A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism: The SEATTLE II Study
Gregory Piazza, Benjamin Hohlfelder, Michael R Jaff, Kenneth Ouriel, Tod C Engelhardt, Keith M Sterling, Noah J Jones, John C Gurley, Rohit Bhatheja, Robert J Kennedy, Nilesh Goswami, Kannan Natarajan, John Rundback, Immad R Sadiq, Stephen K Liu, Narinder Bhalla, M Laiq Raja, Barry S Weinstock, Jacob Cynamon, Fakhir F Elmasri, Mark J Garcia, Mark Kumar, Juan Ayerdi, Peter Soukas, William Kuo, Ping-Yu Liu, Samuel Z Goldhaber, SEATTLE II Investigators, Gregory Piazza, Benjamin Hohlfelder, Michael R Jaff, Kenneth Ouriel, Tod C Engelhardt, Keith M Sterling, Noah J Jones, John C Gurley, Rohit Bhatheja, Robert J Kennedy, Nilesh Goswami, Kannan Natarajan, John Rundback, Immad R Sadiq, Stephen K Liu, Narinder Bhalla, M Laiq Raja, Barry S Weinstock, Jacob Cynamon, Fakhir F Elmasri, Mark J Garcia, Mark Kumar, Juan Ayerdi, Peter Soukas, William Kuo, Ping-Yu Liu, Samuel Z Goldhaber, SEATTLE II Investigators
Abstract
Objectives: This study conducted a prospective, single-arm, multicenter trial to evaluate the safety and efficacy of ultrasound-facilitated, catheter-directed, low-dose fibrinolysis, using the EkoSonic Endovascular System (EKOS, Bothell, Washington).
Background: Systemic fibrinolysis for acute pulmonary embolism (PE) reduces cardiovascular collapse but causes hemorrhagic stroke at a rate exceeding 2%.
Methods: Eligible patients had a proximal PE and a right ventricular (RV)-to-left ventricular (LV) diameter ratio ≥0.9 on chest computed tomography (CT). We included 150 patients with acute massive (n = 31) or submassive (n = 119) PE. We used 24 mg of tissue-plasminogen activator (t-PA) administered either as 1 mg/h for 24 h with a unilateral catheter or 1 mg/h/catheter for 12 h with bilateral catheters. The primary safety outcome was major bleeding within 72 h of procedure initiation. The primary efficacy outcome was the change in the chest CT-measured RV/LV diameter ratio within 48 h of procedure initiation.
Results: Mean RV/LV diameter ratio decreased from baseline to 48 h post-procedure (1.55 vs. 1.13; mean difference, -0.42; p < 0.0001). Mean pulmonary artery systolic pressure (51.4 mm Hg vs. 36.9 mm Hg; p < 0.0001) and modified Miller Index score (22.5 vs. 15.8; p < 0.0001) also decreased post-procedure. One GUSTO (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries)-defined severe bleed (groin hematoma with transient hypotension) and 16 GUSTO-defined moderate bleeding events occurred in 15 patients (10%). No patient experienced intracranial hemorrhage.
Conclusions: Ultrasound-facilitated, catheter-directed, low-dose fibrinolysis decreased RV dilation, reduced pulmonary hypertension, decreased anatomic thrombus burden, and minimized intracranial hemorrhage in patients with acute massive and submassive PE. (A Prospective, Single-arm, Multi-center Trial of EkoSonic® Endovascular System and Activase for Treatment of Acute Pulmonary Embolism (PE) [SEATTLE II]; NCT01513759).
Keywords: catheter embolectomy; catheter thrombolysis; fibrinolysis; pulmonary embolism; right ventricular failure; thrombolysis.
Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed