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<front>
<journal-meta>
<journal-id journal-id-type="publisher-id">abcimg</journal-id>
<journal-title-group>
<journal-title>ABC Imagem Cardiovascular</journal-title>
<abbrev-journal-title abbrev-type="publisher">Arq Bras Cardiol: Imagem cardiovasc.</abbrev-journal-title></journal-title-group>
<issn pub-type="epub">2675-312X</issn>
<publisher>
<publisher-name>Sociedade Brasileira de Cardiologia</publisher-name></publisher>
</journal-meta>
<article-meta>
<article-id pub-id-type="doi">10.36660/abcimg.20240118i</article-id>
<article-id pub-id-type="publisher-id">abcimg.20240118i</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Viewpoint</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>A New Horizon in Nuclear Cardiology in Brazil: Impact and Barriers of F-18 Flurpiridaz</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<contrib-id contrib-id-type="orcid">0000-0002-8156-7791</contrib-id>
<name><surname>Brandão</surname><given-names>Simone Cristina Soares</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>
<role>critical revision of the manuscript for intellectual content</role>
<xref ref-type="aff" rid="aff1"><sup>1</sup></xref>
<xref ref-type="aff" rid="aff2"><sup>2</sup></xref>
<xref ref-type="corresp" rid="c1"/>
</contrib>
<aff id="aff1">
<label>1</label>
<institution content-type="orgname">Universidade Federal de Pernambuco</institution>
<addr-line>
<named-content content-type="city">Recife</named-content>
<named-content content-type="state">PE</named-content>
</addr-line>
<country country="BR">Brazil</country>
<institution content-type="original">Universidade Federal de Pernambuco, Recife, PE - Brazil</institution>
</aff>
<aff id="aff2">
<label>2</label>
<institution content-type="orgname">Brigham and Women&apos;s Hospital</institution>
<institution content-type="orgdiv1">Harvard Medical School</institution>
<addr-line>
<named-content content-type="city">Boston</named-content>
<named-content content-type="state">MA</named-content>
</addr-line>
<country country="US">USA</country>
<institution content-type="original">Brigham and Women&apos;s Hospital, Harvard Medical School, Boston, MA - USA</institution>
</aff>
</contrib-group>
<author-notes>
<corresp id="c1"><label>Mailling Address:</label> <bold>Simone Cristina Soares Brandão</bold> • Universidade Federal de Pernambuco. Av. Prof Moraes Rego, SN. Postal code: <postal-code>50670-901</postal-code>. Cidade Universitária, Recife, PE - Brazil E-mail: <email>ssoaresbrandao@bwh.harvard.edu</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>Marcelo Tavares</p></fn>
</author-notes>
<pub-date publication-format="electronic" date-type="pub">
<day>13</day>
<month>12</month>
<year>2024</year></pub-date>
<pub-date publication-format="electronic" date-type="collection">
<year>2024</year>
</pub-date>
<volume>37</volume>
<issue>4</issue>
<elocation-id>e20240118</elocation-id>
<history>
<date date-type="received">
<day>04</day>
<month>11</month>
<year>2024</year>
</date>
<date date-type="rev-recd">
<day>04</day>
<month>11</month>
<year>2024</year></date>
<date date-type="accepted">
<day>05</day>
<month>11</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="en">
<title>Keywords</title>
<kwd>Positron Emission Tomography Computed Tomography</kwd>
<kwd>Coronary Artery Disease</kwd>
<kwd>Radiopharmaceuticals</kwd>
</kwd-group>
<counts>
<fig-count count="0"/>
<table-count count="0"/>
<equation-count count="0"/>
<ref-count count="18"/>
</counts>
</article-meta>
</front>
<body>
<sec sec-type="intro">
<title>Introduction</title>
<p>Advances have been made in positron emission tomography (PET) myocardial perfusion since the Food and Drug Administration (FDA) approved the use of flurpiridaz, which was shown effective in the detection of coronary artery disease (CAD) in two phase III trials, with a high diagnostic precision as compared with Single Photon Emission Computed Tomography (SPECT) scintigraphy.<sup><xref ref-type="bibr" rid="B1">1</xref>-<xref ref-type="bibr" rid="B4">4</xref></sup> Flurpiridaz is an injectable radiotracer, labeled with fluorine-18 (F-18), developed by GE HealthCare, that will be sold as &quot;Flyrcado&quot; in the United States from 2025 onwards.<sup><xref ref-type="bibr" rid="B4">4</xref></sup></p>
