Pulmonary Embolism
Conditions
Keywords
FlowTriever, Catheter-Directed Intervention, Aspirational thrombectomy
Brief summary
International guidelines recommend intravenous thrombolysis (IVT) for high-risk pulmonary embolism (PE). In high-risk PE where IVT is contraindicated or has failed, surgical embolectomy or catheter-directed intervention (CDI) is recommended. CDI is also recommended as an alternative in patients with intermediate-risk PE with haemodynamic deterioration during anticoagulation treatment. Although there is a lack of randomized studies comparing CDI to anticoagulation or systemic thrombolysis in PE, several studies and recent meta-analyses have shown that CDI is an effective treatment that is associated with fewer complications than IVT, especially bleeding.
Detailed description
The FlowTriever® retrieval/aspiration system is the first mechanical thrombectomy device to receive PE as an indication from the United States Food and Drug administration agency. It combines large-bore aspiration with expanding mesh disks designed to trap and subsequently retract the blood clots from the pulmonary arteries. While Inari Medical, the medical device company that produces the FlowTriever® system, has initiated and published a few prospective trials on FlowTriever® in PE, non-industry sponsored studies are small and mostly retrospective. In 2021 FlowTriever® became the primary device for CDI in PE at Sahlgrenska University Hospital in Gothenburg, Sweden. Concurrently, several hospitals in Sweden have started using FlowTriever® in high-risk PE. As such, the method needs evaluation and validation on a local and national level. This retrospective observational study aims to evaluate the outcomes of patients with acute PE treated with the FlowTriever® device in Sweden. A control group consisting of PE patients treated with IVT will be used for comparison.
Interventions
DEVICEMechanical thrombectomy
Aspirational mechanical thrombectomy
Intravenous thrombolysis with tissue-type plasminogen activator (tPA)
Sponsors
Stockholm South General Hospital
Karolinska University Hospital
Danderyd Hospital
University Hospital, Linkoeping
Sunderby Hospital
Kristina Svennerholm
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Acute PE verified by computed tomography (CT) or angiography * PE treated with thrombolysis or FlowTriever® during the time period from January 1st of the year when FlowTriever was introduced at each respective participating center to the end of 2023.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of survival and major bleeding | up to 7 days and up to 30 days | Composite endpoint of survival at 30 days and major bleeding within 7 days, after intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Bleeding | up to 7 days | Major bleeding within 7 days after intervention. |
| Survival | up to 30 days | Survival at 30 days. |
| Right Ventricle/Left Ventricle (RV/LV) ratio | from 48 hours before intervention up to 48 hours after intervention | Change in RV/LV-ratio with the intervention. |
| Total Length of stay in the ICU or IMCU | From administration until discharge from ICU/IMCU, up to 30 days | Length of stay in the ICU/IMCU |
| Total Length of stay in hospital | From diagnosis of PE until discharge from hospital, up to 30 days | Length of stay in hospital |
Countries
Sweden
Outcome results
None listed