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.
Acute pulmonary embolism (PE) remains the third leading cause of cardiovascular-related death in the United States (1,2). Patients with intermediate-risk PE show evidence of right ventricular (RV) strain on imaging and biochemical markers, without overt hemodynamic instability (3,4). The optimal treatment for this group remains undefined. These patients have significantly higher event rates than those with low-risk PE, suggesting that a more aggressive therapeutic approach is needed (3). Systemic thrombolysis for intermediate-risk PE was studied in the PEITHO (Pulmonary Embolism Thrombolysis) trial, demonstrating a reduction in the combined endpoint of mortality and hemodynamic deterioration. However, there was an increase in fatal and intracranial bleeding (4). Recently, catheter-based interventions have been used to treat intermediate- and high-risk PE. Catheter-directed thrombolysis (CDT) has been shown to be effective at reducing the RV/left ventricular (LV) ratio faster than anticoagulation alone (5). However, CDT still poses risk for major bleeding and is contraindicated for a sizable proportion of the PE population (6).
Percutaneous mechanical thrombectomy may avoid the potential complications associated with thrombolytic therapy, though it has not yet been studied systematically. Current guidelines recommend catheter-based mechanical thrombectomy only for hypotensive patients who have high bleeding risk, failed thrombolysis, or shock (7). We hereby report the first investigational device exemption trial outcomes for a mechanical thrombectomy device as treatment for acute intermediate-risk PE (NCT02692586).
The FLARE (FlowTriever Pulmonary Embolectomy Clinical Study) was a prospective, single-arm, multicenter investigational device exemption trial in which patients with acute intermediate-risk PE were treated with the FlowTriever Retrieval/Aspiration System (Inari Medical, Irvine, California). Inari Medical sponsored this study.
Patients 18 to 75 years of age with symptomatic, computed tomography (CT)–documented proximal PE of ≤14 days’ duration were eligible for enrollment. Patients were required to be hemodynamically stable with no vasopressor requirement, heart rate <130 beats/min, systolic blood pressure ≥90 mm Hg at baseline assessment, and site-reported RV/LV ratio (on the basis of CT) of ≥0.9. Exclusion criteria included thrombolytic therapy within 30 days of baseline assessment, active cancer, or contraindication to anticoagulant therapy (full inclusion and exclusion criteria are listed in Online Table 1). Patients with recent surgery and other high bleeding risks were not excluded.
Device description and study procedure
The FlowTriever Retrieval/Aspiration System is a single-use mechanical thrombectomy device indicated for use in the peripheral vasculature and pulmonary arteries (PAs). It received U.S. Food and Drug Administration 510(k) clearance for the PE indication in May 2018. Large-bore femoral venous access (20- to 22-F) is required. Anticoagulation with heparin is recommended per routine catheterization laboratory practice to prevent thrombosis of the catheter. The 20-F aspiration guide catheter (AGC) is advanced over a 0.035-inch wire to the level of the right or left PA, just proximal to the occlusive thrombus. The FlowTriever Catheter (Figure 1A) is then advanced through the AGC (Figure 1B) over the guidewire, and the disks are deployed into the clot. Once engaged, the clot is extracted via aspiration through the AGC. The AGC is then removed and cleared of the aspirated thrombus and can be reinserted. The procedure can be repeated several times per side at the discretion of the physician, depending on the amount of clot retrieved and the improvement in distal flow on repeat angiography. Three different FlowTriever sizes are available (6 to 10, 11 to 14, and 15 to 18 mm), depending on the size of the vessel. A single FlowTriever or any combination of the 3 can be used during a given procedure.
Pulmonary angiography and evaluation of hemodynamic parameters were performed per site-specific protocols (Figure 2). Hemodynamic measurements were obtained pre- and post-procedure. Following thrombectomy, use of adjunctive local thrombolytic therapy was per operator discretion. Patients treated with thrombolytic agents were excluded from subsequent analyses. Patients underwent protocol-mandated CT angiography at 48 h for measurement of the primary endpoint and clinical follow-up visits at 48 h and 30 days.
