Felix Mahfoud1, Giuseppe Mancia2, Roland Schmieder3, Krzysztof Narkiewicz4, Luis Ruilope5, Markus Schlaich6, Robert Whitbourn7, Andreas Zirlik8, Thomas Zeller9, Philipp Stawowy10, Sidney A Cohen11, Martin Fahy12, Michael Böhm13. 1. Department of Internal Medicine, Saarland University Hospital, Homburg/Saar, Germany. Electronic address: Felix.Mahfoud@uks.eu. 2. University of Milano-Bicocca and Policlinico di Monza, Monza, Italy. 3. Department of Nephrology and Hypertension, University Hospital Erlangen, Erlangen, Germany. 4. Department of Hypertension and Diabetology, Medical University of Gdansk, Gdansk, Poland. 5. Department of Cardiovascular Risk, Hospital Universitario 12 de Octubre and CIBERCV and School of Doctoral Studies and Research, Universidad Europea de Madrid, Madrid, Spain. 6. Department of Medicine, Dobney Hypertension Centre, School of Medicine-Royal Perth Hospital Unit, The University of Western Australia, Perth, Western Australia, Australia. 7. Department of Cardiology, Saint Vincent's Hospital, Melbourne, Victoria, Australia. 8. Department of Cardiology, Medizinische Universität Graz, Graz, Austria. 9. Department of Angiology, Universitäts-Herzzentrum Freiburg, Bad Krozingen, Germany. 10. Department of Cardiology, Deutsches Herzzentrum Berlin, Berlin, Germany. 11. Coronary and Structural Heart Division, Medtronic PLC, Santa Rosa, California; Department of Cardiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. 12. Coronary and Structural Heart Division, Medtronic PLC, Santa Rosa, California. 13. Department of Internal Medicine, Saarland University Hospital, Homburg/Saar, Germany.
Abstract
BACKGROUND: Renal denervation (RDN) is under investigation for treatment of uncontrolled hypertension and might represent an attractive treatment for patients with high cardiovascular (CV) risk. It is important to determine whether baseline CV risk affects the efficacy of RDN. OBJECTIVES: The purpose of this study was to assess blood pressure (BP) reduction and event rates after RDN in patients with various comorbidities, testing the hypothesis that RDN is effective and durable in these high-risk populations. METHODS: BP reduction and adverse events over 3 years were evaluated for several high-risk subgroups in the GSR (Global proSpective registrY for syMPathetic renaL denervatIon in seleCted IndicatIons Through 3 Years Registry), an international registry of RDN in patients with uncontrolled hypertension (n = 2,652). Comparisons were made for patients age ≥65 years versus age <65 years, with versus without isolated systolic hypertension, with versus without atrial fibrillation, and with versus without diabetes mellitus. Baseline cardiovascular risk was estimated using the American Heart Association (AHA)/American College of Cardiology (ACC) atherosclerosis cardiovascular disease (ASCVD) risk score. RESULTS: Reduction in 24-h systolic BP at 3 years was -8.9 ± 20.1 mm Hg for the overall cohort, and for high-risk subgroups, BP reduction was -10.4 ± 21.0 mm Hg for resistant hypertension, -8.7 ± 17.4 mm Hg in patients age ≥65 years, -10.2 ± 17.9 mm Hg in patients with diabetes, -8.6 ± 18.7 mm Hg in isolated systolic hypertension, -10.1 ± 20.3 mm Hg in chronic kidney disease, and -10.0 ± 19.1 mm Hg in atrial fibrillation (p < 0.0001 compared with baseline for all). BP reduction in patients with measurements at 6, 12, 24, and 36 months showed similar reductions in office and 24-h BP for patients with varying baseline ASCVD risk scores, which was sustained to 3 years. Adverse event rates at 3 years were higher for patients with higher baseline CV risk. CONCLUSIONS: BP reduction after RDN was similar for patients with varying high-risk comorbidities and across the range of ASCVD risk scores. The impact of baseline risk on clinical event reduction by RDN-induced BP changes could be evaluated in further studies. (Global proSpective registrY for syMPathetic renaL denervatIon in seleCted IndicatIons Through 3 Years Registry; NCT01534299).