<p>With a half-life of 110 minutes, F-18-flurpiridaz requires neither a generator nor a local production of tracers, allowing a more efficient distribution among hospitals and imaging centers,<sup><xref ref-type="bibr" rid="B5">5</xref></sup> similarly to Fluorodeoxyglucose labeled with Fluorine-18 (F-18 FDG).<sup><xref ref-type="bibr" rid="B6">6</xref></sup> This feature may favor the adoption of myocardial perfusion PET, benefiting more patients with cardiovascular diseases.<sup><xref ref-type="bibr" rid="B7">7</xref></sup> Besides, the longer half-life of F-18-flurpiridaz allows the combination of a physical stress test, optimizing the evaluation of ischemia and improving patients&apos; experience.<sup><xref ref-type="bibr" rid="B7">7</xref>,<xref ref-type="bibr" rid="B8">8</xref></sup></p>
<p>Flurpiridaz approval, announced on September 27, 2024,<sup><xref ref-type="bibr" rid="B3">3</xref></sup> marks the beginning of a new era in nuclear cardiology, with the expectation to expand the use of myocardial perfusion PET in the United States and in the world.<sup><xref ref-type="bibr" rid="B7">7</xref></sup> In Brazil, this technology brings opportunities and challenges, that will be discussed in this paper, focusing on advantages, regulatory and access barriers to the implementation of myocardial perfusion PET.</p>
<sec>
<title>The role of PET with F-18 flurpiridaz in the new CAD phenotype</title>
<p>CAD was the main cause of death in Brazil in the last decade.<sup><xref ref-type="bibr" rid="B9">9</xref></sup> Projections of cardiovascular health by 2050 are alarming, highlighting the need for significant interventions. The prevalence of risk factors is expected to increase, with more than 50% of the general population and 80% of specific groups suffering from hypertension and obesity.<sup><xref ref-type="bibr" rid="B10">10</xref>,<xref ref-type="bibr" rid="B11">11</xref></sup> Demographic changes and population aging may exacerbate the impact of cardiovascular diseases globally, aggravated by diabetes and obesity, despite promising reductions in smoking and hypercholesterolemia.<sup><xref ref-type="bibr" rid="B9">9</xref>-<xref ref-type="bibr" rid="B11">11</xref></sup></p>
<p>In 2019, data from the Brazilian national health report showed that 57.5% of men and 62.6% of women were overweight, and 21.8% of men and 29.5% of women were obese.<sup><xref ref-type="bibr" rid="B9">9</xref></sup> The increase in cardiometabolic disorders, like diabetes and chronic renal disease, is associated with factors that increase the risk of cardiovascular diseases and death. Conditions affecting the coronary circulation, like atherosclerosis and microvascular dysfunction, are critical for cardiovascular morbidity.<sup><xref ref-type="bibr" rid="B12">12</xref>,<xref ref-type="bibr" rid="B13">13</xref></sup></p>
<p>Myocardial perfusion scintigraphy using SPECT or PET has been crucial in the measurement of ischemia. The clinical efficacy of these tests should consider all variables that influence patient management.<sup><xref ref-type="bibr" rid="B14">14</xref></sup> Studies have suggested that coronary revascularization in patients with chronic chest pain does not necessarily improves long term outcomes, due to the diffuse nature of CAD. The insufficient role of imaging techniques in guiding this therapy raises questions about the accuracy of these tests, often obsolete and ineffective in detecting subendocardial ischemia.<sup><xref ref-type="bibr" rid="B8">8</xref></sup></p>
