Catheter-based renal denervation is a novel treatment approach for patients with hypertension and initial unblinded trials have shown promising results. The Paradise™ Ultrasound Renal Denervation System (ReCor Medical, CA, USA) is an ultrasound-based catheter with a distal balloon that acts as a coolant to protect the renal arterial wall. This device received CE-mark in 2012. Randomized, sham-controlled trials and postmarket studies have shown promising efficacy and safety results. Currently, three additional ongoing randomized, sham-controlled trials are underway in the USA, Europe, Japan and Korea, and the results will be pivotal in device approval in some of these countries. These studies with larger numbers of patients and longer duration of follow-up are needed to further confirm the safety and efficacy of this device.

Keywords:

Papers of special note have been highlighted as: • of interest; •• of considerable interest

References

1. Ettehad D, Emdin CA, Kiran A et al. Blood pressure lowering for prevention of cardiovascular disease and death: a systematic review and meta-analysis. Lancet 387(10022), 957–967 (2016).
MedlineGoogle Scholar
2. Noubiap JJ, Nansseu JR, Nyaga UF, Sime PS, Francis I, Bigna JJ. Global prevalence of resistant hypertension: a meta-analysis of data from 3.2 million patients. Heart 105(2), 98–105 (2019).
MedlineGoogle Scholar
3. Kumbhani DJ, Steg PG, Cannon CP et al. Resistant hypertension: a frequent and ominous finding among hypertensive patients with atherothrombosis. Eur. Heart J. 34(16), 1204–1214 (2013).
Medline CASGoogle Scholar
4. Krum H, Schlaich MP, Sobotka PA et al. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the SYMPLICITY HTN-1 study. Lancet 383(9917), 622–629 (2014).
MedlineGoogle Scholar
5. Patel HC, Hayward C, Vassiliou V, Patel K, Howard JP, Di Mario C. Renal denervation for the management of resistant hypertension. Integr. Blood Press. Control 8, 57–69 (2015).
Medline CASGoogle Scholar
6. Rocha-Singh KJ. Renal artery denervation: a brave new frontier. Endovascular Today 45–53 (2012).
Google Scholar
7. Bhatt DL, Kandzari DE, O'Neill WW et al. A controlled trial of renal denervation for resistant hypertension. N. Engl. J. Med. 370(15), 1393–1401 (2014). • Fails to show the efficacy of the renal denervation.
Medline CASGoogle Scholar
8. Kandzari DE, Bhatt DL, Brar S et al. Predictors of blood pressure response in the SYMPLICITY HTN-3 trial. Eur. Heart J. 36(4), 219–227 (2015).
MedlineGoogle Scholar
9. Mahfoud F, Bakris G, Bhatt DL et al. Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. Eur. Heart J. 38(2), 93–100 (2017).
Medline CASGoogle Scholar
10. Sakakura K, Roth A, Ladich E et al. Controlled circumferential renal sympathetic denervation with preservation of the renal arterial wall using intraluminal ultrasound: a next-generation approach for treating sympathetic overactivity. EuroIntervention 10(10), 1230–1238 (2015). •• Evaluates the Paradise System.
MedlineGoogle Scholar
11. Sakakura K, Ladich E, Cheng Q et al. Anatomic assessment of sympathetic peri-arterial renal nerves in man. J. Am. Coll. Cardiol. 64(7), 635–643 (2014). • Describes the anatomy of the peri-arterial nerve in renal artery.
MedlineGoogle Scholar
12. Pathak A, Coleman L, Roth A et al. Renal sympathetic nerve denervation using intraluminal ultrasound within a cooling balloon preserves the arterial wall and reduces sympathetic nerve activity. EuroIntervention 11(4), 477–484 (2015). •• Evaluates the Paradise System.
MedlineGoogle Scholar
13. Mauri L, Kario K, Basile J et al. A multinational clinical approach to assessing the effectiveness of catheter-based ultrasound renal denervation: the RADIANCE-HTN and REQUIRE clinical study designs. Am. Heart J. 195, 115–129 (2018).
MedlineGoogle Scholar
14. Mabin T, Sapoval M, Cabane V, Stemmett J, Iyer M. First experience with endovascular ultrasound renal denervation for the treatment of resistant hypertension. EuroIntervention 8(1), 57–61 (2012).
MedlineGoogle Scholar
15. Daemen J, Mahfoud F, Kuck KH et al. Safety and efficacy of endovascular ultrasound renal denervation in resistant hypertension: 12-month results from the ACHIEVE study. J. Hypertens. 37(9), 1906–1912 (2019).
Medline CASGoogle Scholar
16. Azizi M, Schmieder RE, Mahfoud F et al. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet 391(10137), 2335–2345 (2018). •• Explains the Paradise System.
MedlineGoogle Scholar
