Conical Mesh-Disc Catheter-Directed Mechanical Thrombectomy for Acute Pulmonary Embolism: A Nationwide Prospective,...

Catheter-directed mechanical thrombectomy for acute pulmonary embolism (PE) has expanded rapidly, yet device-related pulmonary vascular injury has been reported with existing large-bore systems. We evaluated the feasibility and safety of a novel mechanical thrombectomy system incorporating conical nitinol mesh discs.

This nationwide prospective, single-arm, multicenter study enrolled adults with computed tomography pulmonary angiography (CTPA) confirmed acute PE, symptom duration ≤14 days, systolic blood pressure ≥90 mm Hg, and baseline right ventricular (RV) to left ventricle (LV) diameter ratio ≥0.9. The primary effectiveness endpoint was change in CTPA-derived RV/LV ratio from baseline to 48 hours. The primary safety endpoint was major adverse events (MAEs) within 48 hours. Secondary endpoints included changes in echocardiography-derived systolic pulmonary artery pressure (sPAP) and oxygenation, as well as 30-day outcomes.

Among 127 patients treated at 13 centers, device delivery, deployment, and removal were successful in all cases. RV/LV ratio decreased from 1.47 ± 0.37 to 0.83 ± 0.17 at 48 hours (95% CI: -0.69 to -0.59; P < 0.0001). Echocardiography-estimated sPAP decreased from 45.82 ± 14.46 to 36.66 ± 13.18 mm Hg (mean change: -9.69 ± 14.33; P < 0.001). Arterial oxygen partial pressure increased by 17.79 ± 15.50 mm Hg at 48 hours (P < 0.001) under standardized sampling conditions. No MAE occurred within 48 hours. No deaths or symptomatic recurrent PE occurred within 30 days.

In hemodynamically stable patients with intermediate-risk acute PE and RV dilation, mechanical thrombectomy using a conical mesh-disc system was feasible and associated with early improvements in RV size and echocardiography-estimated pulmonary artery pressures, with no MAE observed within 48 hours. Given the single-arm design, comparative effectiveness versus anticoagulation or other devices cannot be inferred.