Interventional Therapies for Acute Pulmonary Embolism: Current Status and Principles for the Development of Novel Evidence: A Scientific Statement From the American Heart Association

Abstract

Pulmonary embolism (PE) represents the third leading cause of cardiovascular mortality. The technological landscape for management of acute intermediate- and high-risk PE is rapidly evolving. Two interventional devices using pharmacomechanical means to recanalize the pulmonary arteries have recently been cleared by the US Food and Drug Administration for marketing, and several others are in various stages of development. The purpose of this document is to clarify the current state of endovascular interventional therapy for acute PE and to provide considerations for evidence development for new devices that will define which patients with PE would derive the greatest net benefit from their use in various clinical settings. First, definitions and limitations of commonly used risk stratification tools for PE are reviewed. An adjudication of risks and benefits of available interventional therapies for PE follows. Next, considerations for optimal future evidence development in this field are presented in the context of the current US regulatory framework. Finally, the document concludes with a discussion of the pros and cons of the rapidly expanding PE response team model of care delivery.

COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up

“…During the COVID-19 pandemic, similar to other consultative services, PERTs should transition from in-person inpatient evaluation to e-consults using phone calls or telemedicine systems whenever feasible. It is important to note that, there are minimal available data demonstrating lower mortality from routine use of advanced VTE therapies (91,92). Therefore, the use of catheter-directed therapies during the current outbreak should be limited to the most critical situations.…”

Safety of Therapeutic Anticoagulation with Low-Molecular-Weight Heparin or Unfractionated Heparin Infusion during Catheter-Directed Thrombolysis for Acute Pulmonary Embolism

“…(3) classification), thus attempting to clarify the question of anticoagulation during CDT while facilitating future comparisons and meta-analyses (13). The current study reports GUSTO-major (1.9%, including a single intracranial hemorrhage), GUSTO-moderate (1.9%), and GUSTO-minor (2.6%) complication rates that are similar (13,14) or lower (15,16) than those reported in studies using full therapeutic-dose anticoagulation (14,15), the GUSTO (16) classification, and in a meta-analysis (13). The SEATTLE II trial (16), the largest CDT trial to use GUSTO criteria, reported 0.7% GUSTO-major complications (1 groin Final systolic PAP (mmHg) 42.5 ± 11.6 42.5 ± 11.9 42.5 ± 11.5 .9…”

Catheter-Directed Thrombolysis With Ultrasound Assistance for Acute Pulmonary Embolism

“…These teams now have access to a wide variety of US Food and Drug Administration 510(k)-cleared devices (nine to be exact) to treat PE from an interventional perspective. 5 One increasingly used modality for the treatment of intermediate-high and high-risk PE is infusion of a thrombolytic agent via a catheter inserted into the pulmonary artery (known as catheter-directed thrombolysis [CDT]). 5,6 One device, the 5F catheterbased EkoSonic endovascular system (EKOS Corporation), is cleared by the US Food and Drug Administration for acute PE therapy and is an ultrasound-assisted thrombolytic (CDT-US) alternative to simple delivery of thrombolytic agents via a multi-holed infusion catheter.…”

“…5 One increasingly used modality for the treatment of intermediate-high and high-risk PE is infusion of a thrombolytic agent via a catheter inserted into the pulmonary artery (known as catheter-directed thrombolysis [CDT]). 5,6 One device, the 5F catheterbased EkoSonic endovascular system (EKOS Corporation), is cleared by the US Food and Drug Administration for acute PE therapy and is an ultrasound-assisted thrombolytic (CDT-US) alternative to simple delivery of thrombolytic agents via a multi-holed infusion catheter. The addition of focused ultrasound energy to traditional CDT aims to disrupt thrombus ultrastructure, allowing for more effective penetration of thrombolytic molecules into a thrombus.…”

“…This finding was remarkably similar to the 0.7% rate of ICH with CDT (inclusive of both standard CDT and CDT-US) seen in a recent metaanalysis of 556 patients treated in prospective studies of CDT. 5 Although it is difficult to use nonrandomized administrative data to compare outcomes in patients receiving CDT vs systemic thrombolysis, given vulnerability to treatment selection bias and unmeasured confounding, patient characteristics are less likely to influence the choice of CDT vs CDT-US. The authors' analysis of comparative outcomes differences between CDT and CDT-US was rigorous, using both hierarchical logistic regression models and inverse probability treatment weighting techniques.…”