Safety Of Renal Denervation Research Articles

Effect of RDN on long-term blood pressure in refractory hypertensive patients with different cardiovascular risk stratification

Objective: To investigate the long-term therapeutic effects and safety of renal denervation (RDN) on hypertensive patients with different cardiovascular risks, as well as its impact on adverse events, cardiovascular death and all-cause mortality. Methods: This was a single-center, single-arm, real-world retrospective study. Patients with refractory hypertension who underwent RDN at Tianjin First Central Hospital from July 6, 2011 to December 23, 2015 were enrolled and divided into either a high or intermediate-low risk group based on baseline cardiovascular risk. The treatment responsiveness of hypertensive patients with different cardiovascular stratification to RDN was assessed by comparing the results of office blood pressure, home blood pressure, and 24-h ambulatory blood pressure monitoring at 1, 5, and 11 years after RDN. Long-term safety of RDN was assessed by creatinine, and estimated glomerular filtration rate (eGFR) at 1 and 11 years after RDN. In addition, the total defined daily dose (DDD) of antihypertensive medications and the incidence of long-term adverse events, cardiovascular deaths, and all-cause deaths after RDN were followed up 11 years after RDN in person or by telephone. Results: A total of 62 patients with refractory hypertension, aged (50.2±15.0) years, of whom 35 (56.5%) were male, were included. There were 35 cases in high-risk group and 27 cases in low and medium risk group. The decrease in clinic systolic blood pressure (high risk vs. low-medium risk: (-38.0±15.1) mmHg vs. (-25.0±16.6) mmHg(1 mmHg=0.133kPa),P=0.002), home self-measured systolic blood pressure ((-28.4±12.7) mmHg vs. (-19.7±13.1) mmHg,P=0.011) and clinic systolic blood pressure 11 years after RDN ((-43.0±18.4) mmHg vs. (-27.8±17.9) mmHg,P=0.003) in the high-risk group was significantly higher than that in the low-medium risk group. The differences in heart rate and the decrease in total DDD number of antihypertensive drugs between the two groups were not statistically significant (all P>0.05). Creatinine and eGFR levels in the two groups at 1 and 11 years after RDN were not statistically significant when compared with the baseline values (all P>0.05). The cumulative cardiovascular mortality rate was 1.6% (1/62) and 8.1% (5/62), and the cumulative all-cause mortality rate was 3.2% (2/62) and 11.3% (7/62) at 5 and 11 years after RDN, respectively. The differences in the incidence rate of adverse events, cardiovascular mortality, and all-cause mortality rate between the two groups were not statistically significant (all P>0.05). Conclusions: RDN has long-term antihypertensive effect and good safety. Hypertensive patients who belong to the high-risk stratification of cardiovascular risk may respond better to RDN treatment.

Promising areas of renal denervation application

The review systematizes the latest data on renal denervation (RDN) potential in the treatment of pathologies associated with sympathetic hyperactivation. Despite the controversial results obtained at the beginning of its clinical application, the antihypertensive effect and safety of RDN were subsequently convincingly proven in a number of large randomized studies, which is reflected in current clinical guidelines. Study of RDN effect on the course of resistant hypertension, positive effects on other conditions associated with sympathetic hyperactivation were also identified. In particular, on the course of chronic kidney disease, chronic heart failure, as well as on the decrease of the frequency of paroxysmal atrial fibrillation and ventricular arrhythmia episodes, which ultimately may help for wider method implementation in routine clinical practice. For a long time, many studies have been aimed at identifying the effect of RDN on carbohydrate metabolism and improving the diabetes control. However, despite this, this issue still remains open and the possible future prospects for using RDN to improve the control and prognosis of diabetes in patients with this pathology are currently unclear.

Renal Denervation for Uncontrolled Hypertension

What Is the Issue?
 
 It is estimated that 23% of adults in Canada have hypertension. About 1/3 of this population have uncontrolled hypertension, a condition in which (BP) blood pressure levels continue to remain high despite treatment. People with high BP despite being prescribed 3 or more blood pressure-lowering (antihypertensive) medicines are considered to have uncontrolled resistant hypertension.
 Renal denervation is a therapy that involves disrupting activity in the sympathetic nerves in the renal artery using a minimally invasive catheter-based procedure to treat high BP.
 We wanted to know if renal denervation would effectively and safely reduce BP in people with uncontrolled hypertension.
 
 What Did We Do?
 
