A press release reports that, at 48 hours post procedure, the major adverse event rate and mortality rate were low, at 1.4% and 0.2%, respectively. None of the deaths or major adverse events were device related. Collectively, these PE patients experienced substantial on-table improvements in haemodynamics and symptoms, which translated to six-month improvements in cardiac function, functional status, and quality of life measures.
The outcomes were achieved while limiting utilisation of hospital resources, the release adds, with less than 4% of patients receiving adjunctive therapy and a median of zero days in the intensive care unit (ICU) post procedure.
FLASH is a prospective, multicentre, single-arm registry evaluating real-world patient outcomes after treatment of PE with FlowTriever. The 500-patient interim results were presented on 27 October via webcast at Transcatheter Cardiovascular Therapeutics (TCT) 2021 by principal investigator Catalin Toma, an interventional cardiologist at University of Pittsburgh Medical Center (UPMC) in Pittsburgh, USA. TCT 2021 will be held in person and broadcast live online 4–6 November in Orlando, USA.
“These interim results reinforce the strong safety profile of the FlowTriever system in real-world PE patients, with substantial on-table clinical improvements and immediate symptom relief,” said Toma.
“We believe these six-month follow-up data suggest that removal of clot burden without the risks of lytics has potential positive long-term implications for PE patients, including strikingly low rates of hospital readmissions, dyspnoea, CTED [chronic thromboembolic disease], and CTEPH [chronic thromboembolic pulmonary hypertension]. These data suggest that treatment with FlowTriever may fundamentally improve the natural course of the disease, and that is tremendously exciting.”