scholarly journals First-in-Human Study to Assess the Safety and Feasibility of the Bashir Endovascular Catheter for the Treatment of Acute Intermediate-Risk Pulmonary Embolism

2020 ◽  
Author(s):  
Akhilesh K. Sista ◽  
Rohit Bhatheja ◽  
Parth Rali ◽  
Kannan Natarajan ◽  
Philip Green ◽  
...  
Keyword(s):  
Pulmonary Embolism ◽  
Adverse Events ◽  
Right Ventricular ◽  
Human Study ◽  
Left Ventricular ◽  
Diameter Ratio ◽  
Tissue Type ◽  
Intermediate Risk ◽  
Unique Identifier ◽  
Left Ventricular Diameter

Background: The Bashir Endovascular Catheter (BEC) is a novel pharmaco-mechanical device designed to enhance thrombolysis by increasing the exposure of thrombus to endogenous and exogenous thrombolytics. The aim of this prospective, multicenter, single-arm study was to evaluate the feasibility and initial safety of the BEC in patients with acute intermediate-risk pulmonary embolism (PE). Methods: Patients with symptomatic PE and right ventricular to left ventricular diameter ratio ≥0.9 as documented by computer tomography angiography were eligible for enrollment. The primary safety end points were device related death or adverse events, and major bleeding within 72 hours after BEC directed therapy. Results: Nine patients were enrolled across 4 US sites. The total dose of r-tPA (recombinant tissue-type plasminogen activator) was 14 mgs in bilateral PE and 12 mgs in unilateral PE over 8 hours delivered via the expanded BEC. At 30-day follow-up, there were no deaths or device-related adverse events. At 48 hours post-BEC therapy, the right ventricular to left ventricular diameter ratio decreased from 1.52±0.26 to 0.97±0.06 ( P =0.0009 [95% CI, 0.33–0.82]; 37.0% reduction). Thrombus burden as measured by the Modified Miller Index decreased from 25.4±5.3 to 16.0±4.0 ( P =0.0005; [95% CI, 5.5–13.4]; 37.1% reduction). Conclusions: In this early feasibility study of the BEC for intermediate-risk PE, there were no deaths or device-related adverse events and a significant reduction in right ventricular to left ventricular diameter ratio and thrombus burden. REGISTRATION: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03927508.

scholarly journals One-Year Echocardiographic, Functional, and Quality of Life Outcomes After Ultrasound-Facilitated Catheter-Based Fibrinolysis for Pulmonary Embolism

2020 ◽  
Vol 13 (8) ◽  
Author(s):  
Gregory Piazza ◽  
Keith M. Sterling ◽  
Victor F. Tapson ◽  
Kenneth Ouriel ◽  
Andrew S.P. Sharp ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Embolism ◽  
Functional Status ◽  
Left Ventricular ◽  
Diameter Ratio ◽  
Left Ventricular Diameter ◽  
Submassive Pulmonary Embolism ◽  
Dosing Regimens ◽  
Minute Walk

Background: Accelerated tPA (tissue-type plasminogen activator) dosing regimens for ultrasound-facilitated, catheter-directed fibrinolysis improve short-term computed tomographic-measured right ventricular (RV)-to-left ventricular diameter ratio in massive and submassive pulmonary embolism. The impact on RV remodeling, functional status, and quality of life over the long-term remains unclear. Methods: To study 1-year changes in RV remodeling, functional status, and quality of life, we assessed patients with acute submassive pulmonary embolism randomly assigned to 1 of 4 tPA dosing regimens for ultrasound-facilitated, catheter-directed fibrinolysis in the OPTALYSE-PE trial (Optimum Duration and Dose of r-tPA With the Acoustic Pulse Thrombolysis Procedure for Intermediate-Risk Pulmonary Embolism; 8 mg/2 hours, 8 mg/4 hours, 12 mg/6 hours, and 24 mg/6 hours). Echocardiographic assessment included RV-to-left ventricular diameter ratio within 4 hours of treatment end, and at 48 hours, 30 days, 90 days, and 1 year. Functional status was assessed by 6-minute walk test at 30 days, 90 days, and 1 year and PROMIS-PF-6b scores at 30 days, 90 days, 180 days, 270 days, and 1 year. Quality of life was evaluated by PEmb-QOL scores at 30 days, 90 days, 180 days, 270 days, and 1 year. Results: Mean RV-to-left ventricular diameter ratio decreased from baseline to 4 hours and further at 48 hours and 30 days, with reductions maintained at 90 days and 1 year in all groups. Mean 6-minute walk distance, PROMIS-PF-6b, and PEmb-QOL scores improved over the course of 1 year in all groups. Conclusions: Accelerated lower-dose tPA regimens for ultrasound-facilitated, catheter-directed fibrinolysis resulted in sustained recovery of RV-to-left ventricular diameter ratio and tricuspid annular plane systolic excursion and improvements in functional status and quality of life over 1 year. Registration: URL: https://www.ClinicalTrials.gov . Unique Identifier: NCT02396758.

