頑固性高血壓的介入治療腎神經(jīng)消融

頑固性高血壓的介入治療

經(jīng)皮經(jīng)導(dǎo)管腎神經(jīng)消融術(shù)

需要積極穩(wěn)妥開展臨床研究1整理ppt2整理ppt歷史回憶降壓藥物問世前，上世紀20-50年代，嘗試外科切除內(nèi)臟交感神經(jīng)治療高血壓，雖然降壓有效，中/遠期生存率明顯提高，但圍術(shù)期的致死、致殘率高，中/遠期并發(fā)癥多。3整理ppt盡管當代降壓藥物有長足開展，但仍有部

分標準服藥的患者血壓不能達標此外：交感神經(jīng)抑制劑、直接腎素抑制劑、非特異性血管擴張劑、抗高血壓疫苗…高血壓是全球公共衛(wèi)生的難題，難治性高血壓約占10%-20%，有更高心血管事件風險Resistanthypertension:Circulation2021;117:e510–264整理ppt理論根底的啟示：尋找解決方法Sympatheticnervoussystemandthekidneyinhypertension.

Carotidbaroreflexandhypertension腎交感神經(jīng)阻斷？頸動脈體迷走神經(jīng)興奮？5整理ppt經(jīng)導(dǎo)管腎交感神經(jīng)消融術(shù)6整理ppt7整理ppt8整理ppt9整理pptSymplicityHTN-1ThreeYearand

SymplicityHTN-2OneYearSummarySustainedBPReductionstoThreeYearsFirstSymplicityHTN-1patienttreatedJune2007ThreeyearreportingshowsnodiminishmentofeffectandimpressivelongtermsafetyForpatientsthathavecompleted3yearfollowup,100%havebeenclassifiedasresponders(>10mmHgreduction),whileat6months71%ofpatientswereclassifiedasresponders.SuperiorResultsConfirmedinRandomisedStudySymplicityHTN-2treatmentpopulationshowssustainedtreatmenteffectat12monthfollow-upControlcross-overpatientsalsoshowsignificantBPreductionOnlytheSymplicity?renaldenervationsystemhasprovensafe,superiorandsustainedBPreductions

10整理pptSignificant,SustainedBloodPressureReductionstoatLeast3YearsExpandedresultspresentedattheAmericanCollegeofCardiologyAnnualMeeting2021(Krum,H.)p<0.01for

frombaselineforalltimepoints11整理pptImpressiveSafetyRecordContinuesinLongTermFollow-up81patientswith6-monthrenalCTA,MRAorduplexNovascularabnormalitiesatanysiteofRFdeliveryOneprogressionofapre-existingstenosisunrelatedtoRFtreatment(stentedwithoutfurthersequelae)Onenewmoderatestenosiswhichwasnothemodynamicallyrelevantandnottreated3deathswithinthefollow-upperiod;allunrelatedtothedeviceortherapyNohypotensiveeventsthatrequiredhospitalizationTherewerenoobservedchangesinmeanelectrolytesoreGFRExpandedresultspresentedattheAmericanCollegeofCardiologyAnnualMeeting2021(Krum,H.)12整理pptPercentageRespondersIncreasesOverTimeResponderwasdefinedasanofficeSBPreduction≥10mmHg(n=143)(n=148)(n=144)(n=130)(n=107)(n=59)(n=24)(n=24)ExpandedresultspresentedattheAmericanCollegeofCardiologyAnnualMeeting2021(Krum,H.)13整理pptSymplicityHTN-2:RDNSuperiortoMedicalManagement,ReductionsSustainedto12M?fromBaselineto6Months(mmHg)PrimaryEndpoint:84%ofRDNpatientshad≥10mmHgreductioninSBP10%ofRDNpatientshadnoreductioninSBPSystolicDiastolicSystolicDiastolicExpandedresultspresentedattheAmericanCollegeofCardiologyAnnualMeeting2021(Esler,M.)RDN(n=49)?fromBaselineto12Months(mmHg)SystolicDiastolicPrimaryEndpoint(6MpostRandomisation)LatestFollow-up(12MpostRandomisation)LatestFollow-up:Controlcrossover(n=35):-24/-8mmHg(AnalysisonpatientswithSBP≥160mmHgat6M)p<0.01for

frombaselinep<0.01fordifferencebetweenRDNandControl14整理pptMedicationChangesat6and12Months

