Volume 20, Issue 11 , Pages 1431-1440, November 2009
Catheter-directed Therapy for the Treatment of Massive Pulmonary Embolism: Systematic Review and Meta-analysis of Modern Techniques
Purpose
Systemic thrombolysis for the treatment of acute pulmonary embolism (PE) carries an estimated 20% risk of major hemorrhage, including a 3%–5% risk of hemorrhagic stroke. The authors used evidence-based methods to evaluate the safety and effectiveness of modern catheter-directed therapy (CDT) as an alternative treatment for massive PE.
Materials and Methods
The systematic review was initiated by electronic literature searches (MEDLINE, EMBASE) for studies published from January 1990 through September 2008. Inclusion criteria were applied to select patients with acute massive PE treated with modern CDT. Modern techniques were defined as the use of low-profile devices (≤10 F), mechanical fragmentation and/or aspiration of emboli including rheolytic thrombectomy, and intraclot thrombolytic injection if a local drug was infused. Relevant non-English language articles were translated into English. Paired reviewers assessed study quality and abstracted data. Meta-analysis was performed by using random effects models to calculate pooled estimates for complications and clinical success rates across studies. Clinical success was defined as stabilization of hemodynamics, resolution of hypoxia, and survival to hospital discharge.
Results
Five hundred ninety-four patients from 35 studies (six prospective, 29 retrospective) met the criteria for inclusion. The pooled clinical success rate from CDT was 86.5% (95% confidence interval [CI]: 82.1%, 90.2%). Pooled risks of minor and major procedural complications were 7.9% (95% CI: 5.0%, 11.3%) and 2.4% (95% CI: 1.9%, 4.3%), respectively. Data on the use of systemic thrombolysis before CDT were available in 571 patients; 546 of those patients (95%) were treated with CDT as the first adjunct to heparin without previous intravenous thrombolysis.
Conclusions
Modern CDT is a relatively safe and effective treatment for acute massive PE. At experienced centers, CDT should be considered as a first-line treatment for patients with massive PE.
Abbreviations: CDT, catheter-directed therapy, CI, confidence interval, FDA, Food and Drug Administration, PE, pulmonary embolism
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D.Y.S. is a consultant for MediGene, Inc. and Jennerex Biotherapeutics, Inc. He is on the medical advisory board for Lunar Design, Inc., and he is a shareholder of Nitinol Devices and Components, Inc. None of these are related to the subject matter of this article. L.V.H. is on the scientific advisory board for Bacchus Vascular and Portola Pharmaceuticals. He is a speaker for Cook. None of these are related to the subject matter of this article. None of the other authors have identified a conflict of interest.
PII: S1051-0443(09)00802-1
doi:10.1016/j.jvir.2009.08.002
© 2009 SIR. Published by Elsevier Inc. All rights reserved.
Volume 20, Issue 11 , Pages 1431-1440, November 2009
