External validation of the YEARS diagnostic algorithm for suspected pulmonary embolism

Background Validated diagnostic algorithms are used to manage patients with suspected pulmonary embolism (PE). The recently published YEARS study proposed a simplified diagnostic strategy to reduce the use of computed tomography pulmonary angiography. Objectives To externally validate this strategy in an independent cohort. Methods We analyzed data from three previous prospective cohort studies of outpatients with suspected PE. We retrospectively applied the YEARS algorithm. The three YEARS clinical criteria are: clinical signs of deep vein thrombosis, hemoptysis, and PE as the most likely diagnosis. If zero YEARS criteria are met, a D-dimer < 1000 ng/mL will rule out PE. If >= 1 YEARS criteria are met, a D-dimer < 500 ng/mL will rule out PE. Results Of the 3314 patients, 731 (22.1%) had PE. Applying the YEARS diagnostic algorithm, 1423 (42.9%) patients could have had PE ruled out without imaging. Of these patients, 17 (1.2%; 95% confidence interval 0.8-1.9) were diagnosed with PE at initial testing. All 17 had no YEARS item and a D-dimer < 1000 ng/mL. All 17 had a D-dimer level above their age-adjusted cutoff. Among the 272 patients with no YEARS criteria and a D-dimer < 1000 ng/mL but above their age-adjusted D-dimer cutoff, PE was diagnosed in 6.3% (17/272; 95% confidence interval 3.9-9.8). Conclusion We provide external validation of the YEARS diagnostic algorithm in an independent cohort. The rule appears to safely exclude PE. However, caution is required in patients with no YEARS item and a D-dimer < 1000 ng/mL but above their age-adjusted D-dimer cutoff.