 We identified and summarized the literature comparing the clinical effectiveness and safety of renal denervation in individuals with uncontrolled hypertension to help guide decisions on the use of this intervention.
 An information specialist searched for peer-reviewed and grey literature sources published between January 1, 2019, and February 5, 2024. The search was limited to English-language documents. One reviewer screened articles for inclusion based on predefined criteria, critically appraised the included studies, and narratively summarized the findings.
 
 What Did We Find?
 
 The evidence for this report was based on 2 systematic reviews and 3 randomized controlled trials (RCTs).
 Renal denervation could lead to a reduction in BP compared to sham in adults with uncontrolled nonresistant hypertension.
 It is uncertain if renal denervation is an effective treatment for resistant hypertension and suspected hypertensive heart disease due to the methodological limitations of the included studies.
 Serious side effects of renal denervation were rare.
 
 What Does This Mean?
 
 Our findings agree with evidence-based guidelines and real-world evidence that suggest renal denervation can be considered a treatment option for patients with uncontrolled nonresistant hypertension. Other factors, including costs and resources, equity, acceptability, and patient selection, should be considered when implementing renal denervation in Canada, where it remains an emerging medical technology.
 Future research should assess important patient outcomes, such as quality of life.

Ten-year follow-up of very-high risk hypertensive patients undergoing renal sympathetic denervation.

Renal denervation (RDN) has been proven to be effective in lowering blood pressure (BP) in patients, but previous studies have had short follow-ups and have not examined the effects of RDN on major cardiovascular outcomes. This study aimed to demonstrate the effectiveness and safety of RDN in the long-term treatment of hypertension and to determine if it has an effect on cardiovascular outcomes. All patients with resistant hypertension who underwent RDN between 2011 and 2015 at Tianjin First Central Hospital were included in the study. Patients were followed up at 1,5 and 10 years and the longest follow-up was 12 years. Data were collected on office BP, home BP, ambulatory BP monitoring (ABPM), renal function, antihypertensive drug regimen, major adverse events (including acute myocardial infarction, stroke, cardiovascular death and all cause death) and safety events. A total of 60 participants with mean age 50.37 ± 15.19 years (43.33% female individuals) completed long-term follow-up investigations with a mean of 10.02 ± 1.72 years post-RDN. Baseline office SBP and DBP were 179.08 ± 22.05 and 101.17 ± 16.57 mmHg under a mean number of 4.22 ± 1.09 defined daily doses (DDD), with a reduction of -35.93/-14.76 mmHg as compared with baseline estimates ( P < 0.0001). Compared with baseline, ambulatory SBP and DBP after 10-years follow-up were reduced by 14.31 ± 10.18 ( P < 0.001) and 9 ± 4.35 ( P < 0.001) mmHg, respectively. In comparison to baseline, participants were taking fewer antihypertensive medications ( P < 0.001), and their mean heart rate had decreased ( P < 0.001). Changes in renal function, as assessed by estimated glomerular filtration rate (eGFR) and creatinine, were within the expected rate of age-related decline. No major adverse events related to the RDN procedure were observed in long-term consequences. All-cause mortality and cardiovascular mortality rates were 10 and 8.34%, respectively, for the 10-year period. The BP-lowering effect of RDN was safely sustained for at least 10 years post-procedure. More importantly, to the best of my knowledge, this is the first study to explore cardiovascular and all-cause mortality at 10 years after RDN.

Blood pressure reduction after renal denervation in patients with or without chronic kidney disease.

Renal denervation (RDN) has emerged as an adjacent option for the treatment of hypertension. This analysis of the Erlanger registry aimed to compare the blood pressure (BP)-lowering effects and safety of RDN in patients with and without chronic kidney disease (CKD). In this single-center retrospective analysis, 47 patients with and 127 without CKD underwent radiofrequency-, ultrasound- or alcohol-infusion-based RDN. Office and 24-h ambulatory BP and estimated glomerular filtration rate (eGFR) were measured at baseline, and after 6 and 12months. A total of 174 patients with a mean age of 59.0±10years were followed up for 12months. At baseline, mean eGFR was 55.8±21mL/min/1.73 m2 in patients with CKD and 87.3±13mL/min/1.73 m2 in patients without CKD. There was no significant eGFR decline in either of the groups during 12months of follow-up. In patients without CKD, office systolic and diastolic BP were reduced by -15.3±17.5/-7.9±10.8mmHg 6months after RDN and by -16.1±18.2/-7.7±9.6mmHg 12months after RDN. In patients with CKD, office systolic and diastolic BP were reduced by -10.7±24.0/-5.8±13.2mmHg 6months after RDN and by -15.1±24.9/-5.9±12.9mmHg 12months after RDN. Accordingly, in patients without CKD, 24-h ambulatory systolic and diastolic BP were reduced by -7.2±15.8/-4.9±8.8mmHg 6months after RDN and by -9.0±17.0/-6.2±9.8mmHg 12months after RDN. In patients with CKD, 24-h systolic and diastolic BP were reduced by -7.4±12.9/-4.2±9.9mmHg 6months after RDN and by -8.0±14.0/-3.6±9.6mmHg 12months after RDN. There was no difference in the reduction of office and 24-h ambulatory BP between the two groups at any time point (all P>.2). Similar results have been found for the 6months data. With exception of rare local adverse events, we did not observe any safety signals. According to our single-center experience, we observed a similar reduction in 24-h, day and night-time ambulatory BP as well as in-office BP in patients with and without CKD at any time point up to 12months. We conclude that RDN is an effective and safe treatment option for patients with hypertension and CKD.

