Samuel Francis

Multicenter Evaluation of the YEARS Criteria in Emergency Department Patients Evaluated for Pulmonary Embolism.

BACKGROUNDnIt may be possible to safely rule out pulmonary embolism (PE) in patients with low pretest probability (PTP) using a higher than standard D-dimer threshold. The YEARS criteria, which include three questions from the Wells PE score to identify low-PTP patients and a variable D-dimer threshold, was recently shown to decrease the need for imaging to rule out PE by 14% in a multicenter study in the Netherlands. However, the YEARS approach has not been studied in the United States.nnnMETHODSnThis study was a prospective, observational study of consecutive adult patients evaluated for PE in 17 U.S. emergency departments. Prior to diagnostic testing, we collected the YEARS criteria: Does the patient have clinical signs or symptoms of DVT? Does the patient have hemoptysis? Are alternative diagnoses less likely than PE? with YEARS (+) being any yes response. A negative D-dimer wasxa0<1000 mg/dL for YEARS (-) patients andxa0<500 mg/dL for YEARS (+) patients. We calculated test characteristics and used Fishers exact test to compare proportions of patients who would have been referred for imaging and patients who would have had PE missed.nnnRESULTSnOf 1,789 patients, 84 (4%) had PE, 1,134 (63%) were female, 1,038 (58%) were white, and mean (±SD) age was 48 (±16) years. Using the standard D-dimer threshold, 940 (53%) would not have had imaging, with two (0.2%, 95% confidence interval [CI]xa0= 0.02%-0.60%) missed PE. Using YEARS adjustment, 1,204 (67%, 95% CIxa0= 65%-69%) would not have been referred for imaging, with six (0.5%, 95% CIxa0= 0.18%-1.1%) missed PE, and using alternative diagnoses less likely than PE adjustment, 1,237 (69%, 95% CIxa0= 67%-71%) would not have had imaging with six (0.49%, 95% CIxa0= 0.18%-1.05%) missed PE. Sensitivity was 97.6% (95% CIxa0= 91.7%-99.7%) for the standard threshold and 92.9% (95% CIxa0= 85%-97%) for both adjusted thresholds. Negative predictive value (NPV) was nearly 100% for all approaches.nnnCONCLUSIONSnD-dimer adjustment based on PTP may result in a reduced need for imaging to evaluate possible PE, with some additional missed PE but no decrease in NPV.

International, multicenter evaluation of a new D-dimer assay for the exclusion of venous thromboembolism using standard and age-adjusted cut-offs.

INTRODUCTIONnWe sought to determine the test characteristics of an automated INNOVANCE D-dimer assay for the exclusion of pulmonary embolism (PE) and deep venous thrombosis (DVT) in emergency department (ED) patients using standard and age-adjusted cut-offs.nnnMETHODSnCross-sectional, international, multicenter study of consecutive patients with suspected DVT or PE in 24 centers (18 USA, 6 Europe). Evaluated patients had low or intermediate Wells PE or DVT scores. For the standard cut-off, a D-dimer result <500u202fng/ml was negative. For the age adjusted cut-off, we used the formula: Age (years)u202f∗u202f10. The diagnostic standard was imaging demonstrating PE or DVT within 3u202fmonths. We calculated test characteristics using standard methods. We also explored modifications of the age adjustment multiplier.nnnRESULTSnWe included 3837 patients and excluded 251. The mean age of patients evaluated for PE (nu202f=u202f1834) was 48u202f±u202f16u202fyears, with 676 (37%) male, and 1081 (59%) white. The mean age of evaluated for DVT (nu202f=u202f1752) was 53u202f±u202f16u202fyears, with 710 (41%) male, and 1172 (67%) white. D-dimer test characteristics for PE were: sensitivity 98.0%, specificity 55.4%, negative predictive value (NPV) 99.8%, positive predictive value (PPV) 11.4%, and for DVT were: sensitivity 92.0%, specificity 44.8%, NPV 98.8%, PPV 10.3%. Age adjustment increased specificity (59.6% [PE], 51.1% [DVT]), but increasing the age-adjustment multiplier decreased sensitivity without increasing specificity.nnnCONCLUSIONSnINNOVANCE D-dimer is highly sensitive and can exclude PE and DVT in ED patients with low- and intermediate- pre-test probability. Age-adjustment increases specificity, without increasing false negatives.

