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Clinical Trial
. 2019 May 13;12(9):859-869.
doi: 10.1016/j.jcin.2018.12.022.

A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study

Thomas Tu  1 , Catalin Toma  2 , Victor F Tapson  3 , Christopher Adams  4 , Wissam A Jaber  5 , Mitchell Silver  6 , Sameer Khandhar  7 , Rohit Amin  8 , Mitchell Weinberg  9 , Tod Engelhardt  10 , Monica Hunter  11 , David Holmes  12 , Glenn Hoots  13 , Hussam Hamdalla  14 , Robert L Maholic  15 , Scott M Lilly  16 , Kenneth Ouriel  17 , Kenneth Rosenfield  18 ; FLARE Investigators
Affiliations
Free article
Clinical Trial

A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study

Thomas Tu et al. JACC Cardiovasc Interv. .
Free article

Abstract

Objectives: The 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).

Background: Catheter-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.

Methods: Patients 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.

Results: From 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.

Conclusions: Percutaneous 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.

Keywords: RV/LV ratio; percutaneous mechanical thrombectomy; pulmonary embolism.

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Comment in

  • Moving Forward by Pulling Back?
    Pinto DS, Carroll BJ. Pinto DS, et al. JACC Cardiovasc Interv. 2019 May 13;12(9):870-872. doi: 10.1016/j.jcin.2019.01.218. JACC Cardiovasc Interv. 2019. PMID: 31072508 No abstract available.
  • Is a Flare at the Dawn of Pulmonary Embolism?
    Kaymaz C, Akbal ÖY, Karagöz A, Hakgör A, Tanyeri S. Kaymaz C, et al. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1743-1744. doi: 10.1016/j.jcin.2019.06.008. JACC Cardiovasc Interv. 2019. PMID: 31488305 No abstract available.
  • Reply: Is a Flare at the Dawn of Pulmonary Embolism?
    Tu T. Tu T. JACC Cardiovasc Interv. 2019 Sep 9;12(17):1744-1745. doi: 10.1016/j.jcin.2019.06.040. JACC Cardiovasc Interv. 2019. PMID: 31488306 No abstract available.

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