Therapeutic anticoagulation (AC) is standard care for pulmonary embolism (PE). Endovascular therapy with mechanical thrombectomy (MT) is commonly performed for PE and well-studied in single-arm trials. The efficacy benefit of MT over AC alone in a randomized fashion remains unstudied.

STORM-PE (ClinicalTrials.gov Identifier: NCT05684796) is a post-market, international, open-label trial conducted in partnership with The Pulmonary Embolism Response Team Consortium. Up to 100 patients with confirmed acute intermediate-high-risk PE demonstrated by right ventricular (RV) dysfunction with a right-to-left ventricular (RV/LV) ratio ≥1.0 and elevated cardiac biomarkers will be randomized 1:1 to receive AC alone or AC plus computer assisted vacuum thrombectomy (CAVT) with the Indigo Aspiration System (Penumbra Inc.). The primary outcome is a mean change in RV/LV ratio at 48 hours, assessed by computed tomographic pulmonary angiography (CTPA) and adjudicated by a blinded, independent imaging Core Lab. Additional endpoints are composite major adverse events, functional outcomes (6-minute walk test, New York Heart Association classification, post-venous thromboembolism functional status scale, modified Medical Research Council Dyspnea Scale, Borg Scale), quality of life (Pulmonary Embolism Quality of Life Questionnaire and EQ-5D-5L), mortality, and symptomatic PE recurrence through 90 days. A Clinical Events Committee will adjudicate adverse events for causality and attribution and an independent Data Safety Monitoring Board will oversee the study. STORM-PE is funded by Penumbra Inc.

The STORM-PE trial will help inform future guidelines and standards of care related to frontline treatment using mechanical thrombectomy with CAVT for patients with acute intermediate-high-risk PE.

STORM-PE, NCT05684796, is registered at https://clinicaltrials.gov/study/NCT05684796.

Catheter-directed therapy has been increasingly used in acute pulmonary embolism (PE). Whether ultrasound-assisted thrombolysis (USAT) is superior to standard catheter-directed thrombolysis (SCDT) remains unclear. This is a systemic review and meta-analysis of comparative trials on USAT and SCDT for PE to determine whether either modality yielded better clinical efficacy and safety.

Major databases including PubMed, Embase, Cochrane Central, and Web of Science were searched through March 16, 2023. Studies that reported outcomes of SCDT and USAT for acute PE were included. Studies reported data on therapeutic efficacy (a reduction in the right ventricle [RV]/left ventricle [LV] ratio, a reduction in the systolic pulmonary artery pressure [mm Hg], change in Miller index, length of intensive care unit [ICU] and hospital stay) and safety outcomes (in-hospital mortality, overall and major bleeding events).

A total of 9 studies with 2610 patients were included in the meta-analysis. The analysis showed significantly greater improvement in the RV/LV ratio in the SCDT group than in the USAT group (mean difference [MD]: -0.155; 95% confidence interval [CI]: -0.249 to -0.006). No statistically significant differences were found between groups comparing change in systolic pulmonary artery pressure (MD: 0.592 mm Hg; 95% CI: -2.623 to 3.807), change in Miller index (MD: -4.1%; 95% CI: -9.5 to 1.3%), hospital stay (MD: 0.372 days; 95% CI: -0.972 to 1.717), and ICU stay (MD: -0.073.038 days; 95% CI: -1.184 to 1). No significant difference was noted in safety outcomes, including in-hospital mortality (pooled odds ratio: 0.984; 95% CI: 0.597 to 1.622), and major bleeding (pooled odds ratio: 1.162; 95% CI: 0.714 to 1.894).

In our meta-analysis of observational and randomized studies, USAT is not superior to SCDT in patients with acute PE.INSPLAY registration number: INPLASY202240082.Clinical ImpactThis study compared SCDT and USAT in patients with acute pulmonary embolism. We found no additional benefit in PA pressure change, thrombus reduction, hospital stay, mortality and major bleeding rate. Additional study using consistent treatment protocol is necessary for further investigation.

Ultrasound-assisted catheter-directed thrombolysis (USAT) for acute pulmonary embolism (PE) has garnered specific interest and is commonly employed in intermediate-risk PE to prevent cardiac decompensation and death. However, evidence supporting the effectiveness and safety of USAT in routine clinical practice is limited. We therefore aimed to investigate the safety and effectiveness of USAT in a large patient population with PE.

The ERASE PE (Bern Acute Pulmonary Embolism Registry) is a single-center cohort study investigating the safety and effectiveness of PE treatment according to the decision of the local PE response team. The specified primary outcome was in-hospital mortality. Between October 2017 and April 2023, 315 patients (mean age 64.3±14.2 years; 38% female) with intermediate-high (n=257, 82%) and high risk (n=58, 18%) PE were treated with USAT. Patients presented with tachycardia (heart rate 104.3±20.4 bpm), hypoxemia (peripheral oxygen saturation 89.2%±7.5%), elevated mean pulmonary artery pressures (30.7±8.0 mm Hg), and reduced mixed venous saturation (venous oxygen saturation 58.5%±10.2%). Patients received USAT with a cumulative dose of 19.8±6.6mg rt-PA over 14.4±2.2 hours. USAT was effective in reducing right ventricular overload and pulmonary artery pressure in 88% of patients with a mean reduction of right ventricular/left ventricular ratio of 0.37±0.29 and mean pulmonary artery pressure of 8.5±7.7 mm Hg, respectively. The primary end point was observed in 10 patients (3.2%). One patient had an embolic stroke (0.3%), 25 patients (7.9%) exhibited bleeding, including 3 patients with intracranial hemorrhage (1.0%), and 3 patients (1.0%) had recurrent PE.

Among patients with acute PE, USAT effectively reduces right ventricular overload and mean pulmonary artery pressure with low rates of in-hospital mortality and bleeding.

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04355975.

Catheter-directed interventions (CDIs) for pulmonary embolism (PE) continue to evolve. However, due to the paucity of data, their use has been limited in patients with underlying kidney disease.

The National Readmission Database (2016-2020) was utilized to identify intermediate to high-risk PE (IHR-PE) patients requiring CDI (thrombectomy, thrombolysis, and ultrasound-assisted thrombolysis). Cohorts were stratified based on the presence of CKD stage ≥3, including ESRD. A Propensity Score Matching (PSM) model was applied to compare outcomes.

From 2016-2020, 20795 patients with IHR-PE underwent CDIs. Most were done in the non-CKD/ESRD population (N:18438, 88.7 %), while only 2357 (11.3 %) were done in the CKD/ESRD population. After propensity matching, the CKD/ESRD population had higher adverse events, including mortality (7.3 % vs. 5.1 %, p: 0.036), need for transfusions (52.6 % vs. 44.7 %, p < 0.001), and acute bleeding (15.4 % vs. 10.6 %, p < 0.001). CKD/ESRD population had a higher median LOS (5 vs. 4 days, p < 0.001) and total cost ($32935 vs. $29805, p < 0.001) in the index admission. Over the study period, total cost decreased in the CKD/ESRD population ($37829 to $31436, p-trend: 0.024) but remained the same in the non-CKD/ESRD population (p-trend>0.05). 180-day readmission rates were higher in the CKD/ESRD population (24.7 % vs. 17.5 %, p: 0.006). Our subgroup analysis, excluding ESRD patients, showed no significant difference in in-hospital mortality (6.5 % vs. 7.3 %, p > 0.05), but the rates of thoracic or respiratory bleeding (4.5 % vs. 2.6 %, p:0.012), need for transfusions (52.4 % vs.. 43.5 %, p < 0.001), and AKI (57.1 % vs. 23.2 %, p < 0.001) were higher in patients with CKD undergoing CDIs for IHF-PE.

