A Prospective, Single-Arm, Multicenter Trial of Ultrasound-Facilitated, Catheter-Directed, Low-Dose Fibrinolysis for Acute Massive and Submassive Pulmonary Embolism
| Autor: | Michael R. Jaff, Juan Ayerdi, Immad Sadiq, Stephen K. Liu, Mark J. Garcia, Robert J. Kennedy, Narinder Bhalla, Ping-Yu Liu, Noah Jones, Nilesh J. Goswami, Samuel Z. Goldhaber, John C. Gurley, M. Laiq Raja, Seattle Ii Investigators, Kenneth Ouriel, Peter A. Soukas, John H. Rundback, Gregory Piazza, Rohit Bhatheja, Benjamin Hohlfelder, William T. Kuo, Tod C. Engelhardt, Jacob Cynamon, Mark H. Kumar, Barry S. Weinstock, Keith M. Sterling, Kannan Natarajan, Fakhir Elmasri |
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| Rok vydání: | 2015 |
| Předmět: |
medicine.medical_specialty
business.industry medicine.medical_treatment Thrombolysis medicine.disease Pulmonary hypertension Surgery Pulmonary embolism Catheter Multicenter trial Internal medicine Fibrinolysis medicine Cardiology Prospective cohort study business Cardiology and Cardiovascular Medicine Fibrinolytic agent |
| Zdroj: | JACC: Cardiovascular Interventions. 8(10):1382-1392 |
| ISSN: | 1936-8798 |
| DOI: | 10.1016/j.jcin.2015.04.020 |
| Popis: | 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 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 ) |
| Databáze: | OpenAIRE |
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