Abstract 13272: Efficacy and Safety of Non-invasive Renal Denervation Study Using Externally Delivered Focused Ultrasound in Severe Resistant Hypertension

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Roland E Schmieder ◽  
John A Ormiston ◽  
Petr Neuzil ◽  
Zdenek Stárek ◽  
Patrick Kay ◽  
...  
Keyword(s):  
Resistant Hypertension ◽  
Renal Denervation ◽  
Focused Ultrasound ◽  
Surrounding Tissue ◽  
Renal Nerves ◽  
Antihypertensive Medications ◽  
Serious Adverse Events ◽  
Sound System ◽  
Invasive Approach ◽  
Non Invasive

Background: Invasive catheter based techniques for renal denervation have been extensively examined in treating patients with resistant hypertension, with mixed results and some periprocedural complications. New evidence suggested that not all renal nerves are in the range of invasive procedures limited to a distance 4 to 6 mm from the lumen. Aims: To evaluate the safety and efficacy of an entirely non-invasive approach to renal denervation using externally delivered focused ultrasound to the peri-renal artery tissue with real time Doppler-based image guidance. Methods and results: Twenty-seven patients with severe, treatment resistant hypertension, defined as persistent systolic blood pressure (BP) > 160 mmHg despite 3 or more antihypertensive medications, were treated non-invasively with the Kona Medical Surround Sound System™. Focused ultrasound energy was delivered to the renal arteries bilaterally and surrounding tissue using Doppler-based imaging and continuous tracking with automatic correction for kidney motion throughout treatment. Patients received conscious sedation during the treatment period. At this time, all patients have completed 24 weeks and 23 patients 52 weeks of follow up. Post-denervation, the mean changes from baseline BP (175/92 mmHg) were -16.8/-8.6 mmHg at 3 weeks, -23.2/-10.8 mmHg at 6 weeks, -29.7/-13.1 mmHg at 12 weeks, -21.6/-8.7 mmHg at 24 weeks and -25.6/-10.1 mmHg at 52 weeks . No serious device-related events have been reported to date. Forty-one percent of subjects (11/27) reported mild back pain immediately following the denervation treatment. The majority of cases (7/11) completely resolved within three days post treatment without any significant intervention and no case was associated with any motor, sensory deficits. Conclusions: This is the first study in humans using a non-invasive renal denervation system in severe resistant hypertension. Results showed clinically meaningful reductions from baseline in office BP through 52 weeks post-denervation. The procedure was well-tolerated with no serious adverse events. This technology should enable patients to benefit from renal denervation therapy without the invasive risks associated with catheter based techniques.

scholarly journals TCT-87 Non-invasive Renal Denervation Study Using Externally Delivered Focused Ultrasound in Severe Resistant Hypertension: 1 Year Follow up Results

2015 ◽  
Vol 66 (15) ◽  
pp. B40 ◽  
Author(s):  
Roland E. Schmieder ◽  
John A. Ormiston ◽  
Petr Neuzil ◽  
Zdenek Starek ◽  
Patrick Kay ◽  
...  
Keyword(s):  
Resistant Hypertension ◽  
Renal Denervation ◽  
Focused Ultrasound ◽  
Non Invasive

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.

Renal denervation: current implications and future perspectives

2013 ◽  
Vol 126 (1) ◽  
pp. 41-53 ◽  
Author(s):  
Jianzhong Xu ◽  
Dagmara Hering ◽  
Yusuke Sata ◽  
Antony Walton ◽  
Henry Krum ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Resistant Hypertension ◽  
Renal Denervation ◽  
Interventional Procedure ◽  
Strong Association ◽  
Blood Pressure Reduction ◽  
Pressure Control ◽  
Renal Nerves ◽  
Renal Nerve ◽  
Disease States

SNS (sympathetic nervous system) activation is a common feature of arterial hypertension and has been demonstrated to contribute to the development and progression of the hypertensive state. Persuasive evidence suggests a strong association between SNS overactivity and variety of disease states, including chronic renal failure, insulin resistance, congestive heart failure, sleep apnoea, ventricular arrhythmias and others. Although sympatholytic agents are available to target SNS overactivity pharmacologically, they are not widely used in clinical practice, leaving the SNS unopposed in many patients. The recent introduction of catheter-based renal denervation as an alternative approach to target the SNS therapeutically has been demonstrated to result in a clinically relevant blood pressure reduction in patients with resistant hypertension, presumably through its effects on both efferent and afferent renal nerve traffic. Available data on this interventional procedure demonstrate a favourable vascular and renal safety profile. Preliminary data obtained primarily from small and mostly uncontrolled studies in related disease states often characterized by overactivity of the SNS are promising, but require confirmation in appropriately designed clinical trials. In the present paper, we briefly review the physiology of the renal nerves and their role in hypertension and other relevant disease states, summarize the data currently available from clinical studies pertaining to the safety and efficacy of renal denervation in resistant hypertension, discuss potential future implications and the available data supporting such a role for renal denervation, and describe some of the newer devices currently under investigation to achieve improved blood pressure control via renal denervation.

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.

Sign in / Sign up

Export Citation Format

Share Document