PB0933 - International expert consensus on criteria to assess the safety of home treatment of patients with acute pulmonary embolism

Monday, June 24, 2024

13:45 – 14:45 ICT

Room: Exhibition Hall

Co-Author(s)

MS

Mathieu Servent

Emergency Medicine Resident
Emergency Department, Angers University Hospital, Angers, France
Angers, Pays de la Loire, France
SC

Scott D. Casey

Emergency Physician
Division of Research, Kaiser Permanente Northern California, Oakland, California; Department of Emergency Medicine, Kaiser Permanente Vacaville Medical Center, Vacaville, California, USA
Vacaville, California, United States
WS

William-May B. Stubblefield

Emergency Physician and Assistant Professor
Department of Emergency Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
Nashville, Tennessee, United States
DD

Delphine Douillet

Emergency Physician and Assistant Professor
Emergency Department, Angers University Hospital; UNIV Angers, UMR MitoVasc CNRS 6015 – INSERM 1083, Equipe CARME, Angers, France; F-CRIN INNOVTE Network, Saint-Etienne, France
Angers, Pays de la Loire, France

Co-Author(s)

FG

Federico Germini

Assistant Professor
McMaster University
Hamilton, Ontario, Canada

Co-Author(s)

AP

Andrea Penaloza

Professor of Emergency Medicine
Emergency Department, Cliniques Universitaires Saint-Luc, Université Catholique de Louvain, Brussels, Belgium; F-CRIN INNOVTE Network, Saint-Etienne, France
Brussels, Brussels Hoofdstedelijk Gewest, Belgium

Presenting Author(s)

Christopher Kabrhel, MD MPH

Director, Center for Vascular Emergencies
Massachusetts General Hospital
Boston, Massachusetts, United States

Co-Author(s)

MH

Menno V. Huisman

Professor of Medicine
Department of Medicine – Division of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands; Dutch Thrombosis Network, The Netherlands.
Leiden, Zuid-Holland, Netherlands
DV

David Vinson

Professor of Emergency Medicine
Division of Research, Kaiser Permanente Northern California, Oakland, California; Department of Emergency Medicine, Kaiser Permanente Roseville, Medical Center, Roseville, California, USA
Roseville, California, United States
PR

Pierre-Marie Roy

Professor of Emergency Medicine
Emergency Department, Angers University Hospital; UNIV Angers, UMR MitoVasc CNRS 6015 – INSERM 1083, Equipe CARME, Angers, France; F-CRIN INNOVTE Network, Saint-Etienne, France
Angers, Pays de la Loire, France

Background: Several trials have evaluated the safety of home treatment of patients with acute pulmonary embolism (PE), with varying outcomes. The most common is the 3-month rate of recurrent venous thromboembolism (VTE) although other criteria and a different period of follow-up may be more appropriate.

Aims: To establish a consensus definition of serious adverse events and timeframes for their occurrence to be considered as safety outcomes in clinical trials assessing home treatment of PE patients.

Methods: An international panel of experts was asked their opinion using a Delphi method until consensus was reached (Figure). For each possible outcome, experts answered the question “Does the occurrence of this event after home discharge from the emergency department (ED) suggests that home treatment was an inappropriate disposition?”. Responses were collected using Likert scales. The same method was used for the outcomes' timeframe.

Results: Fifty-five experts were invited and 35 participated (Table). Six adverse events were identified as outcomes: 1/ Confirmed new onset of hypoxemia ( < 90%) requiring oxygen or ventilation support (retained in round 2); 2/ Confirmed new onset of severe hypotension (i.e., systolic blood pressure < 90 mmHg or 40 mmHg decrease from baseline) or shock index > 1 requiring specific treatment (round 2); 3/ New confirmed symptomatic cardiac arrhythmia requiring urgent treatment (round 4); 4/ Major bleeding (ISTH definition) (round 1); 5/ Symptomatic PE recurrence or proximal DVT requiring specific treatment (round 4); 6/ Death possibly or confirmed to be related to PE (round 4). The timeframe of occurrence was set at 7 days after ED discharge (round 3).

Conclusion(s): The expert panel identified the occurrence of six clinical deterioration criteria to be used as safety outcomes when determining if home treatment is an inappropriate disposition for PE patients. These outcomes should be considered in future trials and measured within 7 days from ED discharge.