Catheter-directed Treatment Research Articles

Comparison of ultrasound-assisted thrombolysis and mechanical thrombectomy in patients with intermediate-high-risk pulmonary embolism

Abstract Background Pulmonary embolism (PE) can cause right heart failure and is associated with a high mortality. Early risk stratification is critical for individualized management. In patients with intermediate-high-risk PE, guidelines recommend to consider a percutaneous catheter-directed treatment (CDT). While different techniques are available, comparisons between treatments regarding right heart function and outcome are still scarce. Purpose To compare changes in right heart function as well as outcome in patients with intermediate-high-risk PE after catheter-directed treatment with ultrasound-assisted thrombolysis as compared to mechanical thrombectomy. Methods This is a retrospective, single-center study in intermediate-high-risk PE. According to the ESC guidelines, all patients had PESI class III-V, RV dysfunction and elevated cardiac troponin levels, but were hemodynamically stable. PE was confirmed by CT angiography. All patients underwent a catheter-directed treatment. One group received an ultrasound-assisted thrombolysis (USAT), while the other had a large-bore mechanical thrombectomy (MT). Right heart function (RV-Diameter, RV-/LV-Ratio, TAPSE) assessed via transthoracic echocardiography before and after CDT as well as interventional characteristics and postinterventional hospital stay were compared. Results From June 2022 to January 2024, 27 patients (43% female; aged 62 ± 14 years) were diagnosed with pulmonary embolism with intermediate-high-risk and underwent a catheter-directed treatment. Most patients (89%) had bilateral pulmonary embolisms. 15 patients (55%) received an ultrasound-assisted thrombolysis. 12 patients (45%) had a mechanical thrombectomy via a large-bore aspiration system. The mean procedural time was 41 ± 19 minutes for USAT and 106 ± 33 minutes for MT (p < 0.001). Right ventricular / left ventricular ratio reduction was -0.48 ± 0.25 in the USAT group (p < 0.001) and -0.34 ± 0.14 in the MT group (p < 0.001) (between group difference p = 0.2). TAPSE increased by 8 mm ± 4.4 mm in the USAT group (p < 0.001) and by 8.7mm ± 3.8 mm in the MT group (p < 0.001) (between group difference p = 0.7). The median postinterventional hospital stay was 7 days for the USAT patients and 7 days for the MT patients (between group difference p = 1). Conclusions In patients with intermediate-high-risk PE both ultrasound-assisted thrombolysis and large-bore mechanical thrombectomy lead to an improved right heart function with both interventions leading to a similar length of postprocedural hospital stay. Further randomized data have to discriminate differential impact of novel tools for the treatment of intermediate risk PE.