D-dimer levels in VTE patients with distal and proximal clots

Objectives: There is growing evidence that venous thromboembolism (VTE) patients with distal clots (distal calf deep vein thrombosis [DVT] and sub‐segmental pulmonary embolism [PE]) may not routinely benefit from anticoagulation. We compared the D‐dimer levels in VTE patients with distal and proximal clots. Methods: We conducted a multinational, prospective observational study of low‐to‐intermediate risk adult patients presenting to the emergency department (ED) with suspected VTE. Patients were classified as distal (calf DVT or sub‐segmental PE) or proximal (proximal DVT or non‐sub‐segmental PE) clot groups and compared with univariate and multivariate analyses. Results: Of 1752 patients with suspected DVT, 1561 (89.1%) had no DVT, 78 (4.4%) had a distal calf DVT, and 113 (6.4%) had a proximal DVT. DVT patients with proximal clots had higher D‐dimer levels (3760 vs. 1670 mg/dL) than with distal clots. Sensitivity and negative predictive value (NPV) for proximal DVT at an optimal D‐dimer cutoff of 5770 mg/dL were 40.7% and 52.1% respectively. Of 1834 patients with suspected PE, 1726 (94.1%) had no PE, 7 (0.4%) had isolated sub‐segmental PE, and 101 (5.5%) had non‐sub‐segmental PE. PE patients with proximal clots had higher D‐dimer levels (4170 vs. 2520 mg/dL) than those with distal clots. Sensitivity and NPV for proximal PE at an optimal D‐dimer cutoff of 3499 mg/dL were 57.4% and 10.4% respectively. Conclusions: VTE patients with proximal clots had higher D‐dimer levels than patients with distal clots. However, D‐dimer levels cannot be used alone to discriminate between VTE patients with distal or proximal clots.

Emergency Department Discharge of Pulmonary Embolus Patients.

Abstract Background Hospitalization for low‐risk pulmonary embolism (PE) is common, expensive, and of questionable benefit. Objective The objective was to determine if low‐risk PE patients discharged from the emergency department (ED) on rivaroxaban require fewer hospital days compared to standard of care (SOC). Methods Multicenter, open‐label randomized trial in low‐risk PE defined by Hestia criteria. Adult subjects were randomized to early ED discharge on rivaroxaban or SOC. Primary outcome was total number of initial hospital hours, plus hours of hospitalization for bleeding or venous thromboembolism (VTE), 30 days after randomization. A 90‐day composite safety endpoint was defined as major bleeding, clinically relevant nonmajor bleeding, and mortality. Results Of 114 randomized subjects, 51 were early discharge and 63 were SOC. Of 112 (98.2%) receiving at least one dose of study drug, 99 (86.8%) completed the study. Initial hospital LOS was 4.8 hours versus 33.6 hours, with a mean difference of –28.8 hours (95% confidence interval [CI] = –42.55 to –15.12 hours) for early discharge versus SOC, respectively. At 90 days, mean total hospital days (for any reason) were less for early discharge than SOC, 19.2 hours versus 43.2 hours, with a mean difference of 26.4 hours (95% CI = –46.97 to –3.34 hours). At 90 days, there were no bleeding events, recurrent VTE, or deaths. The composite safety endpoint was similar in both groups, with a difference in proportions of 0.005 (95% CI = –0.18 to 0.19). Total costs were

Iconography : D-dimer levels in VTE patients with distal and proximal clots

1,496 for early discharge and

12 Highly Elevated Quantitative D-Dimer Assay Values Increase the Likelihood of Venous Thromboembolism

4,234 for SOC, with a median difference of

53 Analyzing the Components of the Wells' Score for Pulmonary Embolus Can Strengthen Unstructured Physician Gestalt

2,496 (95% CI = –

70 Multicenter Trial of Rivaroxaban for Early Discharge of Pulmonary Embolism from the Emergency Department

2,999 to –

54 Physician Gestalt is the Most Predictive Component of the Wells' Deep Venous Thrombosis Score in Diagnosing Subsequent Deep Venous Thrombosis

2,151). Conclusions Low‐risk ED PE patients receiving early discharge on rivaroxaban have similar outcomes to SOC, but fewer total hospital days and lower costs over 30 days.