High-risk Pulmonary Embolism Patients Research Articles

Integration of Extracorporeal Membrane Oxygenation into the Management of High-Risk Pulmonary Embolism: An Overview of Current Evidence.

High-risk pulmonary embolism (PE) refers to a large embolic burden causing right ventricular failure and hemodynamic instability. It accounts for approximately 5% of all cases of PE but contributes significantly to overall PE mortality. Systemic thrombolysis is the first-line revascularization therapy in high-risk PE. Surgical embolectomy or catheter-directed therapy is recommended in patients with an absolute contraindication to systemic thrombolysis. Extracorporeal membrane oxygenation (ECMO) provides respiratory and hemodynamic support for the most critically ill PE patients with refractory cardiogenic shock or cardiac arrest. The complex management of these individuals requires urgent yet coordinated multidisciplinary care. In light of existing evidence regarding the utility of ECMO in the management of high-risk PE patients, a number of possible indications for ECMO utilization have been suggested in the literature. Specifically, in patients with refractory cardiac arrest, resuscitated cardiac arrest, or refractory shock, including in cases of failed thrombolysis, venoarterial ECMO (VA-ECMO) should be considered, either as a bridge to percutaneous or surgical embolectomy or as a bridge to recovery after surgical embolectomy. We review here the current evidence on the use of ECMO as part of the management strategy for the highest-risk presentations of PE and summarize the latest data in this indication.

Contemporary Management and Outcomes of Patients With High-Risk Pulmonary Embolism

BackgroundContemporary care patterns/outcomes in high-risk pulmonary embolism (PE) patients are unknown. ObjectivesThis study sought to characterize the management of high-risk PE patients and identify factors associated with poor outcomes. MethodsA retrospective analysis of the PERT (Pulmonary Embolism Response Team) Consortium Registry was performed. Patients presenting with intermediate-risk PE, high-risk PE, and catastrophic PE (those with hemodynamic collapse) were identified. Patient characteristics were compared with chi-square testing for categorical covariates and Student's t-test for continuous covariates. Multivariable logistic regression was used to assess associations between clinical characteristics and outcomes in the high-risk population. ResultsOf 5,790 registry patients, 2,976 presented with intermediate-risk PE and 1,442 with high-risk PE. High-risk PE patients were more frequently treated with advanced therapies than intermediate-risk PE patients (41.9% vs 30.2%; P < 0.001). In-hospital mortality (20.6% vs 3.7%; P < 0.001) and major bleeding (10.5% vs. 3.5%; P < 0.001) were more common in high-risk PE. Multivariable regression analysis demonstrated vasopressor use (OR: 4.56; 95% CI: 3.27-6.38; P < 0.01), extracorporeal membrane oxygenation use (OR: 2.86; 95% CI: 1.12-7.30; P = 0.03), identified clot-in-transit (OR: 2.26; 95% CI: 1.13-4.52; P = 0.02), and malignancy (OR: = 1.70; 95% CI: 1.13-2.56; P = 0.01) as factors associated with in-hospital mortality. Catastrophic PE patients (n = 197 [13.7% of high-risk PE patients]) had higher in-hospital mortality (42.1% vs 17.2%; P < 0.001) than those presenting with noncatastrophic high-risk PE. Extracorporeal membrane oxygenation (13.3% vs. 4.8% P < 0.001) and systemic thrombolysis (25% vs 11.3%; P < 0.001) were used more commonly in catastrophic PE. ConclusionsIn the largest analysis of high-risk PE patients to date, mortality rates were high with the worst outcomes among patients with hemodynamic collapse.

Фактори несприятливого прогнозу в жінок із високим ризиком гострої тромбоемболії легеневої артерії

