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“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
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AS: aortic stenosis; TAVR: transcatheter aortic valve replacement.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Ricardo Fontes-Carvalho, Cláudio Guerreiro, Eduardo Infante Oliveira, Pedro Braga" "autores" => array:4 [ 0 => array:2 [ "nombre" => "Ricardo" "apellidos" => "Fontes-Carvalho" ] 1 => array:2 [ "nombre" => "Cláudio" "apellidos" => "Guerreiro" ] 2 => array:2 [ "nombre" => "Eduardo Infante" "apellidos" => "Oliveira" ] 3 => array:2 [ "nombre" => "Pedro" "apellidos" => "Braga" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2174204920303172?idApp=UINPBA00004E" "url" => "/21742049/0000003900000009/v1_202012210618/S2174204920303172/v1_202012210618/en/main.assets" ] "en" => array:12 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Editorial comment</span>" "titulo" => "“A momentary lapse of opinion”: The reader should be aware of the iatrogenic potential of this publication" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "489" "paginaFinal" => "491" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "Rui Campante Teles" "autores" => array:1 [ 0 => array:4 [ "nombre" => "Rui Campante" "apellidos" => "Teles" "email" => array:1 [ 0 => "rcteles@outlook.com" ] "referencia" => array:3 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] ] "afiliaciones" => array:3 [ 0 => array:3 [ "entidad" => "UNICARV (Unidade de Intervenção Cardiovascular), Hospital de Santa Cruz, CHLO, Carnaxide, Portugal" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "CEDOC (Centro de Estudos de Doenças Crónicas), NOVA Medical School, Lisboa, Portugal" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Champion Valve For Life, Portugal" "etiqueta" => "c" "identificador" => "aff0015" ] ] ] ] "titulosAlternativos" => array:1 [ "pt" => array:1 [ "titulo" => "«Um lapso de opinião momentâneo»: O leitor deve estar consciente do potencial iatrogénico desta publicação" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Aortic stenosis is the most frequent native valve disease in Europe, and as the elderly population increases, together with the high prevalence of comorbidities and the extension of indications to low-risk patients, the number of individuals requiring transcatheter aortic valve replacement (TAVR) is likely to increase substantially.<a class="elsevierStyleCrossRefs" href="#bib0095"><span class="elsevierStyleSup">1–3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Frailty, dependence and comorbidities affect the lives of some of these patients, raising the question whether the intervention justifies the economic cost. High-quality American and European analyses of TAVR have shown generally acceptable cost-effectiveness, with the higher cost of the procedure being offset by the considerable benefits in quality of life and survival. It is, however, important to examine the specifics at a national level, since large differences have been observed between countries.<a class="elsevierStyleCrossRefs" href="#bib0110"><span class="elsevierStyleSup">4–8</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The article by Fontes-Carvalho et al. 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. In this case the time for this objective has passed, which since these authors are well respected I would suggest should be put down to a momentary lapse of opinion. In fact it is now 18 years since the first TAVR procedure was performed, and it was the Gaia Hospital group that introduced it to the Iberian peninsula in 2007.</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. On the basis of detailed data from 2017 from a single center, it sets out to estimate the potential impact of expanding the indications for TAVR in three hypothetical scenarios, concluding that public expenditure on this treatment is likely to grow considerably. The authors suggest a centralized approach to the management of the required economic and clinical resources, as well as optimization of the procedure itself.</p><p id="par0025" class="elsevierStylePara elsevierViewall">There are two questions that this study raises in 2020.</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. The answer is no, for the following reasons:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">a)</span><p id="par0035" class="elsevierStylePara elsevierViewall">Firstly, since 2017, not only has there been an increase of 33% in the number of TAVR procedures, but in line with recommendations there have been improvements in the technique, with simplified protocols for arterial access and sedation. These have led to reductions in costs, complications (stroke, vascular complications, bleeding and valvular regurgitation) and rehospitalizations.