Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism.
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: 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
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.
Toma, Catalin; Jaber, Wissam A; Weinberg, Mitchell D; Bunte, Matthew C; Khandhar, Sameer; Stegman, Brian; Gondi, Sreedevi; Chambers, Jeffrey; Amin, Rohit; Leung, Daniel A; Kado, Herman; Brown, Michael A; Sarosi, Michael G; Bhat, Ambarish P; Castle, Jordan; Savin, Michael; Siskin, Gary; Rosenberg, Michael; Fanola, Christina; Horowitz, James M; and Pollak, Jeffrey S, "Acute outcomes for the full US cohort of the FLASH mechanical thrombectomy registry in pulmonary embolism." (2022). Articles, Abstracts, and Reports. 6713.