cujo acesso foi totalmente percut&#226;neo, os procedimentos foram realizados atrav&#233;s de corte de 3 a 4 cm na pele do lado direito do pesco&#231;o e exposi&#231;&#227;o da veia jugular direita. Todos os pacientes relataram melhora da classe funcional e RT menor que leve no controle ecocardiogr&#225;fico de 30 dias.<sup><xref ref-type="bibr" rid="B8">8</xref></sup> Pacientes com hipertens&#227;o arterial pulmonar grave (press&#227;o sist&#243;lica da art&#233;ria pulmonar &#8805;55 mmHg), outras les&#245;es valvares que requeressem interven&#231;&#227;o cir&#250;rgica, fra&#231;&#227;o de eje&#231;&#227;o do ventr&#237;culo esquerdo &lt;50%, anomalia cong&#234;nita de Ebstein, displasia arritmog&#234;nica do ventr&#237;culo direito ou doen&#231;a arterial coronariana grave n&#227;o tratada foram exclu&#237;dos.</p>
      <p>A interven&#231;&#227;o transcateter mais utilizada em pacientes com insufici&#234;ncia card&#237;aca direita &#233; o reparo transcateter tric&#250;spide borda a borda. No entanto, muitos pacientes tornam-se inadequados para a t&#233;cnica, pois apresentam grandes falhas de coapta&#231;&#227;o, <italic>tethering</italic> de folhetos e RT torrencial. Para estes pacientes, a SVTT surgiu como uma alternativa atrativa, apesar de um registro de mundo real sobre a sele&#231;&#227;o de candidatos a SVTT demonstrar uma elevada taxa de exclus&#227;o, principalmente relacionada com o grande di&#226;metro do anel tric&#250;spide.<sup><xref ref-type="bibr" rid="B9">9</xref></sup> A natureza progressiva da doen&#231;a e os seus efeitos a longo prazo sobre a fun&#231;&#227;o card&#237;aca e extracard&#237;aca alertam para o momento apropriado de interven&#231;&#227;o. No TRIGISTRY, um grande registro internacional multic&#234;ntrico, a taxa de sobrevida em 2 anos de 2.413 pacientes com RT funcional isolada grave foi estratificada de acordo com o TRI-SCORE, com base em oito par&#226;metros cl&#237;nicos, biol&#243;gicos e ecocardiogr&#225;ficos (idade, classe funcional pela NYHA, sinais de insufici&#234;ncia card&#237;aca direita, dose di&#225;ria de furosemida, taxa de filtra&#231;&#227;o glomerular, n&#237;vel de bilirrubina total, fra&#231;&#227;o de eje&#231;&#227;o ventricular esquerda e fun&#231;&#227;o ventricular direita).<sup><xref ref-type="bibr" rid="B10">10</xref></sup> A interven&#231;&#227;o cir&#250;rgica ou transcateter bem-sucedida na v&#225;lvula tric&#250;spide foi associada a uma melhor sobrevida quando comparadas ao manejo conservador nas categorias de risco TRI-SCORE baixo e, em menor grau, intermedi&#225;rio, enquanto a sobrevida foi semelhante independentemente do tratamento na categoria de risco alto.<sup><xref ref-type="bibr" rid="B2">2</xref></sup> Nosso caso ilustra a indica&#231;&#227;o de SVTT em uma paciente com TRI-SCORE intermedi&#225;rio, com sintomas refrat&#225;rios e fun&#231;&#227;o biventricular preservada, situa&#231;&#227;o em que o referenciamento precoce possibilita um progn&#243;stico favor&#225;vel.</p>
      <p>A SVTT ortot&#243;pica &#233; uma alternativa promissora de tratamento devido &#224; previsibilidade na redu&#231;&#227;o da RT e da t&#233;cnica de implante. No entanto, as limita&#231;&#245;es anat&#244;micas ainda representam importante causa de exclus&#227;o de potenciais candidatos. A melhoria cont&#237;nua dos dispositivos atuais e novas tecnologias, como LuX-Valve Plus, t&#234;m o potencial de aumentar as op&#231;&#245;es de tratamento e simplificar os procedimentos.</p>
    </sec>
  </body>
  <back>
    <fn-group>
      <fn fn-type="financial-disclosure" id="fn1">
        <label>Fontes de financiamento</label>
        <p>O presente estudo n&#227;o teve fontes de financiamento externas.</p>
      </fn>
      <fn fn-type="other" id="fn2">
        <label>Vincula&#231;&#227;o acad&#234;mica</label>
        <p>N&#227;o h&#225; vincula&#231;&#227;o deste estudo a programas de p&#243;s-gradua&#231;&#227;o.</p>
      </fn>
      <fn fn-type="other" id="fn3">
        <label>Aprova&#231;&#227;o &#233;tica e consentimento informado</label>
        <p>Este estudo foi aprovado pelo Comit&#234; de &#201;tica do Hospital e Maternidade S&#227;o Luiz -HMSL sob o n&#250;mero de protocolo 77658424.5.1001.0087. Todos os procedimentos envolvidos nesse estudo est&#227;o de acordo com a Declara&#231;&#227;o de Helsinki de 1975, atualizada em 2013. O consentimento informado foi obtido de todos os participantes inclu&#237;dos no estudo.</p>
      </fn>
