111例冷盐水灌注导管行肾动脉去交感神经消融术安全性调查
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江苏省卫生厅课题 (H201302);南京医科大学第一附属医院?江苏省人民医院临床新技术新项目 (JPH2012017)


Safety of renal sympathetic denervation using an saline-irrigated radiofrequency ablation catheter in 111 patients
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    摘要:

    目的:评估冷盐水灌注导管行肾动脉去交感神经消融术(renal sympathetic denervation,RSD)的安全性-方法:观察111例行冷盐水灌注导管RSD术患者的术中反应,比较术前术后6个月血肌酐-尿素氮-血胱抑素和中腹部CT血管造影(CT angiography,CTA)等指标来评估RSD术对肾功能和肾动脉结构的影响-结果:111例患者[男79例,女32例,年龄(53.7 ± 13.1)岁]因高血压-房颤和心衰等行RSD术,双侧肾动脉消融平均点数-每点时间-总时间-能量-温度-消融前阻抗-消融中阻抗平均下降分别为(16.1 ± 2.5)个-(71.6 ± 19.5) s-(1 144.6 ± 338.3) s-(9.2 ± 1.5) W-(39.3 ± 1.2)℃-(173.7 ± 27.2) Ω和(10.9 ± 11.3) Ω-急性不良反应包括疼痛110例(99%)-迷走反应25例(22.5%)-右肾动脉夹层1例(0.9%)-血管痉挛1例(0.9%)和穿刺点血肿1例(0.9%);疼痛和迷走反应停止消融后即消失,1例夹层植入肾动脉支架1枚-55例完成6个月随访,肾功能与术前相比,血肌酐-尿素氮和血胱抑素分别为(79.0 ± 21.7)μmol/L vs(77.4 ± 19.5) μmol/L(P > 0.05)-(6.0 ± 1.7)mmol/L vs(5.9 ± 1.7) mmol/L(P > 0.05)和(1.10 ± 0.26)mg/L vs.(1.07 ± 0.25) mg/L,均无显著性差异(P > 0.05);CTA检查发现2根肾动脉狭窄,其中1例右肾动脉近端90%狭窄,另1例右肾双动脉上支完全闭塞,其余肾动脉均未发现明显异常-结论:冷盐水灌注导管行RSD术相对安全-急性肾动脉夹层发生率0.9%;6个月随访肾功能正常,动脉狭窄发生率3.6%(2/55)-

    Abstract:

    Objective:To evaluate the safety of renal sympathetic denervation (RSD) using a saline-irrigated radiofrequency ablation catheter in 111 patients. Methods:Acute adverse events were recorded during bilateral RSD procedure with a saline-irrigated catheter. To evaluate renal function and renal artery structure,Serum creatinine(Scr),urea nitrogen(BUN),cystatin C and renal artery CTA were obtained in 55 patients from baseline to 6 month after RSD. Results:Total 111 patients (79 males and 32 females,aged 53.7 ± 13.1 years old) with hypertension,atrial fibrillation and/or heart failure etc. underwent RSD procedure. The number of lesions,average lesion duration,total duration,ablation power,ablation temperature,start impedance,and mean impedance decreasing were (16.1 ± 2.5) points,(71.6 ± 19.5)s,(1144.6 ± 338.3)s,(9.2 ± 1.5)W,(39.3 ± 1.2)℃,(173.7 ± 27.2)Ω and (10.9 ± 11.3)Ω,respectively. Acute adverse events included lesion area pain (110 cases,99%),vasovagal reflex (25 cases,22.5%),right renal artery dissection(one case,0.9%),vasospasm (one case,0.9%) and hematoma at the femoral access site (one case,0.9%) during procedure. The pain and vasovagal reflex disappeared after RSD procedure. The Renal artery dissection was treated with a stent without any subsequent complication. Fifty-five patients have completed 6-month follow-up. Scr,BUN and cystatin C concentrations had no significant change from baseline to 6 months follow-up[(77.4 ± 19.5)μmol/L vs (79.0 ± 21.7) μmol/L,P>0.05,(5.9 ± 1.7)mmol/L vs (6.0 ± 1.7)mmol/L,P > 0.05,(1.07 ± 0.25)mg/L vs (1.1 ± 0.26)mg/L,P > 0.05,respectively]. Renal artery CTA scan showed that two renal arteries had serious stenosis in 2 individuals. Ninety percent stenosis in the proximal portion of the right renal artery was observed in one patient,and right upper branch of renal artery had completely closed in another patient. The rest of renal arteries were normal at 6-month after RSD. Conclusion:Renal sympathetic denervation with irrigation catheter is relative safety. The rate of acute renal artery dissection was 0.9%(1/111). Renal function had no significant change and serious renal stenosis occurred in two patients( 3.6%,2/55) at 6 months follow-up.

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蒋 慧,陈 椿,耿 洁,郭纪群,邱 敏,汪 强,周忠霞,张 刚,魏忠诚,邹胜岚,周秀娟,钱卫冲,戴振华,唐立钧,单其俊.111例冷盐水灌注导管行肾动脉去交感神经消融术安全性调查[J].南京医科大学学报(自然科学版),2014,(11):1522-1526

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  • 收稿日期:2014-04-19
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  • 在线发布日期: 2014-11-21
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