Catheter-based Renal Denervation Research Articles

Catheter-Based Renal Artery Denervation

Catheter-Based Renal Artery Denervation

F-3 | The Effect Of Catheter-Based Renal Denervation On Cardiovascular Outcomes and Atrial Fibrillation In Recent Clinical Trials: A Systematic Review

F-3 | The Effect Of Catheter-Based Renal Denervation On Cardiovascular Outcomes and Atrial Fibrillation In Recent Clinical Trials: A Systematic Review

ENDOVASCULAR RADIOFREQUENCY RENAL DENERVATION IN DIFFICULT TO TREAT ARTERIAL HYPERTENSION: A SINGLE CENTER EXPERIENCE

Objective: To assess safety and effectiveness of catheter-based renal denervation (RDN) for reduction of blood pressure (BP) in patients with difficult to treat arterial hypertension. Design and method: Thirtyfive patients selected with difficult to treat arterial hypertension, underwent RDN. Secondary forms of hypertension were excluded, and an appropriate renal artery anatomy was confirmed in all patients. Every patient underwent follow-up at 30 days, and then every 12 months, consisting in clinical examination, office BP measurements, ambulatory blood pressure monitoring, and biochemical analysis. At 12 months tansthoracic echocardiography and renal duplex sonography were performed. Results: The median value of systolic clinic BP decreased from 161 mmHg (25th-75th percentiles 158 - 191) at baseline to 144 mmHg (25th-75th percentiles 136 - 153) at follow up (p= 0.012), and the median value of diastolic clinic BP decreased from 102 mmHg (25th-75th percentiles 94 - 122) at baseline to 90 mmHg (25th-75th percentiles 78 - 99) at follow-up (p= 0.012). The number of medications changed from 5 (range 2-8) at baseline to 3.3 (range 0-6) at follow up. A significant decrease of left ventricular mass index from a median of 160 g/m2 (25th-75th percentiles 147 - 151) at baseline to 126 g/m2 (25th-75th percentiles 107 - 151) at follow-up (p= 0.043) was detected. The renal function did not demonstrate significant changes, however plasma renin activity and HOMA index were significantly reduced. No periprocedural or long term complications were observed. Conclusions: Our data confirm that RDN may constitute an effective and safe therapeutic choice for the treatment of difficult to treat hypertension.

Sympathetic Pathophysiology in Hypertension Origins: The Path to Renal Denervation.

The importance of the sympathetic nervous system in essential hypertension has been recognized in 2 eras. The first was in early decades of the 20th century, through to the 1960s. Here, the sympathetic nervous system was identified as a target for the treatment of hypertension, and an extensive range of antiadrenergic therapies were developed. Then, after a period of lapsed interest, in a second era from 1985 on, the development of precise measures of human sympathetic nerve firing and transmitter release allowed demonstration of the importance of neural mechanisms in the initiation and maintenance of the arterial blood pressure elevation in hypertension. This led to the development of a device treatment of hypertension, catheter-based renal denervation, which we will discuss.

Renal denervation in the management of hypertension.

Arterial hypertension is a global leading cause of cardiovascular, cerebrovascular, and renal disease, as well as mortality. Although pharmacotherapy is safe and effective in lowering blood pressure (BP) and cardiovascular disease risk, BP control remains poor, and the mortality rates associated with high BP have been steadily increasing. Device-based therapies have been investigated to overcome barriers to pharmacotherapy, including non-adherence and low rates of persistence to daily medications. Among these device-based therapies, catheter-based renal denervation (RDN) has been most extensively examined over the past 15 years. In this state-of-the-art article, we summarise the rationale for RDN, review the available evidence, provide recommendations for a safe procedure, and discuss the role of RDN in current guidelines and clinical practice.

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

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. 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. 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. 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.

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

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. This study evaluates the 10-year safety and efficacy of renal denervation in resistant hypertension. 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. Thirty-nine patients completed the 10-year follow-up (mean follow-up duration 9.4 ± 0.7years). Baseline office and 24-h ambulatory systolic blood pressure were 164 ± 23mmHg and 153 ± 16mmHg, respectively. After 10years, 24-h ambulatory and office systolic blood pressure were reduced by 16 ± 17mmHg (P < 0.001) and 14 ± 23mmHg (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 60mL/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. Renal denervation was safe and sustainedly reduced ambulatory and office blood pressure out to 10years in patients with resistant hypertension.