    </fn-group>
    <ref-list>
      <title>Refer&#234;ncias</title>
      <ref id="B1">
        <label>1</label>
        <element-citation publication-type="journal">
          <person-group person-group-type="author">
            <name>
              <surname>Hahn</surname>
              <given-names>RT</given-names>
            </name>
          </person-group>
          <article-title>Tricuspid Regurgitation</article-title>
          <source>N Engl J Med</source>
          <year>2023</year>
          <volume>388</volume>
          <issue>20</issue>
          <fpage>1876</fpage>
          <lpage>1891</lpage>
          <pub-id pub-id-type="doi">10.1056/NEJMra2216709</pub-id>
        </element-citation>
        <mixed-citation>1 Hahn RT. Tricuspid Regurgitation. N Engl J Med. 2023;388(20):1876-91. doi: 10.1056/NEJMra2216709.</mixed-citation>
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  <sub-article article-type="translation" id="S1" xml:lang="en">
    <front-stub>
      <article-id pub-id-type="doi">10.36660/abc.20240201i</article-id>
      <article-categories>
        <subj-group subj-group-type="heading">
          <subject>Research Letter</subject>
        </subj-group>
      </article-categories>
      <title-group>
        <article-title>First Performance of Transjugular Transcatheter Tricuspid Valve Replacement with the Lux-Valve Plus System in Latin America. A Case Report</article-title>
      </title-group>
      <contrib-group>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0003-1152-8946</contrib-id>
          <name>
            <surname>Esteves</surname>
            <given-names>Vinicius</given-names>
          </name>
          <role>Conception and design of the research</role>
          <role>Acquisition of data</role>
          <role>Analysis and interpretation of the data</role>
          <role>Writing of the manuscript</role>
          <xref ref-type="aff" rid="aff6">
            <sup>1</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <contrib-id contrib-id-type="orcid">0000-0003-3511-7375</contrib-id>
          <name>
            <surname>Andrade</surname>
            <given-names>Pedro Beraldo de</given-names>
          </name>
          <role>Analysis and interpretation of the data</role>
          <role>Writing of the manuscript</role>
          <xref ref-type="aff" rid="aff7">
            <sup>2</sup>
          </xref>
          <xref ref-type="corresp" rid="c2"/>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Kreimer</surname>
            <given-names>Sergio</given-names>
          </name>
          <role>Acquisition of data</role>
          <role>Critical revision of the manuscript for content</role>
          <xref ref-type="aff" rid="aff8">
            <sup>3</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Esteves</surname>
            <given-names>Fernanda Almeida</given-names>
          </name>
          <role>Acquisition of data</role>
          <role>Critical revision of the manuscript for content</role>
          <xref ref-type="aff" rid="aff6">
            <sup>1</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Magalh&#227;es</surname>
            <given-names>Francisco Monteiro de Almeida</given-names>
          </name>
          <role>Acquisition of data</role>
          <role>Critical revision of the manuscript for content</role>
          <xref ref-type="aff" rid="aff9">
            <sup>4</sup>
          </xref>
        </contrib>
        <contrib contrib-type="author">
          <name>
            <surname>Modine</surname>
            <given-names>Thomas</given-names>
          </name>
          <role>Conception and design of the research</role>
          <role>Analysis and interpretation of the data</role>
          <role>Critical revision of the manuscript for content</role>
          <xref ref-type="aff" rid="aff10">
            <sup>5</sup>
          </xref>
        </contrib>
        <aff id="aff6">
          <label>1</label>
          <addr-line>
            <named-content content-type="city">S&#227;o Paulo</named-content>
            <named-content content-type="state">SP</named-content>
          </addr-line>
          <country country="BR">Brazil</country>
          <institution content-type="original">Rede D'Or Sao Luiz, S&#227;o Paulo, SP &#8211; Brazil</institution>
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        <aff id="aff7">
          <label>2</label>
          <addr-line>
            <named-content content-type="city">Mar&#237;lia</named-content>
            <named-content content-type="state">SP</named-content>
          </addr-line>
          <country country="BR">Brazil</country>
          <institution content-type="original">Santa Casa de Miseric&#243;rdia de Mar&#237;lia &#8211; Cardiologia Invasiva, Mar&#237;lia, SP &#8211; Brazil</institution>
        </aff>
        <aff id="aff8">
          <label>3</label>
          <addr-line>
            <named-content content-type="city">Santo Andr&#233;</named-content>
            <named-content content-type="state">SP</named-content>
          </addr-line>
          <country country="BR">Brazil</country>
          <institution content-type="original">Hospital e Maternidade Brasil, Santo Andr&#233;, SP &#8211; Brazil</institution>
        </aff>
        <aff id="aff9">
          <label>4</label>
          <addr-line>
            <named-content content-type="city">S&#227;o Paulo</named-content>
            <named-content content-type="state">SP</named-content>
          </addr-line>
          <country country="BR">Brazil</country>
          <institution content-type="original">Instituto do Cora&#231;&#227;o do Hospital das Cl&#237;nicas da Faculdade de Medicina da Universidade de S&#227;o Paulo, S&#227;o Paulo, SP &#8211; Brazil</institution>
        </aff>
        <aff id="aff10">
          <label>5</label>
          <addr-line>
            <named-content content-type="city">Bordeaux</named-content>
          </addr-line>
          <country country="FR">France</country>
          <institution content-type="original">Centre Hospitalier Universitaire de Bordeaux, Bordeaux, Nouvelle-Aquitaine &#8211; France</institution>
        </aff>
      </contrib-group>
      <author-notes>
        <corresp id="c2"><label>Mailing Address:</label><bold>Pedro Beraldo de Andrade</bold> &#8226; Santa Casa de Miseric&#243;rdia de Mar&#237;lia &#8211; Cardiologia Invasiva &#8211; Rua Vicente Ferreira, 828. Postal Code <postal-code>17515-900</postal-code>, Mar&#237;lia, SP &#8211; Brazil E-mail: <email>pedroberaldo@gmail.com</email> </corresp>
        <fn fn-type="conflict">
          <label>Potential conflict of interest</label>
          <p>No potential conflict of interest relevant to this article was reported.</p>
        </fn>
        <fn fn-type="edited-by">
          <label>Editor responsible for the review:</label>
          <p>Pedro Lemos</p>
        </fn>
      </author-notes>
      <kwd-group xml:lang="en">
        <title>Keywords</title>
        <kwd>Tricuspid Valve Insufficiency</kwd>
        <kwd>Heart Failure</kwd>
        <kwd>Heart Valve Prosthesis Implantation</kwd>
      </kwd-group>
    </front-stub>
    <body>
      <sec sec-type="intro">
        <title>Introduction</title>
        <p>The prevalence of tricuspid regurgitation (TR) increases with age, concomitant left-side heart disease, and chronic atrial fibrillation.<sup><xref ref-type="bibr" rid="B1">1</xref></sup> Moderate or severe TR is associated with excess mortality and poor outcomes.<sup><xref ref-type="bibr" rid="B2">2</xref></sup> The interventional treatment of choice is tricuspid valve repair, with a prosthetic ring capable of reducing the tricuspid annulus diameter, improving valve leaflet coaptation, and correcting regurgitation. Valve replacement is reserved for patients who do not have anatomical conditions for repair. However, an isolated surgical approach to the tricuspid valve continues to be rarely indicated, and there are still no data showing improved survival with TR surgical treatment alone, making this condition undertreated in clinical practice, despite the increased mortality rate in patients with moderate to severe TR clinically-only managed.<sup><xref ref-type="bibr" rid="B3">3</xref></sup></p>
        <p>Based on these observations, the treatment of TR has recently been shifting from a conservative to a more interventional approach. This shift has led to first-in-human attempts at transcatheter tricuspid valve interventions (TTVI). Several devices have been developed, with strategies based on reducing the valve annulus, improving coaptation between the leaflets, or valve replacement.<sup><xref ref-type="bibr" rid="B4">4</xref></sup> In a propensity-matched case-control study, TTVI was associated with 40% greater survival and freedom from heart failure rehospitalization.<sup><xref ref-type="bibr" rid="B5">5</xref></sup></p>
