A new study shows that pulmonary embolism (PE) patients treated with mechanical thrombectomy using the FlowTriever System (Inari Medical) have significant improvements in symptom burden, cardiac function, and quality of life at six months. The findings  were presented today as late-breaking clinical research at the Society for Cardiovascular Angiography & Interventions (SCAI) 2023 Scientific Sessions.

PE, a blood clot that emerges in the vessels and travels to the lung, stands as the third leading cause of cardiovascular death, behind only heart attack and stroke. Patients who survive PE often suffer from continual shortness of breath and difficulty exercising, leading to an overall decreased quality of life. Early data show that long-bore thrombectomy, the removal of blood clots utilizing a mechanical catheter, is more effective for the treatment of PE compared to standard of care, but less is known about how it works in the long term.

The FlowTriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) registry is a single-arm, multicenter study consisting of 800 patients (54.1% male, mean age, 61.2) with acute PE enrolled across 50 US sites. Overall, 599 patients completed six-month follow-up, and were assessed for: Modified Medical Research Council (mMRC) dyspnea score, right ventricular (RV) function, 6-minute walk test (6MWT) distances, and PEmb Quality of Life (QoL) scores).

According to the results:

• Median mMRC dyspnea scores improved from 3.0 at study baseline to 0.0 at 6 months.
• The percentage of patients with normal RV function increased from 15.1% at baseline to 95.1% at at 6 months.
• Median 6-MWT distances went up from 180 m at 48 hours to 398 m at 6 months.
• Median PEmb QoL scores enhanced from 12.5 at 48 hr to 1.6 at 6 months.

“It’s encouraging to see the dramatic and rapid improvement in both clinical outcomes and daily activities of our patients, like taking a walk without running out of breath,” said Sameer Khandhar, MD Assistant Professor of Clinical Medicine Perelman School of Medicine at the University of Pennsylvania Penn Presbyterian Medical Center in Philadelphia, Penn. and study co-author via a press release on the findings. “We’re hopeful these FLASH data serve as a next step in understanding the importance of thrombectomy as a treatment option for patients that shows in their recovery and improvements in day-to-day quality of life.”