Catheter-Based Ultrasound Renal Denervation in Patients with Resistant Hypertension: A Systematic Review

Background: The maintenance and development of hypertension are fundamentally dependent on renal sympathetic hyperactivity. Through regulation of the renal sympathetic nerves, catheter-based renal sympathetic denervation has been demonstrated to dramatically lower blood pressure (BP) in patients with resistant hypertension (systolic blood pressure 160 mm Hg on three or more antihypertensive medicines, including a diuretic). This study assessed a catheter-based ultrasound device of the next generation intended to maximize nerve coverage using circumferential ultrasound energy. This study's objective is to describe the results of renal denervation (RDN) in patients with resistant hypertension using a catheter-based ultrasonography device to measure blood pressure and safety. A potential new non-pharmacological therapy for resistant hypertension is renal denervation. Method: PubMed, Web of Science, Science Direct, Cochrane Library, and Google Scholar were thoroughly searched for relevant material. Throughout this meticulous process, the Rayyan QRCI was used. Results: our review included 10 studies with parameters including the period of study, age range of patients, office blood pressure, ambulatory blood pressure and the used approach. Clinical studies are required to determine whether this method is effective in treating this resistant hypertension. Conclusion: In individuals with resistant hypertension, catheter-based ultrasound renal denervation significantly and persistently lowers blood pressure and has no negative effects on renal function or renal artery anatomy.

Taming resistant hypertension: The promise of novel pharmacologic approaches and renal denervation.

Resistant hypertension is associated with an exceedingly high cardiovascular risk and there remains an unmet therapeutic need driven by pathophysiologic pathways unaddressed by guideline-recommended therapy. While spironolactone is widely considered as the preferable fourth-line drug, its broad application is limited by its side effect profile, especially off-target steroid receptor-mediated effects and hyperkalaemia in at-risk subpopulations. Recent landmark trials have reported promising safety and efficacy results for a number of novel compounds targeting relevant pathophysiologic pathways that remain unopposed by contemporary drugs. These include the dual endothelin receptor antagonist, aprocitentan, the aldosterone synthase inhibitor, baxdrostat and the nonsteroidal mineralocorticoid receptor antagonist finerenone. Furthermore, the evidence base for consideration of catheter-based renal denervation as a safe and effective adjunct therapeutic approach across the clinical spectrum of hypertension has been further substantiated. This review will summarise the recently published evidence on novel antihypertensive drugs and renal denervation in the context of resistant hypertension.

Long-term outcomes of renal denervation in the treatment of comorbid patients with hypertension, diabetes and coronary atherosclerosis

Aim. To study the clinical effects and long-term outcomes of catheterbased renal denervation (CRD) in patients with cardiovascular disease and diabetes.Material and methods. This single-center prospective observational study included 60 patients with uncontrolled hypertension, type 2 diabetes, and coronary artery disease after complete endovascular revascularization. Patients were divided into 30 groups into the CRD group and the control group. CRD was performed via femoral access using a Spyral catheter (Medtronic, USA). The primary endpoint was the change in glycemic levels after 12 months.Results. In the CRD group, a significant decrease in basal glycemia level from 9,3 (7,67-10,12) to 6,05 (5,2-8,3) mmol/l, glycated hemoglobin from 7,6 (6,98,4) to 6,6 (6,2-7,2)%, Homeostasis Model Assessment Insulin Resistance (HOMA-IR) from 6,6 (3,73-11,2) to 4,76 (2,73-7,1) — in the absence of significant changes in the control group. A significant decrease in the average level of office systolic (-14 (-24; -10) mm Hg, p=0,0002) and diastolic blood pressure (-10 (-10; -6) mm Hg, p=0,0002), p=0,0007) was also revealed — in the absence of significant changes in the control group. There were no significant differences in late lumen loss between the groups: 21,8% (17,3-28,8) in the CRD group vs 26,3% (19,5-34,0) in the control group (p=0,09).Conclusion. A positive effect of CRD on carbohydrate metabolism in patients with type 2 diabetes, hypertension and coronary artery disease was revealed. The hypothesis of the pleiotropic effects of CRD was confirmed.

Italian Society of Interventional Cardiology (GISE) and Italian Society of Arterial Hypertension (SIIA) Consensus document on the role of renal denervation in the management of the difficult to treat hypertension

Arterial hypertension is the most prevalent cardiovascular risk factor worldwide. Despite the availability of many and effective antihypertensive medications, the prevalence of uncontrolled blood pressure (BP) remains high. As sympathetic hyperactivity has long been recognized as a major contributor to resistant hypertension, catheter-based renal denervation (RDN) has emerged as a new strategy to reduce BP. RDN aims to interrupt the activity of renal sympathetic nerves by applying radiofrequency (RF) energy, ultrasound (US) energy, or injection of alcohol in the perivascular space. The Symplicity HTN-3 trial, the largest sham-controlled trial using the first-generation RF-based RDN device, failed to significantly reduce BP. Since then, new devices and techniques have been developed and consequently many sham-controlled trials using second-generation RF or US-based RDN devices have demonstrated the BP lowering efficacy and safety of the procedure. A multidisciplinary team involving hypertension experts, interventionalists with expertise in renal interventions and anesthesiologists, plays a pivotal role from the selection of the patient candidate for the procedure to the post-procedural care. The aim of this consensus document is to summarize the current evidence about the use of RDN in difficult to treat hypertension and to propose a management strategy from the selection of the patient candidate for the procedure to the post-procedural care.

