Proceedings from the European clinical consensus conference for renal denervation: considerations on future clinical trial design: Figure 1

Mahfoud, Felix; Böhm, Michael; Azizi, Michel; Pathak, Atul; Durand-Zaleski, Isabelle; Ewen, Sebastian; Tsioufis, K; Andersson, Bert; Blankestijn, Peter J.; Burnier, Michel; Châtellier, Gilles; Gafoor, Sameer; Grassı, Guıdo; Joner, Michael; Kjeldsen, Sverre E.; Lüscher, Thomas F.; Lobo, Melvin D.; Lotan, Chaim; Parati, Gianfranco; Redón, Josep; Ruilope, Luís M.; Sudano, Isabella; Ukena, Christian; Leeuwen, Evert van; Volpe, Massimo; Windecker, Stephan; Witkowski, Adam; Wijns, William; Zeller, Thomas; Schmieder, Roland E.

doi:10.1093/eurheartj/ehv192

Cited by 172 publications

(108 citation statements)

References 87 publications

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“…While the restoration of nerve physiology seems histologically unlikely due to the disrupted architecture of the neuromatous tangles at the RF lesion sites (neuromatous regeneration), this needs to be evaluated at longer term chronic follow up and the translation of these findings to humans remains to be determined. 32 …”

Section: Limitation Of the Studymentioning

confidence: 99%

Sub-acute Safety and Efficacy Evaluation of Single versus Double Treatment Cycles of a Monopolar Radiofrequency Catheter-Based Renal Nerve Ablation and its Chronic Evolution in a Large Animal Model

Hubbard¹,

Sakaoka²,

Brants³

et al. 2016

J.ATAMIS

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Aims:We aimed to evaluate the transcatheter renal denervation(RDN) effects delivered by a mono-electrode catheter in a large animal model including safety implications of delivery of one cycle versus two cycles of ablations.Methods and Results:18 animals underwent bilateral RDN; 4 untreated naïve swine were enrolled as controls for norepinephrine levels(NE) only. Animals recieved 120-second (follow up-7,30 and 90 days) or 240-second cycles ablations (follow up-7 days). Norepinephrine evaluation, histology and immunohistochemistry evaluation was performed. No luminal obstruction was observed at follow up. A 70% decrease in NE levels (76.68±57.87ng/g) was observed at 7 days, 81% at 30 days(49.05±45.81ng/g), and 51% at 90 days(12.7±73.2 ng/g) compared to naïve controls(254.1±54.1ng/g;p<0.05). Histologically, the thermal effect extended to a complete circumferential involvement with a depth ~8mm. The primary histological feature at 7 days was nerve necrosis and distal atrophy; at 30 days, necrosis was replaced by healing changes of fibrosis. Neuromatous regeneration was apparent at 30 days at RF treated levels. At 90 days these features progressed to become more conspicuous. There were no appreciable differences in depth and circumferential extent of RF injury between one and two cycle treatment groups.Conclusion:RDN performed with a mono-electrode catheter (Iberis) appears to be safe following single or double-cycle RF ablation.NE decrease following RDN was demonstrated at 7, 30, and 90 days compared to naïve controls, suggesting efficient nerve ablation with the device as intended for human use.

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Section: Limitation Of the Studymentioning

confidence: 99%

Sub-acute Safety and Efficacy Evaluation of Single versus Double Treatment Cycles of a Monopolar Radiofrequency Catheter-Based Renal Nerve Ablation and its Chronic Evolution in a Large Animal Model

Hubbard¹,

Sakaoka²,

Brants³

et al. 2016

J.ATAMIS

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“…Our findings have important implications for the design of future RDN studies. With revised procedural guidelines [37][38][39] (including more 4-quadrant ablations and stricter oversight of medication adherence), we hope to see a greater decline in these parameters as well as in overall 24-hour ambulatory BP, raising the possibility that a clinically significant reduction in cardiovascular events might follow RDN treatment, although this will need to be proved in appropriately designed randomized trials. …”

