September 18, 2022
2 minute read
Toma C, et al. Cutting-edge clinical science in vascular disease and hypertension: Session III, in collaboration with the Journal of the American Medical Association. Presented at: TCT Scientific Symposium; September 16-19, 2022; Boston (hybrid meeting).
The study was funded by Inari Medical. Toma claims to be a consultant for Medtronic and Philips. Please see the study for relevant financial information from other authors.
BOSTON — In intermediate- and high-risk pulmonary embolism patients, mechanical thrombectomy was safe and associated with good short-term hemodynamic and clinical outcomes, according to data from the FLASH Registry.
The cohort included 800 US patients with PE (mean age, 61 years; 54% male; 76.7% intermediate risk), 32.1% of whom had contraindications to thrombolysis. All underwent mechanical thrombectomy with a system (FlowTriever System, Inari Medical) which extracts the PE thrombus by aspiration or mechanical methods without the use of thrombolytics, Catalin Toma, MD, assistant professor of medicine at the University of Pittsburgh School of Medicine and director of Interventional Cardiology and Interventional Cardiology Fellowship at UPMC Cardiac and Vascular Center, said at a press conference at TCT 2022 .
The results were published simultaneously in Eurointervention.
“Mortality remains high in the PE space, up to 10% at 30 days in recent records,” Toma said at the press conference. “Perhaps less appreciated is the comorbidity of these patients with readmission rates, and up to 50% still have symptoms 6 months after their acute PE. Current guidelines do not place much emphasis on advanced therapies; they are reserved for patients who … have a contraindication to lytics or treatment failure. The problem with the initial lytic approach is the risk of bleeding and the requirement for intensive care. The mechanical thrombectomy approach may allow rapid clot resolution and improved hemodynamics without the risk of bleeding.
The primary endpoint of major adverse events — device-related death at 48 hours, major bleeding at 48 hours, and device- or procedure-related intraprocedural events — occurred in 1.8% of patients, Toma said. , noting that there were no deaths, 11 major bleeds, and three intraprocedural events related to the device or procedure.
All-cause mortality rates were 0.3% at 48 hours, 0.8% at 30 days and 5% at 6 months, he said.
The 30-day mortality rate was much lower than that seen in the PERT Consortium Quality Database and in a meta-analysis of catheter-directed thrombolysis studies, Toma said.
He added that 30-day readmission rates were 6.2% for any cause, 1.4% for something related to PE treatment, and 4.8% for something unrelated to PE treatment. the P. This was far lower than that seen in the PERT consortium, he said.
During the procedure, pulmonary artery pressure dropped by an average of 7.6 mm Hg, or 23% (P 2i.e. 18.9% (P
More than half (62.6%) of the patients did not need to spend the night in intensive care.
At 48 hours, the right ventricle/left ventricle ratio on echocardiography decreased from 1.23 to 0.98 (P
The percentage of patients with severe dyspnea fell from 66.5% at baseline to 15.6% at 48 hours, Toma and colleagues found.
“The FLASH Registry demonstrates the excellent safety profile of the FlowTriever System in a real-world PE population,” Toma said at a press conference. “These are patients who, based on their baseline characteristics, are at high risk. Nevertheless, mortality remained below 1% at the 30-day visit. More importantly, hemodynamics rapidly improved during the procedure and clinical recovery continued for 6 months.
Randomized controlled trials, including PEERLESS, are planned, he said.