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猪模型中基于化学和射频的肾去神经支配的随机、盲法和对照比较研究。

Randomised, blinded and controlled comparative study of chemical and radiofrequency-based renal denervation in a porcine model.

作者信息

Bertog Stefan, Fischel Tim A, Vega Félix, Ghazarossian Vartan, Pathak Atul, Vaskelyte Laura, Kent Darrin, Sievert Horst, Ladich Elena, Yahagi Kazuyuki, Virmani Renu

机构信息

CardioVascular Center Frankfurt, Frankfurt, Germany.

出版信息

EuroIntervention. 2017 Feb 3;12(15):e1898-e1906. doi: 10.4244/EIJ-D-16-00206.

Abstract

AIMS

The blood pressure-lowering effect of percutaneous renal denervation (RDN) is controversial. The success of RDN may be device-dependent. We sought to compare the efficacy of RDN by chemical neurolysis using alcohol (Peregrine System Infusion Catheter; Ablative Solutions, Inc., Menlo Park, CA, USA) to RDN by radiofrequency (RF) ablation with the single-electrode RF catheter (Symplicity Flex; Medtronic, Minneapolis, MN, USA) in a porcine model.

METHODS AND RESULTS

This was a prospective, randomised, blinded study. Pigs were assigned to undergo bilateral RF ablation or chemical neurolysis. Primary endpoints were ablation depth and renal tissue norepinephrine (NE) concentrations at three-month follow-up. Twelve pigs underwent RF ablation (n=4) or chemical neurolysis by infusion of 0.3 mL (n=4) or 0.6 mL (n=4) alcohol. Ninety days after RF ablation and chemical neurolysis with 0.3 mL and 0.6 mL of alcohol, mean maximal tissue injury depth was 3.9±1.2 mm, 6.6±1.7 mm and 8.2±2.2 mm, respectively (p<0.001 for either dose of alcohol vs. RF ablation). Compared with historical controls, median renal tissue NE concentration reductions were 66%, 78% and 83% after RF ablation and chemical neurolysis using 0.3 mL and 0.6 mL alcohol, respectively (p=0.107 for chemical neurolysis vs. RF ablation). Mean total ablation area was significantly greater in both (0.3 mL and 0.6 mL) alcohol groups (p=0.0001 for both) than the RF ablation group (30.8±13.7 mm2, 41.6±12.4 mm2 and 11.0±7.5 mm2, respectively).

CONCLUSIONS

RDN is more effective using chemical neurolysis than single-electrode RF ablation. Our findings suggest that the efficacy of RDN may be device-dependent.

摘要

目的

经皮肾去神经支配术(RDN)的降压效果存在争议。RDN的成功可能取决于设备。我们试图在猪模型中比较使用酒精进行化学神经溶解(派瑞金系统输注导管;消融解决方案公司,美国加利福尼亚州门洛帕克)的RDN与使用单电极射频(RF)导管(Symplicity Flex;美敦力公司,美国明尼苏达州明尼阿波利斯)进行射频消融的RDN的疗效。

方法与结果

这是一项前瞻性、随机、盲法研究。猪被分配接受双侧射频消融或化学神经溶解。主要终点是三个月随访时的消融深度和肾组织去甲肾上腺素(NE)浓度。12头猪接受了射频消融(n = 4)或分别输注0.3 mL(n = 4)或0.6 mL(n = 4)酒精进行化学神经溶解。在使用0.3 mL和0.6 mL酒精进行射频消融和化学神经溶解90天后,平均最大组织损伤深度分别为3.9±1.2 mm、6.6±1.7 mm和8.2±2.2 mm(两种酒精剂量与射频消融相比,p < 0.001)。与历史对照相比,射频消融以及使用0.3 mL和0.6 mL酒精进行化学神经溶解后,肾组织NE浓度中位数降低分别为66%、78%和83%(化学神经溶解与射频消融相比,p = 0.107)。两个酒精组(0.3 mL和0.6 mL)的平均总消融面积均显著大于射频消融组(分别为30.8±13.7 mm²、41.6±12.4 mm²和11.0±7.5 mm²,p均为0.0001)。

结论

使用化学神经溶解的RDN比单电极射频消融更有效。我们的研究结果表明,RDN的疗效可能取决于设备。

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