Among 61 high-risk pulmonary embolism (PE) patients followed through to the 30-day visit in the U.S. cohort of the FLASH registry, no mortalities were recorded, while at 48 hours post-treatment with the FlowTriever mechanical embolectomy system, likewise, there were no major adverse events (MAEs), nor serious adverse events (SAEs) reported.
The outcomes emerged during a venous thromboembolism (VTE) session at the 2023 annual meeting of the American Venous Forum held in San Antonio, Texas (Feb. 22–25) in a paper delivered by James Horowitz, MD, from NYU Grossman School of Medicine in New York City.
The sub-analysis was drawn from the 800-patient prospective, multicenter, real-world registry in light of a paucity of data regarding the use of the percutaneous system among high-risk patients, Horowitz noted.
Horowitz reported that, post-embolectomy using the FlowTriever system, hemodynamic improvements were observed, with mean pulmonary artery pressure decreasing from 31.5mmHg to 24.3mmHg, and cardiac index (CI) increasing from 1.5L/min/m2 to 1.9L/min/m2. “Patients demonstrated immediate hemodynamic and vital-sign improvements following the procedure,” he added. “Echocardiographic, dyspnea and quality-of-life outcomes improved through 30 days.”
Horowitz and colleagues highlighted that the large-bore mechanical embolectomy system “has a favorable safety and effectiveness profile” in the high-risk group. They concluded: “In high-risk PE patients, there were no mortalities through 30 days or MAEs after mechanical embolectomy with the FlowTriever system. High-risk patients demonstrated significant improvement of acute hemodynamics and functional outcomes. Results from the FLASH registry suggest mechanical embolectomy is safe and effective for high-risk PE, leading to markedly lower acute mortality compared to previously reported mortality rates for this population.”