李月平,卢成志,蒋雄京,余静,马为,胡嘉禄,张毅,周玉杰,孙宁玲,霍勇,葛均波

• 1:首都医科大学附属北京安贞医院
• 2:天津市第一中心医院
• 3:中国医学科学院阜外医院
• 4:兰州大学第二医院

摘要(Abstract)：

高血压是心脑血管疾病最主要的危险因素之一。虽然改善生活方式和药物治疗是有效的降压方式，但是高血压的控制率依然很低。经皮去肾神经术（RDN）治疗已经成为有发展前景、临床证据最多的器械治疗改善血压、提高血压控制率的方法。多项随机、假手术对照的临床研究表明RDN可以持久、有效降压，且安全性良好。RDN治疗高血压中国专家科学声明旨在介绍RDN目前国内外的临床证据、治疗进展，阐述对RDN治疗高血压的观点和目前的应用建议，希望借此指导在中国健康、有序、安全和规范地开展RDN治疗高血压的临床实践。

关键词(KeyWords)： 高血压;难治性高血压;未控制的高血压;去肾神经术;交感神经系统

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 李月平,卢成志,蒋雄京,余静,马为,胡嘉禄,张毅,周玉杰,孙宁玲,霍勇,葛均波

参考文献(References)：

• [1]Blood Pressure Lowering Treatment Trialists'Collaboration.Pharmacological blood pressure lowering for primary and secondary prevention of cardiovascular disease across different levels of blood pressure:an individual participant-level data meta-analysis[J].Lancet,2021,397(10285):1625-1636.DOI:10.1016/S0140-6736(21)00590-0.
• [2]Vrijens B,Vincze G,Kristanto P,et al.Adherence to prescribed antihypertensive drug treatments:longitudinal study of electronically compiled dosing histories[J].BMJ,2008,336(7653):1114-1147.DOI:10.1136/bmj.39553.670231.25.
• [3]Tajeu GS,Kent ST,Huang L,et al.Antihypertensive medication nonpersistence and low adherence for adults<65 years initiating treatment in 2007-2014[J].Hypertension,2019,74(1):35-46.DOI:10.1161/HYPERTENSIONAHA.118.12495.
• [4]Carey RM,Calhoun DA,Bakris GL,et al.Resistant hypertension:detection,evaluation,and management:a scientific statement from the American Heart Association[J].Hypertension,2018,72(5):e53-e90.DOI:10.1161/HYP.0000000000000084.
• [5]Yoon M,You SC,Oh J,et al.Prevalence and prognosis of refractory hypertension diagnosed using ambulatory blood pressure measurements[J].Hypertens Res,2022,45(8):1353-1362.DOI:10.1038/s41440-021-00845-5.
• [6]Krum H,Schlaich M,Whitbourn R,et al.Catheter-based renal sympathetic denervation for resistant hypertension:a multicentre safety and proof-of-principle cohort study[J].Lancet,2009,373(9671):1275-1281.DOI:10.1016/S0140-6736(09)60566-3.
• [7]Kario K,Kim BK,Aoki J,et al.Renal denervation in Asia:consensus statement of the asia renal denervation consortium[J].Hypertension,2020,75(3):590-602.DOI:10.1161/HYPERTENSIONAHA.119.13671.
• [8]Schmieder RE,Mahfoud F,Mancia G,et al.European Society of Hypertension position paper on renal denervation 2021[J].J Hypertens,2021,39(9):1733-1741.DOI:10.1097/HJH.0000000000002933.
• [9]Kandzari DE,Townsend RR,Bakris G,et al.Renal denervation in hypertension patients:proceedings from an expert consensus roundtable cosponsored by SCAI and NKF[J].Catheter Cardiovasc Interv,2021,98(3):416-426.DOI:10.1002/ccd.29884.
• [10]Barbato E,Azizi M,Schmieder RE,et al.Renal denervation in the management of hypertension in adults.A clinical consensus statement of the ESC Council on Hypertension and the European Association of Percutaneous Cardiovascular Interventions(EAPCI)[J].Eur Heart J,2023,44(15):1313-1330.DOI:10.1093/eurheartj/ehad054.