CKD/ESRD patients requiring catheter-directed interventions for IHR-PE had higher periprocedural mortality and acute bleeding. The presence of ESRD mainly drove periprocedural mortality in our study, while the presence of non-dialyzed CKD was associated with higher rates of non-fatal localized hemorrhage.

Evidence is limited regarding the comparative effectiveness and safety of mechanical thrombectomy (MT) vs catheter-directed thrombolysis (CDT) for high-risk pulmonary embolism (PE).

This observational study aimed to compare the outcomes of older adults with high-risk PE treated with MT vs CDT using a target trial emulation framework.

We included Medicare fee-for-service beneficiaries aged 65 to 99 years admitted with high-risk PE (defined by cardiac arrest, shock, and vasopressor use) who underwent MT/CDT from 2017 to 2020. We evaluated 1-year mortality using an inverse probability of treatment weighting approach, controlling for 62 baseline covariates. We also evaluated readmissions and in-hospital outcomes, including intracranial hemorrhage. Patients were followed from the date of the index procedure to the outcomes of interest, 1 year, or December 2020.

We included 235 and 484 patients in the MT and CDT groups, respectively. The absolute risk of 1-year mortality was 48.4% (95% CI: 34.1%-63.3%) in the MT group and 45.4% (95% CI: 37.8%-55.8%) in the CDT group, with an adjusted HR of 1.16 (95% CI: 0.84-1.59). We found no evidence that all-cause readmission (MT vs CDT; subdistribution HR: 0.89; 95% CI: 0.56-1.40), intracranial hemorrhage (adjusted OR: 0.36; 95% CI: 0.07-1.77), or transfusions (adjusted OR: 0.96; 95% CI: 0.52-1.76) differed significantly between the 2 groups.

Among older adults with high-risk PE treated with catheter-based therapies, the clinical outcomes were similar between the patients treated with MT vs CDT. Randomized trials are needed to confirm our findings.

Standard catheter-directed thrombolysis (SCDT) and Ultrasound-assisted thrombolysis (USAT) are used in intermediate and high-risk pulmonary embolism (PE). SCDT uses low-dose thrombolytic agents, minimizing bleeding risk. USAT adds acoustic energy to improve fibrin breakdown and thrombolytic penetration. A systematic literature search spanning PubMed/Medline, Embase, CENTRAL, CINAHL, and ClinicalTrials.gov databases (from inception to 17 June 2024) was conducted to retrieve studies comparing USAT to SCDT for managing acute PE. Risk of bias was assessed using Cochrane tools for randomized and non-randomized trials. Odds ratio (OR) and mean difference (MD) were pooled using random effects models. Statistical analyses were performed in R version 4.2.2. 11 studies with 37,398 patients (8,762: USAT and 28,636: SCDT) were included. The mean reduction in right ventricular to left ventricular diameter ratio was lower for USAT (MD: -0.12; 95% CI: -0.19, -0.06) compared to SCDT. There was no statistically significant difference between USAT and SCDT for odds of in-hospital mortality, intracranial hemorrhage, bleeding requiring transfusion or for means of hospital or ICU length of stay, or reduction in pulmonary artery pressures. Safety or efficacy of USAT is not superior to SCDT in patients with acute PE. Results were limited due to variable infusion protocol across studies and heterogeneity of results among studies. Large-scale randomized controlled trials (RCTs) are needed to corroborate these findings.

Background/Objectives: The incidence, timing, and predictors of hemodynamic and respiratory deterioration in patients with high-risk or intermediate-high-risk pulmonary embolism (PE) undergoing pulmonary mechanical thrombectomy (PMT) remain poorly understood. This hemodynamic and respiratory instability can lead to modifications in the anesthetic management. This study investigates these key factors and quantifies the 30-day mortality following thrombectomy. Methods: A retrospective study was conducted on 98 patients aged ≥18 years who underwent PMT. Patients were categorized based on the occurrence of cardiac arrest (CA). Results: Of the 98 patients, 34 had high-risk PE, 62 intermediate/high-risk, and 2 low risk. There were 27 cases of CA, 17 pre- and 10 intra-PMT. An SBP < 90 mmHg increases the risk of CA by 33 (p < 0.001); men have an 8-fold higher risk than women (p = 0.004); SpO2 <90% by 6 (p = 0.012); and pre-existing respiratory conditions increase the risk by 4 (p = 0.047)). N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels were 8206 ± 11660.86 and 2388.50 ± 5683.71 pg/mL (p = 0.035) in patients with and without CA, respectively. During PMT, 14% of patients required increased vasoactive drug use, and 38.77% were intubated, including 12 who required ECMO support. Sedation was administered in 64.3% of patients, while general anesthesia was used in 38.8%, with a preemptive indication in 23.5%. The survival rate of patients without CA before and/or during PMT was 96%. Conclusions: While PMT was successfully performed in all patients, hemodynamic and respiratory instability remained a significant concern. More than 10% of patients experienced severe hemodynamic instability, primarily during thrombus extraction, requiring conversion from sedation to general anesthesia. Male sex, pre-existing respiratory disease, SpO2 < 90%, and SBP < 90 mmHg were associated with an increased risk of CA. Additionally, elevated NT-proBNP levels were linked to a higher incidence of CA.

Intermediate risk (IR)- and high risk (HR)-pulmonary embolism (PE) are associated with mortality rates that span 1.8% to 17% and greater than 31% respectively. Catheter-directed embolectomy (CDE) and surgical embolectomy (SE) for IR- and HR-PE offer alternatives to systemic thrombolysis, but data comparing CDE versus SE is limited. We assessed the outcomes of patients with acute PE who received CDE or SE for IR- and HR-PE.

A retrospective review of all adult patients who had undergone CDE or SE for IR- and HR-PE in the Mount Sinai Health System between August, 2019 to June, 2022 was performed. Fisher's exact test and Student's t-test (or Mann-Whitney U-test) were used for comparing qualitative and quantitative outcomes respectively between the CDE and SE groups.

Fifteen (15) patients received SE, and 25 patients received CDE. Patients who received SE included 53% IR- and 47% HR-PE, while those who received CDE included 60% IR- and 40% HR-PE. CDE and SE had 96% and 100% technical success rates respectively. The 30-day all-cause mortality rates were 13.3% and 8% in the SE and CDE groups respectively (p > 0.05). The rates of major hemorrhagic complications in the CDE and SE groups were 4% and 26.7% respectively (p > 0.05).

CDE and SE were associated with high technical success rates in patients with IR- and HR-PE along with a low risk of major complications and acceptable 30-day all-cause mortality rates. In the absence of significant contraindications, CDE may provide a less invasive alternative to SE.