Catheter-directed treatment in acute pulmonary embolism

Abstract Background Pulmonary embolism (PE) is a potentially life-threatening emergency. PE occurs when venous thrombi embolize to the pulmonary circulation, resulting in vascular occlusion, impairing gas exchange and circulation. Initial risk stratification of acute PE is based on clinical symptoms, cardiac adaptations, comorbidities, and, in particular signs of haemodynamic instability. The primary aim of the treatment is to restore blood flow to the affected areas of the lungs, resolving/removing embolus burden and preventing further clot formation. In patients with severe PE, comprising decompensation or intended hemodynamic compromise, immediate reperfusion is recommended. Catheter-directed therapies (CDT) are an innovative treatment option for patients with severe PE to resolve embolus and restore pulmonic perfusion. These procedures are less invasive and are supposed to have a lower risk of bleeding complications compared to systemic thrombolysis or surgical embolectomy. Recent studies have shown that CDT are safe and effective treatment options for PE. Purpose Nevertheless, CDT have to demonstrate their non-inferiority and benefits regarding patients’ outcomes in real-world settings. Methods The German nationwide inpatient sample was used to identify and include all hospitalizations of patients with PE 2005-2020 in Germany. PE patients were stratified for use of CDT. Temporal trends of the usage and the impact of CDT on case-fatality and other outcomes were investigated (source: RDC of the Federal Statistical Office and the Statistical Offices of the federal states, DRG Statistics 2005-2020, own calculations). Results Overall, 1,373,084 hospitalisations of patients with PE (55.9% aged ≥70 years; 53.0% females) were included in this study 2005-2020. Among these, 427,238 (31.1%) were categorized as severe PE and 3330 (0.2%) were treated with CDT with an annual increase from 0.17% (2005) to 0.51% (2020). PE patients of younger age, male sex, with previous surgery, and with severe PE were more often treated with CDT. In patients with severe PE, CDT was attributed to lower MACCE (28.2% vs. 34.2%, P<0.001) and in-hospital case-fatality rate (24.9% vs. 31.0%, P<0.001), but higher prevalence of major bleeding (29.5% vs. 17.5%, P<0.001). CDT was associated with reduced MACCE (OR 0.91 [95%CI 0.83-0.99], P=0.031), a trend towards lower case-fatality (OR 0.92 [95%CI 0.84-1.01], P=0.068), but increased major bleeding (OR 2.12 [95%CI 1.92-2.33], P<0.001) in severe PE. The benefit of CDT regarding case-fatality was age-dependent, with the largest benefit in the 8th and 9th decade of life. Conclusions Although the annual rate of CDT increased from 2005 to 2020 in Germany, only 0.2% of the PE patients were treated with CDT. Selection criteria for CDT treatment were younger age, male sex, previous surgery, and severe PE. CDT treatment was associated with reduced MACCE and case-fatality rate in PE patients with severe PE.

Modelling costs of interventional pulmonary embolism treatment: implications of US trends for a European healthcare system.

Catheter-directed treatment (CDT) of acute pulmonary embolism (PE) is entering a growth phase in Europe following a steady increase in the USA in the past decade, but the potential economic impact on European healthcare systems remains unknown. We built two statistical models for the monthly trend of proportion of CDT among patients with severe (intermediate- or high-risk) PE in the USA. The conservative model was based on admission data from the National Inpatient Sample (NIS) 2016-20 and the model reflecting increasing access to advanced treatment from the PERT™ national quality assurance database registry 2018-21. By applying these models to the forecast of annual PE-related hospitalizations in Germany, we calculated the annual number of severe PE cases and the expected increase in CDT use for the period 2025-30. The NIS-based model yielded a slow increase, reaching 3.1% (95% confidence interval 3.0-3.2%) among all hospitalizations with PE in 2030; in the PERT-based model, increase would be steeper, reaching 8.7% (8.3-9.2%). Based on current reimbursement rates, we estimated an increase of annual costs for PE-related hospitalizations in Germany ranging from 15.3 to 49.8 million euros by 2030. This calculation does not account for potential cost savings, including those from reduced length of hospital stay. Our approach and results, which may be adapted to other European healthcare systems, provide a benchmark for healthcare costs expected to result from CDT. Data from ongoing trials on clinical benefits and cost savings are needed to determine cost-effectiveness and inform reimbursement decisions.

Treatment of acute pulmonary embolism after catheter-directed thrombolysis with dabigatran vs warfarin: Results of a multicenter randomized RE-SPIRE trial

BackgroundThrombolytic 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). MethodsThe 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. ResultsThere 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). ConclusionsThe 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.

Is it Time to Reappraise for Black-Box Warning on AngioJet Rheolytic Thrombectomy in Patients with Pulmonary Embolism: A Systematic Review and Meta-analysis.