<a class="elsevierStyleCrossRefs" href="#bib0115"><span class="elsevierStyleSup">5,10–12</span></a> As Fontes-Carvalho et al. point out in their article, cost-effectiveness studies such as theirs are most valuable before the technique enters clinical practice, which has already happened.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">b)</span><p id="par0040" class="elsevierStylePara elsevierViewall">Secondly, in Portugal the laboratories and technicians required to perform TAVR are often unavailable. The European Society of Cardiology (ESC) Atlas<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">13</span></a> shows that Portugal is lagging in 23rd and 34th place, respectively, among ESC member countries for these two parameters.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">c)</span><p id="par0045" class="elsevierStylePara elsevierViewall">Thirdly, there is no sound economic justification for centralization of material acquisition, which was proposed without success some years ago in the area of coronary intervention. 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 (NHS), but this alone does not justify such a change.<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, and the studies referred to are from the UK and the American PARTNER trial, which are of doubtful applicability to Portugal, unlike studies on measures to increase the efficiency of hospital protocols, which are reproducible in any center.<a class="elsevierStyleCrossRefs" href="#bib0150"><span class="elsevierStyleSup">12,15,16</span></a></p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">d)</span><p id="par0050" class="elsevierStylePara elsevierViewall">Fourthly, times have changed, and it is important to overcome inequalities in regional access to cutting-edge technology, without compromising clinical excellence. In an era of rapidly increasing and improving professional mentoring and interchange, 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. This risks losing one of the main strengths of interventional cardiology, that of universality, the clearest example of which is the coronary fast-track system.</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">e)</span><p id="par0055" class="elsevierStylePara elsevierViewall">Finally, the true value of a theoretical cost-effectiveness analysis would be seen if it were directed at areas that really are emerging, such as coronary lithoplasty, coronary sinus narrowing, or intervention for structural mitral regurgitation.</p></li></ul></p><p id="par0060" class="elsevierStylePara elsevierViewall">The second question is whether the study's methodological limitations are important. I would like to say they are not, but in fact they are, for the following reasons:<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">a)</span><p id="par0065" class="elsevierStylePara elsevierViewall">The fact that only two of the six devices available nationally are analyzed introduces a selection bias, ignoring around a quarter of the TAVR procedures reported in the Portuguese Registry on Interventional Cardiology (RNCI) run by the Portuguese Association of Cardiovascular Intervention (APIC).</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">b)</span><p id="par0070" class="elsevierStylePara elsevierViewall">A cautious estimate would have been preferable to the approach of Fontes-Carvalho et al.’s study and its three scenarios, since the difference between their projections and the reality is over three-fold. The RNCI recorded 746 TAVR procedures in 2019, in contrast to the 2516 in the meta-analysis by Durko et al.<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">17</span></a> and the 2488 in Fontes-Carvalho et al.’s scenario 2. It is clear that in this country the recommended criteria for TAVR in higher-risk patients aged over 65 years are often not followed; the study by Fontes-Carvalho et al. assumes that in such cases patients undergo surgical aortic valve replacement (SAVR). The number of individuals treated by SAVR in Portugal is not known, to the shame of all the country's cardiac surgery departments, but not even the highest estimates could explain the difference of around 1700 cases, which is probably due to patients being neither diagnosed nor referred. Durko et al. include among the limitations of their study the fact that their estimates are based on a model that contains multiple steps, and that it did not consider all local differences in health care systems among individual countries in Europe.