scholarly journals 4120Distal renal denervation in segmental branches of renal artery versus conventional main trunk therapy: 12 months study in patients with resistant hypertension

2017 ◽  
Vol 38 (suppl_1) ◽  
Author(s):  
S. Pekarskiy ◽  
A. Baev ◽  
V. Mordovin ◽  
T. Ripp ◽  
A. Falkovskaya ◽  
...  
Keyword(s):  
Renal Artery ◽  
Resistant Hypertension ◽  
Renal Denervation ◽  
Main Trunk

scholarly journals Early Morphologic Alterations in Renal Artery Wall and Renal Nerves in Response to Catheter-Based Renal Denervation Procedure in Sheep: Difference Between Single-Point and Multiple-Point Ablation Catheters

2017 ◽  
pp. 601-614 ◽  
Author(s):  
M. TÁBORSKÝ ◽  
D. RICHTER ◽  
Z. TONAR ◽  
T. KUBÍKOVÁ ◽  
A. HERMAN ◽  
...  
Keyword(s):  
Renal Artery ◽  
Resistant Hypertension ◽  
Renal Denervation ◽  
Single Point ◽  
Renal Tissue ◽  
Renal Nerves ◽  
Multiple Point ◽  
Renal Nerve ◽  
Jude Medical ◽  
Novel Strategy

Renal sympathetic hyperactivity is critically involved in hypertension pathophysiology; renal denervation (RDN) presents a novel strategy for treatment of resistant hypertension cases. This study assessed effects of two RDN systems to detect acute intravascular, vascular and peri-vascular changes in the renal artery, and renal nerve alterations, in the sheep. The procedures using a single-point or multi-point ablation catheters, Symplicity FlexTM, Medtronic versus EnligHTNTM, St. Jude Medical were compared; the intact contralateral kidneys served as controls. Histopathological and immunohistochemical assessments were performed 48 h after RDN procedures; the kidney and suprarenal gland morphology was also evaluated. Special staining methods were applied for histologic analysis, to adequately score the injury of renal artery and adjacent renal nerves. These were more pronounced in the animals treated with the multi-point compared with the single-point catheter. However, neither RDN procedure led to complete renal nerve ablation. Forty-eight hours after the procedure no significant changes in plasma and renal tissue catecholamines were detected. The morphologic changes elicited by application of both RDN systems appeared to be dependent on individual anatomical variability of renal nerves in the sheep. Similar variability in humans may limit the therapeutic effectiveness of RDN procedures used in patients with resistant hypertension.

scholarly journals Distal renal denervation: cardioprotection in patients with resistant hypertension

2020 ◽  
Vol 19 (4) ◽  
pp. 2225
Author(s):  
E. S. Sitkova ◽  
V. F. Mordovin ◽  
S. E. Pekarsky ◽  
T. M. Ripp ◽  
A. Yu. Falkovskaya ◽  
...  
Keyword(s):  
Renal Artery ◽  
Resistant Hypertension ◽  
Renal Denervation ◽  
Myocardial Damage ◽  
Left Ventricular ◽  
Double Blind Study ◽  
Double Blind ◽  
Damage Area ◽  
Main Renal Artery ◽  
Group 2