AngioJet rheolytic thrombectomy (ART) system has been widely used as a catheter-directed treatment (CDT) method in acute pulmonary embolism (PE), however, there has been a controversy regarding the safety of its use. In this systematic review and meta-analysis, we evaluated the efficacy and safety outcomes of ART in patients with PE. Our meta-analysis have been based on search in the MEDLINE, EMBASE, and Cochrane Library for studies published up to August 2022. The primary outcomes were overall pooled rates of major bleeding (MB) and minor bleeding (mB), worsening renal function (WRF), bradycardia/conduction disturbance (BCD), and PE-related and all-cause mortality in patients who underwent ART. Among the 233 studies documented at initial search, 24 studies were eligible for meta-analysis, and a total of 427 PE patients who underwent ART were evaluated. Overall pooled rates of MB and mB were 9.6% (95% CI 5.9%-15.2%) and 9.2% (95% CI 6.1%-13.6%), transient BCD and WRF were 18.2% (95% CI 12.4%-26%) and 15% (95% CI 10%-21.8%), and PE-related death and all-cause death were 12.7% (95% CI 9.1%-17.3%) and 15% (95% CI 11%-20%), respectively. However, significant heterogeneity and some evidence of funnel plot asymmetry and publication bias were noted for MB, BCD and WRF, but not for PE-related death and all-cause death. Overall pooled rates of bleeding events, BCD and WRF episodes, PE-related death and all-cause death may be considered as encouraging results for efficacy and safety issues of ART utilization in specific scenarios of acute PE, and a reappraisal for black-box warning on ART seems to be necessary.

Abstract 15011: Recent Trends in Interventional Treatment of Acute Pulmonary Embolism and Their Implications for a National Healthcare System

Introduction: Catheter-directed treatment (CDT) of acute pulmonary embolism (PE) is gaining popularity in Europe, following a trend that originated earlier in the US. For healthcare systems, reimbursement of CDT depends on their clinical benefits along with assessing the impact on hospital costs. Hypothesis-Aims: To estimate how increasing use of CDT, as reflected by prospective US data, may affect costs of PE treatment in the German hospital remuneration system (G-DRG). Methods: We analyzed data from the German nationwide inpatient sample (Federal Statistical Office), covering all hospitalizations for PE, for the years 2018-2019. For the same period, we analyzed prospective patient-level data from the multicenter US registry of the Pulmonary Embolism Response Team (PERT) Consortium. Results: During the study period, 196,167 patients were hospitalized for acute PE in Germany. Of these, 64,056 (33%) had intermediate-risk or high-risk PE, but overall ≤ 1% received CDT. Median reimbursement was є3,572 (IQR, 2,804-5,869), corresponding to є4,088 in inflation-adjusted 2022 currency ($5,678, adjusted for purchase parity power). Of 1,349 patients with intermediate- or high-risk PE included in the US registry in 2018-2019, 284 (21%) received CDT, mostly aspiration thrombectomy (63/1,349; 4.7%), ultrasound-assisted catheter thrombolysis (151; 11.2%), or non-assisted catheter thrombolysis (47; 3.5%). Median length of stay was 4.5 (2.8-8.2) days. Based on current reimbursement rates in the G-DRG, fees for PE treated with aspiration thrombectomy amount to є12,179-15,753, and for catheter-directed thrombolysis (with or without ultrasound) to є9,858-13,829. Considering, (a) the shorter length of stay; (b) the proportion of patients receiving CDT in the elevated-risk US cohort in 2018-19; and (c) that of intermediate- and high-risk PE in the German PE inpatient sample, average remuneration per patient would rise from currently є4,088 to є4,724 ($6,552). Conclusions: CDT for PE patients at elevated risk would currently lead to a 16% increase in average per-patient hospital costs in Germany. Together with clinical validation of CDT in ongoing studies, these estimates may inform decision making on reimbursement of interventional treatment options.

Efficacy and safety of catheter-directed treatment in intermediate-risk pulmonary embolism: a single-centre experience in Singapore.

Efficacy and safety of catheter-directed treatment in intermediate-risk pulmonary embolism: a single-centre experience in Singapore.

The Use of a Pulmonary Embolism Response Team (PERT) and Catheter-Directed Treatment in a Far North Queensland Regional Centre

The Use of a Pulmonary Embolism Response Team (PERT) and Catheter-Directed Treatment in a Far North Queensland Regional Centre

Role of catheter-directed therapies in the treatment of acute pulmonary embolism. Expert opinion of the Polish PERT Initiative, Working Group on Pulmonary Circulation, Association of Cardiovascular Interventions, and Association of Intensive Cardiac Care of the Polish Cardiac Society.

