Percutaneous Renal Denervation Research Articles

Percutaneous Renal Denervation Should Be Considered in Hypertension Treatment

Percutaneous Renal Denervation Should Be Considered in Hypertension Treatment

Percutaneous renal denervation in the management of hypertension: Chinese expert scientific statement

Hypertension constitutes a critical risk factor for cardio-cerebrovascular disease. Despite the effectiveness of lifestyle adjustments and medications in blood pressure (BP) management, the hypertension control rates remain inadequate. Percutaneous renal denervation (RDN) has emerged as a forward-looking and evidence-supported interventional modality for the improvement of BP regulation and enhancement of hypertension control. Comprehensive evidence from randomized, sham-controlled clinical trials supports the sustained the efficacy and satisfactory safety profile of RDN in lowing BP. This scientific statement, endorsed by Chinese authorities, aims to provide a comprehensive overview of global and national clinical evidence on RDN. It seeks to highlight the therapeutic advancements of RDN, articulate expert consensus and recommendations for its utilization in hypertension management. Through the promotion of structured, safe, and standardized incorporation of RDN into clinical practice, this statement strives to optimize hypertension treatment within the Chinese medical community.

Percutaneous Renal Denervation (RDN), is an Innovative Strategy in the Control of Refractory Blood Pressure. A Case Report.

Arterial hypertension (HBP) is a heterogeneous diseasecharacterized by havinga high degree of morbimortality in patients who suffer from it. Clinically it is diagnosedby taking blood pressure (BP) 1, when a value equal to or higherthan 130/80 mmHg is obtained.Among its classification there is "Refractory Arterial Hypertension" 4-5 which has a low incidence but with a high cardiovascular risk and costs to the health system. Given its high impact, minimally invasive strategies have been created that have had a significant effect in reducing blood pressure levels; this procedure is calledPercutaneous Renal Denervation (RDN) 6-7.

Renal denervation for resistant hypertension and heart failure with a reduced ejection fraction

Hypertension is a risk factor for the development of heart failure and has a negative impact on the survival of these patients. Although patients with these two conditions usually take different antihypertensive medications, some patients do not achieve adequate blood pressure control and their hypertension becomes resistant or refractory. In this scenario, percutaneous renal denervation has emerged in recent years as an alternative to achieve blood pressure control goals. We present the case of a 53-year-old woman with a medical history of essential hypertension, hypercholesterolemia, unipolar depression, and diabetes, who was diagnosed with dilated cardiomyopathy with reduced left ventricular ejection fraction (33%). Despite the initiation of multiple antihypertensive medications and placement of a cardiac resynchronization therapy pacemaker, the patient remained hypertensive with a left ventricular ejection fraction of 40%. At that time, percutaneous renal denervation was performed without complications, and one year after the procedure, the patient had improved better blood pressure control and the left ventricular ejection fraction increased to 51%. This case illustrates one of the clinical scenarios in which it has been suggested that renal denervation may be more beneficial, as in the situation of patients with refractory hypertension and heart failure.

The role of renal nerve stimulation in percutaneous renal denervation for hypertension: A mini-review.

Recent trials have demonstrated the efficacy and safety of percutaneous renal sympathetic denervation (RDN) for blood pressure (BP)‐lowering in patients with uncontrolled hypertension. Nevertheless, major challenges exist, such as the wide variation of BP‐lowering responses following RDN (from strong response to no response) and lack of feasible and reproducible peri‐procedural predictors for patient response. Both animal and human studies have demonstrated different patterns of BP responses following renal nerve stimulation (RNS), possibly related to varied regional proportions of sympathetic and parasympathetic nerve tissues along the renal arteries. Animal studies of RNS have shown that rapid electrical stimulation of the renal arteries caused renal artery vasoconstriction and increased norepinephrine secretion with a concomitant increase in BP, and the responses were attenuated after RDN. Moreover, selective RDN at sites with strong RNS‐induced BP increases led to a more efficient BP‐lowering effect. In human, when RNS was performed before and after RDN, blunted changes in RNS‐induced BP responses were noted after RDN. The systolic BP response induced by RNS before RDN and blunted systolic BP response to RNS after RDN, at the site with maximal RNS‐induced systolic BP response before RDN, both correlated with the 24‐h ambulatory BP reductions 3–12 months following RDN. In summary, RNS‐induced BP changes, before and after RDN, could be used to assess the immediate effect of RDN and predict BP reductions months following RDN. More comprehensive, large‐scale and long term trials are needed to verify these findings.

