Effect of extravascular renal denervation on 24-hour blood pressure patterns in resistant hypertension
H Park, H K Kim, J H Kim, D J Choi, M Yoon, S Kwak, J S Kim, S Park, C J Lee, Y H Lim, D H Kim, W B Chung, E H Choo, C W Jeong, J ShinAbstract
Background
Ideal blood pressure control encompasses sustained 24-hour control, a normal circadian rhythm, and appropriate blood pressure variability to reduce cardiovascular events. The mechanism of renal denervation (RDN) may be well suited to achieving consistent 24-hour blood pressure control. Percutaneous catheter-based intravascular renal denervation (iRDN) has gained continued scientific and clinical interest for reducing blood pressure and has also revealed interesting new insights into the 24-hour profile of blood pressure reduction associated with the therapy.
Purpose
We evaluated the effects of an extravascular RDN (eRDN), an emerging alternative to iRDN, on 24-hour blood pressure patterns in patients with resistant hypertension. This eRDN approach is intended to enable more circumferential and complete ablation of renal sympathetic nerves.
Methods
In this open-label, single-arm first in human pilot study, patients (20 ~ 80 years) with resistant hypertension despite three or more antihypertensive drugs (including a diuretic) were enrolled. Eligible patients had an office blood pressure ≥ 140/90 mmHg and a 24-hour daytime ambulatory systolic blood pressure (ASBP) ≥ 135 mmHg. All patients underwent eRDN. Twenty four hour ABP was assessed using a validated device at baseline and 3 months after eRDN.
Results
Between November 2023 and December 2025, 10 patients were enrolled; 9 completed 3-month follow-up as of now. After eRDN, median 24-hour ASBP decreased from 146.0 mmHg (interquartile range [IQR] 140.0–161.0) at baseline to 124.0 mmHg (IQR 116.0–131.0) at 3 months. Corresponding reductions in nighttime ASBP (142.0 [132.0–154.0] to 116.0 [106.0–133.0]) and daytime ASBP (151.0 [145.0–158.0] to 128.0 [120.0–140.0]) were found. Median 24-hour ambulatory diastolic blood pressure (ADBP) also declined, from 95.0 mmHg (IQR 89.0–99.0) at baseline to 81.0 mmHg (IQR 72.0–87.0) at 3 months. Nighttime and daytime ADBP showed similar decreases (91.0 [87.0–99.0] to 75.0 [67.0–83.0] and 98.0 [90.0–99.0] to 85.0 [75.0–92.0], respectively). The changes in ABP measurement by 3 months following eRDN were evident over the 24-hour monitoring period, including an effect during the time of the morning BP surge (Figure 1 and 2). All these ABP changes were significant (p<0.05) except daytime ADBP changes (p=0.054).
Conclusion(s)
eRDN produced substantial 3-month BP reductions, with ABP improvements sustained throughout the 24-hour period. Ongoing 12-month follow-up will determine the durability of this approach.Figure 1Figure 2