The aim – to determine the risk factors of an unfavorable prognosis in patients with pulmonary embolism (PE) depending on gender.Materials and methods. A retrospective analysis of the data of 635 patients with a verified diagnosis of PE according to multispiral computed tomographic angiography (MSCT-angiography) of pulmonary vessels and/or according to autopsy results, who were consecutively hospitalized at Kharkiv City Clinical Hospital No. 8 for the period from January 1, 2017 to January 1, 2023. Patients were divided into two groups: IA group included patients with high-risk acute PE who were discharged from the hospital, IВ group – patients with high-risk acute PE who died during the hospital period. Clinical and anamnestic, laboratory and instrumental indicators were analyzed, statistical processing of data depending on gender was carried out.Results and discussion. When analyzing the obtained data, it was established that in the group of deceased patients with a high risk there was probably a higher proportion of women (72 % at p=0.014). Deceased males had more severe clinical manifestations than deceased females, as evidenced by significantly lower SpO2 values (p=0.022) and larger right ventricular dimensions on echocardiography (p=0.036). In turn, such a risk factor of PE as obesity was more common in women than in men (61.1 % vs. 28.6 % at p=0.039). In order to determine independent factors associated with in-hospital mortality in high-risk PE patients in women, we conducted uni- and multifactorial logistic regression analysis of the influence of the studied factors. Since the small number of deceased men in the sample (n=14) does not allow us to draw reasonable conclusions, the analysis of factors affecting mortality is given only for the group of women. Factors associated with in-hospital death were the presence of arterial hypertension in the anamnesis (p=0.043), a decrease in systolic blood pressure (p=0.0003) in the acute period, and the localization of a thrombus at the bifurcation of the pulmonary arteries (p=0.012). After performing the regression analysis, we derived a formula for individual prediction of the risk of in-hospital death for gender with high-risk PE. Using the ROC analysis, it was established that the sensitivity of the obtained prognostic formula is 75.0 %; specificity – 83.9 (area under the ROC curve 0.867; 95 % confidence interval 0.762–0.938, p&lt;0.0001). The formula developed by us includes available general clinical indicators and allows specifying the individual risk of in-hospital mortality for female patients with high-risk PE.Conclusions. The results of a comparative analysis of two subgroups of patients with high-risk PE who died, depending on gender, showed that men were more likely to have lower SpO2 values and larger right ventricular sizes according to echocardiography. In turn, such risk factors as obesity were more common in women than in men. According to multivariate logistic regression analysis, additional independent factors that are associated with the development of death during the hospital period in women with high-risk PE are the presence of arterial hypertension in the anamnesis, a decrease in systolic blood pressure in the acute period, and the localization of a thrombus at the bifurcation of the pulmonary arteriesof. Proposed formula, according to which Y&gt;0.5 establishes an additional high risk of in-hospital death in women with high-risk PE.

Imaging-based risk stratification of patients with pulmonary embolism based on dual-energy CT-derived radiomics.

Technological progress in the acquisition of medical images and the extraction of underlying quantitative imaging data has introduced exciting prospects for the diagnostic assessment of a wide range of conditions. This study aims to investigate the diagnostic utility of a machine learning classifier based on dual-energy computed tomography (DECT) radiomics for classifying pulmonary embolism (PE) severity and assessing the risk for early death. Patients who underwent CT pulmonary angiogram (CTPA) between January 2015 and March 2022 were considered for inclusion in this study. Based on DECT imaging, 107 radiomic features were extracted for each patient using standardized image processing. After dividing the dataset into training and test sets, stepwise feature reduction based on reproducibility, variable importance and correlation analyses were performed to select the most relevant features; these were used to train and validate the gradient-boosted tree models. The trained machine learning classifier achieved a classification accuracy of .90 for identifying high-risk PE patients with an area under the receiver operating characteristic curve of .59. This CT-based radiomics signature showed good diagnostic accuracy for risk stratification in individuals presenting with central PE, particularly within higher risk groups. Models utilizing DECT-derived radiomics features can accurately stratify patients with pulmonary embolism into established clinical risk scores. This approach holds the potential to enhance patient management and optimize patient flow by assisting in the clinical decision-making process. It also offers the advantage of saving time and resources by leveraging existing imaging to eliminate the necessity for manual clinical scoring.

Outcomes of Catheter-Based Therapy for Cancer-Associated Intermediate or High-Risk Pulmonary Embolism

