D-dimer in patients with clinically suspected pulmonary embolism.

STUDY OBJECTIVE: To determine whether measurement of D-dimer, using an enzyme-linked immunosorbent assay (ELISA) with a cutoff of 300 ng/ml, and a latex agglutination assay with a cutoff of 500 ng/ml, is clinically useful in patients with suspected pulmonary embolism (PE). DESIGN: Prospective cohort. SETTING: Tertiary care referral center, university-affiliated hospital. PATIENTS: Two hundred twenty-one consecutive patients with clinically suspected PE. INTERVENTION: All patients had blood drawn to measure levels of D-dimer and underwent ventilation/perfusion (V/Q) lung scanning and bilateral impedance plethysmography (IPG); pulmonary angiography was performed in nine patients. Patients were classified as follows: (1) PE-positive; positive pulmonary angiography or high probability V/Q scan or non-high-probability V/Q scan and either abnormal IPG (either at presentation or on serial testing and confirmed by contrast venography) or symptomatic thromboembolic event within 3 months of presentation; or (2) PE-negative; normal V/Q scan or normal pulmonary angiography or non-high-probability V/Q scan and either normal serial IPG or abnormal IPG with normal venography and absence of symptomatic venous thromboembolism within 3 months of followup. Forty-three patients were classified as PE positive and 178 patients were classified as PE negative. MEASUREMENTS AND RESULTS: The sensitivities, specificities, positive predictive values, and negative predictive values of the ELISA and latex agglutination assay were calculated for all patients and for the subgroup of patients with non-high-probability V/Q scans. The ELISA D-dimer, using a cutoff of 300 ng/ml, showed a sensitivity and negative predictive value of 100 percent in all patients and patients with non-high-probability V/Q scans, but the corresponding specificities were only 26 percent and 13 percent, respectively. The latex agglutination assay for D-dimer using a cutoff of 500 ng/ml showed the following: sensitivities of 84 percent in all patients and 90 percent in patients with non-high-probability scans, negative predictive values of 93 percent in all patients, and 98 percent in patients with non-high-probability scans and specificities of 56 percent in all patients and 55 percent in patients with non-high-probability scans. CONCLUSIONS: This study demonstrates that an ELISA D-dimer result of less than 300 ng/ml excludes PE but occurs in a small proportion of patients with clinically suspected PE. The latex agglutination assay, using a cutoff of 500 ng/ml, has potential clinical utility in excluding PE in the subgroup of patients with clinically suspected PE and non-high-probability V/Q scans. However, the 95 percent confidence interval on the observed sensitivity of the latex agglutination assay in patients with non-high-probability V/Q scans is wide. Therefore, these promising results should be confirmed in a large clinical trial before the latex agglutination assay is used to make management decisions.

Venous thrombosis in patients who have undergone major hip or knee surgery: detection with compression US and impedance plethysmography.

To compare the sensitivity, specificity, and predictive values of compression ultrasonography (US) in postoperative orthopedic patients with those of (a) impedance plethysmography in postoperative patients and (b) compression US in symptomatic outpatients, the authors performed an investigator-blinded cohort study. One hundred thirty-four consecutive inpatients who had undergone elective knee-replacement surgery or surgery for a fractured hip and 65 consecutive outpatients with clinically suspected venous thrombosis who had undergone venography were evaluated. Compression US allowed detection of 11 of 21 (52.4%) proximal-vein thrombi but was insensitive to calf-vein thrombi in the orthopedic patients. Compression US had a significantly greater specificity and positive predictive value than impedance plethysmography for all thrombi in orthopedic patients; compression US also had greater sensitivity. The sensitivity of compression US for proximal-vein thrombi was significantly higher (92.1%) in symptomatic outpatients than in orthopedic patients. The authors conclude that compression US has significant advantages over impedance plethysmography in the detection of proximal-vein thrombi in patients who have undergone hip- or knee-replacement surgery.