Department of Cardiology, Erasmus University Medical Center, Room Rg-628, P.O. Box 2040, 3000 CA, Rotterdam, The Netherlands.
Department of Cardiothoracic Surgery, Erasmus University Medical Center, Rotterdam, The Netherlands.
Clin Res Cardiol. 2022 Nov;111(11):1256-1268. doi: 10.1007/s00392-022-02056-5. Epub 2022 Jul 18.
Renal denervation (RDN) proved to significantly lower blood pressure (BP) at 2-6 months in patients on and off antihypertensive drugs. Given a lack of longer-term follow-up data, our aim was to assess the safety and efficacy of RDN up to five years taking into account antihypertensive drug regimen changes over time.
In the present single-center study, patients underwent RDN for (therapy resistant) hypertension. Patients underwent protocolized yearly follow-up out to five years. Data were collected on 24-h ambulatory BP and office BP monitoring, renal function, antihypertensive drug regimen, and safety events, including non-invasive renal artery imaging at 6/12 months. Efficacy analyses were performed using linear mixed-effects models.
Seventy-two patients with mean age 63.3 ± 9.5 (SD) years (51% female) were included. Median follow-up time was 3.5 years and Clark's Completeness Index was 72%. Baseline ambulatory daytime BP was 146.1/83.7 ± 17.4/12.2 mmHg under a mean number of 4.9 ± 2.7 defined daily doses (DDD). At five years, ambulatory daytime systolic BP as calculated from the mixed model was 120.8 (95% CI 114.2-127.5) mmHg and diastolic BP was 73.3 (95% CI 69.4-77.3) mmHg, implying a reduction of -20.9/-8.3 mmHg as compared to baseline estimates (p < 0.0001). The number of DDDs remained stable over time (p = 0.87). No procedure-related major adverse events resulting in long-term consequences were observed.
The BP-lowering effect of RDN was safely maintained at least five years post-procedure as reflected by a significant decrease in ambulatory daytime BP in the absence of escalating antihypertensive drug therapy over time.
肾去神经术（RDN）在接受和不接受抗高血压药物治疗的患者中，在 2-6 个月时可显著降低血压（BP）。由于缺乏长期随访数据，我们的目的是评估 RDN 的安全性和有效性，最长可达 5 年，并考虑到随时间推移抗高血压药物治疗方案的变化。
在本单中心研究中，患者因（治疗抵抗性）高血压而行 RDN。患者接受了为期 5 年的每年一次的方案随访。收集了 24 小时动态血压和诊室血压监测、肾功能、抗高血压药物治疗方案以及安全性事件的数据，包括 6/12 个月时的非侵入性肾动脉成像。使用线性混合效应模型进行疗效分析。
纳入 72 名平均年龄为 63.3±9.5（SD）岁（51%为女性）的患者。中位随访时间为 3.5 年，Clark 完整性指数为 72%。基线时，平均使用 4.9±2.7 个定义日剂量（DDD）时，24 小时动态白天收缩压为 146.1/83.7±17.4/12.2mmHg。在 5 年时，从混合模型计算出的动态白天收缩压为 120.8（95%CI 114.2-127.5）mmHg，舒张压为 73.3（95%CI 69.4-77.3）mmHg，与基线估计值相比降低了-20.9/-8.3mmHg（p<0.0001）。DDD 的数量随时间保持稳定（p=0.87）。未观察到与程序相关的导致长期后果的重大不良事件。
RDN 的降压效果在至少 5 年的时间内保持安全，这反映在随时间推移抗高血压药物治疗方案没有升级的情况下，动态白天 BP 显著降低。
