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1、1,顽固性高血压的介入治疗肾神经消融,顽固性高血压的介入治疗经皮经导管肾神经消融术需要积极稳妥开展临床研究,顽固性高血压的介入治疗肾神经消融,2,顽固性高血压的介入治疗肾神经消融,3,历史回顾 降压药物问世前，上世纪20-50年代，尝试外科切除内脏交感神经治疗高血压，虽然降压有效，中/远期生存率明显提高，但围术期的致死、致残率高，中/远期并发症多。,顽固性高血压的介入治疗肾神经消融,4,尽管当代降压药物有长足发展，但仍有部分规范服药的患者血压不能达标,此外： 交感神经抑制剂、直接肾素抑制剂、非特异性血管扩张剂、抗高血压疫苗,高血压是全球公共卫生的难题，难治性高血压约占10% -20%，有更高心
2、血管事件风险 Resistant hypertension: Circulation 2008;117: e51026,顽固性高血压的介入治疗肾神经消融,5,理论基础的启示：寻找解决办法,Sympathetic nervous system and the kidney in hypertension.,Carotid baroreflex and hypertension,肾交感神经阻断？,颈动脉体迷走神经兴奋？,顽固性高血压的介入治疗肾神经消融,6,经导管肾交感神经消融术,顽固性高血压的介入治疗肾神经消融,7,顽固性高血压的介入治疗肾神经消融,8,顽固性高血压的介入治疗肾神经消融,9,顽固
3、性高血压的介入治疗肾神经消融,10,Symplicity HTN-1 Three Year and Symplicity HTN-2 One Year Summary,Sustained BP Reductions to Three Years First Symplicity HTN-1 patient treated June 2007 Three year reporting shows no diminishment of effect and impressive long term safety For patients that have completed 3 year fol
4、low up, 100% have been classified as responders (10 mmHg reduction), while at 6 months 71% of patients were classified as responders. Superior Results Confirmed in Randomised Study Symplicity HTN-2 treatment population shows sustained treatment effect at 12 month follow-up Control cross-over patient
5、s also show significant BP reduction,Only the Symplicity renal denervation system has proven safe, superior and sustained BP reductions,顽固性高血压的介入治疗肾神经消融,11,Significant, Sustained Blood Pressure Reductions to at Least 3 Years,Expanded results presented at the American College of Cardiology Annual Mee
6、ting 2012 (Krum, H.),p 0.01 for from baseline for all time points,顽固性高血压的介入治疗肾神经消融,12,Impressive Safety Record Continues in Long Term Follow-up,81 patients with 6-month renal CTA, MRA or duplex No vascular abnormalities at any site of RF delivery One progression of a pre-existing stenosis unrelated
7、to RF treatment (stented without further sequelae) One new moderate stenosis which was not hemodynamically relevant and not treated 3 deaths within the follow-up period; all unrelated to the device or therapy No hypotensive events that required hospitalization There were no observed changes in mean
8、electrolytes or eGFR,Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.),顽固性高血压的介入治疗肾神经消融,13,Percentage Responders Increases Over Time,Responder was defined as an office SBP reduction 10 mmHg,(n=143),(n=148),(n=144),(n=130),(n=107),(n=59),(n=24),(n=24),Exp
9、anded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.),顽固性高血压的介入治疗肾神经消融,14,Symplicity HTN-2: RDN Superior to Medical Management, Reductions Sustained to 12M, from Baseline to 6 Months (mmHg),Primary Endpoint: 84% of RDN patients had 10 mmHg reduction in SBP 10%
10、of RDN patients had no reduction in SBP,Systolic,Diastolic,Systolic,Diastolic,Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Esler, M.),RDN (n= 49), from Baseline to 12 Months (mmHg),Systolic,Diastolic,Primary Endpoint (6M post Randomisation),Latest Follow-up (
