Key result
FlowTriever mechanical thrombectomy achieves a 0% major adverse event rate in high-risk PE.
Why the study?
Acute mortality for high-risk pulmonary embolism remains near 30% despite advanced therapies, prompting evaluation of the safety and effectiveness of mechanical thrombectomy in this population.
Is mechanical thrombectomy using the FlowTriever System safe and effective in reducing acute mortality and improving hemodynamics in patients with high-risk pulmonary embolism?
Cohort (n=63)
Yes
Is mechanical thrombectomy using the FlowTriever System safe and effective in reducing acute mortality and improving hemodynamics in patients with high-risk pulmonary embolism?
In 63 patients with high-risk pulmonary embolism, large-bore mechanical thrombectomy with the FlowTriever System resulted in immediate hemodynamic improvement with 0% major adverse events at 48 hours and 0% mortality through 30 days.
Answers are grounded in this paper and cite their sources.
Supports safety of FlowTriever thrombectomy in high-risk PE; leaves open confirmation of benefit in randomized trials.
Background Acute mortality for high-risk, or massive, pulmonary embolism (PE) is almost 30% even when treated using advanced therapies. This analysis assessed the safety and effectiveness of mechanical thrombectomy (MT) for high-risk PE. Methods The prospective, multicenter FlowTriever All-comer Registry for Patient Safety and Hemodynamics (FLASH) study is designed to evaluate real-world PE patient outcomes after MT with the FlowTriever System (Inari Medical). In this study, acute outcomes through 30 days were evaluated for the subset of patients with high-risk PE as determined by the sites and following European Society of Cardiology guidelines. An independent medical monitor adjudicated adverse events (AEs), including major AEs: device-related mortality, major bleeding, or intraprocedural device-related or procedure-related AEs. Results Of the 799 patients in the US cohort, 63 (7.9%) were diagnosed with high-risk PE; 30 (47.6%) patients showed a systolic blood pressure <90 mm Hg, 29 (46.0%) required vasopressors, and 4 (6.3%) experienced cardiac arrest. The mean age of patients with high-risk PE was 59.4 ± 15.6 years, and 34 (54.0%) were women. At baseline, 45 (72.6%) patients were tachycardic, 18 (54.5%) showed elevated lactate levels of ≥2.5 mM, and 21 (42.9%) demonstrated depressed cardiac index of <2 L/min/m 2 . Immediately after MT, heart rate improved to 93.5 ± 17.9 bpm. Twenty-five (42.4%) patients did not require an overnight stay in the intensive care unit, and no mortalities or major AEs occurred through 48 hours. Moreover, no mortalities occurred in 61 (96.8%) patients followed up through the 30-day visit. Conclusions In this cohort of 63 patients with high-risk PE, MT was safe and effective, with no acute mortalities reported. Further prospective data are needed in this population.
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Horowitz et al. (2023) conducted a cohort in High-risk (massive) pulmonary embolism (n=63). Mechanical thrombectomy with the FlowTriever System was evaluated on Composite of major adverse events (device-related mortality, major bleeding, and intraprocedural device-related or procedure-related adverse events) within 48 hours. Mechanical thrombectomy with the FlowTriever System resulted in a 0% rate of major adverse events within 48 hours and 0% all-cause mortality through 30 days in 63 patients with high-risk PE.
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