• [11]Wang TD,Lee YH,Chang SS,et al.2019 consensus statementof the Taiwan hypertension society and the Taiwan society of cardiology on renal denervation for the management of arterial hypertension[J].Acta Cardiol Sin,2019,35(3):199-230.DOI:10.6515/ACS.201905_35(3).20190415A.
• [12]DiBona GF,Esler M.Translational medicine:the antihypertensive effect of renal denervation[J].Am J Physiol Regul Integr Comp Physiol,2010,298(2):R245-8253.DOI:10.1152/ajpregu.00647.2009.
• [13]Esler MD,Krum H,Sobotka PA,et al.Renal sympathetic denervation in patients with treatment-resistant hypertension(The Symplicity HTN-2 Trial):a randomised controlled trial[J].Lancet,2010,376(9756):1903-1909.DOI:10.1016/S0140-6736(10)62039-9.
• [14]Bhatt DL,Kandzari DE,O'Neill WW,et al.A controlled trial of renal denervation for resistant hypertension[J].N Engl J Med,2014,370(15):1393-1401.DOI:10.1056/NEJMoa1402670.
• [15]Mahfoud F,Townsend RR,Kandzari DE,et al.Changes in plasma renin activity after renal artery sympathetic denervation[J].J Am Coll Cardiol,2021,77(23):2909-2919.DOI:10.1016/j.jacc.2021.04.044.
• [16]Townsend RR,Mahfoud F,Kandzari DE,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[J].Lancet,2017,390(10108):2160-2170.DOI:10.1016/S0140-6736(17)32281-X.
• [17]Kandzari DE,B?hm 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[J].Lancet,2018,391(10137):2346-2355.DOI:10.1016/S0140-6736(18)30951-6.
• [18]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[J].Lancet,2018,391(10137):2335-2345.DOI:10.1016/S0140-6736(18)31082-1.
• [19]Kario K,Rumoroso JR,Okawara Y,et al.Renal sympathetic denervation in patients with resistant hypertension:a feasibility study[J].Pulse(Basel),2019,6(3-4):137-143.DOI:10.1159/000490620.
• [20]Kim CJ,Chang K,Kim BK,et al.An open-label,singlearm,multicenter feasibility study evaluating the safety of catheter-based renal denervation with DENEX~(TM)in patients with uncontrolled hypertension on standard medical therapy[J].Korean Circ J,2021,51(1):43-55.DOI:10.4070/kcj.2020.0391.
• [21]Tsioufis C,Dimitriadis K,Tsioufis P,et al.ConfidenHT~(TM)system for diagnostic mapping of renal nerves[J].Curr Hypertens Rep,2018,20(6):49.DOI:10.1007/s11906-018-0847-1.
• [22]Chernin G,Szwarcfiter I,Scheinert D,et al.First-in-man experience with a novel catheter-based renal denervation system of ultrasonic ablation in patients with resistant hypertension[J].J Vasc Interv Radiol,2018,29(8):1158-1166.DOI:10.1016/j.jvir.2018.03.022.
• [23]Fischell TA,Ebner A,Gallo S,et al.Transcatheter alcohol-mediated perivascular renal denervation with the peregrine system:first-in-human experience[J].JACC Cardiovasc Interv,2016,9(6):589-598.DOI:10.1016/j.jcin.2015.11.041.
• [24]Wang Sun N,Ge J,et al.Rationale and design of Sympathetic Mapping/Ablation of Renal Nerves Trial(SMART)for the treatment of hypertension:a prospective,multicenter,single-blind,randomized and sham procedure-controlled study[J].J Cardiovasc Transl Res,2023,16(2):358-370.DOI:10.1007/s12265-022-10307-z.
• [25]Li Y,Nawabi AQ,Feng Y,et al.Safety and efficacy of a new renal denervation catheter in hypertensive patients in the absent of antihypertensive medications:a pilot study[J].Int J Hypertens,2019,2019:7929706.DOI:10.1155/2019/7929706.
• [26]Azizi M,Sapoval M,Gosse 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[J].Lancet,2015,385(9981):1957-1965.DOI:10.1016/S0140-6736(14)61942-5.
