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    "titulo" => "Assessing response to cardiac resynchronization therapy&#58; Time to settle on some definitive criteria"
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        "titulo" => "Avalia&#231;&#227;o da resposta &#224; terap&#234;utica de ressincroniza&#231;&#227;o card&#237;aca&#46; &#201; necess&#225;rio estabelecer crit&#233;rios definitivos"
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Cardiac resynchronization therapy &#40;CRT&#41; is a 20-year-old technology&#46; Since its introduction&#44; there has been considerable debate about the non-response rate&#44; especially in view of the initial cost of the system and the need for a surgical procedure to implant it&#46; In fact&#44; the non-response rate&#44; generally around 30&#37;&#44; is not so different from that of other therapies for heart failure &#40;HF&#41;&#46;</p><p id="par0010" class="elsevierStylePara elsevierViewall">There is much confusion about response to CRT&#46; Firstly&#44; it is highly dependent on the criteria used to define response&#59; studies have shown that response rates range from 32&#37; to 91&#37; depending on the criteria used&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> Rates tend to be higher when subjective clinical measures are used&#44; but much lower on outcome measures&#46; Secondly&#44; there is disagreement between different methods of assessing response&#46; The lack of correlation between different ways of defining success&#44; and their association with prognosis in terms of decreased mortality and morbidity&#44; was first addressed by Yu et al&#46;&#44;<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> who demonstrated that increase in left ventricular ejection fraction &#40;LVEF&#41; was associated with longer survival but not with improvement in symptoms&#46;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Subsequently&#44; Cha et al&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> concluded otherwise&#44; demonstrating that clinical improvement influenced outcome but that reverse remodeling was not needed for this survival benefit&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">It is necessary to decide which should be defined as response to CRT&#58; living better or living longer&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">The class I indication for CRT in HF was based not on improvement in symptoms or exercise capacity&#44; but on its effect on mortality or morbidity&#46; The ultimate response to CRT should accordingly be a decrease in mortality and morbidity&#44; i&#46;e&#46; fewer HF events&#46; All other clinical&#44; echocardiographic or laboratory improvements are merely surrogate markers of the real response&#46; Any attempt to predict outcome by means of clinical or echocardiographic surrogates is hampered by its subjective nature&#46; Although non-responders usually have worse outcomes than responders&#44; this is not always the case&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">Finally&#44; there is an additional issue to consider when using surrogate markers of outcome&#44; which is the timing to assess results and cutoff values&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">In addition to the above&#44; HF is a progressive disease&#44; so many factors may influence outcome&#44; not only CRT response&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">In this issue of the <span class="elsevierStyleItalic">Journal</span>&#44; Rodrigues et al&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> chose eleven criteria used in previous CRT trials and assessed the accuracy of each of these criteria alone and in combination for predicting survival free from major adverse cardiac events &#40;MACE&#41;&#46; They found that the only three isolated criteria that could predict outcome were a clinical criterion &#40;a decrease of at least one New York Heart Association &#91;NYHA&#93; functional class&#41; and two echocardiographic parameters&#44; reflecting an absolute and a relative increase in LVEF&#46; No other criteria were able to predict outcome&#46; However&#44; even these three were not ideal&#58; a reduction of &#8805;1 NYHA functional class showed an unadjusted reduction of 61&#37; in the probability of MACE&#44; and a &#62;15&#37; increase in LVEF showed an unadjusted reduction of 57&#37;&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">One of the disadvantages of clinical criteria is the subjective nature of their measurement&#44; which depends on the patient&#39;s or physician&#39;s point of view&#44; but this study demonstrates that measurement of peak oxygen consumption &#40;pVO<span class="elsevierStyleInf">2</span>&#41; was less accurate than reduction in NYHA class&#46; When no hospitalization for HF within six months was added to reduced NYHA class and increased pVO<span class="elsevierStyleInf">2</span>&#44; the risk reduction was 79&#37;&#44; highlighting the superiority of an objective clinical criterion &#40;absence of hospitalization&#41;&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Composite endpoints are often used in clinical trials of CRT&#46; However&#44; they are only reliable when each component is of similar importance&#44; and previous studies have shown that combining parameters&#44; which complicates the reporting of results&#44; does not increase accuracy&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">In my opinion&#44; it would have been useful if this paper had assessed adjusted hazard ratios&#44; at least with the more representative variables&#46; The authors did not test interactions between the criteria considered and prognostic parameters such as age&#44; QRS duration&#44; serum creatinine&#44; B-type natriuretic peptide and HF etiology&#46; Boidol et al&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> showed that response criteria have different predictive power in different patient subgroups depending on baseline characteristics&#46; Similarly&#44; Rodrigues et al&#46; highlight the lack of agreement between different criteria&#59; in their study only three criteria &#40;5&#46;5&#37;&#41; had Cohen&#39;s kappa &#40;&#954;&#41; values in the range of strong agreement&#46; More worrisome is the lack of correlation between the two most accurate criteria &#40;&#954; 0&#46;20 between &#62;1 reduction in NYHA class and &#62;5&#37; absolute increase in LVEF&#41;&#44; which calls into question the usefulness of comparing studies using different criteria&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Another important issue is the timing of response