Definitions and endpoints
Data management was provided by Syntactx (New York, New York). Pre- and post-procedure CT scans were evaluated by the Syntactx core laboratory (Figure 3). RV/LV ratio was measured using multiplanar reformatted reconstructions from CT angiographic images (the modified Quiroz technique) to obtain measurements of the short axis of each ventricle (8). A refined modified Miller score was used to quantify thrombus burden, with scores totaling up to 20 points per side (8,9). The primary effectiveness endpoint was the change in RV/LV ratio from baseline to 48 h (±8 h or discharge, whichever occurred first), as assessed using CT angiography. The primary safety endpoint was a composite major adverse event (MAE) rate, defined as any of the following events within 48 h of treatment: device-related death, major bleeding, treatment-related clinical deterioration, treatment-related pulmonary vascular injury, and treatment-related cardiac injury. Bleeding events meeting the criteria of life threatening or disabling bleeding or major bleeding per the Valve Academic Research Consortium-2 guidelines were considered major bleeding events (10). Cardiac injury and pulmonary vascular injury were defined as injury to the heart (or major pulmonary arterial branch) requiring intervention. Clinical deterioration comprised treatment-related events such as unplanned requirement for mechanical ventilation, arterial hypotension (>1 h or requiring vasopressors), cardiopulmonary resuscitation, persistent worsening in oxygenation, or emergency surgical embolectomy. A secondary safety endpoint comprised all primary safety events as well as mortality, device-related serious adverse events (SAEs) and symptomatic recurrence of embolism within 30 days of index procedure. An independent medical monitor reviewed all adverse events and referred any major events to a clinical events committee for adjudication. A data and safety monitoring board assessed safety-related events in the aggregate.
Study subjects with no thrombolytic agents administered during the index procedure (n = 104) formed the modified intention-to-treat (mITT) population (Online Figure 1). Baseline demographic and clinical data, procedural characteristics, safety outcomes, and effectiveness outcomes were assessed for the mITT population. It was estimated that mean reduction in RV/LV ratio in mITT patients (the primary effectiveness endpoint) would be >0.12, on the basis of the average RV/LV ratio (0.12) observed across 4 randomized controlled trials (RCTs) in which acute PE was treated with anticoagulant agents (Online Appendix). It was estimated that <25% of study subjects would experience MAEs (the primary safety endpoint), on the basis of the upper limit of the 95% confidence interval for the average composite MAE rate (16.3%) observed across 7 RCTs in which acute PE was treated with thrombolysis compared with an anticoagulant control (Online Appendix). The hypothesized composite MAE rate was expected to be about 13%.
Pre-specified effectiveness analyses were conducted to assess whether there was heterogeneity across study sites with regard to the primary effectiveness endpoint (mean change in RV/LV ratio). Pre-specified effectiveness and safety regression analyses assessed whether key baseline characteristics significantly affected primary endpoints. A p value of <0.05 was considered to indicate statistical significance. Summary statistics were presented as mean ± SD or number (percentage). Comparisons of clinical and hemodynamic characteristics before and after the index procedure were conducted with paired Student’s t-tests or the Fisher exact test.
Baseline demographics and procedural characteristics
From April 2016 to October 2017, 106 patients with acute intermediate-risk PE were enrolled at 18 U.S. sites. A majority were male (53.8%); the average age was 55.6 years (Table 1). Residual deep vein thrombosis was observed in 73 patients (70.2%). The overwhelming majority of patients (90.4%) presented with site-assessed bilateral PE. Forty-six patients (44.2%) had a simplified PE severity index score of at least 1 (11). Elevated cardiac troponin and natriuretic peptides were observed in 59.6% and 72.4% of patients, respectively (Table 1).
One hundred one patients (97%) were on anticoagulation pre-procedure. Femoral vein access was used in all cases (Table 2). Total AGC time was 57.1 min; total procedural time was 93.8 min. Technical complications occurred in 2 patients. In both cases, the catheter kinked after device removal, necessitating that a new device be used for additional passes. This did not affect either procedure, as kinking occurred after device removal; both patients experienced good outcomes. Two patients (1.9%) received thrombolytics immediately following thrombectomy and were thus not included in the mITT population (inclusion of these 2 patients in analyses did not change any results appreciably). This was done at the investigator’s discretion because of perceived large thrombus burden in both cases and not because of clinical decompensation. These 2 patients both exhibited significant reduction in RV/LV ratio post-procedure (RV/LV ratio reductions of 0.65 and 0.31), with neither patient experiencing any adverse events through 30-day follow-up.