<p>Structural and functional abnormalities of coronary circulation, including diffuse non-obstructive atherosclerosis and coronary microvascular dysfunction, are important mediators of cardiovascular morbidity and mortality in individuals with cardiometabolic diseases. Over the last years, the use of PET in the assessment of myocardial perfusion and coronary flow has increased in the United States, and an even greater increase is expected with the introduction of F-18 flurpiridaz.<sup><xref ref-type="bibr" rid="B3">3</xref>,<xref ref-type="bibr" rid="B4">4</xref>,<xref ref-type="bibr" rid="B7">7</xref>,<xref ref-type="bibr" rid="B8">8</xref></sup> A recent, large-scale study showed that PET with myocardial flow reserve detects nonobstructive CAD and microvascular dysfunction more precisely than SPECT, especially in high cardiovascular risk patients.<sup><xref ref-type="bibr" rid="B15">15</xref></sup> Therefore, PET should be preferably considered for individuals with cardiometabolic diseases, aiming at more effective preventive therapies.<sup><xref ref-type="bibr" rid="B14">14</xref>,<xref ref-type="bibr" rid="B15">15</xref></sup></p>
<p>In Brazil, despite investments made by some centers in SPECT with dedicated gamma cameras, the accuracy of this technique remains lower than that of PET.<sup><xref ref-type="bibr" rid="B1">1</xref>,<xref ref-type="bibr" rid="B3">3</xref>,<xref ref-type="bibr" rid="B8">8</xref></sup> These cameras are specific for cardiac tests, limiting its applicability and elevating the costs of investments. On the other hand, myocardial perfusion PET stands out for its high diagnostic accuracy and for the existing infrastructure of PET/CT in Brazil (thanks to the oncology field), which, with the emergence of F-18 flurpiridaz, will potentially be used in nuclear cardiology.<sup><xref ref-type="bibr" rid="B16">16</xref></sup> The adoption of F-18 flurpiridaz provides a new perspective for cardiac perfusion tests, with meaningful benefits to the centers where PET is already available.</p>
</sec>
<sec>
<title>Will F-18 flurpiridaz really coming to Brazil?</title>
<p>We still don&apos;t know. As far as we know, F-18 flurpiridaz (Flyrcado, GE HealthCare) will become available in the United States only. Unfortunately in Brazil, the entry of novel radiopharmaceuticals usually faces great challenges, as we have seen with MIBG-I123 (for assessment of cardiac sympathetic activity), technetium-99m-pyrophosphate (for scanning for transthyretin cardiac amyloidosis), markers of cerebral amyloid plaques in PET (PiB-C11, F-18 flutemetamol, F-18 florbetaben, F-18 florbetapir), PSMA-Ga68 (primarily for prostate cancer), I-123 Ioflupane (for Parkinson disease), among others. The truth is that few centers have access to these technologies in Brazil, especially in the national Unified Health System (SUS). The access, when exists, is usually limited to private services or to a very restricted number of public or philanthropic research institutions.</p>
<p>However, despite this unfavorable background, we cannot give up. In spite of these challenges, significant progress has been made. In Brazil, overcoming obstacles to provide the population with cutting-edge resources requires immense resilience, perseverance and focus. In addition to difficulties commonly seen in first world countries, like staff training and technical excellence, we must face additional barriers. Nevertheless, each step given is a victory, and the advances, despite gradual, pave the way to a more accessible and promising future for nuclear medicine in our country.</p>
</sec>
<sec>
<title>Barriers to F-18 flurpiridaz implementation in Brazil</title>
<p>The entry of F-18 flurpiridaz in Brazil will probably face several challenges to the implementation of this technology in country.<sup><xref ref-type="bibr" rid="B16">16</xref>-<xref ref-type="bibr" rid="B18">18</xref></sup></p>
<list list-type="bullet">
<list-item><p>Regulatory barriers: the approval of F-18 flurpiridaz by the Brazilian Health Regulatory Agency is one of the main obstacles. The regulatory process may be complex and take a long time, and the lack of a viable business model for GE HealthCare and nuclear medicine centers in Brazil may delay the introduction of the product nationwide.</p></list-item>
<list-item><p>Limited infrastructure: despite the presence of a solid infrastructure for PET/CT exams, most equipment distributed across several regions in Brazil was acquired for oncology studies. Therefore, these services must be adapted to nuclear cardiology purposes and costs must be optimized to make the use of F-18 flurpiridaz feasible.</p></list-item>
