1、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,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。,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%，有更高心血管事件风险 Resistant hypertension: Circulation 2008;117: e51026,理论基础的启示：寻找解决办法,Sym
2、pathetic 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？,经导管肾交感神经消融术,Symplicity HTN-1 Three Year and Symplicity HTN-2 One Year Summary,Sustained BP Reductions to Three YearsFirst Symplicity HTN-1 patient treated June 2007 Three year reporting s
3、hows no diminishment of effect and impressive long term safetyFor patients that have completed 3 year follow 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 StudySymplicity HTN-2
4、 treatment population shows sustained treatment effect at 12 month follow-upControl cross-over patients also show significant BP reduction,Only the Symplicity renal denervation system has proven safe, superior and sustained BP reductions,Significant, Sustained Blood Pressure Reductions to at Least 3
5、 Years,Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.),p 0.01 for from baseline for all time points,Impressive Safety Record Continues in Long Term Follow-up,81 patients with 6-month renal CTA, MRA or duplexNo vascular abnormalities at any site of RF d
6、eliveryOne progression of a pre-existing stenosis unrelated to RF treatment (stented without further sequelae)One new moderate stenosis which was not hemodynamically relevant and not treated3 deaths within the follow-up period; all unrelated to the device or therapyNo hypotensive events that require
7、d hospitalization There were no observed changes in mean electrolytes or eGFR,Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.),Percentage Responders Increases Over Time,Responder was defined as an office SBP reduction 10 mmHg,(n=143),(n=148),(n=144),(n=
8、130),(n=107),(n=59),(n=24),(n=24),Expanded results presented at the American College of Cardiology Annual Meeting 2012 (Krum, H.),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 reduc
9、tion in SBP10% 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),Lat
10、est Follow-up(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,Medication Changes at 6 and 12 Months Post-Renal Denervation,Physicians were allowed t
11、o make changes to medicationsOnce the 6 month primary endpoint was reached*,*Further analysis of Medications is ongoing,Symplicity RDN Safety Record Continues to be Strong in Expanded Results,Symplicity HTN-2 Investigators. The Lancet. 2010.,RDNN=47,CrossoverN=35,Treated at Randomisation,Treated aft
12、er 6-mo follow-up,First-in-Man (AU),Series of Pilot Studies(EU, US & AU),Symplicity HTN-2Initial RCT(EU & AU),SYMPLICITY HTN-3US Pivotal Trial (US),Global SYMPLICITY Registry(Approved Regions),Expand HTN Indication(Approved Regions),Post-Market Registry(US),SYMPLICITY HF,Symplicity HTN-1（n=153),Pilo
13、t Studies inNew Indications(Approved Regions),Trials under way,Comprehensive SYMPLICITY Clinical Trial Program follows over 5000 patients across multiple indications,This report,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。,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
14、达标，即达到 BP250秒(2)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,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,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,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！,