POSA77 Radiofrequency-Based Renal Denervation for Treatment-Resistant Hypertension in Italy: A Budget Impact Analysis

Blood pressure (BP) reduction in uncontrolled hypertension (HTN) is associated with reduced risk for cerebro-cardiovascular (CV) events and end-stage renal-disease (ESRD). The safety and efficacy of catheter-based percutaneous renal denervation (RDN) for reducing BP has been demonstrated in patients with uncontrolled HTN, including so-called “treatment resistant” hypertension (trHTN)(uncontrolled BP despite prescription of ≥ 3 antihypertensive drugs). We assessed the economic impact of RDN in trHTN from the Italian healthcare (NHS) perspective, considering the potential economic benefits through avoidance of potential CV events and ESRD.

Renal denervation – not an easy road to treatment of arterial hypertension and concomitant diseases

Percutaneous renal denervation (RDN) has been introduced in clinical trials as the possible interventional method of treatment of resistant hypertension more than one decade ago. The results of trials: SYMPLICITY HTN-1 (single-arm), HTN-2 (randomized, single-blinded) and HTN-3 (with sham procedure) are summarized in this article. The author presents the results of second-generation trials with new technologies: Spyral catheter (radiofrequency RDN) and Paradise system (ultrasound RDN). The favorable results of these studies justify the revision of the current recommendations, limiting this method only to clinical trials. Also the studies on RDN applied in atrial fibrillation and obstructive sleep apnea – diseases related to sympathetic nervous system activity – are discussed.

Review and meta-analysis of renal artery damage following percutaneous renal denervation with radiofrequency renal artery ablation.

We aimed to estimate the rate of renal artery adverse events following renal denervation with the most commonly applied radiofrequency catheter system based on a comprehensive review of published reports. We reviewed 50 published renal denervation (RDN) trials reporting on procedural safety including 5,769 subjects with 10,249 patient-years of follow-up. Twenty-six patients with renal artery stenosis or dissection (0.45%) were identified of whom 24 (0.41%) required renal artery stenting. The primary meta-analysis of all reports indicated a 0.20% pooled annual incidence rate of stent implantation (95% CI: 0.12 to 0.29% per year). Additional sensitivity analyses yielded consistent pooled estimates (range: 0.17 to 0.42% per year). Median time from RDN procedure to all renal intervention was 5.5 months (range: 0 to 33 months); 79% of all events occurred within one year of the procedure. A separate review of 14 clinical trials reporting on prospective follow-up imaging using either magnetic resonance imaging, computed tomography or angiography following RDN in 511 total subjects identified just 1 new significant stenosis (0.20%) after a median of 11 months post procedure (one to 36 months). Renal artery reintervention following renal denervation with the most commonly applied RF renal denervation system (Symplicity) is rare. Most events were identified within one year.

Laparoscopic Renal Denervation System for Treating Resistant Hypertension: Overcoming Limitations of Catheter-Based Approaches.

