Faisal Sharif*1, Markus Schlaich2, Felix Mahfoud3, Bryan Williams4, Luis Ruilope5, Krzysztof Narkiewicz6, Martin Fahy7, Giuseppe Mancia8, Michael Böhm3 1University Hospital Galway and National University of Ireland Galway, Galway, Ireland, 2Dobney Hypertension Centre, Medical School –Royal Perth Hospital Unit, The University of Western Australia, Perth, Australia, 3Saarland University Hospital, Homburg/Saar, Germany, 4University College London and National Institute for Health Research University College London Hospitals Biomedical Research Centre, London, United Kingdom, 5Hospital Universitario 12 de Octubre and CIBERCV and School of Doctoral Studies and Research, Universidad Europea de Madrid, Madrid, Spain, 6Medical University of Gdansk, Gdansk, Poland, 7Medtronic, Santa Rosa, United States, 8University of Milano-Bicocca, Milan, Italy

Introduction: Results from randomized sham-controlled clinical trials have demonstrated the safety and efficacy of catheter-based radiofrequency renal denervation (RDN) to lower blood pressure (BP) in hypertensive patients with and without antihypertensive medications [1–4].

Methods: The Global SYMPLICITY Registry (GSR) is a prospective registry to assess the safety and efficacy of radiofrequency RDN. Office and ambulatory systolic BP measurements were collected at baseline, 3, 6, 12, 24, and 36 months per standard of care. Adverse events were collected out to 36 months. “In this analysis, we present safety and efficacy data for patients who received RDN with the multi-electrode Symplicity Spyral catheter in GSR” [5].

Results: As of March 2021, 641 patients were treated with the Symplicity Spyral catheter in GSR (baseline office systolic BP (SBP) “168 ± 25 mmHg, 4.6 ± 1.5 prescribed anti-hypertensive medication classes, mean age 60.5 ± 12.5 years, 56.9% male, 42.5% history of cardiac disease, 37.2% type II diabetes mellitus, and 19.1% renal insufficiency with eGFR<60 ml/min/1.73 m2)” [5]. Mean change in eGFR from baseline to 36 months was −6.5 ± 15.7 mL/min/1.73 m2. Of patients with 36-month follow-up, change in mean 24-hour SBP was −17.1 mmHg (N = 55) and mean office SBP change was −18.6 mmHg (n = 167). At 36 months, there were no cases of new renal artery stenosis >70% or renal artery re-intervention. Rates of other adverse events at 36 months included new onset end stage renal disease (2.4%), cardiovascular death (1.6%) and myocardial infarction (0.8%) [5].

Conclusions: Office and 24-hour SBP were significantly reduced from baseline after catheter-based radiofrequency RDN with the Symplicity Spyral catheter, with no instances of renal artery re-intervention [5].

Disclosures: FS has received speaker and consulting fees and research support from Medtronic. MS is supported by an NHMRC Senior Research Fellowship; and has received consulting fees and/or travel and research support from Medtronic, Abbott, Novartis, Servier, Pfizer, and Boehringer Ingelheim. FM is supported by Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Forschungsgemeinschaft (SFB TRR219), and Deutsche Herzstiftung and has received scientific support and speaker honoraria from Astra-Zeneca, Bayer, Boehringer Ingelheim, Medtronic and ReCor Medical. BW and LR have nothing to report. KN has received speaker and consulting honoraria from Berlin-Chemie/Menarini, Egis, Idorsia, Gedeon Richter, Krka, Medtronic, Novo Nordisk, Polpharma, Recordati, Sandoz and Servier. MF is an employee of Medtronic. GM has received speaker’s fees from Servier, Sanofi, Medtronic, Menarini, Merk, and Recordati. MB is supported by the Deutsche Forschungsgemeinschaft (German Research Foundation; TTR 219, project number 322900939) and reports personal fees from Abbott, Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Medtronic, Novartis, ReCor Medical, Servier, and Vifor during the conduct of the study.

References:

1. Mahfoud F, Kandzari DE, Kario K, et al. Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial. The Lancet 2022:S014067362200455X.

2. Kandzari DE, Böhm M, Mahfoud F, et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. The Lancet 2018;391:2346–2355.

3. Townsend RR, Mahfoud F, Kandzari DE, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. The Lancet 2017;390:2160–2170.

4. Böhm M, Kario K, Kandzari DE, et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. The Lancet 2020;395:1444–1451.

5. Schlaich MP, Mahfoud F, Williams B, et al. Long-Term Safety and Efficacy of Renal Denervation with the Symplicity Spyral Catheter in the Global SYMPLICITY Registry. PO1810, J Am Soc Nephrol 2021; 32: 560.