Anticoagulation in patients with mechanical heart valves (MHV) is associated with a risk of major bleeding episodes (MBE). In case of MBE, anticoagulant interruption is advocated. However, there is lack of data regarding the thrombo-embolic events (TE) risk associated with anticoagulant interruption. The main objective of the study was to evaluate the rate and risk factors of 6-months of TEs in patients with MHV experiencing MBE. This observational study was conducted over a 13-year period. Adult patients with a MHV presenting with a MBE were included. The main study endpoint was 6-month TEs, defined by clinical TEs or an echocardiographic documented thrombosis, occurring during an ICU stay or within 6-months. Thromboembolic events were recorded at ICU discharge, and 6 months after discharge. Seventy-nine MBEs were analysed, the rate of TEs at 6-months was 19% CI [11-29%]. The only difference of presentation and management between 6-month TEs and free-TE patients was the time without effective anticoagulation (TWA). The Receiver Operator Characteristic curve identified the value of 122 h of TWA as a cut-off. The multivariate analysis identified early bleeding recurrences (OR 3.62, 95% CI [1.07–12.25], p = 0.039), and TWA longer than 122 h (OR 4.24, 95% CI [1.24–14.5], p = 0.021), as independent risk factors for 6-month TEs. A higher rate of TE was associated with anticoagulation interruption longer than 5 days and early bleeding recurrences. However, the management should still be personalized and discussed for each case given the heterogeneity of causes of MBE and possibilities of haemostatic procedures.

机械心脏瓣膜（MHV）患者的抗凝治疗与大出血事件（MBE）的风险相关。对于MBE，建议中断抗凝治疗。然而，缺乏与抗凝中断相关的血栓栓塞事件（TE）风险的数据。该研究的主要目的是评估经历 MBE 的 MHV 患者 6 个月 TE 的发生率和危险因素。这项观察性研究持续了 13 年。患有 MHV 并出现 MBE 的成年患者也被纳入其中。主要研究终点是 6 个月的 TE，由临床 TE 或超声心动图记录的血栓形成定义，发生在 ICU 住院期间或 6 个月内。出院时以及出院后 6 个月记录血栓栓塞事件。分析了 79 个 MBE，6 个月时的 TE 率为 19% CI [11-29%]。 6 个月 TE 患者和未接受 TE 患者的表现和管理的唯一区别是未接受有效抗凝治疗 (TWA) 的时间。接收者操作员特征曲线将 122 小时 TWA 的值确定为截止值。多变量分析确定了早期出血复发（OR 3.62，95% CI [1.07–12.25]，p  = 0.039），以及 TWA 超过 122 小时（OR 4.24，95% CI [1.24–14.5]，p  = 0.021），如6 个月 TE 的独立风险因素。较高的 TE 发生率与抗凝中断超过 5 天和早期出血复发有关。然而，考虑到MBE原因的异质性和止血程序的可能性，治疗仍应个性化并针对每个病例​​进行讨论。