Devices for the treatment of arterial hypertension
By:
References
- Bunker J, Chang CL, Chapman N, Poulter N, Thom S, Thornton-Jones L, Sever P. True resistant hypertension following observed drug ingestion: A systematic evaluation. J Clin Hypertens. 2017; 19: 250–255.
- Vega J, Bisogano JD. The prevalence, incidence, prognosis, and associated conditions of resistant hypertension. Semin Nephrol. 2014; 34: 247–256.
- Tomaszewski M, White C, Patel P, Masca N, Damani R, Hepworth J, Samani NJ, Gupta P, Madira W, Stanley A, et al. High rates of non-adherence to antihypertensive treatment revealed by high-performance liquid chromatography-tandem mass spectrometry (HP LC-MS/MS) urine analysis. Heart. 2014; 100: 855–861.
- Peacock E, Krousel-Wood M. Adherence to antihypertensive therapy. Med Clin North Am. 2017; 101: 229–245.
- Bergo KK, Larstorp AC, Hoffmann P, Hjørnholm U, Cataliotti A, Høieggen A, Rostrup M, Fadl Elmula FEM. Renal sympathetic denervation lowers systemic vascular resistance in true treatment-resistant hypertension. Blood Press 2021; 30: 31–40.
- Carey RM, Calhoun JL, Bakris GL, Brook RD, Daugherty SL, Dennison-Himmelfarb CR, Egan BM, Flack JM, Gidding SS, Judd E, et al. Resistant hypertension: Detection, evaluation, and management: A scientific statement from the American Association. Hypertension. 2018; 72: e53–e90.
- Esler M. The sympathetic nervous system in hypertension: back to the future? Curr Hypertens Rep. 2015; 17: 11. doi: 10.1007/s11906-014-0519-8.
- Grassi G, Mark A, Esler M. The sympathetic nervous system alterations in human hypertension. Circ Res. 2015; 116: 976–990.
- Schlainch MP, Sobotka PA, Kum H, Lambert E, Esler M. Renal sympathetic-nerve ablation for uncontrolled hypertension. N Engl J Med. 2009; 361: 932–934.
- Lohmeier TE, Hall JE. Device-based neuromodulation for resistant hypertension therapy: too early for prime time? Circ Res. 2019; 14: 1071–1093.
- Kalarus Z, Merkey B, Neuzil O, Grabowski M, Mitkowski P, Marinskis G, Erglis A, Kaźmierczak JTA, Pluta S, Gellér L, et al. Pacemaker-based cardiac neuromodulation therapy in patients with hypertension. A pilot study. Am Heart Association. 2021; 10, Nr 16: e020492. doi: 10.1161/JAHA.120.020492.
- Esler MD. Krum H. Sobotka PA, Schlaich MP, Schmieder RE, Böhm M. Symplicity HTN-2 Investigators. Renal sympathetic denervation in patients with treatment resistant hypertension (The Symplicity HTN-2 Trial): A randomised controlled trial. Lancet. 2010; 376: 1903–1909.
- Krum H, Schlaich M, Whitbourn R, Sobotka PA, Sadowski J, Bartus K, Kapelak B, Walton A, Sievert H, Thambar S, et al. Catheter-based renal sympathetic denervation for resistant hypertension: a multi-centre safety and proof-of-principle cohort study. Lancet. 2009; 373: 1275–1281.
- Bhatt D, Kandzari DE, O’Neill WW, D’Agostino R, Flack JM, Katzen BT, Leon MB, Liu M, Mauri L, Negoita M, et al. Controlled trial of renal denervation for resistant hypertension. N Engl J Med. 2014; 370: 1393–1401.
- Mahfoud F, Schlaich MP, Lobo MD. Device therapy of hypertension. Circulation Research. 2021; 128: 1080–1099.
- Bohm M, Mahfoud F, Ukena C, Hoppe UC, Narkiewicz K, Negoita M, Ruilope L, Schlaich MP, Schmieder RE, Whitbourn R, et al. First report of the Global SYMPLICITY Registry on the effect of renal artery denervation in patients with uncontrolled hypertension. Hypertension. 2015; 65: 766–774.
- Azizi M, Sapoval M, Gosse P, Monge M, Bobrie G, Delsart P, Midulla M, Mounier-Véhier C, Courand PY, Lantelme P, et al. Optimum and stepped care standardised antihypertensive treatment with or without renal denervation for resistant hypertension (DENER-HTN): a multicentre, open-label, randomised controlled trial. Lancet. 2015; 385: 1957–1965.
- Mahfoud F, Böhm M, Schmieder R, Narkiewicz K, Ewen S, Ruilope L, Schlaich M, Williams B, Fahy M, Mancia G. Effects of renal denervation on kidney function and long-term outcomes: 3-year follow-up from the Global SYMPLICITY Registry. Eur Heart J. 2019; 40: 3474–3482.
