Chest
Volume 154, Issue 2, August 2018, Pages 249-256
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Original Research: Pulmonary Vascular Disease
Management of Low-Risk Pulmonary Embolism Patients Without Hospitalization: The Low-Risk Pulmonary Embolism Prospective Management Study

Part of this article has been presented in a plenary session at the ACEP 2016 Annual Scientific Assembly, October 16, 2016, Las Vegas, NV.
https://doi.org/10.1016/j.chest.2018.01.035Get rights and content

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 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 EDs. 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 (PESI) score (< 86), echocardiography, and whole-leg compression ultrasound (CUS). The primary intervention was observation in the ED or hospital (observation status) for > 12 to < 24 h, followed by outpatient management with Food and Drug Administration-approved therapeutic anticoagulation. Patients were excluded for a PESI ≥ 86, echocardiographic signs of right heart strain, 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 one 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 because of the small sample size relative to the end point and the generalizability surrounding availability of emergent echocardiography.

Section snippets

Study Design

This was a single-arm prospective cohort management study performed at five centers: one tertiary referral center with an American College of Surgeons designation of a level 1 trauma center with an annual ED census of > 90,000 visits, and four suburban community hospitals each with an annual census of 20 to 50,000 visits.

Procedures

Consecutive patients diagnosed with low-risk acute PE by CT pulmonary arteriography (CTPA) or high-probability ventilation/perfusion scan, and having a PESI score < 86

Patients

Of 1,003 consecutive patients diagnosed with acute PE and assessed for eligibility, 790 were excluded: 341 had a PESI score > 85, 419 met another exclusion criterion, 123 declined to provide informed consent, and 30 potentially eligible patients could not be screened (e-Appendix 3), leaving 213 patients who initially met all inclusion criteria (Fig 1). Of these, imaging studies resulted in exclusion of six patients (2.8%) who had DVT proximal to the popliteal vein and four patients (1.9%) with

Discussion

We report key outcomes of patients undergoing an outpatient management strategy for low-risk PE. Outpatient management was associated with a low rate of recurrent VTE, major bleeding, and death, and resulted in high patient satisfaction.

Our study used a prospective cohort (management study) methodology, which is similar to prior trials of VTE management.17, 18, 19 Previous studies of outpatient PE treatment, including three randomized controlled trials,4, 5, 20 note a low rate of adverse

Acknowledgments

Author contributions: J. R. B. takes responsibility for the paper as a whole. J. R. B., T. M., T. A., S. M. S., and S. C. W. conceived the study, designed the trial, and obtained research funding. J. R. B. and V. A. supervised the conduct of the trial and data collection. J. R. B., V. A., S. M. S., S. C. W., and R. P. undertook recruitment of participating patients and managed the data, including quality control. T. A., L. D., and J. L. provided additional data acquisition. B. D. H. provided

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    FUNDING/SUPPORT: This study was funded by the Intermountain Research and Medical Foundation through a grant [Grant No. 641] awarded to J. R. B.

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