Long-term effectiveness of radiofrequency renal denervation in patients with resistant arterial hypertension (10-year follow-up results)

The aim – to determine the long-term efficacy and safety of renal denervation (RDN) at 10-year follow-up.Materials and methods. We selected 1146 patients with resistant arterial hypertension (RAH) who received 3 or more antihypertensive drugs. 16 patients were selected for renal artery denervation. RDN was performed in 8 patients (0.70 %). 8 patients refused the procedure. The age was 52.13 ± 3.88 years (40–66), the duration of hypertension was 16.75 ± 2.17 (12–25) years. The number of antihypertensive drugs was 5.5 ± 0.18. Office SBP/DBP on optimization of therapy in patients was 156.88/95.00 ± 2.98 mm Hg and heart rate – 68.88 ± 3.28 beats/min. 24SBP/DBP was 149.16 ± 5.40/86.98 ± 5.08 mm Hg. 24HR was 70.12 ± 2.94 beats/min. All patients tolerated the procedure well.Results and discussion. The decrease in office SBP/DBP was –12.59/–10.0 mm Hg; –11.17/–2.57 mm Hg; –20.31/–11.71 mm Hg, –27.71/–13.33 mm Hg and –30.21/–16.67 mm Hg, in the dynamics of 1 month, 12 months, 2 years, 5 years and 10 years, respectively, p &lt;0.05 for all values compared to the initial. The office heart rate at the stages of 1 month, 6, 12 months, 2 years, 5 and 10 years decreased, its dynamics were –3.74 bpm, –4.68 bpm, –1.45 bpm, –2.13 bpm, –4.21 bpm, –3.88 bpm, respectively. The decrease in 24SBP/DBP was –14.45/–6.95 mmHg, –8.70/–10.01 mm Hg, –19.45/–12.37 mm Hg, –19.91/–11.24 mm Hg, –29.93/–13.61 mm Hg. and –26.13/–23.35 mm Hg (p&lt;0.05 for all values). 24HR dynamics: –3.16 bpm, – 4.19 bpm, + 1.43 bpm, –1.51 bpm, –4.46 bpm, and –5.49 bpm, respectively. After 2, 5, and 10 years, all patients reached the target blood pressure level both in the office and with ABPM. Patients reduced the number of antihypertensive drugs from 5.50 ± 0.18 to 3.50 ± 0.30 – after 5 years and 3.67 ± 0.18 – after 10 years after RDN. GFR practically did not change over 10 years from 76.10 ± 5.62 to 64.60 ± 1.93 ml/min/1.73m2, p&gt;0.05. One patient died of thyroid cancer 2 years later. All other patients are alive and have not had any cardiovascular event or death during 10 years.Conclusion. Long-term results of renal artery denervation showed no cases of cardiovascular events, development of diabetes or cardiovascular death over 10 years. RDN contributed to a reduction in the number of antihypertensive drugs from 5.5 to 3.67 after 10 years of therapy against the background of 100 % achievement of the target BP level.

Efficacy and safety of renal denervation in resistant hypertension: two years follow-up

Hypertension remains a major cause of cardiovascular morbidity and mortality globally. Difficulties faced by clinicians to obtain adequate blood pressure control in patients with resistant hypertension have led to the development of alternative device-based treatment methods, one of which is renal artery denervation. In the current paper, the results of the study carried out in the Hypertension Department of the Institute of Cardiology regarding the evaluation of the effectiveness and safety of renal artery denervation in patients with resistant HTN two years post-procedural are presented.

