Abstract
As catheter-based renal denervation (RDN) has been a recently introduced invasive treatment, confirming the safety of the procedure has been a central issue in the conducted trials. Preclinical data have identified limited changes in the vessel wall including local oedema, thrombus formation and fibrosis. Clinical trials reported only few periprocedural adverse events such as access site complications and renal artery dissections, while follow-up of patients for up to 3 years showed that this is an overall safe procedure. Adverse events potentially associated with autonomic dysfunction, such as orthostatic hypotension, have been rare and in general not associated with RDN. A number of reports on new renal artery stenosis, theoretically associated with the radiofrequency-induced tissue injury, have raised concerns for such a complication, even though the relative incidence is notably small. In trials with different catheters as well as running registries, renal function has been shown to remain stable or mildly deteriorate. Thorough recording of events in all studies as well as comparisons of safety among current and developing devices are pivotal in order to provide a clearer picture of long-term safety.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Abbreviations
- BP:
-
Blood pressure
- CT:
-
Computed tomography
- dRHT:
-
Drug-resistant hypertension
- eGFR:
-
Estimated glomerular filtration rate
- HTN:
-
Hypertension
- MR:
-
Magnetic resonance
- OCT:
-
Optical coherence tomography
- RDN:
-
Renal denervation
References
Krum H, Schlaich MP, Sobotka PA, Böhm M, Mahfoud F, Rocha-Singh K et al (2014) Percutaneous renal denervation in patients with treatment-resistant hypertension: final 3-year report of the Symplicity HTN-1 study. Lancet 383:622–629
Esler MD, Böhm M, Sievert H, Rump CL, Schmieder RE, Krum H et al (2014) 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 35:1752–1759
Bhatt DL, Kandzari DE, O’Neill WW, D’Agostino R, Flack JM, Katzen BT et al (2014) A controlled trial of renal denervation for resistant hypertension. N Engl J Med 370:1393–1401
Worthley SG, Tsioufis CP, Worthley MI, Sinhal A, Chew DP, Meredith IT et al (2013) Safety and efficacy of a multi-electrode renal sympathetic denervation system in resistant hypertension: the EnligHTN I trial. Eur Heart J 34:2132–2140
Sievert H, Schofer J, Ormiston J, Hoppe UC, Meredith IT, Walters DL et al (2015) Renal denervation with a percutaneous bipolar radiofrequency balloon catheter in patients with resistant hypertension: 6-month results from the REDUCE-HTN clinical study. EuroIntervention 10:1213–1220
Böhm M, Mahfoud F, Ukena C, Hoppe UC, Narkiewicz K, Negoita M, et al; GSR Investigators (2015) First report of the Global SYMPLICITY Registry on the effect of renal artery denervation in patients with uncontrolled hypertension. Hypertension 65:766–774
Rippy MK, Zarins D, Barman NC, Wu A, Duncan KL, Zarins CK (2011) Catheter-based renal sympathetic denervation: chronic preclinical evidence for renal artery safety. Clin Res Cardiol 100:1095–1101
Steigerwald K, Titova A, Malle C, Kennerknecht E, Jilek C, Hausleiter J et al (2012) Morphological assessment of renal arteries after radiofrequency catheter-based sympathetic denervation in a porcine model. J Hypertens 30:2230–2239
Templin C, Jaguszewski M, Ghadri JR, Sudano I, Gaehwiler R, Hellermann JP et al (2013) Vascular lesions induced by renal nerve ablation as assessed by optical coherence tomography: pre- and post-procedural comparison with the Simplicity catheter system and the EnligHTN multi-electrode renal denervation catheter. Eur Heart J 34:2141–2148, 2148b
Pathak A, Coleman L, Roth A, Stanley J, Bailey L, Markham P et al (2015) Renal sympathetic nerve denervation using intraluminal ultrasound within a cooling balloon preserves the arterial wall and reduces sympathetic nerve activity. EuroIntervention 11:477–484
Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K et al (2009) Catheter-based renal sympathetic denervation for resistant hypertension: a multicentre safety and proof-of-principle cohort study. Lancet 373:1275–1281
Symplicity HTN-1 Investigators (2011) Catheter-based renal sympathetic denervation for resistant hypertension: durability of blood pressure reduction out to 24 months. Hypertension 57:911–917
Esler MD, Krum H, Sobotka PA, Schlaich MP, Schmieder RE, Böhm M (2010) Renal sympathetic denervation in patients with treatment-resistant hypertension (The Symplicity HTN-2 Trial): a randomised controlled trial. Lancet 376:1903–1909
Esler MD, Krum H, Schlaich M, Schmieder RE, Böhm M, Sobotka PA, Symplicity HTN-2 Investigators (2012) Renal sympathetic denervation for treatment of drug-resistant hypertension: one-year results from the Symplicity HTN-2 randomized, controlled trial. Circulation 126:2976–2982
Applegate RJ, Sacrinty MT, Kutcher MA, Kahl FR, Gandhi SK, Santos RM et al (2008) Trends in vascular complications after diagnostic cardiac catheterization and percutaneous coronary intervention via the femoral artery, 1998 to 2007. J Am Coll Cardiol Intv 1:317–326
Papademetriou V, Tsioufis CP, Sinhal A, Chew DP, Meredith IT, Malaiapan Y et al (2014) Catheter-based renal denervation for resistant hypertension: 12-month results of the EnligHTN I first-in-human study using a multielectrode ablation system. Hypertension 64:565–572
Tsioufis CP, Papademetriou V, Dimitriadis KS, Kasiakogias A, Tsiachris D, Worthley MI et al (2015) Catheter-based renal denervation for resistant hypertension: twenty-four month results of the EnligHTN I first-in-human study using a multi-electrode ablation system. Int J Cardiol 201:345–350
Verheye S, Ormiston J, Bergmann MW, Sievert H, Schwindt A, Werner N et al (2015) Twelve-month results of the rapid renal sympathetic denervation for resistant hypertension using the OneShotTM ablation system (RAPID) study. EuroIntervention 10:1221–1229
Kaiser L, Beister T, Wiese A, von Wedel J, Meincke F, Kreidel F et al (2014) Results of the ALSTER BP real-world registry on renal denervation employing the Symplicity system. EuroIntervention 10:157–165
Vogel B, Kirchberger M, Zeier M, Stoll F, Meder B, Saure D et al (2014) Renal sympathetic denervation therapy in the real world: results from the Heidelberg registry. Clin Res Cardiol 103:117–124
Davis MI, Filion KB, Zhang D, Eisenberg MJ, Afilalo J, Schiffrin EL et al (2013) Effectiveness of renal denervation therapy for resistant hypertension: a systematic review and meta-analysis. J Am Coll Cardiol 62:231–241
Sun D, Li C, Li M, Liu J, Wen S (2015) Renal denervation vs pharmacotherapy for resistant hypertension: a meta-analysis. J Clin Hypertens (Greenwich). doi:10.1111/jch.12742
FadlElmula FE, Jin Y, Yang WY, Thijs L, Lu YC, Larstorp AC, Persu A, et al; European Network Coordinating Research On Renal Denervation (ENCOReD) Consortium (2015) Meta-analysis of randomized controlled trials of renal denervation in treatment-resistant hypertension. Blood Press 24:263–274
Lenski M, Mahfoud F, Razouk A, Ukena C, Lenski D, Barth C et al (2013) Orthostatic function after renal sympathetic denervation in patients with resistant hypertension. Int J Cardiol 169:418–424
Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J et al (2005) Worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circulation 111:1100–1105
Lambert T, Nahler A, Reiter C, Schwarz S, Gammer V, Blessberger H et al (2015) Frequency of renal artery stenosis after renal denervation in patients with resistant arterial hypertension. Am J Cardiol 115:1545–1548
Vonend O, Antoch G, Rump LC, Blondin D (2012) Secondary rise in blood pressure after renal denervation. Lancet 380:778
Kaltenbach B, Id D, Franke JC, Sievert H, Hennersdorf M, Maier J et al (2012) Renal artery stenosis after renal sympathetic denervation. J Am Coll Cardiol 60:2694–2695
Cordeanu ME, Gaertner S, Bronner F, Jahn C, Prinz E, Hannedouche T et al (2014) Neointimal thickening resulting in artery stenosis following renal sympathetic denervation. Int J Cardiol 177:e117–e119
