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

Abstract

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 3 years. Baseline office and 24-h ambulatory systolic BP (SBP) were 166 ± 25 and 154 ± 18 mmHg, respectively. SBP reduction after RDN was sustained over 3 years, including decreases in both office (-16.5 ± 28.6 mmHg, P < 0.001) and 24-h ambulatory SBP (-8.0 ± 20.0 mmHg; P < 0.001). Twenty-one percent of patients had a baseline estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2. Between baseline and 3 years, renal function declined by 7.1 mL/min/1.73 m2 in patients without chronic kidney disease (CKD; eGFR ≥60 mL/min/1.73 m2; baseline eGFR 87 ± 17 mL/min/1.73 m2) and by 3.7 mL/min/1.73 m2 in patients with CKD (eGFR <60 mL/min/1.73 m2; baseline eGFR 47 ± 11 mL/min/1.73 m2). 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.

Keywords: Ambulatory blood pressure monitoring; Denervation; Hypertension; Renal function; SYMPLICITY.

Figure 1

Patient disposition. ABPM, ambulatory blood pressure measurement; OBP, office blood pressure.

Figure 2

Change in (A) office systolic blood pressure and (B) 24-h ambulatory systolic blood pressure. Error bars represent 95% confidence intervals.

Figure 3

Change in office (A) and 24-h ambulatory (B) systolic blood pressure stratified by patients with and without severe resistant hypertension. Error bars represent 95% confidence intervals.

Figure 4

(A) Change in estimated glomerular filtration rate. Data are stratified by estimated glomerular filtration rate ≥ and <60 mL/min/1.73 m². Error bars represent 95% confidence intervals. (B) Change in 24-h systolic blood pressure for patients with baseline estimated glomerular filtration rate ≥ and <60 mL/min/1.73 m². There were no statistically significant differences in changes between groups.

Take home figure

(A) Reduction in 24-h and office systolic blood pressure at 6, 12, 24 and 36 months. (B) Change in estimated glomerular filtration rate. Data are stratified by in estimated glomerular filtration rate ≥ and <60 mL/min/1.73 m². Error bars represent 95% confidence intervals.