Efficacy and safety of pulmonary vein isolation combined with renal sympathetic denervation in patients with atrial fibrillation and hypertension:A Meta-analysis and a sequential trial
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摘要: 目的:通过Meta分析方法评价肺静脉隔离(PVI)联合肾交感神经消融术(RDN)治疗心房颤动(房颤)合并高血压患者的有效性及安全性。方法:在Cochrane Library、PubMed、EMBASE、中国知网及万方数据库中,检索自建库至2020年10月发表的关于PVI联合RDN与单独PVI治疗房颤合并高血压的临床研究,经筛选后用于Meta分析。主要结局指标为房颤复发、血压下降的幅度、左心功能改变[左室舒张末期内径(LEVDD)、左室重量指数(LV mass index)]、手术时间、透视时间、并发症的发生率。采用Rev Man 5.3统计分析软件进行数据处理。采用TSA 0.9软件对术后房颤复发率等进行试验序贯分析。结果:总共纳入7篇临床试验,共纳入734例患者,RDN+PVI较单纯PVI房颤复发率明显下降(OR=0.41,95%CI0.30~0.56,P<0.01),血压下降幅度更大(收缩压:WMD=-10.94,95%CI-16.43~-5.45,P<0.01;舒张压:WMD=-5.39,95%CI-8.84~-1.94,P<0.01),左心功能改变更显著(LEVDD:WMD=-3.96,95%CI-5.34~-2.58,P<0.01;LV mass index:WMD=-13.35,95%CI-19.08~-7.62,P<0.01),手术时间(WMD=24.96,95%CI20.36~29.56,P<0.01)、透视时间(WMD=5.59,95%CI3.31~7.86,P<0.01)也相应延长,但并发症的发生率差异无统计学意义(P>0.05)。试验序贯分析提示,PVI联合RDN在降低房颤复发率及血压下降上证据确切。结论:与单纯PVI相比,PVI联合RDN在治疗房颤合并高血压患者,可在一定程度上降低术后房颤复发率及更好地控制患者血压、改善左心功能,且并不增加患者相关并发症的发生率。Abstract: Objective: To systematically review the efficacy and safety of pulmonary vein isolation(PVI) combined with renal denervation(RDN) in patients with atrial fibrillation(AF) and hypertension.Methods: In the Cochrane Library, PubMed, EMBASE, CNKI and Wanfang database, we searched the clinical study of PVI combined with RDN and PVI alone in treating AF with hypertension, which was published until October 2020. The main outcome measures were AF recurrence, the extent of blood pressure drop, the change of left ventricular function(LEVDD, LV mass index), operation time, fluoroscopy time, and the incidence of complications. Data processing were performed using Rev Man 5.3 software. TSA 0.9 software was used for trial sequential analysis(TSA) of the postoperative recurrence rate of AF.Results: A total of 7 studies involved 734 patients were finally included. Compared with PVI alone, RDN+PVI significantly decreased the risk of AF recurrence[OR = 0.41, 95% CI(0.3-0.56), P< 0.01], increased blood pressure drop[ SP: WMD =-10.94, 95% CI(-16.43--5.45), P< 0.01],[ DP: WMD =-5.39, 95%CI(-8.84--1.94), P< 0.01]and improved the left heart function(LEVDD: WMD=-3.96, 95%CI-5.34--2.58, P<0.00001)(LV Mass Index: WMD=-13.35, 95%CI-19.08--7.62), the operative time(WMD=24.96, 95%CI 20.36-29.56, P<0.01) and the fluoroscopic time(WMD=5.59, 95%CI 3.31-7.86, P<0.01) were also prolonged, but there was no significant difference in the incidence of complications(P>0.05). TSA analysis showed that the evidence of Meta analysis was reliable.Conclusion: The combination of PVI and RDN can reduce the recurrence rate of AF, control the blood pressure and improve the left heart function, while does not increase the incidence of related complications.
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