SCVS 2024 saw Zachary AbuRahma, DO, an assistant professor of vascular surgery at West Virginia University and the Charleston Area Medical Center in Charleston, West Virginia, presented data from a single-center experience focused on the use of the FlowTriever device (Inari Medical) in catheter-directed mechanical thrombectomies for submassive pulmonary embolism (PE) patients. The study, which involved cases performed between January 2019 and June 2023, established safety and effectiveness, with 94% of patients moved to room air post-procedure after 0% were on room air pre-procedure.
“Pulmonary embolism is the third leading cause in cardiovascular mortality behind CAD [coronary artery disease] and stroke, with over 100,000 deaths per year,” AbuRahma said. “According to the CDC [US Center for Disease Control], 25% of patients present sudden death as the first symptom and 10–30% of patients will die within one month of diagnosis.”
AbuRahma and colleagues determined that, with so few single-center studies that show the clinical benefits of endovascular intervention using mechanical suction thrombectomy for pulmonary embolism (PE) being published, they would analyze both the initial experience and clinical outcomes in the treatment of PE using the FlowTriever.
AbuRahma told the audience that the study “described the clinical features, findings and outcomes of patients with sudden massive PE undergoing catheter directed mechanical thrombectomy.”
“It was a retrospective study of 50 consenting patients with intermediate to high-risk PE. They received [a] catheter-direct thrombectomy using the Inari device,” AbuRahma stated. “Clinical success was defined by improvement in internal pulmonary pressures and oxygen therapy.”
The patient population had a mean age of 68 years old, with a male-to-female ratio of 1 to 1. All patients had a right ventricular strain and either required oxygen therapy or an increase in oxygen therapy from baseline.
Of those patients, AbuRahma said that about 12% of the patients in the study were active COVID-19 patients, about 18% of the patients had stage III chronic kidney disease, and about 72% had a hypothyroid disorder.
The results of the study concluded that, among the 50 patients at a mean follow-up time of eight months, there was significant improvement in fraction of inspired oxygen (FiO2) noted from the mean pre-procedural 40.6% to 28.3% 24 hours after the procedure. Some 94% of patients moved to room air post-procedure after 0% were on room air pre-procedure. In a later follow-up, 94.4% of patients were improved from baseline for oxygenation, 89% improved for physical activity, and 97% improved for beathing status.
AbuRahma and his team use the Modified Medical Research Council Dyspnea Score (mMRC). Using mMRC, 93% of patients reported a pre-op score of 4, which means that the patients reported being too breathless to leave the house. During a later follow-up, 70% of patients reported scores of 0 or 1, which means they experienced no breathlessness during normal activity or shortness of breath when hurrying. All patients showed improvement using the mMRC score.
In conclusion, AbuRahma and his team determined that the FlowTriever device is both safe and effective for patients with submassive acute pulmonary embolism. “Most patients perioperatively and at eight-month follow-up were back to baseline clinically with regard to activity level, O2 needs and breathing,” he added.
