Safety and efficacy of endovascular ultrasound renal denervation in resistant hypertension

Daemen, Joost; Mahfoud, Felix; Kück, Karl‐Heinz; Andersson, Bert; Böhm, Michael; Graf, Tobias; Sievert, Horst; Iyer, Mano; Zeller, Thomas

doi:10.1097/hjh.0000000000002120

Cited by 20 publications

(16 citation statements)

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“…The magnitude of renal function decline observed in our study was in line with previous observations from a large cohort study demonstrating an annual decrease in eGFR of -0.88 ml/min/1.73 m 2 in patients with a history of hypertension [ 20 ]. Whereas our short-term findings are in line with previous work, the present data support the safety of RDN up to 5 years post-procedure [ 9 , 21 – 25 ].…”

Section: Discussionsupporting

confidence: 93%

Long-term follow-up of patients undergoing renal sympathetic denervation

et al. 2022

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Objectives Renal denervation (RDN) proved to significantly lower blood pressure (BP) at 2–6 months in patients on and off antihypertensive drugs. Given a lack of longer-term follow-up data, our aim was to assess the safety and efficacy of RDN up to five years taking into account antihypertensive drug regimen changes over time. Methods In the present single-center study, patients underwent RDN for (therapy resistant) hypertension. Patients underwent protocolized yearly follow-up out to five years. Data were collected on 24-h ambulatory BP and office BP monitoring, renal function, antihypertensive drug regimen, and safety events, including non-invasive renal artery imaging at 6/12 months. Efficacy analyses were performed using linear mixed-effects models. Results Seventy-two patients with mean age 63.3 ± 9.5 (SD) years (51% female) were included. Median follow-up time was 3.5 years and Clark’s Completeness Index was 72%. Baseline ambulatory daytime BP was 146.1/83.7 ± 17.4/12.2 mmHg under a mean number of 4.9 ± 2.7 defined daily doses (DDD). At five years, ambulatory daytime systolic BP as calculated from the mixed model was 120.8 (95% CI 114.2–127.5) mmHg and diastolic BP was 73.3 (95% CI 69.4–77.3) mmHg, implying a reduction of -20.9/-8.3 mmHg as compared to baseline estimates (p < 0.0001). The number of DDDs remained stable over time (p = 0.87). No procedure-related major adverse events resulting in long-term consequences were observed. Conclusions The BP-lowering effect of RDN was safely maintained at least five years post-procedure as reflected by a significant decrease in ambulatory daytime BP in the absence of escalating antihypertensive drug therapy over time. Graphical abstract

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Section: Discussionsupporting

confidence: 93%

Long-term follow-up of patients undergoing renal sympathetic denervation

et al. 2022

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“…It is likely that with modest procedural refinements, uRDN could be performed via transradial access in ambulatory settings, further limiting the overall risks and resource use involved with the procedure. Of course, longer-term safety and durability of effect need to be established, but based on initial data from SOLO, TRIO, and the ACHIEVE registry 23,24 as well as data from radiofrequency-based RDN, 25,26 safety and efficacy findings have been reassuring.…”

