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 Evaluation of Transcatheter Alcohol-Mediated Perivascular Renal Denervation to Treat Resistant Hypertension

2020 ◽  
Vol 9 (6) ◽  
pp. 1881
Author(s):  
Adam Janas ◽  
Marek Król ◽  
Mariusz Hochuł ◽  
Monika Jochymczyk ◽  
Claudia Hayward-Costa ◽  
...  
Keyword(s):  
Renal Artery ◽  
Resistant Hypertension ◽  
Renal Denervation ◽  
Blood Pressure Monitoring ◽  
Systolic Pressure ◽  
Sympathetic Nerves ◽  
Safety Issues ◽  
Variable Success ◽  
The Difference

Catheter-based renal denervation (RDN) has been investigated for hypertension (HTN) treatment with variable success. One of the novel approaches to RDN is the delivery of micro-doses of dehydrated alcohol to the adventitial space of the renal artery to perform perivascular ablation of the sympathetic nerves. We sought to assess the safety and efficiency of transcatheter alcohol-mediated perivascular renal denervation in patients with resistant hypertension. Fifty adult patients who had been referred for resistant HTN were screened. To qualify for the study, the patients had to have a mean 24 h systolic pressure ≥ 135 mmHg based upon ambulatory blood pressure monitoring (ABPM) and acceptable renal artery anatomy confirmed by the contrast computer tomography (AngioCT) and nephrologist consultation. Ten patients were eligible for chemical RND. There were no safety issues throughout the 24 months of follow-ups. The mean decrease in the office BP (OBP) was significant during 24 months of follow-up (p < 0.01). The difference in the BP in the ABPM was statistically significant in the 1st, 3rd and 12th months (p < 0.01), whereas during the 3-month follow-up, a trend was observed. The modifications of anti-hypertension drugs throughout the follow-up period were minimal. This study has shown that transcatheter alcohol-mediated renal denervation in patients with resistant hypertension is feasible and safe. Nevertheless, it is a hypothesis-generating study.

scholarly journals Renal denervation in a patient with a highly tortuous renal artery using a guide extension catheter: a case report

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Peijiang Wang ◽  
Jindong Wan ◽  
Jixin Hou ◽  
Sen Liu ◽  
Fei Ran
Keyword(s):  
Case Report ◽  
Renal Artery ◽  
Resistant Hypertension ◽  
Renal Denervation ◽  
Secondary Hypertension ◽  
Renal Arteries ◽  
Left Renal Artery ◽  
Case Presentation ◽  
Support Force

Abstract Background Catheter-based renal denervation (RDN) has been introduced to treat resistant hypertension. Although the technology of RDN has been largely improved, denervation of tortuous renal arteries remains challenging. Case presentation This is a case report of a 49-year-old man with drug resistant hypertension. The patient was selected for RDN after ruling out possible causes of secondary hypertension. Computed tomography angiography showed a highly tortuous left renal artery. An Iberis multielectrode ablation catheter failed to reach the target vessel with a regular guiding catheter. A 5-French extension catheter was introduced into the proximal segment of the main left renal artery to provide extra support force, which enabled successful ablation of the highly tortuous left renal artery. His ambulatory blood pressure was significantly decreased at 1 month follow-up. Conclusions It is feasible and effective to use a guide extension catheter for denervation of highly tortuous renal arteries. The present study provides a useful method to ablate tortuous and angled renal arteries and branches.

scholarly journals Copeptin Levels in Patients With Treatment-Resistant Hypertension Before and 6 Months After Renal Denervation

2019 ◽  
Author(s):  
Agnes Bosch ◽  
Axel Schmid ◽  
Christian Ott ◽  
Dennis Kannenkeril ◽  
Marina V Karg ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Clinical Trial ◽  
Renal Artery ◽  
Resistant Hypertension ◽  
Renal Denervation ◽  
Treatment Resistant ◽  
Clinical Trial Registration ◽  
All Cause Mortality ◽  
Stage 1

Abstract BACKGROUND Copeptin, the C-terminal peptide of provasopressin, is released from the neurohypophysis and reflects the activity of the hormone arginine vasopressin in patients with hypertension. Elevated copeptin levels are associated with increased cardiovascular and all-cause mortality. The aim of this study is to compare copeptin levels in patients with treatment-resistant hypertension (TRH) before and 6 months after renal denervation (RDN). METHODS Copeptin was measured in 34 patients with TRH and 30 patients with primary hypertension stage 1 or 2 (HT). In addition, copeptin levels were measured in patients with TRH at 6-month follow-up visit after RDN. RDN was performed by an experienced interventionalist applying at least 4 ablations longitudinally and rotationally within the lengths of each renal artery to cover a full 4-quadrant ablation. RESULTS In patients with TRH 24-hour ambulatory blood pressure (BP) decreased from 154 ± 15/87 ± 12 mm Hg to 146 ± 13/83 ± 7.9 mm Hg after RDN (systolic: P = 0.001, diastolic: P = 0.034). There was no significant change in copeptin levels in these 34 patients with TRH before vs. 6 months after RDN (median 8.4 [interquartile range 3.6–14] vs. 8.5 [4.5–13] pmol/l, P = 0.334). Patients with TRH had higher copeptin levels (P = 0.024) than patients with HT (24-hour ambulatory BP: 142 ± 11/91 ± 8.3 mm Hg, copeptin: 4.2 [2.8–6.3] pmol/l). CONCLUSION Patients with TRH showed 2-fold higher copeptin levels than patients with HT. RDN did not lead to any change of copeptin levels in patients with TRH 6 months after procedure despite significant fall in BP. CLINICAL TRIAL REGISTRATION NCT01318395, NCT01687725

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.

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 Relevance of Targeting the Distal Renal Artery and Branches with Radiofrequency Renal Denervation Approaches—A Secondary Analysis from a Hypertensive CKD Patient Cohort

2019 ◽  
Vol 8 (5) ◽  
pp. 581 ◽  
Author(s):  
KIUCHI ◽  
SCHLAICH ◽  
CHEN ◽  
VILLACORTA ◽  
HO ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Renal Artery ◽  
Renal Denervation ◽  
Secondary Analysis ◽  
Distal Segment ◽  
Renal Arteries ◽  
Lowering Effect ◽  
Post Hoc

We searched for an association between changes in blood pressure (BP) at 12 and 24 months after renal denervation (RDN) and the different patterns of ablation spots placement along the renal artery vasculature. We performed a post-hoc analysis of a 24‐month follow‐up evaluation of 30 patients who underwent RDN between 2011 and 2012 using our previous database. Patients who had (i) resistant hypertension, as meticulously described previously, and (ii) Chronic kidney disease (CKD) stages 2, 3 and 4. Correlations were assessed using the Pearson or Spearman correlation tests as appropriate. The mean change in systolic ambulatory BP monitoring (ABPM) compared to baseline was –19.4 ± 12.7 mmHg at the 12th (p < 0.0001) and –21.3 ± 14.1 mmHg at the 24th month (p < 0.0001). There was no correlation between the ABPM Systolic Blood Pressure (SBP)-lowering effect and the total number of ablated spots in renal arteries (17.7 ± 6.0) either at 12 (r = –0.3, p = 0.1542) or at 24 months (r = –0.2, p = 0.4009). However, correlations between systolic BP-lowering effect and the number of ablation spots performed in the distal segment and branches were significant at the 12 (r = –0.7, p < 0.0001) and 24 months (r = –0.8, p < 0.0001) follow-up. Our findings indicate a substantial correlation between the numbers of ablated sites in the distal segment and branches of renal arteries and the systolic BP-lowering effect in the long-term.

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