Outcomes of Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism, Results of a Swedish Retrospective Analysis
| Registry | NCT06187987 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 132 (Actual) |
| Sponsor | Kristina Svennerholm (Other); collaborators: Stockholm South General Hospital, Karolinska University Hospital, Danderyd Hospital, University Hospital, Linkoeping, Sunderby Hospital |
| Conditions | Pulmonary Embolism |
| Interventions | Mechanical thrombectomy, Intravenous thrombolysis (Device, drug) |
| Dates | start 2023-04-01, primary completion 2025-01-31, completion 2025-03-31, first posted 2024-01-03, last updated 2025-05-20 |
| Locations | 1 site in Sweden |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| FlowTriever | Device: Mechanical thrombectomy | Acute PE patients treated with the FlowTriever device | |
| Intravenous Thrombolysis | Drug: Intravenous thrombolysis | Acute PE patients treated with intravenous thrombolysis |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | Sweden |