论文题名(中文): | 去肾神经术治疗高血压的临床研究 |
姓名: | |
论文语种: | chi |
学位: | 硕士 |
学位类型: | 学术学位 |
学校: | 北京协和医学院 |
院系: | |
专业: | |
指导教师姓名: | |
论文完成日期: | 2025-03-20 |
论文题名(外文): | Clinical study on renal denervation for the treatment of hypertension |
关键词(中文): | |
关键词(外文): | renal denervation resistant hypertension long-term clinical outcomes transfemoral access upper extremity access |
论文文摘(中文): |
背景:目前,国内外多项大型随机对照临床研究已证实经导管去肾神经术(Renal denervation,RDN)治疗难治性高血压(Resistant hypertension, RH)短期疗效显著且不良事件发生率低,然而,关于该疗法的长期临床效果研究仍较为有限,特别是其对心脑血管事件的潜在获益尚缺乏充分证据。因此,我们回顾性分析在国家心血管病中心行RDN治疗的患者资料,以期总结RDN远期疗效,为国内外长期研究进一步提供参考。 方法:本研究回顾性分析了2012.02-2019.11期间在国家心血管病中心接受经股动脉路径行RDN治疗的58例RH患者。所有患者于术后1、3、6、12个月及之后每年通过门诊或电话随访,末次访视时间为 2023.06。本研究收集患者的基线、血压及心率、降压药物、肾功能改变(估算肾小球滤过率:estimated glomerular filtration rate, eGFR)以及主要不良事件(肾动脉狭窄、致命性急性心肌梗死及 致命性脑卒中等)发生率等临床数据。采用国内外风险评估模型评估RDN对患者10 年心脑血管事件风险的影响。 结果:58例患者中41例(70.7%)患者完成末次随访,平均随访(10.2±1.8)年。 末次随访时诊室收缩压较基线下降(12.6±21.7)mmHg(1 mmHg=0.133 kPa),诊 室舒张压较基线下降(9.9±14.3)mmHg,24 小时平均收缩压下降(11.3±15.3) mmHg;舒张压下降(7.9±12.3)mmHg,24小时平均心率由基线时76.6次/min降至 74.1 次/min ( P>0.05),降压药种类由基线时平均3.7种降至末次随访时2.7种, 平均减少(1.2±2.3)种(P<0.01),总降压药物每日负荷剂量由基线时的4.0降至末次随访时2.5,平均降低(1.5±2.4)( P<0.001),eGFR较基线(93.4±18.8) ml/(min·1.73 m2)下降(6.8±18.4)ml/(min·1.73 m2)(P<0.05)。10年随访期间内,1 例(1/58,1.7%)患者死于肺癌,无肾动脉狭窄、夹层及动脉瘤等不良事件发生。RDN对10年心血管事件及脑卒中风险的影响:采用Framingham风险评估,其10年心血管疾病、冠心病及脑卒中事件发生风险为19.1%、11.6%及4.6%, 较随访实际事件发生率分别下降14.2%、9.2%及2.2%;采用国人心脑血管风险模型, 10 年心血管疾病、冠心病、脑卒中事件发生风险为10.6%、9.9%及19.9%,较实际事件发生率分别下降5.7%、7.5%及17.5%。 结论:RDN不仅能显著降低RH患者血压水平,还能减少患者对降压药物的依赖,同时未对心率和肾功能产生显著不良影响,并有望进一步降低心脑血管事件发生风险。 背景:经导管射频去肾神经术(Renal denervation,RDN)的常规入路是右股动脉,但部分患者由于肾动脉、腹主动脉或髂动脉等解剖因素难以经股动脉入路行 RDN, 此时应更换入路。目前国内外尚无基于血管形态选择RDN消融路径长期有效性和安全性的报道。因此,本研究回顾国家心血管病中心所有行RDN治疗的患者资料,首次探究基于血管形态选择RDN消融路径的长期结局。 方法:回顾性纳入2012.02-2019.11期间在国家心血管病中心接受RDN治疗的难治性高血压(Resistant hypertension,RH)患者,共计85例。按照射频消融路径分为经股动脉入路(Transfemoral access, TFA)与经上肢动脉入路(Upper extremity access, UEA)两组,分别记录两组患者的基线和手术资料,并于RDN术后6个月、 1 年和3年进行随访,末次访视为2023.06。 结果:共入组85例RH患者,其中58例(68.2%)患者经TFA行RDN,27例(31.8%) 患者经UEA行RDN。TFA组X线曝光时间更短(TFA组:12.2±5.7 min vs. UEA组: 15.2±7.2 min;P=0.038),但两组在手术时间(TFA组:40.8±14.9 min vs. UEA 组:38.6±11.6 min;P=0.506)及造影剂用量(TFA组:78.2±25.9 mL vs. UEA 组:91.9±39.7 mL;P=0.061)方面无明显差异。围术期内两组均无手术相关并发症发生。共58例患者完成末次随访,平均随访9.5年(3-12年)。末次随访时, 两组在诊室血压、24小时平均血压、降压药物用量和药物负荷及估算肾小球滤过率方面均无明显组间差异。随访期间内,TFA组中1例患者死于肺癌。心肌梗死(1/41 例患者,2.4% vs. 1/17 例患者,5.9%;P=0.504)和卒中(1/41例患者,2.4% vs. 0/17 例患者,0.0%;P=1.0)发生率两组间差异不显著。 结论:研究表明,与传统的股动脉入路相比,经上肢路径行RDN是一种技术上可行、 相对安全和有效的替代方法。 |
论文文摘(外文): |
Objectives: Currently, multiple large-scale randomized controlled trials conducted globally have consistently demonstrated that catheter-based renal denervation (RDN) has significant short-term therapeutic efficacy with a favorable safety profile in treating resistant hypertension (RH). Nevertheless, evidence regarding its long-term clinical outcomes remains limited, particularly concerning its potential cardiovascular and cerebrovascular benefits. Therefore, we retrospectively analyzed the data of patients who underwent RDN treatment at the National Center for Cardiovascular Diseases to summarize their long-term efficacy and safety, and provide further reference. Methods: This study retrospectively analyzed 58 patients with RH who underwent RDN via the transfemoral approach at the National Center for Cardiovascular Diseases between February 2012 and November 2019. All patients were followed up at 1, 3, 6, and 12 months postoperatively, and annually thereafter, either through outpatient visits or telephone interviews, with the last follow-up conducted in June 2023. Clinical data collected included baseline characteristics, blood pressure and heart rate, antihypertensive medications, changes in renal function (estimated glomerular filtration rate, eGFR), and the incidence of major adverse events (renal artery stenosis, fatal myocardial infarction and stroke). Both international and domestic risk assessment models were used to evaluate the impact of RDN on the 10-year risk of cardiovascular and cerebrovascular events. Results: Among the 58 patients, 41 (70.7%) completed the final follow-up, with an average follow-up duration of (10.2±1.8) years. At the last follow-up, office systolic blood pressure decreased by (12.6±21.7) mmHg (1 mmHg = 0.133 kPa), office diastolic blood pressure decreased by (9.9±14.3) mmHg, 24-hour average systolic blood pressure decreased by (11.3±15.3) mmHg, and diastolic blood pressure decreased by (7.9±12.3) mmHg. The 24-hour mean heart rate showed a non-significant decrease from 76.6 bpm at baseline to 74.1 bpm at final follow-up (P>0.05).The mean number of antihypertensive drug classes was reduced from 3.7 at baseline to 2.7 at final follow-up, with a mean reduction of(1.2±2.3)classes (P<0.01), and the total daily antihypertensive drug load decreased from 4.0 to 2.5, representing a mean reduction of(1.5±2.4)(P<0.001). Additionally, eGFR demonstrated a significant decline from baseline (93.4±18.8) mL/min/1.73m² to final follow-up, with a mean reduction of (6.8±18.4) mL/min/1.73m² (P<0.05). During the 10-year follow-up period, 1 patient (1/58, 1.7%) died from lung cancer, and no adverse events such as renal artery stenosis, dissection, or aneurysm were observed. The impact of RDN on the 10-year risk of cardiovascular events and stroke was assessed using the Framingham risk assessment model. The postoperative 10-year risks of cardiovascular disease, coronary heart disease, and stroke were 19.1%, 11.6%, and 4.6%, respectively, representing reductions of 14.2%, 9.2%, and 2.2% compared to the actual event rates during follow-up. When evaluated using the Chinese cardiovascular risk prediction model, the postoperative 10-year risks for cardiovascular disease, coronary heart disease, and stroke were 10.6%, 9.9%, and 19.9%, respectively, corresponding to reductions of 5.7%, 7.5%, and 17.5% relative to the observed event rates. Conclusions: RDN not only significantly reduces blood pressure of RH patients, but also decreases patients' reliance on antihypertensive medications, without significantly adversely affecting heart rate or renal function. Furthermore, it holds promise for further reducing the risk of cardiovascular and cerebrovascular events. Objectives:Renal denervation (RDN) via the femoral artery pathway was a routine procedure, but it was difficult for some patients to perform RDN via the femoral artery pathway due to anatomical factors from the renal artery, the infrarenal abdominal aorta, and iliac arteries. Therefore, RDN should be performed via the upper limb artery pathway in this condition. However, there have been no reports on the long-term effectiveness and safety of RDN ablation pathways in literature. Therefore, we retrospectively analyzed all patients who underwent RDN treatment at our institution, and for the first time explored the long-term outcomes of selecting RDN ablation pathways based on vascular morphology. Methods:We retrospectively enrolled all patients(85 patients)with resistant hypertension (RH) who underwent RDN treatment at the National Center for Cardiovascular Diseases between February 2012 and November 2019. They were divided into two groups according to the ablation approach: transfemoral access (TFA) and the upper extremity access (UEA). Baseline and procedural data were recorded for both groups, and follow-up was conducted at 6 months, 1 year, and 3 years after RDN, and the last visit was June 2023. Results:A total of 85 RH patients were enrolled, 58 (68.2%) of them were treated via TFA, and 27 patients (31.8%) via UEA. The fluoroscopy time was less in the TFA group (12.2±5.7 min vs. 15.2±7.2 min; P=0.038). The procedure time (TFA group: 40.8±14.9 min vs. UEA group: 38.6±11.6 min; P=0.506) and contrast volume (TFA group: 78.2±25.9 mL vs. UEA group: 91.9±39.7 mL; P=0.061) were similar between two groups, without procedure-related complications. During a follow-up period ranging from 3 to 12 years (averaging 9.5±1.3 years), 58 participants completed the final visit. The two groups exhibited similar changes in office blood pressure and 24-hour mean blood pressure. There was also no significant difference in change of antihypertensive drug dosage and load, and estimated glomerular filtration rate over this period. In the long-term follow-up, one patient from the TFA group suffered from lung cancer. Additionally, no significant differences were observed between the groups in terms of myocardial infarction incidence (2.4% in 1 out of 41 patients vs. 5.9% in 1 out of 17 patients; P=0.504) or stroke incidence (2.4% in 1 out of 41 patients vs. 0.0% in 0 out of 17 patients; P=1.0). Conclusions: The study showed RDN via UEA was a feasible and safe approach particularly in patients with illegal vascular morphology compared with TFA. |
开放日期: | 2025-06-05 |