ObjectivesAcute pulmonary embolism (PE) is one of the most serious forms of venous thromboembolism (VTE) with high mortality and morbidity. PE may present with right ventricular dysfunction and hemodynamic disturbances. Early diagnosis and appropriate treatment approaches play a critical role in improving survival. In this study, we evaluated the efficacy and safety of catheter-mediated thrombolytic therapy in intermediate-high-risk PE patients.MethodsOur retrospective study was conducted at Ankara University between 2015 and 2020 and 66 intermediate-high-risk PE patients were analyzed. Clinical, biochemical and echocardiographic data of the patients were analyzed and their response to treatment was evaluated. The primary endpoint was 30-day mortality and secondary endpoints were hemodynamic improvement, length of hospitalization and complication rates.ResultsThe mean age of the patients was 65 years and all of them presented with a diagnosis of symptomatic PE. After treatment, significant improvement was observed in right ventricular function, RV/LV ratio, ProBNP and Troponin I levels decreased significantly. Pulmonary artery pressures decreased and hemodynamic parameters improved. The early mortality rate after the procedure was 3% and the rate of major bleeding was low.ConclusionsCatheter-mediated thrombolytic therapy provides hemodynamic improvement in intermediate-high-risk PE patients, while offering a low bleeding risk. Our results suggest that this therapy may be a safe and effective alternative. However, long-term results should be evaluated in large-scale, randomized studies.

Pulmonary embolism (PE) is the leading cause of hospital death and the third most frequent cause of cardiovascular mortality. Traditionally, treatment options have included anticoagulation, thrombolysis, or surgery; however, catheter-directed interventions (CDI), including catheter-directed thrombolysis and aspiration thrombectomy, have been developed for patients with intermediate- or high-risk PE. These techniques can rapidly improve right ventricular function, hemodynamic status, and mortality in some patients, although there is a lack of evidence from randomized controlled trials. This document, prepared by the Interventional Cardiology Association, the Association of Ischemic Heart Disease and Acute Cardiovascular Care, and the Working Group on Pulmonary Hypertension of the Spanish Society of Cardiology (SEC), reviews the current recommendations and available evidence on the management of PE. It emphasizes the importance of rapid response teams, risk stratification, and early patient monitoring in identifying candidates for reperfusion. Based on existing clinical evidence on CDI, the document discusses various clinical scenarios and provides guidance on patient selection, particularly in situations of uncertainty due to insufficient evidence. Lastly, it describes periprocedural support, highlighting the necessary multidisciplinary approach to improve outcomes and reduce morbidity and mortality in patients with PE.

A 70-year-old man with a history of left-sided renal donation surgery 11 days earlier developed rupture of a pancreaticoduodenal artery (PDA) aneurysm caused by median arcuate ligament syndrome (MALS). The patient also had a congenital anomaly and left-sided inferior vena cava (IVC). Surgical hemostasis was performed; however, the patient developed a massive pulmonary embolism on day 4 of hospitalization. Chest contrast-enhanced computed tomography revealed compression of the IVC by the abdominal aorta and a hematoma resulting from aneurysm rupture, which was considered the source of deep vein thrombi. Although PDA aneurysms related to MALS and left-sided IVC are rare conditions, PDA aneurysm rupture is life-threatening, and left-sided IVC presents a potential risk for deep vein thrombosis. However, comprehensive management strategies for these conditions have not yet been established.

To compare the safety and efficacy of mechanical thrombectomy (MT) and ultrasound-accelerated thrombolysis (USAT) in pulmonary embolism (PE) management by performing a systematic review of the literature.

The PubMed database was searched to identify articles on Inari's FlowTriever and Penumbra's Indigo mechanical thrombectomy devices (Group A) and the Ekos Endovascular system (Group B). Outcomes variables analyzed include pre- and post-procedure RV/LV ratio, pre- and post-procedure pulmonary artery pressure, hospital length of stay, technical success, specific complications, and mortality rate. Mean values were calculated using the weighted mean approach. RevMan Version 5.4 (Cochrane Collaboration) was used to perform the meta-analysis for this study. Cochrane Collaboration's Risk of Bias (RoB 2.0) approach was used to perform a quality assessment of the included articles in order to verify the validity and reliability of the research.

27 studies were in Group A and 28 studies pertained to Group B. There were 1662 patients in Group A and 1273 patients in Group B. Both groups had similar technical success (99.6% vs 99.4%). Thrombectomy showed longer mean procedure time (73.03 ± 14.57 min vs 47.35 ± 3.15 min), lower mean blood loss (325.20 ± 69.15 mL vs 423.05 ± 64.95 mL), shorter mean ICU stay (2.35 ± 1.64 days vs 3.22 ± 1.27 days), and shorter mean overall hospital stay (6.94 ± 4.38 days vs 7.23 ± 2.31 days). EKOS showed greater mean change in Miller Index (9.05 ± 3.35 vs 4.91 ± 3.70) and greater mean change in pulmonary artery pressure (14.17 ± 6.35 mmHg vs 8.11 ± 4.39 mmHg).

Ultrasound accelerated thrombolysis and percutaneous mechanical thrombectomy are effective therapies for pulmonary embolism with comparable clinical outcomes.

Pulmonary embolism is associated with a significant burden of morbidity, mortality, and health care costs. Catheter-directed thrombolysis has emerged as a promising option for patients with intermediate-risk pulmonary embolism which aims to improve outcomes over standard anticoagulation.

We constructed a decision-analytic model comparing the cost-effectiveness of catheter-directed thrombolysis to anticoagulation alone for the management of intermediate-risk pulmonary embolism. Cost-effectiveness was determined by calculating deaths averted and incremental cost-effectiveness ratios (ICER). Uncertainty was addressed by plotting cost-effectiveness planes and acceptability curves for various willingness-to-pay thresholds. The main outcome was ICER (US dollars/deaths averted).

In the base case analysis, derived using systemic lysis data, the cost associated with catheter-directed thrombolysis was estimated at $22,353 with a probability of survival at 1 month of 0.984. For the anticoagulation alone strategy, the cost was $25,060, and the probability of survival at 1 month was 0.958. Overall, catheter-directed thrombolysis resulted in savings of $104,089 per death averted (ICER,-$104,089 per death averted). Sensitivity analysis revealed that catheter-directed thrombolysis would no longer be cost-effective when its associated mortality is greater than 0.042. In the probabilistic analysis, at a willingness-to-pay of $100,000, catheter-directed thrombolysis had a 63% chance of being cost-effective, and in cost-effectiveness acceptability curves, it was cost-effective in 63%-78% of simulations for a willingness to pay ranging from $0 to $100,000.

If the assumptions made in our model are shown to be accurate then CDT would be cost-effective and may lead to considerable cost savings if used where clinically appropriate.

To compare changes in hemoglobin (HB) following catheter-directed thrombolysis (CDT) versus large-bore aspiration thrombectomy (LBAT) of acute pulmonary embolism (PE).

A single-center retrospective review of patients with acute high- or intermediate-risk PE treated with CDT or LBAT between December 2009 and September 2023 was performed. The LBAT group was divided according to usage of an autotransfusion device (ATD). There were 166 patients in the CDT group (56 years ± 15). LBAT patients were treated without (LBAT, n = 58, 61 years ± 16) or with (LBATw, n = 47, 62 years ± 15) an ATD. Endpoints included change in HB between preprocedural and postprocedural measurements, the 7-day postprocedural nadir (low point), and adverse events (AEs).

