Background The current diagnostic delay of chronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary embolism (PE) is unacceptably long, causing loss of quality-adjusted life years and excess mortality. Validated screening strategies for early CTEPH diagnosis are lacking. Echocardiographic screening among all PE survivors is associated with overdiagnosis and cost-ineffectiveness. We aimed to validate a simple screening strategy for excluding CTEPH early after acute PE, limiting the number of performed echocardiograms. Methods In this prospective, international, multicentre management study, consecutive patients were managed according to a screening algorithm starting 3 months after acute PE to determine whether echocardiographic evaluation of pulmonary hypertension (PH) was indicated. If the ‘CTEPH prediction score’ indicated high pretest probability or matching symptoms were present, the ‘CTEPH rule-out criteria’ were applied, consisting of ECG reading and N-terminalpro-brain natriuretic peptide. Only if these results could not rule out possible PH, the patients were referred for echocardiography. Results 424 patients were included. Based on the algorithm, CTEPH was considered absent in 343 (81%) patients, leaving 81 patients (19%) referred for echocardiography. During 2-year follow-up, one patient in whom echocardiography was deemed unnecessary by the algorithm was diagnosed with CTEPH, reflecting an algorithm failure rate of 0.29% (95% CI 0% to 1.6%). Overall CTEPH incidence was 3.1% (13/424), of whom 10 patients were diagnosed within 4 months after the PE presentation. Conclusions The InShape II algorithm accurately excluded CTEPH, without the need for echocardiography in the overall majority of patients. CTEPH was identified early after acute PE, resulting in a substantially shorter diagnostic delay than in current practice. Data are available upon reasonable request.

中文翻译：

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急性肺栓塞后慢性血栓栓塞性肺动脉高压的无创早期排除：InShape II 研究

背景 目前，肺栓塞 (PE) 后慢性血栓栓塞性肺动脉高压 (CTEPH) 的诊断延迟时间长得令人无法接受，这会导致质量调整生命年的损失和死亡率过高。缺乏用于早期 CTEPH 诊断的经过验证的筛查策略。所有 PE 幸存者的超声心动图筛查与过度诊断和成本无效有关。我们旨在验证一种简单的筛查策略，用于在急性 PE 后早期排除 CTEPH，从而限制执行超声心动图的数量。方法 在这项前瞻性、国际性、多中心管理研究中，连续患者在急性 PE 后 3 个月开始根据筛查算法进行管理，以确定是否需要对肺动脉高压 (PH) 进行超声心动图评估。如果“CTEPH 预测评分”表明存在高预测概率或存在匹配症状，则应用“CTEPH 排除标准”，包括心电图读数和 N 端脑利钠肽前体。只有当这些结果不能排除可能的 PH 时，才会将患者转诊进行超声心动图检查。结果共纳入424例患者。根据该算法，343 名 (81%) 患者认为 CTEPH 不存在，剩下 81 名患者 (19%) 转诊进行超声心动图检查。在 2 年的随访中，一名患者的超声心动图被算法认为是不必要的，被诊断为 CTEPH，反映算法失败率为 0.29%（95% CI 0% 至 1.6%）。总体 CTEPH 发生率为 3.1% (13/424)，其中 10 名患者在 PE 出现后 4 个月内被诊断出。结论 InShape II 算法准确排除了 CTEPH，而不需要对大多数患者进行超声心动图检查。CTEPH 是在急性 PE 后早期发现的，与目前的实践相比，诊断延迟时间大大缩短。可根据合理要求提供数据。