POSITION PAPERSEuropean Society of Hypertension position paper on renal denervation 2021Schmieder, Roland E.a; Mahfoud, Felixb; Mancia, Giuseppec; Azizi, Michaeld; Böhm, Michaele; Dimitriadis, Kyriakosf; Kario, Kazuomig; Kroon, Abraham A.h; D Lobo, Melvini; Ott, Christiana,j; Pathak, Atulk; Persu, Alexandrel; Scalise, Filippom; Schlaich, Markusn; Kreutz, Reinholdo; Tsioufis, Costasp; on behalf of members of the ESH Working Group on Device-Based Treatment of HypertensionAuthor Information aUniversity Hospital Erlangen, Department of Nephrology and Hypertension, Erlangen bDepartment of Internal Medicine, Universitätsklinikum des Saarlandes, Saarland, University, Homburg/Saar, Germany cUniversity of Milano-Bicocca, Milan, Italy dUniversité de Paris, INSERM, AP-HP, Hypertension Department and DMU CARTE, Hôpital Européen Georges-Pompidou Paris, France eUniversitätsklinikum des Saarlandes, Klinik für Innere Medizin III, Saarland University (Kardiologie, Angiologie und Internistische Intensivmedizin), Homburg/Saar, Germany fNational and Kapodistrian University of Athens, 1st Cardiology Clinic, Hippocratio Hospital, Athens, Greece gDivision of Cardiovascular Medicine, Department of Medicine, Jichi Medical University of Medicine, Tochigi, Japan hDepartment of Internal Medicine, Maastricht University Medical Center & Cardiovascular Research Institute Maastricht (CARIM), Maastricht University, Maastricht, the Netherlands iBarts NIHR Biomedical Research Centre, William Harvey Research Institute, Queen Mary University of London, London, UK jDepartment of Nephrology and Hypertension, Paracelsus Medical University, Nürnberg, Germany kDepartment of Cardiovascular Medicine, Princess Grace Hospital, Monaco and Research Unit Toulouse University, Centre National de la Recherche Scientifique UMR 5288, Toulouse, France lPole of Cardiovascular Research, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, and Division of Cardiology, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium mInterventional Cardiology Department, Heart Center, Policlinico di Monza, Monza, Italy and ESH Excellence Center, Istituto Clinico Verano Brianza, Verano Brianza, Italy nDobney Hypertension Centre, School of Medicine - Royal Perth Hospital Unit, Medical Research Foundation, Faculty of Medicine, Dentistry & Health Sciences, The University of Western Australia, Perth Australia and Departments of Cardiology and Nephrology, Royal Perth Hospital, Perth, Western Australia, Australia oCharité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Clinical Pharmacology and Toxicology, Berlin, Germany pNational and Kapodistrian University of Athens, 1st Cardiology Clinic, Hippocratio Hospital, Athens, Greece Correspondence to Roland E. Schmieder, MD, Head of the Clinical Research Center, Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich Alexander University Erlangen/Nürnberg, Ulmenweg 18, 91054 Erlangen, Germany. Tel: +49 9131 85 39002; fax: +49 9131 85 36215; e-mail: [email protected], [email protected] Abbreviations: BP, blood pressure; eGFR, estimated glomerular filtration rate; GSR, Global Symplicity Registry; RCT, randomized clinical trial; RDN, renal denervation; SNS, sympathetic nervous system Received 6 June, 2021 Accepted 7 June, 2021 Journal of Hypertension: September 2021 - Volume 39 - Issue 9 - p 1733-1741 doi: 10.1097/HJH.0000000000002933 Buy Metrics Abstract This ESH Position Paper 2021 with updated proposed recommendations was deemed necessary after the publication of a set of new pivotal sham-controlled randomized clinical trials (RCTs), which provided important information about the efficacy and safety of endovascular device-based renal denervation (RDN) for hypertension treatment. RDN is effective in reducing or interrupting the sympathetic signals to the kidneys and decreasing whole body sympathetic activity. Five independent, fully completed, sham-controlled RCTs provide conclusive evidence that RDN lowers ambulatory and office blood pressure (BP) to a significantly greater extent than sham treatment. BP-lowering efficacy is evident both in patients with and without concomitant antihypertensive medication. The average decrease of 10 mmHg in office BP is estimated to lower the incidence of cardiovascular events by 25–30%, based on meta-analyses of RCTs using pharmacological treatment. Neither peri-procedural, nor short-term or long-term adverse events or safety signals (available up to 3 years) have been observed. Implementing RDN as an innovative third option in the armamentarium of antihypertensive treatment requires a structured process that ensures the appropriate performance of the endovascular RDN procedure and adequate selection of hypertensive patients. The latter should also incorporate patients’ perspective and preference that needs to be respected in a shared decision-making process. Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.