冷冻球囊消融治疗心力衰竭伴左心室射血分数降低患者的疗效和安全性：一项多中心研究。
Efficacy and Safety of Cryoballoon Ablation in Patients With Heart Failure and Reduced Left Ventricular Ejection Fraction - A Multicenter Study.
机构信息
Department of Cardiology, Asklepios Klinik St. Georg.
University Heart Center Luebeck, Medical Clinic II (Department of Cardiology, Angiology and Intensive Care Medicine), Sektion Elektropjysiologie, University Hospital Schleswig-Holstein.
出版信息
Circ J. 2019 Jul 25;83(8):1653-1659. doi: 10.1253/circj.CJ-19-0151. Epub 2019 Jun 28.
BACKGROUND
Second-generation cryoballoon (CB2)-based pulmonary vein isolation (PVI) has demonstrated encouraging results in the treatment of atrial fibrillation (AF). This study sought to assess data on the safety, efficacy and clinical success of CB2-based PVI in patients with heart failure (HF) and reduced ejection fraction (HFrEF).
METHODS AND RESULTS
CB2-based PVI was performed in 551 consecutive patients in 3 highly experienced EP centers. Patients with HF and LVEF ≤40% were included (HFrEF group, n=50/551, 9.1%). Data were compared with propensity score-matched patients without HF and preserved left ventricular EF (LVEF) (n=50, control group). The median LVEF was HFrEF: 37% (35, 40) and control: 55% (55, 55), P<0.0001. Major periprocedural complications were registered in 4/50 (8%, HFrEF group) and 3/50 (6%, control group), P=0.695. The 12-month freedom from AF recurrence was 73.1% (95% confidence interval (CI): 61-88, HFrEF group) and 72.6% (95% CI: 61-87, control group), P=0.25. NYHA class decreased from 2.4±0.8 (baseline) to 1.7±0.8 at 12-month follow-up (P<0.0001). LVEF improved from a median of 37% (35, 40) prior to ablation to a median of 55% (40, 55), P<0.0001.
CONCLUSIONS
CB2-based PVI in patients with HFrEF appeared to be safe, was associated with comparable periprocedural complications and showed promising clinical success rates equal to those for patients with preserved LVEF. NYHA class and LVEF significantly improved at 12-month follow-up.
背景
基于第二代冷冻球囊（CB2）的肺静脉隔离（PVI）在治疗心房颤动（AF）方面已取得令人鼓舞的结果。本研究旨在评估 CB2 为基础的 PVI 在射血分数降低的心力衰竭（HFrEF）患者中的安全性、疗效和临床成功率的数据。
方法和结果
在 3 个经验丰富的电生理中心，对 551 例连续患者进行了 CB2 为基础的 PVI。纳入射血分数≤40%的心力衰竭患者（HFrEF 组，n=50/551，9.1%）。数据与无心力衰竭和保留左心室射血分数（LVEF）的倾向评分匹配患者（n=50，对照组）进行比较。HFrEF 组的中位数 LVEF 为 37%（35，40），对照组为 55%（55，55），P<0.0001。在 50 例 HFrEF 患者中有 4 例（8%）和 50 例对照组中有 3 例（6%）发生主要围手术期并发症，P=0.695。12 个月无 AF 复发率为 73.1%（95%可信区间：61-88，HFrEF 组）和 72.6%（95%可信区间：61-87，对照组），P=0.25。NYHA 分级从基线时的 2.4±0.8 降至 12 个月时的 1.7±0.8（P<0.0001）。LVEF 从消融前的中位数 37%（35，40）改善至中位数 55%（40，55），P<0.0001。
结论
在 HFrEF 患者中，基于 CB2 的 PVI 似乎是安全的，与围手术期并发症相当，并显示出与保留 LVEF 的患者相当的有前景的临床成功率。NYHA 分级和 LVEF 在 12 个月随访时显著改善。
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