• Thomas Tu, Catalin Toma, Victor F Tapson, Christopher Adams, Wissam A Jaber, Mitchell Silver, Sameer Khandhar, Rohit Amin, Mitchell Weinberg, Tod Engelhardt, Monica Hunter, David Holmes, Glenn Hoots, Hussam Hamdalla, Robert L Maholic, Scott M Lilly, Kenneth Ouriel, Kenneth Rosenfield, and FLARE Investigators.
• Baptist Health Louisville, Louisville, Kentucky. Electronic address: ttu@bellsouth.net.
• JACC Cardiovasc Interv. 2019 May 13; 12 (9): 859-869.

ObjectivesThe aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a prospective trial of patients with acute intermediate-risk pulmonary embolism (PE).BackgroundCatheter-directed thrombolysis has been shown to improve right ventricular (RV) function in patients with PE. However, catheter-directed thrombolysis increases bleeding risk and many patients with PE have relative and absolute contraindications to thrombolysis.MethodsPatients with symptomatic, computed tomography-documented PE and RV/left ventricular (LV) ratios ≥0.9 were eligible for enrollment. The primary effectiveness endpoint was core laboratory-assessed change in RV/LV ratio. The primary safety endpoint comprised device-related death, major bleeding, treatment-related clinical deterioration, pulmonary vascular injury, or cardiac injury within 48 h of thrombectomy.ResultsFrom April 2016 to October 2017, 106 patients were treated with the FlowTriever System at 18 U.S. sites. Two patients (1.9%) received adjunctive thrombolytics and were analyzed separately. Mean procedural time was 94 min; mean intensive care unit stay was 1.5 days. Forty-three patients (41.3%) did not require any intensive care unit stay. At 48 h post-procedure, average RV/LV ratio reduction was 0.38 (25.1%; p < 0.0001). Four patients (3.8%) experienced 6 major adverse events, with 1 patient (1.0%) experiencing major bleeding. One patient (1.0%) died, of undiagnosed breast cancer, through 30-day follow-up.ConclusionsPercutaneous mechanical thrombectomy with the FlowTriever System appears safe and effective in patients with acute intermediate-risk PE, with significant improvement in RV/LV ratio and minimal major bleeding. Potential advantages include immediate thrombus removal, absence of thrombolytic complications, and reduced need for post-procedural critical care.Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.

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