Catalin Toma (University of Pittsburgh, Pittsburgh, USA) recently presented interim results from the FLASH registry during a late-breaking session at TCT Connect (14–18 October, virtual), the 32nd annual scientific symposium of the Cardiovascular Research Foundation (CRF).
FLASH (FlowTriever all-comer registry for patient safety and haemodynamics) is a 500-patient prospective, multicentre registry designed to evaluate real-world outcomes after the treatment of patients with intermediate- and high-risk pulmonary embolism (PE) with the FlowTriever device (Inari Medical).
“Current data suggest we still have ample opportunity to improve care in acute PE,” Toma told the TCT audience. “This remains a deadly disease,” he added, noting that mortality rates can be as high as 15%.
According to Toma, the FlowTriever system is the first purpose-built, PE thrombectomy system that was approved by the US Food and Drug Administration (FDA) in 2016, following the results of the FLARE (FlowTriever pulmonary embolectomy) investigational device exemption (IDE) study.
The FLASH registry was created to evaluate the safety and effectiveness of the FlowTriever system for the treatment of PE in a real-world patient population with a broader risk profile than the FLARE IDE study.
At TCT, Toma reported results of an interim analysis in 230 patients enrolled so far since 2019. Mortality through 48 hours was 0% and that just three patients out of 320 (1.3%) experienced major adverse events—all of which were major bleeds.
“I would like to point out that this an elevated-risk PE patient population that has a large amount of clot. Seven per cent of patients fall into the high-risk for massive PE category and 38% of these patients had a contraindication,” Toma detailed.
He added that there were no intraprocedural device or procedure-related adverse events, and no patient experienced heart or lung damage.
In terms of haemodynamics, Toma relayed that the average heart rate prior to intervention was 113bpm, “which is quite elevated,” but this decreased “significantly” post procedure, to 90bpm.
Ending his presentation, Toma concluded: “The interim results of the FLASH registry reinforce the excellent FlowTriever safety profile in 230 real-world patients.”