University of Pittsburgh Medical Center Heart and Vascular Institute, Pittsburgh, PA, USA.
Emory University Hospital, Atlanta, GA, USA.
EuroIntervention. 2023 Feb 20;18(14):1201-1212. doi: 10.4244/EIJ-D-22-00732.
Evidence supporting interventional pulmonary embolism (PE) treatment is needed.
We aimed to evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population.
FLASH is a multicentre, prospective registry enrolling up to 1,000 US and European PE patients treated with mechanical thrombectomy using the FlowTriever System. The primary safety endpoint is a major adverse event composite including device-related death and major bleeding at 48 hours, and intraprocedural adverse events. Acute mortality and 48-hour outcomes are reported. Multivariate regression analysed characteristics associated with pulmonary artery pressure and dyspnoea improvement.
Among 800 patients in the full US cohort, 76.7% had intermediate-high risk PE, 7.9% had high-risk PE, and 32.1% had thrombolytic contraindications. Major adverse events occurred in 1.8% of patients. All-cause mortality was 0.3% at 48-hour follow-up and 0.8% at 30-day follow-up, with no device-related deaths. Immediate haemodynamic improvements included a 7.6 mmHg mean drop in mean pulmonary artery pressure (-23.0%; p<0.0001) and a 0.3 L/min/m mean increase in cardiac index (18.9%; p<0.0001) in patients with depressed baseline values. Most patients (62.6%) had no overnight intensive care unit stay post-procedure. At 48 hours, the echocardiographic right ventricle/left ventricle ratio decreased from 1.23±0.36 to 0.98±0.31 (p<0.0001 for paired values) and patients with severe dyspnoea decreased from 66.5% to 15.6% (p<0.0001). Conclusions: Mechanical thrombectomy with the FlowTriever System demonstrates a favourable safety profile, improvements in haemodynamics and functional outcomes, and low 30-day mortality for intermediate- and high-risk PE.
需要有介入性肺栓塞 (PE) 治疗的证据支持。
我们旨在评估在大型真实人群中使用 FlowTriever 系统进行机械血栓切除术治疗中高危 PE 的急性安全性和有效性。
FLASH 是一项多中心、前瞻性登记研究，纳入了 1000 名美国和欧洲接受 FlowTriever 系统机械血栓切除术治疗的 PE 患者。主要安全性终点是包括设备相关死亡和 48 小时内大出血在内的主要不良事件复合终点，以及术中不良事件。报告了急性死亡率和 48 小时结局。多变量回归分析了与肺动脉压和呼吸困难改善相关的特征。
在全美国队列的 800 名患者中，76.7%的患者为中高危 PE，7.9%的患者为高危 PE，32.1%的患者有溶栓禁忌证。1.8%的患者发生主要不良事件。48 小时随访时全因死亡率为 0.3%，30 天随访时为 0.8%，无设备相关死亡。立即血流动力学改善包括平均肺动脉压平均下降 7.6mmHg（-23.0%；p<0.0001）和心指数平均增加 0.3L/min/m（18.9%；p<0.0001），基线值降低的患者。大多数患者（62.6%）术后无需过夜入住重症监护病房。48 小时时，超声心动图右心室/左心室比值从 1.23±0.36 降至 0.98±0.31（配对值 p<0.0001），严重呼吸困难患者从 66.5%降至 15.6%（p<0.0001）。
FlowTriever 系统的机械血栓切除术具有良好的安全性，可改善血流动力学和功能结局，且中高危 PE 的 30 天死亡率较低。