- Booth LC, Nishi EE, Yao ST, Ramchandra R, Lambert GW, Schlaich MP, May CN. 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.
- Mompeo B, Marnillo E, Garcia-Touchrd A, Larkin T, Sanudo J. The gross anatomy of the renal sympathetic nerve revisited. Clin Anat. 2016; 29: 660–664.
- Sakakura K, Ladich E, Cheng Q, Otsuka F, Yahagi K, Fowler DR, Kolodgie FD, Virmani R, Joner M. Anatomic assessment of sympathetic peri-arterial renal nerves in man. J Am Coll Cardiol. 2014; 64: 635–643.
- Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA, Ewen S, Tsioufis K, Tousoulis D, Sharp ASP, et al. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017; 390: 2160–2170.
- Kandzari DE, Bohm M, Mahfoud F, Weber A, Pocock S, Tsioufis K, Tousoulis D, Choi JW, East C, Brar S, et al. Effect of renal denervation on blood pressure of antihypertensive drugs: 6-month efficacy and safety results from the SPYRAL HTN-ON MED proof-concept randomized trial. Lancet. 2018; 391: 2346–2355.
- Azizi M, Schmieder RE, Mahfoud F, Weber MA, Daemen J, Davies J, Basile J, Kirtane AJ, Wang Y, Lobo MD, et al. Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial. Lancet 2018; 391: 2335–2345.
- Azizi M, Daemen J, Lobo MD, Mahfoud F, Sharp ASP, Schmieder RE, Wang Y, Saxena M, Lurz P, Sayer J, et al. 12 months result from the un-blinded phase of the RADIANCE-HTN SOLO Trial of ultrasound renal denervation. JACC-Cardiovasc Interv. 2020; 13: 2922–2933.
- Chermin G, Szwarcfiter I, Scheinert A, Blessing E, Diehm N, Dens J, Walton A, Verheye S, Shetty S, Jonas M. First-in man experience with a novel catheter-based renal denervation system of ultrasonic ablation in patients with resistant hypertension. J Vasc Interv Radiol. 2018; 299: 1158–1166.
- Schmieder RE, Ott C, Toennes SW, Bramlage P, Gertner M, Dawood O, Baumgart P, O’Brien B, Dasgupta I, Nickenig G, et al. Phase II randomized sham-controlled study of renal denervation for individuals with uncontrolled hypertension - WAVE IV. J Hypertens. 2018 Mar; 36: 680–689. doi: 10.1097/HJH.0000000000001584. PMID: 29035942
- Mahfoud F, Renkin J, Sievert H, Bertog S, Ewen S, Böhm M, Lengelé JP, Wojakowski W, Schmieder R, van der Giet M, et al. Alcohol-mediated renal denervation using the peregrine system infusion catheter for treatment of hypertension. JACC. Cardiovasc Inter. 2020; 13: 471–484.
- Haribabu S, Sharif F, Zafar H. Recent trends in renal denervation devices for resistant hypertension treatment. Irish J Med. Science. 2021; 190: 971–997.
- Cheng X, Zhang D, Luo S, Qin S. Effect of catheter-based renal denervation on uncontrolled hypertension: A systematic review and meta-analysis. Mayo Clin Proc. 2019; 94: 1695–1706.
- Maqsood MH, Rubab K, Anwar F, Khan AMT, Maqsood MA, Farooq M, Tabaza L, Rangaswami J, Virk HUH. A systematic review of randomized controlled trials comparing renal sympathetic denervation versus sham procedure for the management of uncontrolled hypertension. J Cardiovasc Pharmacol. 2021; 77: 153–158.
- Ogoyama Y, Tada K, Abe M, Nanto S, Shibata H, Mukoyama M, Kai H, Arima H, Kario K. Effects of renal denervation on blood pressures in patients with hypertension: a systematic review and meta-analysis of randomized sham-controlled trials. Hypertens Res. 2022; 45: 210–220.
- Qi XY, Cheng B, Li YL, Wang YF. Renal denervation, adjusted drugs, or combined therapy for resistant hypertension: A meta-regression. Medicine. 2016; Jul; 95: e3939. doi: 10.1097/MD.0000000000003939.
- Silverwath J, Marti KE, Phan MT, Re Amin H, Roman YM, Pasupuleti V, Banach M, Barboza JJ, Hernandez AV. Renal denervation for uncontrolled and resistant hypertension: Systematic review and network meta-analysis of randomized trials. J Clin Med. 2021; 10: 782. doi: 10.3390/jcm10040782.
- Stavropoulos K, Patoulias D, Imprialos K, Doumas M, Katsimardou A, Dimitriadis K, Tsioufis C, Papademetriou V. Efficacy and safety of renal denervation for the management of arterial hypertension: A systematic reviewed meta-analysis of randomized, sham-controlled, catheter-based trials. J Clin Hypertens. (Greenwich). 2020; 22: 572–584.
