Updated: Feb 19, 2021
February 9, 2021
February 9, 2021—Findings from the first-in-human (FIH) study assessing the safety and feasibility of the Bashir endovascular catheter (BEC; Thrombolex, Inc.) for the treatment of acute intermediate-risk pulmonary embolism (PE) were published by Akhilesh K. Sista, MD, et al in Circulation: Cardiovascular Intervention (2021;14).
The BEC is a pharmacomechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombolytics.
In Circulation: Cardiovascular Interventions, the investigators concluded, “In this early feasibility study of the BEC for intermediate - risk PE, there were no deaths or device-related adverse events and a significant reduction in right ventricular (RV) to left ventricular (LV) diameter ratio and thrombus burden.”
As summarized in Circulation: Cardiovascular Interventions, this prospective, multicenter, single-arm study enrolled patients with symptomatic PE and RV/LV diameter ratio ≥ 0.9 as documented by computer tomography angiography. The primary safety endpoints were device-related death or adverse events and major bleeding within 72 hours after BEC-directed therapy.
The study was composed of nine patients enrolled at four sites in the United States. The total dose of recombinant tissue-type plasminogen activator (r-tPA) was 14 mg in bilateral PE and 12 mg in unilateral PE over 8 hours delivered via the expanded BEC.
The investigators reported the following in Circulation: Cardiovascular Interventions:
At 30-day follow-up, there were no deaths or device-related adverse events.
At 48 hours post-BEC therapy, the RV/LV diameter ratio decreased 37% from 1.52 ± 0.26 to 0.97 ± 0.06 (95% CI, 0.33-0.82; P = .0009).
Thrombus burden as measured by the Modified Miller Index decreased 37.1% from 25.4 ± 5.3 to 16 ± 4 (95% CI, 5.5-13.4; P = .0005).
In March 2020, Thrombolex announced that the data from the study had been presented at AVF 2020, the annual meeting of the American Venous Forum in Amelia Island, Florida. In the company’s press release from AVF 2020, Dr. Sista, the study’s Coprincipal Investigator, commented, “The results from the [FIH] study for the BEC are exciting—the PE patients treated were real-world patients [who] had high thrombus burden and major RV dilation. The amount of thrombus removed with less than 14 mg of r-tPA was impressive. I look forward to seeing what this device can do in a larger study and a randomized cohort.”
Co-principal Investigator Kenneth Rosenfield, MD, added, “The innovative design of the BEC enables it to engage and fissure the thrombus, as well as deliver fibrinolytic throughout the entire cross-sectional volume of the clot. In theory, this potentially allows for more prompt restoration of flow to the lungs and relief of RV overload. The results of this early feasibility study appear to corroborate this mechanism of action. We look forward to further evidence of this effect in a larger cohort.”
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