The mean HB changes between preprocedural and postprocedural measurements in the CDT, LBAT, and LBATw groups were -1.3 g/dL ± 1.3, -1.6 g/dL ± 0.98, and -1.1 g/dL ± 0.9, respectively (P = .098). The mean HB changes to the 7-day postprocedural nadir in the CDT, LBAT, and LBATw groups were -1.7 g/dL (SD ± 1.4), -2.4 g/dL (SD ± 1.3), and -1.8 g/dL (SD ± 1.3), respectively (P = .008). The minor hemorrhagic AE rates were 3.6% in the CDT group, 12.1% in the LBAT group, and 14.9% in the LBATw group (P = .010). There was no significant difference in moderate (P = .079) and major (P = .529) hemorrhagic AEs between the groups. There were no procedure-related mortalities.

The use of LBAT without ATD resulted in a significant decrease in HB to the 7-day postprocedural nadir compared with CDT or LBAT with ATD. This did not translate into significantly higher transfusion rates or moderate or major hemorrhagic events. Findings suggest that the decision between CDT and LBAT should not be based solely on the expected blood loss consideration.

Over the past decade, new modalities have emerged to treat acute pulmonary embolism (PE). However, PE remains a leading cause of morbidity and mortality worldwide. In the absence of robust clinical trial data and definitive guidelines and recommendations for a variety of clinical situations, individual patient treatment decisions have become paradoxically more challenging as innovation in the space has grown. In this review, we discuss a practical and current approach to patients diagnosed with PE, focusing on their risk stratification and treatment selection.

Long-term exercise intolerance and functional limitations are common after an episode of acute pulmonary embolism (PE), despite 3 to 6 months of anticoagulation. These persistent symptoms are reported in more than half of the patients with acute PE and are referred as "post-PE syndrome." Although these functional limitations can occur from persistent pulmonary vascular occlusion or pulmonary vascular remodeling, significant deconditioning can be a major contributing factor. Herein, the authors review the role of exercise testing to elucidate the mechanisms of exercise limitations to guide next steps in management and exercise training for musculoskeletal deconditioning.

The objective of this study was to evaluate the safety and efficacy of catheter-directed thrombolysis (CDT) and mechanical aspiration (MA) for acute pulmonary embolism (PE).

From February 2022 to October 2024, the clinical data of patients with high- and intermediate-risk PE who received endovascular therapy were retrospectively reviewed. Patients were categorized based on the treatment strategy.

Fifty-eight consecutive patients were identified. CDT was initiated in 29 patients, while the remaining 29 received MA treatment. The time of thrombolysis and the dosage of urokinase were both lower in the MA group (P <0.05). No differences were found in cardiac biomarkers after 48 hours, perioperative bleeding events, heart/valve injury, and mortality. The total cost of the MA group was much higher compared to CDT alone. The MA group showed better improvement in right ventricular (RV) function with a higher reduction in the right ventricular-to-left ventricular ratio (0.55 ± 0.46 vs. 0.13 ± 0.53, P = 0.017). No differences were found in the reduction of the CT obstruction index.

CDT and MA seem to have similar outcomes for patients with acute high- and intermediate-risk PE. MA is more effective in improving RV function with less thrombolysis time and fewer thrombolytics.

Intermediate-high risk pulmonary embolism (PE) carries a significant risk of hemodynamic deterioration or death. Treatment should balance efficacy in reducing clot burden with the risk of complications, particularly bleeding. Previous studies on high-dose, short-term thrombolysis with alteplase (rtPA) showed a reduced risk of hemodynamic deterioration but no change in mortality and increased bleeding complications. Catheter-based techniques, including ultrasound-assisted thrombolysis (USAT), and low-dose thrombolysis may offer reasonable efficacy with lower risk. However, studies comparing these methods have been few. This trial aims to address this gap by randomizing patients to three treatment modalities.

Multicenter, randomized trial with 1:1:1 allocation of 210 patients with acute intermediate-high risk PE, excluding those with absolute contraindications to thrombolysis. Patients are eligible for inclusion if they are > 18 years of age, have had symptoms < 14 days, and are able to give informed consent. Patients are allocated 1:1:1 into three treatment strategies: (1) unfractionated heparin (UFH)/low molecular weight heparin (LMWH), (2) UFH/LMWH + 20 mg rtPA/6 h intravenously (IV), or (3) UFH + 20 mg rtPA/6 h via USAT. Co-primary outcomes include reduction in clot burden as assessed by refined Miller score from pre-treatment to follow-up (48-96 h) computed tomography pulmonary angiogram (CTPA) comparing low-dose rtPA (± USAT) groups to UFH/LMWH group (p < 0.01, N = 210) and reduction in refined Miller score on follow-up CT angiography comparing low-dose rtPA by USAT to intravenous rtPA, p < 0.04, N = 140). Secondary outcomes comprise bleeding complications, duration of index admission, FiO2, blood pressure, respiratory and heart rate at the time of follow-up CT angiography, mortality in the three groups, incidence of tricuspid regurgitation pressure gradient < 40 mmHg at 3 months follow-up echocardiography, 6-min walk test at 3 months comparing the three groups, and health-related quality of life at 3 months follow-up comparing the three groups.

We hypothesize that in patients with intermediate-high risk PE (1) administration of 20 mg rtPA leads to a greater reduction in clot burden compared to heparins and (2) administration of 20 mg rtPA via USAT results in a greater reduction in clot burden compared to 20 mg rtPA intravenous.

ClinicalTrials.gov NCT04088292. Registered in September 2019 (retrospectively registered).

Pulmonary embolism is the third most common cardiovascular disease. Interventional treatment options as an alternative to systemic lysis therapy of hemodynamically stable, submassive pulmonary embolisms have received an unprecedented boost in innovation in recent years. The treatment options are heterogeneous and can be roughly divided into local thrombolysis and local thrombectomy. For years in our center we have been carrying out catheter-assisted, locoregional lysis therapy with side-hole lysis catheters and a cumulative dose per pulmonary branch of 10 mg alteplase over 15 h for hemodynamically stable, submassive pulmonary emboli.

The aim of this retrospective study was to review this therapeutic concept and to collect data on clinical endpoints and possible complications.

The study included data from 01/2018-03/2023. For this purpose, the patients were selected based on the OPS codes (8.838.60 and 1‑276.0), and the data was collected using the medical records. Biometric data, data on previous illnesses and vital parameters, laboratory chemistry data, CT diagnostic data, echocardiographic data, data on drug treatment and data on complications were collected anonymously.

There was a significant reduction in the strain on the right heart. Peripheral oxygen saturation also improved significantly and heart rate decreased significantly. The complication rate remained low and was almost exclusively limited to access-related problems.

Catheter-assisted, locoregional lysis therapy is a safe and effective treatment method for submassive pulmonary embolism.

High/intermediate-risk pulmonary embolism (PE) confers increased risk of cardiovascular morbidity and mortality. International guidelines recommend the formation of a PE response team (PERT) for PE management because of the complexity of risk stratification and emerging treatment options. However, there are currently no available Australian data regarding outcomes of PE managed through a PERT.

