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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Aortic stenosis is the most frequent native valve disease in Europe&#44; and as the elderly population increases&#44; together with the high prevalence of comorbidities and the extension of indications to low-risk patients&#44; the number of individuals requiring transcatheter aortic valve replacement &#40;TAVR&#41; is likely to increase substantially&#46;<a class="elsevierStyleCrossRefs" href="#bib0095"><span class="elsevierStyleSup">1&#8211;3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Frailty&#44; dependence and comorbidities affect the lives of some of these patients&#44; raising the question whether the intervention justifies the economic cost&#46; High-quality American and European analyses of TAVR have shown generally acceptable cost-effectiveness&#44; with the higher cost of the procedure being offset by the considerable benefits in quality of life and survival&#46; It is&#44; however&#44; important to examine the specifics at a national level&#44; since large differences have been observed between countries&#46;<a class="elsevierStyleCrossRefs" href="#bib0110"><span class="elsevierStyleSup">4&#8211;8</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The article by Fontes-Carvalho et al&#46; of the Centro Hospitalar de Vila Nova de Gaia in this issue of the <span class="elsevierStyleItalic">Journal</span><a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">9</span></a> points to the need to assess the cost-effectiveness and economic impact of the adoption of new technologies before their dissemination in clinical practice&#46; In this case the time for this objective has passed&#44; which since these authors are well respected I would suggest should be put down to a momentary lapse of opinion&#46; In fact it is now 18 years since the first TAVR procedure was performed&#44; and it was the Gaia Hospital group that introduced it to the Iberian peninsula in 2007&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The article is of interest because it assesses health technology in structural interventional cardiology from a national viewpoint&#46; On the basis of detailed data from 2017 from a single center&#44; it sets out to estimate the potential impact of expanding the indications for TAVR in three hypothetical scenarios&#44; concluding that public expenditure on this treatment is likely to grow considerably&#46; The authors suggest a centralized approach to the management of the required economic and clinical resources&#44; as well as optimization of the procedure itself&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">There are two questions that this study raises in 2020&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The first question is whether economic considerations are paramount for a technique that is considered the first-line treatment for high-risk patients and for which good evidence is emerging for low-risk individuals&#46; The answer is no&#44; for the following reasons&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">a&#41;</span><p id="par0035" class="elsevierStylePara elsevierViewall">Firstly&#44; since 2017&#44; not only has there been an increase of 33&#37; in the number of TAVR procedures&#44; but in line with recommendations there have been improvements in the technique&#44; with simplified protocols for arterial access and sedation&#46; These have led to reductions in costs&#44; complications &#40;stroke&#44; vascular complications&#44; bleeding and valvular regurgitation&#41; and rehospitalizations&#46;<a class="elsevierStyleCrossRefs" href="#bib0115"><span class="elsevierStyleSup">5&#44;10&#8211;12</span></a> As Fontes-Carvalho et al&#46; point out in their article&#44; cost-effectiveness studies such as theirs are most valuable before the technique enters clinical practice&#44; which has already happened&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">b&#41;</span><p id="par0040" class="elsevierStylePara elsevierViewall">Secondly&#44; in Portugal the laboratories and technicians required to perform TAVR are often unavailable&#46; The European Society of Cardiology &#40;ESC&#41; Atlas<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">13</span></a> shows that Portugal is lagging in 23rd and 34th place&#44; respectively&#44; among ESC member countries for these two parameters&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">c&#41;</span><p id="par0045" class="elsevierStylePara elsevierViewall">Thirdly&#44; there is no sound economic justification for centralization of material acquisition&#44; which was proposed without success some years ago in the area of coronary intervention&#46; The empirical data are inconclusive concerning the advantages and disadvantages of the mixed funding model of a fixed budget and diagnostic-related groups used by the Portuguese national health system &#40;NHS&#41;&#44; but this alone does not justify such a change&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">14</span></a> There are no reports of such attempts in other areas of medicine in Portugal&#44; and the studies referred to are from the UK and the American PARTNER trial&#44; which are of doubtful applicability to Portugal&#44; unlike studies on measures to increase the efficiency of hospital protocols&#44; which are reproducible in any center&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">12&#44;15&#44;16</span></a></p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">d&#41;</span><p id="par0050" class="elsevierStylePara elsevierViewall">Fourthly&#44; times have changed&#44; and it is important to overcome inequalities in regional access to cutting-edge technology&#44; without compromising clinical excellence&#46; In an era of rapidly increasing and improving professional mentoring