Catheter-based radio-frequency renal nerve denervation lowers blood pressure in obese hypertensive swine model

Mahfoud, Felix; Moon, L. Boyce; Pipenhagen, Catherine; Jensen, Jakob D.; Pathak, Atul; Papademetriou, Vasilios; Ewen, Sebastian; Linz, Dominik; Böhm, Michael

doi:10.1097/hjh.0000000000001021

Cited by 21 publications

(24 citation statements)

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“…Several recent randomized sham controlled trials proved the blood pressure lowering effect of RDN in both hypertensive patients taken off medication as well as in patients with uncontrolled hypertension, respectively [ 12 , 24 – 26 ]. The multi-electrode EnligHTN™ catheter showed to decrease BP based on ABPM and to reduce renal norepinephrine in previous animal studies [ 27 , 28 ]. Specifically related to the present human study, similar BP lowering effect was observed with the same catheter in patients with treatment-resistant hypertension [ 29 ].…”

Section: Discussionmentioning

confidence: 98%

Atrial fibrillation reduction by renal sympathetic denervation: 12 months’ results of the AFFORD study

et al. 2018

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Aim The purpose of this pilot study was to assess whether renal sympathetic denervation (RDN) decreases atrial fibrillation (AF) burden in hypertensive patients with symptomatic AF at 6- and 12-month follow-up, as measured using an implantable cardiac monitor (ICM). Methods and results A total of 20 patients with symptomatic paroxysmal or persistent AF (EHRA ≥ II) and primary hypertension with a mean office systolic blood pressure (BP) of > 140 mmHg were enrolled. After enrolment, an ICM was implanted 3 months pre-RDN to monitor AF burden. Quality of life (QOL) was assessed using the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) questionnaire. Mean age was 64 ± 7 years and 55% were females. AF burden in min/day decreased from a median (IQR) of 1.39 (0–11) pre-RDN to 0.67 (0–31.6) at 6 months ( p = 0.64) and to 0.94 (0–6.0) at 12 months (pre-RDN vs. 12 months; p = 0.03). QOL improved significantly at both 6 months (+ 11 ± 15 points, p = 0.006) and 12 months (+ 10 ± 19, p = 0.04) as compared to pre-RDN. Office BP decreased significantly at 12-month follow-up (− 20 ± 19/− 7 ± 10 mmHg), p < 0.01) as compared to pre-RDN. Ambulatory BP decreased − 7 ± 16/− 3 ± 9 mmHg ( p > 0.05) at 12-month follow-up as compared to pre-RDN. Conclusion This pilot study suggests that RDN might be able to decrease AF burden in min/day as measured using an ICM, with a positive effect on QOL. Large-scale randomized trials are needed to prove the definite value of RDN in hypertensive patients with atrial fibrillation. Electronic supplementary material The online version of this article (10.1007/s00392-018-1391-3) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 98%

Atrial fibrillation reduction by renal sympathetic denervation: 12 months’ results of the AFFORD study

et al. 2018

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“…In order to extend the knowledge obtained in earlier pre-clinical studies (Booth et al 2015, Sakakura et al 2015, Gan et al 2015, Mahfoud et al 2016, we aimed to examine the effects of the single-point and multi-point ablation catheters at 48 h post-RDN procedure. This early phase post-RDN has not yet been investigated.…”

Section: Discussionmentioning

confidence: 99%

“…An innovative multi-ablation device, the EnligHTN TM multi-electrode RNA catheter from St. Jude Medical has been tested in pig, dog and also in humans (Worthley et al 2013, Henegar et al 2014, Gan et al 2015, Mahfoud et al 2016. This multi-point ablation catheter operates at multiple depth levels of the renal artery at the same time.…”

Section: Introductionmentioning

confidence: 99%

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

Táborský

Richter²,

Tonar³

et al. 2017

Physiol Res

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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.

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“…Disruption of these structures reduces the sympathetic nerve innervation of the kidney and through alteration of afferent nerve signalling whole body sympathetic activity [ 20 ]. The distribution pattern and density of sympathetic nerves along the renal arteries have been identified to impact the success of RDN [ 21 ]. Human histological studies as well as preclinical animal studies indicate that the maximal number of nerves are located around the proximal and middle segments of the renal artery, whereas lower number of nerves are located around distal structures.…”

Section: Discussionmentioning

confidence: 99%

Procedural and anatomical predictors of renal denervation efficacy using two radiofrequency renal denervation catheters in a porcine model

Wolf

Hubbard²,

Sakaoka

et al. 2018

Journal of Hypertension

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Introduction:Several renal denervation (RDN) systems are currently under investigation for treatment of hypertension by ablation of renal sympathetic nerves. The procedural efficacy of devices, however, is variable and incompletely understood. This study aimed at investigating procedural and anatomical predictors of RDN efficacy by comparing two radiofrequency catheter systems in a porcine model.Methods:Domestic swine were assigned into two treatment groups (n = 10) and one sham group (n = 3). Bilateral RDN in main and in branch segments of renal arteries was performed using two different multielectrode catheter systems [Symplicity Spyral (SPY) and IberisBloom (IBB)]. After 7 days, measurement of norepinephrine (NEPI) tissue concentrations and histological analyses have been performed.Results:Renal NEPI tissue concentration following RDN was significantly reduced when compared with Sham (SPY: −95 ± 3% vs. Sham, P < 0.001; IBB: −88 ± 11% vs. Sham, P < 0.001). Histological evaluation showed comparable lesion depth and lesion area (lesion depth: SPY-main 6.26 ± 1.62 mm vs. SPY-branch 3.49 ± 1.11 mm; IBB-main 5.93 ± 1.88 mm vs. IBB-branch: 3.26 ± 1.26 mm, P < 0.001; lesion area: SPY-main 43.5 ± 29.5 mm2 vs. SYP-branch 45.0 ± 38.0 mm2; IBB-main 52.3 ± 34.8 mm2 vs. IBB-branch 44.0 ± 42.6 mm2, P = 0.77; intergroup SPY vs. IBB, P = 0.73). Histological investigations documented a significant correlation between number of ablations per millimeter length of renal artery and reduction in NEPI tissue concentration.Conclusion:The two devices under investigation demonstrated similar histopathological lesion characteristics and similar reduction of renal NEPI levels. An increase in number of ablations per millmeter length of renal artery resulted in improved efficacy and reduced variability in treatment effects.

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Catheter-based radio-frequency renal nerve denervation lowers blood pressure in obese hypertensive swine model

Abstract: Catheter-based RDN, using a multielectrode system, resulted in a significant reduction in 24-h BP in this drug-naïve, hypertensive animal model.

Cited by 21 publications

References 20 publications

Atrial fibrillation reduction by renal sympathetic denervation: 12 months’ results of the AFFORD study

Atrial fibrillation reduction by renal sympathetic denervation: 12 months’ results of the AFFORD study

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

Procedural and anatomical predictors of renal denervation efficacy using two radiofrequency renal denervation catheters in a porcine model

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