Versaci F, Trivisonno A, Olivieri C, Caranci F, Brunese L, Prati F (2014) Late renal artery stenosis after renal denervation: is it the tip of the iceberg? Int J Cardiol 172:e507–e508
JaénÁguila F, Mediavilla Garcia JD, Navarro EM, Vargas Hitos JA, Fernandez-Torres C (2014) Bilateral renal artery stenosis after renal denervation. Hypertension 63:e126–e127
Chandra AP, Marron CD, Puckridge P, Spark JI (2015) Severe bilateral renal artery stenosis after transluminal radiofrequency ablation of renal sympathetic nerve plexus. J Vasc Surg 62:222–225
Bacaksiz A, Uyarel H, Jafarov P, Kucukbuzcu S (2014) Iatrogenic renal artery stenosis after renal sympathetic denervation. Int J Cardiol 172:e389–e390
Bhamra-Ariza P, Rao S, Muller DW (2014) Renal artery stenosis following renal percutaneous denervation. Catheter Cardiovasc Interv 84:1180–1183
Pucci G, Battista F, Lazzari L, Dominici M, Boschetti E, Schillaci G (2014) Progression of renal artery stenosis after renal denervation. Impact on 24-hour blood pressure. Circ J 78:767–768
Raman B, Pathik B, Bridgman C (2014) Recurrent pulmonary oedema after percutaneous radiofrequency renal denervation. Int J Cardiol 174:e42–e43
Celik IE, Acar B, Kurtul A, Murat SN (2015) De novo renal artery stenosis after renal sympathetic denervation. J Clin Hypertens (Greenwich) 17:242–243
Koppelstaetter C, Kerschbaum J, Lenzhofer M, Glodny B, Esterhammer R, Frick M et al (2015) Distal renal artery stenosis after percutaneous renal denervation leading to renal impairment but normotension. J Clin Hypertens (Greenwich) 17:162–164
Versaci F, Trivisonno A, Olivieri C, Magri G, Caranci F, Prati F (2014) 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 21:191–196
Karanasos A, Van Mieghem N, Bergmann MW, Hartman E, Ligthart J, van der Heide E et al (2015) Multimodality intra-arterial imaging assessment of the vascular trauma induced by balloon-based and nonballoon-based renal denervation systems. Circ Cardiovasc Interv 8(7):e002474
Ziegler AK, Franke J, Bertog SC (2013) Renal denervation in a patient with prior renal artery stenting. Catheter Cardiovasc Interv 81:342–345
Berra E, Rabbia F, Rossato D, Covella M, Totaro S, Chiara F et al (2014) Renal sympathetic denervation in a previously stented renal artery. J Clin Hypertens (Greenwich) 16:238–239
Bausback Y, Friedenberger J, Hertting K, Werner M, Branzan D, Freitas B et al (2014) Renal denervation for hypertension refractory to renal artery stenting. J Endovasc Ther 21:181–190
Mahfoud F, Tunev S, Ruwart J, Schulz-Jander D, Cremers B, Linz D et al (2014) Efficacy and safety of catheter-based radiofrequency renal denervation in stented renal arteries. Circ Cardiovasc Interv 7:813–820
Petidis K, Anyfanti P, Doumas M (2011) Renal sympathetic denervation: renal function concerns. Hypertension 58(4):e19
Dörr O, Liebetrau C, Möllmann H, Achenbach S, Sedding D, Szardien S et al (2013) Renal sympathetic denervation does not aggravate functional or structural renal damage. J Am Coll Cardiol 61:479–480
Mahfoud F, Cremers B, Janker J, Link B, Vonend O, Ukena C et al (2012) Renal hemodynamics and renal function after catheter-based renal sympathetic denervation in patients with resistant hypertension. Hypertension 60:419–424
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2016 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Thomopoulos, C., Kasiakogias, A., Kallikazaros, I., Tsioufis, C. (2016). Safety of Renal Denervation. In: Tsioufis, C., Schmieder, R., Mancia, G. (eds) Interventional Therapies for Secondary and Essential Hypertension. Updates in Hypertension and Cardiovascular Protection. Springer, Cham. https://doi.org/10.1007/978-3-319-34141-5_15
Download citation
DOI: https://doi.org/10.1007/978-3-319-34141-5_15
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-34140-8
Online ISBN: 978-3-319-34141-5
eBook Packages: MedicineMedicine (R0)