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Bipolar radiofrequency renal denervation with the Vessix catheter in patients with resistant hypertension: 2-year results from the REDUCE-HTN trial

Journal of Human Hypertension volume 31, pages 366–368 (2017)Cite this article

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One hundred forty-six hypertensive patients were treated with bipolar radiofrequency balloon-based renal denervation. Significant office blood pressure (BP) reductions were sustained through 2 years of follow-up, with few patients experiencing related serious adverse events. Although confirmatory randomised controlled trials with designs to minimise confounding factors are needed, long-term follow-up after renal denervation continues to support procedure safety and suggests that it may have a lowering effect on BP.

Between 5 and 30% of hypertensive adults have resistant hypertension, which confers a high cardiovascular risk.1, 2 Percutaneous catheter-based renal denervation has been proposed as an adjunctive therapy for blood pressure control in these patients. Several observational studies have shown favourable short-term (that is, 6 month) effects of radiofrequency renal denervation on office BP but results are more controversial in randomised controlled trials, especially when assessing the BP lowering effects with ambulatory BP monitoring.3 The reasons for this controversy have been largely discussed.4 Moreover, the long-term persistence of the BP lowering effect of renal denervation remains to be demonstrated, taking into account possible renal nerve regrowth which has been reported in animal models.5, 6 We report here the 2-year BP effects of renal denervation with the Vessix Renal Denervation System (Boston Scientific, Marlborough, MA, USA).

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References

  1. Mancia G, Fagard R, Narkiewicz K, Redon J, Zanchetti A, Bohm M et al. ESH/ESC guidelines for the management of arterial hypertension: the Task Force for the Management of Arterial Hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC). Eur Heart J 2013; 34: 2159–2219.

    Article  Google Scholar 

  2. Persell SD . Prevalence of resistant hypertension in the United States, 2003–2008. Hypertension 2011; 57: 1076–1080.

    Article  CAS  Google Scholar 

  3. Howard JP, Nowbar AN, Francis DP . Size of blood pressure reduction from renal denervation: insights from meta-analysis of antihypertensive drug trials of 4,121 patients with focus on trial design: the CONVERGE report. Heart 2013; 99: 1579–1587.

    Article  Google Scholar 

  4. Mahfoud F, Bohm M, Azizi M, Pathak A, Durand Zaleski I, Ewen S et al. Proceedings from the European clinical consensus conference for renal denervation: considerations on future clinical trial design. Eur Heart J 2015; 36: 2219–2227.

    Article  Google Scholar 

  5. Booth LC, Nishi EE, Yao ST, Ramchandra R, Lambert GW, Schlaich MP et al. Reinnervation of renal afferent and efferent nerves at 5.5 and 11 months after catheter-based radiofrequency renal denervation in sheep. Hypertension 2015; 65: 393–400.

    Article  CAS  Google Scholar 

  6. Rousselle SD, Brants IK, Sakaoka A, Hubbard B, Jackson ND, Wicks JR et al. Neuromatous regeneration as a nerve response after catheter-based renal denervation therapy in a large animal model: immunohistochemical study. Circ Cardiovasc Interv 2015; 8: e002293.

    Article  Google Scholar 

  7. Sievert H, Schofer J, Ormiston J, Hoppe UC, Meredith IT, Walters DL et al. Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. EuroIntervention 2015; 10: 1213–1220.

    Article  Google Scholar 

  8. Mahfoud F, Cremers B, Janker J, Link B, Vonend O, Ukena C et al. Renal hemodynamics and renal function after catheter-based renal sympathetic denervation in patients with resistant hypertension. Hypertension 2012; 60: 419–424.

    Article  CAS  Google Scholar 

  9. Grassi G, Quarti-Trevano F, Seravalle G, Arenare F, Volpe M, Furiani S et al. Early sympathetic activation in the initial clinical stages of chronic renal failure. Hypertension 2011; 57: 846–851.

    Article  CAS  Google Scholar 

  10. Krum H, Schlaich MP, Bohm M, Mahfoud F, Rocha-Singh K, Katholi R et al. Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet 2014; 383: 622–629.

    Article  Google Scholar 

  11. Worthley SG, Tsioufis CP, Worthley MI, Sinhal A, Chew DP, Meredith IT et al. Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial. Eur Heart J 2013; 34: 2132–2140.

