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"tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "205" "paginaFinal" => "206" ] ] "autores" => array:1 [ 0 => array:3 [ "autoresLista" => "Eduardo Infante de Oliveira" "autores" => array:1 [ 0 => array:3 [ "nombre" => "Eduardo" "apellidos" => "Infante de Oliveira" "email" => array:1 [ 0 => "E.infante.de.oliveira@gmail.com" ] ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Serviço de Cardiologia, Hospital de Santa Maria, Faculdade de Medicina, Universidade de Lisboa, Lisboa, Portugal" "identificador" => "aff0005" ] ] ] ] "titulosAlternativos" => array:1 [ "pt" => array:1 [ "titulo" => "Desnervação simpática renal – fenómeno ou númeno?" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Among percutaneous techniques, renal sympathetic denervation has probably generated the greatest expectations in recent years. The possibility of non-pharmacological treatment of hypertension has aroused interest not only in the medical and scientific community but also in the non-specialist media and the general population. Pilot studies<a class="elsevierStyleCrossRefs" href="#bib0005"><span class="elsevierStyleSup">1,2</span></a> reported results that many considered too good to be true, but despite this skepticism, they were also too good to be ignored, given the large scale of this health problem.<a class="elsevierStyleCrossRefs" href="#bib0015"><span class="elsevierStyleSup">3,4</span></a> The technique is commercially available in many countries and has been applied primarily in patients with resistant hypertension. It is estimated that, two years after the publication of the Symplicity HTN-2 study, over 5000 patients have been treated. The initial experience of centers using the technique has been similar to that reported in the pilot studies,<a class="elsevierStyleCrossRefs" href="#bib0025"><span class="elsevierStyleSup">5,6</span></a> although with a higher but still acceptable rate of non-responders. Registries have been established whose preliminary results have gone some way to validating the method.<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">7–9</span></a> Another important development has been the widening of selection criteria to include less severe forms of hypertension, which is contrary to the recommendations of medical societies.<a class="elsevierStyleCrossRefs" href="#bib0050"><span class="elsevierStyleSup">10–14</span></a> Nevertheless, even here the results have been favorable in terms of safety and hemodynamic benefits.<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a> Other benefits have also been reported,<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> including improvements in glucose metabolism and diabetic status, left ventricular mass index and diastolic function, reduced recurrence of atrial fibrillation following pulmonary vein isolation, and control of ventricular arrhythmias refractory to medical therapy. Other conditions that are characterized by hyperactivation of the sympathetic nervous or renin–angiotensin–aldosterone systems, such as heart failure, have been suggested as therapeutic targets and clinical trials have begun.<a class="elsevierStyleCrossRef" href="#bib0080"><span class="elsevierStyleSup">16</span></a> Many companies have joined the ‘gold rush’ and developed renal denervation systems using radiofrequency, ultrasound, cryoablation or neurotoxins.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a> Many other systems have appeared on the European market and pilot studies report similar results to the original model.<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">17</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Interest in the technique grew exponentially until January 9, 2014, when the announcement<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">18</span></a> that the Symplicity HTN-3 study had failed to meet the primary efficacy endpoint curbed this enthusiasm. Although details are still awaited, many clinical trials have been suspended (HTN-Japan, HTN-India and Symplicity HTN-4 in the US), as has the activity of many centers. The Symplicity HTN-3 trial<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a> was designed to meet the requirements of the US Food and Drug Administration for possible approval. The differences between this and previous Symplicity HTN studies included the larger sample size (530 patients), use of ambulatory blood pressure monitoring in patient selection, and a sham procedure in a control group, blinded to the patients and investigators responsible for blood pressure measurement.