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Original Research: Pulmonary Vascular Disease |

Pulmonary Embolism Response to Fragmentation, Embolectomy, and Catheter Thrombolysis (PERFECT)Early Results of the Multicenter PERFECT Registry: Initial Results From a Prospective Multicenter Registry

William T. Kuo, MD, FCCP; Arjun Banerjee, BS; Paul S. Kim, MD; Frank J. DeMarco, Jr, MD, FCCP; Jason R. Levy, MD; Francis R. Facchini, MD; Kamil Unver, MBiomedE, MBA; Matthew J. Bertini, MD; Akhilesh K. Sista, MD; Michael J. Hall, MD; Jarrett K. Rosenberg, PhD; Miguel A. De Gregorio, MD, PhD
Author and Funding Information

From the Division of Vascular and Interventional Radiology (Drs Kuo and Rosenberg and Messrs Banerjee and Unver), Stanford University Medical Center, Stanford, CA; Vascular and Interventional Radiology (Dr Kim), Spectrum Medical Group, South Portland, ME; Critical Care Medicine (Dr DeMarco), Northside Hospital, Cumming, GA; Vascular and Interventional Radiology (Dr Levy), Northside Radiology Associates, Atlanta GA; Vascular and Interventional Radiology (Drs Facchini and Bertini), Adventist Midwest Health, Hinsdale, IL; Division of Interventional Radiology (Dr Sista), Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY; Vascular and Interventional Radiology (Dr Hall), Memorial Hospital of South Bend, South Bend, IN; and Minimally Invasive Techniques Research Group (GITMI) (Dr De Gregorio), University of Zaragoza, Zaragoza, Spain.

CORRESPONDENCE TO: William T. Kuo, MD, Division of Vascular and Interventional Radiology, Stanford University Medical Center, 300 Pasteur Dr, H-3651, Stanford, CA 94305-5642; e-mail: wkuo@stanford.edu


Part of this article has been presented in abstract form at the Cardiovascular and Interventional Radiological Society of Europe Annual Scientific Meeting, September 13-17, 2014, Glasgow, Scotland.

FUNDING/SUPPORT: This study was funded by the Stanford Division of Vascular and Interventional Radiology.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians. See online for more details.


Chest. 2015;148(3):667-673. doi:10.1378/chest.15-0119
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BACKGROUND:  Systemic thrombolysis for acute pulmonary embolism (PE) carries up to a 20% risk of major bleeding, including a 2% to 5% risk of hemorrhagic stroke. We evaluated the safety and effectiveness of catheter-directed therapy (CDT) as an alternative treatment of acute PE.

METHODS:  One hundred one consecutive patients receiving CDT for acute PE were prospectively enrolled in a multicenter registry. Massive PE (n = 28) and submassive PE (n = 73) were treated with immediate catheter-directed mechanical or pharmacomechanical thrombectomy and/or catheter-directed thrombolysis through low-dose hourly drug infusion with tissue plasminogen activator (tPA) or urokinase. Clinical success was defined as meeting all the following criteria: stabilization of hemodynamics; improvement in pulmonary hypertension, right-sided heart strain, or both; and survival to hospital discharge. Primary safety outcomes were major procedure-related complications and major bleeding events.

RESULTS:  Fifty-three men and 48 women (average age, 60 years [range, 22-86 years]; mean BMI, 31.03 ± 7.20 kg/m2) were included in the study. The average thrombolytic doses were 28.0 ± 11 mg tPA (n = 76) and 2,697,101 ± 936,287 International Units for urokinase (n = 23). Clinical success was achieved in 24 of 28 patients with massive PE (85.7%; 95% CI, 67.3%-96.0%) and 71 of 73 patients with submassive PE (97.3%; 95% CI, 90.5%-99.7%). The mean pulmonary artery pressure improved from 51.17 ± 14.06 to 37.23 ± 15.81 mm Hg (n = 92) (P < .0001). Among patients monitored with follow-up echocardiography, 57 of 64 (89.1%; 95% CI, 78.8%-95.5%; P < .0001) showed improvement in right-sided heart strain. There were no major procedure-related complications, major hemorrhages, or hemorrhagic strokes.

CONCLUSIONS:  CDT improves clinical outcomes in patients with acute PE while minimizing the risk of major bleeding. At experienced centers, CDT is a safe and effective treatment of both acute massive and submassive PE.

TRIAL REGISTRY:  ClinicalTrials.gov; No.: NCT01097928; URL: www.clinicaltrials.gov

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