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"documento" => "simple-article" "crossmark" => 1 "subdocumento" => "crp" "cita" => "Med Clin. 2021;157:530-4" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Brief report</span>" "titulo" => "Effectiveness of the EQ-5D and CRES-4 questionnaire for assessing the impact on the quality of life of patients and the level of satisfaction after exchanging dicumarinics for edoxabán: Real-life experience based on a multicentre study" "tienePdf" => "en" "tieneTextoCompleto" => "en" "tieneResumen" => array:2 [ 0 => "en" 1 => "es" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "530" "paginaFinal" => "534" ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Utilidad del cuestionario EQ-5D y CRES-4 para la valoración de la calidad de vida y grado de satisfacción tras el cambio de dicumarínicos por edoxabán: experiencia vida real de un estudio multicéntrico" ] ] "contieneResumen" => array:2 [ "en" => true "es" => true ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1617 "Ancho" => 2083 "Tamanyo" => 126850 ] ] "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at0010" "detalle" => "Fig. " "rol" => "short" ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">On the left, a bar chart with questions 3 and 4 of the CRES-4 questionnaire before (“general emotional state when treatment started”) and after starting edoxaban (“general emotional state at this time”), carried out between 3 and 6 months. 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"apellidos" => "Guerrero-Márquez" ] 1 => array:2 [ "nombre" => "Ignacio" "apellidos" => "Sainz-Hidalgo" ] 2 => array:2 [ "nombre" => "Pablo" "apellidos" => "Cristobo Sainz" ] 3 => array:2 [ "nombre" => "Inmaculada" "apellidos" => "Sigler Vilches" ] 4 => array:2 [ "nombre" => "Alberto" "apellidos" => "Avilés Toscano" ] 5 => array:2 [ "nombre" => "Basilio" "apellidos" => "Soto-Espinosa de los Monteros" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S0025775320306497" "doi" => "10.1016/j.medcli.2020.07.032" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0025775320306497?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2387020621005921?idApp=UINPBA00004N" "url" => "/23870206/0000015700000011/v1_202112030828/S2387020621005921/v1_202112030828/en/main.assets" ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Editorial article</span>" "titulo" => "Transcatheter valve implantation in 2021: A reality whose limits we still do not know" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "535" "paginaFinal" => "536" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Pedro Luis Cepas-Guillén, Manel Sabate" "autores" => array:2 [ 0 => array:2 [ "nombre" => "Pedro Luis" "apellidos" => "Cepas-Guillén" ] 1 => array:4 [ "nombre" => "Manel" "apellidos" => "Sabate" "email" => array:1 [ 0 => "masabate@clinic.cat" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Sección de Hemodinámica Cardíaca, Instituto Clínic Cardiovascular (ICCV), Hospital Clínic, IDIBAPS, Universitat de Barcelona, Barcelona, Spain" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Los implantes valvulares transcatéter en el 2021: una realidad cuyos límites aún desconocemos" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Within medicine, and more specifically in the field of cardiology, there is a growing interest in valvular disease due to the changes that have occurred in the last 60 years both in its presentation and, above all, in its treatment. In recent decades we have witnessed a progressive shift from the prevalence of valvular disease of rheumatic aetiology to that of degenerative origin.<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> In this paradigm shift, the aging of the population plays a particularly important role. The world is experiencing a sustained and unprecedented change in its population pyramid, driven by increased life expectancy and declining fertility levels. It is a story of human success that reflects the advancement of medicine in terms of public health, disease control and a reduction of the risk of premature death, as well as economic and social development.<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> This increase in life expectancy has resulted in a tremendous growth in the number of older people in the total population. This fact will affect the incidence of valvular heart disease, which will increase in parallel with the aging of the population. Among valvular heart disease, aortic stenosis (AS) is the most common among patients referred for treatment in industrialized countries, with a prevalence of 2-4% in those over 75 years of age, reaching up to 15% in patients over 80 years of age.<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> Therefore, although the development of the transcatheter valve implantation for the mitral and tricuspid valves has gained popularity in recent years, its use is still residual compared to the transcatheter aortic valve implantation (TAVI).