17. Azizi M, Schmieder RE, Mahfoud F et al. Six-month results of treatment-blinded medication titration for hypertension control following randomization to endovascular ultrasound renal denervation or a sham procedure in the RADIANCE-HTN SOLO trial. Circulation 139, 2542–2553 (2019).
CASGoogle Scholar
18. Whelton PK, Carey RM, Aronow WS et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J. Am. Coll. Cardiol. 71(19), e127–e248 (2018).
MedlineGoogle Scholar
19. Kandzari DE, Bohm M, Mahfoud F et al. Effect of renal denervation on blood pressure in the presence of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-of-concept randomised trial. Lancet 391(10137), 2346–2355 (2018).
MedlineGoogle Scholar
20. Böhm M, Kario K, Kandzari DE et al. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet 27(20), 30554–30557 (2020).
Google Scholar
21. Mahfoud F, Mancia G, Schmieder R et al. Renal denervation in high-risk patients with hypertension. J. Am. Coll. Cardiol. 75(23), 2879–2888 (2020).
MedlineGoogle Scholar
22. Pucci G, Battista F, Lazzari L, Dominici M, Boschetti E, Schillaci G. Progression of renal artery stenosis after renal denervation. Impact on 24-hour blood pressure. Circ. J. 78(3), 767–768 (2014).
MedlineGoogle Scholar
23. Versaci F, Trivisonno A, Olivieri C, Caranci F, Brunese L, Prati F. Late renal artery stenosis after renal denervation: is it the tip of the iceberg? Int. J. Cardiol. 172(3), e507–e508 (2014).
MedlineGoogle Scholar
24. Versaci F, Trivisonno A, Olivieri C, Magri G, Caranci F, Prati F. Is an abnormal vascular response after renal sympathetic denervation predictive of permanent damage? An unusual case of late renal artery stenosis after energy delivery. J. Endovasc. Ther. 21(2), 191–196 (2014).
MedlineGoogle Scholar
25. Fengler K, Höllriegel R, Okon T et al. Ultrasound-based renal sympathetic denervation for the treatment of therapy-resistant hypertension: a single-center experience. J. Hypertens. 35(6), 1310–1317 (2017).
Medline CASGoogle Scholar
26. Fengler K, Rommel KP, Blazek S et al. A three-arm randomized trial of different renal denervation devices and techniques in patients with resistant hypertension (RADIOSOUND-HTN). Circulation 139(5), 590–600 (2019). •• Compares the efficacy of the Paradise System to the Spyral radiofrequency renal denervation system.
MedlineGoogle Scholar
27. Stiermaier T, Okon T, Fengler K et al. Endovascular ultrasound for renal sympathetic denervation in patients with therapy-resistant hypertension not responding to radiofrequency renal sympathetic denervation. EuroIntervention 12(2), e282–e289 (2016).
MedlineGoogle Scholar
28. Al Raisi SI, Pouliopoulos J, Barry MT et al. Evaluation of lesion and thermodynamic characteristics of Symplicity and EnligHTN renal denervation systems in a phantom renal artery model. EuroIntervention 10(2), 277–284 (2014).
MedlineGoogle Scholar
29. Sato Y, Kawakami R, Jinnouchi H et al. Comprehensive assessment of human accessory renal artery periarterial renal sympathetic nerve distribution. JACC Cardiovasc. Interv. 14(3), 304–315 (2021). • Evaluates the anatomy of the peri-arterial nerve in accessory renal artery.
MedlineGoogle Scholar
30. Patel HC, Otero S, Moser JB et al. A cross-sectional imaging study to identify organs at risk of thermal injury during renal artery sympathetic denervation. Int. J. Cardiol. 197, 235–240 (2015).
MedlineGoogle Scholar
31. Lauder L, Ewen S, Tzafriri AR et al. Anatomical and procedural determinants of ambulatory blood pressure lowering following catheter-based renal denervation using radiofrequency. Cardiovasc. Revasc. Med. 19(7 Pt B), 845–851 (2018).
MedlineGoogle Scholar
32. Sakakura K, Tunev S, Yahagi K et al. Comparison of histopathologic analysis following renal sympathetic denervation over multiple time points. Circ. Cardiovasc. Interv. 8(2), e001813 (2015).
MedlineGoogle Scholar
33. Sakakura K, Ladich E, Edelman ER et al. Methodological standardization for the pre-clinical evaluation of renal sympathetic denervation. JACC Cardiovasc. Interv. 7(10), 1184–1193 (2014).
MedlineGoogle Scholar
34. Williams B, Mancia G, Spiering W et al. 2018 ESC/ESH guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH). Eur. Heart J. 39(33), 3021–3104 (2018).
MedlineGoogle Scholar
35. Schmieder RE, Mahfoud F, Azizi M et al. European Society of Hypertension position paper on renal denervation 2018. J. Hypertens. 36(10), 2042–2048 (2018).
Medline CASGoogle Scholar