scholarly journals Low-dose thrombolysis for submassive pulmonary embolism

2021 ◽  
pp. jim-2021-001816
Author(s):  
Emine Serap Yilmaz ◽  
Oğuz Uzun
Keyword(s):  
Pulmonary Embolism ◽  
Pulmonary Hypertension ◽  
Left Ventricular ◽  
Tissue Type ◽  
Bleeding Complications ◽  
Intermediate Risk ◽  
Risk Of Bleeding ◽  
Submassive Pulmonary Embolism ◽  
Half Dose

The role of thrombolysis in submassive pulmonary embolism (PE) is controversial due to the high risk of hemorrhage. This study aimed to evaluate the role of half-dose tissue-type plasminogen activator (rt-PA) in preventing death/hemodynamic decompensation in submassive (intermediate-risk) PE without increasing the risk of bleeding. In a prospective, non-randomized, open-label, single-center trial, we compared 50 mg rt-PA plus low molecular weight heparin (LMWH) with LMWH in submassive (intermediate-risk) PE. Eligible cases had confirmed pulmonary hypertension on echocardiography, and/or right ventricular cavity expansion and/or interventricular septal deviation on echocardiography, and/or right to left ventricular ratio equal to or greater than 0.9 mm on CT angiography. The primary outcome was death or hemodynamic decompensation within 7 and 30 days after treatment was given. The primary safety outcome was major extracranial bleeding or hemorrhagic stroke within 7 days. Seventy-six patients were included in the study. Total death/hemodynamic decompensation in the first 7 and 30 days was significantly less in the half-dose rt-PA group than in the LMWH group (p=0.028 and p=0.009, respectively). No significant differences were found between the two groups in terms of recurrent embolism and pulmonary hypertension at 6-month follow-up (p=1.000 and p=0.778). There was no intracranial hemorrhage in any of the patients. There were no statistically significant differences between the two groups in terms of major or minor bleeding complications. This trial showed half-dose rt-PA treatment in submassive (intermediate-risk) PE prevented death/hemodynamic decompensation in the first 7-day and 30-day period compared with LMWH treatment without increasing the risk of bleeding.

scholarly journals Prognostic characteristics and body mass index in patients with pulmonary embolism: does size matter?

2020 ◽  
Vol 6 (1) ◽  
pp. 00163-2019 ◽  
Author(s):  
Ludo F.M. Beenen ◽  
Luuk J.J. Scheres ◽  
Jaap Stoker ◽  
Saskia Middeldorp
Keyword(s):  
Body Mass Index ◽  
Pulmonary Embolism ◽  
Adverse Events ◽  
Right Ventricular ◽  
Clinical Outcomes ◽  
Body Mass ◽  
Ventricular Dysfunction ◽  
Right Ventricular Dysfunction ◽  
Left Ventricular ◽  
World Health

ObjectiveThe aim of this study was to explore the impact of body mass index (BMI) on prognostic indicators and clinical outcomes in patients with pulmonary embolism.MethodsPatients with pulmonary embolism from the Hokusai venous thromboembolism (VTE) randomised clinical trial that compared two anticoagulant regimens were followed-up for 1 year (n=1911). Patients were analysed with regard to World Health Organization (WHO) BMI categories at baseline (underweight (<18.5), normal (18.5 to <25), overweight (25 to <30), obese I (30 to <35), obese II (35 to <40), and obese III (≥40)). Clinical and radiological prognostic characteristics for right ventricular dysfunction and adverse events were assessed with normal weight as a reference. Clinical outcomes were mortality, recurrent VTE, hospitalisation, bleeding and overall adverse events.ResultsThe relationship between BMI categories and both prognostic parameters and clinical outcomes showed U-shaped curves. Adjusted odds ratios (aORs) were highest in patients who were grade III obese for both clinical parameters (N-terminal pro-brain natriuretic peptide (NT-proBNP) >600 and simplified pulmonary embolism severity index (sPESI)≥1; 2.9 and 1.6), and radiological parameters (pulmonary trunk>29 mm, right-to-left-ventricular ratio>1.0, and central emboli; aOR=4.3, 2.1 and 2.3). Bleeding was observed more frequently in the higher categories of obesity. In patients who were underweight, for NT-proBNP>600 and sPESI≥1 the aORs were 2.6 and 2.5, respectively; however, no major bleeding occurred in this category.ConclusionSeveral clinical and radiological prognostics characteristics and right ventricular dysfunction in pulmonary embolism are not evenly distributed among BMI categories. This is reflected in a trend towards worse outcomes in patients who are overweight and underweight.

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