Indigo Aspiration System for Treatment of Pulmonary Embolism

• Published in: JACC. Cardiovascular interventions Vol. 14; no. 3; pp. 319 - 329
• Main Authors: Sista, Akhilesh K., Horowitz, James M., Tapson, Victor F., Rosenberg, Michael, Elder, Mahir D., Schiro, Brian J., Dohad, Suhail, Amoroso, Nancy E., Dexter, David J., Loh, Christopher T., Leung, Daniel A., Bieneman, Bruce Kirke, Perkowski, Paul E., Chuang, Michael L., Benenati, James F.
• Format: Journal Article
• Language: English
• Published: Elsevier Inc 08.02.2021
• Subjects: mechanical aspiration; pulmonary embolism; thrombectomy; RV; tPA; thrombectomy; CI; sPESI; ITT; mechanical aspiration; LV; mITT; CTA; PA; PE; SAE; IRB; pulmonary embolism
• ISSN: 1936-8798; 1876-7605
• DOI: 10.1016/j.jcin.2020.09.053

This study sought to prospectively evaluate the safety and efficacy of the Indigo aspiration system in submassive acute pulmonary embolism (PE). PE treatment with thrombolytics has bleeding risks. Aspiration thrombectomy can remove thrombus without thrombolytics, but data are lacking. This study was a prospective, single-arm, multicenter study that enrolled patients with symptomatic acute PE ≤14 days, systolic blood pressure ≥90 mm Hg, and right ventricular-to-left ventricular (RV/LV) ratio >0.9. The primary efficacy endpoint was change in RV/LV ratio from baseline to 48 h post-procedure on core lab–adjudicated computed tomography angiography. The primary safety endpoint was a composite of 48-h major adverse events: device-related death, major bleeding, and device-related serious adverse events (clinical deterioration, pulmonary vascular, or cardiac injury). All sites received Institutional Review Board approval. A total of 119 patients (mean age 59.8 ± 15.0 years) were enrolled at 22 U.S. sites between November 2017 and March 2019. Median device insertion to removal time was 37.0 (interquartile range: 23.5 to 60.0) min. Two (1.7%) patients received intraprocedural thrombolytics. Mean RV/LV ratio reduction from baseline to 48 h post-procedure was 0.43 (95% confidence interval: 0.38 to 0.47; p < 0.0001). Two (1.7%) patients experienced 3 major adverse events. Rates of cardiac injury, pulmonary vascular injury, clinical deterioration, major bleeding, and device-related death at 48 h were 0%, 1.7%, 1.7%, 1.7%, and 0.8%, respectively. In this prospective, multicenter study the Indigo aspiration system was associated with a significant reduction in the RV/LV ratio and a low major adverse event rate in submassive PE patients. Intraprocedural thrombolytic drugs were avoided in 98.3% of patients. (Evaluating the Safety and Efficacy of the Indigo aspiration system in Acute Pulmonary Embolism [EXTRACT-PE]; NCT03218566) [Display omitted]