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      EKOS™ Jena Experience: Safety, Feasibility, and Midterm Outcomes of Percutaneous Ultrasound-Assisted Catheter-Directed Thrombolysis in Patients with Intermediate-High-Risk or High-Risk Pulmonary Embolism

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          Abstract

          Background

          Percutaneous catheter-based ultrasound-assisted thrombolysis (UACDT) is recommended for patients with intermediate-high-risk or high-risk pulmonary embolism (PE) in whom systemic thrombolysis has failed or is contraindicated.

          Aim

          To evaluate the safety and efficiency of UACDT in patients with intermediate-high-risk or high-risk PE.

          Methods

          Between October 2017 and January 2020, we performed UACDT using the EkoSonic™ Endovascular System (EKOS™) in 51 patients (21 males, age 63 ± 18 years) with a sPESI of 1.3 ± 0.7. The EKOS™-catheter was implanted within 24 h after admission. Over 15 hours, 11.5 mg of alteplase was administered per catheter. We evaluated right ventricular stress and cardiac biomarkers before and after UACDT.

          Results

          24 h post-UACDT, median RV/LV ratio decreased from 1.13 to 0.96 ( p < 0.001) and the mean sPAP decreased from 47 ± 3 to 32 ± 2 mmHg + CVP ( p < 0.0002). There were 6 major bleeding events resulting in transfusion. No stroke, myocardial infarction, right heart decompensation, or recurrent PE occurred. 31 patients (63%) were discharged without any signs of right ventricular stress. After at least 3 months, 73% of our patients did not show any signs of right ventricular dysfunction. The mean RV/LV ratio decreased to 0.75 ± 0.03 ( p < 0.0001) in comparison with pre-UACDT, sPAP to 23  mmHg + CVP ( p < 0.0001), and BNP to 40 pg/ml ( p < 0.0001).

          Conclusions

          The treatment with UACDT reduced right heart stress during the first 24 hours and midterm in patients with intermediate-high-risk or high-risk PE at an acceptable rate of severe complications.

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          Most cited references26

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          2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS)

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            Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium.

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              Global Burden of Thrombosis: Table.

              Thromboembolic conditions were estimated to account for 1 in 4 deaths worldwide in 2010 and are the leading cause of mortality. Thromboembolic conditions are divided into arterial and venous thrombotic conditions. Ischemic heart disease and ischemic stroke comprise the major arterial thromboses and deep-vein thrombosis and pulmonary embolism comprise venous thromboembolism. Atrial fibrillation is a major risk factor for stroke and systemic arterial thromboembolism. Estimates of the global burden of disease were obtained from Global Burden of Disease Project reports, recent systematic reviews, and searching the published literature for recent studies reporting measures of incidence, burden, and disability-adjusted life-years. Estimates per 100 000 of the global incidence rate (IR) for each condition are ischemic heart disease, IR=1518.7; myocardial infarction, IR=139.3; ischemic stroke, IR=114.3; atrial fibrillation, IR=77.5 in males and 59.5 in females; and venous thromboembolism, IR=115 to 269. Mortality rates (MRs) for each condition are ischemic heart disease, MR=105.5; ischemic stroke, MR=42.3; atrial fibrillation, MR=1.7; and venous thromboembolism, MR=9.4 to 32.3. Global public awareness is substantially lower for pulmonary embolism (54%) and deep-vein thrombosis (44%) than heart attack (88%) and stroke (85%). Over time, the incidence and MRs of these conditions have improved in developed countries, but are increasing in developing countries. Public health efforts to measure disease burden and increase awareness of symptoms and risk factors need to improve, particularly in low- and middle-income regions to address this leading cause of morbidity and mortality.
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                Author and article information

                Contributors
                Journal
                Can Respir J
                Can Respir J
                CRJ
                Canadian Respiratory Journal
                Hindawi
                1198-2241
                1916-7245
                2022
                27 February 2022
                : 2022
                : 7135958
                Affiliations
                Department of Internal Medicine I, Division of Cardiology, University Hospital Jena, Jena, Germany
                Author notes

                Academic Editor: Youfeng Zhu

                Author information
                https://orcid.org/0000-0002-9560-1313
                https://orcid.org/0000-0003-1319-6738
                https://orcid.org/0000-0001-7536-5811
                Article
                10.1155/2022/7135958
                8898866
                35265230
                4319923a-b9b0-4e49-8f9b-f4b246036e2b
                Copyright © 2022 Friederike Klein et al.

                This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 29 October 2021
                : 28 January 2022
                : 7 February 2022
                Categories
                Research Article

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