Abstract

Background: Randomized sham-controlled trials have confirmed the efficacy and safety of catheter-based renal denervation (RDN) for hypertension treatment for up to three years. Data on the very long-term effects of RDN are scarce.

Objectives: To evaluate the 10-year safety and efficacy of RDN in patients with resistant hypertension.

Methods: This prospective study included patients with resistant hypertension undergoing radiofrequency RDN between 2010 and 2012. Office blood pressure (BP), 24-hour (24h) ambulatory BP, antihypertensive medication, renal artery duplex sonography, and renal function were assessed at 1-, 2- and 10-year follow-ups.

Results: A total of 39 patients (36% female) completed the 10-year follow-up (mean follow-up duration 9.4±0.7 years). Baseline office and 24h ambulatory systolic BP were 164.0±23.0 mmHg and 152.5±16.1 mmHg, respectively. At 10 years, 24h- and office systolic BP were reduced by 16.2±17 mmHg (P<0.001) and 14.2±23 mmHg (P=0.001), respectively. The number of antihypertensive drugs did not differ significantly between baseline and follow-up (4.9±1.4 versus 4.5±1.2 drugs; P=0.087). The estimated glomerular filtration rate declined within the expected range from 68.7 mL/min/1.73m² (95% CI 63.3 to 74.0) to 60.2 mL/min/1.73m² (95% CI 52.5 to 67.9; P<0.001) at 10-year follow-up. Three renal artery interventions were performed during follow-up (progression of pre-existing renal artery stenosis, n=2; new-onset renal artery stenosis, n=1). No other serious adverse events were observed during the follow-up.

Conclusion: Catheter-based RDN in patients with resistant hypertension was associated with significant and sustained reductions in ambulatory and office BP out to 10 years without long-term complications.

Central Illustration: right panel, Change in 24-hour and office SBP. Left panel, eGFR over time.  SBP, systolic blood pressure; eGFR, estimated glomerular filtration rate.