Diagnosis and Management of Infantile Hemangioma

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Diagnosis and Management of Infantile Hemangioma Structured Abstract Objectives. To systematically review evidence addressing the diagnosis and management of infantile hemangiomas (IH). Data sources. Multiple databases from 1982 to June 2015. Review methods. We included comparative studies of interventions, case series addressing harms, and any study to address contextual questions. Two investigators independently screened studies and rated study quality. We extracted and summarized data qualitatively and quantitatively via network meta-analysis, which provides a relative ranking of anticipated effects among treatments. We also assessed strength of the evidence (SOE). Results. Among 148 unique studies, 42 addressed effectiveness outcomes (6 good, 22 fair, and 14 poor quality), and 144 studies reported harms (14 good, 3 fair, and 127 poor quality). Two small studies reported differing findings for the sensitivity of ultrasound and effectiveness of imaging modalities. Studies of steroids assessed different agents; treated children typically had improvement in lesion size. Steroid harms frequently included Cushingoid facies, irritability/mood changes, and growth retardation. Beta-blockers typically demonstrated significantly greater effects on reducing lesion size than did control or other active comparators. In network meta-analysis, oral propranolol had the largest mean estimate of expected clearance (95%; 95% Bayesian credible interval [BCI]: 88% to 99%) relative to oral corticosteroids (43%, 95% BCI: 21%-66%) and control (6%, 95% BCI: 1%-11%). Beta-blocker harms included hypotension, hypoglycemia, bradycardia, sleep disturbances, and cold extremities. Surgical intervention studies primarily addressed variations of pulse dye laser (PDL) to manage IH size. Most studies reported a higher success rate with longer-pulse PDL compared to observation, with differing magnitude of effect. Laser treatment harms included hypopigmentation and scarring. No studies explicitly evaluated treatments following failure of beta-blockers or corticosteroids. Literature addressing contextual questions suggested that referral indications include large size; segmental type; risk for complications including bleeding, ulceration, and pain; involvement of critical structures; risk factors for occult lesions (numerous cutaneous lesions, beard distribution); and potential for psychosocial concerns in some cases. Multiple case series reported associations between multiple cutaneous lesions and airway or hepatic IH and facial lesions in a beard distribution and airway IH. Conclusions. Our review for contextual questions described a range of indications for referral and suggested support for a higher index of suspicion of extracutaneous IH in children with multiple cutaneous lesions or facial lesions in a beard distribution. Corticosteroids demonstrated moderate effectiveness at reducing IH size/volume (moderate SOE for improvement in IH with oral steroids compared with observation/placebo; low SOE for intralesional steroids versus observation/placebo; moderate SOE for association with clinically important harms). Propranolol had high SOE for effects on reducing lesion size compared with observation/placebo. Clearance of IH was greater in propranolol arms compared with placebo/observation and active comparators in most studies. Meta-analysis indicated high mean rates of IH clearance with oral propranolol (95%, 95% BCI: 88%-99%) and moderate rates for steroids (43% to 58%, with wide vii
BCI; moderate SOE for effects of propranolol compared with steroids). Beta-blockers and steroids also may cause clinically important harms (moderate SOE for association of oral propranolol with harms). Laser studies generally found PDL more effective than other lasers, but effects remain unclear (insufficient to low SOE for effects of laser types on IH clearance; moderate SOE for association of PDL with skin pigmentation changes; low SOE for association with pain). Data were inadequate to address the role of imaging in guiding treatment (insufficient SOE). viii
Page 1 and 2: Comparative Effectiveness Review Nu
Page 3 and 4: This report is based on research co
Page 5 and 6: Acknowledgments The authors gratefu
Page 7: Peer Reviewers Prior to publication
Page 11 and 12: Overview of the Literature ........
Page 13 and 14: Executive Summary Introduction Infa
Page 15 and 16: for contextual questions as few eff
Page 17 and 18: Figure B. Analytic framework for KQ
Page 19 and 20: Table A. Inclusion criteria (contin
Page 21 and 22: precision (precise, imprecise), and
Page 23 and 24: Figure D. Estimates of expected IH
Page 25 and 26: majority of studies to date have in
Page 27 and 28: effectiveness outcomes. The evidenc
Page 29 and 30: changes. We considered the strength
Page 31 and 32: Table C. Summary of evidence in stu
Page 37 and 38: Table D. Summary of evidence in stu
Page 39 and 40: Applicability We set inclusion crit
Page 41 and 42: quantitative meta-analyses. Researc
Page 43 and 44: surgically. Lesion characteristics
Page 45 and 46: References 1. Wassef M, Blei F, Ada
Page 47 and 48: 39. Yu L, Li S, Su B, et al. Treatm
Page 49 and 50: modalities. The questions of imagin
Page 51 and 52: KQ2. Among newborns, infants, and c
Page 53 and 54: of data, and compiling evidence. We
Page 55 and 56: We only included studies published
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Determining Quality Ratings • We
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Results We present results for Cont
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defects, urogenital anomalies, ulce
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Results of Literature Searches for
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Table 3. Characteristics of include
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scans, had a sensitivity of 20 perc
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of the model fit to all studies, bu
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Detailed Analysis Effectiveness of
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Table 6. Key resolution outcomes in
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with prednisolone included endocrin
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children in 8 studies), skin atroph
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hypopigmentation, impaired wound he
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fair quality for effectiveness outc
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studies of nadolol and atenolol. No
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Table 10. Key resolution outcomes i
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old. 100 Thirty percent of children
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Table 11. Resolution outcomes in st
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Table 15. Key outcomes in studies c
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Table 22. Harms/adverse effects in
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Table 24. Adverse effects in case s
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Table 24. Adverse effects in case s
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• In two RCTs reporting level of
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Nd:YAG Laser With Cooling Compared
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long term follow information was av
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Discussion State of the Literature
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Table 34. Strength of evidence for
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Effectiveness and Harms of Beta-Blo
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older children. One comparative stu
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case series reporting on rarer pres
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agents is critical, especially as u
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References 1. Wassef M, Blei F, Ada
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Abbreviations and Acronyms Used in
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Appendix A. Search Strategies Searc
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Searches for Comparative Effectiven
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Appendix B. Screening and Quality A
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Harms Risk of Bias Assessment Form
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QUADAS Diagnostic Accuracy Rating T
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Infantile Hemangioma CER: Risk of B
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where ΦΦ(xx) is the cumulative di
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Figure D-1. Estimates of expected I
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Figure D-3. Posterior SUCRA estimat
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Figure D-5. Network diagram of comp
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Appendix E. Study Design Classifica
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Author, Year Hogeling 2011 10 Alloc
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Author, Year Representativeness of
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Author, Year Were the harms predefi
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Appendix G. Applicability Tables Ta
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Appendix H. Harms Reported in Packa
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o Acquired (autoimmune) hemolytic a
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o Ankylosing spondylitis o Dermatom
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H-7 • Increased dosage of rapidly
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Elocon® (mometason e furoate) 11 T
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Timoptic® (timolol maleate) 15 Tim
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Harms Data for Medications Included
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Table H-3: Adverse Events from Flo-
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(
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thromboembolism, thrombophlebitis,
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grades): 103 (48%), erosion/ulcerat
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acute myocardial infarction: 3 (Rat
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Discontinuations Patients utilizing
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ocular irritation including blephar
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Diagnosis and Management of Infantile Hemangioma

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