</p><p id="par0010" class="elsevierStylePara elsevierViewall">The natural history of patients with severe AS is widely known, and it can be divided into two phases according to the presence or absence of symptoms. Patients with severe AS may remain asymptomatic for months, with the development of symptoms assuming a turning point in the prognosis of the disease. The occurrence of symptoms related to AS, mainly the classic triad of angina, dyspnoea and syncope, determines a clear increase in mortality: as soon as symptoms occur, the prognosis for severe AS is bleak.<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> Surgical aortic valve replacement (AVR) was the only effective treatment for AS. This has led to a high percentage of patients with severe AS being rejected for AVR because the risks involved in this surgical intervention outweigh its possible benefits. TAVI implantation, with its minimally invasive approach, has radically changed the management of severe symptomatic AS in the last decade.</p><p id="par0015" class="elsevierStylePara elsevierViewall">The first TAVI implantation procedure was performed on 16<span class="elsevierStyleSup">th</span> April 2002 by the interventional cardiologist, Professor Alain Cribier at the Charles Nicolle University Hospital in Ruan (France).<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> It was performed in a 57-year-old male in <span class="elsevierStyleItalic">cardiogenic shock</span>, with multiple comorbidities (previous lung cancer, chronic pancreatitis and peripheral vascular disease with <span class="elsevierStyleItalic">aortofemoral bypass</span>, with very severe ventricular dysfunction (LVEF 12%) and who had previously been rejected by three cardiac surgery teams. The procedure was successful and, since then, TAVI implantation has not stopped reaching new heights and overcoming new challenges. Initially presented as a «rescue» therapy for inoperable patients with severe AS, as demonstrated by the first procedure performed, TAVI is currently a viable option for high and intermediate risk patients,<a class="elsevierStyleCrossRefs" href="#bib0030"><span class="elsevierStyleSup">6,7</span></a> which broadens the spectrum of patients with severe AS eligible for treatment and moves away from the poor results associated with standard treatment (related to a 5-year mortality of almost 93%).<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a> On the other hand, the results of the recently published PARTNER 3 studies,<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a> which demonstrated the superiority of TAVI over AVR at one year of follow-up with respect to the composite primary outcome of mortality, stroke, and rehospitalization (8.5 vs. 15.1%, p = 0.001), and <span class="elsevierStyleItalic">Evolut Low Risk</span>,<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a> which showed the non-inferiority of TAVI versus AVR in the composite primary outcome at two years of mortality or disabling stroke (5.3 vs. 6.7%), could lead in the near future to an expansion of TAVI in low-risk patients.</p><p id="par0020" class="elsevierStylePara elsevierViewall">Two decades after the first TAVI implantation procedure, there are still two issues to be resolved regarding TAVI: the long-term durability of the implanted prostheses and the optimisation of patient selection to avoid procedure futility. Knowledge of durability needs to be expanded in order to extend the indication for TAVI implantation to patients at low surgical risk. The eight-year results of the NOTION<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a> study, which randomised patients with severe AS and low surgical risk to TAVI versus AVR, have recently been published. This is the first study to show a long-term follow-up comparing both therapeutic options, finding no significant differences in the risk of mortality from all causes, stroke or myocardial infarction, or prosthetic cardiac valve dysfunction after eight years of follow-up. Although the results of this study are promising, further studies are needed to expand the current evidence for definitive conclusions and to assess the impact of the need for permanent pacemaker implantation and the presence of residual periprosthetic insufficiency, two complications associated with the procedure whose incidence is common.</p><p id="par0025" class="elsevierStylePara elsevierViewall">On the other hand, the ageing of the population and the development of new health technologies are two of the main factors which significantly contribute to the increase in health expenditure.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a> Considering the economic implications of the TAVI procedure, it should be a priority to identify those patients in whom TAVI implantation is likely to be a futile procedure. The latest <span class="elsevierStyleItalic">American Heart Association</span> clinical practice guidelines on the management of valve disease recommend TAVI as the first option ahead of cardiac surgery in patients over 80 years of age.