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

被引：679

作者：

Piazza, Gregory ^{[1
]}

Hohlfelder, Benjamin ^{[1
]}

Jaff, Michael R. ^{[2
]}

Ouriel, Kenneth ^{[3
]}

Engelhardt, Tod C. ^{[4
]}

Sterling, Keith M. ^{[5
]}

Jones, Noah J. ^{[6
]}

Gurley, John C. ^{[7
]}

Bhatheja, Rohit ^{[8
]}

Kennedy, Robert J. ^{[9
]}

Goswami, Nilesh ^{[10
]}

Natarajan, Kannan ^{[11
]}

Rundback, John ^{[12
]}

Sadiq, Immad R. ^{[13
]}

Liu, Stephen K. ^{[14
]}

Bhalla, Narinder ^{[15
]}

Raja, M. Laiq ^{[16
,17
]}

Weinstock, Barry S. ^{[18
]}

Cynamon, Jacob ^{[19
]}

Elmasri, Fakhir F. ^{[20
]}

Garcia, Mark J. ^{[21
]}

Kumar, Mark ^{[22
]}

Ayerdi, Juan ^{[23
]}

Soukas, Peter ^{[24
]}

Kuo, William ^{[25
]}

Liu, Ping-Yu ^{[26
]}

Goldhaber, Samuel Z. ^{[2
]}

机构：

[1] Harvard Univ, Brigham & Womens Hosp, Sch Med, Cardiovasc Div,Dept Med, Boston, MA 02115 USA

[2] Harvard Univ, Massachusetts Gen Hosp, Sch Med, Cardiovasc Div,Dept Med, Boston, MA USA

[3] Syntactx, New York, NY USA

[4] East Jefferson Gen Hosp, Metairie, LA USA

[5] INOVA Alexandria Hosp, Cardiovasc & Intervent Associates, Alexandria, VA USA

[6] Mt Carmel East Hosp, Columbus, OH USA

[7] Univ Kentucky, Gill Heart Inst, Lexington, KY USA

[8] Florida Hosp, Florida Heart Grp, Orlando, FL USA

[9] Holmes Reg Med Ctr, Melbourne, FL USA

[10] St Johns Hosp, Prairie Heart Inst, Springfield, IL USA

[11] St Vincent Med Grp, Indianapolis, IN USA

[12] Holy Name Med Ctr, Teaneck, NJ USA

[13] Hartford Hosp, Vasc Med Div, Hartford, CT 06115 USA

[14] Mem Med Ctr, Lifelink Intervent Ctr, Modesto, CA USA

[15] Baptist Med Ctr, River Reg Cardiol Associates, Montgomery, AL USA

[16] Providence Mem Hosp, El Paso Cardiol Associates, PA, El Paso, TX USA

[17] Sierra Med Hosp, El Paso, TX USA

[18] Leesburg Reg Med Ctr, Leesburg, FL USA

[19] Montefiore Med Ctr, Div Vasc Intervent Radiol, Dept Radiol, Bronx, NY 10467 USA

[20] Lakeland Reg Med Ctr, Radiol & Imaging Specialists Lakeland, Lakeland, FL USA

[21] Christiana Care Ctr Heart & Vasc Hlth, Newark, DE USA

[22] Overlook Med Ctr, Cardiovasc Care Grp, Summit, NJ USA

[23] Med Ctr Georgia, Macon Cardiovasc Inst, Macon, GA USA

[24] Miriam Cardiol Inc, Miriam Hosp, Providence, RI USA

[25] Stanford Univ, Stanford, CA 94305 USA

[26] Fred Hutchinson Canc Res Ctr, Seattle, WA 98104 USA

来源：

JACC-CARDIOVASCULAR INTERVENTIONS | 2015年 / 8卷 / 10期

关键词：

catheter embolectomy; catheter thrombolysis; fibrinolysis; pulmonary embolism; right ventricular failure; thrombolysis; PERCUTANEOUS MECHANICAL THROMBECTOMY; THROMBOLYTIC THERAPY; COMPUTED-TOMOGRAPHY; MANAGEMENT; RISK; EMBOLECTOMY; HEMORRHAGE; THROMBOSIS; EFFICACY; OUTCOMES;

D O I：

10.1016/j.jcin.2015.04.020

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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. (C) 2015 by the American College of Cardiology Foundation.

引用

页码：1382 / 1392

页数：11

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