Length of intensive care unit stay averaged 1.5 days, with 43 patients (41.3%) not requiring any intensive care unit stay. Average hospital stay was 4.1 days. All 104 mITT patients had 48-h follow-up assessment; 101 patients (97.1%) had available 30-day follow-up, with 2 patients lost to follow-up. All patients were treated with anticoagulant therapy at the 48-h visit.
The primary effectiveness endpoint of the study was reduction in RV/LV ratio. At baseline assessment, average RV/LV ratio was 1.56 (n = 104). Following thrombectomy, 101 patients had 48-h RV/LV ratio measurement (1.15, on average). In these 101 patients, RV/LV ratio decreased by 0.38 on average (p < 0.0001) (Figure 4). This equated to an average post-procedural RV/LV reduction of 25.1%; the FlowTriever System was considered to have met its performance goal (p < 0.0001). A pre-specified primary effectiveness analysis found no evidence of site heterogeneity in effectiveness outcomes (p = 0.85, analysis of variance). A pre-specified regression analysis found no baseline variables to be significantly predictive of effectiveness outcomes.
Average post-procedural mean PA pressure (mPAP) decreased significantly from pre-procedure (29.8 mm Hg vs. 27.8 mm Hg, respectively, p = 0.001). This effect was limited largely to the 70 patients with pulmonary hypertension on presentation (>25 mm Hg). These patients exhibited a 3.2 mm Hg reduction in mPAP (p < 0.0001) (Figure 5). Conversely, there was no difference in mPAP (0.8 mm Hg) in those patients who presented with normal mPAP (p = .79) (Figure 5). A small but statistically significant change in anatomic degree of thrombus was also observed, as measured by computed tomography (pre-procedural refined modified Miller score of 20.8 ± 2.4 vs. 18.9 ± 2.9 at post-procedure; p < 0.001). There were no significant changes in blood pressure, heart rate, and oxygen saturation immediately following the procedure; however, significant differences were observed within 30 days (Online Table 2).
Four patients (3.8%) experienced 6 MAEs within 48 h of the index procedure. This rate (as well as the upper 95% confidence limit, 8.6%) was significantly lower than the performance goal of <25% (p < 0.0001). All MAEs were adjudicated by the clinical events committee to be procedure related but not device related: all 4 patients exhibited clinical deterioration: 1 major bleeding event and 1 pulmonary vascular injury (the major bleeding event experienced by 1 patient was also classified as pulmonary vascular injury and clinical deterioration). This patient experienced intraprocedural pulmonary hemorrhage likely due to pulmonary infarct and reperfusion injury, requiring a lower lobectomy. Surgical pathologic results reported residual thrombus in the PAs but did not observe PA injury. Two patients with minimal thrombus removal during thrombectomy experienced respiratory deterioration during or immediately after the procedure requiring emergent intubation. Last, 1 patient became agitated during the procedure, required increasing sedation, and had a ventricular fibrillation event requiring cardioversion and emergent intubation. Underlying coronary disease with ST-segment elevation was diagnosed, with coronary angioplasty and stenting performed before resuming thrombectomy.
An additional 10 patients experienced SAEs within 30 days of index procedure, with no further events adjudicated by the clinical events committee to be device or procedure related. In total, 14 patients (13.2%) experienced 26 SAEs within 30 days, with 5 patients experiencing multiple SAEs (Online Table 3). One patient died 23 days after the index procedure because of respiratory failure from undiagnosed metastatic breast cancer. No baseline variables were found to be significantly associated with composite MAE rate in a pre-specified regression analysis.
In this first report of prospective trial outcomes with a percutaneous thrombectomy device for acute intermediate-risk PE, we report an acceptable effectiveness profile comparable with that observed with CDT, with an average RV/LV ratio reduction of 0.38 (25.1%). This was achieved with a favorable safety profile and a composite MAE rate of 3.8%.