and interchange&#44; a move toward greater concentration would go against current practice and could hamper the ability of several catheterization laboratories to offer techniques that are becoming simpler and easier&#46; This risks losing one of the main strengths of interventional cardiology&#44; that of universality&#44; the clearest example of which is the coronary fast-track system&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">e&#41;</span><p id="par0055" class="elsevierStylePara elsevierViewall">Finally&#44; the true value of a theoretical cost-effectiveness analysis would be seen if it were directed at areas that really are emerging&#44; such as coronary lithoplasty&#44; coronary sinus narrowing&#44; or intervention for structural mitral regurgitation&#46;</p></li></ul></p><p id="par0060" class="elsevierStylePara elsevierViewall">The second question is whether the study&#39;s methodological limitations are important&#46; I would like to say they are not&#44; but in fact they are&#44; for the following reasons&#58;<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">a&#41;</span><p id="par0065" class="elsevierStylePara elsevierViewall">The fact that only two of the six devices available nationally are analyzed introduces a selection bias&#44; ignoring around a quarter of the TAVR procedures reported in the Portuguese Registry on Interventional Cardiology &#40;RNCI&#41; run by the Portuguese Association of Cardiovascular Intervention &#40;APIC&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">b&#41;</span><p id="par0070" class="elsevierStylePara elsevierViewall">A cautious estimate would have been preferable to the approach of Fontes-Carvalho et al&#46;&#8217;s study and its three scenarios&#44; since the difference between their projections and the reality is over three-fold&#46; The RNCI recorded 746 TAVR procedures in 2019&#44; in contrast to the 2516 in the meta-analysis by Durko et al&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">17</span></a> and the 2488 in Fontes-Carvalho et al&#46;&#8217;s scenario 2&#46; It is clear that in this country the recommended criteria for TAVR in higher-risk patients aged over 65 years are often not followed&#59; the study by Fontes-Carvalho et al&#46; assumes that in such cases patients undergo surgical aortic valve replacement &#40;SAVR&#41;&#46; The number of individuals treated by SAVR in Portugal is not known&#44; to the shame of all the country&#39;s cardiac surgery departments&#44; but not even the highest estimates could explain the difference of around 1700 cases&#44; which is probably due to patients being neither diagnosed nor referred&#46; Durko et al&#46; include among the limitations of their study the fact that their estimates are based on a model that contains multiple steps&#44; and that it did not consider all local differences in health care systems among individual countries in Europe&#46;<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">9&#44;10&#44;17</span></a></p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">c&#41;</span><p id="par0075" class="elsevierStylePara elsevierViewall">The costs of the artificial valves&#44; which are central to the analysis&#44; were based on figures from a single center in 2017&#44; and are now lower&#46; It should also be noted that estimates of in-hospital costs &#40;human resources and facilities&#41; are complicated by the unreliability of any nationwide analysis&#44; which would be of necessity based on official reports&#44; given the systematic lack of credible analytical data derived from cost-based management&#44; which is commonplace in private practice but practically unheard of in the NHS&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">14</span></a></p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">d&#41;</span><p id="par0080" class="elsevierStylePara elsevierViewall">Finally&#44; the opinions expressed in the article are not shared by those working in this area in other centers&#44; which significantly limits their validity&#44; especially when the authors were unable to include data from even a second hospital&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">18</span></a></p></li></ul></p><p id="par0085" class="elsevierStylePara elsevierViewall">To conclude&#44; this article seemed promising&#44; but has unfortunately become obsolete&#46; Percutaneous aortic valve implantation is now an established technique&#44; due to its clinical benefit and ever-improving patient selection processes&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">The study by Fontes-Carvalho et al&#46; has the merits of originality&#44; of developing credible economic studies in the field of interventional cardiology&#44; and of challenging medical societies to adopt a national strategy&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">If the methodology behind their estimates had been solid&#44; I would still disagree with their proposed concentration of resources&#44; due to the &#8216;iatrogenic&#8217; impact of blocking the expansion of access to TAVR with no guarantee of adding value to what is most important &#8211; clinical outcomes and knowledge of the cost-effectiveness of the technique at national level&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">Even so&#44; I remain an optimist&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0105" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare&#46;</p></span></span>"
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Editorial comment
“A momentary lapse of opinion”: The reader should be aware of the iatrogenic potential of this publication
«Um lapso de opinião momentâneo»: O leitor deve estar consciente do potencial iatrogénico desta publicação
Rui Campante Telesa,b,c
a UNICARV (Unidade de Intervenção Cardiovascular), Hospital de Santa Cruz, CHLO, Carnaxide, Portugal
