Ricke J, Seidensticker M, Becker S, Schiefer J, Adamchic I, Lohfink K, Kandulski M, Heller A, Mertens P R
Department of Radiology and Nuclear Medicine, Universitätsklinikum Magdeburg AöR, Otto-von-Guericke University Magdeburg, Leipziger Straße 44, 39120, Magdeburg, Germany.
Deutsche Akademie für Mikrotherapie, Magdeburg, Germany.
Cardiovasc Intervent Radiol. 2016 Feb;39(2):251-60. doi: 10.1007/s00270-015-1261-6. Epub 2015 Dec 3.
CT-guided ethanol-mediated renal sympathetic denervation in treatment of therapy-resistant hypertension was performed to assess patient safety and collect preliminary data on treatment efficacy.
Eleven patients with therapy-resistant hypertension (blood pressure of >160 mmHg despite three different antihypertensive drugs including a diuretic) and following screening for secondary causes were enrolled in a phase II single arm open label pilot trial of CT-guided neurolysis of sympathetic renal innervation. Primary endpoint was safety, and secondary endpoint was a decrease of the mean office as well as 24-h systolic blood pressure in follow-up. Follow-up visits at 4 weeks, 3, and 6 months included 24-h blood pressure assessments, office blood pressure, laboratory values, as well as full clinical and quality of life assessments.
No toxicities ≥3° occurred. Three patients exhibited worsened kidney function in follow-up analyses. When accounting all patients, office systolic blood pressure decreased significantly at all follow-up visits (maximal mean decrease -41.2 mmHg at 3 months). The mean 24-h systolic blood pressure values decreased significantly at 3 months, but not at 6 months (mean: -9.7 and -6.3 mmHg, respectively). Exclusion of five patients who had failed catheter-based endovascular denervation and/or were incompliant for antihypertensive drug intake revealed a more pronounced decrease of 24-h systolic blood pressure (mean: -18.3 and -15.2 mmHg at 3 and 6 months, p = 0.03 and 0.06).
CT-guided sympathetic denervation proved to be safe and applicable under various anatomical conditions with more renal arteries and such of small diameter.
进行CT引导下乙醇介导的肾交感神经去神经术治疗难治性高血压，以评估患者安全性并收集治疗效果的初步数据。
11例难治性高血压患者（尽管使用了包括利尿剂在内的三种不同抗高血压药物，血压仍>160 mmHg），经继发性病因筛查后，纳入一项CT引导下肾交感神经去神经术的II期单臂开放标签试验。主要终点是安全性，次要终点是随访时诊室平均收缩压和24小时收缩压的降低。4周、3个月和6个月的随访包括24小时血压评估、诊室血压、实验室检查值以及全面的临床和生活质量评估。
未发生≥3级毒性反应。3例患者在随访分析中肾功能恶化。计算所有患者时，所有随访时诊室收缩压均显著降低（3个月时最大平均降低-41.2 mmHg）。3个月时24小时平均收缩压值显著降低，但6个月时未降低（平均分别为-9.7和-6.3 mmHg）。排除5例基于导管的血管内去神经术失败和/或未遵医嘱服用抗高血压药物的患者后，24小时收缩压下降更为明显（3个月和6个月时平均分别为-18.3和-15.2 mmHg，p=0.03和0.06）。
CT引导下的交感神经去神经术在各种解剖条件下，包括肾动脉较多且直径较小的情况下，被证明是安全且可行的。