- Vogiatzakis N, Tsioufis C, Georgiopoulos G, Thomopoulos C, Dimitriadis K, Kasiakogias A, Konstantinidis D, Kalos T, Mahfoud F, Doumas M, Papademetriou V, Tousoulis D. Effect of renal sympathetic denervation on short-term blood pressure variability in resistant hypertension: a meta-analysis. J Hypertens. 2017; 35: 1750–1757.
- Pappaccogli M, Covella M, Berra E, Fulcheri C, Di Monaco S, Perlo E, Burrello J, Monticone S, Rossato D, Rabbia F, et al. Effectiveness of renal denervation in resistant hypertension. A meta-analysis of 11 controlled studies. Cochrane Database Syst Rev. 2017; 2017(2): CD011499. doi: 10.1002/14651858.CD011499.
- Chen C, Zhu XY, Li D, Zhou K, Lin Q. Clinical efficacy and safety of spironolactone in patients with resistant hypertension: A systematic review and meta-analysis. Medicine. 2020. 99: e21694. doi: 10.1097/MD.0000000000021694. PMID: 32846786.
- Schmieder RE, Mahfoud F, Mancia G, Azizi M, Böhm M, Dimitriadis K, Kario K, Kroon AAD, Lobo M, Ott C, et al. European Society of Hypertension position paper on renal denervation 2021. J Hypertens. 2021; 39: 1733–1741.
- Baik J, Song WH, Yim D, Lee S, Yang S, Lee HY, Choi EK, Jeong CW, Park SM. Laparoscopic renal denervation system for treating resistant hypertension: overcoming limitation of catheter-based approaches. Trans Biomed Eng. 2020; 67: 3425–3437.
- Cai X, Yang Y, Shen Y, Wang W, Qian L, Cai J, Chi R, Fei Y, Yu S, Wei L, et al. Noninvasive stereotactic radiotherapy for renal denervation in a swine model. J Am Coll Cardiol. 2019; 74: 1697–1709.
- Mahfoud F, Edelman E, Bhatt N. Stereotactic radiotherapy for renal denervation: to beam, or not to beam? J Am Cardiol. 2019; 74: 1710–1713.
- Lohmeier TE, Iliescu R, Terry M, Dwyer M, Lohmeier TE, Iliescu R, Terry M, Dwyer TM, et al. Sustained suppression of sympathetic activity and arterial pressure during chronic activation of the carotid baroreflex. Am J Physiol Heart Circ Physiol. 2010; 299: H402–H409.
- Wallbach M, Halbach M, Reuter H, Passauer J, Lüders S, Böhning E, Zenker D, Müller GA, Wachter R, Koziolek MJ. Baroreflex activation therapy in patients with prior renal denervation. J Hypertens. 2016; 34: 1630–1638.
- Scheffers IJ, Kroon AA, Schmidli J, Jordan J, Tordoir JJ, Mohaupt MG, Luft FC, Haller H, Menne S, Ceral S, et al. Novel baroreflex activation therapy in resistant hypertension: results of a European multi-center feasibility study. J Am Coll Cardiol. 2010; 56: 1254–1258.
- Bakris GL, Nadim MK, Haller H, Lovett EG, Schafer JE, Bisognano JD. Baroreflex activation therapy provides durable benefit in patients with resistant hypertension: results of long-term follow-up in the Rheos Pivotal Trial. Am Soc Hypertension. 2012; 6: 152–158.
- Hoppe UC, Brandt MC, Wachter R, Beige J, Rump LC, Kroon AA, Cates AW, Lovett EG, Haller H. Minimally invasive system for baroreflex activation therapy chronically lowers blood pressure with pacemaker-like safety profile: results from the Barostim neo trial. J Am Soc Hypertens. 2012; 6: 270–276.
- Spiering W, Williams V, Van der Heyden J, van Kleef M, Lo R, Versmissen J, Moelker A, Kroon A, Reuter H, Ansel G, et al. Endovascular baroreflex amplification for resistant hypertension: A safety and proof-of-principle clinical study. Lancet. 2017; 390: 2655–2661
- Bates MC, Stone GW, Chen C-Y, Spiering W. Device profile on the MobiusHD EVBA system for the treatment of resistant hypertension: overview of its mechanism of action, safety and efficacy. Expert Rey Med Devices. 2020; 17: 649–665.
- Groenland EH, Spiering W. Baroreflex amplification and carotid body modulation for the treatment of resistant hypertension. Curr Hypertens Rep. 2020; 22: 27. doi: 10.1007/s11906-020-1024-x
- Van Kleef MEAM, Devireddy CM, van der Heyden J, Bates MC, Bakris GL, Stone GW, Williams B, Spiering W. CALM-FIM Investigators. Treatment of resistant hypertension with endovascular baroreflex amplification: 3 years of results from CALM-FIM study: JACC Cardiovascular results from CALM-FJM study. JACC Cardiovascular Intrev. 2022; 15: 321–332.