The acute mortality in PE is driven by hemodynamic compromise due to RV failure. RV dilatation associated with acute cor pulmonale is a strong predictor of mortality in PE. Schoepf et al. (12) found that patients with baseline RV/LV ratios >0.9 were 3.4 times more likely to die within 30 days of initial diagnostic chest CT scan. A meta-analysis investigating CT predictors for short-term PE outcomes found that across 49 studies and 13,162 patients with acute PE, RV/LV diameter ratio was the strongest predictor of short-term mortality and adverse outcomes (more so than thrombus load and PE location, which were not significantly predictive) (13). In addition to its prognostic role, the RV/LV ratio change has been used as a marker of therapeutic effectiveness. In the ULTIMA (Ultrasound Accelerated Thrombolysis of Pulmonary Embolism) RCT comparing CDT with the EkoSonic device versus anticoagulation alone, investigators found that CDT was superior to anticoagulation in RV/LV ratio reduction (5). There was no change in RV/LV ratio with anticoagulation alone at 24 to 48 h. SEATTLE II (A Prospective, Single-Arm, Multi-Center Trial of EkoSonic Endovascular System and Activase for Treatment of Acute Pulmonary Embolism) confirmed device effectiveness (6).
Although these studies all enrolled similar patients, the baseline RV/LV ratio can be used as an overall measure of the severity of PE and clinical risk. In ULTIMA, it was 1.28 ± 0.19, indicating a generally lower risk population. The SEATTLE II baseline RV/LV was 1.55 ± 0.39, which was very similar to the FLARE study population. The RV/LV ratio reduction observed in FLARE of 0.38 compares favorably with the 0.34 value reported in recent meta-analysis of the CDT trials (14). This reduction was associated with a significant but modest reduction in the anatomic degree of PA obstruction on CT imaging.
Although effective at reducing RV strain, bleeding remains a concern with CDT. Dreaded intracerebral hemorrhage (ICH), although rare, has been reported at a rate of 1.5%, with major bleeding occurring in 9.3% of patients (15). Bleeding, including ICH, can occur even with reduced thrombolytic dosing (9). The major bleeding rate observed in FLARE was 0.9%, notably with no ICH, indicating an excellent safety profile from a bleeding standpoint. No major vascular complications were seen, despite the large-bore vascular access required for this procedure. There were no device-related pulmonary or cardiac injury events. There were 4 patients with clinical deterioration during the procedure, similar to the incidence with CDT (16), and possibly related to additional embolization, progression of RV dysfunction, or respiratory failure. In a similar patient population from the PEITHO trial, the rate of clinical deterioration with anticoagulation alone was reported at 5% (4). Thus, these data demonstrate a favorable safety profile of percutaneous mechanical thrombectomy with the FlowTriever device in intermediate-risk PE.
The optimal treatment of intermediate-risk PE remains to be determined (17). Current guidelines recommend anticoagulation alone, with catheter intervention reserved for patients who fail to respond to conservative therapy (7). Although it is universally agreed that patients with RV dilation, elevated biomarkers, and residual deep vein thrombosis (such as the patients included in our study) are at higher risk for deterioration (3), no therapy in addition to anticoagulation has yet been demonstrated to have an impact on hard clinical events. In PEITHO, systemic tenecteplase did result in a significant reduction in the combined primary endpoint of death and clinical deterioration. This benefit was offset by increased major bleeding and ICH (4). Other than the ULTIMA trial and registry evidence, the impact of CDT on clinical outcomes relative to conservative therapy has not been studied in a rigorous fashion (5,16). A therapeutic approach based on percutaneous mechanical thrombectomy has several advantages. First, it can potentially achieve similar hemodynamic benefit as systemic or local thrombolysis, but in a more rapid fashion. Indeed, in the present study, patients presenting with pulmonary hypertension achieved a significant decrease in PA pressure immediately following thrombectomy. Second, FlowTriever thrombectomy can be used for patients who are at high risk for bleeding, such as post-operative patients, who represent about 30% of the PE population. In ICOPER (International Cooperative Pulmonary Embolism Registry), 28.9% patients had recent surgery, 11.2% had recent trauma, 4.4% had low platelets, and 2.4% had active bleeding (18). These patients are thought to be too high risk for either systemic or local thrombolysis. Third, mechanical thrombectomy has the potential to positively affect hospital costs, given the reduced need for ICU stay and short hospital stay, as illustrated in this study.