Thanks to advances in interventional cardiology technologies, catheter-directed treatment has become recently a viable therapeutic option in the treatment of patients with acute pulmonary embolism at high risk of early mortality. Current transcatheter techniques allow for local fibrinolysis or embolectomy with minimal risk of complications. Therefore, these procedures can be considered in high-risk patients as an alternative to surgical pulmonary embolectomy when systemic thrombolysis is contraindicated or ineffective. They are also considered in patients with intermediate-high-risk pulmonary embolism who do not improve or deteriorate clinically despite anticoagulation. The purpose of this article is to present the role of transcatheter techniques in the treatment of patients with acute pulmonary embolism. We describe current knowledge and expert opinions in this field. Interventional treatment is described in the broader context of patient care organization and therapeutic modalities. We present the organization and responsibilities of pulmonary embolism response team, role of pre-procedural imaging, periprocedural anticoagulation, patient selection, timing of intervention, and intensive care support. Currently available catheter-directed therapies are discussed in detail including standardized protocols and definitions of procedural success and failure. This expert opinion has been developed in collaboration with experts from various Polish scientific societies, which highlights the role of teamwork in caring for patients with acute pulmonary embolism.

Progress in the treatment of acute pulmonary embolism and chronic thrombo-embolic pulmonary hypertension/disease.

The combination of an initial clinical approach aimed at evaluating the early risk of mortality with subsequent diagnostic and therapeutic approaches articulated on the overall patient's profile is recommended in acute pulmonary embolism (PE). The presence of pulmonary hypertension associated with the persistence of chronic vascular obstructions in the pulmonary arteries after one or more acute thrombo-embolic events identifies a condition defined as chronic thrombo-embolic pulmonary hypertension (CTEPH). The evolution of technology and knowledge in the field of imaging has allowed us to qualify the computed tomography angiography of the pulmonary arteries as the gold standard for the diagnostic confirmation of both acute PE and CTEPH. In both these conditions, the first therapeutic step is the immediate initiation of anticoagulant therapy. In acute high-risk PE, in addition to anticoagulant therapy, thrombolytic therapy is recommended; in the event of contraindications to thrombolysis, surgical embolectomy or percutaneous catheter-directed treatment represents viable treatment options. In CTEPH, the combination of data collected from cardiac catheterization, computed tomography angiography, and conventional angiography of pulmonary arteries allows a team of experts to identify candidates for pulmonary endarterectomy surgery. Inoperable patients should be considered for percutaneous balloon angioplasty of the pulmonary arteries which can improve patients' symptoms, quality of life, and prognosis.

Blueprint for developing an effective pulmonary embolism response network

IntroductionAcute pulmonary embolism (PE) is a major cause of morbidity and mortality in Portugal. It is the third most common cause of cardiovascular death after stroke and myocardial infarction. However, the management of acute PE remains poorly standardized, and there is a lack of access to mechanical reperfusion when indicated. Methods and resultsThis working group analyzed the current clinical guidelines for the use of percutaneous catheter-directed treatment in this setting and proposed a standardized approach for severe forms of acute PE. This document also proposes a methodology for the coordination of regional resources in order to create an effective PE response network, based on the hub-and-spoke organization design. ConclusionThis model can be applied at the regional level, but it is desirable to extend it to the national level.

Social determinants of health in pulmonary embolism management and outcome in hospitals: Insights from the United States nationwide inpatient sample

