FlowTriever Retrieval System for the treatment of pulmonary embolism: overview of its safety and efficacy

ABSTRACT

Introduction

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. There has been little change in PE mortality rates over the past two decades making this an appealing area for innovation and development.

Areas Covered

While anticoagulation (AC) and systemic thrombolysis (ST) are the mainstay treatments for high-risk PE and intermediate-high-risk PE with decompensation, advancements in catheter- based therapies offer potential alternatives. Areas covered here will include present guidelines for PE treatment and the landscape of catheter-directed therapies with a focus on the FlowTriever (FT) Retrieval System. Available safety and efficacy data will be reviewed. An online search via Google Scholar and PubMed with the keywords INARI Flowtriever, venous thromboembolism, and pulmonary embolism, alongside bibliographies of published articles, was undertaken as a review of the literature on the FlowTriever system for this device overview.

Expert opinion

The five-year outlook on the role of catheter-directed therapies in the management of PE includes continued innovation in catheter-directed therapies and a number of high-quality trials on the horizon.

KEYWORDS:

• Large bore embolectomy
• massive pulmonary embolism
• submassive pulmonary embolism
• high-risk pulmonary embolism
• intermediate-high-risk pulmonary embolism
• mechanical thrombectomy
• catheter-directed therapy
• non-lytic pulmonary embolism therapy

Article highlights

• Current guidelines recommend ST for the treatment of massive PE patients and those submassive PE patients who develop hemodynamic compromise. Catheter-based therapy is recommended for those who have a contraindication to, or have failed ST.

• The goal of treatment for high risk PE is to rapidly reverse hemodynamic instability given the high mortality associated with this diagnosis. For intermediate risk PE, goals are to expedite symptom resolution and avert hemodynamic decompensation.

• The risks and benefits of ST in intermediate risk PE are closely balanced against one another presenting an opportunity for catheter-based therapies. Thus far, limited data on catheter-based therapies demonstrate immediate improvement in RV dysfunction, but do not support a short-term mortality benefit with these therapies.

• Catheter embolectomy potentially has a lower chance of bleeding complications associated with the use of thrombolytic therapy; it rapidly improves RV dysfunction, but has yet to be systematically studied against other catheter-based therapies or against ST.

• Large bore catheter embolectomy with the FT system may be particularly well suited for the rapid removal of large and saddle PE. Single arm observational studies are underway looking at FT for high risk and intermediate risk PE.

Declaration of interest

VL Bishay is a consultant for Inari Medical. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This paper was not funded.