Vol. 17, No. 6

Metrics

Downloaded 220 times

History

Received 15 December 2020

Accepted 18 March 2021

Published online 20 April 2021

Published in print September 2021

Information

Keywords

Author contributions

All the authors met all conditions as follows: (a) substantial contributions to the conception or design of the work; or the acquisition, analysis or interpretation of data for the work; and (b) drafting the work or revising it critically for important intellectual content; and (c) final approval of the version to be published; and (d) agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Company review disclosure

In addition to the peer-review process, with the author’s consent, the manufacturer of the product discussed in this article was given the opportunity to review the manuscript for factual accuracy. Changes were made by the author at their discretion and based on scientific or editorial merit only. The author maintained full control over the manuscript including content, wording and conclusions.

Financial & competing interests disclosure

CVPath Institute has received institutional research support from R01 HL141425 Leducq Foundation Grant, 480 Biomedical, 4C Medical, 4Tech, Abbott, Accumedical, Amgen, Biosensors, Boston Scientific, Cardiac Implants, Celonova, Claret Medical, Concept Medical, Cook, CSI, DuNing, Inc., Edwards LifeSciences, Emboline, Endotronix, Envision Scientific, Lutonix/Bard, Gateway, Lifetech, Limflo, MedAlliance, Medtronic, Mercator, Merill, Microport Medical, Microvention, Mitraalign, Mitra assist, NAMSA, Nanova, Neovasc, NIPRO, Novogate, Occulotech, OrbusNeich Medical, Phenox, Profusa, Protembis, Qool, ReCor Medical, Senseonics, Shockwave, Sinomed, Spectranetics, Surmodics, Symic, Vesper, WL Gore and Xeltis. AV Finn has received honoraria from Abbott Vascular, Biosensors, Boston Scientific, Celonova, Cook Medical, CSI, Lutonix Bard, Sinomed and Terumo Corporation; and is a consultant to Amgen, Abbott Vascular, Boston Scientific, Celonova, Cook Medical, Lutonix Bard and Sinomed. A Cornelissen receives research grants from University Hospital RWTH Aachen. R Virmani has received honoraria from Abbott Vascular, Biosensors, Boston Scientific, Celonova, Cook Medical, Cordis, CSI, Lutonix Bard, Medtronic, OrbusNeich Medical, CeloNova, SINO Medical Technology, ReCor Medical, Terumo Corporation, WL Gore and Spectranetics; and is a consultant to Abbott Vascular, Boston Scientific, Celonova, Cook Medical, Cordis, CSI, Edwards Lifescience, Lutonix Bard, Medtronic, OrbusNeich Medical, ReCor Medical, Sinomededical Technology, Spectranetics, Surmodics, Terumo Corporation, WL Gore and Xeltis. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

PDF download

Paradise™ Ultrasound Renal Denervation System for the treatment of hypertension

Abstract

References