Michael Böhm1, Felix Mahfoud1, Raymond R Townsend2, David E Kandzari3, Stuart Pocock4, Christian Ukena1, Michael A Weber5, Satoshi Hoshide6, Manesh Patel7, Crystal C Tyson8, Joachim Weil9, Tolga Agdirlioglu9, Martin Fahy10, Kazuomo Kario6. 1. Department of Internal Medicine III, University Hospital of Saarland, Saarland University, Kirrberger Street 1, Homburg/Saar, Germany. 2. Department of Medicine, Perelman School of Medicine, University of Pennsylvania, 3400 Civic Center Blvd, Philadelphia, PA, USA. 3. Department of Interventional Cardiology, Piedmont Heart Institute, 275 Collier Rd NW #500, Atlanta, GA, USA. 4. Department of Medical Statistics, London School of Hygiene & Tropical Medicine, Keppel St, Bloomsbury, London, UK. 5. Department of Medicine, SUNY Downstate College of Medicine, 450 Clarkson Ave, Brooklyn, NY, USA. 6. Department of Cardiovascular Medicine, Jichi Medical University School of Medicine, Tochigi, Tochigi-ken, Japan. 7. Department of Cardiology, Duke University Medical Center, 2301 Erwin Road, Durham, NC, USA. 8. Department of Internal Medicine, Duke University Medical Center, 2301 Erwin Road, Durham, NC, USA. 9. Department of Cardiology, Sana Cardiomed Heart Center, Kronsforder Allee 71, Lübeck, Germany. 10. Medtronic PLC, Santa Rosa, CA, USA.
Abstract
AIMS: The randomized sham-controlled SPYRAL HTN-OFF MED trial demonstrated that renal denervation (RDN) using a multi-electrode catheter lowers ambulatory blood pressure (BP) in non-medicated hypertensive patients. The current report describes the effects of RDN on heart rate (HR) in this population. METHODS AND RESULTS:Patients were enrolled with an office systolic BP (SBP) of ≥150 mmHg and <180 mmHg, office diastolic BP (DBP) of ≥90 mmHg, and a mean ambulatory SBP of ≥140 mmHg and <170 mmHg. Patients were drug naïve or removed from their anti-hypertensive medications. Eighty patients were randomized 1:1 to RDN or sham procedure. This post hoc analysis examines the effect at 3 months of RDN on HR and of high baseline 24-h HR on BP and HR changes. There was a significant reduction in 24-h HR at 3 months for the RDN group (-2.5 b.p.m.) compared with sham (-0.2 b.p.m.), P = 0.003 (analysis of covariance). Mean baseline-adjusted treatment differences were significantly different between groups at 3 months for average morning HR (-4.4 b.p.m., P = 0.046) and minimum morning HR (-3.0 b.p.m., P = 0.026). RDN patients with baseline 24-h HR above the median (73.5 b.p.m.) had significant reductions in average ambulatory SBP (-10.7 mmHg difference, P = 0.001) and DBP (-7.5 mmHg, P < 0.001), whereas BP changes in RDN patients with below-median HRs were not significant. CONCLUSION:Average and minimum morning HR were significantly reduced at 3 months for RDN compared with sham patients. A baseline 24-h HR above the median predicted greater BP reductions and may allow physicians to select patients likely to respond to the procedure. Published on behalf of the European Society of Cardiology. All rights reserved.
RCT Entities:
AIMS: The randomized sham-controlled SPYRAL HTN-OFF MED trial demonstrated that renal denervation (RDN) using a multi-electrode catheter lowers ambulatory blood pressure (BP) in non-medicated hypertensivepatients. The current report describes the effects of RDN on heart rate (HR) in this population. METHODS AND RESULTS:Patients were enrolled with an office systolic BP (SBP) of ≥150 mmHg and <180 mmHg, office diastolic BP (DBP) of ≥90 mmHg, and a mean ambulatory SBP of ≥140 mmHg and <170 mmHg. Patients were drug naïve or removed from their anti-hypertensive medications. Eighty patients were randomized 1:1 to RDN or sham procedure. This post hoc analysis examines the effect at 3 months of RDN on HR and of high baseline 24-h HR on BP and HR changes. There was a significant reduction in 24-h HR at 3 months for the RDN group (-2.5 b.p.m.) compared with sham (-0.2 b.p.m.), P = 0.003 (analysis of covariance). Mean baseline-adjusted treatment differences were significantly different between groups at 3 months for average morning HR (-4.4 b.p.m., P = 0.046) and minimum morning HR (-3.0 b.p.m., P = 0.026). RDN patients with baseline 24-h HR above the median (73.5 b.p.m.) had significant reductions in average ambulatory SBP (-10.7 mmHg difference, P = 0.001) and DBP (-7.5 mmHg, P < 0.001), whereas BP changes in RDN patients with below-median HRs were not significant. CONCLUSION: Average and minimum morning HR were significantly reduced at 3 months for RDN compared with sham patients. A baseline 24-h HR above the median predicted greater BP reductions and may allow physicians to select patients likely to respond to the procedure. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Christian Ukena; Tobias Seidel; Konstantinos Rizas; Davide Scarsi; Dominic Millenaar; Sebastian Ewen; Axel Bauer; Felix Mahfoud; Michael Böhm Journal: Clin Res Cardiol Date: 2019-09-25 Impact factor: 5.460
Authors: Lucas Lauder; Milan A Wolf; Sean S Scholz; Mathias Hohl; Felix Mahfoud; Michael Böhm Journal: Curr Cardiol Rep Date: 2019-07-05 Impact factor: 2.931