b CEDOC (Centro de Estudos de Doenças Crónicas), NOVA Medical School, Lisboa, Portugal
c Champion Valve For Life, Portugal
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Aortic stenosis is the most frequent native valve disease in Europe&#44; and as the elderly population increases&#44; together with the high prevalence of comorbidities and the extension of indications to low-risk patients&#44; the number of individuals requiring transcatheter aortic valve replacement &#40;TAVR&#41; is likely to increase substantially&#46;<a class="elsevierStyleCrossRefs" href="#bib0095"><span class="elsevierStyleSup">1&#8211;3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Frailty&#44; dependence and comorbidities affect the lives of some of these patients&#44; raising the question whether the intervention justifies the economic cost&#46; High-quality American and European analyses of TAVR have shown generally acceptable cost-effectiveness&#44; with the higher cost of the procedure being offset by the considerable benefits in quality of life and survival&#46; It is&#44; however&#44; important to examine the specifics at a national level&#44; since large differences have been observed between countries&#46;<a class="elsevierStyleCrossRefs" href="#bib0110"><span class="elsevierStyleSup">4&#8211;8</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The article by Fontes-Carvalho et al&#46; of the Centro Hospitalar de Vila Nova de Gaia in this issue of the <span class="elsevierStyleItalic">Journal</span><a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">9</span></a> points to the need to assess the cost-effectiveness and economic impact of the adoption of new technologies before their dissemination in clinical practice&#46; In this case the time for this objective has passed&#44; which since these authors are well respected I would suggest should be put down to a momentary lapse of opinion&#46; In fact it is now 18 years since the first TAVR procedure was performed&#44; and it was the Gaia Hospital group that introduced it to the Iberian peninsula in 2007&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The article is of interest because it assesses health technology in structural interventional cardiology from a national viewpoint&#46; On the basis of detailed data from 2017 from a single center&#44; it sets out to estimate the potential impact of expanding the indications for TAVR in three hypothetical scenarios&#44; concluding that public expenditure on this treatment is likely to grow considerably&#46; The authors suggest a centralized approach to the management of the required economic and clinical resources&#44; as well as optimization of the procedure itself&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">There are two questions that this study raises in 2020&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The first question is whether economic considerations are paramount for a technique that is considered the first-line treatment for high-risk patients and for which good evidence is emerging for low-risk individuals&#46; The answer is no&#44; for the following reasons&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">a&#41;</span><p id="par0035" class="elsevierStylePara elsevierViewall">Firstly&#44; since 2017&#44; not only has there been an increase of 33&#37; in the number of TAVR procedures&#44; but in line with recommendations there have been improvements in the technique&#44; with simplified protocols for arterial access and sedation&#46; These have led to reductions in costs&#44; complications &#40;stroke&#44; vascular complications&#44; bleeding and valvular regurgitation&#41; and rehospitalizations&#46;<a class="elsevierStyleCrossRefs" href="#bib0115"><span class="elsevierStyleSup">5&#44;10&#8211;12</span></a> As Fontes-Carvalho et al&#46; point out in their article&#44; cost-effectiveness studies such as theirs are most valuable before the technique enters clinical practice&#44; which has already happened&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">b&#41;</span><p id="par0040" class="elsevierStylePara elsevierViewall">Secondly&#44; in Portugal the laboratories and technicians required to perform TAVR are often unavailable&#46; The European Society of Cardiology &#40;ESC&#41; Atlas<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">13</span></a> shows that Portugal is lagging in 23rd and 34th place&#44; respectively&#44; among ESC member countries for these two parameters&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">c&#41;</span><p id="par0045" class="elsevierStylePara elsevierViewall">Thirdly&#44; there is no sound economic justification for centralization of material acquisition&#44; which was proposed without success some years ago in the area of coronary intervention&#46; The empirical data are inconclusive concerning the advantages and disadvantages of the mixed funding model of a fixed budget and diagnostic-related groups used by the Portuguese national health system &#40;NHS&#41;&#44; but this alone does not justify such a change&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">14</span></a> There are no reports of such attempts in other areas of medicine in Portugal&#44; and the studies referred to are from the UK and the American PARTNER trial&#44; which are of doubtful applicability to Portugal&#44; unlike studies on measures to increase the efficiency of hospital protocols&#44; which are reproducible in any center&#46;<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">12&#44;15&#44;16</span></a></p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">d&#41;</span><p id="par0050" class="elsevierStylePara elsevierViewall">Fourthly&#44; times have changed&#44; and it is important to overcome inequalities in regional access to cutting-edge technology&#44; without compromising