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a> At present, there is a large number of very elderly patients with severe symptomatic AS who are considered for TAVI implantation. In these cases, the main question to be answered is whether to perform TAVI implantation or to opt for conservative management, which in the case of AS would be palliative. Following the previously mentioned clinical practice guidelines, TAVI is not recommended in patients with 1) a life expectancy < 1 year (even with a successful procedure); or 2) those with a probability of “survival with benefit” of < 25% after two years. If we transfer these two premises to very elderly patients with severe symptomatic AS, the decision on whether or not to carry out the procedure is even more complex. Therefore, the decision on whether to perform the procedure needs to be made in a consensual manner between multidisciplinary teams that are not only composed of cardiologists (clinical, interventional and imaging) and cardiac surgeons, but also involve other specialists such as internal medicine, geriatrics and rehabilitation who can provide a comprehensive approach to the patient in order to improve patient selection. Thus, the final choice of TAVI versus palliative care is based on a shared decision-making process that takes into account the patient's values and preferences and includes discussion of the indications, risks and benefits for and against each of the therapeutic options.</p><p id="par0030" class="elsevierStylePara elsevierViewall">Once TAVI implantation has been established as a gold standard transcatheter valve therapy, the next step will be to achieve its results in mitral, tricuspid and pulmonary valve disease. This will be far from simple, as there are various “difficulties”, mainly anatomical, which prevent its rapid implementation as a gold standard technique.<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a> Firstly, the anatomy of the mitral and tricuspid valve, with a dynamic structure within the cardiac cycle and the absence of a calcified or rigid annulus that is present in aortic stenosis, makes prosthesis anchoring difficult. On the other hand, interference with adjacent structures, particularly the left ventricular outflow tract, requires a detailed and complex planning of the procedure. Despite this, there is more and more evidence in favour of its use in patients who are not candidates for surgery, such as elderly patients with multiple comorbidities, who benefit from transcatheter mitral or tricuspid valve implantation,<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a> or patients with congenital heart disease corrected in childhood with prosthetic dysfunction (pulmonary prosthetic dysfunction in patients with tetralogy of Fallot), in whom transcatheter valve implantation in the pulmonary position has shown excellent results.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">In 2021, transcatheter valve implantation is a reality in the treatment of AS and it seems inevitable that, due to its minimally invasive approach, it will spread to the rest of valvular heart diseases in the coming years. Its development has made it possible to increase survival and, above all, to add “life to years” by reducing the symptoms of many patients who were previously rejected for surgery, with no alternative but palliative care. Close collaboration between different specialties is essential in order to improve patient selection and, therefore, the efficacy of the procedure.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Funding</span><p id="par0040" class="elsevierStylePara elsevierViewall">This article has not received any type of funding.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflict of interests</span><p id="par0045" class="elsevierStylePara elsevierViewall">The authors declare no conflict of interest.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Funding" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Conflict of interests" ] 2 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Cepas-Guillén PL, Sabate M. Los implantes valvulares transcatéter en el 2021: una realidad cuyos límites aún desconocemos. Med Clin (Barc). 2021;157:535–536.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:15 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Worldwide perspective of valve disease" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "J. Soler-Soler" 1 => "E. 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Journal Information
Vol. 157. Issue 11.
Pages 535-536 (December 2021)
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Vol. 157. Issue 11.
Pages 535-536 (December 2021)
Editorial article
Transcatheter valve implantation in 2021: A reality whose limits we still do not know
Los implantes valvulares transcatéter en el 2021: una realidad cuyos límites aún desconocemos
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Pedro Luis Cepas-Guillén, Manel Sabate
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Sección de Hemodinámica Cardíaca, Instituto Clínic Cardiovascular (ICCV), Hospital Clínic, IDIBAPS, Universitat de Barcelona, Barcelona, Spain
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