First Department of Medicine, University Medical Centre Mannheim (UMM), Faculty of Medicine Mannheim, University of Heidelberg, European Center for AngioScience (ECAS), and DZHK (German Center for Cardiovascular Research) Partner Site Heidelberg/Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Department of Cardiology, Angiology, and Pneumology, Second Medical Clinic, Coburg Hospital, Coburg, Germany.
Clin Res Cardiol. 2021 Jan;110(1):12-20. doi: 10.1007/s00392-020-01638-5. Epub 2020 Apr 15.
Chronic kidney disease (CKD) is associated with an increased complication rate after cardiac interventions. Although CKD has a high prevalence among atrial fibrillation patients, the impact of CKD on periprocedural complications and the outcome after an interventional left atrial appendage closure (LAAC) is unclear. The present study, therefore, aimed to investigate whether CKD influences the procedure's effectiveness and safety.
LAARGE is a prospective, non-randomised registry. LAAC was conducted with different standard commercial devices, and the follow-up period was one year. CKD was defined by an eGFR < 60 mL/min/1.73 m, and subgroups were further analysed (i.e. eGFR < 15, 15-29, and 30-59 mL/min/1.73 m, respectively).
Two hundred ninety-nine of 623 patients (48.0%) revealed a CKD. The prevalence of cardiovascular comorbidity, CHADS-VASc score (4.9 vs. 4.2), and HAS-BLED score (4.3 vs. 3.5) was significantly higher in CKD patients (each p < 0.001). Implantation success was similarly high across all GFR groups (97.9%). Periprocedural MACCE (0.7 vs. 0.3%), and other major complications (4.7 vs. 3.7%) were comparably infrequent. Survival free of stroke was significantly lower among CKD patients within 1 year (82.0 vs. 93.0%; p < 0.001; consistent after adjustment for confounding factors), without significant accentuation in advanced CKD (i.e. eGFR < 30 mL/min/1.73 m; p > 0.05 vs. eGFR 30-59 mL/min/1.73 m). Non-fatal strokes were absolutely infrequent during follow-up (0 vs. 1.1%). Severe non-fatal bleedings were observed only among CKD patients (1.4 vs. 0%; p = 0.021).
Despite an increased cardiovascular risk profile of CKD patients, device implantation was safe, and LAAC was associated with effective stroke prevention across all CKD stages.
慢性肾脏病（CKD）与心脏介入治疗后的并发症发生率增加有关。尽管心房颤动患者中 CKD 的患病率很高，但 CKD 对围手术期并发症的影响以及介入性左心耳封堵（LAAC）后的结果尚不清楚。因此，本研究旨在探讨 CKD 是否会影响该手术的有效性和安全性。
LAARGE 是一项前瞻性、非随机登记研究。使用不同的标准商业设备进行 LAAC，随访期为一年。CKD 定义为 eGFR<60 mL/min/1.73 m，进一步分析了亚组（即 eGFR<15、15-29 和 30-59 mL/min/1.73 m）。
在 623 名患者中，有 299 名（48.0%）患有 CKD。CKD 患者的心血管合并症患病率、CHADS-VASc 评分（4.9 比 4.2）和 HAS-BLED 评分（4.3 比 3.5）显著更高（均 p<0.001）。所有 GFR 组的植入成功率均相似（97.9%）。围手术期 MACCE（0.7%比 0.3%）和其他主要并发症（4.7%比 3.7%）同样罕见。CKD 患者在 1 年内无卒中生存率显著较低（82.0%比 93.0%；p<0.001；在调整混杂因素后一致），但在晚期 CKD 中无明显加重（即 eGFR<30 mL/min/1.73 m；p>0.05 比 eGFR 30-59 mL/min/1.73 m）。随访期间无致命性卒中发生（0 比 1.1%）。仅在 CKD 患者中观察到严重非致命性出血（1.4%比 0%；p=0.021）。
尽管 CKD 患者的心血管风险状况增加，但器械植入是安全的，LAAC 与所有 CKD 阶段的有效卒中预防相关。
