PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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/m2. 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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/m2. 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.
UNASSIGNED: 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.
摘要：
■高危人群的急性死亡率，或者巨大的，即使使用先进疗法治疗，肺栓塞（PE）也几乎占30％。该分析评估了机械血栓切除术（MT）用于高危PE的安全性和有效性。
■预期的，多中心FlowTriever患者安全和血流动力学（FLASH）研究旨在使用FlowTriever系统（InariMedical）评估MT后实际PE患者的预后。在这项研究中,根据研究中心和欧洲心脏病学会指南确定的高危PE患者亚组30天的急性结局进行评估.独立的医疗监督员裁定的不良事件（AE），包括主要不良事件：器械相关死亡率，大出血,或术中器械相关或手术相关的不良事件。
■在美国队列中的799名患者中，63例（7.9％）被诊断为高危PE；30例（47.6％）患者的收缩压<90mmHg，29（46.0％）需要血管加压药，4例(6.3%)出现心脏骤停。高危PE患者的平均年龄为59.4±15.6岁,34名(54.0%)为女性。在基线,45例(72.6%)患者出现心动过速,18（54.5%）显示乳酸水平升高≥2.5mM，和21（42.9％）显示<2L/min/m2的心脏指数降低。在MT之后，心率改善至93.5±17.9bpm。二十五名(42.4%)病人不需要在加护病房过夜,48小时内无死亡或重大不良事件发生。此外，在30天随访期间,61例(96.8%)患者未发生死亡.
■在这个由63名高危PE患者组成的队列中，MT是安全有效的,没有急性死亡报告。该人群需要进一步的前瞻性数据。
■预期的，多中心FlowTriever患者安全和血流动力学（FLASH）研究旨在使用FlowTriever系统（InariMedical）评估MT后实际PE患者的预后。在这项研究中,根据研究中心和欧洲心脏病学会指南确定的高危PE患者亚组30天的急性结局进行评估.独立的医疗监督员裁定的不良事件（AE），包括主要不良事件：器械相关死亡率，大出血,或术中器械相关或手术相关的不良事件。
■在美国队列中的799名患者中，63例（7.9％）被诊断为高危PE；30例（47.6％）患者的收缩压<90mmHg，29（46.0％）需要血管加压药，4例(6.3%)出现心脏骤停。高危PE患者的平均年龄为59.4±15.6岁,34名(54.0%)为女性。在基线,45例(72.6%)患者出现心动过速,18（54.5%）显示乳酸水平升高≥2.5mM，和21（42.9％）显示<2L/min/m2的心脏指数降低。在MT之后，心率改善至93.5±17.9bpm。二十五名(42.4%)病人不需要在加护病房过夜,48小时内无死亡或重大不良事件发生。此外，在30天随访期间,61例(96.8%)患者未发生死亡.
■在这个由63名高危PE患者组成的队列中，MT是安全有效的,没有急性死亡报告。该人群需要进一步的前瞻性数据。