Background: Pulmonary embolism (PE) is a well-known complication of cancer and is associated with significant morbidity and mortality. The standard of care for the treatment of PE is anticoagulation and systemic thrombolysis for high-risk PE. However, both carry risk of bleeding, and patients with cancer are particularly at higher risk of both bleeding and thrombotic complications. The development of catheter-based therapies (CBT) has provided an alternative reperfusion therapy for patients with high-risk and select intermediate risk PE patients. However, despite the increased prevalence of PE, patients with cancer are often excluded from clinical trials of invasive medical devices, including CBT for PE. Therefore, we investigated outcomes of patients with cancer hospitalized for intermediate or high-risk PE treated with or without CBT. Methods: This was a retrospective cohort analysis of the National Readmission Database (NRD) of adult patients with a primary diagnosis of intermediate or high-risk PE from 2017 and 2018 with a history of cancer, which was identified using ICD-10 codes. High-risk PE was defined as PE with hemodynamic instability (either cardiac arrest, cardiogenic shock, or vasopressor use). Intermediate-risk PE was defined as PE with signs of right ventricular strain (type 2 myocardial infarction or cor pulmonale) without hemodynamic instability. Primary outcome was in-hospital mortality. Secondary outcomes were in-hospital major bleeding (composite of gastrointestinal, intracranial, and post-procedural bleeding), and 90-day any-cause, VTE-related, and bleeding-related readmissions. Propensity scores (PS) for estimating probability of CBT were calculated using non-parsimonious multivariable logistic regression that included all baseline patient characteristics examined. Inverse-probability treatment weighting (IPTW) was utilized to adjust for potential confounders. Patients treated with CBT were compared to those without and standardized mean difference (SMD) was calculated for variables before and after IPTW. Imbalances between groups were significant if SMD for any given covariable was ≥ 0.10. Hazard ratios (HR) were estimated for 90-day readmission outcomes using Cox proportional hazards regression, and odds ratio (OR) were calculated for estimating in-hospital outcomes using logistic regression. Results: 3,333 patients were identified of which 388 (11.6%) were treated with CBT. Prior to IPTW, patients treated with CBT were younger (mean age 66.3 vs 67.6 years) and less likely to have metastatic cancer (43.3% vs 50.3%), Khorana high or intermediate risk cancer type (40.5% vs 49.4%) or high-risk PE (34.5% vs 46.3%), Table 1. After IPTW, baseline characteristics were well balanced between groups. After IPTW, CBT was associated with lower risk of in-hospital death (23.3% vs 28.3%, OR 0.77, 95% CI 0.69 - 0.86) but higher risk of in-hospital bleeding (16.4% vs 13.7%, OR 2.34, 95% CI 2.11 - 2.60) which was driven by post-procedure bleeding (12.5% vs 9.2%, OR 1.40, 95% CI 1.20 - 1.64). CBT was also associated with lower 90-day any-cause (HR 0.88, 95% CI 0.79 - 0.98) and VTE-related (HR 0.54, 95% CI 0.35 - 0.83) but not bleeding-related (HR 0.69, 95% CI 0.34 - 1.40) readmissions, Figure 1. Conclusions: Patients with cancer admitted with intermediate or high-risk PE have high rates of in-hospital death and bleeding. Treatment with CBT was associated with lower in-hospital death and 90-day any-cause and VTE-related readmissions at the cost of increased in-hospital bleeding driven by post-procedural bleeding. Prospective studies and trials of CBT in PE should include patients with cancer and further investigation is warranted to confirm our findings.

Catheter-directed therapies impact on intermediate-high- and high-risk pulmonary embolism patients

Abstract Introduction Intermediate-high- and high-risk pulmonary embolism (PE) patients treated with anticoagulation alone are associated with a considerable risk of circulatory collapse, death, or long-term pulmonary hypertension. Pulmonary Embolism Response Teams (PERT) have been created to deliver PE patients a better care. Catheter Directed Therapies (CDT), with mechanical thrombolysis and/or local fibrinolysis allow faster reperfusion and hemodynamic improvement without the systemic hemorrhagic effects of systemic fibrinolysis. The clinical evidence of its benefits is lacking. Objectives This analysis aims to describe the hemodynamics, morphological and perfusion improvement in intermediate-high- and high-risk acute PE patients submitted to CDT. Methods Prospective registry of consecutive intermediate-high- and high-risk PE patients submitted to CDT (mechanical thrombolysis with PenumbraÔ aspiration system and/or intrapulmonary local fibrinolysis with alteplase) in a single tertiary center. A multiparametric follow-up protocol was designed to evaluate echocardiographic, CT-scan, pulmonary angiogram, and right heart catheterization data at admission and at 3 months after CDT. The paired samples t-Test was used for the analysis of the variables. Results 26 PE patients (42.3% male, mean age 59 years old) were submitted to CDT (19% combined Penumbra and local fibrinolysis, 12% isolated Penumbra and 69% isolated local fibrinolysis). Baseline characteristics, laboratorial, imaging and procedure data are summarized in the figure 1. No major bleeding was seen during or after the procedure. 1 pulmonary artery dissection and 1 Penumbra burr partial avulsion occurred, both with conservative treatment with good result. 3 patients died during the follow-up (1 for oncologic disease, 1 for septic shock and 1 after discharge with undetermined cause). Of the remaining, 18 patients completed the 3-month follow-up protocol. At 3 months, a significant improvement was seen in the patients’ hemodynamics with 3.3mmHg mean drop of RA pressure (p 0.007), 16.1mmHg mean drop of systolic PA pressure (p &amp;lt;0.001), 8.0mmHg mean drop of mean PA pressure (p&amp;lt;0.001), 1.4L/min and 0.7L/min/m2 mean increases in cardiac output and index (p 0.003, p 0.001), and a tendency to a 0.8 Wood units decrease in the pulmonary vascular resistance (p 0.093). It was also seen an improvement in the perfusion defects with a mean drop of 7.9 points in the modified Miller index (p &amp;lt;0.001) and an improvement in the RV function with a mean decrease of 0.5 in the RV/LV ratio by CT-scan (p &amp;lt;0.001), a mean increase of 5.6mm in TAPSE (p &amp;lt;0.001) and a decrease of median NT-proBNP levels in 2866pg/ml (p &amp;lt;0.001). Conclusions In patients with intermediate-high- and high-risk PE, the use of CDT with mechanical thrombolysis and/or local fibrinolysis is safe and associated with improvement in hemodynamics, RV function and perfusion defects.Table 1.baseline characteristicsTable 2.results

