Results of a first-in-human study to assess the safety and feasibility of the Bashir endovascular catheter (Thrombolex) for the treatment of acute intermediate-risk pulmonary embolism (PE) have been published in Circulation: Cardiovascular Interventions.
Authors Akhilesh Sista (New York University School of Medicine, New York, USA) and colleagues report that there were no deaths or device-related adverse events and that there was a significant reduction in right ventricular to left ventricular diameter ratio and thrombus burden.
The Bashir endovascular catheter is a novel pharmaco-mechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombolytics. The aim of this prospective, multicentre, single-arm study, Sista et al relay, was to evaluate the feasibility and initial safety of the Bashir endovascular catheter in patients with acute intermediate-risk PE.
The authors note that patients with symptomatic PE and right ventricular to left ventricular diameter ratio ≥0.9 as documented by computer tomography angiography were eligible for enrolment. The primary safety endpoints were device-related death or adverse events, and major bleeding within 72 hours after Bashir endovascular catheter-directed therapy.
The total dose of recombinant tissue-type plasminogen activator (r-tPA) was 14mgs in bilateral PE and 12mgs in unilateral PE over eight hours delivered via the expanded Bashir endovascular catheter, Sista et al detail.
Writing in Circulation: Cardiovascular Interventions, they report that there were no deaths or device-related adverse events at 30-day follow-up among the nine patients enrolled across four US sties. At 48 hours post-therapy with the Bashir endovascular catheter, the right ventricular to left ventricular diameter ratio decreased from 1.52±0.26 to 0.97±0.06; p=0.0009 (95% confidence interval [CI], 0.33–0.82); 37% reduction. In addition, they mention that thrombus burden as measured by the Modified Miller Index decreased from 25.4±5.3 to 16±4; p=0.0005 (95% CI, 5.5–13.4); 37.1% reduction.