Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism 
Catalin Toma, Wissam Jaber, Mitchell Weinberg, Matthew C. Bunte, Sameer Khandhar, Brian Stegman, Sreedevi Gondi, Jeffrey W. Chambers, Rohit Amin, Daniel A. Leung, Herman Kado, Michael Brown, Michael G. Sarosi, Ambarish P. Bhat, Jordan Castle, Michael A. Savin, Gary P. Siskin, Michael S. Rosenberg, Christina Fanola, James M. Horowitz, Jeffrey Pollak
Abstract
BACKGROUND: Evidence supporting interventional pulmonary embolism (PE) treatment is needed. AIMS: We aimed to evaluate the acute safety and effectiveness of mechanical thrombectomy for intermediate- and high-risk PE in a large real-world population. METHODS: 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. RESULTS: 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.