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Pharmacomechanical Catheter-Directed Thrombolysis With the Bashir Endovascular Catheter for Acute Pulmonary Embolism: The RESCUE Study
Foster, Malcolm Iskander, Ayman Darki, Amir Jaber, Wissam Rali, Parth M. Lakhter, Vladimir Gandhi, Ripal Klein, Andrew Bhatheja, Rohit
Foster, Malcolm
Iskander, Ayman
Darki, Amir
Jaber, Wissam
Rali, Parth M.
Lakhter, Vladimir
Gandhi, Ripal
Klein, Andrew
Bhatheja, Rohit
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Journal article
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2022-12-05
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Medicine
Thoracic Medicine and Surgery
Thoracic Medicine and Surgery
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http://dx.doi.org/10.1016/j.jcin.2022.09.011
Abstract
Background: Catheter-directed thrombolysis (CDT) has been associated with rapid recovery of right ventricular (RV) function. The Bashir catheter was developed for enhanced thrombolysis in large vessels such as the pulmonary arteries (PAs) with lower doses of tissue plasminogen activator (tPA). Objectives: The aim of this study was to evaluate the efficacy and safety of tPA infused using a pharmacomechanical (PM) CDT device called the Bashir endovascular catheter in patients with intermediate-risk acute pulmonary embolism (PE). Methods: Patients with symptoms of acute PE with computed tomographic evidence of RV dilatation were enrolled. The Bashir catheter was used to deliver 7 mg tPA into each PA over 5 hours. The primary efficacy endpoint was the core laboratory–assessed change in computed tomographic angiography–derived RV/left ventricular (LV) diameter ratio at 48 hours, and the primary safety endpoint was serious adverse events (SAEs) including major bleeding at 72 hours. Results: At 18 U.S. sites, 109 patients were enrolled. The median device placement time was 15 minutes. At 48 hours after PM-CDT, the RV/LV diameter ratio decreased by 0.56 (33.3%; P < 0.0001). PA obstruction as measured by the refined modified Miller index was reduced by 35.9% (P < 0.0001). One patient (0.92%) had 2 SAEs: a retroperitoneal bleed (procedure related) and iliac vein thrombosis (device related). Two other procedure-related SAEs were epistaxis and non–access site hematoma with anemia. Conclusions: PM-CDT with the Bashir endovascular catheter is associated with a significant reduction in RV/LV diameter ratio and a very low rate of adverse events or major bleeding in patients with intermediate-risk acute PE. The notable finding was a significant reduction in PA obstruction with low-dose tPA.
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Riyaz Bashir, Malcolm Foster, Ayman Iskander, Amir Darki, Wissam Jaber, Parth M. Rali, Vladimir Lakhter, Ripal Gandhi, Andrew Klein, Rohit Bhatheja, Charles Ross, Kannan Natarajan, Aravinda Nanjundappa, John F. Angle, Kenneth Ouriel, Nancy E. Amoroso, Brian G. Firth, Anthony J. Comerota, Gregory Piazza, Kenneth Rosenfield, Akhilesh K. Sista, Pharmacomechanical Catheter-Directed Thrombolysis With the Bashir Endovascular Catheter for Acute Pulmonary Embolism: The RESCUE Study, JACC: Cardiovascular Interventions, Volume 15, Issue 23,
2022, Pages 2427-2436, ISSN 1936-8798, https://doi.org/10.1016/j.jcin.2022.09.011.
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Elsevier
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JACC: Cardiovascular Interventions, Vol. 15, Iss. 23
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