俄罗斯伊麦沙金国家医学研究中心Alexander B. Romanov联合美国罗彻斯特大学医学与牙科学院Jonathan S. Steinberg团队在研究中取得进展。他们比较了肾去神经术联合导管消融与单独导管消融术治疗阵发性房颤和高血压患者的疗效。这一研究成果于2020年1月21日发表在国际顶尖学术期刊《美国医学会杂志》上。

肾去神经术可减少心脏交感神经活动，对心房颤动患者有抗心律失常的作用。

为了探讨肾去神经术联合肺静脉隔离术能否提高长期抗心律失常的疗效，研究组在俄罗斯、波兰和德国的5个房颤导管消融术转诊中心进行了一项研究者发起、多中心、单盲、随机对照试验。

2013年4月至2018年3月，研究组共招募了302名高血压患者，他们至少服用1种降压药物，伴有阵发性心房颤动，并计划进行导管消融术。将其随机分组，其中148名行单独肺静脉隔离术，154名行肺静脉隔离联合肾去神经术。

302名患者的中位年龄为60岁，60.3%为男性，共有283名纳入最终分析。单独肺静脉隔离组中有84名患者（56.5%）在12个月内未发作心房颤动、心房扑动或心动过速，显著低于肺静脉隔离+肾去神经术组（111名患者，72.1%）。

单独肺静脉隔离组从基线到12个月的平均收缩压从151mmHg下降到147mmHg，肺静脉隔离+肾去神经术组则从150mmHg下降到135mmHg，组间差异显著。单独肺静脉隔离组有4.7%的患者出现手术并发症，肺静脉隔离+肾去神经术组有4.5%。

总之，在阵发性房颤和高血压患者中，与单纯导管消融术相比，导管消融联合肾去神经术治疗可显著提高12个月无房颤发作的几率。

附：英文原文

Title: Effect of Renal Denervation and Catheter Ablation vs Catheter Ablation Alone on Atrial Fibrillation Recurrence Among Patients With Paroxysmal Atrial Fibrillation and Hypertension: The ERADICATE-AF Randomized Clinical Trial

Author: Jonathan S. Steinberg, Vitaliy Shabanov, Dmitry Ponomarev, Denis Losik, Eduard Ivanickiy, Evgeny Kropotkin, Konstantin Polyakov, Pawel Ptaszynski, Boris Keweloh, Christopher J. Yao, Evgeny A. Pokushalov, Alexander B. Romanov

Issue&Volume: 2020/01/21

Abstract:

Importance  Renal denervation can reduce cardiac sympathetic activity that may result in an antiarrhythmic effect on atrial fibrillation.

Objective  To determine whether renal denervation when added to pulmonary vein isolation enhances long-term antiarrhythmic efficacy.

Design, Setting, and Participants  The Evaluate Renal Denervation in Addition to Catheter Ablation to Eliminate Atrial Fibrillation (ERADICATE-AF) trial was an investigator-initiated, multicenter, single-blind, randomized clinical trial conducted at 5 referral centers for catheter ablation of atrial fibrillation in the Russian Federation, Poland, and Germany. A total of 302 patients with hypertension despite taking at least 1 antihypertensive medication, paroxysmal atrial fibrillation, and plans for ablation were enrolled from April 2013 to March 2018. Follow-up concluded in March 2019.

Interventions  Patients were randomized to either pulmonary vein isolation alone (n = 148) or pulmonary vein isolation plus renal denervation (n = 154). Complete pulmonary vein isolation to v an end point of elimination of all pulmonary vein potentials; renal denervation using an irrigated-tip ablation catheter delivering radiofrequency energy to discrete sites in a spiral pattern from distal to proximal in both renal arteries.

Main Outcomes and Measures  The primary end point was freedom from atrial fibrillation, atrial flutter, or atrial tachycardia at 12 months. Secondary end points included procedural complications within 30 days and blood pressure control at 6 and 12 months.

Results  Of the 302 randomized patients (median age, 60 years [interquartile range, 55-65 years]; 182 men [60.3%]), 283 (93.7%) completed the trial. All successfully underwent their assigned procedures. Freedom from atrial fibrillation, flutter, or tachycardia at 12 months was observed in 84 of 148 (56.5%) of those undergoing pulmonary vein isolation alone and in 111 of 154 (72.1%) of those undergoing pulmonary vein isolation plus renal denervation (hazard ratio, 0.57; 95% CI, 0.38 to 0.85; P = .006). Of 5 prespecified secondary end points, 4 are reported and 3 differed between groups. Mean systolic blood pressure from baseline to 12 months decreased from 151 mm Hg to 147 mm Hg in the isolation-only group and from 150 mm Hg to 135 mm Hg in the renal denervation group (between-group difference, −13 mm Hg; 95% CI, −15 to −11 mm Hg; P < .001). Procedural complications occurred in 7 patients (4.7%) in the isolation-only group and 7 (4.5%) of the renal denervation group.

Conclusions and Relevance  Among patients with paroxysmal atrial fibrillation and hypertension, renal denervation added to catheter ablation, compared with catheter ablation alone, significantly increased the likelihood of freedom from atrial fibrillation at 12 months. The lack of a formal sham-control renal denervation procedure should be considered in interpreting the results of this trial.

DOI: 10.1001/jama.2019.21187

Source: https://jamanetwork.com/journals/jama/article-abstract/2759005