Clinical study
Catheter-directed Therapy for the Treatment of Massive Pulmonary Embolism: Systematic Review and Meta-analysis of Modern Techniques

Preliminary data for this study were presented at the SIR 2008 annual meeting.
https://doi.org/10.1016/j.jvir.2009.08.002Get rights and content

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.

Section snippets

Materials and Methods

We performed a systematic review by searching electronic databases (MEDLINE, EMBASE) for studies published from January 1990 through September 2008 and by reviewing reference lists of retrieved studies. The study was conducted by using the framework of evidence-based medicine outlined by the McMaster University and National Health Service Centre for Evidence Based Medicine group (7) and published guidelines for integrating current best evidence and clinical expertise (8, 9). The following

Results

A total of 594 patients from 35 uncontrolled studies–six prospective, 29 retrospective–met criteria for inclusion, and the data were identified from 18 countries (Table 2). There were no disagreements among reviewers who selected studies for inclusion. Because they were uncontrolled, all studies were graded as level 2 evidence. Data on the use of systemic thrombolysis before CDT were available in 571 patients. From this subgroup, 546 of the 571 patients (96%) did not receive systemic

Discussion

Despite improvements in the prevention, diagnosis, and treatment of venous thromboembolism, acute PE remains an important clinical problem with a high mortality rate. For patients requiring treatment beyond heparin anticoagulation, systemic thrombolytic therapy is currently indicated for acute massive PE accompanied by unstable hemodynamics (5). However, systemic thrombolysis is also associated with several absolute and relative contraindications (17), and sufficient time (at least 2 hours) is

References (65)

  • A. Chamsuddin et al.

    Catheter-directed thrombolysis with the Endowave system in the treatment of acute massive pulmonary embolism: a retrospective multicenter case series

    J Vasc Interv Radiol

    (2008)
  • E. Skaf et al.

    Catheter-tip embolectomy in the management of acute massive pulmonary embolism

    Am J Cardiol

    (2007)
  • N. Kucher

    Catheter embolectomy for acute pulmonary embolism

    Chest

    (2007)
  • T. Schmitz-Rode et al.

    Massive pulmonary embolism: percutaneous emergency treatment by pigtail rotation catheter

    J Am Coll Cardiol

    (2000)
  • A.J.B. Brady et al.

    Percutaneous catheter fragmentation and distal dispersion of proximal pulmonary embolus

    Lancet

    (1991)
  • R. Uflacker et al.

    Massive pulmonary embolism: preliminary results of treatment with the Amplatz thrombectomy device

    J Vasc Interv Radiol

    (1996)
  • M. Fava et al.

    Mechanical fragmentation and pharmacologic thrombolysis in massive pulmonary embolism

    J Vasc Interv Radiol

    (1997)
  • M. Fava et al.

    Massive pulmonary embolism: treatment with the hydrolyser thrombectomy catheter

    J Vasc Interv Radiol

    (2000)
  • M.A. De Gregorio et al.

    Mechanical and enzymatic thrombolyis for massive pulmonary embolism

    J Vasc Interv Radiol

    (2002)
  • P.T. Zeni et al.

    Use of rheolytic thrombectomy in treatment of acute massive pulmonary embolism

    J Vasc Interv Radiol

    (2003)
  • M. Fava et al.

    Massive pulmonary embolism: percutaneous mechanical thrombectomy during cardiopulmonary resuscitation

    J Vasc Interv Radiol

    (2005)
  • M. Margheri et al.

    Early and long-term clinical results of Angiojet rheolytic thrombectomy in patients with acute pulmonary embolism

    Am J Cardiol

    (2008)
  • G. Eid-Lidt et al.

    Combined clot fragmentation and aspiration in patients with acute pulmonary embolism

    Chest

    (2008)
  • W.T. Kuo et al.

    Catheter-directed embolectomy, fragmentation, and thrombolysis for the treatment of massive pulmonary embolism after failure of systemic thrombolysis

    Chest

    (2008)
  • J.A. Heit et al.

    Estimated annual number of incident and recurrent, non-fatal and fatal venous thromboembolism (VTE) events in the U.S. (abstr)

    Blood

    (2005)
  • V.F. Tapson

    Acute pulmonary embolism

    N Engl J Med

    (2008)
  • D.L. Sackett et al.

    Evidence based medicine: how to practice and teach EBM

    (2000)
  • M. Staunton

    Evidence-based radiology: steps 1 and 2—asking answerable questions and searching for evidence

    Radiology

    (2007)
  • S. Halligan et al.

    Evidence-based practice in radiology: steps 3 and 4—appraise and apply systematic reviews and meta-analyses

    Radiology

    (2007)
  • M.H. Ebell et al.

    Strength of recommendation taxonomy (SORT): a patient-centered approach to grading evidence in the medical literature

    Am Fam Physician

    (2004)
  • N. Mantel et al.

    Statistical aspects of the analysis of data from retrospective studies of disease

    J Natl Cancer Inst

    (1959)
  • A. Stuart et al.

    Kendall's advanced theory of statistics

    (1994)
  • Cited by (0)

    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.

    View full text