Although FLARE represents the largest systematic evaluation of the effectiveness of mechanical thrombectomy for PE, several other devices have been used for thrombectomy. The AngioJet rheolytic thrombectomy device (Boston Scientific, Marlborough, Massachusetts) has been used for intermediate- and high-risk PE (19–21); however, there is currently a Food and Drug Administration–issued black-box warning for its use in the PAs because of reported procedural complications and mortality (often caused by hemoptysis) (22). Experience with the large caliber AngioVac suction thrombectomy system (AngioDynamics, Latham, New York) for PE has been limited because of procedural complexity and high resource expenditure (23–26). Technical success for this indication was relatively low at 12.5%, related primarily to the difficulty in directing this catheter into the PA (23). The Indigo aspiration mechanical thrombectomy system (Penumbra, Alameda, California), originally designed for peripheral thrombectomy, is currently being investigated for use in PE (27,28). Because of its small-caliber (8-F) catheter; however, the efficiency of clot removal may be limited, and the potential for blood loss is significant. The unique features of the FlowTriever System were designed to achieve successful thrombectomy in a variety of clinical scenarios (29–31). The AGC was designed to be easily trackable through the right heart and PAs, with a braided shaft for kink resistance and with a lumen large enough to be effective at removal of large pulmonary emboli.
Treatment of acute PE using percutaneous thrombectomy is more technically demanding than CDT. Using the FlowTriever device requires familiarity with the pulmonary vasculature and expertise to maneuver the flexible AGC through the right ventricle and into position in the PA. An experienced interventionalist requires approximately 3 to 5 cases to optimize procedural technique with the device. Despite the technical learning curve, it should be noted that the majority of study sites enrolled fewer than 5 patients, yet no site heterogeneity was observed regarding effectiveness outcomes, and complications were minimal. There were no instances of cardiac injury and only 1 noted instance of pulmonary vascular injury in the trial, and this was adjudicated as procedure-related, not device-related; the resulting pulmonary hemorrhage led to subsequent embolectomy). Notably, despite the large-caliber venous access required for the FlowTriever, there were no instances of device-related vascular injury. Nevertheless, additional work will be required to optimize use of this device and to define the optimal patients and timing for intervention.
The primary limitation of this trial was its nonrandomized design and the lack of a comparator arm, though study performance goals were established from pooled endpoints attained from systemic thrombolysis versus anticoagulation RCTs. The study design also stipulated study exit at 30 days, limiting data to short-term outcomes. This study assessed the performance of the FlowTriever System specifically in patients with proximal intermediate-risk PE. Further study will be required to assess the effect in low or high-risk PE. In the future, comparative studies and analyses directly assessing long-term clinical benefit with percutaneous thrombectomy compared with CDT in a similar patient population would be valuable.
Mechanical thrombectomy with the FlowTriever System appears safe and effective for treatment of patients with acute intermediate-risk PE, with significant acute improvement in RV function and minimal bleeding complications. Further studies are needed to comparatively evaluate this therapy against other catheter-directed and pharmacological approaches.
WHAT IS KNOWN? CDT has been shown to improve RV function in patients with intermediate-risk PE. However, it is associated with risk for serious bleeding and is contraindicated in patients at high risk for bleeding.
WHAT IS NEW? Mechanical thrombectomy using the FlowTriever system, without thrombolysis, appears safe and effective to treat intermediate-risk PE and should now be considered as a potential therapy for this condition.
WHAT IS NEXT? A future study will assess safety and hemodynamic improvement in a larger cohort of patients. Further investigation will be required to discriminate which therapy (anticoagulation, CDT, mechanical thrombectomy) would be best for which patients.
Dana Bentley (Syntactx) wrote the initial draft of this paper and provided medical writing services.
↵∗ 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.
- Abbreviations and Acronyms
- aspiration guide catheter
- catheter-directed thrombolysis
- computed tomography/tomographic
- intracerebral hemorrhage
- left ventricular
- major adverse event
- modified intention-to-treat
- mean pulmonary artery pressure
- pulmonary artery
- pulmonary embolism
- randomized controlled trial
- right ventricular
- serious adverse event
- Received September 18, 2018.
- Revision received December 3, 2018.
- Accepted December 18, 2018.
- 2019 The Authors
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