BLOOD PRESSURE REDUCTION AFTER RENAL DENERVATION IN PATIENTS WITH OR WITHOUT CHRONIC KIDNEY DISEASE: THE ERLANGER EXPERIENCE

Objective: Renal denervation (RDN) has emerged as an adjacent option for the treatment of hypertension. This analysis of the ERLANGER registry aimed of comparing the blood pressure (BP) lowering effects and safety of RDN in patients with and without CKD. Design and method: Radiofrequency, ultrasound or alcohol-infusion device based RDN was performed in 47 patients with and 127 without CKD. Office and 24-h ambulatory BP were measured at baseline, after 6 and 12 months. We splitted the study cohort based on the median systolic 24h ABP reduction after 6 months into responders and non-responders and compared baseline characteristics between these groups. CKD was defined by clinical diagnosis, estimated glomerular filtration rate (eGFR: 15-59 ml/min/1.73m2) or A2 albuminuria (&gt; = 30 mg/g creatinine ). Results: 174 patients with a mean age of 59.0±10 were followed up for at least 12 months. At baseline mean eGFR was 55.8±21 ml/min/1.73m2 in patients with CKD and 87.3±13 ml/min/1.73m2 in patients without CKD according to the CKD-EPI formula. There was no significant eGFR decline in either of the groups during follow up. Office and 24-h systolic and diastolic BP were significantly reduced from baseline in patients with or without CKD at all time points after RDN (all p&lt;0.01). There was no significant difference in the reduction of 24h, day- and nighttime ABP between the 2 groups at any time point (see table below). In addition to 24h baseline systolic ABP we identified several predictors (all p &lt; 0.05): patients with a high baseline office heart rate (HR), without T2D, without diuretic medication and current smokers were more likely to be responders. With exception of rare local adverse events (e.g. haematoma at the puncture site), we had no safety signals, especially in our patients with CKD. Conclusions: According to our single center experience, we observed a similar reduction in 24-h, day and nighttime ambulatory BP as well as in office BP in patients with and without CKD at any time point up to 12 months. We conclude that RDN is an effective and safe treatment option for patients with arterial hypertension and CKD.

4. Safety of Renal Denervation as Treatment for Resistant Hypertension: A Systematic Review

Hypertension is very common throughout the world's population, which many people are unaware of, but it is still rising in population and causing a major public health problem. One of the methods used in treating resistant hypertension is renal denervation. However, studies on its safety and vascular complications effects are still unknown. The purpose of this study was to find out the safety of renal denervation in patients with resistant hypertension. This review was conducted on 10–17 December 2022. Two independent researchers systematically extracted data from several databases, such as PubMed Central (PMC), Science Direct, and PUBMED by using MeSH terminology of keywords renal denervation, hypertension, and safety. The extracted studies were then analyzed and selected according to our inclusion criteria such as studies in the last 5 years, cohort studies, and case-control studies. We excluded systematic reviews, meta-analyses, case series, case reports, studies on pregnant women, children, and animals. Research quality was assessed using Newcastle-Ottawa (NOS). From 4 cohort studies (166 subjects from various countries), 3 of them showed renal denervation has a favorable safety profile in gaining blood pressure control. The safety endpoint such as all-cause death and vascular complication were reached, but one study reported one patient with progression of renal artery stenosis and hypertensive urgency; All studies have proven good quality based on NOS. In conclusion, renal denervation showed efficacy by sustained blood pressure reducing effect in patients with resistant hypertension. However, further study is needed to confirm these findings.

Renal denervation in management of heart failure with reduced ejection fraction: A systematic review and meta-analysis

BackgroundSome, but not all, recent studies have shown that renal denervation (RDN) can improve cardiac function and exercise tolerance in people who have heart failure with reduced ejection fraction (HFrEF). This study assessed the efficacy and safety of RDN as a treatment for HFrEF. MethodsThe Medline, Cochrane Library, Embase, and PubMed databases were searched through to September 28, 2022 for clinical studies that evaluated the effect of RDN on HFrEF. The primary endpoints were changes in left ventricular ejection fraction (LVEF) and 6-min walk distance (6MWD). Secondary endpoints were changes in echocardiographic parameters, including left ventricular end-diastolic and end-systolic diameters, left atrial diameter, and interventricular septal thickness. N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels, New York Heart Association (NYHA) class, heart rate, and systolic and diastolic blood pressure were also evaluated. Major adverse events were defined as death and rehospitalization for heart failure during follow-up. The estimated glomerular filtration rate (eGFR) and serum creatinine level were extracted as measures of renal function. ResultsEleven trials comprising 313 patients were eligible for quantitative analysis. Pooled analyses showed a mean increase in LVEF of 4.25 % (95 % CI 1.77–6.72; p < 0.001, I2 = 69 %) and an increase in 6MWD (mean difference 50.28 m, 95 % CI 8.78–91.78; p = 0.02; I2 = 81 %) after RDN. Left ventricular end-diastolic and end-systolic diameters, left atrial diameter, and interventricular septal thickness also improved after RDN. NT-proBNP, NYHA class, and heart rate were significantly decreased after RDN. There were no significant changes in blood pressure after RDN. Mortality and HF-related hospitalization rates were relatively low. There was no significant change in eGFR or creatinine after RDN. ConclusionsOur findings suggest that RDN can effectively increase LVEF and 6MWD in patients with HFrEF but require confirmation in studies with larger sample sizes and longer follow-up durations.

