Author + information
- Received September 18, 2018
- Revision received December 3, 2018
- Accepted December 18, 2018
- Published online May 6, 2019.
- Thomas Tu, MDa,∗∗ (, )
- Catalin Toma, MDb,∗,
- Victor F. Tapson, MDc,
- Christopher Adams, MDd,
- Wissam A. Jaber, MDe,
- Mitchell Silver, DOf,
- Sameer Khandhar, MDg,
- Rohit Amin, MDh,
- Mitchell Weinberg, MDi,
- Tod Engelhardt, MDj,
- Monica Hunter, MDk,
- David Holmes, MDl,
- Glenn Hoots, MDm,
- Hussam Hamdalla, MDn,
- Robert L. Maholic, MDo,
- Scott M. Lilly, MD, PhDp,
- Kenneth Ouriel, MDq,
- Kenneth Rosenfield, MDr,
- for the FLARE Investigators
- aBaptist Health Louisville, Louisville, Kentucky
- bUniversity of Pittsburgh Medical Center Heart and Vascular Institute, Pittsburgh, Pennsylvania
- cCedars-Sinai Medical Center, Los Angeles, California
- dCAMC Memorial Hospital, Charleston, West Virginia
- eEmory University Hospital, Atlanta, Georgia
- fOhioHealth Heart and Vascular Physicians, Columbus, Ohio
- gPenn Medicine, Philadelphia, Pennsylvania
- hSacred Heart Hospital Pensacola, Pensacola, Florida
- iNorth Shore University Hospital, Northwell Health, Manhasset, New York
- jEast Jefferson General Hospital, Metairie, Louisiana
- kSt. Vincent’s Birmingham, Birmingham, Alabama
- lEast Alabama Medical Center, Opelika, Alabama
- mTampa General Hospital, Tampa, Florida
- nEphraim McDowell Regional Medical Center, Danville, Kentucky
- oUniversity of Pittsburgh Medical Center Hamot, Erie, Pennsylvania
- pThe Ohio State University Wexner Medical Center, Columbus, Ohio
- qSyntactx, New York, New York
- rMassachusetts General Hospital, Boston, Massachusetts
- ↵∗Address for correspondence:
Dr. Thomas Tu, Baptist Health Louisville, 3900 Kresge Way, Suite 60, Louisville, Kentucky 40207.
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.
↵∗ Drs. Tu and Toma contributed equally to this work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The study sponsor (Inari Medical) was involved in study design and data collection but was not involved in the analysis or interpretation of data or manuscript preparation. Dr. Toma has received consulting fees from Abbott and Philips Volcano. Dr. Tapson has received research funding and consulting fees from Inari Medical, Bayer, Bio2, EKOS/BTG, Janssen, and Portola; and has received speaking honoraria (to Cedars-Sinai) from EKOS/BTG and Janssen. Dr. Jaber has served as a consultant for Inari Medical and AngioDynamics. Dr. Silver has served as a consultant for Inari Medical, Cook Medical, Boston Scientific, Gore Medical, and Noxsano Medical; serves on the Speakers Bureau for Bristol-Myers Squibb and Pfizer; and is a board member with ownership in Contego Medical. Dr. Amin serves as an advisor and a consultant for Inari Medical. Dr. Weinberg received grant support from Inari Medical in 2017; serves as a consultant for Medtronic and Cardiovascular Systems; and received a research grant from Cardiovascular Systems in 2017. Dr. Hunter is a speaker for Abbott; and has conducted research for the CSI Eclipse trial. Dr. Maholic was a speaker for Abbott; is currently a speaker and consultant for EKOS Corporation; is on the Board of Directors of the PERT Consortium. Dr. Ouriel holds equity in and is an employee of Syntactx, which received fees from Inari Medical for clinical trial management, core laboratory, and medical writing services performed for the FLARE trial. Dr. Rosenfield has received consulting fees from and serves on the scientific advisory boards of Abbott Vascular, Cordis, and Philips Volcano; has received consulting fees and served as a clinical trial consultant for Surmodics, the University of Maryland, and the Mayo Clinic; holds stock options in and serves on the scientific advisory boards of Endospan, Micell, Valcare, Shockwave, Capture Vascular, and Magneto; holds equity in and serves on the scientific advisory board of Embolitech; holds equity in PQ Bypass; has received consulting fees from, holds stock options in, and serves on the scientific advisory boards of Cruzar Medical Systems, Eximo, and Silk Road Medical; has received consulting fees, holds stock options and equity interest in, and serves on the scientific advisory boards of Contego and MD Insider; has received research support and served as a principal investigator for the National Institutes of Health; and has received an honorarium from and serves as a board member for VIVA Physicians.
- Received September 18, 2018.
- Revision received December 3, 2018.
- Accepted December 18, 2018.
- 2019 The Authors