Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device

Wible, Brandt C.; Buckley, Jennifer R.; Cho, Kenneth H.; Bunte, Matt C.; Saucier, Nathan A.; Borsa, John J.

doi:10.1016/j.jvir.2019.05.024

Cited by 80 publications

(32 citation statements)

References 28 publications

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“…The use of IVC filters has declined as our experience using mechanical thrombectomy has grown. 33 Our study underscores the heterogeneity of patients treated for PE. This analysis highlights the routine clinical presentations and variability in care that may not be well represented in tightly controlled clinical trials of submassive or high-risk PE.…”

Section: Discussionmentioning

confidence: 65%

Bleeding, death, and costs of care during hospitalization for acute pulmonary embolism: Insights from the Saint Luke’s Outcomes of Pulmonary Embolism (SLOPE) study

et al. 2020

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Limited data exist that comprehensively describe the practical management, in-hospital outcomes, healthcare resource utilization, and rates of post-hospital readmission among patients with submassive and massive pulmonary embolism (PE). Consecutive discharges for acute PE were identified from a single health system over 3 years. Records were audited to confirm presence of acute PE, patient characteristics, disease severity, medical treatment, and PE-related invasive therapies. Rates of in-hospital major bleeding and death, hospital length of stay (LOS), direct costs, and hospital readmission are reported. From January 2016 to December 2018, 371 patients were hospitalized for acute massive or submassive PE. In-hospital major bleeding (12.1%) was common, despite low utilization of systemic thrombolysis (1.8%) or catheter-directed thrombolysis (3.0%). In-hospital death was 10-fold higher among massive PE compared to submassive PE (36.6% vs 3.3%, p < 0.001). Massive PE was more common during hospitalizations not primarily related to venous thromboembolism, including hospitalizations primarily for sepsis or infection (26.8% vs 8.2%, p = 0.001). Overall, the median LOS was 6.0 days (IQR, 3.0–11.0) and the median standardized direct cost of admissions was $10,032 (IQR, $4467–$20,330). Rates of all-cause readmission were relatively high throughout late follow-up but did not differ between PE subgroups. Despite low utilization of thrombolysis, in-hospital bleeding remains a common adverse event during hospitalizations for acute PE. Although massive PE is associated with high risk for in-hospital bleeding and death, those successfully discharged after a massive PE demonstrate similar rates of readmission compared to submassive PE into late follow-up.

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Section: Discussionmentioning

confidence: 65%

Bleeding, death, and costs of care during hospitalization for acute pulmonary embolism: Insights from the Saint Luke’s Outcomes of Pulmonary Embolism (SLOPE) study

et al. 2020

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“…Finally, the recent Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism (FLARE) study demonstrated that the use of the FlowTriever Catheter-directed embolectomy device significantly improved the RV/LV ratio of patients with intermediate-risk PE 28 . A recently published retrospective study on 46 patients from a single centre confirmed improvement in mean pulmonary artery pressure 37 . Therefore, this device may represent another suitable alternative to anticoagulation.…”

Section: Evolving Reperfusion Strategies To Improve Early Outcomesmentioning

confidence: 98%

“…In the FLARE study on FlowTriever, 4/106 (3.8%) patients experienced six major adverse events all adjudicated to be procedure related and not device related, including one major bleeding, two pulmonary vascular injuries, two respiratory deteriorations, and one ventricular fibrillation; an additional 14 patients experienced other not otherwise specified serious adverse events with a broad definition, none adjudicated to be device or procedure related, as well as two malfunctions 28 . A recent single-centre retrospective study reported 2/46 (4.3%) complications, including a self-limited haemoptysis and an acute anaemia 37 . Of the studies on EkoSonic, SEATTLE II reported no procedural complications, 35 ULTIMA reported no serious adverse events related to the study treatment, 34 and OPTALYSE PE did not report on non-death and non-bleeding safety outcomes 36 …”