In a pivotal clinical trial, the percutaneous catheter-based renal denervation system developed to treat resistant hypertension did not show effectiveness in reducing blood pressure because of its fundamental limitation to ablate deeper nerves present around the renal artery. We propose a new renal denervation strategy called laparoscopicdenervation system (LDS) based-on laparoscopy procedure to ablate the renal nerves completely but inhibit the thermal arterial damage.The system has flexible electrodes to bend around the arterial wall to ablate nervesThe simulation study using validated in-silico models evaluated the heat distributionon the outer arterial wall,and an acute animal study (swine model) was conducted to demonstrate the feasibility of LDS in vivo. The simulation studyconfirmedthat LDS could localize the heat distributionbetween the electrode and the outer arterial wall. In the animal study, we could maximize nerve denervation by the localizing ablation energy within the renal nerves and achieve nerve denaturationand decrease in neural density by 20.78% (P < 0.001), while maintaining a constant tip temperature of 65 °C for the duration of 70 s treatment. The study confirmed intact lumen artery through histological analysis and acute reduction in systolic blood pressure by 9.55 mmHg (p < 0.001) Conclusion: The LDS presented here has potential to effectively and safely ablate the renal nerves, independent of anatomical variation and nerve distribution, to control hypertension in real clinical conditions. LDS approach is innovative, inventive, and presents a novel technique totreat hypertension.

Percutaneous renal artery denervation in patients with chronic systolic heart failure: A randomized controlled trial.

Renal denervation (RDN) is as an effective treatment for heart failure (HF), but its effects on cardiac function of patients with HF are not well documented. Here, the aim was to investigate RDN's effect on patients with chronic systolic HF, by conducting a single-center, prospective, randomized, and controlled study. Sixty patients with chronic systolic HF were randomly assigned to the RDN or control groups, receiving percutaneous catheter-based RDN with radiofrequency ablation and drug treatment, respectively. All patients performed a 6-minute walk test, echocardiography, blood pressure measurement, and biochemical test, at both baseline and in a 6-month follow up. Over 6-month follow up, patients in RDN group showed a decrease in N-terminal pro-B-type natriuretic peptide (440.1 ± 226.5 pg/mL vs. 790.8 ± 287.0 pg/mL, p < 0.001, Cohen's d = 1.14), an increase in left ventricular ejection fraction (39.1 ± 7.3% vs. 35.6 ± 3.3%, p = 0.017, Cohen's d = 0.61), improved New York Heart Association class assessment (p = 0.01, Cohen's d = 0.66), and decreased blood pressures (p < 0.001, Cohen's d = 0.91), without reporting hypotension and syncope amaurosis. No significant between-group difference was observed for glomerular filtration rate and heart rate. Renal denervation which effectively and safely improves patient's cardiac function as well as exercise tolerance, could be considered as an effective treatment for chronic systolic HF.

P4566Comparison of standard renal denervation procedure versus novel distal and branch vessel ablation with brachial arterial access

Abstract Objectives We assessed a novel approach to percutaneous renal denervation for uncontrolled hypertension consisting of ablation beyond the proximal main renal artery (Y-pattern), including the primary branches, and compared it to the standard procedure applied only within the main vessel. We also assessed the safety and practicality of a brachial access approach. Methods and results Renal denervation was performed on 119 consecutive patients (60±13 years). In 68 of the patients, femoral arterial vascular approach was used and in 51 brachial. In 80 patients treated with the standard ablation, 12.0±3.0 total ablations (both sides) were applied while 20.4±3.9 total ablations were delivered for the group of 39 patients with Y-pattern denervation (P&lt;0.001). Technically successful renal denervation was achieved in all patients. Office blood-pressure levels at baseline were 170±17/93±10 mm Hg for the standard group and 169±13/96±9 mm Hg for the Y-pattern group. No major adverse events occurred during the procedure or in the postprocedural in-hospital period. Renal denervation was associated with significant decreases in both office and ambulatory systolic and diastolic blood pressure in both groups. The reduction in 24-hour mean ambulatory systolic blood pressure at 6 months was significantly greater (P=0.002) for the Y-Pattern group (−22.1±15.4 mm Hg) compared to the Standard group (−11.8±16.2 mm Hg). Changes in diastolic office and ambulatory pressure were also significantly greater at 6 months in the Y-pattern ablation group. Indices of blood pressure variability improved in both groups. Between group comparison of blood pressure and other parameters at follow up Standard Y-Pattern P (Standard vs Y) Change in Office Diastolic Blood Pressure (mmHg) 1 Month −8.0±13.2* −9.8±8.5* 0.49 3 Months −6.3±6.9* −6.4±9.0* 0.96 6 Months −5.0±9.0* −9.9±10.8* 0.01 Change in Ambulatory Diastolic Pressure (mmHg) 24-Hour −5.2±8.4* −6.2±10.0* 0.61 Daytime −3.2±9.4* −5.6±10.0* 0.24 Night Time −7.6±8.4* −6.5±11.5* 0.56 Antihypertensive Medication Classes 4.9±1.1* 5.3±0.8* 0.07 otal Number of Lesions† 12.0±3.0 20.4±3.9 &lt;0.001 Conclusion Renal denervation using a Y-pattern ablation strategy combined with a greater number of lesions is safe and resulted in significant greater decreases in mean 24-hour ambulatory systolic and diastolic blood pressure compared to the conventional

