Multicenter Implementation of a Novel Management Protocol Increases the Outpatient Treatment of Pulmonary Embolism and Deep Vein Thrombosis

Abstract

Objective: The objective was to determine whether a protocol combining risk stratification, treatment with the direct-acting oral anticoagulant rivaroxaban, and defined follow-up is associated with a greater proportion of patients with venous thromboembolism (VTE) treated as outpatients, without hospital admission. Methods:We performed a multicenter study of patients diagnosed with VTE (pulmonary embolism [PE] or deep vein thrombosis [DVT]) in two urban EDs, 18 months before and 18 months after implementation of an outpatient VTE treatment protocol. Patients with radiographically confirmed acute VTE were eligible. Our primary outcome was the proportion of VTE patients discharged from the ED or observation unit (i.e., without hospital admission). We performed subgroup analyses according to hospital, DVT and PE, and low-risk PE. We also assessed 7-and 30-day mortality, major bleeding, and returns to the ED. We compared proportions using chi-square and Fisher's exact tests.Results: We enrolled 2,212 patients, 1,081 (49%) before protocol and 1,131 (51%) after protocol. Mean age (59 years vs. 60 years), female sex (49% vs. 49%), other demographics, comorbid illness, and PE risk stratification were similar before and after. After protocol, more VTE (35% from 26%, p < 0.001), PE (18% from 12%, p = 0.002), low-risk PE (28% from 18%, p < 0.001), and DVT (60% from 49%, p = 0.002) patients were treated as outpatients. Mortality, bleeding, and returns to ED were rare and did not increase after protocol. Conclusions:A treatment protocol combining risk-stratification, rivaroxaban treatment and defined follow-up is associated with an increase in PE and DVT patients treated as outpatients, with no increase in adverse outcomes.

Reducing the hospital burden associated with the treatment of pulmonary embolism

“…Effective and safe treatment of patients with PE in the outpatient setting requires patient education and robust follow‐up pathways. One recent US multicenter study demonstrated that the implementation of a treatment protocol that combined risk stratification, anticoagulation treatment with rivaroxaban, and well‐defined procedures for follow‐up of patients with DVT or PE increased the rates of patients treated as outpatients without increasing rates of adverse outcomes . Another multicenter US study evaluated the use of an integrated electronic clinical decision support system for risk stratification and on‐site decision making for identifying patients suitable for outpatient treatment of PE.…”

External validation of the modified HOPPE score to predict low risk pulmonary embolism suitable for early discharge

“…8 The keys to safe and effective outpatient treatment are appropriate risk stratifications and close follow-up arrangements. 4 In this external validation, the modified HOPPE score performed well, with very high NPV for in-hospital mortality and the composite outcomes of in-hospital mortality and non-fatal MACE. It showed similar predictive performance to the sPESI score for the composite outcome of in-hospital mortality and non-fatal MACE.…”

“…Outpatient treatment of venous thromboembolism (including, PE and deep venous thrombosis) is becoming more common. 4 Outpatient treatment releases capacity in hospitals, reduces patient exposure to hospital-acquired infections and other complications associated with hospitalization and is associated with high levels of patient satisfaction. 8 The keys to safe and effective outpatient treatment are appropriate risk stratifications and close follow-up arrangements.…”

“…The proportion of patients with low risk PE treated as outpatients is small and appears to be changing slowly over time despite evidence of safety and feasibility. 4,10 Reasons may include lack of confidence in the evidence, medicolegal concerns and lack of systems to support outpatient care of these patients. Use of further risk stratification with investigation for right ventricular dysfunction and troponin and lactate assays may help overcome the first two of these concerns, as abnormal results on these tests have been shown to be associated with poorer outcomes.…”

“…3 The keys to safe and effective outpatient treatment are appropriate risk stratification and close follow-up. 4 The Pulmonary Embolism Severity Index (PESI) is the most widely validated risk stratification score-in either its original or simplified version. If the PESI score is ≤ 65 (classified as very low risk) or 66-85 (low risk) there is a low risk of mortality or morbidity and outpatient management can be considered.…”