ATIENT CHARACTERISTICS ASSOCIATED WITH BRONCHIAL ARTERY ... Artery Embo CHARACTERISTICS ASSOCIATED WITH BRONCHIAL ARTERY EMBOLIZATION OUTCOMES ... hemoptysis, embolization, tuberculosis,

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  • PATIENT CHARACTERISTICS ASSOCIATED WITH BRONCHIAL ARTERY EMBOLIZATION OUTCOMES

    An Evidence Review from Penn Medicines Center for Evidence-based Practice

    June 2015

    Project director: ..................... Kendal Williams, MD, MPH (CEP) Lead analyst: ....................... Matthew D. Mitchell, PhD (CEP) Internal review:...................... Nikhil Mull, MD (CEP)

    Keywords: hemoptysis, embolization, tuberculosis, aspergillosis, cystic fibrosis

    EVIDENCE SUMMARY Published clinical studies of bronchial artery embolization (BAE) for treatment of massive or life-threatening hemoptysis

    used differing thresholds for determining which patients needed this treatment. There were no additional patient selection

    criteria in these studies that could be used in developing evidence-based guidelines for use of this procedure.

    Most patient characteristics including age, sex, underlying disease, and comorbidity do not appear to have an effect on the rate of recurrent hemoptysis after BAE. The evidence for this conclusion is weak; all of the evidence came from retro-

    spective cohort studies conducted in Asia or South Africa. This evidence may be less applicable to patients and practice in

    the United States.

    There is very weak evidence that patients with aspergillosis are at greater risk of recurrent hemoptysis after BAE than patients whose hemoptysis is caused by other diseases. There is no evidence on recurrence risk specific to patients with

    cystic fibrosis or with interstitial lung diseases other than tuberculosis. There is also little or no evidence relating to possible

    differences between groups in procedure success rates, rate of complications, or other relevant outcomes.

    Patients whose hemoptysis is of highest volume (at least 400 ml per 24 hours or 200 ml per event) are at greater risk of recurrent hemoptysis after BAE; though evidence for this conclusion is inconsistent and very weak. Patients with a history

    of previous hemoptysis are also at greater risk of recurrent hemoptysis; the evidence for this conclusion is weak. A history

    of previous BAE was not associated with increased risk of recurrent hemoptysis. There is a possible increase in recurrence

    risk for patients with a bronchio-pulmonary shunt or other abnormal vascular anatomy.

    Copyright 2015 by the Trustees of the University of Pennsylvania. All rights reserved. No part of this publication

    may be reproduced without permission in writing from the Trustees of the University of Pennsylvania. R300

  • CEP Evidence Review: Bronchial artery embolization 2

    Table of Contents

    Introduction ................................................................................................................................................................................................. 3

    Previous CEP reports .............................................................................................................................................................................. 3 Methods....................................................................................................................................................................................................... 4

    Protocol for Systematic Review .............................................................................................................................................................. 4

    Literature Search ..................................................................................................................................................................................... 5 Table 1. Medline search ..................................................................................................................................................................... 5

    Table 2. EMBASE search .................................................................................................................................................................. 6 Table 3. Cochrane Library search ...................................................................................................................................................... 6

    Results ......................................................................................................................................................................................................... 7

    Guidelines ............................................................................................................................................................................................... 7 Reviews ................................................................................................................................................................................................... 7

    Primary literature .................................................................................................................................................................................... 7 Risk of recurrent hemoptysis .............................................................................................................................................................. 7 Table 4. Primary studies: recurrence of hemoptysis ........................................................................................................................ 8

    Other outcomes ................................................................................................................................................................................. 10 Conclusion ................................................................................................................................................................................................ 11

    Table 5. Evidence summary and GRADE analysis ......................................................................................................................... 11

    References ................................................................................................................................................................................................. 13

    Appendix. GRADE criteria for rating a body of evidence on an intervention ........................................................................................ 14

  • CEP Evidence Review: Bronchial artery embolization 3

    Introduction

    There is disagreement among clinicians over how much hemoptysis is necessary for it to warrant immediate action. Concerns with

    overuse of bronchial artery embolization (BAE) and its risks to patients cause some to argue for higher thresholds and selective use of

    BAE while concerns with the consequences of continued bleeding cause others to argue for lower thresholds and broader use of the

    procedure. Published clinical guidelines vary in the threshold defining massive or life-threatening hemoptysis, and they do not

    cite specific evidence to support their thresholds. The purpose of this review is to search for and analyze clinical studies which might

    be used to develop evidence-based guidelines for use of bronchial artery embolization and other interventions to treat massive or life-

    threatening hemoptysis.

    Previous CEP reports

    The Center for Evidence-based Practice has published an Annotated Bibliography on algorithms for management of patients with

    massive hemoptysis (1) and an Evidence Advisory on guidelines for management of patients with massive hemoptysis (2). Neither

    report found evidence-based guidance for deciding which patients should or should not be treated with bronchial artery embolization.

  • CEP Evidence Review: Bronchial artery embolization 4

    Methods

    CENTER FOR EVIDENCE-BASED PRACTICE PROTOCOL FOR SYSTEMATIC REVIEW SPECIFIC AIM:

    Identify patient groups for whom bronchial artery embolization is especially effective, especially ineffective, or for whom potential risk outweighs potential benefit.

    METHODS:

    Inclusion and exclusion criteria:

    Participants: Patients with hemoptysis, particularly massive or life-threatening hemoptysis. Report subgroup of patients with cystic fibrosis if data permits.

    Interventions: Bronchial artery embolization (BAE).

    Comparisons: Subgroups of patients with hemoptysis such as those with particular demographics or comorbidities, those with differing causes of hemoptysis, and those with differing degrees of hemoptysis.

    Outcomes: Mortality, paralysis, other procedure-related adverse events, rebleeding, need for second procedure, length of stay, length of ICU stay.

    Data collection

    Databases: Cochrane databases, Medline, EMBASE.

    Study design: All clinical studies, though RCTs will be given priority.

    Study quality assessment: Randomized trials (if any) assessed using modified Jadad scale.

    Data synthesis (calculation of relative risks and confidence intervals, meta-analyses, exploration of heterogeneity): Random-effects meta-analysis following Cochrane methods if quantity and homogeneity of data permit, otherwise qualitative analysis.

    Assessment of quality of evidence base: GRADE (Appendix).

  • CEP Evidence Review: Bronchial artery embolization 5

    Literature Search

    Searches were completed in May and June 2015 and were not restricted by date. Medline searches made use of diagnosis

    subcategories of the VTE indexing terms. Guideline sources were searched in our previous report on guidelines for management of

    massive hemoptysis, where we found that none of the thresholds in published guidelines were based on specif

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