Top Things to Know: Interventional Therapies for Acute Pulmonary Embolism

Published: October 04, 2019

Pulmonary embolism (PE) represents the third leading cause of cardiovascular mortality in the U.S.
Current interventional therapies for acute pulmonary embolism (PE) include devices that facilitate catheter-directed thrombolysis (CDL) or catheter-based embolectomy.
CDL and catheter-based embolectomy more rapidly reverse right ventricular (RV) dysfunction in acute PE than anticoagulation alone.
Intracranial hemorrhage (ICH) and non-ICH major bleeding are important complications of CDL.
Limited data regarding large-bore embolectomy devices has demonstrated instances of acute hemodynamic and respiratory collapse as well as right heart and pulmonary artery injury.
Treatment options for PE with hemodynamic instability (high-risk PE) include systemic thrombolysis, surgical embolectomy, interventional PE therapy, and/or mechanical circulatory support.
In intermediate-risk PE patients, interventional therapies can be beneficial in the context of patient-specific risks for bleeding or procedural decompensation.
The Pulmonary Embolism Severity Index (PESI) or simplified PESI (sPESI) score as well as objective signs of poor end organ perfusion can be useful to assess the risk of decompensation.
Thus far, interventional PE devices have been classified by the Food & Drug Administration (FDA) as “moderate risk to patients,” resulting in U.S. regulatory clearance via the 510(k) pathway, also known as premarket submission.
Data to support use of interventional devices for intermediate risk PE should come from randomized trials that evaluate traditional clinical outcomes and/or patient-centric, functional/quality of life (QOL) measures.

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Citation

Giri J, Sista AK, Weinberg I, Kearon C, Kumbhani DJ, Desai ND, Piazza G, Gladwin MT, Chatterjee S, Kobayashi T, Kabrhel C, Barnes GD; on behalf of the American Heart Association Council on Peripheral Vascular Disease; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; and Council on Cardiovascular Surgery and Anesthesia. Interventional therapies for acute pulmonary embolism: current status and principles for the development of novel evidence: a scientific statement from the American Heart Association [published online ahead of print October 4, 2019. Circulation. doi: 10.1161/CIR.0000000000000707.