JS-HR-10: ADVANCES IN RENAL DENERVATION FOR TREATING HYPERTENSION

Excessive activation of sympathetic nervous system is closely related to the onset and progression of hypertension. Renal nerves are composed of sympathetic efferent and sensory afferent nerves. Activation of the efferent renal sympathetic nerves induces renin secretion, sodium absorption, and increased renal vascular resistance, which lead to increased blood pressure (BP) and fluid retention. Afferent renal sensory nerves, which are densely innervated in the renal pelvic wall, project to the cardiovascular center in the brain to modulate sympathetic outflow to the periphery, including the heart, kidneys, and arterioles. Renal denervation (RDN) is a neuromodulation therapy that partially interrupts both the efferent outputs from the brain to the kidney and the afferent inputs from the kidney to the brain and has attracted attention as a novel device therapy for hypertension. In clinical practice, denervation is performed through the lumen of the renal artery using a catheter. Radiofrequency, ultrasound, and alcohol-based RDN devices are being developed as new second-generation devices. A randomized sham-controlled trials using 24-hour ambulatory BP measurement is required for approval of clinical use of RDN. The SPYRAL HTN OFF-MED pivotal trial showed the superiority of RDN using radiofrequency-based catheter compared with a sham procedure to safely lower 24-hour systolic BP in the absence of antihypertensive medications. The RADIANCE-HTN TRIO trials showed the superiority of RDN using ultrasound-based catheter compared with a sham procedure to safely lower daytime BP in patients with resistant hypertension. The REQUIRE trial is the first trial of ultrasound RDN in Asian patients from Japan and South Korea with resistant hypertension. The study findings were neutral for the primary endpoint, with similar reductions in 24-hour systolic BP in the RDN and sham control groups. Although BP reduction after RDN was similar to other sham-controlled studies, the sham group in this study showed much greater reduction. Japanese Society of Hypertension performed the meta-analysis of nine randomized sham-controlled trials of RDN including these three trials mentioned above. The results showed that RDN significantly reduced a range of office, home and 24-hour BP parameters in patients with resistant, uncontrolled, and drug-naïve hypertension. There were no significant differences in magnitude of BP reduction between radiofrequency-based and ultrasound-based devices. Recently, the efficacy and safety of RDN in the SPYRAL HTN OFF-MED pivotal trial up to 36 months have been reported. In this session, the latest basic and clinical evidence/aspects of RDN will be summarized and discussed, which is about to be introduced into the clinical practice.

Consensus and inconsistency between different consensus documents on renal denervation worldwide: the way forward.

Given the unsatisfactory hypertension control rates and high rates of non-adherence to antihypertensive medications worldwide, device therapy which can safely provide durable blood pressure-lowering effects can fulfill the unmet need. A series of second-generation randomized sham-controlled renal denervation (RDN) trials have demonstrated the efficacy and safety of RDN in a wide range of hypertensive patients. The four representative consensus documents on RDN (from the Chinese Taiwan Hypertension Society and Taiwan Society of Cardiology [THS/TSOC 2019], Asia Renal Denervation Consortium 2019, European Society of Hypertension [ESH 2021], and Society for Cardiovascular Angiography & Intervention and National Kidney Foundation [SCAI/NKF 2021]) consistently recommend RDN as an alternative or complementary treatment strategy for patients with uncontrolled hypertension. In addition, both documents from Asia further recommend that RDN can be considered as an initial treatment strategy for drug-naïve hypertensive patients. There is still inconsistency regarding whether ambulatory blood pressure monitoring should be used routinely both before and after RDN, and whether patients with a secondary cause of hypertension could be treated with RDN if their blood pressure remains uncontrolled after definitive treatment (treatment-resistant secondary hypertension). The THS/TSOC consensus provides acronyms to summarize key aspects of patient selection (RDNi2) and pre-RDN assessments (RAS). The ESH and SCAI/NKF documents recommend establishing structured pathways for clinical practice and issues regarding reimbursement. All documents identify knowledge gaps in RDN, from identifying predictors of super-responders to demonstrating effects on cardiovascular events. These gaps should be urgently filled to facilitate the wider application of this device therapy for patients with hypertension.

