Acute changes in histopathology and intravascular imaging after catheter‐based renal denervation in a porcine model

Sakaoka, Atsushi; Takami, Akiyuki; Onimura, Yuji; Hagiwara, Hikoichi; Terao, Hisako; Kumagai, Fumiaki; Matsumura, Kiyoshi

doi:10.1002/ccd.27158

Cited by 4 publications

(5 citation statements)

References 23 publications

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“…Our findings demonstrate that RDN caused injury to the vascular intima and media; and the in vitro endothelium-independent tension assay showed that renal arterial relaxation function decreased after the RDN. This result is due to elastic fiber breakage, vascular smooth muscle cell degeneration and necrosis, which was also consistent with the thin media and reduced myofilament density in ablated medial smooth muscle cells after RDN in Sakaoka’s study [28]. Unfortunately, we did not detect endothelium-dependent vascular relaxation function and only detected AKT/eNOS pathway-related protein expression, which explained the endothelial dysfunction molecularly.…”

Section: Discussionsupporting

confidence: 85%

Acute changes in morphology and renal vascular relaxation function after renal denervation using temperature-controlled radiofrequency catheter

Zhao

Gao

et al. 2019

BMC Cardiovasc Disord

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BackgroundResistant hypertension and renal sympathetic hyperactivity are closely linked, and catheter-based renal denervation (RDN) is regarded as a new treatment strategy. However, the acute changes in vascular morphology and relaxation function have yet to be evaluated, and these may be important for the efficacy and safety of the procedure. In this study, we explored these questions by conventional temperature-controlled cardiac radiofrequency catheter-based RDN in a pig model.MethodsSix mini-pigs were randomly divided into the renal denervation (RDN) group (n = 3) and the Sham-RDN group (n = 3). Animals in the RDN group underwent unilateral radiofrequency ablation, and those in the Sham-RDN group underwent the same procedure except for the ablation. The pigs were examined by angiography pre- and post-RDN and were euthanized immediately thereafter. Renal arteries were processed for histological and molecular biology analyses as well as for in vitro vascular tension testing.ResultsCompared with the Sham-RDN group, the RDN caused vascular intima and media injury, renal nerve vacuolization, mild collagen fiber hyperplasia and elastic fiber cleavage (all p < 0.05). The RDN group also significantly exhibited nitric oxide synthase pathway inhibition and decreased endothelium-independent vascular relaxation function Compared to the Sham-RDN group (all p < 0.05).ConclusionsIn this porcine model, renal artery denervation led to vascular wall injury and endothelial dysfunction in the acute phase, which negatively affected vascular relaxation function. Thus, this process may be detrimental to the prognosis and progress of hypertension patients.Electronic supplementary materialThe online version of this article (10.1186/s12872-019-1053-z) contains supplementary material, which is available to authorized users.

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Section: Discussionsupporting

confidence: 85%

Acute changes in morphology and renal vascular relaxation function after renal denervation using temperature-controlled radiofrequency catheter

Zhao

Gao

et al. 2019

BMC Cardiovasc Disord

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“…First, the findings obtained from the normotensive swine may not be applicable to patients with hypertension. However, the normotensive swine is the standard animal model for assessing RDN device safety, because of its anatomical and physiological similarity to humans . Second, because of the small number of animals, adverse findings with a low incidence may have been missed.…”

Section: Discussionmentioning

confidence: 99%

“…The safety of RF‐RDN on the main RA has been confirmed in >1,000 patients, and histopathological changes induced by RF‐RDN around the main RA were assessed in several animal studies, However, the safety of RF‐RDN on the branch RA remains unclear. As the diameter of the branch RA is smaller than that of the main RA, there is a potential risk of disruption or stenosis.…”

Section: Introductionmentioning

confidence: 99%

Safety of catheter‐based radiofrequency renal denervation on branch renal arteries in a porcine model

Sakaoka

Rousselle²,

Hagiwara

et al. 2018

Cathet Cardio Intervent

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Objectives We aimed to investigate the safety of radiofrequency (RF)‐renal denervation (RDN) on branch renal arteries (RAs) in a porcine model. Background The efficacy of RF‐RDN was enhanced by treatment of the branch RA, in addition to the main RA. However, there are concerns regarding the safety of RF‐RDN on branch RA because of their smaller diameter and proximity to the kidney. Methods RF was delivered to 24 RA from 12 swine. A total of 8 RA from 4 swine were untreated. Treated RA were examined by angiography and histopathology at 7, 30, and 90 days. Serum creatinine concentration, biophysical parameters during RF delivery, and renal norepinephrine concentration were also assessed. Results Angiography revealed minimal late lumen loss and diameter stenosis in the main and branch RA at any time point. There was no change in serum creatinine after RF‐RDN. Histopathologically, no augmentation of medial damage or neointimal formation was found in branch RA compared with main RA. No or minimal damage to surrounding tissues including the kidneys, ureters, lymph nodes, and muscles was observed at any time point in both the main and branch RA. Equivalent electrode temperature in the main and branch RA was achieved by automatic adjustment of output power by the generator. The renal norepinephrine concentration was significantly lower in the treated group compared with the untreated group. Conclusions RF‐RDN on branch RA was safe in a porcine model, with stenosis‐free healing of treated arteries and negligible kidney damage at 7, 30, and 90 days.

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“…A catheter provided radial access to minimize vascular complications as well as femoral access. The safety and efficacy of the system were validated by the preclinical animal studies [11][12][13]. This system obtained CE approval in March 2013.…”

Section: Methodsmentioning

confidence: 99%

Renal Sympathetic Denervation in Patients with Resistant Hypertension: A Feasibility Study

Kario

Rumoroso

Okawara

et al. 2018

Pulse

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Background/Aims: We assessed the feasibility of renal sympathetic denervation (RDN) treatment in patients with resistant hypertension using the Iberis® RDN system. This study was a prospective, multicenter, single-arm feasibility registry. Methods: We collected data from patients who underwent RDN treatment using the Iberis system. From November 2014 to February 2016, 16 patients from 6 centers in Europe were enrolled in this registry. Results: Consistent reductions in the 24-h systolic blood pressure (SBP) and diastolic blood pressure were obtained. At any follow-up point, more than 70% of the patients were responders. The change in the 24-h SBP at 1 month was strongly correlated with that at 12 months. Conclusion: The Iberis system is safe and effective in patients for the treatment of resistant hypertension. Furthermore, our results suggest that we can estimate the effect of RDN in the long term at the 1-month follow-up point using the 24-h SBP.

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Acute changes in histopathology and intravascular imaging after catheter‐based renal denervation in a porcine model

Cited by 4 publications

References 23 publications

Acute changes in morphology and renal vascular relaxation function after renal denervation using temperature-controlled radiofrequency catheter

Acute changes in morphology and renal vascular relaxation function after renal denervation using temperature-controlled radiofrequency catheter

Safety of catheter‐based radiofrequency renal denervation on branch renal arteries in a porcine model

Renal Sympathetic Denervation in Patients with Resistant Hypertension: A Feasibility Study

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