BackgroundThe role of social determinants in the treatment and course of acute pulmonary embolism (PE) is understudied. ObjectiveTo investigate the association between social determinants of health with in-hospital management and early clinical outcomes following acute PE. MethodsWe identified hospitalizations of adults with acute PE discharge diagnosis from the nationwide inpatient sample (2016-2018). Multivariable regression was used to investigate the association between race/ethnicity, type of expected primary payer, and income with the use of advanced PE therapies (thrombolysis, catheter-directed treatment, surgical embolectomy, extracorporeal membrane oxygenation), length of stay, hospitalization charges, and in-hospital death. ResultsA total of 1,124,204 hospitalizations with a PE diagnosis were estimated from the 2016–2018 nationwide inpatient sample, corresponding to a hospitalization rate of 14.9/10,000 adult persons-year. The use of advanced therapies was lower in Black and Asian/Pacific Islander (vs. White patients: adjusted odds ratio [ORadjusted], 0.87; 95% confidence interval [CI], 0.81–0.92 and ORadjusted 0.76; 95% CI, 0.59–0.98) and in Medicare- or Medicaid-insured (vs. privately-insured; ORadjusted, 0.73; 95% CI, 0.69–0.77 and ORadjusted, 0.68; 95% CI, 0.63–0.74), although they had the greatest length of stay and hospitalization charges. In-hospital mortality was higher in the lowest income quartile (vs. highest quartile; ORadjusted, 1.09; 95% CI, 1.02–1.17). Among high-risk PE, patients of other than the White race had the highest in-hospital mortality. ConclusionWe observed inequalities in advanced therapies used for acute PE and higher in-hospital mortality in races other than White. Low socioeconomic status was also associated with lesser use of advanced treatment modalities and greater in-hospital mortality. Future studies should further explore and consider the long-term impact of social inequities in PE management.

Successful percutaneous catheter-directed treatment of high-risk pulmonary embolism: a case report

Pulmonary embolism (PE) is an acute cardiovascular syndrome characterized by high incidence and mortality. The therapy of this condition is based on anticoagulation and hemodynamic support, but in case of high-risk mortality, the European Society of Cardiology (ESC) guidelines recommend systemic thrombolytic therapy and surgical embolectomy if thrombolysis is contraindicated or has failed; nowadays several percutaneous catheter-directed treatments for local thrombolysis or mechanical embolectomy are available, but they have IIa class of recommendation, because of lack of robust scientific evidence favoring their use. We described a case of high-risk PE treated with a novel percutaneous system for mechanical embolectomy, which consists of a large aspiration catheter that was advanced in the pulmonary artery, capturing and removing a vast thrombus, of 15 centimeters in length. This therapeutic strategy avoided the risk of hemorrhagic complications related to systemic thrombolysis, exiting in the achievement of fast patient hemodynamic stabilization and symptoms resolution, without complications. Computed tomography (CT) pulmonary angiography after 10 days from the intervention revealed the complete resolution of pulmonary artery filling defects, and the patient was discharged asymptomatic. Percutaneous catheter-directed treatments represent an effective alternative therapy for PE, but further studies are needed to demonstrate safety and superiority over the actually recommended therapy.

Catheter-Directed Treatment of Submassive Pulmonary Embolism—A Cautious Step Closer?

Catheter-Directed Treatment of Submassive Pulmonary Embolism—A Cautious Step Closer?

Pulmonary embolism response team implementation and its clinical value across countries: a scoping review and meta-analysis