TCT-607 Optimizing Safety and Efficacy of Lesion Formation for Percutaneous Renal Denervation: Human and Porcine Histological Analysis

TCT-607 Optimizing Safety and Efficacy of Lesion Formation for Percutaneous Renal Denervation: Human and Porcine Histological Analysis

Abstract P2051: Incidence of Renal Artery Damage Following Percutaneous Renal Denervation With Radio Frequency Renal Artery Ablation Systems

Recent prospective randomized clinical trials have demonstrated blood pressure lowering following renal denervation (RDN) with radiofrequency (RF) ablation systems and minimal adverse events in relatively small populations with short follow up duration. The current analysis estimates the rate of renal artery adverse events based on a comprehensive review of published reports. An online database search was performed to identify trials, registries and case reports that employed either the SYMPLICITY Flex or Spyral RF denervation systems (Medtronic, Santa Rosa, CA). Updated reviews of the SYMPLICITY HTN-3 trial and the Global SYMPLICITY Registry were also included. Renal artery stenoses classified as “significant”, greater than 50%, resulted in stent implant or if not specified were counted. The pooled incidence rate of stent implantation was determined by fixed-effects meta-analysis of the study-level incidence rates. Review of 45 published RDN trials reporting on procedural safety with 10,130 patient-years of follow up identified 0.44% of patients (25 of 5,657) with reported renal artery stenosis or dissection and 0.39% of patients (22 of 5,657) with required renal artery stenting. Meta-analysis of all reports indicated an 0.20% pooled annual incidence rate of stent implantation (95% CI: 0.11 to 0.29 % per patient-year). This result was consistent with a fixed effects Poisson regression model (0.22%; 95% CI: 0.14 to 0.32%). An additional 10 case reports including 11 patients with renal artery stenosis resulting in at least one stent implant were identified, with most cases diagnosed after recurrent hypertension, occasionally with concomitant symptoms. Median time from RDN procedure to all renal artery interventions, including both case reports and clinical trials, was 5.5 months (range: 0 to 33 months). A separate review of 14 clinical trials reporting on prospective follow up high resolution imaging of main renal arteries or branches using either MRI, CT or angiography following RDN found a new significant stenosis rate of 0.20% (one event out of 511 patients). Renal artery stenosis and re-intervention following renal denervation with the most commonly applied RF renal denervation system are rare.

2019 Consensus Statement of the Taiwan Hypertension Society and the Taiwan Society of Cardiology on Renal Denervation for the Management of Arterial Hypertension.