To analyse the clinical and outcome data of patients from an Australian centre with high/intermediate-risk PE requiring PERT-guided management.

We performed a retrospective observational study of 75 consecutive patients with high/intermediate-risk PE who had PERT involvement, between August 2018 and July 2021. We recorded clinical and interventional data at the time of PERT and assessed patient outcomes up to 30 days from PERT initiation. We used unpaired t tests to compare right to left ventricular (RV/LV) ratios by computed tomography criteria or transthoracic echocardiogram (TTE) at baseline and after interventions.

Data were available for 74 patients. Initial computed tomography pulmonary angiography RV/LV ratio was increased at 1.65 ± 0.5 and decreased to 1.30 ± 0.29 following PERT-guided interventions (P < 0.001). TTE RV/LV ratio also decreased following PERT-guided management (1.09 ± 0.19 vs 0.93 ± 0.17; P < 0.001). 20% of patients had any bleeding complication, but two-thirds were mild, not requiring intervention. All-cause mortality was 6.8%, and all occurred within the first 7 days of admission.

The PERT model is feasible in a large Australian centre in managing complex and time-critical PE. Our data demonstrate outcomes comparable with existing published international PERT data. However, successful implementation at other Australian institutions may require adequate centre-specific resource availability and the presence of multispeciality input.

Cardiac arrest during pregnancy does not occur infrequently and is influenced by obstetric and non-obstetric factors. The patient described in this case report is a pregnant woman who suffered a leg injury that required urgent surgical repair. Moments prior to that procedure, the fetus experienced extreme bradycardia on fetal heart tone monitoring. An emergent cesarean section was performed, which was followed by the patient suffering cardiac arrest secondary to an acutely provoked pulmonary embolism. The patient underwent mechanical thrombectomy followed by EkoSonic endovascular system (EKOS) therapy, which was then complicated by a subcapsular hematoma. The patient ultimately had an inferior vena cava (IVC) filter placed, was started on oral anticoagulation, and eventually recovered with discharge to her home with her newborn infant. This report aims to discuss this critical case of obstetric cardiac arrest, detailing the emergent response, clinical management, challenges faced during resuscitation, and subsequent outcomes. Through this report, we seek to contribute to the growing body of knowledge on effectively managing cardiac emergencies in pregnancy, emphasizing interdisciplinary coordination and tailored interventions to enhance survival and recovery in this high-risk group.

Catastrophic Antiphospholipid Syndrome (CAPS), a severe systemic autoimmune disorder, predominantly causes life-threatening multi-organ failure, with a high mortality rate. It primarily affects small vessels, seldom impacting large vessels. Notably, acute massive pulmonary embolism (PE) with bilateral atrial thrombosis is an exceptional occurrence in CAPS. Acute pulmonary embolism (PE) is a common cardiovascular disease that progresses rapidly and has a high mortality rate. Acute massive PE combined with bilateral atrial thrombosis has an even higher mortality rate. PE treatments primarily include pharmaceuticals, catheter interventions, and surgical measures, with integrated treatment strategies demonstrating promising outcomes in clinical practice. Extracorporeal membrane oxygenation (ECMO) can provide cardiopulmonary support for the treatment of high-risk PE patients and is a proven therapeutic measure.

This report presents the case of a 52-year-old male admitted due to fever and sudden onset of impaired consciousness, with cardiac ultrasound and pulmonary artery CT angiography revealing an acute large-scale pulmonary embolism accompanied by bilateral atrial thrombosis, with the condition rapidly worsening and manifesting severe respiratory and circulatory failure. With ECMO support, the patient underwent a thrombectomy using an AngioJet intervention. The diagnosis of CAPS was confirmed through clinical presentation and laboratory examination, and treatment was adjusted accordingly.

The patient made a successful recovery and was subsequently discharged from the hospital.

In CAPS patients, the rare instance of acute massive PE accompanied by bilateral atrial thrombosis significantly risks severe respiratory and circulatory failure, adversely affecting prognosis. Early initiation of ECMO therapy is crucial, offering a vital opportunity to address the root cause. In this case report the patient was successfully treated with an AngioJet thrombectomy supported by ECMO.

Most patients with acute pulmonary embolism (PE) receive anticoagulation only. Reperfusion is required in high-risk and a minority of intermediate-risk PE patients. Systemic thrombolysis (ST) is the first-line reperfusion therapy, but due to contraindications and major bleeding concerns, the use of catheter-directed therapies (CDT) is increasing as a suitable alternative. The objective of the present study was to detect predictors of the use of CDT compared with other therapies in patients with acute PE.

This registry included consecutive intermediate- and high-risk PE patients in 2 tertiary centers with a 24/7 PE response team from 2014 to 2022. The patients were grouped according to the primary treatment: anticoagulation only, CDT, or ST. We evaluated predictors of treatment assignment and safety endpoints.

A total of 274 patients were included. Of them, 112 received anticoagulation only, 96 received ST as the primary treatment, and 66 underwent CDT first. Comorbidities were higher in the CDT group than in the other 2 groups. Patients undergoing ST/CDT had higher PE severity parameters at hospital admission. On multivariable analysis, independent predictors for the use of CDT were Charlson Comorbidity Index (OR, 1.29; 95%CI, 1.05-1.59), recent surgery (OR, 11.07; 95%CI, 3.07-39.87), and bilateral central PE (OR, 2.42; 95%CI, 1.10-5.32). Analysis of early safety outcomes showed that intracranial bleeding occurred only in the ST group (1.8% of patients).

This contemporary registry used CDT as the primary treatment in 24% of intermediate- and high-risk patients, mainly in comorbid and postsurgical patients. CDT was a safe and effective alternative to medical therapy in selected patients.

Thrombolytic therapy is effective method in the high-risk acute pulmonary embolism (PE) treatment. Reduced-dose thrombolysis (RDT) plus oral anticoagulation therapy is effective and safe method in the moderate and severe PE treatment. It is leading to good early and intermediate-term outcomes. In the RE-COVER and RE-COVER II studies, dabigatran showed similar effectiveness as warfarin in the treatment of acute PE. Dabigatran leads to fewer hemorrhagic complications and is not inferior in efficacy to warfarin in the prevention of PE after mechanical fragmentation and RDT (catheter-directed treatment [CDT]+RDT) in patients with high and intermediate to high PE risk. We sought to evaluate the efficacy and safety (incidence of clinically significant recurrence of venous thromboembolic complications and deaths) during a 6-month course of treatment with dabigatran or warfarin in patients with high and intermediate to high acute PE risk after endovascular mechanical thrombus fragmentation procedure with RDT (CDT+RDT).

The RE-SPIRE is a prospective, multicenter randomized double-arm study. Over a 5-year period, 66 consecutive patients with symptomatic high and intermediate to high PE risk after endovascular mechanical thrombus fragmentation procedure with RDT (CDT+RDT) were randomized into two groups within the next 48 hours. The first group continued treatment with dabigatran 150 mg twice a day for 6 months; the second group continued treatment with warfarin under the control of international normalized ratio (2.0-3.0) for 6 months. Both groups received low molecular weight heparins for 2 days after surgery. Then, group 1 continued to receive low molecular-weight-heparin for 5 to 7 days, followed by a switch to dabigatran at a dosage of 150 mg two times a day. Group 2 received both low-molecular-weight heparin and warfarin up to an international normalized ratio of >2.0, followed by heparin withdrawal. The follow-up period was 6 months.

