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Introduction of percutaneous treatment for mitral regurgitation in Portugal
Introdução em Portugal da reparação percutânea da insuficiência mitral
Eduardo Infante de Oliveira
Serviço de Cardiologia, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Instituto de Fisiologia, Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal
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There is thus a clear need for less invasive alternatives. In the last twenty years, various percutaneous devices have been developed, and many concepts and approaches have been tested, including direct and indirect annuloplasty, the NeoChord valve repair device, right ventricular remodeling, leaflet plication, and percutaneous valve replacement. However, to date only one device has progressed beyond the stage of randomized clinical trials<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">4</span></a> and been recommended by regulatory bodies<a class="elsevierStyleCrossRefs" href="#bib0080"><span class="elsevierStyleSup">2,5,6</span></a>: the MitraClip system (Abbott Vascular, Menlo Park, CA, USA). This device reproduces percutaneously the Alfieri surgical technique, in which a double-orifice valve is created by plicating the mid segments of the anterior and posterior leaflets. The MitraClip has a complex delivery mechanism by which, via a transseptal approach, one or more cobalt chromium clips are implanted to bring together the mid segments (A2 and P2 scallops) of the valve leaflets. Over 20 000 MitraClip procedures have been performed worldwide. The EVEREST I and II trials in the USA included a pilot stage to evaluate safety and feasibility, a registry of patients at high surgical risk, and a randomized trial comparing MitraClip therapy with conventional surgery,<a class="elsevierStyleCrossRefs" href="#bib0090"><span class="elsevierStyleSup">4,7–9</span></a> and were followed by the REALISM continued access registry. In October 2013 the US Food and Drug Administration (FDA) approved use of the MitraClip in patients with symptomatic degenerative MR and high surgical risk,<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">5</span></a> while in Europe the device received CE Mark approval in March 2008. Its use has grown exponentially, mostly in patients with functional MR, advanced age and high surgical risk. The ACCESS-EU registry (Phase I and II) included around 1000 interventions.</p><p id="par0010" class="elsevierStylePara elsevierViewall">In the 2012 ESC/EACTS guidelines on the management of valvular heart disease, the MitraClip was given a class IIb recommendation for symptomatic functional or degenerative MR in patients judged inoperable or at high surgical risk.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">2</span></a> The technique has thus, despite its limitations, overcome various hurdles in the evaluation process and has won its place in clinical practice.</p><p id="par0015" class="elsevierStylePara elsevierViewall">In Portugal the first MitraClip procedure took place on January 9, 2013 at Hospital de Santa Maria (<a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>), and others followed at Hospital de Santa Marta and Hospital de Vila Nova de Gaia. This was relatively late compared to other European countries, five years after the device received CE Mark approval and in the same year as its approval by the FDA. Its growth has been slow but steady: in the first half of 2015 around a hundred procedures were performed in the Iberian Peninsula, about 20% of them in Portugal. The results presented by Cacela et al. in this issue of the <span class="elsevierStyleItalic">Journal</span><a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">10</span></a> reflect real-world experience and are comparable to those of large European registries, including the international Transcatheter Valve Treatment Sentinel Pilot Registry<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">11</span></a> and the German TRAMI registry.<a class="elsevierStyleCrossRefs" href="#bib0130"><span class="elsevierStyleSup">12–14</span></a> The three Portuguese centers are expected to participate in the important international RESHAPE-HF 2 trial, confirming the consistent quality of their work in this area. The primary aim of this randomized trial is to assess the impact of the MitraClip on mortality and rehospitalization for heart failure in patients with severe symptomatic functional MR compared to optimal standard of care therapy. It has the potential to bring about profound changes in the treatment of patients with impaired systolic function and secondary MR.