Sympathetic overactivity, an essential mechanism of hypertension, in driving sustained hypertension derives mostly from its effects on renal function. Percutaneous renal denervation (RDN) is designed to disrupt renal afferent and efferent sympathetic nerves to achieve sustained blood pressure (BP) reduction. Since 2017 onward, all three proof-of-concept, sham-controlled RDN trials demonstrated that RDN achieved consistent and clinically meaningful BP reductions [approximately 10 mmHg in office systolic BP (SBP) and 6-9 mmHg in 24-hour SBP] compared to sham operation in patients with mild to moderate or uncontrolled hypertension. There were no serious adverse events. The registry data in Taiwan showed similar 24-hour BP reductions at 12 months following RDN. The Task Force considers RDN as a legitimate alternative antihypertensive strategy and recommends 1) RDN should be performed in the context of registry and clinical studies (Class I, Level C) and 2) RDN should not be performed routinely, without detailed evaluation of various causes of secondary hypertension and renal artery anatomy (Class III, Level C). RDN could be performed in patients who fulfill either of the following BP criteria: 1) office BP ≥ 150/90 mmHg and daytime ambulatory SBP ≥ 135 mmHg or diastolic BP (DBP) ≥ 85 mmHg, irrespective of use of antihypertensive agents (Class IIa, Level B), or 2) 24-hour ambulatory SBP ≥ 140 mmHg and DBP ≥ 80 mmHg, irrespective of use of antihypertensive agents (Class IIa, Level B), with eligible renal artery anatomy and estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2. Five subgroups of hypertensive patients are deemed preferred candidates for RDN and dubbed "RDN i2": Resistant hypertension, patients with hypertension-mediated organ Damage, Non-adherent to antihypertensive medications, intolerant to antihypertensive medications, and patients with secondary (2ndary) causes being treated for ≥ 3 months but BP still uncontrolled. The Task Force recommends assessment of three aspects, dubbed "RAS" (R for renal, A for ambulatory, S for secondary), beforehand to ascertain whether RDN could be performed appropriately: 1) Renal artery anatomy eligibility assessed by computed tomography or magnetic resonance renal angiography if not contraindicated, 2) genuine uncontrolled BP confirmed by 24-hour Ambulatory BP monitoring, and 3) Secondary hypertension identified and properly treated. After the procedure, 24-hour ambulatory BP monitoring, together with the dose and dosing interval of all BP-lowering drugs, should be obtained 6 months following RDN. Computed tomography or magnetic resonance renal angiography should be obtained 12 months following RDN, given that renal artery stenosis might not be clinically evident.

Selección de lo mejor del año 2018 en denervación simpática renal en el tratamiento de la hipertensión arterial

Hypertension is a highly prevalent cardiovascular risk factor that is difficult to control despite the evolution of pharmacological treatment. Percutaneous renal denervation is a procedure that aims to modulate the sympathetic nervous system directly involved in the pathophysiology of hypertension. Despite promising initial results, the SYMPLICITY HTN-3 study failed to demonstrate the efficacy of renal denervation in the treatment of hypertension resistant to drug treatment. Subsequent analysis of the study results revealed potential confounding factors that could explain, at least in part, the unexpected results of the study. Recent studies with a limited number of patients have demonstrated the efficacy of renal denervation in the treatment of moderate hypertension and in the absence of pharmacological treatment. Although the role of renal denervation in the treatment of hypertension is still to be determined, the results of recent studies open a field of applications that should be explored in the coming years.

TCT-31 Comparison of Standard Renal Denervation Procedure versus Novel Distal and Branch Vessel Procedure with Brachial Arterial Access

We assessed a novel approach to percutaneous renal denervation for uncontrolled hypertension consisting of ablation beyond the proximal main renal artery (Y- pattern), including the primary branches, and compared it to the standard procedure applied only within the main vessel. We also assessed the

FIRST-IN-MAN EXPERIENCE OF DISTAL RENAL DENERVATION IN SEGMENTAL BRANCHES OF RENAL ARTERY USING MULTI-ELECTRODE BALLOON DEVICE

Objective:Antihypertensive pharmacotherapy is maximally developed yet population control of hypertension is unsatisfactory prompting a search for non-pharmacological therapies. Percutaneous renal denervation (RDN) emerged as promising endovascular treatment of high blood pressure but failed to consi

Renal denervation - can we press the "ON" button again?