Abstract Background Over the last years, the concept of multidisciplinary pulmonary embolism response teams (PERTs) has been developed to encounter the increasing variety and complexity in the management of acute pulmonary embolism (PE), but data on the use and the benefit of PERT are sparse. Purpose We aimed to systematically investigate the composition of PERT and its clinical value in clinical routine across different countries. Methods We searched PubMed, CENTRAL and Web of Science until January 2022 for full-text, prospective and retrospective observational studies, which included patients with acute PE who were evaluated by a PERT. Eligible articles were designed to either describe the structure and function of PERTs and/or to investigate outcomes related to the implementation of PERT. We performed a random-effects meta-analysis of controlled studies (PERT vs. pre-PERT era) to investigate the impact of PERTs on clinical outcomes and use of advanced therapies. Results We included 22 original studies and four surveys. Overall, 31.5% of patients with PE were evaluated by PERT referred mostly by emergency departments (59.4%). In total, PERT involved a median of 6 (range 2–10) specialties for guiding further diagnostic and treatment modalities. Patients evaluated by a PERT had a mean age of 60 years; of them, 48.7% were females, and 23.5% suffered from malignancy. Right ventricular dysfunction was present in 55% of the patients. In total, 74.5% were classified as intermediate-risk PE and 16% as high-risk PE. In eleven single-arm studies, 1,532 patients with intermediate- and high-risk PE were evaluated by PERT with a mortality rate of 10% and a bleeding rate of 9%. The mean length of stay was 7.3 days and the use of advanced therapy was reported in 30% of all cases. From these, catheter-directed treatment (CDT) was performed in 22% and inferior vena cava filter was inserted in 15%, while systemic thrombolysis was administered in only 6%, surgical thrombectomy in 2% and ECMO in 3% of all cases. When comparing PERT and pre-PERT era no difference in mortality (risk ratio [RR] 0.89, 95% confidence interval [CI] 0.67–1.19, I2=63%) was observed based on nine controlled studies, while mortality tended to be lower when including only intermediate and high-risk patients in the analysis (RR 0.71, 95% CI 045–1.12) (Figure 1). The use of advanced therapies was more common (RR 2.67, 95% CI 1.29–5.50) and the in-hospital stay as well as the duration of treatment in intensive care unit was shorter (mean difference −1.6 days and −1.8 days, respectively) in the PERT era. Conclusion PERT implementation tended to reduce the mortality rate in patients with intermediate- and high-risk PE and resulted in a shorter in-hospital stay. Large prospective studies are needed to further explore the impact of PERTs on clinical outcomes. Funding Acknowledgement Type of funding sources: None.

Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study

BackgroundDue to the bleeding risk of full-dose systemic thrombolysis and the lack of major trials focusing on the clinical benefits of catheter-directed treatment, heparin antiocoagulation remains the standard of care for patients with intermediate-high-risk pulmonary embolism (PE). Methods and resultsThe Higher-Risk Pulmonary Embolism Thrombolysis (HI-PEITHO) study (ClinicalTrials.gov Identifier: NCT04790370) is a multinational multicenter randomized controlled parallel-group comparison trial. Patients with: (1) confirmed acute PE; (2) evidence of right ventricular (RV) dysfunction on imaging; (3) a positive cardiac troponin test; and (4) clinical criteria indicating an elevated risk of early death or imminent hemodynamic collapse, will be randomized 1:1 to treatment with a standardized protocol of ultrasound-facilitated catheter-directed thrombolysis plus anticoagulation, vs anticoagulation alone. The primary outcome is a composite of PE-related mortality, cardiorespiratory decompensation or collapse, or non-fatal symptomatic and objectively confirmed PE recurrence, within 7 days of randomization. Further assessments cover, apart from bleeding complications, a broad spectrum of functional and patient-reported outcomes including quality of life indicators, functional status and the utilization of health care resources over a 12-month follow-up period. The trial plans to include 406 patients, but the adaptive design permits a sample size increase depending on the results of the predefined interim analysis. As of May 11, 2022, 27 subjects have been enrolled. The trial is funded by Boston Scientific Corporation and through collaborative research agreements with University of Mainz and The PERT Consortium. ConclusionsRegardless of the outcome, HI-PEITHO will establish the first-line treatment in intermediate-high risk PE patients with imminent hemodynamic collapse. The trial is expected to inform international guidelines and set the standard for evaluation of catheter-directed reperfusion options in the future.

Pulmonary embolism response team: A multidisciplinary approach to pulmonary embolism treatment. Polish PERT Initiative Report.

