Clinic for Cardiology, Herz- und Diabeteszentrum NRW, Ruhr-Universität Bochum, Georgstraße 11, 32545, Bad Oeynhausen, Germany.
Clin Res Cardiol. 2018 Feb;107(2):182-192. doi: 10.1007/s00392-017-1171-5. Epub 2017 Oct 26.
Catheter ablation is an established treatment option for patients with symptomatic atrial fibrillation (AF). The cornerstone of AF ablation is pulmonary vein isolation (PVI). The second-generation cryoballoon (2G-CB) has shown non-inferiority to radiofrequency (RF) ablation in paroxysmal AF in several trials. Growing evidence suggests that 2G-CB is also effective in patients with persistent AF (perAF). The aim of this study was to summarize and analyze available data on safety and mid-term (≥ 12 months) efficacy of PVI using 2G-CB in patients with perAF.
We did a search in PubMed, Web of Science, Cochrane Library, and clinicaltrials.gov in December 2016 for studies of 2G-CB ablation for perAF. Studies reporting clinical success rates at a follow-up (FU) of ≥ 12 months were included. Success was defined as freedom from any atrial arrhythmia lasting > 30 s after an initial blanking period of 3 months. Acute success and complication rates were also assessed. Data were analyzed applying random-effects model.
A total of 917 patients from 11 studies meeting study inclusion criteria were analyzed. After a mean FU of 16.7 ± 3.0 months, 68.9% were free from recurrences [95% confidence interval (CI) 63.4-74.7%]. Overall acute success rate was 99.7% (95% CI 99.2-100%). Complications occurred in 5.5% (95% CI 2.4-9.6%). Vascular access complications were the most frequent 3.3% (95% CI 1.5-5.6%). The rate of phrenic nerve palsy/injury was 2.09% (95% CI 0.8-3.9%). No death, stroke or myocardial infarction was reported.
The 2G-CB seems to be safe and effective in the treatment of perAF in the mid-term.
导管消融是治疗有症状心房颤动(房颤)患者的一种既定治疗选择。房颤消融的基石是肺静脉隔离(PVI)。第二代冷冻球囊(2G-CB)在几项临床试验中已证明在阵发性房颤中不劣于射频(RF)消融。越来越多的证据表明,2G-CB 对持续性房颤(perAF)患者也有效。本研究的目的是总结和分析目前使用 2G-CB 进行 PVI 治疗 perAF 的安全性和中期(≥12 个月)疗效的可用数据。
我们于 2016 年 12 月在 PubMed、Web of Science、Cochrane Library 和 clinicaltrials.gov 中搜索了 2G-CB 消融治疗 perAF 的研究。包括随访(FU)≥12 个月的临床成功率报告的研究。成功定义为初始空白期为 3 个月后,无任何持续时间>30 秒的房性心律失常。还评估了急性成功率和并发症发生率。数据应用随机效应模型进行分析。
共有 11 项符合研究纳入标准的研究的 917 例患者纳入分析。在平均 FU 16.7±3.0 个月后,68.9%的患者无复发[95%置信区间(CI)63.4-74.7%]。总体急性成功率为 99.7%(95% CI 99.2-100%)。并发症发生率为 5.5%(95% CI 2.4-9.6%)。血管通路并发症最常见,为 3.3%(95% CI 1.5-5.6%)。膈神经麻痹/损伤的发生率为 2.09%(95% CI 0.8-3.9%)。无死亡、卒中和心肌梗死报告。
2G-CB 在中期治疗 perAF 似乎是安全有效的。