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OhioHealth Cardiologist Leads National Study Designed to Treat High-Risk Pulmonary Embolism

The FLAME Trial is the largest prospective study of interventional treatment in high-risk PE

Just this month, OhioHealth Cardiologist Mitchell Silver, DO, was invited to present a national study called the FLAME trial at the American College of Cardiology Conference (ACC). The ACC held its annual scientific sessions from March 4-6 in New Orleans.
“I was invited to present at the late breaking clinical trials portion of the meeting which is typically reserved for research results that may change the current state of practice,” Dr. Silver said. 

FLAME stands for FlowTriever for Acute Massive Pulmonary Embolism. It’s a study that focuses on treating massive or high-risk pulmonary embolism which accounts for five percent of patients who come to the hospital critically ill with blood clots in their lungs. 

Pulmonary Embolism, PE, is a condition in which one or more of the arteries in the lungs are blocked by a blood clot. High-risk PE is the group of patients that have the highest risk of death unless some advanced therapy is undertaken. 

“With the current treatment, which includes either a very potent clot dissolving medicine or surgery, patients with the severe or high-risk pulmonary embolism have a 30 to 40 percent chance of dying,” Dr. Silver says, “The FLAME study evaluated the FlowTriever, the new device, that pulls the blood clots out of the lungs directly instead of using a clot dissolving medicine which has a risk of bleeding and usually takes longer to work.” 

Dr. Silver began this research with Dr. James Horowitz from NYU back on March 16, 2021. It was stopped early on Dec. 19, 2022 due to the significantly positive results found by using the FlowTriever catheter. 

During the trial, there were 10 hospitals within the US that participated in the study with OhioHealth Riverside Methodist Hospital being the only hospital in Ohio. Patients who were critically ill with a high-risk pulmonary embolus either received the FlowTrieiver device or the current standard of care (the clot dissolving medicine or major surgery). The rate of death, complications, and length of hospital stay were analyzed. 

“The rate of death was significantly lower at 1.9 percent with the FlowTriever device compared to 29.5 percent with the standard of care,” Dr. Silver said. 

Using the new device also showed significantly less major bleeding when compared to the current standard of care. 
As for next steps, the FlowTriever technology and physician training will be expanded to other community hospitals over the next few years. 

Patients at OhioHealth who come in with a life-threatening high risk pulmonary embolus can be offered the FlowTriever device. 

“Similar to very efficient care pathways for heart attack and stroke that currently exist, care pathways for pulmonary embolus will be established in the future,” Dr. Silver said. 

Photo Courtesy: Inari Medical