Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry.

Aims Several studies and registries have demonstrated sustained reductions in blood pressure (BP) after renal denervation (RDN). The long-term safety and efficacy after RDN in real-world patients with uncontrolled hypertension, however, remains unknown. The objective of this study was to assess the long-term safety and efficacy of RDN, including its effects on renal function. Methods and results The Global SYMPLICITY Registry is a prospective, open-label registry conducted at 196 active sites worldwide in hypertensive patients receiving RDN treatment. Among 2237 patients enrolled and treated with the SYMPLICITY Flex catheter, 1742 were eligible for follow-up at 3years. Baseline office and 24-h ambulatory systolic BP (SBP) were 16625 and 15418mmHg, respectively. SBP reduction after RDN was sustained over 3years, including decreases in both office (-16.5 +/- 28.6mmHg, P<0.001) and 24-h ambulatory SBP (-8.0 +/- 20.0mmHg; P<0.001). Twenty-one percent of patients had a baseline estimated glomerular filtration rate (eGFR) <60mL/min/1.73m(2). Between baseline and 3years, renal function declined by 7.1mL/min/1.73m(2) in patients without chronic kidney disease (CKD; eGFR >= 60mL/min/1.73 m(2); baseline eGFR 87 +/- 17mL/min/1.73m(2)) and by 3.7mL/min/1.73m(2) in patients with CKD (eGFR <60mL/min/1.73m(2); baseline eGFR 47 +/- 11mL/min/1.73 m(2)). No long-term safety concerns were observed following the RDN procedure. Conclusion Long-term data from the Global SYMPLICITY Registry representing the largest available cohort of hypertensive patients receiving RDN in a real-world clinical setting demonstrate both the safety and efficacy of the procedure with significant and sustained office and ambulatory BP reductions out to 3 years.