• [27]de Jager RL,de Beus E,Beeftink MM,et al.Impact of medication adherence on the effect of renal denervation:the SYMPATHY trial[J].Hypertension,2017,69(4):678-684.DOI:10.1161/HYPERTENSIONAHA.116.08818.
• [28]Desch S,Okon T,Heinemann D,et al.Randomized shamcontrolled trial of renal sympathetic denervation in mild resistant hypertension[J].Hypertension,2015,65(6):1202-1208.DOI:10.1161/HYPERTENSIONAHA.115.05283.
• [29]Mathiassen ON,Vase H,Bech JN,et al.Renal denervation in reatment-resistant essential hypertension.A randomized,SHAM-controlled,double-blinded 24-h blood pres sure-based trial[J].Hypertens,2016,34(8):1639-1647.DOI:10.1097/HJH.0000000000000977.
• [30]Bohm M,Kario K,Kandzari DE,et al.Efficacy of catheterbased renal denervation in the absence of antihypertensive medications(SPYRAL HTN-OFF MED Pivotal):a multicentre,randomised,sham-controlled trial[J].Lancet,2020,395(10234):1444-1451.DOI:10.1016/S0140-6736(20)30554-7.
• [31]Azizi M,Sanghvi K,Saxena M,et al.Ultrasound renal denervation for hypertension resistant to a triple medication pill(RADIANCE-HTN TRIO):a randomised,multicentre,single-blind,sham-controlled trial[J].Lancet,2021,397(10293):2476-2486.DOI:10.1016/S0140-6736(21)00788-1.
• [32]Kandzari ED,Townsend RR,Kario K,et al.Safety and efficacy of renal denvervation in patients taking antihypertensive medications[J].J Am Coll Cardiol,2023,82(19):1809-1823.DOI:10.1016/j.jacc.2023.08.045.
• [33]Kario K,Yokoi Y,Okamura K,et al.Catheter-based ultrasound renal denervation in patients with resistant hypertension:the randomized,controlled REQUIRE trial[J].Hypertens Res,2022,45(2):221-231.DOI:10.1038/s41440-021-00754-7.
• [34]Azizi M,Saxena M,Wang Y,et al.Endovascular ultrasound renal denervation to treat hypertension:the RADIANCE II randomized clinical trial[J].JAMA,2023,329(8):651-661.DOI:10.1001/jama.2023.0713.
• [35]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)[J].Circulation,2019,139(5):590-600.DOI:10.1161/CIRCULATIONAHA.118.037654.
• [36]Mahfoud F,B?hm M,Schmieder R,et al.Effects of renal denervation on kidney function and long-term outcomes:3-year follow-up from the Global SYMPLICITY Registry[J].Eur Heart J,2019,40(42):3474-3482.DOI:10.1093/eurheartj/ehz118.
• [37]Mahfoud F,Kandzari DE,Kario K,et al.Long-term efficacy and safety of renal denervation in the presence of antihypertensive drugs(SPYRAL HTN-ON MED):a randomised,shamcontrolled trial[J].Lancet,2022,399(10333):1401-1410.DOI:10.1016/S0140-6736(22)00455-X.
• [38]Bhatt DL,Vaduganathan M,Kandzari DE,et al.Long-term outcomes after catheter-based renal artery denervation for resistant hypertension:final follow-up of the randomised SYMPLICITY HTN-3 Trial[J].Lancet,2022,400(10361):1405-1416.DOI:10.1016/S0140-6736(22)01787-1.
• [39]Rader F,Kirtane AJ,Wang Y,et al.Durability of blood pressure reduction after ultrasound renal denervation:three-year follow-up of the treatment arm of the randomised RADIANCEHTN SOLO trial[J].EuroIntervention,2022,18(8):e677-e685.DOI:10.4244/EIJ-D-22-00305.
• [40]Kim BK,B?hm M,Mahfoud F,et al.Renal denervation for treatment of uncontrolled hypertension in an Asian population:results from the Global SYMPLICITY Registry in South Korea(GSR Korea)[J].J Hum Hypertens,2016,30(5):315-321.DOI:10.1038/jhh.2015.77.
