Michiels J J, Gadisseur A, Van Der Planken M, Schroyens W, De Maeseneer M, Hermsen J T, Trienekens P H, Hoogsteden H, Pattynama P M T
Hemostasis and Thrombosis Research, Department of Hematology, University Hospital of Antwerp, Belgium.
Int Angiol. 2005 Mar;24(1):27-39.
The requirement for a safe diagnostic strategy should be based on an overall posttest incidence of venous thromboembolism of less than 1% during 3 month follow-up. Compression ultrasonography (CUS) has a negative predictive value (NPV) of 97% to 98% indicating the need of repeated CUS testing. Serial CUS testing is safe but you have to repeat 100 CUS to find 1 or 2 CUS positive for deep vein thrombosis (DVT), which is not cost-effective indicating the need to improve the diagnostic work-up of DVT by the use of clinical score assessment and D-dimer testing. The combination of a less sensitive D-dimer test (SimpliRed) and low clinical score does not, whereas the combination of a sensitive D-dimer test (ELISA VIDAS or Tinaquant) and low clinical score does safely exclude DVT without the need of CUS. The combination of a first negative CUS and a negative less sensitive D-dimer test (SimpliRed) or a sensitive ELISA D-dimer at a higher cut off level of 1,000 ng/ml safely excludes DVT with a NPV of > 99% without the need to repeated CUS in about 60%. The sequential use of a sensitive D-dimer and clinical score assessment will safely reduce the need for CUS testing by 40% to 60%. Large prospective outcome studies demonstrate that one negative examination with complete duplex color ultrasonography (CCUS) of the proximal and distal veins of the affected leg with suspected DVT is safe to withhold anticoagulant treatment with a NPV of 99.5%. This indicates that CCUS is equal or superior to serial CUS or the combined use of clinical score, D-dimer testing and CUS. Pulmonary angiography is the gold standard for segmental pulmonary embolism (PE) but not for subsegmental PE. A normal perfusion lung scan and a normal rapid ELISA VIDAS D-dimer test safely exclude PE. Helical spiral CT detects all clinically relevant PE and a large number of alternative diagnoses in symptomatic patients with a non-diagnostic ventilation perfusion scan (VP-scan) or a high probability VP-scan. Single-slice helical CT as the primary diagnostic test in patients with suspected PE in 5 retrospective studies and in 3 prospective management studies indicate that the NPV of a normal helical spiral CT, a negative CUS of the legs together with a low or intermediate pretest clinical probability is 99%. Helical spiral CT can replace both the VP-scan and pulmonary angiography to safely rule in and out PE. The combination of clinical assessment, a rapid ELISA VIDAS D-dimer followed by CUS will reduce the need for helical spiral CT by 40% to 50%.
安全诊断策略的要求应以3个月随访期间静脉血栓栓塞的总体检测后发病率低于1%为基础。加压超声检查（CUS）的阴性预测值（NPV）为97%至98%，这表明需要重复进行CUS检测。连续CUS检测是安全的，但必须重复100次CUS检测才能发现1或2次CUS检测结果为深静脉血栓形成（DVT）阳性，这并不具有成本效益，表明需要通过临床评分评估和D-二聚体检测来改进DVT的诊断检查。敏感性较低的D-二聚体检测（SimpliRed）与低临床评分相结合不能安全排除DVT，而敏感性较高的D-二聚体检测（ELISA VIDAS或Tinaquant）与低临床评分相结合则可以安全地排除DVT，而无需进行CUS检测。首次CUS检测结果为阴性，再加上敏感性较低的D-二聚体检测（SimpliRed）结果为阴性，或者在较高临界值1000 ng/ml时ELISA D-二聚体检测结果为阴性，可安全排除DVT，NPV>99%，约60%的患者无需重复进行CUS检测。序贯使用敏感性较高的D-二聚体检测和临床评分评估可安全地将CUS检测需求减少40%至60%。大型前瞻性结果研究表明，对疑似DVT的患侧腿部近端和远端静脉进行一次完整的双功彩色超声检查（CCUS）结果为阴性，可安全地停止抗凝治疗，NPV为99.5%。这表明CCUS等同于或优于连续CUS检测，或临床评分、D-二聚体检测和CUS检测的联合使用。肺血管造影是节段性肺栓塞（PE）的金标准，但不是亚段性PE的金标准。正常的灌注肺扫描和正常的快速ELISA VIDAS D-二聚体检测可安全排除PE。螺旋CT可检测出所有具有临床意义的PE以及大量有症状患者中具有非诊断性通气灌注扫描（VP扫描）或高概率VP扫描的其他诊断。在5项回顾性研究和3项前瞻性管理研究中，将单层螺旋CT作为疑似PE患者的主要诊断检测方法，结果表明正常螺旋CT、腿部CUS检测结果为阴性以及检测前临床概率低或中等时的NPV为99%。螺旋CT可替代VP扫描和肺血管造影，安全地排除和确诊PE。临床评估、快速ELISA VIDAS D-二聚体检测随后进行CUS检测的联合应用将使螺旋CT的需求减少40%至50%。