<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">9,10,17</span></a></p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">c)</span><p id="par0075" class="elsevierStylePara elsevierViewall">The costs of the artificial valves, which are central to the analysis, were based on figures from a single center in 2017, and are now lower. It should also be noted that estimates of in-hospital costs (human resources and facilities) are complicated by the unreliability of any nationwide analysis, which would be of necessity based on official reports, given the systematic lack of credible analytical data derived from cost-based management, which is commonplace in private practice but practically unheard of in the NHS.<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">14</span></a></p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">d)</span><p id="par0080" class="elsevierStylePara elsevierViewall">Finally, the opinions expressed in the article are not shared by those working in this area in other centers, which significantly limits their validity, especially when the authors were unable to include data from even a second hospital.<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">18</span></a></p></li></ul></p><p id="par0085" class="elsevierStylePara elsevierViewall">To conclude, this article seemed promising, but has unfortunately become obsolete. Percutaneous aortic valve implantation is now an established technique, due to its clinical benefit and ever-improving patient selection processes.</p><p id="par0090" class="elsevierStylePara elsevierViewall">The study by Fontes-Carvalho et al. has the merits of originality, of developing credible economic studies in the field of interventional cardiology, and of challenging medical societies to adopt a national strategy.</p><p id="par0095" class="elsevierStylePara elsevierViewall">If the methodology behind their estimates had been solid, I would still disagree with their proposed concentration of resources, due to the ‘iatrogenic’ impact of blocking the expansion of access to TAVR with no guarantee of adding value to what is most important – clinical outcomes and knowledge of the cost-effectiveness of the technique at national level.</p><p id="par0100" class="elsevierStylePara elsevierViewall">Even so, I remain an optimist.</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.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:2 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Conflicts of interest" ] 1 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:18 [ 0 => array:3 [ "identificador" => "bib0095" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on valvular heart disease" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:3 [ 0 => "B. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 3 | 1 | 4 |
| 2024 October | 41 | 32 | 73 |
| 2024 September | 38 | 17 | 55 |
| 2024 August | 39 | 35 | 74 |
| 2024 July | 28 | 29 | 57 |
| 2024 June | 22 | 23 | 45 |
| 2024 May | 26 | 15 | 41 |
| 2024 April | 20 | 28 | 48 |
| 2024 March | 31 | 18 | 49 |
| 2024 February | 22 | 23 | 45 |
| 2024 January | 21 | 25 | 46 |
| 2023 December | 23 | 25 | 48 |
| 2023 November | 28 | 32 | 60 |
| 2023 October | 14 | 16 | 30 |
| 2023 September | 20 | 26 | 46 |
| 2023 August | 23 | 15 | 38 |
| 2023 July | 15 | 9 | 24 |
| 2023 June | 24 | 17 | 41 |
| 2023 May | 33 | 31 | 64 |
| 2023 April | 20 | 3 | 23 |
| 2023 March | 36 | 24 | 60 |
| 2023 February | 24 | 19 | 43 |
| 2023 January | 17 | 24 | 41 |
| 2022 December | 42 | 30 | 72 |
| 2022 November | 33 | 35 | 68 |
| 2022 October | 19 | 25 | 44 |
| 2022 September | 18 | 35 | 53 |
| 2022 August | 18 | 22 | 40 |
| 2022 July | 19 | 34 | 53 |
| 2022 June | 22 | 29 | 51 |
| 2022 May | 19 | 24 | 43 |
| 2022 April | 20 | 34 | 54 |
| 2022 March | 19 | 37 | 56 |
| 2022 February | 23 | 35 | 58 |
| 2022 January | 22 | 27 | 49 |
| 2021 December | 17 | 29 | 46 |
| 2021 November | 18 | 37 | 55 |
| 2021 October | 24 | 36 | 60 |
| 2021 September | 14 | 24 | 38 |
| 2021 August | 13 | 24 | 37 |
| 2021 July | 14 | 25 | 39 |
| 2021 June | 17 | 18 | 35 |
| 2021 May | 18 | 39 | 57 |
| 2021 April | 74 | 70 | 144 |
| 2021 March | 35 | 18 | 53 |
| 2021 February | 32 | 16 | 48 |
| 2021 January | 35 | 16 | 51 |
| 2020 December | 15 | 8 | 23 |
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