Section: Perspectivesmentioning

confidence: 99%

Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure

et al. 2015

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U ncontrolled hypertension is associated with an increasing incidence of stroke, cardiovascular events such as myocardial infarction, peripheral artery disease, and end-stage renal disease across all ages, and ethnicities. [1][2][3][4][5] Detailed studies of blood pressure (BP) variability over 24 hours have further described an increased risk of cardiovascular events and stroke with elevated BP during the nighttime 6,7 and early morning hours. 8,9The sympathetic nervous system plays an active role in the modulation of BP, and its overactivation can lead to hypertension.10,11 Percutaneous catheter-based renal denervation (RDN) by radiofrequency ablation of the renal artery nerves has been shown to reduce central sympathetic activity 12,13 and BP in patients with uncontrolled hypertension. Although recently reported results from the Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3) 14 and SYMPLICITY HTN-Japan (HTN-Japan) 15 clinical trials did not demonstrate superiority of RDN over pharmacological management of hypertension based on superiority analyses of office BP or 24-hour ambulatory BP measurements (ABPM), 14,15 further evaluation of the SYMPLICITY HTN-3 trial identified several potential confounding factors that may have impacted the overall results, including insufficient ablation attempts, insufficient 4-quadrant ablations, and antihypertensive medication changes. 16In contrast to the results of SYMPLICITY HTN-3, the recently reported prospective Renal Denervation for Hypertension (DENER HTN) 17 trial reported small but statistically significant reductions in ambulatory BP (though not office or home BP) in denervated patients compared with a nonblinded, randomized control group of patients with resistant hypertension treated with a stepped-care pharmacological strategy. These reductions included greater decreases in both daytime and nighttime ambulatory systolic BP in the denervated group.Abstract-High nighttime and early morning blood pressure (BP) have been associated with greater risk for cardiovascular events than high clinic or daytime BP. BP is typically highest in the rising hours, when morning activities typically begin. We examined the effect of renal denervation on morning (6:00-8:59 AM), daytime (9:00 AM-8:59 PM), and nighttime ( P=0.28), but the classes prescribed and changes in prescription varied by study. Among patients treated with renal denervation, although the number of ablation treatments were similar in both studies (11.2±2.8 versus 11.5±1.9, P=0.55), patients in SYMPLICITY HTN-3 were less likely to receive at least 1 four-quadrant ablation treatment (25% versus 82%, P<0.001). In SYMPLICITY HTN-3, compared with controls (n=159), patients treated with renal denervation (n=325) experienced a significantly greater change in morning (−7.3±19.8 mm Hg, P<0.001) and nighttime (−6.1±18.2 versus −1.6±19.7 mm Hg, P=0.02) but not daytime systolic BP (−7.2±16.2 versus −6.4±18.6 mm Hg, P=0.67). This same trend was observed in the pooled analysis with HTN-Japan. Re...

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“…Catheter-based renal sympathetic denervation (RDN) has been developed as an interventional treatment option for patients with uncontrolled hypertension [1]. The interpretation of current randomized, controlled, trials in RDN is contentious.…”

Section: Introductionmentioning

confidence: 99%

“…The results of the Symplicity HTN-3 trial [5] showed no statistically significant difference between the RDN group and the sham-treated patients. An ineffective method has been postulated as a possible cause for non-response to treatment [1]. The published, controlled and uncontrolled trials [1][2][3][4][5][6] only enrolled patients with favorable renal anatomy, which was defined as i) absence of accessory renal arteries (ARA) or renal atherosclerotic disease including previous angioplasty or stenting, ii) diameter of ≥4 mm and iii) length of ≥20 mm of the main renal artery.…”

Section: Introductionmentioning

confidence: 99%

Anatomical and procedural determinants of catheter-based renal denervation

Ewen

Ukena

Lüscher

et al. 2016

Cardiovascular Revascularization Medicine

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Proceedings from the European clinical consensus conference for renal denervation: considerations on future clinical trial design: Figure 1

Cited by 172 publications

References 87 publications

Sub-acute Safety and Efficacy Evaluation of Single versus Double Treatment Cycles of a Monopolar Radiofrequency Catheter-Based Renal Nerve Ablation and its Chronic Evolution in a Large Animal Model

Sub-acute Safety and Efficacy Evaluation of Single versus Double Treatment Cycles of a Monopolar Radiofrequency Catheter-Based Renal Nerve Ablation and its Chronic Evolution in a Large Animal Model

Effect of Catheter-Based Renal Denervation on Morning and Nocturnal Blood Pressure

Anatomical and procedural determinants of catheter-based renal denervation

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