Nearly ten years ago percutaneous renal denervation (RDN) was introduced in clinical trials as a possible method of interventional treatment of resistant hypertension. The promising results of the first clinical trials initiated the intensive development of this method. However, the role of percutaneous renal denervation in the treatment of patients with resistant hypertension has been questioned since the results of the Symplicity HTN-3 trial have been published. It also resulted in downgrading the indications for RDN in the European Society of Cardiology/European Society of Hypertension Guidelines 2018. The authors discuss potential shortcomings of that trial, describe new generation devices and present the results of recently published trials: SPYRAL HTN-OFF MED, SPYRAL HTN-ON MED, RADIANCE-HTN SOLO and RADIOSOUND-HTN. The results of studies in patients with obstructive sleep apnea are also summarized and discussed. The upcoming large trials (SPYRAL PIVOTAL, RADIANCE II) are outlined – the results of those trials are expected to be published in the next 2–3 years. Until then, according to the European guidelines, the use of device-based therapies is not recommended for the treatment of hypertension, unless in the context of clinical studies and randomized controlled trials.

Denervação simpática renal por cateter com ponta irrigada: estudo de viabilidade

ABSTRACT Background: Catheter-based radiofrequency renal denervation has emerged as a promising tool for blood pressure control in patients with resistant hypertension. The aim of the present study was to evaluate the feasibility and safety of percutaneous renal sympathetic denervation by radiofrequency ablation using an irrigated-tip catheter in patients with true resistant hypertension. Methods: A saline-irrigated catheter was used for renal sympathetic denervation. The sample consisted of a consecutive series of 11 patients with resistant hypertension based on office blood pressure [...]

Effectiveness of renal denervation from intima and adventitia for hypertension

Objective To compare the effects of renal denervation (RDN) from intima and adventitia for hypension. Methods Twenty-five neurogenic hypertensive beagles were randomly divided into intimal group (n=10) gvien percutaneous RDN from the inside of renal artery, and adventitial group (n=10) given RDN from the outside of renal artery. The sham-operated group was set up (n=5). Arterial pressure, renin activity (PRA) and angiotensin Ⅱ (Ang Ⅱ) were detected before and 2, 4, 8 weeks after operation. Results (1) At 8th week after the hypertension model was established, the arterial pressure increased from (107.56±4.37) mmHg (1 mmHg=0.133 kPa) to (125.16±7.86) mmHg (P=0.003) in the intimal group, and from (105.66±5.43) mmHg to (124.08±8.98) mmHg in the adventitial group (P=0.012). In the control group the arterial pressure increased from (106.34±6.45) mmHg to (125.89±9.54) mmHg (P=0.007). PRA and AngII increased simultaneously (P=0.005); (2) At 2nd, 4th, and 8th week after operation, the arterial pressure decreased from (125.16±7.86) mmHg to (117.45±7.98) mmHg (P=0.001), (114.35±7.89) mmHg (P=0.008), (110.32±7.54) mmHg (P=0.003), and from (124.08±8.98) mmHg to (111.23±8.34) mmHg (P=0.004), (108.34±8.65) mmHg (P=0.002), (103.06±8.56) mmHg (P=0.001) in the adventitial group. The arterial pressure decreased more significantly in the adventitial group [(103.06±8.56) mmHg] than that in the intimal group [(110.32±7.54) mmHg] (P=0.013). PRA and AngII decreased simultaneously (P=0.015). The blood pressure had no significant change in the control group; (3) The renoarteriography showed on obvious abnormalities, but the pathological examination showed that a nerve fascicle from all denervation vessels with marked densification of collagen fibers in the surrounding connective tissue and a perineurium thickened, and the perineurium was thicker in the arteries. Conclusion RDN from both intima and adventitia is safe and results in reduction of substantial and sustained blood pressure and renal sympathetic active substances in beagle dog model, and it was better from the adventitia. Key words: Renal denervation; Hypertension; Sympathetic nerve