AVF 2023: REGISTRY SUGGESTS ‘FAVORABLE SAFETY AND EFFECTIVENESS PROFILE’ IN HIGH-RISK PE PATIENTS

patients. Sharing the results of the study, Silver noted that the endpoint was met in the FlowTriever arm, in which a mortality rate of 1.9% was recorded, compared to 29.5% in the context arm. In all, the composite primary endpoint occurred in 17% of patients in the FlowTriever arm, compared to 63.9% in the context arm.

“The remarkably low mortality seen with FlowTriever demonstrates the benefit of rapidly identifying PE patients and getting them to an interventionalist for assessment,” Silver was quoted as saying in a press release issued during ACC 2023. “It is time for our hospital systems to develop standardized care pathways for PE, similar to what has been done in other major cardiovascular diseases such as heart attack and stroke.”

“High-risk PE persists as one of the deadliest cardiovascular diseases,” said James Horowitz, MD, from NYU Grossman School of Medicine in New York City, FLAME national principal investigator.

“Outcomes have remained unchanged for decades. The FLAME data shows that [the] FlowTriever is an important new treatment option that offers a dramatic improvement in survival.”—Will Date

AMONG 61 HIGH-RISK PULMONARY embolism (PE) patients followed through 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.”—Bryan Kay