- Halbach M, Grothaus D, Hoffmann F, Madershahian N, Kuhr K, Reuter H. Baroreflex activation therapy reduces frequency and duration of hypertension-related hospitalizations in patients with resistant hypertension. Clin Auton Res. 2020; 30: 541–548.
- Walbach M, Koziolek M. Baroreceptors in the carotid and hypertension-systematic review and meta-analysis of the effects of baroreflex activation therapy on blood pressure. Nephrol Dial Transplant. 2018; 33: 1485–1493.
- Chunbin W, Fu S, Jing H. Efficacy and safety of baroreflex activation therapy for treatment of resistant hypertension: a systematic review and meta-analysis. Clin Exp Hypertens. 2018; 40: 501–508.
- Abraham WT, Zile MR, Weaver FA, Butter C, Ducharme A, Halbach M, Klug D, Lovett EG, Müller-Ehmsen J, Schafer JE et al. Baroreflex activation therapy for the treatment of heart failure with a reduced ejection fraction. JACC Heart Fail. 2015 Jun; 3: 487–496.
- Coats AJS, Abraham WT, Zile MR, Lindenfeld JA, Weaver FA, Fudim M, Bauersachs J, Duval S, Galle E, Zannad F. Baroreflex activation therapy with the Barostim™ device in patients with heart failure with reduced ejection fraction: a patient level meta-analysis of randomized controlled trials. Eur J Heart Fail. 2022; 24: 1665–1673.
- Neuzil P, Merkely B, Erglis A, Marinskis G, de Groot JR, Schmidinger H, Rodriguez Venegas M, Voskuil M, Sturmberger T, et al. Pacemaker-mediated programmable hypertension control therapy. J Am Heart Assoc. 2017; 6: e006974. doi: 10.1161/JAHA.117.006974.
- Lauder L, Mahfoud F. Pacemaker-based cardiac neuromodulation therapy for the treatment of hypertension: the new kid on the block. J Am Heart Assoc. 2021; 10: e022622. doi: 10.1161/JAHA.121.022622
- Bazoukis G, Korantzopoulos P, Tsioufis C. The impact of renal sympathetic denervation on cardiac electrophysiology and arrhythmias: A systematic review of the literature. Int J Cardiol. 2016; 220: 87–101.
- Lian Z, Yu SR, Song JX, Lee CY, Li SF, Cui YX, Su LN, Chen H. Efficacy and safety of catheter-based renal denervation for heart failure with reduced ejection fraction: a systematic review and meta-analysis. Clin Auton Res. 2020; 30: 521–530.
- Steinberg JS, Shabanov V, Ponomarev D, Losik D, Ivanickiy E, Kropotkin E, Polyakov K, Ptaszynski P, Keweloh B, Yao CJ, et al. Effect of renal denervation and catheter ablation vs catheter ablation alone on atrial fibrillation recurrence among patients with paroxysmal atrial fibrillation and hypertension: The ERADICATE-AF Randomized Clinical Trial. JAMA 2020; 21; 323: 248–255. doi: 10.1001/jama.2019.21187
- Kądziela J, Warchoł-Celińska E, Prejbisz A, Januszewicz A, Witkowski A, Tsioufis K. Renal denervation: can we press the “ON” button again in 2020? Postepy Kardiol Interwencyjnej. 2020 Sep; 16: 262–268. doi: 10.5114/aic.2020.99260. Epub 2020 Oct 2. PMID: 33597990
- Nawar K, Mohammad A, Johns EJ, Abdulla MH. Renal denervation for arterial fibrillation: a comprehensive updated systematic review and meta-analysis. J Hum Hypertens. 2022; 36: 887–897.
- Warchol-Celinska E, Prejbisz A, Kadziela J, Florczak E, Januszewicz A, Michalowska I, Dobrowolski P, Kabat M, et al. Renal denervation in resistant hypertension and obstructive sleep apnea: randomized proof-of concept Phase II trial. Hypertension. 2018; 72: 381–390.
DOI: https://doi.org/10.2478/ahem-2023-0004 | Journal eISSN: 1732-2693
Language: English
Page range: 27 - 35
Submitted on: Mar 25, 2022
Accepted on: Nov 18, 2022
Published on: May 6, 2023
Published by: Hirszfeld Institute of Immunology and Experimental Therapy
In partnership with: Paradigm Publishing Services
Publication frequency: 1 times per year
Keywords:
Related subjects:
© 2023 Jerzy Głuszek, Teresa Kosicka, published by Hirszfeld Institute of Immunology and Experimental Therapy
This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.