<list-item><p>Health coverage: the inclusion of PET with F-18 flurpiridaz into the list of procedures covered by the Brazilian National Health Agency and by the SUS is crucial. Without an appropriate coverage, the access to the exam will be limited to private services or to a very low number of public institutions.</p></list-item>
<list-item><p>Access challenges: the truth is that many Brazilian centers have limited access to new imaging technologies, especially public ones. This results in disparities in the access to advanced diagnosis, which may negatively impact the treatment of patients with cardiovascular diseases.</p></list-item>
<list-item><p>Professional qualification: F-18 flurpiridaz implementation will require training and qualification of healthcare professionals for the correct utilization of the new technology and interpretation of results.</p></list-item>
</list>
</sec>
</sec>
<sec sec-type="conclusions">
<title>Final considerations</title>
<p>The introduction of F-18 flurpiridaz in Brazil can revolutionize the detection of CAD and improve the prognosis of patients with cardiovascular diseases. However, in this regard, it is fundamental to overcome regulatory barriers, guarantee an adequate infrastructure, add PET with F-18 flurpiridaz to the coverage list of Brazilian health systems, and qualify healthcare professionals. In addition, the collaboration between medical societies, government agencies and industry will be crucial to make the implementation of this emerging technology viable in Brazil.</p>
<p>Although geography is not the main limiting factor in this case, cultural, political barriers and inefficient management have hampered access to this important diagnostic technology. As Timothy Marshall highlights in his work &quot;Prisoners of Geography&quot;, it is not always geographical constraints that determine the fate of a nation, but rather the choices, priorities, and will of its leaders and citizens.</p>
</sec>
</body>
<back>
<fn-group>
<fn fn-type="financial-disclosure" id="fn1">
<label>Sources of Funding</label>
<p>There were no external funding sources for this study.</p></fn>
<fn fn-type="other" id="fn2">
<label>Study Association</label>
<p>This study is not associated with any thesis or dissertation work.</p></fn>
<fn fn-type="other" id="fn3">
<label>Ethics Approval and Consent to Participate</label>
<p>This article does not contain any studies with human participants or animals performed by any of the authors.</p></fn>
</fn-group>
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<sub-article article-type="translation" id="S1" xml:lang="pt">
<front-stub>
<article-id pub-id-type="doi">10.36660/abcimg.20240118</article-id>
<article-categories>
<subj-group subj-group-type="heading">
<subject>Ponto de Vista</subject>
</subj-group>
</article-categories>
<title-group>
<article-title>Novo Horizonte na Cardiologia Nuclear Brasileira: O Impacto e as Barreiras do Flurpiridaz-F18</article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<contrib-id contrib-id-type="orcid">0000-0002-8156-7791</contrib-id>
<name><surname>Brandão</surname><given-names>Simone Cristina Soares</given-names></name>
<role>Concepção e desenho da pesquisa</role>
<role>obtenção de dados</role>
<role>análise e interpretação dos dados</role>
<role>redação do manuscrito</role>
<role>revisão crítica do manuscrito quanto ao conteúdo intelectual importante</role>
<xref ref-type="aff" rid="aff3"><sup>1</sup></xref>
<xref ref-type="aff" rid="aff4"><sup>2</sup></xref>
<xref ref-type="corresp" rid="c2"/>
</contrib>
<aff id="aff3">
<label>1</label>
<addr-line>
<named-content content-type="city">Recife</named-content>
<named-content content-type="state">PE</named-content>
</addr-line>
<country country="BR">Brasil</country>
<institution content-type="original">Universidade Federal de Pernambuco, Recife, PE - Brasil</institution>
</aff>
<aff id="aff4">
<label>2</label>
<addr-line>
<named-content content-type="city">Boston</named-content>
<named-content content-type="state">MA</named-content>
</addr-line>
<country country="US">EUA</country>
<institution content-type="original">Brigham and Women&apos;s Hospital, Harvard Medical School, Boston, MA - EUA</institution>
</aff>
</contrib-group>
<author-notes>