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">19</span></a> The primary efficacy endpoint was whether renal sympathetic denervation reduced office systolic blood pressure at six months, but it did not, which in the absence of additional data has led to much speculation. An important aspect of the trial was the fact that blinding was ended at six months, with control group patients being offered the procedure. This invalidates any comparison between the groups in a longer follow-up, which may well be necessary for the placebo effect to wear off. Previous studies suggest that the placebo effect may help control stage 1 and 2 hypertension for 12 months in a third of patients, with a similar adverse effect rate to active treatment.<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a> The rate of major blood pressure elevation is higher, but this occurred after more than 12 months in over 50% of cases.<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">20</span></a> Thus, the placebo effect appears to lose its therapeutic effect over time and a high crossover rate in the Symplicity HTN-3 trial may compromise any analysis. The insignificant difference between blood pressure at baseline and at six months in the group undergoing renal denervation is a more serious concern for the future of the technique. It also calls into question the results not only of the previous Symplicity trials but also of the Global Symplicity Registry, pilot studies using other systems, and single-center registries and experiences like the one by Dores et al. published in this issue of the <span class="elsevierStyleItalic">Journal</span>.<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">21</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">What lies behind the conflicting results? In Kant's philosophy, phenomena represent the world as we perceive it, as distinguished from noumena or things-in-themselves, the world that exists independently of our experience. How important are the patient's perception, the investigator's bias and the procedure itself? Is renal sympathetic denervation and associated blood pressure reduction phenomenon or noumenon?</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Conflicts of interest</span><p id="par0020" 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. Desnervação simpática renal – fenómeno ou númeno? 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2023 July | 26 | 15 | 41 |
2023 June | 45 | 12 | 57 |
2023 May | 40 | 21 | 61 |
2023 April | 10 | 2 | 12 |
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2022 April | 32 | 19 | 51 |
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2021 August | 26 | 33 | 59 |
2021 July | 16 | 26 | 42 |
2021 June | 18 | 25 | 43 |
2021 May | 23 | 42 | 65 |
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2021 March | 52 | 21 | 73 |
2021 February | 59 | 9 | 68 |
2021 January | 25 | 12 | 37 |
2020 December | 32 | 10 | 42 |
2020 November | 34 | 22 | 56 |
2020 October | 16 | 5 | 21 |
2020 September | 40 | 7 | 47 |
2020 August | 15 | 16 | 31 |
2020 July | 40 | 7 | 47 |
2020 June | 43 | 2 | 45 |
2020 May | 31 | 7 | 38 |
2020 April | 34 | 9 | 43 |
2020 March | 36 | 12 | 48 |
2020 February | 59 | 38 | 97 |
2020 January | 33 | 4 | 37 |
2019 December | 42 | 5 | 47 |
2019 November | 25 | 4 | 29 |
2019 October | 16 | 4 | 20 |
2019 September | 23 | 10 | 33 |
2019 August | 29 | 4 | 33 |
2019 July | 41 | 13 | 54 |
2019 June | 26 | 9 | 35 |
2019 May | 43 | 10 | 53 |
2019 April | 15 | 11 | 26 |
2019 March | 130 | 10 | 140 |
2019 February | 103 | 11 | 114 |
2019 January | 94 | 12 | 106 |
2018 December | 111 | 10 | 121 |
2018 November | 102 | 16 | 118 |
2018 October | 223 | 18 | 241 |
2018 September | 59 | 17 | 76 |
2018 August | 39 | 8 | 47 |
2018 July | 18 | 3 | 21 |
2018 June | 37 | 7 | 44 |
2018 May | 45 | 14 | 59 |
2018 April | 62 | 5 | 67 |
2018 March | 58 | 5 | 63 |
2018 February | 28 | 5 | 33 |
2018 January | 59 | 13 | 72 |
2017 December | 95 | 6 | 101 |
2017 November | 46 | 15 | 61 |
2017 October | 38 | 16 | 54 |
2017 September | 35 | 8 | 43 |
2017 August | 46 | 15 | 61 |
2017 July | 49 | 9 | 58 |
2017 June | 61 | 8 | 69 |
2017 May | 52 | 13 | 65 |
2017 April | 22 | 6 | 28 |
2017 March | 34 | 19 | 53 |
2017 February | 42 | 7 | 49 |
2017 January | 25 | 1 | 26 |
2016 December | 23 | 10 | 33 |
2016 November | 16 | 3 | 19 |
2016 October | 28 | 7 | 35 |
2016 September | 18 | 5 | 23 |
2016 August | 2 | 2 | 4 |
2016 July | 7 | 2 | 9 |
2016 June | 4 | 1 | 5 |
2016 May | 9 | 5 | 14 |
2016 April | 21 | 1 | 22 |
2016 March | 32 | 13 | 45 |
2016 February | 54 | 21 | 75 |
2016 January | 40 | 7 | 47 |
2015 December | 40 | 9 | 49 |
2015 November | 35 | 9 | 44 |
2015 October | 50 | 12 | 62 |
2015 September | 41 | 9 | 50 |
2015 August | 37 | 12 | 49 |
2015 July | 27 | 11 | 38 |
2015 June | 26 | 4 | 30 |
2015 May | 37 | 7 | 44 |
2015 April | 32 | 12 | 44 |
2015 March | 29 | 8 | 37 |
2015 February | 26 | 5 | 31 |
2015 January | 28 | 4 | 32 |
2014 December | 50 | 8 | 58 |
2014 November | 26 | 11 | 37 |
2014 October | 45 | 9 | 54 |
2014 September | 51 | 15 | 66 |
2014 August | 34 | 16 | 50 |
2014 July | 56 | 21 | 77 |
2014 June | 94 | 47 | 141 |