Standardized Data Elements for Patients With Acute Pulmonary Embolism: A Consensus Report From the Pulmonary Embolism Research Collaborative.

Recent advances in therapy and the promulgation of multidisciplinary pulmonary embolism teams show great promise to improve management and outcomes of acute pulmonary embolism (PE). However, the absence of randomized evidence and lack of consensus leads to tremendous variations in treatment and compromises the wide implementation of new innovations. Moreover, the changing landscape of health care, where quality, cost, and accountability are increasingly relevant, dictates that a broad spectrum of outcomes of care must be routinely monitored to fully capture the impact of modern PE treatment. We set out to standardize data collection in patients with PE undergoing evaluation and treatment, and thus establish the foundation for an expanding evidence base that will address gaps in evidence and inform future care for acute PE. To do so, >100 international PE thought leaders convened in Washington, DC, in April 2022 to form the Pulmonary Embolism Research Collaborative. Participants included physician experts, key members of the US Food and Drug Administration, patient representatives, and industry leaders. Recognizing the multidisciplinary nature of PE care, the Pulmonary Embolism Research Collaborative was created with representative experts from stakeholder medical subspecialties, including cardiology, pulmonology, vascular medicine, critical care, hematology, cardiac surgery, emergency medicine, hospital medicine, and pharmacology. A list of critical evidence gaps was composed with a matching comprehensive set of standardized data elements; these data points will provide a foundation for productive research, knowledge enhancement, and advancement of clinical care within the field of acute PE, and contribute to answering urgent unmet needs in PE management. Evidence produced through the Pulmonary Embolism Research Collaborative, as it is applied to data collection, promises to provide crucial knowledge that will ultimately produce a robust evidence base that will lead to standardization and harmonization of PE management and improved outcomes.

Outcomes in High-Risk Pulmonary Embolism Patients Undergoing FlowTriever Mechanical Thrombectomy or Other Contemporary Therapies: Results From the FLAME Study.

BACKGROUND: Hemodynamically unstable high-risk, or massive, pulmonary embolism (PE) has a reported in-hospital mortality of over 25%. Systemic thrombolysis is the guideline-recommended treatment despite limited evidence. The FLAME study (FlowTriever for Acute Massive PE) was designed to generate evidence for interventional treatments in high-risk PE. METHODS: The FLAME study was a prospective, multicenter, nonrandomized, parallel group, observational study of high-risk PE. Eligible patients were treated with FlowTriever mechanical thrombectomy (FlowTriever Arm) or with other contemporary therapies (Context Arm). The primary end point was an in-hospital composite of all-cause mortality, bailout to an alternate thrombus removal strategy, clinical deterioration, and major bleeding. This was compared in the FlowTriever Arm to a prespecified performance goal derived from a contemporary systematic review and meta-analysis. RESULTS: A total of 53 patients were enrolled in the FlowTriever Arm and 61 in the Context Arm. Context Arm patients were primarily treated with systemic thrombolysis (68.9%) or anticoagulation alone (23.0%). The primary end point was reached in 9/53 (17.0%) FlowTriever Arm patients, significantly lower than the 32.0% performance goal (P<0.01). The primary end point was reached in 39/61 (63.9%) Context Arm patients. In-hospital mortality occurred in 1/53 (1.9%) patients in the FlowTriever Arm and in 18/61 (29.5%) patients in the Context Arm. CONCLUSIONS: Among patients selected for mechanical thrombectomy with the FlowTriever System, a significantly lower associated rate of in-hospital adverse clinical outcomes was observed compared with a prespecified performance goal, primarily driven by low all-cause mortality of 1.9%. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT04795167.

Mechanical Thrombectomy in Pulmonary Embolism Associated with COVID-19: A "Clotography" Gallery.