Management of Resistant Hypertension.

Resistant hypertension (RH) is a severe form of hypertension associated with increased cardiovascular risk. Although true RH affects less than 10% of the patients receiving antihypertensive therapy, the absolute number is high and continues to increase. The workup of these patients requires screening for secondary hypertension and pseudoresistance, including poor adherence to prescribed medicines and the white-coat phenomenon. The treatment of RH consists of lifestyle modifications and pharmacological therapies. Lifestyle modifications include dietary adjustments, weight loss, physical activity, and limiting alcohol consumption; pharmacological therapies include diuretics, mineralocorticoid receptor antagonists, beta blockers, angiotensin receptor-neprilysin inhibitors, and others. Over the last 15 years, interventional approaches have emerged as adjunct treatment options; we highlight catheter-based renal denervation. This review summarizes the rationales and latest clinical evidence and, based thereon, proposes an updated algorithm for the management of RH.

Endovascular ultrasound renal denervation to lower blood pressure in young hypertensive women planning pregnancy: study protocol for a multicentre randomised, blinded and sham controlled proof of concept study

IntroductionA major issue confronting clinicians treating hypertension in pregnancy is the limited number of pharmacological options. Endovascular catheter-based renal denervation (RDN) is a new method to lower blood pressure (BP)...

Renal Denervation as a Complementary Treatment Option for Uncontrolled Arterial Hypertension: A Situation Assessment.

Uncontrolled arterial hypertension is a major global health issue. Catheter-based renal denervation has shown to lower blood pressure in sham-controlled trials and represents a device-based, complementary treatment option for hypertension. In this situation assessment, the authors, who are practicing experts in hypertension, nephrology, general practice and cardiology in the Republic of Ireland, discuss the current evidence base for the BP-lowering efficacy and safety of catheter-based renal denervation with different modalities. Although important questions remain regarding the identification of responders, and long-term efficacy and safety of the intervention, renal denervation has the potential to provide much-needed help to address hypertension and its adverse consequences. The therapeutic approach needs to be multidisciplinary and personalised to take into account the perspective of patients and healthcare professionals in a shared decision-making process.

Catheter-based renal artery denervation: facts and expectations

Catheter-based renal artery denervation (RAD) is entering a new era. After the disappointing results of SYMPLICITY-HTN 3 trial in year 2014, several technical and methodological advancements led to execution of important SHAM-controlled randomized trials with promising results. Now, the 2023 ESH Guidelines give RAD a class of recommendation II with a Level of Evidence B. Currently, catheter-based RAD has two main areas of application: (a) Hypertensive patients who are still untreated, in whom RAD is a sort of a first-line treatment; (b) Difficult-to-control or true resistant hypertensive patients. Notably, randomized SHAM-controlled trials met their primary end-point in both these conditions. So far, we do not dispose of established predictors of the antihypertensive response to RAD. Some data suggest that younger patients with systo-diastolic hypertension, absence of diffuse atherosclerosis and evidence of sympathetic nervous system overactivity experience a better BP response to the procedure. We reviewed the available data on catheter-based RAD and included an updated meta-analysis of the results of the available SHAM-controlled trials. Overall, the reduction in 24-h systolic blood pressure (BP) after RAD exceeded that after SHAM by 4.58 mmHg (95% CI 3.07–6.10) in untreated patients, and by 3.82 mmHg (95% CI 2.46–5.18) in treated patients, without significant heterogeneity across trials, patient phenotype (untreated versus treated patients) and technique (radiofrequency versus ultrasound). There were no important safety signals related to the procedure. Notably, some data suggest that RAD could be an effective additional approach in patients with atrial fibrillation and other conditions characterized by sympathetic nervous system overactivity.

Possible organ-protective effects of renal denervation: insights from basic studies.

Inappropriate sympathetic nervous activation is the body's response to biological stress and is thought to be involved in the development of various lifestyle-related diseases through an elevation in blood pressure. Experimental studies have shown that surgical renal denervation decreases blood pressure in hypertensive animals. Recently, minimally invasive catheter-based renal denervation has been clinically developed, which results in a reduction in blood pressure in patients with resistant hypertension. Accumulating evidence in basic studies has shown that renal denervation exerts beneficial effects on cardiovascular disease and chronic kidney disease. Interestingly, recent studies have also indicated that renal denervation improves glucose tolerance and inflammatory changes. In this review article, we summarize the evidence from animal studies to provide comprehensive insight into the organ-protective effects of renal denervation beyond changes in blood pressure.