<corresp id="c2"><label>Correspondência:</label> <bold>Simone Cristina Soares Brandão</bold> • Universidade Federal de Pernambuco. Av. Prof Moraes Rego, SN. CEP: <postal-code>50670-901</postal-code>. Cidade Universitária, Recife, PE - Brasil E-mail: <email>ssoaresbrandao@bwh.harvard.edu</email></corresp>
<fn fn-type="conflict"><label>Potencial Conflito de Interesse</label>
<p>Declaro não haver conflito de interesses pertinentes.</p></fn>
<fn fn-type="edited-by"><label>Editor responsável pela revisão:</label> <p>Marcelo Tavares</p></fn>
</author-notes>
<kwd-group xml:lang="pt">
<title>Palavras-chave</title>
<kwd>Tomografia por Emissão de Pósitrons combinada à Tomografia Computadorizada</kwd>
<kwd>Doença Arterial Coronariana</kwd>
<kwd>Compostos Radiofarmacêuticos</kwd>
</kwd-group>
</front-stub>
<body>
<sec sec-type="intro">
<title>Introdução</title>
<p>A imagem de perfusão miocárdica por tomografia de emissão de pósitrons (PET) avançou com a aprovação do flurpiridaz pela Food and Drug Administration (FDA), que demonstrou sua eficácia na detecção de doença arterial coronariana (DAC) em dois ensaios de fase III, apresentando maior precisão diagnóstica em comparação à cintilografia SPECT (Single Photon Emission Computed Tomography) <sup><xref ref-type="bibr" rid="B1">1</xref>-<xref ref-type="bibr" rid="B4">4</xref>, <xref ref-type="bibr" rid="B10">10</xref>,<xref ref-type="bibr" rid="B11">11</xref></sup></p>
<p>O flurpiridaz é um radiotraçador injetável, marcado com flúor-18, desenvolvido pela GE HealthCare e que será comercializado como Flyrcado nos Estados Unidos a partir de 2025.<sup><xref ref-type="bibr" rid="B4">4</xref></sup></p>
<p>Com uma meia-vida de 110 minutos, o flurpiridaz-F18 elimina a necessidade de geradores e produção local de traçadores, permitindo uma distribuição mais eficiente em hospitais e centros de imagem,<sup><xref ref-type="bibr" rid="B5">5</xref></sup> de maneira semelhante ao Fluordeoxiglicose marcado com Flúor-18 (FDG-F18).<sup><xref ref-type="bibr" rid="B6">6</xref></sup> Essa característica pode aumentar a adoção da PET de perfusão miocárdica, beneficiando mais pacientes com doenças cardiovasculares.<sup><xref ref-type="bibr" rid="B7">7</xref></sup> Além disso, a meia-vida mais longa possibilita a combinação de testes de estresse físico com a tecnologia, otimizando a avaliação de isquemia e melhorando a experiência do paciente.<sup><xref ref-type="bibr" rid="B7">7</xref>,<xref ref-type="bibr" rid="B8">8</xref></sup></p>
<p>A aprovação anunciada em 27 de setembro de 2024<sup><xref ref-type="bibr" rid="B3">3</xref></sup> marca o início de uma nova era na cardiologia nuclear, com a expectativa de impulsionar o uso da PET de perfusão miocárdica nos Estados Unidos e no mundo.<sup><xref ref-type="bibr" rid="B7">7</xref></sup> Para o Brasil, essa tecnologia traz oportunidades e desafios, que serão discutidos neste artigo, focando nas vantagens, barreiras regulatórias e de acesso à implementação da PET de perfusão miocárdica.</p>
<sec>
<title>A importância da PET com flurpiridaz-F18 no novo fenótipo da doença arterial coronária</title>
<p>A DAC foi a principal causa de morte no Brasil na última década.<sup><xref ref-type="bibr" rid="B9">9</xref></sup> As projeções para a saúde cardiovascular até 2050 são alarmantes, destacando a necessidade de intervenções significativas. Espera-se que fatores de risco cresçam consideravelmente, com hipertensão e obesidade superando 50% na população geral e 80% em alguns subgrupos específicos.<sup><xref ref-type="bibr" rid="B10">10</xref>,<xref ref-type="bibr" rid="B11">11</xref></sup> As mudanças demográficas e o envelhecimento da população podem intensificar o impacto das doenças cardiovasculares globalmente, agravado pelo aumento de diabetes e obesidade, apesar das promissoras reduções no tabagismo e hipercolesterolemia.<sup><xref ref-type="bibr" rid="B9">9</xref>-<xref ref-type="bibr" rid="B11">11</xref></sup></p>