Venous thromboembolism from a "thrombotic storm"-like syndrome is a major cause of morbidity and mortality in patients with active or "recovered" COVID-19. Patients should be risk-stratified, optimally by a pulmonary embolism (PE) response team (PERT), and considered for escalation of care if found with intermediate or high-risk PE. We present a series of patients with COVID-19-associated PE and thrombotic storm with D-dimer >10 000 ng/mL who underwent successful mechanical thrombectomy for intermediate to high-risk PE. All patients had immediate improvement in hemodynamics and large amounts of thrombi were retrieved.

Hemodynamic compromise in pulmonary embolism: "A tale of two ventricles".

In acute pulmonary embolism (PE), low cardiac output (CO)-hypotension results from disparate ventricular conditions: The left ventricle (LV) is under-filled and contracting vigorously, whereas the right ventricle (RV) is failing and dilated. The proximate cause of LV preload deprivation is thrombus-induced pulmonary vascular obstruction; abruptly increased pulmonary vascular resistance (PVR) induces acute RV systolic dysfunction which further compromises trans-pulmonary flow. "Escalation of Care" interventions (thrombolytics and aspiration thrombectomy) improve systemic hemodynamics by increasing LV preload delivery directly by reducing PVR and indirectly by relief of the strained failing RV.

Ultrasound-accelerated thrombolysis (USAT) versus standard catheter-directed thrombolysis (CDT) for treatment of pulmonary embolism: A retrospective analysis.

Ultrasound-accelerated thrombolysis (USAT) is advocated in pulmonary embolism (PE) based on the hypothesis that adjunctive ultrasound provides superior clinical efficacy compared to standard catheter-directed thrombolysis (CDT). This retrospective study was designed to compare outcomes between the two modalities. We analyzed patients with computed tomography-diagnosed PE at our institution treated with either USAT or standard CDT. Efficacy parameters assessed included invasive pulmonary artery systolic pressure (PASP; pre- and 24 hours post-treatment), non-invasive right-to-left ventricle (RV/LV) ratio (pre- and post-treatment), and general clinical outcomes (length-of-stay, significant bleeding, and mortality). We analyzed 98 cases (62 USAT and 36 CDT), in whom massive PE was diagnosed in 7%, intermediate/high risk in 81%, and intermediate/low risk in 12%. Overall, 92% had bilateral clot and 40% saddle embolus. At 24 hours, PASP decreased similarly in both groups (CDT Δ14.7 mmHg, USAT Δ10.8 mmHg; p = 0.14). Post-treatment, CDT showed similar improvement in the RV/LV ratio (CDT Δ0.58 vs USAT Δ0.45; p = 0.07), despite the baseline ratio being greater in the CDT group, indicating more severe RV strain (1.56 ± 0.36 vs 1.40 ± 0.29; p = 0.01). Intensive care unit and hospital length-of-stays were similar in both groups. A trend toward lesser significant bleeding rates in the CDT group (8.3% vs 12.9%, p = 0.74) as well as improved survival-to-discharge (97.2% vs 91.9%, p = 0.66) was observed. Compared to USAT, standard CDT achieves similar beneficial effects on hemodynamics, RV/LV ratios, and clinical outcomes. These observations suggest that salutary clinical results may be achieved without the need for very expensive devices.

Low-dose systemic thrombolytic therapy for treatment of submassive pulmonary embolism: Clinical efficacy but attendant hemorrhagic risks.

