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既往颅内或胃肠道出血患者行左心耳封堵术的临床结局:来自 LOGIC(胃肠道或颅内出血患者左心耳封堵术)国际多中心注册研究的结果。

Clinical outcomes of left atrial appendage occlusion in patients with previous intracranial or gastrointestinal bleeding: Insights from the LOGIC (Left atrial appendage Occlusion in patients with Gastrointestinal or IntraCranial bleeding) International Multicenter Registry.

机构信息

Department of Cardiology, Ospedale dell'Angelo, Venezia, Italy.

Texas Cardiac Arrhythmia Institute, St. David's Medical Center, Austin, Texas, USA.

出版信息

Catheter Cardiovasc Interv. 2023 May;101(6):1144-1153. doi: 10.1002/ccd.30629. Epub 2023 Mar 15.

Abstract

AIMS

To compare outcomes of patients who underwent left atrial appendage occlusion (LAAO) for nonvalvular atrial fibrillation (NVAF) and contraindication to anticoagulants due to history of either gastrointestinal (GI) or intracranial (IC) bleeding.

METHODS

Patients with NVAF that underwent LAAO for GI or IC bleeding from seven centers were included in this observational study. Baseline characteristics, procedural features, and follow-up data were collected, and compared between the two groups. The primary outcomes were incidence of ischemic and hemorrhagic events at 12-month.

RESULTS

Six hundred twenty-eight patients were included, 57% with previous GI-bleeding, and 43% with previous IC-bleeding. Median CHA 2 DS 2-VASc score was 4 (interquartile range [IQRs]: 3-5) for both GI-bleeding and IC-bleeding patients, while GI-bleeding patients had a higher HAS-BLED score (4 [IQRs: 3-4] vs. 3 [IQRs]: 2-3]; p = 0.001). At 12-month follow-up, relative risk reduction for stroke was similar between the two groups. The GI-bleeding group had more hemorrhagic events compared to IC-bleeding group (any bleeding 8.4% vs. 3.2%; p = 0.012; major bleeding BARC 3-5: 4.3% vs. 1.8; p = 0.010). At multivariate analysis history of GI bleeding was an independent predictor of hemorrhagic events (adjusted HR: 2.39, 95% confidence interval: 1.02-5.63; p = 0.047).

CONCLUSIONS

Outcomes after LAAO may be affected by the different indications for the procedure. In our study, GI-bleeding and IC-bleeding as indication to LAAO differ in their baseline characteristics. LAAO confirms its efficacy in ischemic risk reduction in both groups, while GI bleeding seems to be an independent predictor of bleeding recurrence at 12 months behind the antithrombotic regimen.

摘要

目的

比较因胃肠道(GI)或颅内(IC)出血史而存在抗凝禁忌证并接受左心耳封堵术(LAAO)治疗非瓣膜性心房颤动(NVAF)的患者的结局。

方法

本观察性研究纳入了来自 7 个中心的因 GI 或 IC 出血而接受 LAAO 治疗的 NVAF 患者。收集了基线特征、手术特征和随访数据,并对两组数据进行了比较。主要结局为 12 个月时缺血性和出血性事件的发生率。

结果

共纳入 628 例患者,57%的患者有既往 GI 出血史,43%的患者有既往 IC 出血史。GI 出血和 IC 出血患者的 CHA 2 DS 2 -VASc 评分中位数均为 4(四分位距[IQR]:3-5),而 GI 出血患者的 HAS-BLED 评分更高(4 [IQR:3-4] vs. 3 [IQR:2-3];p = 0.001)。在 12 个月的随访中,两组的卒中相对风险降低相似。与 IC 出血组相比,GI 出血组的出血事件更多(任何出血 8.4% vs. 3.2%;p = 0.012;BARC 3-5 大出血:4.3% vs. 1.8%;p = 0.010)。多变量分析显示,GI 出血史是出血事件的独立预测因素(调整后的 HR:2.39,95%置信区间:1.02-5.63;p = 0.047)。

结论

LAAO 后的结局可能受到手术适应证的影响。在我们的研究中,因 GI 出血和 IC 出血而接受 LAAO 的适应证在基线特征上存在差异。LAAO 证实了其在两组患者中降低缺血风险的疗效,而 GI 出血似乎是抗血栓治疗方案后 12 个月内出血复发的独立预测因素。

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