Section: Discussionmentioning

confidence: 99%

Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials

et al. 2023

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ImportanceUltrasound renal denervation (uRDN) was shown to lower blood pressure (BP) in patients with uncontrolled hypertension (HTN). Establishing the magnitude and consistency of the uRDN effect across the HTN spectrum is clinically important.ObjectiveTo characterize the effectiveness and safety of uRDN vs a sham procedure from individual patient-level pooled data across uRDN trials including either patients with mild to moderate HTN on a background of no medications or with HTN resistant to standardized triple-combination therapy.Data SourcesA Study of the ReCor Medical Paradise System in Clinical Hypertension (RADIANCE-HTN SOLO and TRIO) and A Study of the ReCor Medical Paradise System in Stage II Hypertension (RADIANCE II) trials.Study SelectionTrials with similar designs, standardized operational implementation (medication standardization and blinding of both patients and physicians to treatment assignment), and follow-up.Data Extraction and SynthesisPooled analysis using individual patient-level data using linear regression models to compare uRDN with sham across the trials.Main Outcomes and MeasuresThe primary outcome was baseline-adjusted change in 2-month daytime ambulatory systolic BP (dASBP) between groups.ResultsA total of 506 patients were randomized in the 3 studies (uRDN, 293; sham, 213; mean [SD] age, 54.1 [9.3]; 354 male [70.0%]). After a 1-month medication stabilization period, dASBP was similar between the groups (mean [SD], uRDN, 150.3 [9.2] mm Hg; sham, 150.8 [10.5] mm Hg). At 2 months, dASBP decreased by 8.5 mm Hg to mean (SD) 141.8 (13.8) mm Hg among patients treated with uRDN and by 2.9 mm Hg to 147.9 (14.6) mm Hg among patients treated with a sham procedure (mean difference, −5.9; 95% CI, −8.1 to −3.8 mm Hg; P &lt; .001 in favor of uRDN). BP decreases from baseline with uRDN vs sham were consistent across trials and across BP parameters (office SBP: −10.4 mm Hg vs −3.4 mm Hg; mean difference, −6.4 mm Hg; 95% CI, −9.1 to –3.6 mm Hg; home SBP: −8.4 mm Hg vs −1.4 mm Hg; mean difference, −6.8 mm Hg; 95% CI, −8.7 to −4.9 mm Hg, respectively). The BP reductions with uRDN vs sham were consistent across prespecified subgroups. Independent predictors of a larger BP response to uRDN were higher baseline BP and heart rate and the presence of orthostatic hypertension. No differences in early safety end points were observed between groups.Conclusions and RelevanceResults of this patient-level pooled analysis suggest that BP reductions with uRDN were consistent across HTN severity in sham-controlled trials designed with a 2-month primary end point to standardize medications across randomized groups.Trial RegistrationClinicalTrials.gov Identifier: NCT02649426 and NCT03614260

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“…Similar to previous studies on the renal sympathetic nerve in patients with resistant hypertension, our review of ABPM and office BP obtained during a follow-up period of 24 months showed a significant decrease in the ambulatory BP, especially the systolic ambulatory BP after RDN. This difference was maintained until 1, 3, 6, 12, and 24 months postoperatively [29,30]. As a more selective method of reducing renal sympathetic secretion, RDN effectively removes sympathetic nerve overactivity and leads to a systemic decrease in sympathetic tone [31].…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of renal denervation for hypertension in patients with chronic kidney disease: a meta-analysis

Xia

Liu

Chen

et al. 2021

International Journal of Hyperthermia

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Background: Renal denervation (RDN) is a new treatment for hypertension in patients with chronic kidney disease (CKD), but its efficacy is still debated. This meta-analysis aimed to evaluate the efficacy and safety of RDN for hypertension in patients with CKD. Methods: PubMed, Web of Science, EMBASE, and Ovid databases were searched for relevant studies published. We performed both fixed-and random-effects meta-analyses of the changes in blood pressure, estimated glomerular filtration rate (eGFR), and urinary albumin-to-creatinine ratio (UACR) after RDN. Results: The meta-analysis included 238 patients from 11 single-center, non-randomized, uncontrolled studies. Office blood pressure and 24-hour ambulatory blood pressure (24 h-ABP) showed a significant reduction 1 month after RDN (p < 0.05). This decrease of 24 h-ABP persisted for 24 months after RDN showed difference systolic blood pressure (p < 0.001) and diastolic blood pressure (p ¼ 0.001). The 24 h-ABP exhibited a similar trend in the subgroup analysis. eGFR measurements obtained at each time point of analysis after RDN were not significantly different from those obtained before (p > 0.05). UACR levels were significantly reduced at 3 months and 6 months after RDN (p < 0.001). After RDN, the heart rate showed no significant changes (p > 0.05), and few major complications were encountered. Conclusions: The meta-analysis showed that RDN may be effective and safe for treating CKD patients with hypertension. Well-designed randomized controlled trials of RDN are urgently needed to confirm the safety and reproducibility of RDN and to assess its impact on clinical outcomes.

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Safety and efficacy of endovascular ultrasound renal denervation in resistant hypertension

Cited by 20 publications

References 14 publications

Long-term follow-up of patients undergoing renal sympathetic denervation

Long-term follow-up of patients undergoing renal sympathetic denervation

Patient-Level Pooled Analysis of Ultrasound Renal Denervation in the Sham-Controlled RADIANCE II, RADIANCE-HTN SOLO, and RADIANCE-HTN TRIO Trials

Efficacy and safety of renal denervation for hypertension in patients with chronic kidney disease: a meta-analysis

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