PulseRider支架治疗分叉部宽颈动脉瘤ANSWER试验结果

ResultsoftheANSWERTrialUsingthePulseRiderfortheTreatmentofBroad-Necked,BifurcationAneurysms

神经血管内支架辅助宽颈动脉瘤介入栓塞和载瘤动脉重建(AdjunctiveNeurovascularSupportofWide-neckaneurysmEmbolizationandReconstruction,ANSWER)试验是一项前瞻性、非随机的单组临床试验,对PulseRider支架(PulsarVascular,LosGatos,California)治疗分叉部宽颈动脉瘤的安全性及预期获益进行了研究。

ThesafetyandprobablebenefitofthePulseRider(PulsarVascular,LosGatos,California)forthetreatmentofbroad-necked,bifurcationaneurysmswasstudiedinthecontextoftheprospective,nonrandomized,singlearmclinicaltrial—theAdjunctiveNeurovascularSupportofWide-neckaneurysmEmbolizationandReconstruction(ANSWER)Trial.

目的:介绍ANSWER临床试验中PulseRider支架在美国的应用结果。

OBJECTIVE:TopresenttheresultsoftheUnitedStatescasesemployingthePulseRiderdeviceaspartoftheANSWERclinicaltrial.

方法:对完成ANSWER试验网站注册、使用PulseRider支架治疗的动脉瘤病例进行前瞻性研究,并总结研究结果。研究对象为发生在颈内动脉末端或基底动脉尖的相对宽颈动脉瘤。

METHODS:AneurysmstreatedwiththePulseRiderdeviceamongsitesenrollingintheANSWERtrialwereprospectivelystudiedandtheresultsaresummarized.AneurysmsarisingateitherthecarotidterminusorbasilarapexthatwererelativelybroadneckedwereconsideredcandidatesforinclusionintotheANSWERstudy.

结果:全组34例,其中女性29例,男性5例;平均年龄60.9岁;动脉瘤位于基底动脉尖27例,位于颈内动脉末端7例;动脉瘤体长径2.4-15.9mm,瘤颈平均直径5.2mm(2.3-11.6mm)。全组患者均使用PulseRider支架,术后动脉瘤Raymond-Roy闭塞分级I或II级者达82.4%,术后6个月随访增加到87.9%;94%的患者术后6个月改良Rankin评分≤2分。

RESULTS:Thirty-fourpatientswereenrolled(29femaleand5male)withameanageof60.9years(27basilarapexand7carotidterminus).Meananeurysmheightrangedfrom2.4to15.9mmwithameannecksizeof5.2mm(range2.3-11.6mm).Inallpatients,thedevicewasdeliveredanddeployed.ImmediateRaymondIorIIocclusionwasachievedin82.4%andprogressedto87.9%at6-monthfollow-up.AmodifiedRankinScoreof2orlesswasseenin94%ofpatientsat6months.

结论:ANSWER试验结果表明,使用PulseRider支架治疗基底动脉尖或颈内动脉末端的分叉部动脉瘤是安全的,且有可能获益,可以作为神经血管内治疗装备的有益补充。

CONCLUSION:TheresultsfromtheANSWERtrialdemonstratethatthePulseRiderdeviceissafeandoffersprobablebenefitasforthetreatmentofbifurcationaneurysmsarisingatthebasilarapexorcarotidterminus.Assuch,itrepresentsausefuladditiontothearmamentariumoftheneuroendovascularspecialist.

关键词:动脉瘤,栓塞治疗,装备

KEYWORDS:Aneurysm,Embolization,Device

原文出处:SpiottaAM,DerdeynCP,TateshimaS,etal.ResultsoftheANSWERTrialUsingthePulseRiderfortheTreatmentofBroad-Necked,BifurcationAneurysms.Neurosurgery.;81(1):56–65.

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