Cost-Effectiveness of Catheter-Based Radiofrequency Renal Denervation for the Treatment of Uncontrolled Hypertension: An Analysis for the UK Based on Recent Clinical Evidence

Cost-Effectiveness of Catheter-Based Radiofrequency Renal Denervation for the Treatment of Uncontrolled Hypertension: An Analysis for the UK Based on Recent Clinical Evidence

Changes in blood pressure after catheter-based renal denervation in South Africa.

Renal denervation (RDN) is an interventional treatment for patients with uncontrolled hypertension. The Global SYMPLICITY Registry (GSR) is a prospective, all-comer, world-wide registry designed to assess the safety and efficacy of RDN. We evaluated the outcomes in South African patients in the GSR over 12 months. Eligible patients with hypertension had a daytime mean blood pressure (BP) > 135/85 mmHg or night-time mean BP > 120/70 mmHg. Office and 24-hour ambulatory systolic BP reduction and adverse events over 12 months were evaluated. South African patients (n = 36) in the GSR had a mean age of 54.4 ± 9.9 years with a median of four prescribed antihypertensive medication classes. At 12 months, mean changes in office and 24-hour ambulatory systolic BP were -16.9 ± 24.2 and -15.3 ± 18.5 mmHg, respectively, with only one adverse event recorded. RDN safety and efficacy in South African patients were consistent with world-wide GSR results.

The effect of catheter-based sham renal denervation in hypertension: systematic review and meta-analysis

BackgroundRenal denervation (RDN) has emerged in recent years as a possible treatment for hypertension. The first sham-controlled trial showed a small magnitude and non-significant in the blood pressure (BP) lowering effect, also due to a substantial decrease of BP in sham arm. Considering this, we aimed to quantify the magnitude of BP decrease within the sham arm of Randomized Controlled Trials (RCT) with RDN in patients with hypertension.MethodsElectronic databases were searched since inception until January 2022 for randomized sham-controlled trials which assessed the efficacy in lowering BP of the sham intervention for catheter-based RDN in adult patients with hypertension. The outcomes were change in ambulatory/office systolic and diastolic BP.ResultsA total of 9 RCT were included in the analysis enrolling a total of 674 patients. Sham intervention showed a decrease in all evaluated outcomes. Office systolic BP had a reduction of -5.52 mmHg [95%CI -7.91, -3.13] and office diastolic BP of -2.13 mmHg [95%CI -3.08, -1.17]. Sham procedure for RDN also showed a reduction of -3.41 mmHg [95%CI -5.08, -1.75] in ambulatory systolic BP and − 2.44 mmHg [95%CI -3.31, -1.57] in ambulatory diastolic BP.ConclusionDespite recent data indicating that RDN might be an effective treatment for patients with resistant hypertension when compared to a sham intervention, our results indicate that the sham intervention for RDN also has a significant effect on lowering Office and Ambulatory (24-h) Blood Pressure in adult patients with hypertension. This highlights that BP itself might be sensitive to placebo-like effect and also brings further difficulties in establishing the BP lowering efficacy of invasive interventions due to the magnitude of the sham effect.

Renal denervation in the management of hypertension in adults. A clinical consensus statement of the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

Since the publication of the 2018 European Society of Cardiology/European Society of Hypertension (ESC/ESH) Guidelines for the Management of Arterial Hypertension, several high-quality studies, including randomised, sham-controlled trials on catheter-based renal denervation (RDN) were published, confirming both the blood pressure (BP)-lowering efficacy and safety of radiofrequency and ultrasound RDN in a broad range of patients with hypertension, including resistant hypertension. A clinical consensus document by the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) on RDN in the management of hypertension was considered necessary to inform clinical practice. This expert group proposes that RDN is an adjunct treatment option in uncontrolled resistant hypertension, confirmed by ambulatory BP measurements, despite best efforts at lifestyle and pharmacological interventions. RDN may also be used in patients who are unable to tolerate antihypertensive medications in the long term. A shared decision-making process is a key feature and preferably includes a patient who is well informed on the benefits and limitations of the procedure. The decision-making process should take (i) the patient's global cardiovascular (CV) risk and/or (ii) the presence of hypertension-mediated organ damage or CV complications into account. Multidisciplinary hypertension teams involving hypertension experts and interventionalists evaluate the indication and facilitate the RDN procedure. Interventionalists require expertise in renal interventions and specific training in RDN procedures. Centres performing these procedures require the skills and resources to deal with potential complications. Future research is needed to address open questions and investigate the impact of BP-lowering with RDN on clinical outcomes and potential clinical indications beyond hypertension.