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冷冻球囊消融治疗心房颤动患者安全有效
作者:小柯机器人 发布时间:2020/11/19 11:11:16

美国克利夫兰医学中心Oussama M. Wazni团队研究了冷冻球囊消融治疗心房颤动的效果。2020年11月16日,该研究发表在《新英格兰医学杂志》上。

在对药物无反应的症状性阵发性房颤患者中,导管消融术与抗心律失常药物治疗相比,更能维持窦性心律。但冷冻球囊消融作为初始一线治疗的安全性和有效性尚未明确。

研究组进行了一项多中心试验,招募了203例患有阵发性房颤的18至80岁的患者,他们以前均未接受过节律控制疗法。将其按1:1随机分组,其中99位接受抗心律失常药物(I或III类药物)治疗,104位接受冷冻球囊隔离肺静脉治疗。在12个月内定期对两组患者进行心律失常监测。主要疗效终点为治疗成功率。

消融组患者中手术的最初成功率达到了97%。Kaplan–Meier评估消融组在12个月时得到成功治疗的患者占74.6%,显著高于药物治疗组(45.0%)。消融组发生了两个重大安全性终点事件,估计发生率为1.9%。

研究结果表明,冷冻球囊消融初始治疗阵发性房颤患者,优于预防房性心律失常复发的药物治疗,且严重不良事件很少见。

附:英文原文

Title: Cryoballoon Ablation as Initial Therapy for Atrial Fibrillation

Author: Oussama M. Wazni, M.D.,, Gopi Dandamudi, M.D.,, Nitesh Sood, M.D.,, Robert Hoyt, M.D.,, Jaret Tyler, M.D.,, Sarfraz Durrani, M.D.,, Mark Niebauer, M.D.,, Kevin Makati, M.D.,, Blair Halperin, M.D.,, Andre Gauri, M.D.,, Gustavo Morales, M.D.,, Mingyuan Shao, Ph.D.,, Jeffrey Cerkvenik, M.S.,, Rachelle E. Kaplon, Ph.D.,, and Steven E. Nissen, M.D.

Issue&Volume: 2020-11-16

Abstract:

Background

In patients with symptomatic paroxysmal atrial fibrillation that has not responded to medication, catheter ablation is more effective than antiarrhythmic drug therapy for maintaining sinus rhythm. However, the safety and efficacy of cryoballoon ablation as initial first-line therapy have not been established.

Methods

We performed a multicenter trial in which patients 18 to 80 years of age who had paroxysmal atrial fibrillation for which they had not previously received rhythm-control therapy were randomly assigned (1:1) to receive treatment with antiarrhythmic drugs (class I or III agents) or pulmonary vein isolation with a cryoballoon. Arrhythmia monitoring included 12-lead electrocardiography conducted at baseline and at 1, 3, 6, and 12 months; patient-activated telephone monitoring conducted weekly and when symptoms were present during months 3 through 12; and 24-hour ambulatory monitoring conducted at 6 and 12 months. The primary efficacy end point was treatment success (defined as freedom from initial failure of the procedure or atrial arrhythmia recurrence after a 90-day blanking period to allow recovery from the procedure or drug dose adjustment, evaluated in a Kaplan–Meier analysis). The primary safety end point was assessed in the ablation group only and was a composite of several procedure-related and cryoballoon system–related serious adverse events.

Results

Of the 203 participants who underwent randomization and received treatment, 104 underwent ablation, and 99 initially received drug therapy. In the ablation group, initial success of the procedure was achieved in 97% of patients. The Kaplan–Meier estimate of the percentage of patients with treatment success at 12 months was 74.6% (95% confidence interval [CI], 65.0 to 82.0) in the ablation group and 45.0% (95% CI, 34.6 to 54.7) in the drug-therapy group (P<0.001 by log-rank test). Two primary safety end-point events occurred in the ablation group (Kaplan–Meier estimate of the percentage of patients with an event within 12 months, 1.9%; 95% CI, 0.5 to 7.5).

Conclusions

Cryoballoon ablation as initial therapy was superior to drug therapy for the prevention of atrial arrhythmia recurrence in patients with paroxysmal atrial fibrillation. Serious procedure-related adverse events were uncommon.

DOI: 10.1056/NEJMoa2029554

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2029554

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于美国麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home