Akhter MS, Hamali HA, Mobarki AA, Rashid H, Oldenburg J, Biswas A. J Clin Med. Prevention of Chronic thromboembolic pulmonary hypertension. Both the 6-minute walk distance and the New York Heart Association dyspnea class have been evaluated in several cohorts of patients with PE. https://doi.org/10.1161/CIR.0000000000000707, National Center Accelerated thrombolysis for pulmonary embolism: will clinical benefit be ULTIMAtely realized? Patients who have low cardiopulmonary reserve and larger thrombus in transit are expected to gain most from active thrombus removal. A Multidisciplinary pulmonary embolism response team: initial 30-month experience with a novel approach to delivery of care to patients with submassive and massive pulmonary embolism. Moreover, these interventions are often made in tandem or in a serial fashion in this critically ill population. These guidelines for thrombolytic use in patients with PE from the American Heart Association (AHA), American College of Chest Physicians (ACCP), European Heart Association (EHA), and American Col-lege of Emergency Physicians (ACEP) are shown in Table 2 (4,5,19,20). Pulmonary artery rupture associated with the Swan-Ganz catheter. Initial data from individual centers demonstrate use of catheter-based therapies in a minority of patients with intermediate- and high-risk acute PE (Table 11).113,122,123 Published reports from several academic centers suggest that CDL, for example, is used in 11% to 29% of PERT activations.113,123,124 Although this represents a minority of patients presenting to these hospitals with PE, these rates of CDL use are substantially higher than that noted in general US practice.125 In addition, within the PERT framework, catheter-based approaches may be supplanting systemic thrombolysis as the active thrombus removal strategy of choice for patients with intermediate- and high-risk PE. Procedural safety of the devices has not been evaluated in a significant number of patients with high-risk PE. Herz. Cardiac arrest should be reported separately whenever possible. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Hansen SL, de Nijs R, Mortensen J, Berg RMG. Prognostic value of troponins in acute pulmonary embolism: a meta-analysis. Presented March 16, 2019 at the American College of Cardiology 68th Annual Scientific Sessions (ACC19): Abstract 402-16. ESC guidelines 2014]. Assuming that effect sizes for interventional therapies are similar to those for systemic thrombolysis in this population, traditional approaches to powering randomized trials for mortality would require 1500 to 2000 patients to demonstrate superiority over a short time period (ie, 7 days). Pulmonary Circulation, Pulmonary Embolism, Right Heart Failure. Given the low numbers of patients with CDL analyzed prospectively thus far, the heterogeneity of study patients treated with systemic thrombolysis versus CDL, and observed rates and CIs of non-ICH major bleeding and ICH, it remains unclear whether this mode of therapy poses lower risks of major bleeding or ICH than systemic thrombolysis. What short- and long-term outcomes are improved by active thrombus removal at initial presentation? Randomized, controlled trial of ultrasound-assisted catheter-directed thrombolysis for acute intermediate-risk pulmonary embolism. In addition, the wires and catheters needed to deliver these devices are often stiffer and less forgiving than those used for infusion catheter placement. Comparison of two prognostic models for acute pulmonary embolism: clinical vs. right ventricular dysfunction-guided approach. It is likely that devices will be developed in the future that seek to more seamlessly use concomitant pharmacomechanical approaches to relieve PA obstruction. Functional or QOL outcomes may include the 6-minute walk distance, Pulmonary Embolism Quality of Life score, New York Heart Association classification, and Short Form-36 scores. The changes are based on the 2019 European Society of Cardiology (ESC) Guidelines on the Diagnosis and Management of Acute Pulmonary Embolism, and include recommendations for the expanded use of direct oral anticoagulants (DOACs) for patients with Table 10. bolytics in PE. Ideally, high-risk PE studies would randomize patients to 2 active comparator therapies, with systemic thrombolytics (AHA Class IIa recommendation) being one of the comparators. 1.2. Right ventricular enlargement on chest computed tomography: a predictor of early death in acute pulmonary embolism. Comparison of two methods for selection of out of hospital treatment in patients with acute pulmonary embolism. Management of massive and submassive pulmonary embolism, iliofemoral deep vein thrombosis, and chronic thromboembolic pulmonary hypertension: a scientific statement from the American Heart Association. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). 24 mg of tPA; 0.42 difference in RV/LV ratio; 10% major bleeding, no ICH; OPTALYSE-PE (Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Pulmonary Embolism) 21. Simplification of the pulmonary embolism severity index for prognostication in patients with acute symptomatic pulmonary embolism. Scope of Guideline. 1-800-242-8721 Surrogate effectiveness end points, including the short-term reduction in RV/LV ratio, should not be a proxy for mortality or other clinical outcomes in studies of patients with intermediate-risk PE. Determining the value of catheter-directed intervention for intermediate-risk PE involves a considerably different calculus. The need for flexibility in management of this patient population would likely lead to a large numbers of crossovers, biasing results to the null. Pulmonary embolism (PE) represents the third leading cause of cardiovascular mortality. Although not part of the formal risk stratification schemes based on hemodynamic criteria, deteriorating respiratory status may prompt an immediate intervention. Systemic thrombolytic therapy for acute pulmonary embolism: a systematic review and meta-analysis. The best primary measure of clinical effectiveness is short-term mortality. Thrombolytic therapy for pulmonary embolism. the Home Treatment of Pulmonary Embolism (HoT-PE) trial. *Presumes equivalence between systemic thrombolytic