    Article  CAS  Google Scholar 

  12. Esler MD, Bohm M, Sievert H, Rump CL, Schmieder RE, Krum H et al. Catheter-based renal denervation for treatment of patients with treatment-resistant hypertension: 36 month results from the SYMPLICITY HTN-2 randomized clinical trial. Eur Heart J 2014; 35: 1752–1759.

    Article  Google Scholar 

  13. White WB, Galis ZS, Henegar J, Kandzari DE, Victor R, Sica D et al. Renal denervation therapy for hypertension: pathways for moving development forward. J Am Soc Hypertens 2015; 9: 341–350.

    Article  Google Scholar 

  14. Azizi M, Sapoval M, Gosse P, Monge M, Bobrie G, Delsart P et al. Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENERHTN): a multicentre, open-label, randomised controlled trial. Lancet 2015; 385: 1957–1965.

    Article  Google Scholar 

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Acknowledgements

This study was supported by Vessix Vascular, Laguna Hills, CA, USA and Boston Scientific Corporation, Marlborough, MA, USA.

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Authors and Affiliations

  1. CardioVascular Center Frankfurt CVC, Frankfurt, Germany

    H Sievert

  2. Neuroscience and Vascular Simulation Unit, Anglia Ruskin University, Chelmsford, UK

    H Sievert

  3. Department of Cardiology, Universitäres Herz- und Gefäßzentrum, Hamburg, Germany

    J Schofer

  4. Mercy Angiography, Auckland, New Zealand

    J Ormiston

  5. Department of Internal Medicine II, Paracelsus Medical University, Salzburg, Austria

    U C Hoppe

  6. MonashHEART, Monash Health, Monash University, Melbourne, Australia

    I T Meredith

  7. Department of Cardiology, The Prince Charles Hospital, Brisbane, Australia

    D L Walters

  8. APHP, Hôpital Européen Georges Pompidou, Hypertension Unit, Paris, France

    M Azizi

  9. Department of Vascular Medicine and Hypertension, Paris Descartes University, Paris, France

    M Azizi

  10. Peripheral Interventions, Boston Scientific Corporation, Marlborough, MA, USA

    J Diaz-Cartelle

Authors
  1. H Sievert
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  2. J Schofer
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  3. J Ormiston
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  4. U C Hoppe
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  5. I T Meredith
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  6. D L Walters
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  7. M Azizi
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  8. J Diaz-Cartelle
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on behalf of the REDUCE-HTN Investigators

Corresponding author

Correspondence to H Sievert.

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Competing interests

HS has received study honoraria, travel expenses and consulting fees from Abbott, Acoredis, Atrium, Biosense Webster, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, CardioKinetix, Celonova, CGuard, Coherex, Comed BV, Contego, CSI, CVRx, ev3, FlowCardia, Gardia, Gore, GTIMD Medical, Guided Delivery Systems, Hemoteq, InspireMD, Kona Medical, Lumen Biomedical, Lifetech, Medtronic, Occlutech, pfm Medical, Recor, SentreHeart, Svelte Medical Systems, Terumo, Trivascular, Valtech, Vascular Dynamics, Venus Medical and Veryan; and has stock options with Cardiokinetix, Access Closure, Coherex, SMT.

JS received speakers’ honoraria from Boston Scientific Corporation.

UCH has received grant support and honoraria from Boston Scientific Corporation/Vessix Vascular, grant support and consultancy fees from Medtronic, Inc., and consultancy fees from St Jude Medical.

IM received honoraria and consulting fees from Boston Scientific.

MA has received honoraria for advisory board meetings from Vessix, Boston Scientific Corporation, and Cordis and speakers’ honoraria from Cordis and CVRx.

JD-C is an employee of Boston Scientific Corporation and holds stock in the company. The remaining authors declare no conflict of interest.

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Sievert, H., Schofer, J., Ormiston, J. et al. Bipolar radiofrequency renal denervation with the Vessix catheter in patients with resistant hypertension: 2-year results from the REDUCE-HTN trial. J Hum Hypertens 31, 366–368 (2017). https://doi.org/10.1038/jhh.2016.82

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