Joseph R Bledsoe1, Scott C Woller2, Scott M Stevens2, Valerie Aston3, Rich Patten4, Todd Allen5, Benjamin D Horne6, Lydia Dong7, James Lloyd8, Greg Snow9, Troy Madsen10, C Gregory Elliott11. 1. Department of Emergency Medicine, Stanford University-Intermountain Medical Center, Salt Lake City, UT. Electronic address: Joseph.bledsoe@imail.org. 2. Department of Medicine, University of Utah-Intermountain Medical Center, Salt Lake City, UT. 3. Intermountain Office of Research, Intermountain Medical Center, Salt Lake City, UT. 4. Riverton Hospital, Riverton, UT. 5. Department of Emergency Medicine, Stanford University-Intermountain Healthcare-Institute for Healthcare Delivery Research, Salt Lake City, UT. 6. Department of Cardiology, Intermountain Heart Institute, Intermountain Medical Center, Salt Lake City, UT. 7. Intermountain Healthcare-Institute for Healthcare Delivery Research, Salt Lake City, UT. 8. Department of Informatics, Intermountain Medical Center, Salt Lake City, UT. 9. Intermountain Statistical Data Center, Intermountain Medical Center, Salt Lake City, UT. 10. Department of Surgery, Division of Emergency Medicine, University of Utah SOM, Salt Lake City, UT. 11. Department of Medicine, University of Utah SOM, Intermountain Medical Center, Salt Lake City, UT.
Abstract
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. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT02355548; URL: www.clinicaltrials.gov.
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. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT02355548; URL: www.clinicaltrials.gov.
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