therapy and endovascular thrombus removal. High-quality comparative effectiveness analyses of varying strategies for active thrombus removal, including systemic thrombolysis, surgical embolectomy, and interventional PE therapies, have not been performed in patients with thrombus in transit. Ideally, device safety would be evaluated in the context of randomized controlled trials by rates of non-ICH major bleeding, ICH, hemodynamic decompensation, pulmonary decompensation, and cardiopulmonary injury. It is currently not known which patients will recover and whether immediate intervention prevents these long-term complications. Among those who remain hemodynamically stable, a careful assessment for factors that elevate risk of decompensation should be undertaken, including elevated PESI or simplified PESI score, severe PE-related functional impairment, and objective signs of severely diminished end-organ perfusion or stroke volume. The specific end point that has been most favored has been the short-term (24–48 hours) change in the RV/LV ratio as measured by serial CT angiography or echocardiography.53 The outcome has become the surrogate of choice based on observational data indicating significantly elevated 30-day mortality rates when the RV/LV ratio >0.9. Chronic thromboembolic disease following pulmonary embolism: more work ahead. Catheter-based embolectomy represents an option for patients in this cohort with elevated bleeding risk, with the caveat that concerns for procedural hemodynamic or respiratory decompensation exist with these technologies.4,12,35 Finally, clinicians must also be aware that the presence of markers of poor prognosis does not necessarily equate to improved long-term clinical outcomes with reperfusion therapy.91. CTEPH, classified as World Health Organization group 4 pulmonary hypertension, is characterized by persistent macrovascular obstruction, pulmonary vasoconstriction, and a secondary small-vessel arteriopathy eventually resulting in right-sided heart failure.67 The incidence of CTEPH after an acute PE at 2 years has been identified as 2% to 5% in various observational cohorts.56,68 Although smaller studies suggested that systemic thrombolysis could reduce the risk of CTEPH,50,59 3-year follow-up data of a highly selected subset of patients from PEITHO demonstrated similar rates of CTEPH (2.1% versus 3.2%; P=0.79) in patients undergoing systemic thrombolysis compared with those receiving anticoagulation alone.47. Catheter-directed therapy for the treatment of massive pulmonary embolism: systematic review and meta-analysis of modern techniques. Experience with extracorporeal membrane oxygenation in massive and submassive pulmonary embolism in a tertiary care center. The universal BARC (Bleeding Academic Research Consortium) definitions, a well-validated tool that allows comparison with many prior interventional trials across various disease processes, is a potential option.103 If BARC is used, major bleeding definitions should include BARC 2, 3a, 3b, and 5 categories. Inflammatory Biomarkers in the Short-Term Prognosis of Venous Thromboembolism: A Narrative Review. A Randomized Trial of the Optimum Duration of Acoustic Pulse Thrombolysis Procedure in Acute Intermediate-Risk Pulmonary Embolism: the OPTALYSE PE trial. Thus far, interventional PE devices have been classified as moderate risk to patients, resulting in regulatory clearance via the 510(k) pathway. Achieving multidisciplinary collaboration for the creation of a pulmonary embolism response team: creating a “team of rivals.”. Treatment of submassive pulmonary embolism with tenecteplase or placebo: cardiopulmonary outcomes at 3 months: multicenter double-blind, placebo-controlled randomized trial. Figure 5 attempts to organize an evidence-based approach to intervention in PE, taking into account areas of clinical concern for which data are limited. Venous thromboembolic disease (VTE) is estimated to occur in at least 1 to 2 persons per 1000 population annually, manifesting as deep vein thrombosis (DVT), pulmonary embolism (PE) or in combination.1-3 Effectiveness of rapid response teams on rates of in-hospital cardiopulmonary arrest and mortality: a systematic review and meta-analysis. Rapid response systems: a systematic review. Current prospective data evaluating interventional devices for PE have relied on surrogate outcomes for clinical effectiveness. Expert peer review of AHA Scientific Statements is conducted at the AHA National Center. Prognostic value of echocardiographic right/left ventricular end-diastolic diameter ratio in patients with acute pulmonary embolism: results from a monocenter registry of 1,416 patients. However, risk scores developed for other conditions such as atrial fibrillation have not proved translatable to patients with PE, and externally validated PE-specific scores to predict these complications are lacking.12,14,18,29,88Table 8 outlines knowledge gaps relevant to patient selection for reperfusion therapies. European guidelines]. Acute respiratory collapse can theoretically be precipitated by sudden changes in ventilation/perfusion caused by disruption/distal embolization of thrombi with wires or catheters. An observational pooled analysis of 328 cases of right-sided heart thrombus in transit suggested that thrombolysis (OR, 4.8 [95% CI, 1.5–15.4]) and surgical embolectomy (OR, 2.6 [95% CI, 0.9–7.6]) were more often associated with a favorable outcome than anticoagulation alone.95 Subsequent to this analysis, an adjusted comparison of 255 cases of thrombus in transit treated with anticoagulation and 70 cases treated with reperfusion did not find a convincing difference in all-cause (6.2% versus 14%; P=0.15) or PE-related (4.7% versus 7.8%; P=0.47) mortality.94 Newer catheter-based techniques for treating thrombus in transit exist but have not been rigorously evaluated.45 Although these findings appear to support active thrombus removal in patients with thrombus in transit, this decision is also influenced by the size and nature of the thrombus and the severity of the initial PE. Quality of life after pulmonary embolism: validation of the PEmb-QoL Questionnaire. 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