First experience with endovascular ultrasound renal denervation for the treatment of resistant hypertension

Mabin, Tom; Sapoval, Marc; Cabane, Vincent; Stemmett, Joanne; Iyer, Mano

doi:10.4244/eijv8i1a10

Cited by 122 publications

(72 citation statements)

References 9 publications

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“…Animals received Cefazolin as prophylaxis (1 g IM). At the terminal time point (7,30 or 90 days), animals were heparinized (200U/kg IV) and following final renal angiography and prior to euthanasia, a midline laparotomy was performed and fresh renal cortical tissues harvested for norepinephrine analysis ( Figure 2). Animals that received 2 treatment cycles were not subjected to cortical tissue harvest procedures ( Figure 2).…”

Section: Animal Model and Interventional Proceduresmentioning

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: Animal Model and Interventional Proceduresmentioning

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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“…33 % of the patients reached the target blood pressure range of < 140 mmHg [40]. After renal denervation with the Paradise system (ReCor Medical) in which denervation is performed via ultrasound ablation instead of radiofrequency ablation, lowering of the office blood pressure by 36/17 mmHg or 22/12 mmHg in the ambulatory blood pressure measurement was observed after 3 months [41]. In addition to these industry-initiated studies, data from smaller studies that were able to confirm the above results only partially or not at all have since been presented.…”

Section: Blood Pressure Reductionmentioning

confidence: 99%

“…To date, there has not been significant or clinically relevant worsening of renal function within a year of renal denervation that was to be attributed to renal denervation [33]. Minimal worsening of the GFR (from 87 ± 19 ml/min/ 1.73 m 2 to 82 ± 20 ml/min/1.73 m 2 ) occurred in only one study [41]. Significant worsening was not seen in the denervation group or in the control group even in the HTN-3 study in which the renal function was determined by the serum creatinine, cystatin C and estimated GFR.…”

Section: Side Effects Complicationsmentioning

confidence: 99%

Renal Denervation: Unde Venis et Quo Vadis?

Nähle

Düsing²,

Schild

2015

Fortschr Röntgenstr

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!Objective and Methods: Renal denervation is a minimally invasive, catheter-based option for the treatment of refractory hypertension. Indications and contraindications for renal denervation have been defined in an interdisciplinary manner. The efficacy and safety of the procedure were evaluated. Results: Currently, indication for renal denervation is limited to patients with primary hypertension and a systolic blood pressure of ≥ 160 mm Hg (or ≥ 150 mm Hg in diabetes type 2) despite optimal medical therapy with ≥ 3 different antihypertensive drugs. In this specific patient population, an average blood pressure reduction of 32/14 mmHg was observed in non-randomized/-controlled trials after renal denervation. These results were not confirmed in the first randomized controlled trial with a non-significantly superior blood pressure reduction of 14.1 ± 23.9 mm Hg compared to controls (−11.74 ± 25.94 mm Hg, difference −2.39 mm Hg p = 0.26 for superiority with a margin of 5 mm Hg) who underwent a sham procedure. Conclusion: The efficacy and long-term effects of renal denervation need to be re-evaluated in light of the HTN3 study results. To date, renal denervation should not be performed outside of clinical trials. Future trials should also assess if renal denervation can be performed with sufficient safety and efficacy in patients with hypertension-associated diseases. The use of renal denervation as an alternative therapy (e. g. in patients with drug intolerance) can currently not be advocated. Key points:▶ The indication for renal denervation should be assessed in an interdisciplinary fashion and according to current guidelines with a special focus on ruling out secondary causes for arterial hypertension.▶ 5 -10 % of patients with hypertension suffer from refractory hypertension, but only about 1 % of patients meet the criteria for a renal denervation.▶ Renal denervation leads to a significant decrease in office blood pressure; however, the impact on 24-hour blood pressure measurements remains unclear.▶ In the first randomized controlled trial on renal denervation with a control group undergoing a sham procedure, blood pressure reduction failed to reach the anticipated level of superiority over best medical treatment.▶ Periprocedural complications are rare, but long-term safety can currently not be appraised due to the limited data available. Review 237Nähle CP et al.

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“…The first-inman study, which was conducted in South Africa on 15 patients, demonstrated a beneficial effect, with a persistent decrease in office systolic and diastolic BPs of 32 mm Hg and 17 mm Hg in the 11 patients available for follow-up at 6 months. The average heating time was 4.3 minutes per patient, and all treatments were done with conscious sedation and analgesia only (66). The REALISE (REnAL denervation by ultraSound transcatheter Emission) study is also currently enrolling at two sites in France (goal, N ¼ 20).…”

Section: Other Minimally Invasive Htn Therapiesmentioning

confidence: 99%

Proceedings from the Society of Interventional Radiology Foundation Research Consensus Panel on Renal Sympathetic Denervation

Angle

Prince

Matsumoto

et al. 2014

Journal of Vascular and Interventional Radiology

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ABBREVIATIONSBP = blood pressure, CHF = congestive heart failure, HTN = hypertension, MSNA = muscle sympathetic nerve activity, NE = norepinephrine, LV = left ventricular, OSA = obstructive sleep apnea, PET = positron emission tomography, PAREPET = prediction of arrhythmic events with positron emission tomography, RCP = research consensus panel, RDN = renal denervation, RSNA = renal sympathetic nerve activity

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First experience with endovascular ultrasound renal denervation for the treatment of resistant hypertension

Abstract: Ultrasound renal denervation appears to be a safe and effective treatment for resistant hypertension and further studies will be performed to confirm these preliminary results.

Cited by 122 publications

References 9 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

Renal Denervation: Unde Venis et Quo Vadis?

Proceedings from the Society of Interventional Radiology Foundation Research Consensus Panel on Renal Sympathetic Denervation

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