There were 63 patients who completed the study (32 in the dabigatran group and 31 in the warfarin group). In both groups, there was a statistically significant decrease in the mean pulmonary artery pressure. The mean pulmonary artery pressure at the 6-month follow-up after surgery was 24 mm Hg (interquartile range, 20.3-29.25 mm Hg) in the dabigatran group and 23 mm Hg (interquartile range, 20.0-26.3 mm Hg) in the warfarin group. The groups did not differ statistically in the deep vein thrombosis dynamics. Partial recanalization occurred in 52.0% vs 73.1% in the dabigatran and warfarin groups, respectively (P = .15). Complete recanalization occurred in 28.0% vs 19.2% in the dabigatran and warfarin groups, respectively (P = .56). The groups did not differ in the frequency of major bleeding events according to the International Society for Thrombosis and Hemostasis (0% vs 3.2% in the dabigatran and warfarin groups, respectively; P = 1.00). However, there were more nonmajor bleeding events in the warfarin group than in the dabigatran group (16.1% vs 0%, respectively; P = .02).

The results of the study show that dabigatran is comparable in effectiveness to warfarin. Dabigatran has greater safety in comparison with warfarin in the occurrence of all cases of bleeding in the postoperative and long-term periods. Thus, dabigatran may be recommended for the treatment and prevention of PE after CDT with RDT in patients with high and intermediate to high PE risk.

Thromboembolism, which leads to pulmonary embolism and ischemic stroke, remains one of the main causes of death. Ultrasound-assisted thrombolysis (UAT) is an effective thrombolytic method. However, further studies are required to elucidate the mechanism of ultrasound on arterial and venous thrombi.

We employed the blood-on-a-chip technology to simulate thrombus formation in coronary stenosis and deep vein valves. Subsequently, UAT was conducted on the chip to assess the impact of ultrasound on thrombolysis under varying flow conditions. Real-time fluorescence was used to assess thrombolysis and drug penetration. Finally, scanning electron microscopy and immunofluorescence were used to determine the effect of ultrasound on fibrinolysis.

The study revealed that UAT enhanced the thrombolytic rate by 40% in the coronary stenosis chip and by 10% in the deep venous valves chip. This enhancement is attributed to the disruption of crosslinked fibrin fibers by ultrasound, leading to increased urokinase diffusion within the thrombus and accumulation of plasminogen on the fibrinogen α chain. Moreover, the acceleration of the dissolution rate of thrombi in the venous valve chip by ultrasound was not as significant as that in the coronary stenosis chip.

These findings highlight the differential impact of ultrasound on thrombolysis under various flow conditions and emphasize the valuable role of the blood-on-a-chip technology in exploring thrombolysis mechanisms.

Management of PE has become streamlined with the implementation of PE Response Teams (PERT). Race, ethnicity and insurance status are known to influence the outcomes of patients with acute PE. However, whether the implementation of PERT-based care mitigates these racial and ethnic disparities remains unknown. Our aim was to assess the association of race, ethnicity and insurance with outcomes for patients with acute PE managed by PERT.

We performed a retrospective chart review of 290 patients with acute PE, who were admitted to one of three urban teaching hospitals in the Mount Sinai Health System (New York, NY) from January 2021 to October 2023. A propensity score-weighted analysis was performed to explore the association of race, ethnicity and insurance status with overall outcomes.

Median age of included patients was 65.5 years and 149 (51.4%) were female. White, Black and Asian patients constituted 56.2% (163), 39.6% (115) and 3.5% [10] of the cohort respectively. Patients of Hispanic or Latino ethnicity accounted for 8.3% [24] of the sample. The 30-day rates of mortality, major bleeding and 30-day re-admission were 10.3%, 2.1% and 12.8% respectively. Black patients had higher odds of major bleeding (odds ratio [OR]: 1.445; p < 0.0001) when compared to White patients. Patients of Hispanic or Latino ethnicity had lower odds of receiving catheter-directed thrombolysis (OR: 0.966; p = 0.0003) and catheter-directed or surgical embolectomy (OR: 0.906; p < 0.0001) when compared to non-Hispanic/Latino patients. Uninsured patients had higher odds of receiving systemic thrombolysis (OR: 1.034; p = 0.0008) and catheter-directed thrombolysis (OR: 1.059; p < 0.0001), and lower odds of receiving catheter-directed or surgical embolectomy (OR: 0.956; p = 0.015) when compared to insured patients, although the odds of 30-day mortality and 30-day major bleeding were not significantly different.

Within a cohort of PE patients managed by PERT, there were significant associations between race, ethnicity and overall outcomes. Hispanic or Latino ethnicity and uninsured status were associated with lower odds of receiving catheter-directed or surgical embolectomy. These results suggest that disparities related to ethnicity and insurance status persist despite PERT-based care of patients with acute PE.

Pulmonary embolism (PE) is a significant contributor to global cardiovascular-related mortality that mainly depends on the severity of the event. The treatment approach for intermediate and high-risk PE remains a topic of debate due to the fine balance between hemodynamic deterioration and bleeding risk. The initial treatment choice for intermediate-risk PE with hemodynamic deterioration and high-risk PE is historically systemic thrombolysis, but this approach is not always effective and carries a notable risk of severe bleeding. For such patients, various interventional treatments have been introduced to clinical practice, including catheter-directed lysis (CDL), ultrasound-assisted CDL, pharmacomechanical CDL, and aspiration thrombectomy. However, the optimal treatment approach remains uncertain. Encouraging outcomes have been presented assessing the novel endovascular treatments, in terms of reducing right ventricular dysfunction and improving hemodynamic stability, opening the possibility of using these devices to prevent hemodynamic instability in less severe cases. However, ongoing randomized trials that assess the efficacy and the association with mortality, especially for aspiration devices, have not yet published their final results. This article aims to offer a comprehensive update of the available catheter-directed therapies for PE, with a focus on novel mechanical thrombectomy techniques, assessing their safety and efficacy, after comparison to the conventional treatment. CRITICAL RELEVANCE STATEMENT: This is a comprehensive review of the indications of use, techniques, and clinical outcomes of the most novel endovascular devices for the treatment of pulmonary embolism. KEY POINTS: Mechanical thrombectomy is an effective tool for patients with PE. Aspiration devices prevent hemodynamic deterioration. Catheter directed therapy reduces bleeding complications.

Intermediate-high-risk pulmonary embolism (IHR PE) is a challenging form of embolism obstruction that causes right ventricular (RV) dysfunction. The optimal management of IHR PE has not been established. This single-center prospective, observational study aimed to evaluate the efficacy and safety of complex catheter-directed therapy (CDT) - catheter-directed mechanical aspiration thrombectomy (CDMT) supplemented with catheter-directed thrombolysis (hybrid CDT) in comparison to CDMT alone for IHR PE.