Large-bore mechanical thrombectomy for intermediate- and high-risk pulmonary embolism: interim outcomes from the European cohort of the FLASH registry

Abstract Background/Introduction Mechanical thrombectomy is utilized for the treatment of acute pulmonary embolism (PE), but reported outcomes are limited in the European patient population. Purpose To report interim results from the European cohort of a large, prospective all-comer registry of mechanical thrombectomy for PE treatment. Methods The FLASH registry is a multinational, prospective, observational study of safety and effectiveness outcomes for PE treatment using a large-bore mechanical thrombectomy system. FLASH is currently enrolling up to 200 patients in Europe. The primary endpoint is a composite of Major Adverse Events (MAEs) within 48 hours, including device-related deaths, major bleeding, and intraprocedural AEs. Additional assessments include invasive hemodynamics, hospital resource usage, and dyspnea improvement. Results Interim results through 48 hours post-thrombectomy are presented for the first 29 patients enrolled in the European cohort across 4 institutions. Mean patient age was 64.9±14.5 years, 51.7% of patients were male, 10.3% were contraindicated for thrombolysis, 51.7% had concomitant deep vein thrombosis, and 79.3% had centrally located thrombus involving one or both main pulmonary arteries. Per ESC guidelines, 58.6% of patients were classified as high-risk. The remaining 41.4% of patients were classified as intermediate-risk, with 31.0% being intermediate-high-risk. Pre-thrombectomy, the median RV/LV ratio from a composite of computed tomography and echocardiography was 1.31 [IQR: 1.08-1.44], and 38.9% of patients who had cardiac index (CI) measured were in cardiogenic shock (CI ≤2 L/min/m²). Procedural characteristics included a median thrombectomy time of 39 minutes [IQR: 26-49]. Extracorporeal membrane oxygenation was used in 6.9% of patients. Post-thrombectomy, the median length of stay in the intensive care unit (ICU) was 1 overnight [IQR: 0-2], and 48.1% of patients required no overnight ICU stay. In addition, hemodynamic variables, vitals, dyspnea symptoms, and reliance on supplemental oxygen all improved significantly post-thrombectomy (Table 1). Acute safety and mortality outcomes were highly favorable following the procedure (Table 2). All patients survived through 48 hours post-thrombectomy. There were no MAEs (0%), no major access site complications (0%), and no device-related Serious AEs (0%) through 48-hour follow-up. Conclusions Interim results from the first 29 patients in the European cohort of the FLASH registry suggest that large-bore mechanical thrombectomy can be safely performed in both intermediate- and high-risk PE patients, with no MAEs or mortalities observed through 48 hours. Significant improvements observed in multiple hemodynamic and dyspnea-related variables further suggest that thrombectomy can offer effective reperfusion treatment for acute PE.

Risk stratification of poor short-term prognosis in patients with high-risk pulmonary embolism

