1Suhail Dohad,2Michael Rosenberg, 3Michael Rosenberg, 4James M. Horowitz
1Smidt Heart Institute, Cedars-Sinai Medical Center, 2Department of Radiology, Rush University, 3Department of Radiology, University of Minnesota, 4Department of Radiology, NYU Grossman School of Medicine
The EXTRACT-PE trial evaluated safety and performance of the Indigo Aspiration System (Penumbra, Inc.) with an 8F system for the treatment of pulmonary embolism (PE) without use of thrombolytics. This subgroup analysis evaluates performance outcomes of patients with main pulmonary artery (PA) emboli versus discrete unilateral or bilateral PA emboli without main PA involvement.
Material(s) and Method(s):
The EXTRACT-PE trial was a prospective, single-arm, multicenter trial that enrolled 119 patients with acute submassive PE. Emboli location was collected at the time of enrollment; patients were then grouped based on whether emboli involved the main PA (with or without branch vessels) or not (branch vessels alone). CT obstruction was measured using the Qanaldi method (Core Lab). Procedural device time and changes in right ventricle to left ventricle (RV/LV) ratio and systolic PA pressure from before to after treatment with continuous mechanical aspiration thrombectomy were compared between the groups.
Out of the 119 patients enrolled, 44 (37.0%) had emboli that involved the main PA and 75 (63.0%) branch emboli. No significant difference was observed between these groups for procedural device time, changes in RV/LV ratio or for systolic PA pressure from before to after treatment. Mean absolute reduction in clot burden was significant in both groups, main PA 3.6 (p = .03) and branch vessels 5.8 (p = .0004).
The Indigo Aspiration System was effective at improving clinical outcomes for submassive PE patients regardless of emboli location. Clot burden was significantly reduced in both groups.