BACKGROUND: Renal denervation (RDN) is under investigation for treatment of uncontrolled hypertension and might represent an attractive treatment for patients with high cardiovascular (CV) risk. It is important to determine whether baseline CV risk affects the efficacy of RDN. OBJECTIVES: The purpose of this study was to assess blood pressure (BP) reduction and event rates after RDN in patients with various comorbidities, testing the hypothesis that RDN is effective and durable in these high-risk populations. METHODS: BP reduction and adverse events over 3 years were evaluated for several high-risk subgroups in the GSR (Global proSpective registrY for syMPathetic renaL denervatIon in seleCted IndicatIons Through 3 Years Registry), an international registry of RDN in patients with uncontrolled hypertension (n = 2,652). Comparisons were made for patients age ≥65 years versus age <65 years, with versus without isolated systolic hypertension, with versus without atrial fibrillation, and with versus without diabetes mellitus. Baseline cardiovascular risk was estimated using the American Heart Association (AHA)/American College of Cardiology (ACC) atherosclerosis cardiovascular disease (ASCVD) risk score. RESULTS: Reduction in 24-h systolic BP at 3 years was -8.9 ± 20.1 mm Hg for the overall cohort, and for high-risk subgroups, BP reduction was -10.4 ± 21.0 mm Hg for resistant hypertension, -8.7 ± 17.4 mm Hg in patients age ≥65 years, -10.2 ± 17.9 mm Hg in patients with diabetes, -8.6 ± 18.7 mm Hg in isolated systolic hypertension, -10.1 ± 20.3 mm Hg in chronic kidney disease, and -10.0 ± 19.1 mm Hg in atrial fibrillation (p < 0.0001 compared with baseline for all). BP reduction in patients with measurements at 6, 12, 24, and 36 months showed similar reductions in office and 24-h BP for patients with varying baseline ASCVD risk scores, which was sustained to 3 years. Adverse event rates at 3 years were higher for patients with higher baseline CV risk. CONCLUSIONS: BP reduction after RDN was similar for patients with varying high-risk comorbidities and across the range of ASCVD risk scores. The impact of baseline risk on clinical event reduction by RDN-induced BP changes could be evaluated in further studies. (Global proSpective registrY for syMPathetic renaL denervatIon in seleCted IndicatIons Through 3 Years Registry; NCT01534299).
Authors: Anna Pisano; Luigi Francesco Iannone; Antonio Leo; Emilio Russo; Giuseppe Coppolino; Davide Bolignano Journal: Cochrane Database Syst Rev Date: 2021-11-22
Authors: Karl Fengler; Paul Reimann; Karl-Philipp Rommel; Karl-Patrik Kresoja; Stephan Blazek; Matthias Unterhuber; Christian Besler; Maximilian von Roeder; Michael Böhm; Steffen Desch; Holger Thiele; Philipp Lurz Journal: J Am Heart Assoc Date: 2021-10-29 Impact factor: 5.501
Authors: David E Kandzari; Felix Mahfoud; Michael A Weber; Raymond Townsend; Gianfranco Parati; Naomi D L Fisher; Melvin D Lobo; Michael Bloch; Michael Böhm; Andrew S P Sharp; Roland E Schmieder; Michel Azizi; Markus P Schlaich; Vasilios Papademetriou; Ajay J Kirtane; Joost Daemen; Atul Pathak; Christian Ukena; Philipp Lurz; Guido Grassi; Martin Myers; Aloke V Finn; Marie-Claude Morice; Roxana Mehran; Peter Jüni; Gregg W Stone; Mitchell W Krucoff; Paul K Whelton; Konstantinos Tsioufis; Donald E Cutlip; Ernest Spitzer Journal: Circulation Date: 2022-03-14 Impact factor: 29.690
Authors: Ana Jorbenadze; Marat Fudim; Felix Mahfoud; Phillip B Adamson; Tarek Bekfani; Rolf Wachter; Horst Sievert; Piotr P Ponikowski; John G F Cleland; Stefan D Anker Journal: ESC Heart Fail Date: 2021-05-18