A propensity score based on the pulmonary embolism severity index class and Miller obstruction index (MOI) was calculated, and 21 hybrid CDT cases (mean age 54.8 (14.7) years, 9/21 women) were matched with 21 CDMT cases (mean age 58.8 (14.9) years, 13/21 women). The baseline demographics, clinical, and treatment characteristics were analyzed.

No significant differences were detected regarding baseline demographics and PE severity parameters. Hybrid CDT demonstrated a higher reduction in mean pulmonary artery pressure (mPAP) (hybrid CDT: median mPAP reduction 8 mmHg (IQR: 6-10 mmHg) vs CDMT: median mPAP reduction 6 mmHg (IQR: 4-7 mmHg); P = 0.019), MOI score (hybrid CDT: median change - 5 points (IQR: 5-6 points) vs CDMT median change - 3 points (IQR: 3-5 points); P = 0.019), and median RV: left ventricular ratio (hybrid CDT: median change 0.4 (IQR: 0.3-0.45) vs CDMT median change 0.26 (IQR: 0.2-0.4); P = 0.007). No major bleeding was observed. Both the hybrid CDT and CDMT alone treatments are safe and effective in managing IHR PE.

Hybrid CDT is a promising technique for the management of IHR PE with insufficient thrombus load reduction by CDMT.

NCT0447356-registration date 16 July 2020.

Ultrasound-assisted thrombolysis (USAT) and large-bore-thrombectomy (LBT) are under investigation for the treatment of intermediate-high and high-risk pulmonary embolisms (PE). Comparative studies investigating both devices are scarce.

This study aimed to compare the safety and efficacy of the two most frequently used devices for treatment of acute PE.

This multicenter, retrospective study included 125 patients undergoing LBT or USAT for intermediate- or high-risk PE between 2019 and 2023. Nearest neighbor propensity matching with logistic regression was used to achieve balance on potential confounders. The primary outcome was the change in the right to left ventricular (RV/LV) ratio between baseline and 24 h.

A total of 125 patients were included. After propensity score matching, 95 patients remained in the sample, of which 69 (73%) underwent USAT and 26 (27%) LBT. The RV/LV ratio decrease between baseline and 24 h was greater in the LBT than in the USAT group (adjusted between-group difference: -0.10, 95% CI: -0.16 to -0.04; p = 0.001). Both procedures were safe and adverse events occurred rarely (10% following USAT vs. 4% following LBT; p = 0.439).

In acute intermediate-high and high-risk PE, both LBT and USAT were feasible and safe. The reduction in RV/LV ratio was greater following LBT than USAT. Further randomized controlled trials are needed to confirm these findings.

Pulmonary embolism (PE) ranks as a leading cause of in-hospital mortality and the third most common cause of cardiovascular death. The spectrum of PE manifestations varies widely, making it difficult to determine the best treatment approach for specific patients. Conventional treatment options include anticoagulation, thrombolysis, or surgery, but emerging percutaneous interventional procedures are being investigated for their potential benefits in heterogeneous PE populations. These novel interventional techniques encompass catheter-directed thrombolysis, mechanical thrombectomy, and hybrid approaches combining different mechanisms. Furthermore, inferior vena cava filters are also available as an option for PE prevention. Such interventions may offer faster improvements in right ventricular function, as well as in pulmonary and systemic haemodynamics, in individual patients. Moreover, percutaneous treatment may be a valid alternative to traditional therapies in high bleeding risk patients and could potentially reduce the burden of mortality related to major bleeds, such as that of haemorrhagic strokes. Nevertheless, the safety and efficacy of these techniques compared to conservative therapies have not been conclusively established. This review offers a comprehensive evaluation of the current evidence for percutaneous interventions in PE and provides guidance for selecting appropriate patients and treatments. It serves as a valuable resource for future researchers and clinicians seeking to advance this field. Additionally, we explore future perspectives, proposing "percutaneous primary pulmonary intervention" as a potential paradigm shift in the field.

To evaluate effectiveness and safety of large-bore mechanical thrombectomy of intermediate- or high-risk pulmonary embolism (PE) and factors associated with effectiveness.

A retrospective review of 257 patients with intermediate- or high-risk PE who underwent mechanical thrombectomy using the Flowtriever system (Inari Medical, Irvine, California) between July 2019 and November 2021 was conducted. Data were analyzed using the linear regression and Kaplan-Meier methods with a Type 1 error set at 0.05.

Patients' mean age was 62 years, and 51% were male. PE risk was classified as high, intermediate-high, and intermediate-low in 37 (14%), 201 (78%), and 18 (7%) of the patients, respectively. Procedural technical success was 100%. The mean pulmonary artery pressure (MPAP) decreased from a mean of 32 mmHg (SD ± 9) before to 24 mmHg (SD ± 9) after thrombectomy (mean decrease, 8 mmHg [SD ± 6]; P < .0001). Immediate complications occurred in 2% of the patients. Postprocedural 30-day and all-time PE-attributable mortality in a mean of 1.3-year follow-up was 2% and 6%, respectively. In multivariate analysis, the presence of lower extremity DVT at presentation (β ± SE, -7.60 ± 3.22; P = .019) and a higher prethrombectomy MPAP (β ± SE, -0.19 ± 0.04; P < .001) were associated with lower degrees of decrease in MPAP in the intermediate-high-risk PE group. Among 14 patients with postthrombectomy PE-attributable mortality, 13 had postthrombectomy MPAPs of >20 mmHg.

Large-bore aspiration thrombectomy is a safe and effective treatment for reducing PAP in patients with intermediate- or high-risk PE. Postthrombectomy MPAPs of >20 mmHg might indicate postthrombectomy PE-attributable mortality in high-risk patients.

Pulmonary embolism (PE) is a potentially life-threatening condition requiring prompt diagnosis and treatment. Recent advances have led to the development of newer techniques and drugs aimed at improving PE management, reducing its associated morbidity and mortality and the complications related to anticoagulation. This review provides an overview of the current knowledge and future perspectives on PE treatment. Anticoagulation represents the first-line treatment of hemodynamically stable PE, direct oral anticoagulants being a safe and effective alternative to traditional anticoagulation: these drugs have a rapid onset of action, predictable pharmacokinetics, and low bleeding risk. Systemic fibrinolysis is suggested in patients with cardiac arrest, refractory hypotension, or shock due to PE. With this narrative review, we aim to assess the state of the art of newer techniques and drugs that could radically improve PE management in the near future: (i) mechanical thrombectomy and pulmonary embolectomy are promising techniques reserved to patients with massive PE and contraindications or failure to systemic thrombolysis; (ii) catheter-directed thrombolysis is a minimally invasive approach that can be suggested for the treatment of massive or submassive PE, but the lack of large, randomized controlled trials represents a limitation to widespread use; (iii) novel pharmacological approaches, by agents inhibiting thrombin-activatable fibrinolysis inhibitor, factor Xia, and the complement cascade, are currently under investigation to improve PE-related outcomes in specific settings.

Catheter-directed therapy (CDT) for acute pulmonary embolism (PE) is an emerging therapy that combines heterogeneous techniques. The aim of the study was to provide a nationwide contemporary snapshot of clinical practice and CDT-related outcomes.

This Investigator-initiated multicenter registry aimed to include consecutive patients with intermediate-high risk (IHR) or high-risk (HR), acute PE eligible for CDT. The primary outcome of the study was in-hospital all-cause death.