A pulmonary embolism response team (PERT) is a multidisciplinary team established to improve clinical care for patients with pulmonary embolism (PE). However, data regarding detailed institutional experience and clinical outcomes from such teams are sparse. We aim to assess the frequency of activations, patients' characteristics, PE severity, applied treatments, and outcomes of PE patients treated by Polish PERTs. The survey registry was conducted between June 2018 and July 2020. All consecutive PERT activations of four institutionalized PERTs in Poland were analyzed. Patients' characteristics, therapies applied, and in-hospital outcomes were evaluated. There were 680 unique PERT activations. Most activations originated from Emergency Departments (44.9%), and the remaining originated from internal medicine/cardiology units (31.1%), surgery/orthopedics (9.1 %), oncology (6.3%), intensive care units (6.0%), and others (2.5%). The origin of activation varied significantly among institutions (P <0.01). Most PERT cases were patients with intermediate-high risk PE (42.9%), whereas high-risk PE occurred in 10% of patients. Anticoagulation alone was delivered to 80.3% of patients, and 23.3% of patients received at least one advanced therapy: catheter-directed therapies (11.3%), systemic thrombolysis (5.3%), surgical embolectomy (2.4%), vena cava filter placement (3.7%), and extracorporeal membrane oxygenation (0.6%). In-hospital mortality in the whole study group was 5.1%, with significant differences between institutions (P = 0.01). The frequency of PE severity, type of delivered catheter-directed treatment, and in-hospital mortality vary between institutions without significant discrepancies in PERT activations. This variation between expert centers highlights the local differences in PERTs' organizational and operational forms.

Current use of catheter directed treatment of acute PE in Europe: results of survey of EAPCI and ESC Working Group on Pulmonary Circulation and Right Ventricular Function

Abstract Aims This survey conducted by the European Association of Percutaneous Cardiovascular Interventions (EAPCI) and ESC Working Group on Pulmonary Circulation &amp; Right Ventricular Functioncollected information on current practices in catheter-directed treatment (CDT) of acute pulmonary embolism (PE) among cardiology intervention centers in European countries. Methods and results Responses from 157 Catheterization laboratories (Cath Lab) representing European countries were collated and analyzed.Sixty seven centers (43%) centers reported application of CDT in PE patients. Almost all centers performing CDT (96%) provided 24/7 service and had experience with a wide spectrum of percutaneous interventions including those for the treatment of structural heart diseases; 53% of the Cath labs utilizing CDT were located in teaching hospitals, and involved 5 to 10 interventional cardiologists performing more than 600 coronary procedures per year. The survey showed a rapid increase in CDT use in European countries after 2015 (45 out of 67 centers). Over 60% of responding centers performed 5–10 CDT procedures per year. It was estimated that 24 patients were treated with CDT per center on a yearly base. The majority of centers (80.3%) indicated that CDT is used in high-risk PE patients, while 38% also apply CDT to intermediate high risk PE. The survey revealed that pigtail catheters are most commonly used for CDT (49%), while dedicated systems such as AngioJet, Indigo and EKOS were reported to be used in 25%, 23.81% and 20.24% of the centers, respectively. Local thrombolysis during CDT was used in 71% of the procedures. More than 60% of the responders indicated that according to their expert opinion CDT will be routinely used in PE patients in the future. However, they stressed the need for randomized trials to evaluate the safety and efficacy of CDT and determine the patients that would benefit most. Conclusions According to the survey, use of CDT in patients with PE is increasing over time. Currently, it is mostly but not exclusively applied to patients with high-risk PE. The respondents indicated the need for high-quality randomized trials to establish the optimal indication for CDT and further standardize the use of the available techniques. Funding Acknowledgement Type of funding sources: None.

Safety and efficacy of percutaneous catheter-directed treatment for intermediate-high risk pulmonary embolism