• [41]Kim BK,Kim HS,Park SJ,et al.Long-term outcomes after renal denervation in an Asian population:results from the Global SYMPLICITY Registry in South Korea(GSR Korea)[J].Hypertens Res,2021,44(9):1099-1104.DOI:10,1038/s41440-021-00683-5.
• [42]Lee CK,Wang TD,Lee YH,et al.Efficacy and safety of renal denervation for patients with uncontrolled hypertension in taiwan:3-year results from the global SYMPLICITY registry-Taiwan(GSR-Taiwan)[J].Acta Cardiol Sin,2019,35(6):618-626.DOI:10.6515/ACS.201911 35(6).20190826A.
• [43]Al Ghorani H,Kulenthiran S,Recktenwald MJM,et al.10-year outcomes of catheter-based renal denervation in patients with resistant hypertension[J].J Am Coll Cardiol,2023,81(5):517-519.DOI:10.1016/j.jacc.2022.11.038.
• [44]Townsend RR,Walton A,Hettrick DA,et al.Review and Meta-analysis of renal artery damage following percutaneous renal denervation with radiofrequency renal artery ablation[J].EuroIntervention,2020,16(1):89-96.DOI:10.4244/EIJ-D-19-00902.
• [45]Sanders MF,Reitsma JB,Morpey M,et al.Renal safety of catheter-based renal denervation:systematic review and metaanalysis[J].Nephrol Dial Transplant,2017,32(9):1440-1447.DOI:10.1093/ndt/gfx088.
• [46]Azizi M,Schmieder RE,Mahfoud F,et al.Six-month results of treatment-blinded medication titration for hypertension control after randomization to endovascular ultrasound renal denervation or a sham procedure in the RADIANCE-HTN SOLO trial[J].Circulation,2019,139(22):2542-2553.DOI:10.1161/CIRCULATIONAHA.119.040451.
• [47]Kandzari DE,Bhatt DL,Brar S,et al.Predictors of blood pressure response in the SYMPLICITY HTN-3 trial[J].Eur Heart J,2015,36(4):219-227.DOI:10.1093/eurheartj/ehu441.
• [48]Gosse P,Cremer A,Pereira H,et al.Twenty-four-hour blood pressure monitoring to predict and assess impact of renal denervation:the DENERHTN study(Renal Denervation for Hypertension)[J].Hypertension,2017,69(3):494-500.DOI:10.1161/HYPERTENSIONAHA.116.08448.
• [49]Reshetnik A,Gohlisch C,Scheurig-Münkler C,et al.Predictors for success in renal denervation-a single centre retrospective analysis[J].Sci Rep,2018,8(1):15505.DOI:10.1038/s41598-018-33783-3.
• [50]Gosse P,Cremer A,Kirtane AJ,et al.Ambulatory blood pressure monitoring to predict response to renal denervation:a post hoc analysis of the RADIANCE-HTN SOLO study[J].Hypertension,2021,77(2):529-536.DOI:10.1161/HYPERTENSIONAHA.120.16292.
• [51]Saxena M,Schmieder RE,Kirtane AJ,et al.Predictors of blood pressure response to ultrasound renal denervation in the RADIANCE-HTN SOLO study[J].J Hum Hypertens,2022,36(7):629-639.DOI:10.1038/s41371-021-00547-y.
• [52]Zhou H,Xu Y,Chen W,et al.Present evidence of determinants to predict the efficacy of renal denervation[J].Int J Hypertens,2022,2022:5694127.DOI:10.115 5/2022/5 6 94127.
• [53]Rohla M,Nahler A,Lambert T,et al.Predictors of response to renal denervation for resistant arterial hypertension:a single center experience[J].J Hypertens,2016,34(1):123-129.DOI:10.1097/HJH.0000000000000764.
• [54]Id D,Bertog SC,Ziegler AK,et al.Predictors of blood pressure response:obesity is associated with a less pronounced treatment response after renal denervation[J].Catheter Cardiovasc Interv,2016,87(1):E30-E38.DOI:10.1002/ccd.26068.
• [55]Fengler K,Rommel KP,Hoellriegel R,et al.Pulse wave velocity predicts response to renal denervation in isolated systolic hypertension[J].J Am Heart Assoc,2017,6(5):e005879.DOI:10.1161/JAHA.117.005879.
• [56]Burlacu A,Brinza C,Floria M,et al.Predicting renal denervation response in resistant high blood pressure by arterial stiffness assessment:a systematic review[J].J Clin Med,2022,11(16):4837.DOI:10.3390/jcm11164837.
• [57]Liu H,Li Y,Zhou H,et al.Renal nerve stimulation identifies renal innervation and optimizes the strategy for renal denervation in canine[J].J Transl Med,2023,21(1):100.DOI:10.1186/s12967-023-03919-9.
• [58]Huang HC,Pan HY,Wang TD.Renal nerve stimulation predicted blood pressure-lowering responses to percutaneous renal denervation[J].Circ Cardiovasc Interv,2023,16(2):e012779.DOI:10.116 1/CIRCINTERVENTIONS.122.012779.
• [59]Fudim M,Sobotka AA,Yin YH,et al.Selective vs.global renal denervation:a case for less is more[J].Curr Hypertens Rep,2018,20(5):37.DOI:10.1007/s11906-018-0838-2.
• [60]Pocock SJ,Ariti CA,Collier TJ,et al.The win ratio:a newapproach to the analysis of composite endpoints in clinical trials based on clinical priorities[J].Eur Heart J,2012,33(2):176-182.DOI:10.10 9 3/eurheartj/ehr352.
• [61]Wan SH,Hart M,Hajjar I.A novel measurement index for antihypertensive medication burden and its use[J].Hypertension,2009,54(5):e135-e136.DOI:10.1161/HYPERTENSIONAHA.109.140681.
• [62]Fatani N,Dixon DL,Van Tassell BW,et al.Systolic blood pressure time in target range and cardiovascular outcomes in patients with hypertension[J].J Am Coll Cardiol,2021,77(10):1290-1299.DOI:10.1016/j.jacc.2021.01.014.
• [63]Doumas M,Tsioufis C,Fletcher R,et al.Time in therapeutic range,as a determinant of all-cause mortality in patients with hypertension[J].J Am Heart Assoc,2017,6(11):e007131.DOI:10.1161/JAHA.117.007131.
• [64]Mahfoud F,Mancia G,Schmieder RE,et al.Cardiovascular risk reduction after renal denervation according to time in therapeutic systolic blood pressure range[J].J Am Coll Cardiol,2022,80(20):1871-1880.DOI:10.1016/j.jacc.2022.08.802.
• [65]Wang J.Pivotal trial of target renal denervation to treat hypertension:SMART study.Presented at:EuroPCR 2023.May17,2023.Paris,France.
• [66]Gao F.Effectiveness and safety of the Netrod six-electrode radiofrequency renal denervation system for the treatment of uncontrolled essential hypertension:a prospective multicenter randomized sham-controlled clinical trial[J/OL].(2023-5-17)https://media.pcronline.com/diapos/EuroPCR2023/1264-20230517_1115_Room_Maillot_Gao_Fei_1111100(12683)/Gao_Fei_20230517_1030_Room_Maillot.pdf.
• [67]Jiang XJ,R.G.Effectiveness and safety of Iberis four-electrode radiofrequency renal denervation system for the treatment of uncontrolled primary hypertension(Iberis-htn study)[J/OL].(2023-7-1)http://www.citmd.com/CIT/2023/program_search_cn.php?act=list&s_type=86&keytype=2.
• [68]Kordalis A,Tsiachris D,Pietri P,et al.Regression of organ damage following renal denervation in resistant hypertension:a Meta-analysis[J].J Hypertens,2018,36(8):1614-1621.DOI:10.1097/HJH.0000000000001798.
• [69]Mahfoud F,Urban D,Teller D,et al.Effect of renal denervation on left ventricular mass and function in patients with resistant hypertension:data from a multi-centre cardiovascular magnetic resonance imaging trial[J].Eur Heart J,2014,35(33):2224-31b.DOI:10.1093/eurheartj/ehu093.