Resistant hypertension: integrated strategies between pharmacological treatment and renal denervation

The achievement of adequate blood pressure (BP) control and the management of resistant hypertension still represent two burning "unmet needs" in the field of cardiovascular diseases, thus originating a continuous search for more efficacious pharmacological and non-pharmacological strategies including radiofrequency and ultrasound renal denervation (RDN). The most recent guidelines recommend a combination therapy of two or more antihypertensive agents, preferably in a single-pill formulation, as first-line strategy to achieve an effective and early BP control also improving adherence to prescribed treatments. In the last few years several sham-controlled trials have confirmed both the BP-lowering efficacy and safety of RDN in a broad range of patients with hypertension, showing a significant reduction of office and ambulatory BP levels without a relevant increase of procedure-related adverse events such as renal artery stenosis and worsening renal function. These results have been recently confirmed by the analyses of 3-year follow-up data. According to these findings, RDN may represent a useful tool in addition to pharmacological treatment with more compelling indications for patients with resistant hypertension, those who are non-adherent or intolerant to multiple antihypertensive drugs or express a preference to undergo RDN. Further studies are necessary to explore the efficacy of RDN on prevention of hypertension-mediated organ damage and reduction of major cardiovascular events.

Long-term efficacy and safety of renal denervation: another brick for building a hybrid therapy for hypertension?

Long-term efficacy and safety of renal denervation: another brick for building a hybrid therapy for hypertension?

Insight on Efficacy of Renal Artery Denervation for Refractory Hypertension with Chronic Kidney Diseases: A Long-Term Follow-Up of 24-Hour Ambulatory Blood Pressure.

Aims To explore the long-term efficacy and safety of renal denervation in patients with RHT and CKD, a post hoc analysis of eGFR subgroups was completed. Methods Fifty-four patients with refractory hypertension with chronic kidney disease were treated with RDN and enrolled in the study. Patients were divided into three groups according to eGFR: eGFR 46–90 ml/min group, eGFR 15–45 ml/min group, and eGFR <15 ml/min group. The planned follow-up period was 48 months to assess 24 h ambulatory blood pressure, renal function, type of antihypertensive medication, and RDN complications. Results The ablation sites of the GFR 46–90 ml/min group and GFR 15–45 ml/min group were 32.57 ± 2.99 and 29.53 ± 5.47, respectively. No complications occurred in the GFR 46–90 ml/min group. The GFR<15 ml/min group was treated with 27.07 ± 5.59 ablation. Renal artery dissection occurred in each group of GFR 15–45 ml/min and GFR <15 ml/min. And renal stent implantation artery was performed on these two patients. No severe renal artery stenosis occurred. There were no significant differences in Scr and eGFR between the three groups at each follow-up point. Compared with baseline, SBP was significantly of each group decreased to varying degrees at each follow-up time point. SBP decreased most in the GFR 46–90 ml/min group. Compared with baseline, the type of antihypertensive drugs used in the GFR46-90 ml/min group decreased significantly except for 36 and 48 months. At 48 months' postadmission, there was a significant decrease in the type of antihypertensive medication used in the GFR15-45 ml/min group, and there was no significant decrease in the type of antihypertensive medication used in the GFR<15 ml/min group. Conclusions RDN can safely reduce SBP in CKD patients combined with RHT for 48 months, with the most pronounced reduction in the GFR15-45 ml/min group. The variety of antihypertensive drugs was significantly reduced after RDN. This was particularly evident in patients with GFR 15–45 ml/min.

Renal denervation in resistant hypertension treatment.

