Outcomes In High-risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy: Results From The FLAME Study

Ezgi Güzel

Published Congress: ACC 2023

https://academic.oup.com/ehjacc/advance-article-abstract/doi/10.1093/ehjacc/zuad022/7071692?redirectedFrom=fulltext&login=false

Introduction:

A mechanical-based thrombectomy using the FlowTriever (FT) System is viable as a front-line treatment for high-risk pulmonary embolism (PE), in order to improve short term mortality and long term quality of life  according to findings presented at the American College of Cardiology Annual Scientific Sessions 2023 in New Orleans.

Objective:

FLAME study was designed to evaluate outcomes  in high risk PE patients treated with large- bore mechanical thrombectomy or other contemporary treatments.

Methods:

Study designed as a prospective, multicenter, non-randomized observational trial as suggested by an AHA Scientific Statement to generate evidence in high-risk PE patient population.enrollment of 53 patients for the FT arm of the study, the primary endpoint composite was a composite of in-hospital adverse clinical outcomes : All-cause mortality, major bleeding, clinical deterioration, and bailout to alternate thrombus removal strategy.

Results:

Large-bore mechanical thrombectomy with FlowTriever was associated with a significantly lower occurrence of meaningful in-hospital adverse clinical outcomes.
The study was terminated early due to a significant reduction in mortality in the FlowTriever (FT group) of 1.9% compared to 29.5% other non-FlowTriever therapies (context group). The primary endpoint positively supported the FT group with 17.0% versus 63.9% in the context group, with lower rate than the performance goal of 32.0%. Further findings revealed that components were numerically lower in the FT group than the context group, including in-hospital mortality (1.9% vs. 29.5%), bailout strategy (3.8% vs. 26.2%), clinical deterioration (15.1% vs. 21.3%), and major bleeding (11.3% vs. 24.6%).

Conclusion:

The FLAME study is the largest interventional trial in high-risk PE
Large-bore mechanical thrombectomy with FlowTriever was associated with a significantly lower occurence of meaningful in-hospital adverse clinical outcomes
(in- hospital mortality, bailout,clinical deterioration , major bleeding).

Interpretations:

Patients with massive and high-risk submissive PE may deteriorate quickly and consequently progress to cardiogenic shock, or cardiac arrest.  Right ventricular infarction from severe demand mismatch may be the underlying cause of high mortality and thus advanced thrombectomy therapies such as large-bore mechanical thrombectomy with the FlowTriever System may reverse this phenomenon rapidly.
These results indicate that mechanical thrombectomy with the FlowTriever System will play an increasing role in the management of pulmonary embolism with significant ontable hemodynamic improvements and positive long-term functional
outcomes.