A total of 253 patients were included, of whom 93 (36.8%) had HR-PE, and 160 (63.2%) had IHR-PE with a mean age of 62.3±15.1 years. Local thrombolysis was performed in 70.8% and aspiration thrombectomy in 51.8%, with 23.3% of patients receiving both. However, aspiration thrombectomy was favored in the HR-PE cohort (80.6% vs 35%; P<.001). Only 51 patients (20.2%) underwent CDT with specific PE devices. The success rate for CDT was 90.9% (98.1% of IHR-PE patients vs 78.5% of HR-PE patients, P<.001). In-hospital mortality was 15.5%, and was highly concentrated in the HR-PE patients (37.6%) and significantly lower in IHR-PE patients (2.5%), P<.001. Long-term (24-month) mortality was 40.2% in HR-PE patients vs 8.2% in IHR-PE patients (P<.001).

Despite the high success rate for CDT, in-hospital mortality in HR-PE is still high (37.6%) compared with very low IHR-PE mortality (2.5%).

Reperfusion therapy is generally recommended in acute high-risk pulmonary embolism (HR-PE), but several population-based studies report that it is underused. Data on epidemiology, management and outcomes of HR-PE in Portugal are scarce.

To determine the reperfusion rate in HR-PE patients, the reasons for non-reperfusion, and how it influences outcomes.

In this retrospective cohort study of consecutive HR-PE patients admitted to a thromboembolic disease referral center between 2008 and 2018, independent predictors for non-reperfusion were assessed by multivariate logistic regression. PE-related mortality and long-term MACE (cardiovascular mortality, PE recurrence and chronic thromboembolic disease) were calculated according to the Kaplan-Meier method. Differences stratified by reperfusion were assessed using the log-rank test.

Of 1955 acute PE patients, 3.8% presented with hemodynamic instability. The overall reperfusion rate was 50%: 35 patients underwent systemic thrombolysis, one received first-line percutaneous embolectomy and one rescue endovascular treatment. Independent predictors of non-reperfusion were: age, with >75 years representing 12 times the risk of non-treatment (OR 11.9, 95% CI 2.7-52.3, p=0.001); absolute contraindication for thrombolysis (31.1%), with recent major surgery and central nervous system disease as the most common reasons (OR 16.7, 95% CI 3.2-87.0, p<0.001); and being hospitalized (OR 7.7, 95% CI 1.4-42.9, p=0.020). At a mean follow-up of 2.5±3.3 years, the survival rate was 33.8%. Although not reaching statistical significance for hospital mortality, mortality in the reperfusion group was significantly lower at 30 days, 12 months and during follow-up (relative risk reduction of death of 64% at 12 months, p=0.013). Similar results were found for MACE.

In this population, the recommended reperfusion therapy was performed in only 50% of patients, with advanced age and absolute contraindications to fibrinolysis being the main predictors of non-reperfusion. In this study, thrombolysis underuse was associated with a significant increase in short- and long-term mortality and events.

Systemic thrombolysis (ST) is the guideline-recommended treatment for high-risk pulmonary embolism (PE), although catheter-directed thrombolysis (CDT) may provide a treatment alternative associated with lower rates of bleeding. Furthermore, the treatment trends and outcomes among those with high-risk PE according to treatment assignments of no lytic therapy (NLT), ST, and CDT are underreported.

Patients hospitalized for high-risk PE between 2016 and 2019 were identified by administrative claims codes from the National Readmission Database. Therapy assignment was similarly defined by administrative codes, then stratified into NLT, ST, and CDT cohorts to report patient characteristics, care settings, and clinical outcomes. The primary outcome was in-hospital mortality with rates adjusted for patient and hospital characteristics using multivariable logistic regression. Secondary outcomes included intracranial hemorrhage (ICH), gastrointestinal bleeding (GIB), and 90-day readmission. Over the years of interest, trends in lytic treatment along with concomitant use of mechanical or surgical thrombectomy were reported.

Among 74,516 patients with high-risk PE, 61,569 (82.6%) received NLT, 8445 (11.3%) received ST, and 4502 (6.04%) received CDT. The NLT subgroup, relative to ST and CDT, tended to be older (66.1 ± 15.4, 62.8 ± 15.3, and 63.4 ± 14.4; p < 0.001) and more frequently women (56.0%, 54.4%, and 51.3%; p < 0.001), respectively. The unadjusted in-hospital mortality rate was highest for ST (18.8%, 34.1%, and 18.3% for NLT, ST, and CDT, respectively; p < 0.001) and persisted after multivariable adjustment (adjusted odds ratio (aOR) 0.43; 95% CI 0.38-0.49; p < 0.0001) of in-hospital mortality for CDT relative to ST. The unadjusted rate of ICH or GIB was lowest for NLT (1.0%, 2.0%, and 0.6% for NLT, ST, and CDT, respectively; p < 0.001). CDT, relative to ST, was associated with reduced odds of ICH (aOR 0.32; 95% CI 0.18-0.55; p < 0.0001) and GIB (aOR 0.78; 95% CI 0.62-0.98; p < 0.0001). Readmissions were highest for NLT (21.7%, 9.6%, and 12.1% for NLT, ST, and CDT, respectively; p < 0.001). CDT was associated with a higher incidence of 90-day readmission relative to ST (aOR 1.32; 95% CI 1.10-1.57; p < 0.001). From 2016 to 2019, individual treatment trends were not significantly different, although NLT tended to be offered among smaller and rural hospitals. Rates of concomitant thrombectomy were low in all three treatment groups.

Among a large, contemporary, US cohort with high-risk PE, over 80% of patients did not receive any form of thrombolysis. High-risk PE that did receive systemic thrombolysis was associated with the highest rates of in-hospital mortality, suggesting opportunities to study the implementation of lytic and nonlytic-based treatments to improve outcomes for those presenting with high-risk PE.

Catheter-based revascularization procedures were developed as an alternative to systemic thrombolysis for patients with intermediate-high- and high-risk pulmonary embolisms. USAT IH-PE is a retrospective and prospective multicenter registry of such patients treated with ultrasound-facilitated, catheter-directed thrombolysis, whose preliminary results are presented in this study. The primary endpoint was the incidence of pulmonary hypertension (PH) at follow-up. Secondary endpoints were short- and mid-term changes in the echocardiographic parameters of right ventricle (RV) function, in-hospital and all-cause mortality, and procedure-related bleeding events. Between March 2018 and July 2023, 102 patients were included. The majority were at intermediate-high-risk PE (86%), were mostly female (57%), and had a mean age of 63.7 ± 14.5 years, and 28.4% had active cancer. Echocardiographic follow-up was available for 70 patients, and in only one, the diagnosis of PH was confirmed by right heart catheterization, resulting in an incidence of 1.43% (CI 95%, 0.036-7.7). RV echocardiographic parameters improved both at 24 h and at follow-up. In-hospital mortality was 3.9% (CI 95%, 1.08-9.74), while all-cause mortality was 11% (CI 95%, 5.4-19.2). Only 12% had bleeding complications, of whom 4.9% were BARC ≥ 3. Preliminary results from the USAT IH-PE registry showed a low incidence of PH, improvement in RV function, and a safe profile.