Invasive Strategies for the Treatment of Pulmonary Embolism. Where Are We in 2020?

Abstract

Pulmonary Embolism (PE) is the third most common cause of cardiovascular mortality in the United States, with 60,000-100,000 deaths per year following myocardial infarction and stroke. During the past 5 years, there has been an introduction of novel interventions as a result of a renewed interest in optimizing PE management, particularly among those individuals with more severe disease of hemodynamic significance. The cornerstone treatment for PE is anticoagulation. More aggressive alternatives have been considered for patients with intermediate and high-risk PE. In general, these options can be grouped into 3 different categories: systemic thrombolysis, catheter-directed interventions, and surgical embolectomy. Systemic thrombolysis has shown statistical benefit in several randomized trials for intermediate- and high-risk PE, however, this benefit has been offset by an elevated risk of major bleeding and intracerebral hemorrhage, limiting their use in clinical practice. Catheter-directed thrombolysis refers to catheter-directed injection of a thrombolytic drug directly into the pulmonary artery. Three interventional devices (EKOSonic endovascular system, FlowTriever embolectomy device and the Indigo thrombectomy system) have recently been cleared by the US Food and Drug Administration for marketing, and several others are in various stages of development. As of today, catheter-based interventions are limited to small randomized trials and single arm-prospective studies focused on short-term surrogate endpoints. Although single arm studies carry some value establishing the preliminary safety and effectiveness of these devices, they are not sufficient to stratify risk and guide clinical practice. Furthermore, no trials have been performed with enough power to assess potential mortality benefit with the use of catheter-directed thrombolysis or catheter-based embolectomy devices, hence treatment decisions continue to be influenced by individual risk of bleeding, the location of thrombus and operator expertise until additional evidence becomes available.