Purpose of the study is the assessment of the effectiveness of renal denervation with different types of catheters, as well as its long-term effects, in the patients with resistant hypertension. This single-center prospective study included 81 patients who underwent a renal denervation procedure using 2 types of catheters: monopolar and helical (Medtronic Inc., Minneapolis, Minnesota, the USA) between 2015 and 2018. Baseline demographics, clinical, functional and laboratory characteristics of the patients were assessed. A comparative analysis of the dynamics of office systolic and diastolic blood pressure during 5 years of follow-up was carried out. The Kaplan-Meier method was used to study the survival of the patients with resistant hypertension after renal denervation. A total of 81 patients with a mean age of 57.79 ± 9.87 years, of whom 37.04 % were men, were included in the 2-stage study (first stage using monopolar catheters and second stage using spiral catheters). At the time of inclusion, study participants were receiving an average of 4.5 ± 1.4 antihypertensive medications. In 36 (or 44.4 %), the procedure was performed using a monopolar catheter; in 45 (or 55.6 %), a spiral catheter was used. There were no statistically significant differences between the two groups of the patients. The analysis established statistically significant changes in the dynamics of office SBP and DBP (p < 0.001) assessed 1, 2, 3, 4, and 5 years after the renal denervation procedure. The analysis demonstrated a stability in the reduction of office SBP and DBP during the 5-year follow-up. The results of the study showed that the median survival time was 1061 days from the beginning of follow-up (95% CI: 728.03 to 1 393.97 days); the median survival time in the monopolar catheter group was 777 days (95% CI: 692.314 to 861.686) and in the spiral catheter group 1 294 days (95% CI: 713.079 to 1 874.921). Our results demonstrated the efficiency and safety of renal denervation in both short-term and long-term follow-up using monopolar and spiral catheters in the treatment of uncontrolled hypertension with combined antihypertensive therapy. The most significant is the demonstrated stability of the effect after the procedure. In addition, the survival rate of the patients with resistant hypertension after the intervention has been carried out (Tab. 2, Fig. 3, Ref. 22).

Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs (SPYRAL HTN-ON MED): a randomised, sham-controlled trial

Renal denervation has been shown to lower blood pressure in the presence of antihypertensive medications; however, long-term safety and efficacy data from randomised trials of renal denervation are lacking. In this pre-specified analysis of the SPYRAL HTN-ON MED study, we compared changes in blood pressure, antihypertensive drug use, and safety up to 36 months in renal denervation versus a sham control group. This randomised, single-blind, sham-controlled trial enrolled patients from 25 clinical centres in the USA, Germany, Japan, the UK, Australia, Austria, and Greece, with uncontrolled hypertension and office systolic blood pressure between 150 mm Hg and 180 mm Hg and diastolic blood pressure of 90 mm Hg or higher. Eligible patients had to have 24-h ambulatory systolic blood pressure between 140 mm Hg and less than 170 mm Hg, while taking one to three antihypertensive drugs with stable doses for at least 6 weeks. Patients underwent renal angiography and were randomly assigned (1:1) to radiofrequency renal denervation or a sham control procedure. Patients and physicians were unmasked after 12-month follow-up and sham control patients could cross over after 12-month follow-up completion. The primary endpoint was the treatment difference in mean 24-h systolic blood pressure at 6 months between the renal denervation group and the sham control group. Statistical analyses were done on the intention-to-treat population. Long-term efficacy was assessed using ambulatory and office blood pressure measurements up to 36 months. Drug surveillance was used to assess medication use. Safety events were assessed up to 36 months. This trial is registered with ClinicalTrials.gov, NCT02439775; prospectively, an additional 260 patients are currently being randomly assigned as part of the SPYRAL HTN-ON MED Expansion trial. Between July 22, 2015, and June 14, 2017, among 467 enrolled patients, 80 patients fulfilled the qualifying criteria and were randomly assigned to undergo renal denervation (n=38) or a sham control procedure (n=42). Mean ambulatory systolic and diastolic blood pressure were significantly reduced from baseline in the renal denervation group, and were significantly lower than the sham control group at 24 and 36 months, despite a similar treatment intensity of antihypertensive drugs. The medication burden at 36 months was 2·13 medications (SD 1·15) in the renal denervation group and 2·55 medications (2·19) in the sham control group (p=0·26). 24 (77%) of 31 patients in the renal denervation group and 25 (93%) of 27 patients in the sham control group adhered to medication at 36 months. At 36 months, the ambulatory systolic blood pressure reduction was -18·7 mm Hg (SD 12·4) for the renal denervation group (n=30) and -8·6 mm Hg (14·6) for the sham control group (n=32; adjusted treatment difference -10·0 mm Hg, 95% CI -16·6 to -3·3; p=0·0039). Treatment differences between the renal denervation group and sham control group at 36 months were -5·9 mm Hg (95% CI -10·1 to -1·8; p=0·0055) for mean ambulatory diastolic blood pressure, -11·0 mm Hg (-19·8 to -2·1; p=0·016) for morning systolic blood pressure, and -11·8 mm Hg (-19·0 to -4·7; p=0·0017) for night-time systolic blood pressure. There were no short-term or long-term safety issues associated with renal denervation. Radiofrequency renal denervation compared with sham control produced a clinically meaningful and lasting blood pressure reduction up to 36 months of follow-up, independent of concomitant antihypertensive medications and without major safety events. Renal denervation could provide an adjunctive treatment modality in the management of patients with hypertension. Medtronic.

