Horowitz James M, Jaber Wissam A, Stegman Brian, Rosenberg Michael, Fanola Christina, Bhat Ambarish P, Gondi Sreedevi, Castle Jordan, Ahmed Mustafa, Brown Michael A, Amin Rohit, Bisharat Mohannad, Butros Paul, DuCoffe Aaron, Savin Michael, Pollak Jeffrey S, Weinberg Mitchell D, Brancheau Daniel, Toma Catalin
Division of Cardiology, Department of Medicine, NYU Grossman School of Medicine, New York, New York.
Emory University Hospital, Atlanta, Georgia.
J Soc Cardiovasc Angiogr Interv. 2023 Oct 31;3(1):101124. doi: 10.1016/j.jscai.2023.101124. eCollection 2024 Jan.
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.
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.
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. 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.
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.
即使采用先进疗法治疗，高危或大面积肺栓塞（PE）的急性死亡率仍接近30%。本分析评估了机械血栓切除术（MT）治疗高危PE的安全性和有效性。
前瞻性、多中心的FlowTriever全人群患者安全与血流动力学注册研究（FLASH）旨在评估使用FlowTriever系统（Inari Medical）进行MT后真实世界中PE患者的结局。在本研究中，根据各研究点及欧洲心脏病学会指南确定为高危PE的患者亚组，评估其30天内的急性结局。由独立医学监测人员判定不良事件（AE），包括主要不良事件：与器械相关的死亡、大出血或术中与器械相关或与手术相关的AE。
在美国队列的799例患者中，63例（7.9%）被诊断为高危PE；30例（47.6%）患者收缩压<90 mmHg，29例（46.0%）需要使用血管升压药，4例（6.3%）发生心脏骤停。高危PE患者的平均年龄为59.4±15.6岁，34例（54.0%）为女性。基线时，45例（72.6%）患者心动过速，18例（54.5%）乳酸水平升高≥2.5 mM，21例（42.9%）心脏指数降低<2 L/min/m²。MT后即刻，心率改善至93.5±17.9次/分。25例（42.4%）患者无需在重症监护病房过夜，48小时内未发生死亡或主要AE。此外，在随访至30天访视的61例（96.8%）患者中未发生死亡。
在这63例高危PE患者队列中，MT安全有效，未报告急性死亡病例。该人群还需要进一步的前瞻性数据。