11、12M post Randomisation),Latest Follow-up: Control crossover (n = 35): -24/-8 mmHg (Analysis on patients with SBP 160 mmHg at 6 M),p 0.01 for from baseline,p 0.01 for difference between RDN and Control,顽固性高血压的介入治疗肾神经消融,15,Medication Changes at 6 and 12 Months Post-Renal Denervation,Physicians were al
12、lowed to make changes to medications Once the 6 month primary endpoint was reached*,*Further analysis of Medications is ongoing,顽固性高血压的介入治疗肾神经消融,16,Symplicity RDN Safety Record Continues to be Strong in Expanded Results,Symplicity HTN-2 Investigators. The Lancet. 2010.,RDN N=47,Crossover N=35,Treate
13、d at Randomisation,Treated after 6-mo follow-up,顽固性高血压的介入治疗肾神经消融,17,First-in-Man (AU),Series of Pilot Studies (EU, US & AU),Symplicity HTN-2 Initial RCT (EU & AU),SYMPLICITY HTN-3 US Pivotal Trial (US),Global SYMPLICITY Registry (Approved Regions),Expand HTN Indication (Approved Regions),Post-Market
14、 Registry (US),SYMPLICITY HF,Symplicity HTN-1（n=153),Pilot Studies in New Indications (Approved Regions),Trials under way,Comprehensive SYMPLICITY Clinical Trial Program follows over 5000 patients across multiple indications,This report,顽固性高血压的介入治疗肾神经消融,18,目前的初步结果鼓舞人心 作为抑制交感神经过度激活的一种新方法，可能有潜在巨大的临床应用
15、前景。但仍有许多问题尚不明了，积极稳妥的开展相关的临床研究很有必要。,顽固性高血压的介入治疗肾神经消融,19,没有即刻评价神经消融技术成功指标 Symplicity HTN-1中仅39%消融患者血压控制达标，即达到 BP140/90 mm Hg 6/45(13%)患者收缩压下降不足10 mm Hg (non-response),顽固性高血压的介入治疗肾神经消融,20,操作简单易行，需防止过度治疗应用 为提高消融程度，增加消融能量、位点或时间， 可能增加肾动脉狭窄、动脉瘤等并发症 研发新一代专用消融导管，使操作更方便、省时、可靠,顽固性高血压的介入治疗肾神经消融,21,肾神经有重要的生理功能，去
16、神经的中远期影响尚不清楚 自分泌或全身交感反馈机制可能使降压效果不能持久 传入神经不能再生，但传出神经再生是否会影响长期效果？ 目前的研究样本量小，统计效能有限，中远期疗效未明 是否真正减少心脑血管事件及死亡？,顽固性高血压的介入治疗肾神经消融,22,费用较高，效益/费用比以及并发症 / 终生用药利弊如何权衡？,顽固性高血压的介入治疗肾神经消融,23,判定手术成功的即刻指标和 预测消融效果的检测方法 长期安全性和疗效 风险效益比的评价 临床适应症的选择等方面,未来的临床研究要探索,1. Renal Denervation in Patients With Resistant Hypertens
17、ion and Obstructive Sleep Apnea 2. Renal Denervation in Patients With Uncontrolled Hypertension (Symplicity HTN-3) 3. Renal Denervation in Patients With Chronic Heart Failure & Renal Impairment Clinical Trial 4. Recruiting Combined Treatment of Resistant Hypertension and Atrial Fibrillation 5. Renal
18、 Denervation in End Stage Renal Disease Patients With Refractory Hypertension 6.Recruiting Sympathetic Activity and Renal Denervation 7.阜外医院 a) Active, on-going Renal Denervation in Patients With Resistant Hypertension b) Active, on-going Renal Denervation in swine model,相关试验,顽固性高血压的介入治疗肾神经消融,25,我院改
19、良的RDN入选标准,顽固性高血压的介入治疗肾神经消融,26,排除标准(存在1项即排除):,顽固性高血压的介入治疗肾神经消融,27,常规选择经皮股动脉路径。目前设计的Symplicity Catheter 导管推送杆长度为100CM，而经桡动脉入路至肾动脉往往需要100CM以上的指引导管，因此射频导管的头端无法申出指引导管。如果以后有更长推送杆的射频导管，桡动脉入路也是好的选择,入路选择,顽固性高血压的介入治疗肾神经消融,28,指引导管的选择,顽固性高血压的介入治疗肾神经消融,29,顽固性高血压的介入治疗肾神经消融,30,(1)抗凝：一般普通肝素5000-7500IU，要求ACT250秒 (2)
20、止疼:射频前经静脉予吗啡和/或芬太尼 (3)血管扩张:射频中如发现肾动脉收缩明显,予硝酸甘油100-200ug经导管给药 (4)降压:如血压明显升高,予硝普钠经静脉泵入 (5)心动过缓/血压下降:阿托品0.5mg和/或多巴胺2-3mg经静脉推注,术中用药与监护,顽固性高血压的介入治疗肾神经消融,31,射频导管头端自肾动脉远端至开口，螺旋型后撤，每隔5mm选一个点消融，射频导管头端充分贴壁后，每点传递能量8w,2分钟，一般一条肾动脉要消融5-6个点,顽固性高血压的介入治疗肾神经消融,32,术后观察与随访,术后重点观察血压变化、肾功能和微量蛋白尿，要依据血压下降的情况调整降压药。建议考虑口服阿司匹林50-100mg/天，共一个月，预防肾动脉射频后血栓形成,顽固性高血压的介入治疗肾神经消融,33,阜外医院10例顽固性高血压患者RDN （ Symplicity Catheter 导管）一个月随访结果,无降压应答2例（2/10） 较基线血压下降20/10mmHg 较基线降压药数量或剂量下降8例（8/10） 肾功能与尿常规无显著变化 无并发症发生,谢谢！,