Catheter-Based Renal Denervation: 9-Year Follow-Up Data on Safety and Blood Pressure Reduction in Patients With Resistant Hypertension

Abstract

BACKGROUND: Recent sham-controlled randomized clinical trials have confirmed the safety and efficacy of catheter-based renal denervation (RDN). Long-term safety and efficacy data beyond 3 years are scarce. Here, we report on outcomes after RDN in a cohort of patients with resistant hypertension with an average of ≈9-year follow-up (FU). METHODS: We recruited patients with resistant hypertension who were previously enrolled in various RDN trials applying radiofrequency energy for blood pressure (BP) lowering. All participants had baseline assessments before RDN and repeat assessment at long-term FU including medical history, automated office and ambulatory BP measurement, and routine blood and urine tests. We analyzed changes between baseline and long-term FU. RESULTS: A total of 66 participants (mean±SD, 70.0±10.3 years; 76.3% men) completed long-term FU investigations with a mean of 8.8±1.2 years post-procedure. Compared with baseline, ambulatory systolic BP was reduced by −12.1±21.6 (from 145.2 to 133.1) mm Hg ( P <0.0001) and diastolic BP by −8.8±12.8 (from 81.2 to 72.7) mm Hg ( P <0.0001). Mean heart rate remained unchanged. At long-term FU, participants were on one less antihypertensive medication compared with baseline ( P =0.0052). Renal function assessed by eGFR fell within the expected age-associated rate of decline from 71.1 to 61.2 mL/min per 1.73 m 2 . Time above target was reduced significantly from 75.0±25.9% at baseline to 47.3±30.3% at long-term FU ( P <0.0001). CONCLUSIONS: RDN results in a significant and robust reduction in both office and ambulatory systolic and diastolic BP at ≈9-year FU after catheter-based RDN on less medication and without evidence of adverse consequences on renal function.

Salt sensitivity risk derived from nocturnal dipping and 24-h heart rate predicts long-term blood pressure reduction following renal denervation

“…This becomes more unlikely when we consider the substantial blood pressure lowering effects across all SSI risk classes. Moreover, while across this cohort a total reduction in antihypertensive load was evident [31], we show here significant reduction in beta blocker DDDs only in the moderate group at long-term follow-up. With the chronotropic effects of beta blockers, their effect on HR and thus SSI Risk is evident.…”

Renal denervation in hypertension: An updated meta‐analysis of the randomized controlled trials

“…23 In a recent cohort study of 66 patients, RDN had a consistent benefit over a 9-year follow-up without adversely affecting kidney function. 24 Previous meta-analyses of RCTs showed significant benefits of RDN over sham procedures in reducing AMB and daytime BP. 25,26 In a sub-analysis of patients with resistant HTN, Ahmed et al 27 found no significant difference between RDN and sham with respect to 24 h AMB systolic and diastolic BP.…”

“…Still, a question of the long‐term sustainability of the benefit of RDN remains, especially with respect to any new adverse outcomes 23 . In a recent cohort study of 66 patients, RDN had a consistent benefit over a 9‐year follow‐up without adversely affecting kidney function 24 …”

Salt-Sensitive Hypertension and the Kidney

“…60 In Dahl-SS rats, during the early period, renal denervation does not decrease BP, 61 and increased sympathetic activity is not observed upon salt-induced hypertension, 62 although the Dahl-SS rats at 4 to 8 weeks with chronic kidney disease showed increased renal sympathetic activity and significant BP reduction by renal denervation, indicating heterogeneity in the pathophysiology of SS-HT. Notably, renal denervation has been proven in many trials to lower BP in patients with hypertension, 63 and in 2023, the Food and Drug Administration approved renal denervation with specific types of devices. However, the impact of renal denervation on SSBP in humans remains to be resolved.…”