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Policymaker Summary – Jun. 21, 2016

Management of Infantile Hemangioma

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Table of Contents

Key Issue

Access to early treatment may be critical for a subset of children facing significant impact from infantile hemangioma (IH). This is a summary of a systematic review evaluating the evidence regarding the efficacy, comparative effectiveness, and adverse effects of pharmacological and surgical therapies for IH. The systematic review included 148 unique studies published from 1982 to June 2015.

Background

Infantile hemangioma (IH) is generally a benign vascular neoplasm. The International Society for the Study of Vascular Anomalies (ISSVA) classifies IH lesions as vascular tumors, which are differentiated from vascular malformations.2 IH affects 4 to 5 percent of children in the United States, with a higher prevalence among babies who are white or born prematurely.

IH commonly develops in neonates within their first month of life. Most IH lesions undergo rapid initial proliferation, plateau in infants aged about 9 to 12 months, and then enter an involution phase.

With a course of expectant observation, many patients experience a complete involution without significant sequelae. However, in a fraction of patients, early referral for treatment is important. These patients include:

  • Children who have IH in functionally sensitive areas (e.g., eyes, liver, or airways)
  • Children whose IH causes pain, ulceration, and bleeding
  • Children whose IH causes significant disfigurement (e.g., large lesions on the face)

Management of IH is highly individualized and may include pharmacotherapy or surgery.

Propranolol (Hemangeol™) is an oral medication that was approved by the U.S. Food and Drug Administration as treatment for IH. Steroids used to treat IH mainly include oral steroids and intralesional steroids (e.g., triamcinolone). Surgical interventions such as resection, laser ablation, and radiofrequency ablation may be used as primary management of high-risk lesions prone to complications. The most common type of lasers used to treat IH are pulse dye lasers.

Uncertainty exists about which interventions might be most beneficial as first-line therapies for IH and about when alternative therapies are appropriate after first-line treatment is unsuccessful.

Summary of Evidence From the Systematic Review1
  • Propranolol and steroids are effective in reducing the size of IH lesions (i.e., lesion clearance). (See Table 1.)
  • Propranolol is more effective than steroids in reducing the size of IH lesions. (See Table 1.)
  • Limited evidence suggested that pulse dye laser treatments may be more effective in clearing IH lesions when compared with observation. (See Table 1.)
  • Clinically important, short-term harms of propranolol included hypotension, hypoglycemia, bradycardia, bronchospasm, and seizures.
  • Clinically important harms of steroids—some of which may be short lived—included Cushingoid facies, irritability/mood changes, abdominal pain, growth retardation, hypertension, and infection.
  • Harms associated with pulse dye lasers included hypopigmentation, bleeding, pain, and scarring.
Considerations for Programs and Policies*
  • Early identification of the subset of children in whom lesion proliferation can lead to functional impairment and disfigurement is key to improving treatment effectiveness and preventing complications such as ulceration, psychosocial sequelae, or both.
  • Policymakers may have an important role to play in decisionmaking that leads to timely diagnosis and treatment to optimize health outcomes.

*These considerations were not evaluated in the systematic review but are offered to assist policymakers in applying this evidence.

Table 1: Summary of Findings and Strength of Evidence for the Effectiveness of Treatment Interventions for Infantile Hemangioma
Intervention Comparison Outcome Studies N Finding SOE
IH = infantile hemangioma; N = number of subjects enrolled; N/A = not applicable; SOE = strength of evidence
BETA-BLOCKERS Propranolol vs. observation or placebo Improvement in IH Network meta-analysis; 4 additional studies 555 Propranolol more effective evidence high
Rebound growth/need for further treatment 2 studies 501 Low level of rebound growth/need for further treatment in propranolol arm (fewer than 15% of children) evidence medium
Propranolol vs. steroids Improvement in IH Network meta-analysis; 5 additional studies 237 Propranolol more effective evidence medium
Propranolol vs. other beta-blockers (atenolol or nadolol) Improvement in IH 3 studies 100 Equivalent response evidence low
Topical timolol vs. placebo or observation Improvement in IH Network meta-analysis; 3 additional studies 188 Timolol more effective evidence low
STEROIDS Oral steroids vs. observation or placebo Improvement in IH Network meta-analysis N/A Oral steroids more effective evidence medium
Intralesional steroids (triamcinolone) vs. observation or placebo Improvement in IH Network meta-analysis N/A Intralesional steroids more effective evidence low
LASER TREATMENTS Pulse dye laser vs. observation Improvement in IH 2 studies 143 Pulse dye laser more effective evidence low
Quality of life 2 studies 143 No significant difference evidence low
Long-pulse dye laser vs. other laser types and protocols Improvement in IH 3 studies 264 No significant difference evidence low
Strength of Evidence Scale

High: evidence high
High confidence that the evidence reflects the true effect. Further research is very unlikely to change our confidence in the estimate of effect.

Moderate: evidence medium
Moderate confidence that the evidence reflects the true effect. Further research may change our confidence in the estimate of effect and may change the estimate.

Low: evidence low
Low confidence that the evidence reflects the true effect. Further research is likely to change our confidence in the estimate of effect and is likely to change the estimate.

Insufficient:evidence insufficient
Evidence is either unavailable or does not permit a conclusion.

References

  1. Chinnadurai S, Snyder K, Sathe N, et al. Diagnosis and Management of Infantile Hemangioma. Comparative Effectiveness Review No. 168. (Prepared by the Vanderbilt University Evidence-based Practice Center under Contract No. 290-2010-0009-I.) AHRQ Publication No. 16-EHC002-EF. Rockville, MD: Agency for Healthcare Research and Quality; January 2016. http://www.effectivehealthcare.ahrq.gov/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=2170.
  2. Wassef M, Blei F, Adams D, et al; ISSVA Board and Scientific Committee. Vascular Anomalies Classification: Recommendations From the International Society for the Study of Vascular Anomalies. Pediatrics. 2015 Jul;136(1):e203-14. PMID: 26055853.

Source

The information in this summary is based on Chinnadurai S, Snyder K, Sathe N, Fonnesbeck C, Morad A, Likis FE, Surawicz T, Ness G, Ficzere C, McPheeters ML. Diagnosis and Management of Infantile Hemangioma. Comparative Effectiveness Review No. 168. (Prepared by the Vanderbilt University Evidence-based Practice Center under Contract No. 290-2010-0009-I.) AHRQ Publication No. 16-EHC002-EF. Rockville, MD: Agency for Healthcare Research and Quality; January 2016.

This summary was prepared by the John M. Eisenberg Center for Clinical Decisions and Communications Science at Baylor College of Medicine, Houston, TX. It was written by Geetha Achanta, Ph.D., Winifred W. Yu, Ph.D., R.D., Raegan Hunt, M.D., Ph.D., Trudy Millard Krause, Dr.P.H., CPHQ, and Michael Fordis, M.D.