冷冻球囊或射频消融治疗症状性阵发性或持续性心房颤动的结果。

Outcomes of cryoballoon or radiofrequency ablation in symptomatic paroxysmal or persistent atrial fibrillation.

机构信息

Department of Cardiology and Internal Intensive Care Medicine, Heart Center Munich-Bogenhausen - Munich Municipal Hospital Group, Englschalkinger Str. 77, Munich, Germany.

Department of Medical Biometry and Epidemiology, University Medical Center Eppendorf, Hamburg, Germany.

出版信息

Europace. 2019 Sep 1;21(9):1313-1324. doi: 10.1093/europace/euz155.

AIMS

To evaluate the effectiveness and safety of cryoballoon ablation (CBA) compared with radiofrequency ablation (RFA) for symptomatic paroxysmal or drug-refractory persistent atrial fibrillation (AF).

METHODS AND RESULTS

Prospective cluster cohort study in experienced CBA and RFA centres. Primary endpoint was 'atrial arrhythmia recurrence', secondary endpoints were as follows: procedural results, safety, and clinical course. A total of 4189 patients were included: CBA 2329 (55.6%) and RFA 1860 (44.4%). Cryoballoon ablation population was younger, with fewer comorbidities. Procedure time was longer in the RFA group (P = 0.01). Radiation exposure was 2487 (CBA) and 1792 cGycm2 (RFA) (P < 0.001). Follow-up duration was 441 (CBA) and 511 days (RFA) (P < 0.0001). Primary endpoint occurred in 30.7% (CBA) and 39.4% patients (RFA) [adjusted hazard ratio (adjHR) 0.85, 95% confidence interval (CI) 0.70-1.04; P = 0.12). In paroxysmal AF, CBA resulted in a lower risk of recurrence (adjHR 0.80, 95% CI 0.64-0.99; P = 0.047). In persistent AF, the primary outcome was not different between groups. Major adverse cardiovascular and cerebrovascular event rates were 1.0% (CBA) and 2.8% (RFA) (adjHR 0.53, 95% CI 0.26-1.10; P = 0.088). Re-ablations (adjHR 0.46, 95% CI 0.34-0.61; P < 0.0001) and adverse events during follow-up (adjHR 0.64, 95% CI 0.48-0.88; P = 0.005) were less common after CBA. Higher rehospitalization rates with RFA were caused by re-ablations.

CONCLUSIONS

The primary endpoint did not differ between CBA and RFA. Cryoballoon ablation was completed rapidly; the radiation exposure was greater. Rehospitalization due to re-ablations and adverse events during follow-up were observed significantly less frequently after CBA than after RFA. Subgroup analysis suggested a lower risk of recurrence after CBA in paroxysmal AF.

TRIAL REGISTRATION

ClinicalTrials.gov (NCT01360008), https://clinicaltrials.gov/ct2/show/NCT01360008.

目的

评估冷冻球囊消融（CBA）与射频消融（RFA）治疗症状性阵发性或药物难治性持续性心房颤动（AF）的有效性和安全性。

方法和结果

在经验丰富的 CBA 和 RFA 中心进行前瞻性聚类队列研究。主要终点为“房性心律失常复发”，次要终点为以下几点：手术结果、安全性和临床病程。共纳入 4189 例患者：CBA 组 2329 例（55.6%），RFA 组 1860 例（44.4%）。CBA 组患者更年轻，合并症更少。RFA 组的手术时间更长（P=0.01）。辐射暴露量分别为 2487（CBA）和 1792 cGycm2（RFA）（P<0.001）。随访时间分别为 441（CBA）和 511 天（RFA）（P<0.0001）。主要终点分别在 30.7%（CBA）和 39.4%的患者中发生（RFA）[调整后的危险比（adjHR）为 0.85，95%置信区间（CI）为 0.70-1.04；P=0.12]。在阵发性 AF 中，CBA 导致复发风险降低（adjHR 为 0.80，95%CI 为 0.64-0.99；P=0.047）。在持续性 AF 中，两组之间的主要结局无差异。主要不良心血管和脑血管事件发生率分别为 1.0%（CBA）和 2.8%（RFA）（adjHR 为 0.53，95%CI 为 0.26-1.10；P=0.088）。CBA 后再次消融（adjHR 为 0.46，95%CI 为 0.34-0.61；P<0.0001）和随访期间不良事件（adjHR 为 0.64，95%CI 为 0.48-0.88；P=0.005）的发生率较低。RFA 后较高的再入院率归因于再次消融。