Aim. To study the effectiveness of using the anatomically optimized distal renal denervation (RDN) in comparison with the standard approach for reducing myocardial damage and left ventricular (LV) hypertrophy in patients with resistant hypertension (HTN).Material and methods. The randomized double-blind study of the efficacy and safety of distal RDN compared to conventional main renal artery intervention (ClinicalTrials.gov NCT02667912) for the treatment of resistant HTN included 26 patients. All patients were divided into two groups: group 1 (n=16) — distal RDN, group 2 (n=10) — conventional RDN. In addition to 24-hour blood pressure (BP) monitoring, initially and 12 months after the intervention, contrast- enhanced cardiac magnetic resonance imaging was performed to determine the left ventricular mass and non-coronary myocardial damage area. All patients signed informed consent. Twenty-four patients completed the present study.Results. After 12 months, the mean 24-hour BP significantly decreased after both distal RDN (from 167,2±28,5/93,2±19,3 to 147,0±13,7/81,5±9,3 mm Hg (p<0,05)) and conventional RDN (from 157,5±22,5/90,6±23,9 to 139,9±17,7/80,0±16,7 (p<0,05)). Also in both cases, a trend to LV mass decrease was revealed: from 252,6±85,2 to 221,0±60,3 gm (p=0,096) after the distal RDN; from 214,3±54,1 to 186,4±48,1 gm (p=0,071) after the conventional RDN. In contrast, the myocardial damage area decreased only after distal RDN (from 2,33±1,33 to 1,35±0,67 cm3 (p=0,02)) and did not change after conventional RDN.Conclusion. In comparison with the conventional main renal artery intervention, distal RDN in patients with resistant HTN has an additional cardioprotective effect — a decrease in LV myocardial damage area.

scholarly journals Technical advance in silico and in vitro development of a new bipolar radiofrequency ablation device for renal denervation

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Noel Pérez ◽  
Karl Muffly ◽  
Stephen E. Saddow
Keyword(s):  
Radiofrequency Ablation ◽  
Renal Artery ◽  
Resistant Hypertension ◽  
In Silico ◽  
Renal Denervation ◽  
Bipolar Electrode ◽  
Ablation Zone ◽  
Catheter Design ◽  
Basket Catheter

Abstract Background Renal denervation with radiofrequency ablation has become an accepted treatment for drug-resistant hypertension. However, there is a continuing need to develop new catheters for high-accuracy, targeted ablation. We therefore developed a radiofrequency bipolar electrode for controlled, targeted ablation through Joule heating induction between 60 and 100 °C. The bipolar design can easily be assembled into a basket catheter for deployment inside the renal artery. Methods Finite element modeling was used to determine the optimum catheter design to deliver a minimum ablation zone of 4 mm (W) × 10 mm (L) × 4 mm (H) within 60 s with a 500 kHz, 60 Vp-p signal, and 3 W maximum. The in silico model was validated with in vitro experiments using a thermochromic phantom tissue prepared with polyacrylamide gel and a thermochromic ink additive that permanently changes from pink to magenta when heated over 60 °C. Results The in vitro ablation zone closely matched the size and shape of the simulated area. The new electrode design directs the current density towards the artery walls and tissue, reducing unwanted blood temperature increases by focusing energy on the ablation zone. In contrast, the basket catheter design does not block renal flow during renal denervation. Conclusions This computational model of radiofrequency ablation can be used to estimate renal artery ablation zones for highly targeted renal denervation in patients with resistant hypertension. Furthermore, this innovative catheter has short ablation times and is one of the lowest power requirements of existing designs to perform the ablation.

scholarly journals Non-invasive quantification of anatomical and functional renal artery vessel wall changes in patients with resistant hypertension undergoing renal denervation using MRI

2014 ◽  
Vol 16 (Suppl 1) ◽  
pp. P172
Author(s):  
Adelina Doltra ◽  
Arthur Hartmann ◽  
Bernhard Schnackenburg ◽  
Christopher Schneeweis ◽  
Rolf Gebker ◽  
...  
Keyword(s):  
Renal Artery ◽  
Resistant Hypertension ◽  
Vessel Wall ◽  
Renal Denervation ◽  
Non Invasive

scholarly journals Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension

2021 ◽  
Author(s):  
Felix Mahfoud ◽  
Horst Sievert ◽  
Stefan Bertog ◽  
Lucas Lauder ◽  
Sebastian Ewen ◽  
...  
Keyword(s):  
Renal Artery ◽  
Resistant Hypertension ◽  
Renal Denervation ◽  
Multicenter Trial ◽  
Long Term Results ◽  
Open Label ◽  
Antihypertensive Medications ◽  
Unique Identifier ◽  
Spot Urine

