Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism - a Retrospective Analysis
- Conditions
- Pulmonary Embolism
- Interventions
- Drug: Intravenous thrombolysisDevice: Mechanical thrombectomy
- Registration Number
- NCT06187987
- Lead Sponsor
- Kristina Svennerholm
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 132
- 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.
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intravenous Thrombolysis Intravenous thrombolysis Acute PE patients treated with intravenous thrombolysis FlowTriever Mechanical thrombectomy Acute PE patients treated with the FlowTriever device
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Survival up to 30 days Survival at 30 days.
Major Bleeding up to 7 days Major bleeding within 7 days after intervention.
Total Length of stay in hospital From diagnosis of PE until discharge from hospital, up to 30 days Length of stay in hospital
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
Trial Locations
- Locations (1)
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden