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Abstract: PO1810

Long-Term Safety and Efficacy of Renal Denervation with the Symplicity Spyral Catheter in the Global SYMPLICITY Registry

Session Information

Category: Hypertension and CVD

  • 1402 Hypertension and CVD: Clinical, Outcomes, and Trials

Authors

  • Schlaich, Markus P., The University of Western Australia, Perth, Western Australia, Australia
  • Mahfoud, Felix, Universitatsklinikum des Saarlandes und Medizinische Fakultat der Universitat des Saarlandes, Homburg, Saarland, Germany
  • Williams, Bryan, University College London, London, London, United Kingdom
  • Ruilope, Luis M., Hospital Universitario 12 de Octubre, Madrid, Comunidad de Madrid, Spain
  • Narkiewicz, Krzysztof, Gdanski Uniwersytet Medyczny, Gdansk, Poland
  • Fahy, Martin, Medtronic Inc, Minneapolis, Minnesota, United States
  • Mancia, Giuseppe, Universita degli Studi di Milano-Bicocca, Milano, Lombardia, Italy
  • Böhm, Michael, Universitatsklinikum des Saarlandes und Medizinische Fakultat der Universitat des Saarlandes, Homburg, Saarland, Germany
Background

Catheter-based renal denervation (RDN) therapy targets overactivity of the sympathetic nervous system to treat hypertension. Results from recent randomized sham-controlled clinical trials have demonstrated the safety and efficacy of RDN, but long-term safety and durability of the procedure in real-word patients is also important.

Methods

The Global SYMPLICITY Registry (GSR) is a prospective, international registry of patients who receive radiofrequency RDN treatment due to uncontrolled hypertension or conditions associated with excessive sympathetic nervous system activation. Office and ambulatory blood pressure (BP) levels were measured at baseline, 3, 6, 12, 24, and 36 months per standard of care. Adverse events were collected out to 3 years. In this analysis, we present safety and efficacy data for patients who received RDN with the multi-electrode Symplicity Spyral catheter in GSR.

Results

Currently there are 641 patients treated with the Symplicity Spyral catheter (baseline office BP 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/1.73m2). At 3 years, there were no cases of new renal artery stenosis >70% or renal artery re-intervention. Rates of other adverse events at 3 years included new onset end stage renal disease (2.4%), cardiovascular death (1.6%) and myocardial infarction (0.8%). Mean change in eGFR from baseline to 3 years was -6.5±15.7 mL/min/1.73m2. Changes in mean 24-hour and office BP from baseline to 6, 12, 24 and 36 months are shown in the Figure.

Conclusion

Office and 24-hour BP were significantly reduced from baseline at all follow up time-points after RDN with the Symplicity Spyral catheter, with no instances of renal artery re-intervention.

Funding

  • Commercial Support –