Bratisl Lek Listy. 2022;123(10):710-715. doi: 10.4149/BLL_2022_113.
Purpose of the study is the assessment of the effectiveness of renal denervation with different types of catheters, as well as its long-term effects, in the patients with resistant hypertension.
This single-center prospective study included 81 patients who underwent a renal denervation procedure using 2 types of catheters: monopolar and helical (Medtronic Inc., Minneapolis, Minnesota, the USA) between 2015 and 2018. Baseline demographics, clinical, functional and laboratory characteristics of the patients were assessed. A comparative analysis of the dynamics of office systolic and diastolic blood pressure during 5 years of follow-up was carried out. The Kaplan-Meier method was used to study the survival of the patients with resistant hypertension after renal denervation.
A total of 81 patients with a mean age of 57.79 ± 9.87 years, of whom 37.04 % were men, were included in the 2-stage study (first stage using monopolar catheters and second stage using spiral catheters). At the time of inclusion, study participants were receiving an average of 4.5 ± 1.4 antihypertensive medications. In 36 (or 44.4 %), the procedure was performed using a monopolar catheter; in 45 (or 55.6 %), a spiral catheter was used. There were no statistically significant differences between the two groups of the patients. The analysis established statistically significant changes in the dynamics of office SBP and DBP (p < 0.001) assessed 1, 2, 3, 4, and 5 years after the renal denervation procedure. The analysis demonstrated a stability in the reduction of office SBP and DBP during the 5-year follow-up. The results of the study showed that the median survival time was 1061 days from the beginning of follow-up (95% CI: 728.03 to 1 393.97 days); the median survival time in the monopolar catheter group was 777 days (95% CI: 692.314 to 861.686) and in the spiral catheter group 1 294 days (95% CI: 713.079 to 1 874.921).
Our results demonstrated the efficiency and safety of renal denervation in both short-term and long-term follow-up using monopolar and spiral catheters in the treatment of uncontrolled hypertension with combined antihypertensive therapy. The most significant is the demonstrated stability of the effect after the procedure. In addition, the survival rate of the patients with resistant hypertension after the intervention has been carried out (Tab. 2, Fig. 3, Ref. 22).
本研究的目的是评估使用不同类型导管进行肾去神经术的效果，以及其在难治性高血压患者中的长期效果。
这是一项单中心前瞻性研究，纳入了 2015 年至 2018 年间接受肾去神经术的 81 例患者，使用了 2 种导管：单极和螺旋导管（美敦力公司，明尼苏达州明尼阿波利斯市，美国）。评估了患者的基线人口统计学、临床、功能和实验室特征。对 5 年随访期间诊室收缩压和舒张压的动态进行了比较分析。采用 Kaplan-Meier 法研究肾去神经术后难治性高血压患者的生存情况。
共有 81 例平均年龄为 57.79 ± 9.87 岁的患者（其中 37.04%为男性）纳入了 2 期研究（第 1 期使用单极导管，第 2 期使用螺旋导管）。纳入时，研究参与者平均服用 4.5 ± 1.4 种降压药物。36 例（44.4%）患者使用单极导管进行了手术；45 例（55.6%）患者使用了螺旋导管。两组患者之间无统计学差异。分析结果显示，肾去神经术后 1、2、3、4 和 5 年，诊室 SBP 和 DBP 的动态变化有统计学意义（p<0.001）。在 5 年随访期间，诊室 SBP 和 DBP 的降低保持稳定。研究结果显示，中位随访时间为 1061 天（95%CI：728.03-1393.97 天）；单极导管组的中位生存时间为 777 天（95%CI：692.314-861.686 天），螺旋导管组为 1294 天（95%CI：713.079-1874.921 天）。
我们的结果表明，使用单极和螺旋导管进行肾去神经术治疗联合降压治疗的未控制高血压，在短期和长期随访中均具有有效性和安全性。最重要的是，术后效果稳定。此外，还对难治性高血压患者进行了干预后生存情况分析（表 2，图 3，参考文献 22）。
