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

Wolf, Milan; Hubbard, Brad; Sakaoka, Atsushi; Rousselle, Serge; Téllez, Armando; Jiang, Xiongjing; Kario, Kazuomi; Hohl, Mathias; Böhm, Michael; Mahfoud, Felix

doi:10.1097/hjh.0000000000001840

Cited by 12 publications

(6 citation statements)

References 23 publications

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“…While informative renal nerve distributions in animals and humans have been published [18][19][20] quantitative correlations of nerve distribution with treatment effects of RDN devices are limited 12,16,21 . Although the recently published studies provided proof of principle for the BP lowering efficacy of RDN, the sensitivity of efficacy and variance to anatomical and device parameters is poorly understood 6 .…”

Section: Discussionmentioning

confidence: 99%

Procedural and Anatomical Determinants of Multielectrode Renal Denervation Efficacy

Tzafriri¹,

Mahfoud

Keating³

et al. 2019

Hypertension

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Radiofrequency renal denervation is under investigation for treatment of hypertension with variable success. We developed preclinical models to examine the dependence of ablation biomarkers on renal denervation treatment parameters and anatomic variables. One hundred twenty-nine porcine renal arteries were denervated with an irrigated radiofrequency catheter with multiple helically arrayed electrodes. Nerve effects and ablation geometries at 7 days were characterized histomorphometrically and correlated with associated renal norepinephrine levels. Norepinephrine exhibited a threshold dependence on the percentage of affected nerves across the range of treatment durations (30–60 s) and power set points (6–20 W). For 15 W/30 s treatments, norepinephrine reduction and percentage of affected nerves tracked with number of electrode treatments, confirming additive effects of helically staggered ablations. Threshold effects were only attained when ≥4 electrodes were powered. Histomorphometry and computational modeling both illustrated that radiofrequency treatments directed at large neighboring veins resulted in subaverage ablation areas and, therefore, contributed suboptimally to efficacy. Account for measured nerve distribution patterns and the annular geometry of the artery revealed that, regardless of treatment variables, total ablation area and circumferential coverage were the prime determinants of renal denervation efficacy, with increased efficacy at smaller diameters.

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Section: Discussionmentioning

confidence: 99%

Procedural and Anatomical Determinants of Multielectrode Renal Denervation Efficacy

Tzafriri¹,

Mahfoud

Keating³

et al. 2019

Hypertension

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“…[28] Currently, clinical trials are being conducted in Japan by Japan Medtronic (SPYRAL denervation system), JIMRO of the Otsuka Holdings Group (Paradise denervation system), and Terumo (IBERIS denervation system, radio wave) [Table 1]. [29] The global SYMPLICITY registry (GSR)…”

Section: Evidence From the Japanese Populationmentioning

confidence: 99%

Device-Based Treatment in Hypertension: At the Forefront of Renal Denervation

Kario

Hettrick

Esler

2021

Cardiology Discovery

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Percutaneous renal denervation is a novel device therapy that modifies the circulatory regulatory system and has received considerable attention recently. This treatment partially blocks the renal sympathetic nervous system, which is an organ-connecting pathway between the brain and the kidney. Denervation techniques currently under clinical investigation include radiofrequency, ultrasonic, and chemical ablation with alcohol, all of which are executed through transcatheter access to the renal artery. All recently published randomized sham-controlled trials have shown a clear antihypertensive effect of renal denervation over 24 hours, including during the nighttime and early morning. This treatment has promise in the management of poorly controlled hypertension as well as in the prevention of the development or aggravation of arrhythmias and heart failure.

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“…The performance of LDS and the ablation protocol were evaluated using a swine model. The swine is physiologically and anatomically similar to humans and are most commonly used in preclinical studies of cardiovascular devices [40].…”

Section: B Swine Modelmentioning

confidence: 99%

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

Baik

Song

Yim

et al. 2020

IEEE Trans. Biomed. Eng.

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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. Methods: We propose a new renal denervation strategy called laparoscopic denervation 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 nerves The simulation study using validated in-silico models evaluated the heat distribution on the outer arterial wall, and an acute animal study (swine model) was conducted to demonstrate the feasibility of LDS in vivo. Results: The simulation study confirmed that LDS could localize the heat distribution between 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 denaturation and decrease in neural density by 20.78 % (P<0.001), while maintaining a constant tip temperature of 65 ℃ 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. Significance: LDS approach is innovative, inventive, and presents a novel technique to treat hypertension.

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

Cited by 12 publications

References 23 publications

Procedural and Anatomical Determinants of Multielectrode Renal Denervation Efficacy

Procedural and Anatomical Determinants of Multielectrode Renal Denervation Efficacy

Device-Based Treatment in Hypertension: At the Forefront of Renal Denervation

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

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