Section: Evolving Reperfusion Strategies To Improve Early Outcomesmentioning

confidence: 99%

Immediate and late impact of reperfusion therapies in acute pulmonary embolism

Valerio

Klok

2019

European Heart Journal Supplements

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Haemodynamic instability and right ventricular dysfunction are the key determinants of short-term prognosis in patients with acute pulmonary embolism (PE). Residual thrombi and persistent right ventricular dysfunction may contribute to post-PE functional impairment, and influence the risk of developing chronic thromboembolic pulmonary hypertension. Patients with haemodynamic instability at presentation (high-risk PE) require immediate primary reperfusion to relieve the obstruction in the pulmonary circulation and increase the chances of survival. Surgical removal of the thrombi or catheter-directed reperfusion strategies is alternatives in patients with contraindications to systemic thrombolysis. For haemodynamically stable patients with signs of right ventricular overload or dysfunction (intermediate-risk PE), systemic standard-dose thrombolysis is currently not recommended, because the risk of major bleeding associated with the treatment outweighs its benefits. In such cases, thrombolysis should be considered only as a rescue intervention if haemodynamic decompensation develops. Catheter-directed pharmaco-logical and pharmaco-mechanical techniques ensure swift recovery of echocardiographic and haemodynamic parameters and may be characterized by better safety profile than systemic thrombolysis. For survivors of acute PE, little is known on the effects of reperfusion therapies on the risk of chronic functional and haemodynamic impairment. In intermediate-risk PE patients, available data suggest that systemic thrombolysis may have little impact on long-term symptoms and functional limitation, echocardiographic parameters, and occurrence of chronic thromboembolic pulmonary hypertension. Ongoing and future interventional studies will clarify whether ‘safer’ reperfusion strategies may improve early clinical outcomes without increasing the risk of bleeding and contribute to reducing the burden of long-term complications after intermediate-risk PE.

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“…Access is provided via a 22 F introducer sheath and the catheter is pushed through the aspiration cannula into the thrombus. Once out of the cannula, the disks are deployed and facilitate clot aspiration by the aspiration cannula in a similar way to stent retriever thrombectomy for stroke treatment [ 34 , 35 , 36 ]. A recent prospective multicentre trial demonstrated the efficacy and safety of the FlowTriever system with a major complication rate of 3.8% and the need for adjunctive thrombolytics in only 2% of patients [ 36 ] .…”

Section: State Of the Art Of Reperfusion Therapiesmentioning

confidence: 99%

Endovascular therapies for pulmonary embolism

Rousseau

Giudice²,

Sanchez

et al. 2021

Heliyon

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Purpose The aim of this article is to define the place of new endovascular methods for the management of pulmonary embolisms (PE), on the basis of a multidisciplinary consensus. Method and results Briefly, from the recent literature, for high-risk PE presenting with shock or cardiac arrest, systemic thrombolysis or embolectomy is recommended, while for lowrisk PE, anticoagulation alone is proposed. Normo-tense patients with PE but with biological or imaging signs of right heart dysfunction constitute a group known as “at intermediate risk” for which the therapeutic strategy remains controversial. In fact, some patients may require more aggressive treatment in addition to the anticoagulant treatment, because approximately 10% will decompensate hemodynamically with a high risk of mortality. Systemic thrombolysis may be an option, but with hemorrhagic risks, particularly intra cranial. Various hybrid pharmacomechanical approaches are proposed to maintain the benefits of thrombolysis while reducing its risks, but the overall clinical experience of these different techniques remains limited. Patients with high intermediate and high risk pulmonary embolism should be managed by a multidisciplinary team combining the skills of cardiologists, resuscitators, pneumologists, interventional radiologists and cardiac surgeons. Such a team can determine which intervention – thrombolysis alone or assisted, percutaneous mechanical fragmentation of the thrombus or surgical embolectomy – is best suited to a particular patient. Conclusions This consensus document define the place of endovascular thrombectomy based on an appropriate risk stratification of PE.

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Safety and Efficacy of Acute Pulmonary Embolism Treated via Large-Bore Aspiration Mechanical Thrombectomy Using the Inari FlowTriever Device

Cited by 80 publications

References 28 publications

Bleeding, death, and costs of care during hospitalization for acute pulmonary embolism: Insights from the Saint Luke’s Outcomes of Pulmonary Embolism (SLOPE) study

Bleeding, death, and costs of care during hospitalization for acute pulmonary embolism: Insights from the Saint Luke’s Outcomes of Pulmonary Embolism (SLOPE) study

Immediate and late impact of reperfusion therapies in acute pulmonary embolism

Endovascular therapies for pulmonary embolism

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