Background. Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. High-risk PE patients have more severe course of disease and poor prognosis. The question of additional factors which may be associated with prognosis in such patients remains poorly understood. The aim is to identify factors associated with mortality in high-risk PE patients and to determine contribution of these factors to the risk stratification of death. Materials and methods. A retrospective analysis of 635 medical cards of patients with PE diagnosis hospitalized in Kharkiv City Clinical Hospital 8 from January 1, 2017 to January 1, 2023 was conducted. The diagnosis was verified by multispiral computed tomography pulmonary angiography (CTPA) and/or by autopsy. Patients were divided into groups: group І — high-risk (113 — 17.8 %); group II — low-risk (522 — 82.2 %). Group I was divided into subgroups: IA — 63 (55.8 %) individuals, who were discharged from the hospital with improved status, IB — 50 (44.2 %) people, who died in hospital. Clinical, anamnestic, laboratory and instrumental parameters were measured. Statistical analysis was performed. Results. Patients from group I were older, there were more women among them. In subgroup ІВ, there are more women, more cases of obesity and deep vein thrombosis. Patients from group IB had lower blood oxygen saturation (SpO2) and systolic blood pressure (SBP), lower left ventricular ejection fraction (LVEF) measured by echocardiography. Bilateral segmental pulmonary embolism according to CTPA was more common in IB group. According to uni- and multivariate analysis, independent factors affecting in-hospital mortality in patients with high-risk PE were determined, among them: female gender, presence of bifurcation thrombus, lower SBP, SpO2, LVEF. Using the additional regression analysis, the formula for individual prediction of the risk of in-hospital mortality in high-risk PE patients was created. According to the receiver operating characteristic analysis, the sensitivity of the formula is 64.0 %, specificity is 92.1 %. The SBAFS (S — SpO2, B — Bifurcation thrombus, A — Arterial hypotension, F — left ventricular ejection Fraction, S — female Sex) score was formed, where the score of 2 or more indicates additional high risk of in-hospital mortality in high-risk PE patients. Conclusion. The high-risk PE patients who died during hospitalization had more cases of obesity, hypertension, lower SpO2, SBP, and LVEF, and there were more women among them. According to the multivariate logistic regression analysis, additional independent factors associated with in-hospital mortality in high-risk PE patients are female sex, thrombus in bifurcation of the pulmonary trunk, SpO2, SBP, LVEF. The formula for risk stratification of in-hospital death in high-risk PE patients was created and validated. The SBAFS score was formed to indicate additional high risk of in-hospital mortality in high-risk PE patients.

TCT-294 Comparison of Predicted to Observed Mortality in High-Risk Pulmonary Embolism Patients Undergoing Thrombectomy

TCT-294 Comparison of Predicted to Observed Mortality in High-Risk Pulmonary Embolism Patients Undergoing Thrombectomy

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

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. 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. 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. 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%. URL: https://www. gov; Unique identifier: NCT04795167.

317 Outcomes in High-Risk Pulmonary Embolism Patients Presenting in Advanced Shock: Insights From the FLAME Study

317 Outcomes in High-Risk Pulmonary Embolism Patients Presenting in Advanced Shock: Insights From the FLAME Study

When should we involve interventional radiology in the management of acute pulmonary embolism?

Pulmonary embolism (PE) is a common disease associated with high morbidity and mortality. Currently, guidelines recommend systemic thrombolysis in patients with haemodynamic instability (high-risk PE) or patients with intermediate-high-risk PE with haemodynamic deterioration. Nevertheless, more than half of high-risk PE patients do not receive systemic thrombolysis due to a perceived increased risk of bleeding. In these cases, percutaneous catheter-directed therapy (CDT) or surgical embolectomy should be considered. CDT has emerged and appears to be an effective alternative in treating PE, with a hypothetical lower risk of bleeding than systemic thrombolysis, acting directly in the thrombus with a much lower dose of thrombolytic drug or even without thrombolytic therapy. CDT techniques include catheter-directed clot aspiration or fragmentation, mechanical embolectomy, local thrombolysis, and combined pharmaco-mechanical approaches. A few observational prospective studies have demonstrated that CDT improves right ventricular function with a low rate of haemorrhage. Nevertheless, the evidence from randomised controlled trials is scarce. Here we review different scenarios where CDT may be useful and trials ongoing in this field. These results may change the upcoming guidelines for management and treatment of PE, establishing CDT as a recommended treatment in patients with acute intermediate-high-risk PE.

How to initiate aspirational embolectomy program for pulmonary embolism: single centre initial experience

