Management of Low-risk Pulmonary Embolism (LoPE) Patients without Hospitalization: The LoPE Prospective Management Study.
Chest. 2018 Feb 01;:
Authors: Bledsoe J, Woller S, Stevens S, Aston V, Patten R, Allen T, Horne B, Dong L, Lloyd J, Snow G, Madsen T, Elliott G
BACKGROUND: The efficacy and safety of managing patients with low-risk pulmonary embolism (PE) without hospitalization requires objective data from US medical centers. We sought to determine the 90-day composite rate of recurrent symptomatic venous thromboembolism (VTE), major bleeding events, and all-cause mortality among consecutive patients diagnosed with acute low-risk PE managed without inpatient hospitalization; and to measure patient satisfaction.
METHODS: We performed a prospective cohort single-arm management study conducted from January 2013 to October 2016 in five emergency departments. We enrolled 200 consecutive adults diagnosed with objectively confirmed acute PE and assessed to have a low risk for mortality using the Pulmonary Embolism Severity Index Score (PESI <86), echocardiography and whole leg compression ultrasound (CUS). The primary intervention was observation in the Emergency Department (ED) or the hospital (observation status) for >12 to <24 hours, followed by outpatient management with FDA approved therapeutic anticoagulation. Patients were excluded for PESI >86, echocardiographic signs of right heart strain, deep vein thrombosis (DVT) proximal to the popliteal vein, hypoxia, hypotension, hepatic or renal failure, contraindication to therapeutic anticoagulation or another condition requiring hospital admission. The primary outcome was 90-day composite rate of all-cause mortality, recurrent symptomatic VTE, and major bleeding.
RESULTS: The composite outcome occurred in 1 of 200 patients (90-day composite rate=0.5% 95% CI 0.02-2.36%). No patient suffered recurrent VTE or died during the 90-day follow-up period. A major bleed occurred in one patient. Patients indicated a high level of satisfaction with their care.
CONCLUSIONS: Treatment of carefully selected patients with acute PE and low-risk by PESI <86, echocardiography and CUS without inpatient hospitalization is safe and acceptable to patients. Results must be viewed with caution due to the small sample size relative to the endpoint and the generalizability surrounding availability of emergent echocardiography.
PMID: 29410163 [PubMed - as supplied by publisher]