OBJECTIVES: The purpose of the present study is to evaluate the safety and efficacy of "low-dose" systemic thrombolytic therapy (TT) for treatment of patients with intermediate-high risk submassive pulmonary embolism (PE). BACKGROUND: TT is increasingly utilized in acute submassive PE. Strategies for TT include catheter-directed administration as well as traditional IV systemic therapy. Regardless of the route, most studies document the attendant significant bleeding complication rates expected from induction of a systemic lytic state. To mitigate bleeding, "low-dose" systemic TT (Alteplase 50 mg) has been advocated, based on recent studies which demonstrated clinical efficacy with elimination of any significant bleeding complications. METHODS: Over a 24-month period, our institutional PE Response Team treated 45 acute submassive PE patients with "Low Dose" IV Alteplase 50 mg. Clinical outcomes and bleeding complications were assessed. RESULTS: Overall clinical outcome was excellent, with 97.8% of patients surviving to discharge and a 30-day, all-cause mortality of 4.4%. Despite no patients having a HAS-BLED score > 2 (average score = 0.8 +/-), ISTH major and GUSTO moderate bleeding was observed in 11% (n = 5) of cases. CONCLUSIONS: The present observations document that low-dose systemic TT is associated with excellent clinical outcome for intermediate-high risk submassive PE, but with attendant risk for bleeding. These findings are consistent with the concept that induction of a therapeutic lytic state carries inextricable bleeding risk.

Carotid stenting in high-risk patients: early and late outcomes.

PURPOSE: Some patients with severe carotid stenosis have anatomical or clinical comorbidities that place them at high risk for carotid endarterectomy (CEA). The early and late outcomes after carotid artery stenting (CAS) were evaluated in patients at high risk for CEA. METHODS: Between 2002 and 2009, 186 patients were enrolled in a high-risk CAS institutional registry. The primary outcome was major adverse cardiac and cerberovascular events (MACCEs) at 30 days, including death, stroke, and myocardial infarction. Secondary outcomes were technical, procedural, and clinical success; nonstroke neurological events; and death and ipsilateral stroke at 5 years. RESULTS: Twenty-five patients (13.2%) were symptomatic. Thirty day MACCE occurred in 2.6%, including death in 1 (0.5%), stroke in 3 (1.6%), and myocardial infraction in 1 (0.5%) patient. Strokes were nonfatal in 3 (1.6%), major in 2 (1.1%), and minor in 1 (0.5%) patients. Other neurological events included transient ischemic attack in 9 (4.7%) and retinal artery occlusion in 2 (1.1%) patients. After stroke, 2 patients had complete resolution of neurological deficit within 30 days, and 1 patient had improvement in neurological deficit. By Kaplan--Meier analysis, all-cause mortality was 47.5% and ipsilateral stroke was 4.5% at 5 years. CONCLUSIONS: In patients who are high risk for CEA, CAS can be performed with low MACCE at 30 days and ipsilateral stroke at 5 years. However, nearly half of these patients die within 5 years from causes unrelated to stroke.

Patterns of coronary compromise resulting in acute right ventricular ischemic dysfunction.

BACKGROUND: Although proximal right coronary artery (RCA) occlusion is the culprit commonly responsible for acute right ventricular (RV) infarction (RVI), the severity of RV dysfunction ranges broadly. This study was designed to delineate the patterns of coronary compromise that determine the magnitude of RV ischemic dysfunction. METHODS AND RESULTS: In 125 patients with acute inferior myocardial infarction undergoing emergency angiography, the culprit infarct lesion was identified, RV branch flow assessed (TIMI flows and frame counts), and individual patient RV perfusion indices calculated by separately averaging the branch flows and frame counts, which were correlated with RV wall motion by ultrasound. RVI occurred in 53 (42%) patients, with the RCA as the culprit vessel and the lesion sufficiently proximal to compromise flow in at least one RV branch in all cases, thereby resulting in depressed RV perfusion (flow index, 0.7+/-0.2). In patients without RVI, the RCA was the culprit in 89%; the circumflex, in 11%. RCA culprits were proximal in 19% of such cases, with lack of RVI explained by preserved RV perfusion (flow index, 2.7+/-0.3; P=0.001) attributable to at least 1 patent RV branch, spontaneous reperfusion, or prominent collaterals. Overall, there was a strong correlation between RV perfusion and wall motion (Spearman correlation coefficient=0.79). CONCLUSIONS: Proximal RCA occlusion compromising RV branch perfusion commonly results in RV ischemic dysfunction. In some cases with proximal RCA culprits, collaterals or spontaneous reperfusion preserve RV performance.