Background: Primary results of this prospective, open-label, multicenter trial suggested that alcohol-mediated renal denervation with perivascular injection of dehydrated alcohol using the Peregrine System Infusion Catheter safely reduces blood pressure (BP) in patients with resistant hypertension. To date, maintenance of the BP-lowering effect beyond 6 months using this novel technology has not been reported. This article describes the final, 12-month follow-up data on the safety and efficacy of alcohol-mediated renal denervation in these patients. Methods: Forty-five patients with resistant hypertension on a stable regimen of on average 5.1±1.5 antihypertensive medications underwent successful bilateral renal denervation using the Peregrine Catheter with alcohol as the neurolytic agent (0.6 mL per renal artery). Apart from 2 vascular access pseudoaneurysms (both without sequelae), no major procedural complications occurred. Results: At 12 months post-procedure, mean 24-hour ambulatory systolic and diastolic BP were reduced by 10 mm Hg (95% CI, −16 to −5) and 7 mm Hg (−10 to −3), respectively ( P <0.001). Office systolic/diastolic BP was reduced by 20/10 mm Hg (−27, −13/−14, −6; <0.001). Compared with baseline, the number of antihypertensive medications was reduced in 21% of patients, while it was increased in 19%. From baseline to 12 months, serum creatinine, urea, cystatin C, and spot urine albumin levels remained unchanged. The change in estimated glomerular filtration rates (−3.9±10.3 mL/minute per 1.73 m 2 [95% CI, −7.1 to −0.75]; P =0.02) was within the expected range. There were no cases of renal artery stenosis up to 12-month follow-up. Conclusions: Catheter-based chemical renal denervation with dehydrated alcohol using the Peregrine Catheter seems to safely reduce BP at follow-up of up to 12 months. Further randomized and sham controlled studies are underway to further validate these findings. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02570113.

scholarly journals Renal Denervation Therapy (RDT) in Resistant Hypertension

2012 ◽  
Vol 2 (2) ◽  
pp. 104-112
Author(s):  
Mohammad Gaffar Amin ◽  
Hasna Fahmima Haque
Keyword(s):  
Blood Pressure ◽  
Nervous System ◽  
Sympathetic Nervous System ◽  
Renal Artery ◽  
Resistant Hypertension ◽  
Renal Denervation ◽  
Antihypertensive Drugs ◽  
Antihypertensive Agents ◽  
Radiofrequency Energy ◽  
Sympathetic Nervous

Resistant hypertension is defined as blood pressure that remains above therapeutic goal despite the use of three antihypertensive drugs including a diuretic. As much as one third of patients with arterial hypertension are treatmentrefractory as they do not reach sufficient blood pressure control despite combination antihypertensive therapy of significant duration. The hyperactivity of sympathetic nervous system (SNS) in the occurrence of treatment-resistant long standing hypertension has been established both in animal models and in clinical practice. In these patients, the kidneys play a central role as an activator of the sympathetic nervous system. The failure of purely pharmacological approaches to treat resistant hypertension has stimulated interest in invasive device-based treatments based on old concepts. In the absence of orally active antihypertensive agents, patients with severe and complicated hypertension were widely treated by surgical denervation of the kidneys until the 1960s, but this approach was associated with a high incidence of severe adverse events and a high mortality rate. A new catheter system using radiofrequency energy has been developed, allowing an endovascular approach to renal denervation and providing patients, with resistant hypertension, with a new therapeutic option that is minimally invasive and can be performed rapidly under local anaesthesia. With this method the afferent and efferent sympathetic nervous fibers surrounding the renal artery are ablated precisely keeping the renal artery intact. To date, this technique has been evaluated only in open-label trials including small numbers of highly selected resistant hypertensive patients with suitable renal artery anatomy. The available evidence suggests a significant and persistent blood pressure-lowering effect and a very low incidence of short & long term complications with no deleterious effects on renal function. These data, although promising, need confirmation in larger randomized controlled clinical trials with longerterm follow-up.DOI: http://dx.doi.org/10.3329/birdem.v2i2.12325(Birdem Med J 2012; 2(2): 104-112)

scholarly journals Anatomically optimized distal renal denervation — sustained blood pressure lowering efficacy during 3 years after the intervention