Abstract Background Pulmonary embolism (PE) is globally the third most frequent acute cardiovascular syndrome, ranking high among the causes of cardiovascular mortality. Systemic thrombolytic therapy (STT) permits prompt reperfusion after pulmonary obstruction, nevertheless this treatment carries by itself an inherent risk of major bleeding events. Development of new therapies and interventions that allow us to achieve early lung reperfusion along with a reduced risk of bleeding are necessary. Purpose The aim of this study was to evaluate the safety and efficacy of percutaneous catheter-directed treatment (PCDT) on intermediate-high risk PE patients with high bleeding risk or contraindication for STT. Methods We consecutively included all patients with intermediate-high risk PE undergoing PCDT in two university hospitals. Clinical, echocardiographic and hemodynamic variables (pre and post PCDT) were collected, as well as major adverse cardiac and bleeding events during follow-up. Results Between February 2018 and January 2021, we included 30 consecutive patients admitted with intermediate-high risk PE who underwent PCDT. Median age was 60 years, interquartile range (IQR) 51–72, and 41% were women. 14 patients (46.6%) presented an absolute contraindication for STT, which was the main reason for performing PCDT. Catheter-directed local thrombolysis (CDLT) was performed in 27 (90%) patients and mechanical fragmentation-aspiration was performed in 12 (40%) of them. We observed a significant reduction in mean pulmonary artery pressure (mPAP, mmHg) after PCDT: 40±13 vs. 25±12, p&amp;lt;0.001; as well as in NT-proBNP concentrations (pg/ml) 48 hours post-PCDT: 4791±1077 vs. 2311±680, p=0.002, (Figure 1). Echocardiographic parameters of right ventricular (RV) dysfunction also experienced a significant improvement 72 hours post-PCDT: TAPSE (mm) 15±2 vs. 22±3, p=0.001, (Figure 2); basal RV diameter (mm) 51±4 vs. 41±2, p=0.001. During a median follow-up of 13 months, IQR (8–22), 1 patient died from non-cardiac cause and no patient presented a bleeding event. Conclusions PCDT for intermediate-high risk PE is safe and effective, producing an early reduction in mPAP, in prognostic biomarkers such as NT-proBNP, as well as an early improvement of classic echocardiographic parameters of RV dysfunction. Funding Acknowledgement Type of funding sources: None. Figure 1Figure 2

Predictors of unfavourable outcome in clinically stable, low risk acute pulmonary embolism patients (sPESI 0)

Abstract Introduction Nowadays one of the most challenging tasks is to identify, within the large group of normotensive and clinically stable acute pulmonary embolism (APE) patients, those who are at “sufficiently low” risk to permit early discharge and home treatment. Current ESC guidelines suggest, that troponin measurement is optional in sPESI 0 patients. Aim The aim of this study was to assess whether right ventricular dysfunction (RVD) in transthoracic echocardiographic examination (TTE) and/or elevated plasma troponin level improves in-hospital risk stratification in sPESI 0 patients. Methods Post-hoc analysis of a prospective study of 1191 patients with at least segmental APE confirmed in computed tomography (CT). Among this group 434 patients (208 F, age median = 52 yrs [39; 67]) were classified to low risk group according to sPESI. TTE and TnT concentration were assessed within the first 24-hours from admission. Echocardiographic criteria for RVD were RV/LV ratio≥1 or tricuspid regurgitant pressure gradient ≥31 mmHg. The sPESI score was calculated from patient records. The combined endpoint (CE) included in-hospital death of any cause and/or haemodynamic deterioration requiring catecholamines i.v., rescue thrombolysis, cardio-pulmonary resuscitation, cardiac surgical intervention or percutaneous catheter-directed treatment. Results Among 434 sPESI 0 patients, cardiac troponin plasma level was assessed in 409 individuals, 136 results were above the normal limit. CE occurred in 6 patients with elevated and 0 with non-elevated troponin concentration (p=0,0013). In 253 cases high-sensitive troponin (hsTnT) assays were used. Median hsTnT concentration was significantly higher in patients with CE (0,032 ng/ml [0,024; 0,127] vs 0,09 ng/ml [0; 0,025]) SPESI and hsTnT assessment showed AUC ROC=0.834 (0.727–0,941; p=0.000) for the CE with suggested threshold 0,024 ng/ml (Fig. 1). Interestingly, no statistically significant differences in RV/LV ratio or TRPG between CE and non-CE group were observed. Furthermore, CE did not occur more often in patients with RVD (7 vs 1; p=0,067). Conclusion SPESI combined with normal cardiac troponin plasma concentration may be used for predicting favourable outcome in patients with APE and thus select candidates for home treatment. We suggest to assess plasma troponin levels in all normotensive patients early, before discharge to home treatment. However, due to relatively low number of endpoints, these findings need to be confirmed in further studies enrolling more patients. Funding Acknowledgement Type of funding sources: None. Figure 1. hsTnT ROC