        <p>The LuX-Valve (Jenscare Biotechnology Co., Ningbo, China) is a radial force&#8211;independent orthotopic transcatheter tricuspid valve replacement (TTVR) device whose feasibility and efficacy have been previously reported.<sup><xref ref-type="bibr" rid="B6">6</xref>,<xref ref-type="bibr" rid="B7">7</xref></sup> The LuX-Valve Plus system is the second-generation version of the device and can be implanted through the jugular vein.<sup><xref ref-type="bibr" rid="B8">8</xref></sup> We present the first performance of transjugular TTVR with the LuX-Valve Plus system in Latin America in a patient with symptomatic TR at high surgical risk.</p>
      </sec>
      <sec sec-type="cases">
        <title>Case Report</title>
        <p>A 78-year-old female patient with systemic arterial hypertension, atrial fibrillation, diabetes mellitus, dyslipidemia, peripheral arterial obstructive disease, and rheumatoid arthritis presented with signs and symptoms of chronic right heart failure, including peripheral edema, ascites, exercise intolerance, dyspnea, and poor functional capacity. Despite optimized clinical therapy, the patient has had recurrent hospital admissions due to worsening symptoms. Echocardiogram revealed preserved biventricular function, no signs of pulmonary arterial hypertension, significant biatrial enlargement (right atrial indexed volume = 50mL/m<sup>2</sup> and left atrial indexed volume = 75mL/m<sup>2</sup>), severe (3+) TR, with effective regurgitant orifice (ERO) area = 0.4cm<sup>2</sup>, regurgitant volume = 42mL/beat, and tricuspid annular diameter = 46mm. Based on advanced age, 8.4% 30-day mortality risk by Society of Thoracic Surgeons (STS) score, and on a favorable computed tomography scan anatomical analysis, the Heart Team opted for TTVR with LuX-Valve Plus system 30-50.</p>
        <p>LuX-Valve Plus system consists of four components: 1) a trileaflet prosthetic valve with bovine pericardium; 2) a self-expandable nitinol valve stent consisting of an atrial disc; 3) one interventricular septal anchor "tongue"; and 4) two expanded polytetrafluoroethylene-covered graspers (<xref ref-type="fig" rid="f3">Figure 1</xref>). The procedure was performed under general anesthesia with transoesophageal echocardiographic and fluoroscopic guidance. The right internal jugular vein was punctured under ultrasound guidance, a 30 Fr introducer sheath was then placed into the vein, and subsequently, the delivery system was advanced. The valve was released, and the anterior leaflet-grasping clips were expanded. The delivery system was then withdrawn, allowing the capture of the anterior leaflet by the clips. The atrial disc was subsequently deployed, and the valve started to work. The septal tongue (anchoring component) was then deployed and immobilized by firing a 3-pronged nitinol anchor onto the ventricular septum. Finally, the valve was completely released, and the delivery catheter was drawn back and removed (<xref ref-type="fig" rid="f4">Figure 2</xref>). Hemostasis was achieved with 2 Perclose ProGlide<sup>&#8482;</sup> and a pre-closed technique.</p>
        <fig id="f3">
          <label>Figure 1</label>
          <caption>
            <title>LuX-Valve Plus System.</title>
          </caption>
          <graphic xlink:href="1678-4170-abc-121-10-e20240201-40201-gf01-en.tif"/></fig>
        <fig id="f4">
          <label>Figure 2</label>
          <caption>
            <title>LuX-Valve Plus device implantation technique. A) Transjugular percutaneous access. B) System alignment and coaxialization. C) Ventricular release. D) Final release.</title>
          </caption>
          <graphic xlink:href="1678-4170-abc-121-10-e20240201-40201-gf02-en.tif"/></fig>
        <p>The discharge echocardiography showed significant TR reduction and less than mild TR at 30 days. The patient reported significant improvement in New York Heart Association (NYHA) functional status at 30-day follow-up.</p>
      </sec>
      <sec sec-type="discussion">
        <title>Discussion</title>