<p>Em 2019, os dados da pesquisa nacional de saúde no Brasil mostraram que 57,5% dos homens e 62,6% das mulheres estavam com excesso de peso, e a obesidade afetava 21,8% dos homens e 29,5% das mulheres.<sup><xref ref-type="bibr" rid="B9">9</xref></sup> O aumento de distúrbios cardiometabólicos, como diabetes e doença renal crônica, está associado a fatores que elevam o risco de doenças cardiovasculares e morte. Anormalidades na circulação coronária, como aterosclerose e disfunção microvascular, são críticas para a morbidade cardiovascular.<sup><xref ref-type="bibr" rid="B12">12</xref>,<xref ref-type="bibr" rid="B13">13</xref></sup></p>
<p>A cintilografia de perfusão miocárdica, usando SPECT ou PET, tem sido crucial na medição de isquemia. A eficácia clínica desses exames deve considerar todas as variáveis que influenciam o manejo do paciente.<sup><xref ref-type="bibr" rid="B14">14</xref></sup> Estudos sugerem que a revascularização coronária em pacientes com dor torácica crônica não melhora necessariamente os resultados a longo prazo, devido à natureza difusa da DAC. O papel insuficiente das técnicas de imagem em orientar essa terapia levanta questões sobre a precisão desses exames, muitas vezes obsoletos e ineficazes na detecção de isquemia subendocárdica.<sup><xref ref-type="bibr" rid="B8">8</xref></sup></p>
<p>Anormalidades estruturais e funcionais de toda a circulação coronária, incluindo aterosclerose difusa não obstrutiva e disfunção microvascular coronariana, são mediadores importantes da morbidade e mortalidade cardiovascular entre pessoas com doenças cardiometabólicas. Nos últimos anos, o uso da PET para avaliação de perfusão miocárdica e fluxo coronário aumentou nos Estados Unidos, e um crescimento ainda maior é esperado com a introdução do flurpiridaz-F18.<sup><xref ref-type="bibr" rid="B3">3</xref>,<xref ref-type="bibr" rid="B4">4</xref>,<xref ref-type="bibr" rid="B7">7</xref>,<xref ref-type="bibr" rid="B8">8</xref></sup> Um recente estudo de larga escala demonstrou que a PET com avaliação da reserva de fluxo coronário detecta DAC não obstrutiva e disfunção microvascular de forma mais precisa que a SPECT, especialmente em pacientes com perfil de alto risco cardiovascular.<sup><xref ref-type="bibr" rid="B15">15</xref></sup> Assim, a PET deve ser considerada preferencialmente para pacientes com doenças cardiometabólicas, permitindo direcionar tratamentos preventivos mais eficazes.<sup><xref ref-type="bibr" rid="B14">14</xref>,<xref ref-type="bibr" rid="B15">15</xref></sup></p>
<p>No Brasil, apesar de alguns centros terem investido na SPECT com gama-câmaras dedicadas, sua acurácia é inferior à da PET.<sup><xref ref-type="bibr" rid="B1">1</xref>,<xref ref-type="bibr" rid="B3">3</xref>,<xref ref-type="bibr" rid="B8">8</xref></sup> Essas câmaras são específicas para exames cardíacos, limitando sua aplicabilidade e tornando seu investimento mais oneroso. Por outro lado, a PET de perfusão miocárdica destaca-se pela alta precisão diagnóstica e pela infraestrutura de PET/CT existente no Brasil, que inicialmente servia à oncologia, mas com a chegada do flurpiridaz-F18 poderá ser utilizada na cardiologia nuclear.<sup><xref ref-type="bibr" rid="B16">16</xref></sup> A adoção do flurpiridaz-F18 oferece uma nova perspectiva para exames de perfusão cardíaca, prometendo benefícios significativos para os centros que já adotam a PET e para os pacientes em geral.</p>
</sec>
<sec>
<title>Mas será que o flurpiridaz-F18 chega mesmo ao Brasil?</title>
<p>Por enquanto, ainda não sabemos. Até o momento, o flurpiridaz-F18 (Flyrcado, GE HealthCare) será disponibilizado apenas nos Estados Unidos. No Brasil, a chegada de novos radiofármacos, infelizmente, costuma enfrentar grandes desafios, como vimos com o MIBG-I123 (para avaliação da atividade simpática cardíaca), o pirofosfato-Tc99m (para pesquisa de amiloidose cardíaca por transtirretina), os marcadores de placa amiloide para PET cerebral (PiB-C11, flutemetamol-F18, florbetaben-F18, florbetapir-F18), o PSMA-Ga68 (primordialmente para câncer de próstata), o Ioflupano-I123 (para investigação de Parkinson), entre outros. A realidade é que pouquíssimos centros brasileiros têm acesso a essas tecnologias, e no Sistema Único de Saúde (SUS), essa perspectiva se torna ainda mais distante. Quando há acesso, geralmente é limitado a serviços privados ou a um número muito restrito de instituições públicas ou filantrópicas com perfil de pesquisa.</p>
