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超声和 D-二聚体联合诊断急性主动脉综合征:PROFUNDUS 研究。

Diagnosis of acute aortic syndromes with ultrasound and d-dimer: the PROFUNDUS study.

机构信息

Department of Medical Sciences, Università degli Studi di Torino, Torino Italy; Department of Emergency Medicine, Ospedale Molinette, A.O.U. Città della Salute e della Scienza, Torino, Italy.

Department of Medical Sciences, Università degli Studi di Torino, Torino Italy.

出版信息

Eur J Intern Med. 2024 Oct;128:94-103. doi: 10.1016/j.ejim.2024.05.029. Epub 2024 Jun 12.

Abstract

BACKGROUND

In patients complaining common symptoms such as chest/abdominal/back pain or syncope, acute aortic syndromes (AAS) are rare underlying causes. AAS diagnosis requires urgent advanced aortic imaging (AAI), mostly computed tomography angiography. However, patient selection for AAI poses conflicting risks of misdiagnosis and overtesting.

OBJECTIVES

We assessed the safety and efficiency of a diagnostic protocol integrating clinical data with point-of-care ultrasound (POCUS) and d-dimer (single/age-adjusted cutoff), to select patients for AAI.

METHODS

This prospective study involved 12 Emergency Departments from 5 countries. POCUS findings were integrated with a guideline-compliant clinical score, to define the integrated pre-test probability (iPTP) of AAS. If iPTP was high, urgent AAI was requested. If iPTP was low and d-dimer was negative, AAS was ruled out. Patients were followed for 30 days, to adjudicate outcomes.

RESULTS

Within 1979 enrolled patients, 176 (9 %) had an AAS. POCUS led to net reclassification improvement of 20 % (24 %/-4 % for events/non-events, P < 0.001) over clinical score alone. Median time to AAS diagnosis was 60 min if POCUS was positive vs 118 if negative (P = 0.042). Within 941 patients satisfying rule-out criteria, the 30-day incidence of AAS was 0 % (95 % CI, 0-0.41 %); without POCUS, 2 AAS were potentially missed. Protocol rule-out efficiency was 48 % (95 % CI, 46-50 %) and AAI was averted in 41 % of patients. Using age-adjusted d-dimer, rule-out efficiency was 54 % (difference 6 %, 95 % CI, 4-9 %, vs standard cutoff).

CONCLUSIONS

The integrated algorithm allowed rapid triage of high-probability patients, while providing safe and efficient rule-out of AAS. Age-adjusted d-dimer maximized efficiency.

CLINICAL TRIAL REGISTRATION

Clinicaltrials.gov, NCT04430400.

摘要

背景

在出现胸痛/腹痛/背痛或晕厥等常见症状的患者中,急性主动脉综合征(AAS)是罕见的潜在病因。AAS 的诊断需要紧急进行高级主动脉成像(AAI),主要是计算机断层血管造影。然而,AAI 的患者选择存在误诊和过度检查的冲突风险。

目的

我们评估了将临床数据与即时护理超声(POCUS)和 D-二聚体(单值/年龄校正截断值)相结合的诊断方案用于选择进行 AAI 的患者的安全性和效率。

方法

这项前瞻性研究涉及来自 5 个国家的 12 个急诊部门。将 POCUS 结果与符合指南的临床评分相结合,以确定 AAS 的综合预测试概率(iPTP)。如果 iPTP 较高,则需要紧急 AAI。如果 iPTP 较低且 D-二聚体为阴性,则排除 AAS。对患者进行 30 天随访以判定结局。

结果

在纳入的 1979 例患者中,有 176 例(9%)患有 AAS。与仅使用临床评分相比,POCUS 导致净重新分类改善 20%(事件/非事件为 24%/-4%,P<0.001)。如果 POCUS 阳性,AAS 的诊断中位时间为 60 分钟,而如果 POCUS 阴性则为 118 分钟(P=0.042)。在满足排除标准的 941 例患者中,30 天内 AAS 的发生率为 0%(95%CI,0-0.41%);如果不使用 POCUS,则可能会漏诊 2 例 AAS。方案排除效率为 48%(95%CI,46-50%),41%的患者避免了 AAI。使用年龄校正的 D-二聚体,排除效率为 54%(差异 6%,95%CI,4-9%,与标准截断值相比)。

结论

综合算法允许快速对高概率患者进行分诊,同时安全有效地排除 AAS。年龄校正的 D-二聚体最大限度地提高了效率。

临床试验注册

Clinicaltrials.gov,NCT04430400。

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