Log in to MyACC
3-Year Outcomes for Renal Denervation and Kidney Function
Study Questions:
What is the long-term safety and efficacy of renal denervation (RDN), including its effects on renal function?
Methods:
The investigators used data from the Global SYMPLICITY Registry, a prospective, open-label registry conducted at 196 active sites worldwide in hypertensive patients receiving RDN treatment. Among 2,237 patients enrolled and treated with the SYMPLICITY Flex catheter, 1,742 were eligible for follow-up at 3 years. Multivariable linear regression analysis was performed to assess independent correlates of the change in office (and 24-hour ambulatory) systolic blood pressure (SBP) at 12, 24, and 36 months.
Results:
Baseline office and 24-hour ambulatory SBP were 166 ± 25 and 154 ± 18 mm Hg, respectively. SBP reduction after RDN was sustained over 3 years, including decreases in both office (−16.5 ± 28.6 mm Hg, p < 0.001) and 24-hour ambulatory SBP (−8.0 ± 20.0 mm Hg; 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 (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 chronic kidney disease (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.
Conclusions:
The authors concluded that long-term data from the Global SYMPLICITY Registry demonstrate both the safety and efficacy of the procedure with significant and sustained office and ambulatory BP reductions out to 3 years.
Perspective:
This study reports that in the SYMPLICITY Global Registry, SBP reduction was sustained to 3 years including decreases in both office (−16.5 mm Hg) and 24-hour ambulatory SBP (−8.0 mm Hg). Furthermore, in this cohort of severe, uncontrolled hypertensive patients, renal function as assessed by eGFR declined within the range expected for hypertensive patients, with the fall in BP and these characteristics and comorbidities. It should be noted that the Global SYMPLICITY Registry was a single-arm registry and did not have control groups, so there is no way to rule out a Hawthorne/placebo effect, which could be caused by participation and care received during the study. Only an adequately controlled randomized blinded trial can provide definitive evidence on the efficacy of catheter-based renal denervation.
Clinical Topics: Prevention, Hypertension
Keywords: Blood Pressure, Blood Pressure Monitoring, Ambulatory, Catheters, Denervation, Glomerular Filtration Rate, Hypertension, Kidney Diseases, Primary Prevention, Renal Insufficiency, Chronic, Vascular Diseases
< Back to Listings