assessment&#46; In Rodrigues et al&#46;&#8217;s study&#44; the second echocardiogram was performed six months after CRT&#46; It is now known that late reverse remodeling occurs in some patients&#44;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> the effect of which on survival is similar to that of early reverse remodeling&#46; It therefore cannot be ruled out that some of the echocardiographic non-responders in this study may have been late responders&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">This paper highlights the fallacy of cataloging patients into categories according to clinical or echocardiographic response criteria&#46; However&#44; at times some way of assessing CRT response is necessary in order to assess the need to optimize device programming&#44; and this paper demonstrates that simple criteria like increased LVEF and decreased NYHA class may be suitable for this purpose&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Nevertheless&#44; it is important to remember that response to CRT should always be based on hard endpoints&#44; namely improved survival and reduction of HF events&#44; rather than on surrogate endpoints&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0075" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare&#46;</p></span></span>"
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Assessing response to cardiac resynchronization therapy: Time to settle on some definitive criteria
Avaliação da resposta à terapêutica de ressincronização cardíaca. É necessário estabelecer critérios definitivos
Leonor Parreira
Serviço de Cardiologia, Centro Hospitalar de Setúbal, Setúbal, Portugal
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HF is a progressive disease&#44; so many factors may influence outcome&#44; not only CRT response&#46;</p><p id="par0040" class="elsevierStylePara elsevierViewall">In this issue of the <span class="elsevierStyleItalic">Journal</span>&#44; Rodrigues et al&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> chose eleven criteria used in previous CRT trials and assessed the accuracy of each of these criteria alone and in combination for predicting survival free from major adverse cardiac events &#40;MACE&#41;&#46; They found that the only three isolated criteria that could predict outcome were a clinical criterion &#40;a decrease of at least one New York Heart Association &#91;NYHA&#93; functional class&#41; and two echocardiographic parameters&#44; reflecting an absolute and a relative increase in LVEF&#46; No other criteria were able to predict outcome&#46; However&#44; even these three were not ideal&#58; a reduction of &#8805;1 NYHA functional class showed an unadjusted reduction of 61&#37; in the probability of MACE&#44; and a &#62;15&#37; increase in LVEF showed an unadjusted reduction of 57&#37;&#46;</p><p id="par0045" class="elsevierStylePara elsevierViewall">One of the disadvantages of clinical criteria is the subjective nature of their measurement&#44; which depends on the patient&#39;s or physician&#39;s point of view&#44; but this study demonstrates that measurement of peak oxygen consumption &#40;pVO<span class="elsevierStyleInf">2</span>&#41; was less accurate than reduction in NYHA class&#46; When no hospitalization for HF within six months was added to reduced NYHA class and increased pVO<span class="elsevierStyleInf">2</span>&#44; the risk reduction was 79&#37;&#44; highlighting the superiority of an objective clinical criterion &#40;absence of hospitalization&#41;&#46;</p><p id="par0050" class="elsevierStylePara elsevierViewall">Composite endpoints are often used in clinical trials of CRT&#46; However&#44; they are only reliable when each component is of similar importance&#44; and previous studies have shown that combining parameters&#44; which complicates the reporting of results&#44; does not increase accuracy&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a></p><p id="par0055" class="elsevierStylePara elsevierViewall">In my opinion&#44; it would have been useful if this paper had assessed adjusted hazard ratios&#44; at least with the more representative variables&#46; The authors did not test interactions between the criteria considered and prognostic parameters such as age&#44; QRS duration&#44; serum creatinine&#44; B-type natriuretic peptide and HF etiology&#46; Boidol et al&#46;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> showed that response criteria have different predictive power in different patient subgroups depending on baseline characteristics&#46; Similarly&#44; Rodrigues et al&#46; highlight the lack of agreement between different criteria&#59; in their study only three criteria &#40;5&#46;5&#37;&#41; had Cohen&#39;s kappa &#40;&#954;&#41; values in the range of strong agreement&#46; More worrisome is the lack of correlation between the two most accurate criteria &#40;&#954; 0&#46;20 between &#62;1 reduction in NYHA class and &#62;5&#37; absolute increase in LVEF&#41;&#44; which calls into question the usefulness of comparing studies using different criteria&#46;</p><p id="par0060" class="elsevierStylePara elsevierViewall">Another important issue is the timing of response assessment&#46; In Rodrigues et al&#46;&#8217;s study&#44; the second echocardiogram was performed six months after CRT&#46; It is now known that late reverse remodeling occurs in some patients&#44;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a> the effect of which on survival is similar to that of early reverse remodeling&#46; It therefore cannot be ruled out that some of the echocardiographic non-responders in this study may have been late responders&#46;</p><p id="par0065" class="elsevierStylePara elsevierViewall">This paper highlights the fallacy of cataloging patients into categories according to clinical or echocardiographic response criteria&#46; However&#44; at times some way of assessing CRT response is necessary in order to assess the need to optimize device programming&#44; and this paper demonstrates that simple criteria like increased LVEF and decreased NYHA class may be suitable for this purpose&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">Nevertheless&#44; it is important to remember that response to CRT should always be based on hard endpoints&#44; namely improved survival and reduction of HF events&#44; rather than on surrogate endpoints&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0075" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare&#46;</p></span></span>"
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Revista Portuguesa de Cardiologia (English edition)
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