<p>Apesar desse histórico desfavorável, não podemos desistir. É importante lembrar que, mesmo em meio a esses desafios, continuamos avançando. No Brasil, vencer obstáculos para oferecer esses recursos de ponta à nossa população exige resiliência, perseverança e um foco imenso. Além das dificuldades comuns em países de primeiro mundo, como treinamento de equipe e excelência técnica, precisamos enfrentar barreiras adicionais. Contudo, cada passo que damos é uma conquista, e esses avanços, ainda que graduais, pavimentam o caminho para um futuro mais acessível e promissor para a medicina nuclear em nosso país.</p>
</sec>
<sec>
<title>Barreiras para implementação do flurpiridaz-F18 no Brasil</title>
<p>A chegada do flurpiridaz-F18 no Brasil deve enfrentar diversos desafios que dificultará a implementação dessa tecnologia no país.<sup><xref ref-type="bibr" rid="B16">16</xref>-<xref ref-type="bibr" rid="B18">18</xref></sup></p>
<p><italic>Barreiras regulatórias</italic>: a aprovação do flurpiridaz-F18 pela Agência Nacional de Vigilância Sanitária (ANVISA) é um dos principais obstáculos. O processo de regulamentação pode ser demorado e complexo, e a falta de um modelo de negócios viável para a GE HealthCare e serviços de medicina nuclear no Brasil pode atrasar ainda mais a introdução do produto.</p>
<p><italic>Infraestrutura limitada</italic>: embora o Brasil possua uma infraestrutura de PET/CT com vários equipamentos nas diversas regiões do país, a maioria foi adquirida para oncologia. A adaptação desses serviços para a cardiologia nuclear e a otimização de custos são necessárias para viabilizar o uso do flurpiridaz-F18.</p>
<p><italic>Cobertura de saúde</italic>: a inclusão do exame de PET com flurpiridaz-F18 no rol de procedimentos da Agência Nacional de Saúde (ANS) e no SUS é crucial. Sem a cobertura adequada, o acesso ao exame será limitado, restringindo seu uso a serviços privados ou a um número muito restrito de instituições públicas.</p>
<p><italic>Desafios de acesso</italic>: a realidade é que muitos centros brasileiros têm acesso limitado a novas tecnologias de imagem, e a situação é ainda mais crítica no SUS. Isso resulta em uma disparidade no acesso a diagnósticos avançados, o que pode impactar negativamente o tratamento de pacientes com doenças cardiovasculares.</p>
<p><italic>Capacitação profissional</italic>: a implementação do flurpiridaz-F18 exigirá treinamento e capacitação de profissionais de saúde para garantir a correta utilização da nova tecnologia e interpretação dos resultados.</p>
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<title>Considerações Finais</title>
<p>A introdução do flurpiridaz-F18 no Brasil tem o potencial de revolucionar a detecção de DAC e melhorar o prognóstico de pacientes com doenças cardiovasculares. No entanto, para que isso aconteça, é fundamental superar as barreiras regulatórias, garantir a infraestrutura adequada, promover a inclusão do exame nos sistemas de saúde e capacitar os profissionais. A colaboração entre sociedades médicas, agências governamentais e a indústria será essencial para viabilizar a implementação dessa tecnologia emergente no país.</p>
<p>Embora a geografia não seja o principal fator limitante neste caso, as barreiras culturais, políticas e de gestão ineficiente têm aprisionado o Brasil em um atraso no acesso a essa importante tecnologia de diagnóstico. Assim como Timothy Marshall destaca em sua obra &quot;Somos Prisioneiros da Geografia&quot;, nem sempre são os condicionantes geográficos que determinam o destino de uma nação, mas sim as escolhas, prioridades e a vontade de seus líderes e cidadãos.</p>
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<fn fn-type="financial-disclosure" id="fn4">
<label>Fontes de Financiamento</label>
<p>O presente estudo não teve fontes de financiamento externas.</p></fn>
<fn fn-type="other" id="fn5">
<label>Vinculação Acadêmica</label>
<p>Não há vinculação deste estudo a programas de pós-graduação.</p></fn>
<fn fn-type="other" id="fn6">
<label>Aprovação Ética e Consentimento Informado</label>
<p>Este artigo não contém estudos com humanos ou animais realizados por nenhum dos autores.</p></fn>
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