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Recent advances in percutaneous mechanical thrombectomy provide lytic-free methods for treatment of pulmonary embolism (PE). Although guidelines recommend aspirational embolectomy only for high-risk PE patients with contraindication to or failed fibrinolysis, the method is currently being used in treatment of intermediate-high risk PE patients. We present our initial experiences with large bore percutaneous aspirational embolectomy catheter. Methods Patients with intermediate-high risk PE and at least one clinical feature (persistent hypoxemia, tachycardia, hypotension without shock, or dyspnoea on minimal exertion) were considered eligible for the method. Positive high-sensitive troponin was obligatory. PE was diagnosed by computed tomography. Echocardiography and doppler ultrasound of lower limbs venous system were performed upon admission. All procedures were performed by interventional cardiologist in cardiology suite. Light sedation with dexmedetomidine and/or midazolam was used. Ultrasound guided right or left femoral approach was used in all patients. A 7F balloon tipped catheter was used to cross the tricuspid and pulmonary valves and engage pulmonary artery (PA). After exchanging for 6F pigtail catheter an angiography was performed. Then, via multipurpose 6F catheter an extra-stiff wire was introduced distal to the thrombus. Over the wire a 20F or 24F aspirational embolectomy catheter was placed in front of the thrombus followed by the aspiration with 60 ml syringe. Up to 10 aspirations were allowed. Unfractionated heparin was used for periprocedural anticoagulation followed by apixaban or rivaroxaban as soon as hemostasis was achieved. Patients outcomes were recorded prospectively. Results From March to October 2022 a total of 10 patients were treated with aspirational embolectomy (6 females, median age 68.5 years (interquartile range 53.25-74)). Only the first case was performed with 20F catheter. In 9 patients sheathless approach was used due to material unavailability. In one case switching to left-side access was required due to inability to introduce the catheter in common femoral vein. In two cases a "lollipop" phenomenon occurred, one of which was a thrombus-in-transit (TIT) case. This case was complicated with TIT fragmentation on exit and re-embolism with circulatory arrest requiring veno-arterial extracorporeal circulatory support. Procedural success was achieved in all cases (in TIT patient two procedures were needed). All patients reported improvements in dyspnea levels. One patient required oxygen supplementation beyond 24h (TIT patient). Average PA systolic and diastolic blood pressure drop was 24.3±11.0 and 12.3±4.9 mmHg. Nine patients were alive at discharge, while TIT patient was still requiring hospitalisation. Conclusion Aspirational embolectomy can provide sufficient drop in PA pressures and symptom relief. Randomised trials are needed to determine the long term outcomes of the procedure.

Clinical outcomes of ultrasound-assisted coagulation monitoring-adjusted catheter-directed thrombolysis for acute pulmonary embolism

BackgroundUltrasound-assisted catheter-directed thrombolysis (USAT) may reverse right ventricular dysfunction due to acute pulmonary embolism (PE) with a favorable safety profile. MethodsWe studied intermediate-high- and high-risk acute PE patients who underwent USAT at the University Hospital Zurich, 2018–2022. The USAT regimen included alteplase 10 mg per catheter over 15 h, therapeutic-dosed heparin, and dosage adaptations based on routinely monitored coagulation parameters, notably anti-factor Xa activity and fibrinogen. We focused on the mean pulmonary arterial pressure (mPAP) and the National Early Warning Score (NEWS) before and after USAT, and reported the incidence of hemodynamic decompensation, PE recurrence, major bleeding, and death over 30 days. ResultsWe included 161 patients: 96 (59.6 %) were men and the mean age was 67.8 (SD 14.6) years. Mean PAP decreased from a mean of 35.6 (SD 9.8) to 25.6 (SD 8.2) mmHg, whereas the NEWS decreased from a median of 5 (Q1-Q3 4–6) to 3 (Q1-Q3 2–4) points. No cases of hemodynamic decompensation occurred. One (0.6 %) patient had an episode of recurrent PE. Two (1.2 %) major bleeding events occurred, including one (0.6 %) intracranial, fatal hemorrhage in a patient with high-risk PE, severe heparin overdosing, and a recent head trauma (with negative CT scan of the brain performed at baseline). No other deaths occurred. ConclusionsUSAT resulted in a rapid improvement of hemodynamic parameters among patients with intermediate-high risk acute PE and selected ones with high-risk acute PE, without any recorded deaths related to PE itself. A strategy including USAT, therapeutic-dosed heparin, and routinely monitored coagulation parameters may partly explain the overall very low rate of major bleeding.

Outcomes in high-risk pulmonary embolism patients undergoing FlowTriever mechanical thrombectomy: the FLAME study in perspective.

Pulmonary embolism (PE) is a common and life-threatening acute cardiovascular problem. In some patients, an abrupt increase in right ventricular (RV) afterload and impaired gas exchange result in acute RV failure, hypoperfusion, and severe hypoxemia due to V/Q mismatch. State-of-the-art management of acute PE includes early detection, risk stratification based on clinical, imaging, and biomarker criteria, and multidisciplinary decision-making regarding therapy.1,2 The European Society of Cardiology guidelines for management of PE recommend selection of therapy based on clinical severity of the presentation with class I recommendations for anticoagulation and systemic thrombolysis in patients with high-risk PE and for surgical thrombectomy in such patients in whom thrombolysis is contraindicated or has failed.3 Catheter-directed interventions for acute PE are aimed at increasing the cross-sectional area of patent pulmonary vasculature, thereby lowering resistance and alleviating V/Q mismatch.1,2 Percutaneous catheter-directed treatments are recommended as a reasonable alternative (Class IIa) in patients for whom thrombolysis is contraindicated or has failed.

