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. 2024 Oct;113(10):1384-1392.
doi: 10.1007/s00392-024-02417-2. Epub 2024 Mar 7.

Ultra-long-term efficacy and safety of catheter-based renal denervation in resistant hypertension: 10-year follow-up outcomes

Hussam Al Ghorani #  1 , Saarraaken Kulenthiran #  2 , Lucas Lauder  2 , Michael Johannes Maria Recktenwald  2 , Juliane Dederer  2 , Michael Kunz  2 , Felix Götzinger  2 , Sebastian Ewen  2 , Christian Ukena  2   3 , Michael Böhm  2 , Felix Mahfoud  2
Affiliations

Ultra-long-term efficacy and safety of catheter-based renal denervation in resistant hypertension: 10-year follow-up outcomes

Hussam Al Ghorani et al. Clin Res Cardiol. 2024 Oct.

Abstract

Background: Randomized sham-controlled trials have confirmed the efficacy and safety of catheter-based renal denervation in hypertension. Data on the very long-term effects of renal denervation are scarce.

Aims: This study evaluates the 10-year safety and efficacy of renal denervation in resistant hypertension.

Methods: This prospective single-center study included patients with resistant hypertension undergoing radio-frequency renal denervation between 2010 and 2012. Office blood pressure, 24-h ambulatory blood pressure, antihypertensive medication, color duplex sonography, and renal function were assessed after 1-, 2- and 10-years.

Results: Thirty-nine patients completed the 10-year follow-up (mean follow-up duration 9.4 ± 0.7 years). Baseline office and 24-h ambulatory systolic blood pressure were 164 ± 23 mmHg and 153 ± 16 mmHg, respectively. After 10 years, 24-h ambulatory and office systolic blood pressure were reduced by 16 ± 17 mmHg (P < 0.001) and 14 ± 23 mmHg (P = 0.001), respectively. The number of antihypertensive drugs remained unchanged from 4.9 ± 1.4 to 4.5 ± 1.2 drugs (P = 0.087). The estimated glomerular filtration rate declined within the expected range from 69 (95% CI 63 to 74) to 60 mL/min/1.73m2 (95% CI 53 to 68; P < 0.001) through 10-year follow-up. Three renal artery interventions were documented for progression of pre-existing renal artery stenosis in two patients and one patient with new-onset renal artery stenosis. No other adverse events were observed during the follow-up.

Conclusion: Renal denervation was safe and sustainedly reduced ambulatory and office blood pressure out to 10 years in patients with resistant hypertension.

Keywords: 24-h ambulatory blood pressure monitoring; Office blood pressure; Renal function; Resistant hypertension; Safety.

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Conflict of interest statement

HA, MJMR and MK do not have COI to declare. SK has received speaker honoraria from Medtronic and ReCor. LL has received speaker honoraria from AstraZeneca, Medtronic, Pfizer and ReCor. FG received speaker honoraria from AstraZeneca and is supported by the German Foundation for Heart Research/Deutsche Herzstiftung. SE received speaker honoraria and/or travel support from Akcea Therapeutics, AstraZeneca, Bayer, Berlin Chemie, Bristol-Myers Squibb—Pfizer, Boehringer Ingelheim, Daiichi Sankyo, Kaneka Pharma, Medtronic, Novartis and ReCor. CU received scientific support and speaker honoraria from Bayer, Boehringer Ingelheim, Medtronic, Pfizer and ReCor. MB is supported by the Deutsche Forschungsgemeinschaft (German Research Foundation; TRR 219, Project-ID 322900939) and reports personal fees from Amgen, Astra Zeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Servier, Medtronic, Vifor, Novartis and Abbott. FM is supported by Deutsche Gesellschaft für Kardiologie (DGK), Deutsche Forschungsgemeinschaft (SFB TRR219, Project-ID 322900939), and Deutsche Herzstiftung, received scientific support from Ablative Solutions, Medtronic and Recor. He has received speaker honoraria/consulting fees from his institution (Saarland University), Ablative Solutions, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Inari, Medtronic, Merck, ReCor, Servier, and Terumo.

Figures

Fig. 1
Fig. 1
Blood pressure changes. (A) Change in mean 24-h systolic, (B) 24-h diastolic, (C) office systolic and (D) office diastolic blood pressure at 1 year, 2 years, and 10 years follow-up after renal denervation. Error bars represent 95% confidence intervals. The p-values were obtained from a repeated measures ANOVA test with a linear-mixed model
Fig. 2
Fig. 2
Hypertension severity according to 24-h systolic blood pressure. Proportion of patients with 24-h SBP < 140 mmHg at 1 year, 2 years, and 10 years follow-up. Colors or ranges does not represent a recommendation of target blood pressure values. SBP: systolic blood pressure
Fig. 3
Fig. 3
Renal function over time. Values are mean the estimated glomerular filtration rates (eGFR) over time in all patients and in patients (n = 12) with CKD at baseline (eGFR < 60 mL/min/1.73 m2). Error bars represent 95% confidence intervals. eGFR: estimated glomerular filtration rate
See this image and copyright information in PMC

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