1 Department of Cardiovascular Medicine Mayo Clinic Rochester MN.
J Am Heart Assoc. 2019 Mar 5;8(5):e011474. doi: 10.1161/JAHA.118.011474.
Background Available outcomes data for anticoagulation therapy in adults with congenital heart disease ( CHD ) provide assessment of global risk of this therapy for CHD patients (a heterogeneous population), but the risk of complications for the different CHD diagnoses is unknown. The purpose of the study was to describe the indications for anticoagulation, and the incidence and risk factors for major bleeding complication in adults with tetralogy of Fallot. Methods and Results We queried Mayo Adult Congenital Heart Disease (MACHD) database for tetralogy of Fallot patients (aged ≥18 years) that received anticoagulation, 1990-2017. Of 130 patients (42±14 years, 75 men [58%]), warfarin and direct oral anticoagulants were used in 125 (96%) and 5 (4%), respectively because atrial arrhythmias (n=109), mechanical prosthetic valve (n=29), intracardiac thrombus (n=4), pulmonary embolism (n=6), stroke (n=3), and perioperative anticoagulation (n=44). The median hypertension, abnormal renal or liver function; stroke; bleeding history or predisposition; labile international normalized ratio; elderly (>65 years); drug or alcohol use score for the entire cohort was 1 (0-2) and 27 (21%) had hypertension, abnormal renal or liver function; stroke; bleeding history or predisposition; labile international normalized ratio; elderly (>65 years); drug or alcohol use score ≥2. There were 14 minor bleeding events (1.6% per year) and 11 major bleeding events (1.3% per year) in 8 patients during median follow-up of 74 months (856 patient-years). Mechanical prosthesis (hazard ratio 1.78, CI 1.29-3.77, P=0.021) and hypertension, abnormal renal or liver function; stroke; bleeding history or predisposition; labile international normalized ratio; elderly (>65 years); drug or alcohol use score ≥2 (hazard ratio 1.41, CI 1.03-3.88, P=0.046) were risk factors for major bleeding events. All-cause mortality was higher in patients with major bleeding events (n=6, 75%) compared with patients without major bleeding events (n=25, 21%), P=0.001. Conclusions Considering the heterogeneity of the CHD population, data from the current study may be better suited for clinical decision-making in tetralogy of Fallot patients.
先天性心脏病（CHD）成人抗凝治疗的现有结局数据可评估该治疗方法对 CHD 患者（异质性人群）的总体风险，但不同 CHD 诊断的并发症风险尚不清楚。本研究的目的是描述法洛四联症患者接受抗凝治疗的适应证，以及主要出血并发症的发生率和危险因素。
我们在 1990 年至 2017 年间，从梅奥成人先天性心脏病（MACHD）数据库中查询了接受抗凝治疗的法洛四联症患者（年龄≥18 岁）。130 例患者（42±14 岁，75 例男性[58%]）中，125 例（96%）使用华法林，5 例（4%）使用直接口服抗凝剂，因为存在心房颤动（n=109）、机械性人工心脏瓣膜（n=29）、心内血栓形成（n=4）、肺栓塞（n=6）、卒中（n=3）和围手术期抗凝（n=44）。整个队列的中位数高血压、异常肾功能或肝功能；卒中和抗凝治疗评分分别为 1（0-2）和 27（21%），其中 27 例患者有高血压、异常肾功能或肝功能；卒中和抗凝治疗评分≥2。在中位随访 74 个月（856 患者-年）期间，8 例患者中发生了 14 例轻微出血事件（每年 1.6%）和 11 例大出血事件（每年 1.3%）。机械性假体（危险比 1.78，CI 1.29-3.77，P=0.021）和高血压、异常肾功能或肝功能；卒中和抗凝治疗评分≥2（危险比 1.41，CI 1.03-3.88，P=0.046）是大出血事件的危险因素。与无大出血事件的患者（n=25，21%）相比，发生大出血事件的患者（n=6，75%）的全因死亡率更高，P=0.001。
考虑到 CHD 人群的异质性，本研究的数据可能更适合法洛四联症患者的临床决策。
