10-Year Outcomes of Catheter-Based Renal Denervation in Patients With Resistant Hypertension

Ghorani, Hussam Al; Kulenthiran, Saarraaken; Recktenwald, Michael Johannes Maria; Lauder, Lucas; Kunz, Michael; Götzinger, Felix; Ewen, Sebastian; Ukena, Christian; Böhm, Michael; Mahfoud, Felix

doi:10.1016/j.jacc.2022.11.038

Cited by 23 publications

(12 citation statements)

References 5 publications

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“…18 Given the increasing outpatient SBP levels in participants randomized to intensive treatment following the trial, these results highlight the importance of sustained long-term management of hypertension. Based on the findings presented here, long-term management of BP, or rather sustained efficacy of BP-lowering effects, seems to be achievable with RDN, making this Long-term follow-up (LTFU) and baseline data were collected and pooled from Sesa-Ashton et al, 12 Vogt et al, 13 Al Ghorani et al, 14 and Zeijin et al 16 interventional modality an attractive adjunct for long-term management, particularly in view of the experience that long-term BP improvement is often difficult to achieve in patients with resistant hypertension. This is further complicated by poor medication adherence among patients with hypertension 26 and is exacerbated by notable drug intolerances.…”

Section: Discussionmentioning

confidence: 96%

“…During searching, 5 observational studies were found, with 1 not meeting our inclusion criteria due to a lack of ambulatory BP recordings. The included studies were Sesa-Ashton et al (Table 1), 12 Al Ghorani et al, 13 Vogt et al, 14 and Zeijen et al 15 Similarly, 22 studies met our search criteria for sham-controlled studies with only 2 achieving our inclusion criteria: Bhatt et al 7 and Mahfoud et al (Table 2). 8…”

Section: Clinical/pathophysiological Implications?mentioning

confidence: 99%

“…Furthermore, our observational data include data from both ultrasound ablation 15 and single-electrode radiofrequency ablation studies. [12][13][14] While early data suggest that the frequency of clinically significant BP reductions is not different between ultrasound and radiofrequency ablations, 31,32 it is difficult to make comparisons based on 1 observational long-term study and how the modalities fare relative to each other outside of the clinical trial environment.…”

Section: Limitationsmentioning

confidence: 99%

“…Recently, results from long-term observational follow-up studies have been published, [12][13][14][15] indicating durable BPlowering effects without major safety concerns following RDN out to 10 years of follow-up. Moreover, randomized control trials have continued to be reported with favorable results following RDN out to 3 years.…”

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confidence: 99%

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Long-Term Blood Pressure Reductions Following Catheter-Based Renal Denervation: A Systematic Review and Meta-Analysis

Sesa-Ashton,

Nolde,

Muente

et al. 2024

Hypertension

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BACKGROUND: Renal denervation is a recognized adjunct therapy for hypertension with clinically significant blood pressure (BP)-lowering effects. Long-term follow-up data are critical to ascertain durability of the effect and safety. Aside from the 36-month follow-up data available from randomized control trials, recent cohort analyses extended follow-up out to 10 years. We sought to analyze study-level data and quantify the ambulatory BP reduction of renal denervation across contemporary randomized sham-controlled trials and available long-term follow-up data up to 10 years from observational studies. METHODS: A systematic review was performed with data from 4 observational studies with follow-up out to 10 years and 2 randomized controlled trials meeting search and inclusion criteria with follow-up data out to 36 months. Study-level data were extracted and compared statistically. RESULTS: In 2 contemporary randomized controlled trials with 36-month follow-up, an average sham-adjusted ambulatory systolic BP reduction of −12.7±4.5 mm Hg from baseline was observed ( P =0.05). Likewise, a −14.8±3.4 mm Hg ambulatory systolic BP reduction was found across observational studies with a mean long-term follow-up of 7.7±2.8 years (range, 3.5–9.4 years; P =0.0051). The observed reduction in eGFR across the long-term follow-up was in line with the predicted age-related decline. Antihypertensive drug burden was similar at baseline and follow-up. CONCLUSIONS: Renal denervation is associated with a significant and clinically meaningful reduction in ambulatory systolic BP in both contemporary randomized sham-controlled trials up to 36 months and observational cohort studies up to 10 years without adverse consequences on renal function.

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Section: Discussionmentioning

confidence: 96%

Section: Clinical/pathophysiological Implications?mentioning

confidence: 99%

Section: Limitationsmentioning

confidence: 99%

mentioning

confidence: 99%

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Long-Term Blood Pressure Reductions Following Catheter-Based Renal Denervation: A Systematic Review and Meta-Analysis

Sesa-Ashton,

Nolde,

Muente

et al. 2024

Hypertension

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“…Therefore, this study adds to the body of evidence from previous sham-controlled trials 2 and open-label studies with a follow-up of up to 10 years, confirming the safety of RDN. 31,32 Limitations Several limitations of this analysis need to be acknowledged. First, this study was nonrandomized and lacked a comparison treatment group.…”

Section: Discussionmentioning

confidence: 99%

Impact of Renal Denervation on Urinary Peptide-Based Biomarkers in Hypertension

Lauder,

Siwy,

Mavrogeorgis

et al. 2024

Hypertension

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BACKGROUND: Catheter-based renal denervation (RDN) reduces blood pressure in hypertension. Urinary peptides are associated with cardiovascular and renal disease and provide prognostic information. We aimed to investigate the effect of RDN on urinary peptide-based biomarker panels associated with chronic kidney and heart disease and to identify urinary peptides affected by RDN. METHODS: This single-arm, single-center study included patients undergoing catheter-based RDN. Urine samples were collected before and 24 months after RDN and were analyzed using capillary electrophoresis coupled with mass spectrometry. Predefined urinary peptide-based biomarker panels for chronic kidney disease (CKD273), coronary artery disease (CAD238), and heart failure (HF1) were calculated. RESULTS: This study included 48 patients (33% female) with uncontrolled hypertension. At 24 months after RDN, systolic blood pressure (165±17 versus 148±20 mm Hg; P <0.0001), diastolic blood pressure (90±17 versus 81±13 mm Hg; P <0.0001), and mean arterial pressure (115±15 versus 103±13 mm Hg; P <0.0001) decreased significantly. A total of 103 urinary peptides from 37 different proteins, mostly collagens, altered following RDN. CAD238, a 238 coronary artery-specific polypeptide pattern, significantly improved following RDN (Cohen’s d , −0.632; P =0.0001). The classification scores of HF1 ( P =0.8295) and CKD273 ( P =0.6293) did not change significantly. CONCLUSIONS: RDN beneficially affected urinary peptides associated with coronary artery disease. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01888315.

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

Al Ghorani,

Kulenthiran,

Lauder

et al. 2024

Clin Res Cardiol

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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. Graphical abstract Left panel, Change in 24-h and office SBP. Right panel, eGFR over time. SBP, systolic blood pressure; eGFR, estimated glomerular filtration rate.

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10-Year Outcomes of Catheter-Based Renal Denervation in Patients With Resistant Hypertension

Cited by 23 publications

References 5 publications

Long-Term Blood Pressure Reductions Following Catheter-Based Renal Denervation: A Systematic Review and Meta-Analysis

Long-Term Blood Pressure Reductions Following Catheter-Based Renal Denervation: A Systematic Review and Meta-Analysis

Impact of Renal Denervation on Urinary Peptide-Based Biomarkers in Hypertension

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

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