        <p>The LuX-Valve Plus system is a transjugular TTVR system implanted through the jugular vein. The delivery system has the functions of bending, rotation, and expansion, which allow it to meet the requirements of valve positioning and ensure that the valve can be roughly coaxial with the autologous tricuspid valve. Twelve-month results of the first-generation LuX-Valve system implantation in six patients, through a small incision of the right chest and right atrium, confirmed its safety and efficacy, with significant improvements in mean transvalvular gradient, right heart sizes, conventional right ventricle function indices, and global longitudinal strain, reduction in NYHA functional class, and no significant paravalvular leakage in all patients but one, who died three months postoperatively due to moderate paravalvular TR and non-improvement of right heart failure.<sup><xref ref-type="bibr" rid="B7">7</xref></sup></p>
        <p>The first-in-human experience with this second-generation device demonstrated procedural success in all ten cases, with no intraprocedural mortality or conversion to open surgery. Unlike our case, in which the access site was fully percutaneous, the procedures were performed through a 3-4 cm cut in the skin of the right side of the neck and exposure of the right jugular. All patients reported NYHA functional status improvement and less than mild TR at 30-day echocardiographic control.<sup><xref ref-type="bibr" rid="B8">8</xref></sup> Patients with severe pulmonary arterial hypertension (systolic pulmonary artery pressure &#8805;55 mmHg), other valve lesions requiring operative intervention, left ventricular ejection fraction &lt;50%, congenital Ebstein's anomaly or arrhythmogenic right ventricular dysplasia, and untreated severe coronary artery disease were excluded.</p>
        <p>The most used transcatheter intervention for patients with right heart failure is tricuspid transcatheter edge-to-edge repair. However, many patients are rendered unsuitable for the technique, as they present with large coaptation gaps, leaflet tethering, and torrential TR. For these patients, TTVR has emerged as an attractive alternative despite a real-world report of TTVR screening demonstrating a high screening failure rate, mainly related to large tricuspid annular diameter.<sup><xref ref-type="bibr" rid="B9">9</xref></sup> The progressive nature of the disease and its long-term effects on cardiac and extra-cardiac function prompt attention to the appropriate time of intervention. In the TRIGISTRY, a large multicentre international registry, the 2-year survival rate of 2,413 patients with severe isolated functional TR was stratified according to TRI-SCORE, based on eight clinical, biological, and echocardiographic parameters (age, NYHA functional class, right-sided heart failure signs, daily dose of furosemide, glomerular filtration rate, total bilirubin level, left ventricular ejection fraction, and right ventricular function).<sup><xref ref-type="bibr" rid="B10">10</xref></sup> Surgical or successful transcatheter intervention on the tricuspid valve was associated with better survival than conservative management in the low and, to a lesser extent, intermediate TRI-SCORE risk categories, while survival was similar irrespective of treatment in the high TRI-SCORE risk category.<sup><xref ref-type="bibr" rid="B2">2</xref></sup> Our case illustrates the indication of TTVI in a patient with an intermediate TRI-SCORE, with refractory symptoms and preserved biventricular function, a situation in which early referral would envisage a favorable prognosis.</p>
        <p>Orthotopic TTVR is a promising alternative to repair due to the predictability of TR reduction and implant technique. However, anatomical limitations exclude many potential candidates. Continuous improvement of current devices and new technologies like LuX-Valve Plus have the potential to increase treatment options and simplify procedures.</p>
      </sec>
    </body>
    <back>
      <fn-group>
        <fn fn-type="financial-disclosure" id="fn4">
          <label>Sources of funding</label>
          <p>There were no external funding sources for this study.</p>
        </fn>
        <fn fn-type="other" id="fn5">
          <label>Study association</label>
          <p>This study is not associated with any thesis or dissertation work.</p>
        </fn>
        <fn fn-type="other" id="fn6">
          <label>Ethics approval and consent to participate</label>
          <p>This study was approved by the Ethics Committee of the Hospital e Maternidade S&#227;o Luiz -HMSL under the protocol number 77658424.5.1001.0087. All the procedures in this study were in accordance with the 1975 Helsinki Declaration, updated in 2013. Informed consent was obtained from all participants included in the study.</p>
        </fn>
      </fn-group>
    </back>
  </sub-article>
</article>