Effectiveness of systemic thrombolysis on clinical outcomes in high-risk pulmonary embolism patients with venoarterial extracorporeal membrane oxygenation: a nationwide inpatient database study

BackgroundCurrent guidelines recommend systemic thrombolysis as the first-line reperfusion treatment for patients with high-risk pulmonary embolism (PE) who present with cardiogenic shock but do not require venoarterial extracorporeal membrane oxygenation (VA-ECMO). However, little is known about the optimal reperfusion treatment in high-risk PE patients requiring VA-ECMO. We aimed to evaluate whether systemic thrombolysis improved high-risk PE patients’ outcomes who received VA-ECMO.MethodsThis was a retrospective cohort study using the Japanese Diagnosis Procedure Combination inpatient database from July 2010 to March 2021. We identified patients who were diagnosed with PE and received VA-ECMO on the day of admission. Patients who received systemic thrombolysis with monteplase or urokinase within two days of initiating VA-ECMO were defined as the thrombolysis group and the remaining patients as the control group. The primary outcome was in-hospital mortality and secondary outcomes were favorable neurological outcomes, length of hospital stay, VA-ECMO duration, total hospitalization cost, major bleeding, and blood transfusion volume. Propensity-score inverse probability of treatment weighting (IPTW) was performed to compare the outcomes between the groups.ResultsOf 1220 eligible patients, 432 (35%) received systemic thrombolysis within two days of initiating VA-ECMO. Among the unweighted cohort, patients in the thrombolysis group were less likely to have poor consciousness at admission, out-of-hospital cardiac arrest, and left heart catheterization. After IPTW, the patient characteristics were well-balanced between the two groups The crude in-hospital mortality was 52% in the thrombolysis group and 61% in the control group. After IPTW, in-hospital mortality did not differ significantly between the two groups (risk difference: − 3.0%, 95% confidence interval: − 9.6% to 3.5%). There were also no significant differences in the secondary outcomes. Sensitivity analyses showed a significant difference in major bleeding between the monteplase and control groups (risk difference: 6.9%, 95% confidence interval: 1.7% to 12.1%), excluding patients who received urokinase. There were no significant differences in the other sensitivity and subgroup analyses except for the total hospitalization cost.ConclusionsSystemic thrombolysis was not associated with reduced in-hospital mortality or increased major bleeding in the high-risk PE patients receiving VA-ECMO. However, systemic thrombolysis with monteplase was associated with increased major bleeding.

Percutaneous thrombectomy in patients with intermediate- and high-risk pulmonary embolism and contraindications to thrombolytics: a systematic review and meta-analysis.

Catheter-directed interventions have slowly been gaining ground in the treatment of pulmonary embolism (PE), especially in patients with increased risk of bleeding. The goal of this study is to summarize the evidence for the efficacy and safety of percutaneous thrombectomy (PT) in patients with contraindications to systemic and local thrombolysis.We performed a systematic review and meta-analysis using MEDLINE, Cochrane, Scopus and the Web of Science databases for studies from inception to March 2022. We included patients with intermediate- and high-risk PE with contraindications to thrombolysis; patients who received systematic or local thrombolysis were excluded. Primary endpoint was in-hospital and 30-day mortality, with secondary outcomes based on hemodynamic and radiographic changes. Major bleeding events were assessed as a safety endpoint.Seventeen studies enrolled 455 patients, with a mean age of 58.6years and encompassing 50.4% females. In-hospital and 30-day mortality rates were 4% (95% CI 3-6%) and 5% (95% CI 3-9%) for all-comers, respectively. We found a post-procedural reduction in systolic and mean pulmonary arterial pressures by 15.4mmHg (95% CI 7-23.7) and 10.3mmHg (95% CI 3.1-17.5) respectively. The RV/LV ratio and Miller Index were reduced by 0.42 (95% CI 0.38-46) and 7.8 (95% CI 5.2-10.5). Major bleeding events occurred in 4% (95% CI 3-6%).This is the first meta-analysis to report pooled outcomes on PT in intermediate- and high-risk PE patients without the use of systemic or local thrombolytics. The overall mortality rate is comparable to other contemporary treatments, and is an important modality particularly in those with contraindications for adjunctive thrombolytic therapy. Further studies are needed to understand the interplay of anticoagulation with PT and catheter-directed thrombolysis.

