Mechanical Thrombectomy of Pulmonary Emboli With Use of the Indigo System and Lightning 12 Intelligent Aspiration

Abstract

Contemporary treatments for pulmonary embolism (PE) fall into 4 broad categories: systemic anticoagulation, systemic thrombolysis (ST), catheter-directed thrombolysis (CDT), and mechanical thrombectomy (MT). In general, MT has several advantages over CDT and ST in the treatment of submassive and potentially massive PE. This article describes a promising device that enables MT, and an illustrative case is presented. In the SEATTLE II (Submassive and Massive Pulmonary Embolism Treatment With Ultrasound Accelerated Thrombolysis Therapy) trial, which evaluated CDT, thrombolytic agents were associated with a >10% rate of bleeding complications.1 The results in an ST trial, PEITHO (Pulmonary Embolism Thrombolysis Study), were similar.2 In the SEATTLE II trial, thrombolytic agents were given to patients in intensive care for 12 to 24 hours; in the more recent OPTALYSE PE (Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism) trial, CDT was performed in as short a time as 4 hours.3 In contrast, MT is potentially more rapid, and it is safe, effective, and performed on the catheterization laboratory table. Early success with use of the 8F Indigo CAT 8 system (Penumbra, Inc.) for pulmonary thrombectomy prompted the EXTRACT-PE (Evaluating the Safety and Eff icacy of the Indigo Aspiration System in Acute Pulmonary Embolism) trial.4 This single-arm study in 119 patients with submassive PE showed signif icantly reduced right ventricular-to-left ventricular ratios at 48 hours (0.43 ratio reduction; 95% CI, 0.38–0.47; P <0.0001). In addition, procedural pulmonary artery (PA) pressures were reduced in as little as 37 minutes of median overall procedure time. Adjunctive thrombolytic use was minimal (1.7% of patients) and safe (rates of pulmonary vascular injury, clinical deterioration, and major bleeding at 48 hr, all 1.7%; 30-d mortality rate, 2.5%). In the United States, this trial led to the designation of PE as an indication for use of the Indigo CAT 8 system and later the Lightning 8 and Lightning 12 Intelligent Aspiration systems (Penumbra).