Sabri Saher, Horr Samuel, Stegman Brian, Jaber Wissam A, Jolly Michael A, Huff Christopher M, O'Connor David, Younes Ahmad, Tabori Nora E, Monteleone Peter P, Kolluri Raghu, Shishehbor Mehdi H, Li Jun
Divison of Interventional Radiology, MedStar Georgetown University Hospital, Washington, DC.
TriStar Centennial Medical Center, Nashville, Tennessee.
J Soc Cardiovasc Angiogr Interv. 2025 May 2;4(7):103661. doi: 10.1016/j.jscai.2025.103661. eCollection 2025 Jul.
Mechanical thrombectomy has become a first-line adjunctive therapy for anticoagulation in patients with acute intermediate-risk pulmonary embolism (PE). This prospective study evaluated the safety and efficacy of percutaneous mechanical aspiration thrombectomy with autologous blood reinfusion using the next-generation AVENTUS Thrombectomy System (Inquis Medical) in subjects with acute intermediate-risk PE.
Subjects with acute intermediate-risk PE with symptoms ≤14 days were enrolled in this prospective, multicenter, single-arm study. Primary efficacy (defined as the change in the right ventricle to left ventricle [RV/LV] ratio from baseline) and safety defined as a composite rate of device-related major adverse events were both assessed at 48 hours postprocedure. Six-minute walk distance and quality of life were assessed at 30 days.
A total of 120 subjects were enrolled at 22 US sites. As compared to the baseline, the 48-hour RV/LV diameter ratio dropped significantly (0.47 ± 0.36; < .0001), as did the refined modified Miller score (8.7 ± 5.5; < .0001), reflecting a 35.9% reduction in clot burden. The mean estimated blood loss was 49.6 ± 38.9 mL, with no subjects requiring blood transfusion. Within 48 hours, no device-related major adverse events occurred. At 30 days, subjects exhibited a 132.9 m increase in 6-minute walk distance ( < .0001). PE-specific quality of life assessment at 30 days demonstrated decreased symptoms with a reduction of 25.3 points overall ( < .0001).
This study confirms that thrombectomy and autologous blood reinfusion with the AVENTUS Thrombectomy System is a safe and effective primary treatment option in patients with acute intermediate-risk PE to improve RV function and reduce clot burden with minimal blood loss.
机械血栓切除术已成为急性中度风险肺栓塞（PE）患者抗凝治疗的一线辅助疗法。本前瞻性研究评估了使用下一代AVENTUS血栓切除术系统（Inquis Medical）对急性中度风险PE患者进行经皮机械抽吸血栓切除术并自体血回输的安全性和有效性。
症状持续时间≤14天的急性中度风险PE患者纳入本前瞻性、多中心、单臂研究。在术后48小时评估主要疗效（定义为右心室与左心室[RV/LV]比值相对于基线的变化）和安全性（定义为与器械相关的主要不良事件的综合发生率）。在30天时评估6分钟步行距离和生活质量。
在美国22个地点共招募了120名受试者。与基线相比，48小时时RV/LV直径比值显著下降（0.47±0.36；P<.0001），改良的Miller评分也显著下降（8.7±5.5；P<.0001），表明血栓负荷减少了35.9%。估计平均失血量为49.6±38.9 mL，无受试者需要输血。48小时内未发生与器械相关的主要不良事件。在30天时，受试者的6分钟步行距离增加了132.9 m（P<.0001）。30天时的PE特异性生活质量评估显示症状减轻，总体降低了25.3分（P<.0001）。
本研究证实，使用AVENTUS血栓切除术系统进行血栓切除术和自体血回输是急性中度风险PE患者安全有效的主要治疗选择，可改善右心室功能，减少血栓负荷，且失血量最小。
