Renal sympathetic denervation therapy in the real world: results from the Heidelberg registry.

INTRODUCTION: Renal sympathetic denervation (RDN) is a novel treatment option in patients with treatment-resistant arterial hypertension. A subset of recently published randomized and non-randomized trials indicates that RDN leads to sustained lowering of blood pressure (BP) under controlled study conditions. However, registry data that allow evaluation of safety and efficacy in a real-world setting are largely missing.
METHODS: Sixty-three consecutive patients with treatment-resistant hypertension underwent RDN with the radiofrequency-based Symplicity™ catheter. As part of our prospective registry, treatment efficacy and safety were monitored after 3, 6, and 12 months.
RESULTS: At 6 months follow-up, office systolic BP significantly improved by 19 + 23 mmHg as compared to baseline, while diastolic BP values reduced by 6 + 13 mmHg (p < 0.05). One year after RDN, office BP levels further improved (26 + 25 mmHg in systolic BP and 9 + 13 mmHg in diastolic BP, respectively), even though 19 patients had reduced the number and/or dosage of antihypertensive agents. The response rate, defined as reduction of office systolic BP of ≥ 10 mmHg, was 73% after 6 months. Baseline BP was the only significant predictor of blood pressure response, whereas no correlation was found between the number of ablation points and the individual changes in office blood pressure. Interestingly, patients with challenging renal anatomy profited somewhat less from the procedure than those with "normal" renal anatomy. Procedure related adverse events occurred in three patients (4.7%) and were limited to vascular access complications.
CONCLUSIONS: RDN with the Symplicity™ system is safe and effective in patients with treatment-resistant hypertension also in a real-world setting.