869: MORTALITY AND BLEEDING RISKS OF INTERVENTIONS FOR HIGH- AND INTERMEDIATE-RISK PULMONARY EMBOLISM

Introduction: Multiple strategies have been used to treat patients at high and intermediate risk of mortality from an acute pulmonary embolism (PE), but the most effective and safest treatment remains poorly defined. We aimed to investigate the mortality and bleeding complications in high/intermediate risk PE patients following different treatments. Methods: We searched PubMed and EMBASE databases from inception to July 2022 and included observational studies and randomized controlled trials (RCT) encompassing high and intermediate risk PE patients and comparing at least two of the following treatments: systemic thrombolysis (ST), anticoagulation only (AC), catheter-directed intervention (CDI), and surgical embolectomy (SE). The primary outcome was in-hospital mortality. The secondary outcomes were 1-year mortality, major or minor bleeding. Results: This network meta-analysis identified four RCTs and 27 observational studies involving 117,628 patients. CDI was associated with lower in-hospital mortality than ST (OR [95%CI]: 0.42 [0.32-0.55]), AC (OR [95%CI]: 0.43 [0.27-0.66]), and SE (OR [95%CI]: 0.52 [0.33-0.82]). AC was associated with higher 1-year mortality than the other strategies. AC was associated with the lowest risk of major bleeding compared to ST (OR [95%CI]: 0.46 [0.29-0.74]), CDI (OR [95%CI]: 0.61 [0.38-0.99]), and SE (OR [95%CI]: 0.44 [0.23-0.85]). Furthermore, CDI was associated with lower risks of major bleeding than ST (OR [95%CI]: 0.75 [0.58-0.96]). AC was associated with lower risks of minor bleeding than ST and CDI, whereas CDI was also associated with a lower risk of minor bleeding compared to ST. Conclusions: In patients with high/intermediate risk PE, CDI was associated with lower mortality and decreased bleeding complications compared to other treatment strategies. Further studies including randomized control studies are required to validate our findings.

Impact of a blood return system on mechanical thrombectomy-associated blood loss and hemodynamic outcomes in a pulmonary embolism registry

Abstract Background Mechanical thrombectomy can treat pulmonary embolism (PE) while eliminating the bleeding risks associated with thrombolytic-based therapies. In longer and more complex procedures, however, blood loss from aspiration-based mechanical thrombectomy can potentially limit thrombus removal. Purpose Assess a blood return system's ability to reduce mechanical thrombectomy procedure blood loss and characterize hemodynamic outcomes post-procedure. Methods This retrospective analysis of a prospective, multicentre, real-world registry enrolling intermediate- and high-risk PE patients treated with mechanical thrombectomy compared all patients enrolled prior to the availability of a blood return system with all patients whose treatment included use of a blood return system. Linear regression was used to model the blood return system's effect on estimated blood loss. The model was adjusted for patient characteristics and disease factors that may have been different between the treatment groups or related to blood loss. Results Complete case analysis was used to identify 319 patients prior to the availability of a blood return system (no blood return), and 50 patients who were treated using a blood return system through January 2022 (blood return). As shown in Table 1, the only significant differences in the summary statistics for the blood return group were 160 ml decreased estimated blood loss (292.5 to 132.5 ml; p&amp;lt;0.01) and a 13.1 minute increase in thrombectomy time (47.9 to 61.0 minutes; p&amp;lt;0.01). Linear regression modeling revealed that use of a blood return system was associated with a 200 ml (69%) reduction (p&amp;lt;0.01) in blood loss for the average patient and thrombectomy time (Figure 1A). Importantly, the addition of an interaction term between thrombectomy time and blood return showed blood loss reduction increased with thrombectomy time (Figure 1B). Post-procedure mean pulmonary arterial pressure decreased by 7.0 mmHg (33.0 to 26.0 mmHg) in the blood return group and 7.9 mmHg (32.1 to 24.2 mmHg) in the no blood return group. In patients with depressed baseline cardiac index (CI) &amp;lt;2, CI improved by 0.3 L/min/m2 (1.8 to 2.1 L/min/m2) in the blood return group and 0.4 L/min/m2 (1.6 to 2.0 L/min/m2) in the no blood return group, demonstrating normalization of depressed CI in both groups. No hemodynamic outcomes differed significantly between groups (p&amp;gt;0.05). Conclusions Treatment with aspiration mechanical thrombectomy in combination with a blood return system achieved equivalent hemodynamic outcomes compared with mechanical thrombectomy alone, while reducing 69% of procedure blood loss. The fact that blood return patients had equivalent hemodynamic improvements suggests these improvements are related to thrombus removal rather than aspiration-related blood loss. The association identified between blood loss and thrombectomy time indicates that thrombus removal is not limited by blood loss when a blood return system is used. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Inari Medical

OUTCOMES FROM CATHETER-DIRECTED EMBOLECTOMY FOR INTERMEDIATE-RISK AND HIGH-RISK PULMONARY EMBOLISM

OUTCOMES FROM CATHETER-DIRECTED EMBOLECTOMY FOR INTERMEDIATE-RISK AND HIGH-RISK PULMONARY EMBOLISM