clinical excellence&#46; In an era of rapidly increasing and improving professional mentoring and interchange&#44; a move toward greater concentration would go against current practice and could hamper the ability of several catheterization laboratories to offer techniques that are becoming simpler and easier&#46; This risks losing one of the main strengths of interventional cardiology&#44; that of universality&#44; the clearest example of which is the coronary fast-track system&#46;</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">e&#41;</span><p id="par0055" class="elsevierStylePara elsevierViewall">Finally&#44; the true value of a theoretical cost-effectiveness analysis would be seen if it were directed at areas that really are emerging&#44; such as coronary lithoplasty&#44; coronary sinus narrowing&#44; or intervention for structural mitral regurgitation&#46;</p></li></ul></p><p id="par0060" class="elsevierStylePara elsevierViewall">The second question is whether the study&#39;s methodological limitations are important&#46; I would like to say they are not&#44; but in fact they are&#44; for the following reasons&#58;<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">a&#41;</span><p id="par0065" class="elsevierStylePara elsevierViewall">The fact that only two of the six devices available nationally are analyzed introduces a selection bias&#44; ignoring around a quarter of the TAVR procedures reported in the Portuguese Registry on Interventional Cardiology &#40;RNCI&#41; run by the Portuguese Association of Cardiovascular Intervention &#40;APIC&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">b&#41;</span><p id="par0070" class="elsevierStylePara elsevierViewall">A cautious estimate would have been preferable to the approach of Fontes-Carvalho et al&#46;&#8217;s study and its three scenarios&#44; since the difference between their projections and the reality is over three-fold&#46; The RNCI recorded 746 TAVR procedures in 2019&#44; in contrast to the 2516 in the meta-analysis by Durko et al&#46;<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">17</span></a> and the 2488 in Fontes-Carvalho et al&#46;&#8217;s scenario 2&#46; It is clear that in this country the recommended criteria for TAVR in higher-risk patients aged over 65 years are often not followed&#59; the study by Fontes-Carvalho et al&#46; assumes that in such cases patients undergo surgical aortic valve replacement &#40;SAVR&#41;&#46; The number of individuals treated by SAVR in Portugal is not known&#44; to the shame of all the country&#39;s cardiac surgery departments&#44; but not even the highest estimates could explain the difference of around 1700 cases&#44; which is probably due to patients being neither diagnosed nor referred&#46; Durko et al&#46; include among the limitations of their study the fact that their estimates are based on a model that contains multiple steps&#44; and that it did not consider all local differences in health care systems among individual countries in Europe&#46;<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">9&#44;10&#44;17</span></a></p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">c&#41;</span><p id="par0075" class="elsevierStylePara elsevierViewall">The costs of the artificial valves&#44; which are central to the analysis&#44; were based on figures from a single center in 2017&#44; and are now lower&#46; It should also be noted that estimates of in-hospital costs &#40;human resources and facilities&#41; are complicated by the unreliability of any nationwide analysis&#44; which would be of necessity based on official reports&#44; given the systematic lack of credible analytical data derived from cost-based management&#44; which is commonplace in private practice but practically unheard of in the NHS&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">14</span></a></p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">d&#41;</span><p id="par0080" class="elsevierStylePara elsevierViewall">Finally&#44; the opinions expressed in the article are not shared by those working in this area in other centers&#44; which significantly limits their validity&#44; especially when the authors were unable to include data from even a second hospital&#46;<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">18</span></a></p></li></ul></p><p id="par0085" class="elsevierStylePara elsevierViewall">To conclude&#44; this article seemed promising&#44; but has unfortunately become obsolete&#46; Percutaneous aortic valve implantation is now an established technique&#44; due to its clinical benefit and ever-improving patient selection processes&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">The study by Fontes-Carvalho et al&#46; has the merits of originality&#44; of developing credible economic studies in the field of interventional cardiology&#44; and of challenging medical societies to adopt a national strategy&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">If the methodology behind their estimates had been solid&#44; I would still disagree with their proposed concentration of resources&#44; due to the &#8216;iatrogenic&#8217; impact of blocking the expansion of access to TAVR with no guarantee of adding value to what is most important &#8211; clinical outcomes and knowledge of the cost-effectiveness of the technique at national level&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">Even so&#44; I remain an optimist&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0105" class="elsevierStylePara elsevierViewall">The author has no conflicts of interest to declare&#46;</p></span></span>"
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ISSN: 08702551
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2021 Julho 21 26 47
2021 Junho 16 23 39
2021 Maio 25 37 62
2021 Abril 27 62 89
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