Annals of vascular surgery · 2026
Conical Mesh-Disc Catheter-Directed Mechanical Thrombectomy for Acute Pulmonary Embolism: A Nationwide Prospective, Multicenter, Single-Arm Study.
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Zhuang Hui, Chen Xiang, Zhang Zeying, Ye Tianbao, Xu Yiwei, Shen Xuwei, Sun Hu, Zhang Weihua, Ji Qiushang, Guo Mingjin, Zhao Hui, Ye Meng, Li Yiqing, Han Baoshi, Hu Hongyao, Wang Peijian, Sang Hongfei, Chen Yunhui, Shou Xilin, Wang Yan
Аннотация
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.