Sesa-Ashton Gianni, Nolde Janis M, Muente Ida, Carnagarin Revathy, Lee Rebecca, Macefield Vaughan G, Dawood Tye, Sata Yusuke, Lambert Elisabeth A, Lambert Gavin W, Walton Antony, Kiuchi Marcio G, Esler Murray D, Schlaich Markus P
Human Neurotransmitter and Neurovascular Hypertension and Kidney Diseases Laboratories (G.S.-A., R.L., Y.S., M.D.E., M.P.S.), Baker Heart and Diabetes Institute, Melbourne, Australia.
Human Autonomic Neurophysiology Laboratory (G.S.-A., V.G.M., T.D.), Baker Heart and Diabetes Institute, Melbourne, Australia.
Hypertension. 2023 Apr;80(4):811-819. doi: 10.1161/HYPERTENSIONAHA.122.20853. Epub 2023 Feb 10.
BACKGROUND: Recent sham-controlled randomized clinical trials have confirmed the safety and efficacy of catheter-based renal denervation (RDN). Long-term safety and efficacy data beyond 3 years are scarce. Here, we report on outcomes after RDN in a cohort of patients with resistant hypertension with an average of ≈9-year follow-up (FU). METHODS: We recruited patients with resistant hypertension who were previously enrolled in various RDN trials applying radiofrequency energy for blood pressure (BP) lowering. All participants had baseline assessments before RDN and repeat assessment at long-term FU including medical history, automated office and ambulatory BP measurement, and routine blood and urine tests. We analyzed changes between baseline and long-term FU. RESULTS: A total of 66 participants (mean±SD, 70.0±10.3 years; 76.3% men) completed long-term FU investigations with a mean of 8.8±1.2 years post-procedure. Compared with baseline, ambulatory systolic BP was reduced by -12.1±21.6 (from 145.2 to 133.1) mm Hg (<0.0001) and diastolic BP by -8.8±12.8 (from 81.2 to 72.7) mm Hg (<0.0001). Mean heart rate remained unchanged. At long-term FU, participants were on one less antihypertensive medication compared with baseline (=0.0052). Renal function assessed by estimated glomerular filtration rate fell within the expected age-associated rate of decline from 71.1 to 61.2 mL/min per 1.73 m. Time above target was reduced significantly from 75.0±25.9% at baseline to 47.3±30.3% at long-term FU (<0.0001). CONCLUSIONS: RDN results in a significant and robust reduction in both office and ambulatory systolic and diastolic BP at ≈9-year FU after catheter-based RDN on less medication and without evidence of adverse consequences on renal function.
背景:近期的假手术对照随机临床试验已证实基于导管的肾去神经支配术(RDN)的安全性和有效性。超过3年的长期安全性和有效性数据稀缺。在此,我们报告一组难治性高血压患者接受RDN治疗后平均约9年随访(FU)的结果。 方法:我们招募了先前参加过各种应用射频能量降低血压的RDN试验的难治性高血压患者。所有参与者在RDN之前进行了基线评估,并在长期随访时进行了重复评估,包括病史、自动诊室和动态血压测量以及常规血液和尿液检查。我们分析了基线和长期随访之间的变化。 结果:共有66名参与者(平均±标准差,70.0±10.3岁;76.3%为男性)完成了长期随访调查,术后平均随访8.8±1.2年。与基线相比,动态收缩压降低了-12.1±21.6(从145.2降至133.1)mmHg(<0.0001),舒张压降低了-8.8±12.8(从81.2降至72.7)mmHg(<0.0001)。平均心率保持不变。在长期随访时,与基线相比,参与者服用的抗高血压药物减少了一种(P = 0.0052)。通过估计肾小球滤过率评估的肾功能下降在预期的与年龄相关的下降范围内,从71.1降至61.2 mL/(min·1.73 m²)。高于目标值的时间从基线时的75.0±25.9%显著降低至长期随访时的47.3±30.3%(<0.0001)。 结论:基于导管的RDN术后约9年随访时,RDN可显著且有力地降低诊室和动态收缩压及舒张压,服用药物减少,且无证据表明对肾功能有不良影响。
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