</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0020" class="elsevierStylePara elsevierViewall">Percutaneous valvuloplasty to treat MR is now a real solution for carefully selected patients who are considered inoperable or at high surgical risk. It requires allocation of significant resources, including the creation of multidisciplinary teams, but it is the only treatment option for a considerable number of patients. Percutaneous valve replacement may appear a simpler and more widely applicable solution, but it affects the subvalvular apparatus and ventricular geometry, increases the aggressiveness of the procedure and has all the limitations of implanting a biological valve in mitral position. I believe that the future will see the simultaneous development and growth of techniques of percutaneous repair, percutaneous valve replacement and minimally invasive surgery. Such diversity of therapeutic options will widen the range of candidates for treatment, all of which will have a role to play.</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0025" 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 "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Infante de Oliveira E. Introdução em Portugal da reparação percutânea da insuficiência mitral. Rev Port Cardiol. 2015;34:525–527.</p>" ] ] "multimedia" => array:1 [ 0 => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figure 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 711 "Ancho" => 1800 "Tamanyo" => 184178 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">The team responsible for the first MitraClip implantation in Portugal.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:14 [ 0 => array:3 [ "identificador" => "bib0075" "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" => false "autores" => array:1 [ 0 => "B. 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| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 4 | 4 | 8 |
| 2024 October | 30 | 25 | 55 |
| 2024 September | 46 | 24 | 70 |
| 2024 August | 28 | 26 | 54 |
| 2024 July | 34 | 32 | 66 |
| 2024 June | 39 | 26 | 65 |
| 2024 May | 29 | 23 | 52 |
| 2024 April | 32 | 20 | 52 |
| 2024 March | 33 | 31 | 64 |
| 2024 February | 30 | 49 | 79 |
| 2024 January | 24 | 42 | 66 |
| 2023 December | 26 | 23 | 49 |
| 2023 November | 22 | 18 | 40 |
| 2023 October | 27 | 40 | 67 |
| 2023 September | 14 | 21 | 35 |
| 2023 August | 23 | 11 | 34 |
| 2023 July | 26 | 12 | 38 |
| 2023 June | 23 | 10 | 33 |
| 2023 May | 32 | 17 | 49 |
| 2023 April | 14 | 10 | 24 |
| 2023 March | 46 | 23 | 69 |
| 2023 February | 30 | 19 | 49 |
| 2023 January | 25 | 9 | 34 |
| 2022 December | 33 | 28 | 61 |
| 2022 November | 38 | 22 | 60 |
| 2022 October | 26 | 13 | 39 |
| 2022 September | 23 | 34 | 57 |
| 2022 August | 28 | 39 | 67 |
| 2022 July | 27 | 25 | 52 |
| 2022 June | 21 | 23 | 44 |
| 2022 May | 24 | 35 | 59 |
| 2022 April | 20 | 27 | 47 |
| 2022 March | 23 | 26 | 49 |
| 2022 February | 29 | 28 | 57 |
| 2022 January | 23 | 21 | 44 |
| 2021 December | 17 | 29 | 46 |
| 2021 November | 42 | 29 | 71 |
| 2021 October | 34 | 39 | 73 |
| 2021 September | 17 | 33 | 50 |
| 2021 August | 27 | 35 | 62 |
| 2021 July | 27 | 30 | 57 |
| 2021 June | 18 | 18 | 36 |
| 2021 May | 25 | 39 | 64 |
| 2021 April | 49 | 48 | 97 |
| 2021 March | 59 | 12 | 71 |
| 2021 February | 48 | 18 | 66 |
| 2021 January | 26 | 15 | 41 |
| 2020 December | 38 | 14 | 52 |
| 2020 November | 31 | 18 | 49 |
| 2020 October | 25 | 18 | 43 |
| 2020 September | 62 | 14 | 76 |
| 2020 August | 35 | 9 | 44 |
| 2020 July | 58 | 6 | 64 |
| 2020 June | 34 | 7 | 41 |
| 2020 May | 41 | 11 | 52 |
| 2020 April | 32 | 14 | 46 |
| 2020 March | 54 | 10 | 64 |
| 2020 February | 59 | 20 | 79 |
| 2020 January | 38 | 14 | 52 |
| 2019 December | 36 | 2 | 38 |
| 2019 November | 45 | 9 | 54 |
| 2019 October | 44 | 8 | 52 |
| 2019 September | 15 | 10 | 25 |
| 2019 August | 44 | 9 | 53 |
| 2019 July | 48 | 7 | 55 |
| 2019 June | 43 | 17 | 60 |
| 2019 May | 59 | 10 | 69 |
| 2019 April | 36 | 11 | 47 |
| 2019 March | 84 | 7 | 91 |
| 2019 February | 83 | 17 | 100 |
| 2019 January | 83 | 6 | 89 |
| 2018 December | 120 | 15 | 135 |
| 2018 November | 112 | 6 | 118 |
| 2018 October | 256 | 20 | 276 |
| 2018 September | 63 | 10 | 73 |
| 2018 August | 46 | 9 | 55 |
| 2018 July | 33 | 6 | 39 |
| 2018 June | 50 | 8 | 58 |
| 2018 May | 75 | 9 | 84 |
| 2018 April | 59 | 2 | 61 |
| 2018 March | 98 | 11 | 109 |
| 2018 February | 36 | 1 | 37 |
| 2018 January | 49 | 6 | 55 |
| 2017 December | 84 | 14 | 98 |
| 2017 November | 53 | 23 | 76 |
| 2017 October | 38 | 11 | 49 |
| 2017 September | 34 | 13 | 47 |
| 2017 August | 40 | 15 | 55 |
| 2017 July | 25 | 9 | 34 |
| 2017 June | 47 | 20 | 67 |
| 2017 May | 41 | 30 | 71 |
| 2017 April | 36 | 31 | 67 |
| 2017 March | 34 | 20 | 54 |
| 2017 February | 35 | 6 | 41 |
| 2017 January | 53 | 8 | 61 |
| 2016 December | 43 | 18 | 61 |
| 2016 November | 41 | 12 | 53 |
| 2016 October | 37 | 12 | 49 |
| 2016 September | 42 | 12 | 54 |
| 2016 August | 21 | 6 | 27 |
| 2016 July | 18 | 7 | 25 |
| 2016 June | 19 | 5 | 24 |
| 2016 May | 21 | 7 | 28 |
| 2016 April | 25 | 1 | 26 |
| 2016 March | 35 | 16 | 51 |
| 2016 February | 68 | 39 | 107 |
| 2016 January | 41 | 13 | 54 |
| 2015 December | 51 | 21 | 72 |
| 2015 November | 51 | 37 | 88 |
| 2015 October | 127 | 52 | 179 |
| 2015 September | 184 | 92 | 276 |
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