2020 ◽  
Vol 24 (3S) ◽  
pp. 98
Author(s):  
S. E. Pekarskiy ◽  
A. E. Baev ◽  
A. Yu. Falkovskaya ◽  
E. S. Sitkova ◽  
I. V. Zyubanova ◽  
...  
Keyword(s):  
Renal Artery ◽  
Conflict Of Interest ◽  
Renal Denervation ◽  
Secondary Hypertension ◽  
Double Blind ◽  
Main Trunk ◽  
Protein Excretion ◽  
Pressure Lowering ◽  
Severe Comorbidity ◽  
The Mean

<p><strong>Aim</strong>. To test the hypothesis that anatomical optimisation of radiofrequency renal denervation (RDN) by redistribution of treatment to segmental branches of the renal artery causes a durable increase in the efficacy of the intervention.<br /><strong>Methods</strong>. A double-blind randomised control study in parallel groups with a 3-year follow-up was performed in patients with apparent resistant hypertension (office systolic BP ≥160 or diastolic BP ≥100 mmHg despite stable treatment with ≥3 drugs, including a diuretic). Exclusion criteria were secondary hypertension, mean 24-h systolic BP &lt;135 mmHg, eGFR &lt;30 <!-- x-tinymce/html-mce_4595809011604631814436 -->mL/min/m<sup>2</sup> and severe comorbidity increasing procedural risks (investigator’s assessment). Eligible patients were randomised 1:1 into distal RDN or RDN in the main trunk of the renal artery. Treatment assignment was done in the operation room immediately before the procedure. For the duration of the study, the assigned treatment was unknown to patients, physicians and other outcome assessors. Long-term efficacy of the procedure was measured by changes in BP (office and ambulatory), whereas safety was assessed by changes in the 24-h protein excretion, serum creatinine and eGFR 3 years post-procedure.<br /><strong>Results</strong>. Of the 55 randomised patients, 39 (71%) completed a 3-year assessment (21 after distal RDN and 18 after RDN in the main trunk of the renal artery). Compared to baseline, the mean 24-h BP remained significantly lowered in the distal RDN group by −16.9 (95% CI −27.3;−6.5)/−8.5 (95% CI −14.2;−2.9) mmHg, p = 0.002/0.004 (systolic/diastolic, respectively). The lowering of the mean 24-h BP was almost twofold less and non-significant in the group of RDN in the main trunk of the renal artery: −8.7 (95% CI −19.6;2.2)/−5.8 (95% CI −11.8;0.1).<br /><strong>Conclusion</strong>. Anatomical optimisation of endovascular renal denervation produces a powerful and sustained increase in the efficacy of the intervention.</p><p>Received 19 May 2020. Revised 10 July 2020. Accepted 7 September 2020.</p><p><strong>Funding</strong>: The study did not have sponsorship.</p><p><strong>Conflict of interest</strong>: Authors declare no conflict of interest.</p><p><strong>Clin.Trials.gov Identifier</strong>: NCT02667912.</p><p><strong>Author contributions</strong><br />Conception and design: S.E. Pekarskiy<br />Data collection and analysis: S.E. Pekarskiy, A.E. Baev, A.Yu. Falkovskaya, E.S. Sitkova, I.V. Zyubanova, V.A. Lichikaki, V.F. Mordovin<br />Statistical analysis: S.E. Pekarskiy<br />Drafting the article: S.E. Pekarskiy, A.E. Baev<br />Critical revision of the article: S.V. Popov<br />Final approval of the version to be published: S.E. Pekarskiy, A.E. Baev, A.Yu. Falkovskaya, E.S. Sitkova, I.V. Zyubanova, V.A. Lichikaki, V.F. Mordovin, S.V. Popov</p>

Sign in / Sign up

Export Citation Format

Share Document