Post-RenalDenervationRDN(n=47)6month12monthsDecrease(#MedsorDose)20.9%(9/43)27.9%(12/43)Increase(#MedsorDose)11.6%(5/43)18.6%(8/43)Crossover(n=35)6monthspost-RDNDecrease(#MedsorDose)18.2%(6/33)Increase(#MedsorDose)15.2%(5/33)PhysicianswereallowedtomakechangestomedicationsOncethe6monthprimaryendpointwasreached**FurtheranalysisofMedicationsisongoing15整理pptSymplicityRDNSafetyRecordContinuestobeStronginExpandedResultsSymplicityHTN-2Investigators.TheLancet.2021.Baseline6month12monthseGFR(ml/min/1.73m2)76.9±19.3(n=49)77.1±18.8(n=49)78.2±17.4(n=45)CystatinC(mg/L)0.91±0.25(n=38)0.98±0.36(n=40)0.98±0.30(n=38)RDNN=47Baseline6month12monthseGFR(ml/min/1.73m2)88.8±20.7(n=35)89.3±19.5(n=35)85.2±18.3(n=35)CystatinC(mg/L)0.78±0.17(n=27)0.82±0.16(n=26)0.89±0.20(n=26)CrossoverN=35TreatedatRandomisationTreatedafter6-mofollow-up16整理pptFirst-in-Man(AU)SeriesofPilotStudies(EU,US&AU)SymplicityHTN-2InitialRCT(EU&AU)SYMPLICITYHTN-3USPivotalTrial(US)GlobalSYMPLICITYRegistry(ApprovedRegions)ExpandHTNIndication(ApprovedRegions)Post-MarketRegistry(US)SYMPLICITYHFSymplicityHTN-1〔n=153)PilotStudiesinNewIndications(ApprovedRegions)TrialsunderwayComprehensiveSYMPLICITYClinicalTrialProgramfollowsover5000patientsacrossmultipleindications

Thisreport17整理ppt目前的初步結(jié)果鼓舞人心作為抑制交感神經(jīng)過度激活的一種新方法，可能有潛在巨大的臨床應(yīng)用前景。但仍有許多問題尚不明了，積極穩(wěn)妥的開展相關(guān)的臨床研究很有必要。

18整理ppt沒有即刻評價神經(jīng)消融技術(shù)成功指標SymplicityHTN-1中僅39%消融患者血壓控制達標，即到達BP<140/90mmHg6/45(13%)患者收縮壓下降缺乏10mmHg(non-response)19整理ppt操作簡單易行，需防止過度治療應(yīng)用為提高消融程度，增加消融能量、位點或時間，

可能增加腎動脈狹窄、動脈瘤等并發(fā)癥研發(fā)新一代專用消融導(dǎo)管，使操作更方便、省時、可靠20整理ppt腎神經(jīng)有重要的生理功能，去神經(jīng)的中遠期影響尚不清楚自分泌或全身交感反響機制可能使降壓效果不能持久傳入神經(jīng)不能再生，但傳出神經(jīng)再生是否會影響長期效果？目前的研究樣本量小，統(tǒng)計效能有限，中遠期療效未明是否真正減少心腦血管事件及死亡？21整理ppt費用較高，效益/費用比以及并發(fā)癥/終生用藥利弊如何權(quán)衡？22整理ppt判定手術(shù)成功的即刻指標和預(yù)測消融效果的檢測方法長期平安性和療效風險效益比的評價臨床適應(yīng)癥的選擇等方面未來的臨床研究要探索23整理ppt1.RenalDenervationinPatientsWithResistantHypertensionandObstructiveSleepApnea2.RenalDenervationinPatientsWithUncontrolledHypertension(SymplicityHTN-3)3.RenalDenervationinPatientsWithChronicHeartFailure&RenalImpairmentClinicalTrial4.RecruitingCombinedTreatmentofResistantHypertensionandAtrialFibrillation5.RenalDenervationinEndStageRenalDiseasePatientsWithRefractoryHypertension6.RecruitingSympatheticActivityandRenalDenervation7.阜外醫(yī)院a)Active,on-goingRenalDenervationinPatientsWithResistantHypertensionb)Active,on-goingRenalDenervationinswinemodel相關(guān)試驗24整理ppt我院改進的RDN入選標準入選標準(5項均需滿足):1.腎動脈直徑≥4mm且長度≥20mm2.年齡≥18歲，<65歲3.收縮壓≥160mmHg和/或舒張壓≥100mmHg（平均三次診室/病房測量）4.規(guī)律服用三種或以上常規(guī)劑量抗高血壓藥物5.估測GFR（eGFR）≥45ml/min25整理ppt排除標準(存在1項即排除):腎動脈異常的情況包括：1.任一側(cè)腎動脈血流動力學(xué)或解剖學(xué)上明顯的狹窄（≥50%）；2.之前曾行腎動脈球囊成形術(shù)或置入過支架；3.任一側(cè)腎臟存在多支腎動脈，且直徑<4mm（MRA/CTA/血管造影評價）心血管不穩(wěn)定包括：1.六個月內(nèi)心肌梗死、不穩(wěn)定性心絞痛或腦血管病事件2.存在血管內(nèi)血栓或不穩(wěn)定斑塊的廣泛動脈粥樣硬化3.血流動力學(xué)明顯改變的心臟瓣膜疾病4.左心功能不全,EF<40%植入性除顫器（ICD）或起搏器有妊娠、哺乳或計劃懷孕其他嚴重的器質(zhì)性疾病繼發(fā)性高血壓26整理ppt常規(guī)選擇經(jīng)皮股動脈路徑。目前設(shè)計的Symplicity?Catheter導(dǎo)管推送桿長度為100CM，而經(jīng)橈動脈入路至腎動脈往往需要100CM以上的指引導(dǎo)管，因此