Objectives: The aim of this study was to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the FlowTriever System (Inari Medical, Irvine, California) in a ...

A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study

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.

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

Extracorporeal membrane oxygenation (ECMO) has been used increasingly for both respiratory and cardiac failure in adult patients. Indications for ECMO use in cardiac failure include severe refractory cardiogenic shock, refractory ventricular arrhythmia, active cardiopulmonary resuscitation for cardiac arrest, and acute or decompensated right heart failure. Evidence is emerging to guide the use of this therapy for some of these indications, but there remains a need for additional evidence to guide best practices. As a result, the use of ECMO may vary widely across centers. The purpose of this document is to highlight key aspects of care delivery, with the goal of codifying the current use of this rapidly growing technology. A major challenge in this field is the need to emergently deploy ECMO for cardiac failure, often with limited time to assess the appropriateness of patients for the intervention. For this reason, we advocate for a multidisciplinary team of experts to guide institutional use of this therapy and the care of patients receiving it. Rigorous patient selection and careful attention to potential complications are key factors in optimizing patient outcomes. Seamless patient transport and clearly defined pathways for transition of care to centers capable of providing heart replacement therapies (e.g., durable ventricular assist device or heart transplantation) are essential to providing the highest level of care for those patients stabilized by ECMO but unable to be weaned from the device. Ultimately, concentration of the most complex care at high-volume centers with advanced cardiac capabilities may be a way to significantly improve the care of this patient population.

/pdf/position-paper-for-the-organization-of-ecmo-programs-for-cd9yezll9v.pdf

Position paper for the organization of ECMO programs for cardiac failure in adults.

Pulmonary embolism (PE) is a major cause of morbidity and mortality in the United States. Although new therapeutic tools and strategies have recently been developed for the diagnosis and treatment of patients with PE, the outcomes for patients who present with massive or high-risk PE remain dismal. To address this crisis, pulmonary embolism response teams (PERTs) are being created around the world in an effort to immediately and simultaneously engage multiple specialists to determine the best course of action and coordinate the clinical care for patients with acute PE. The scope of this review is to describe the PERT model and purpose, present the structure and organization, examine the available evidence for efficacy and usefulness, and propose future directions for research that is needed to demonstrate the value of PERT and determine if this multidisciplinary approach represents a new standard of care.

https://onlinelibrary.wiley.com/doi/pdf/10.1002/rth2.12216

Pulmonary embolism response teams: Purpose, evidence for efficacy, and future research directions

AIMS Right ventricular (RV) failure causes death from acute pulmonary embolism (PE), due to a mismatch between RV systolic function and increased RV afterload. We hypothesized that an echocardiographic ratio of this mismatch [RV systolic function by tricuspid annular plane systolic excursion (TAPSE) divided by pulmonary arterial systolic pressure (PASP)] would predict adverse outcomes better than each measurement individually, and would be useful for risk stratification in intermediate-risk PE. METHODS AND RESULTS This was a retrospective analysis of a single academic centre Pulmonary Embolism Response Team registry from 2012 to 2019. All patients with confirmed PE and a formal transthoracic echocardiogram performed within 2 days were included. All echocardiograms were analysed by an observer blinded to the outcome. The primary endpoint was a 7-day composite outcome of death or haemodynamic deterioration. Secondary outcomes were 7- and 30-day all-cause mortality. A total of 627 patients were included; 135 met the primary composite outcome. In univariate analysis, the TAPSE/PASP was associated with our primary outcome [odds ratio = 0.028, 95% confidence interval (CI) 0.010-0.087; P < 0.0001], which was significantly better than either TAPSE or PASP alone (P = 0.017 and P < 0.0001, respectively). A TAPSE/PASP cut-off value of 0.4 was identified as the optimal value for predicting adverse outcome in PE. TAPSE/PASP predicted both 7- and 30-day all-cause mortality, while TAPSE and PASP did not. CONCLUSION A combined echocardiographic ratio of RV function to afterload is superior in prediction of adverse outcome in acute intermediate-risk PE. This ratio may improve risk stratification and identification of the patients that will suffer short-term deterioration after intermediate-risk PE.

The echocardiographic ratio tricuspid annular plane systolic excursion/pulmonary arterial systolic pressure predicts short-term adverse outcomes in acute pulmonary embolism.

Pulmonary embolism (PE) is a serious and prevalent cause of vascular disease. Nevertheless, optimal treatment for many phenotypes of PE remains uncertain. Treating PE requires appropriate risk stratification as a first step. For the highest-risk PE, presenting as shock or arrest, emergent systemic thrombolysis or embolectomy is reasonable, while for low-risk PE, anticoagulation alone is often chosen. Normotensive patients with PE but with indicia of right heart dysfunction (by biomarkers or imaging) constitute an intermediate-risk group for whom there is controversy on therapeutic strategy. Some intermediate-risk patients with PE may require urgent stabilization, and ≈10% will decompensate hemodynamically and suffer high mortality, though identifying these specific patients remains challenging. Systemic thrombolysis is a consideration, but its risks of major and intracranial hemorrhages rival overall harms from intermediate PE. Multiple hybrid pharmacomechanical approaches have been devised to capture the benefits of thrombolysis while reducing its risks, but there is limited aggregate clinical experience with such novel interventional strategies. One method to counteract uncertainty and generate a consensus multidisciplinary prognostic and therapeutic plan is through a Pulmonary Embolism Response Team, which combines expertise from interventional cardiology, interventional radiology, cardiac surgery, cardiac imaging, and critical care. Such a team can help determine which intervention-catheter-directed fibrinolysis, ultrasound-assisted thrombolysis, percutaneous mechanical thrombus fragmentation, or percutaneous or surgical embolectomy-is best suited to a particular patient. This article reviews these various modalities and the background for each.

https://www.ahajournals.org/doi/pdf/10.1161/CIRCINTERVENTIONS.116.004345

Interventional Treatment of Pulmonary Embolism

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Interventional Treatment of Pulmonary Embolism