Renal denervation : Really an alternative to reducing blood pressure?

Since the current guidelines were published in 2018, a total of 5sham-controlled high-quality studies evaluating renal denervation have been conducted and the results were published. These five studies clearly confirmed the efficacy and safety of renal denervation, which correspond to the knowledge of the Clinical Consensus Conference. Thus, an update of the guidelines for the treatment of arterial hypertension regarding the clinical significance of renal denervation is urgently necessary. For this reason, the position paper of the working group of the European Society of Hypertension on the current state of renal denervation was reviewed. An approval of this procedure can soon be expected. In Germany there is a diagnosis-related group (DRG) for the reimbursement of renal denervation, which was suspended due to the erroneous Symplicity 3study. This DRG should be revived in practice by a structured process of the implementation of renal denervation. It will then be ajoint task of treating physicians and specialists in certified centers to identify eligible patients. In the future, antihypertensive treatment will consist of three pillars: lifestyle measures, pharmacotherapy and interventional treatment. These three treatment options should not be regarded as competitive (which is better) but alternative (patient preference) and additive (the aim is blood pressure control). It is the task of the treating physician to provide the patient with the ideal treatment concept. Clearly, renal denervation will not replace antihypertensive pharmacotherapy; however, it can lead to areduction of the drug burden and increase of patient adherence to medication. It represents an option of modern antihypertensive treatment and will also become increasingly more important in special patient groups.

Renal denervation in hypertension patients: Proceedings from an expert consensus roundtable cosponsored by SCAI and NKF.

Renal denervation in hypertension patients: Proceedings from an expert consensus roundtable cosponsored by SCAI and NKF.

Ultrasound renal denervation for hypertension resistant to a triple medication pill (RADIANCE-HTN TRIO): a randomised, multicentre, single-blind, sham-controlled trial

Endovascular renal denervation reduces blood pressure in patients with mild-to-moderate hypertension, but its efficacy in patients with true resistant hypertension has not been shown. We aimed to assess the efficacy and safety of endovascular ultrasound renal denervation in patients with hypertension resistant to three or more antihypertensive medications. In a randomised, international, multicentre, single-blind, sham-controlled trial done at 28 tertiary centres in the USA and 25 in Europe, we included patients aged 18-75 years with office blood pressure of at least 140/90 mm Hg despite three or more antihypertensive medications including a diuretic. Eligible patients were switched to a once daily, fixed-dose, single-pill combination of a calcium channel blocker, an angiotensin receptor blocker, and a thiazide diuretic. After 4 weeks of standardised therapy, patients with daytime ambulatory blood pressure of at least 135/85 mm Hg were randomly assigned (1:1) by computer (stratified by centres) to ultrasound renal denervation or a sham procedure. Patients and outcome assessors were masked to randomisation. Addition of antihypertensive medications was allowed if specified blood pressure thresholds were exceeded. The primary endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Safety was also assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT02649426. Between March 11, 2016, and March 13, 2020, 989 participants were enrolled and 136 were randomly assigned to renal denervation (n=69) or a sham procedure (n=67). Full adherence to the combination medications at 2 months among patients with urine samples was similar in both groups (42 [82%] of 51 in the renal denervation group vs 47 [82%] of 57 in the sham procedure group; p=0·99). Renal denervation reduced daytime ambulatory systolic blood pressure more than the sham procedure (-8·0 mm Hg [IQR -16·4 to 0·0] vs -3·0 mm Hg [-10·3 to 1·8]; median between-group difference -4·5 mm Hg [95% CI -8·5 to -0·3]; adjusted p=0·022); the median between-group difference was -5·8 mm Hg (95% CI -9·7 to -1·6; adjusted p=0·0051) among patients with complete ambulatory blood pressure data. There were no differences in safety outcomes between the two groups. Compared with a sham procedure, ultrasound renal denervation reduced blood pressure at 2 months in patients with hypertension resistant to a standardised triple combination pill. If the blood pressure lowering effect and safety of renal denervation are maintained in the long term, renal denervation might be an alternative to the addition of further antihypertensive medications in patients with resistant hypertension. ReCor Medical.