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Diagnosis and Management of Infantile Hemangioma

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Table 31. Harms/adverse effects in comparative studies <strong>of</strong> lasers to treat * IH<br />

Intervention<br />

Harm/Adverse Event<br />

N Studies Reporting Harm<br />

Reported Rates<br />

(# Participants With<br />

Across Studies<br />

Harm/Total Participants)<br />

Pulsed dye laser Purpura 215 1 (25/25) 100%<br />

Swelling 215 1 (25/25 100%<br />

Skin atrophy 212 1 (17/60) 28%<br />

Minimal crusting 210 1 (2/11) 18.2%<br />

Ulceration 212 1 (4/60) 7%<br />

Painful ulceration 212 1 (3/60) 5%<br />

Ulcer formation 211 1 (1/26) 4%<br />

Bleeding 212 1 (2/60) 3%<br />

Infection 212 1 (2/60) 3%<br />

** Atrophic scarring 150,215 1 (2/42) 3%-6%<br />

Hyperpigmentation 211,213,215 3 (12/66) 13%-20%<br />

Texture change 211,213 2 (8/41) 13%-23%<br />

Hypopigmentation 211-213,215 4 (41/126) 10%-45%<br />

Blistering (crusts <strong>and</strong> blisters) 213,215 2 (21/40) 13%-76%<br />

Longer pulse PDL Hypopigmentation 211,213 2 (4/34) 12%-12.5%<br />

Hyperpigmentation 211,213 2 (3/34) 8%-12.5%<br />

Texture change 211,213 2 (2/34) 4%-12.5%<br />

Nd:YAG laser *** Hypopigmentation 215 1 (2/25) 6%<br />

Purpura 215 1 (5/25) 20%<br />

Crusts <strong>and</strong> blisters 215 1 (8/25) 24%<br />

Swelling 215 1 (25/25 100%<br />

Atrophic scarring 215 1 (1/25) 3%<br />

Scarring 217 1 (8/26) 30.8%<br />

Delayed healing 217 1 (1/26) 12.5%<br />

Postoperative bleeding 217 1 (2/26) 7.7%<br />

Postoperative complications 1(35/235) 14.9%<br />

(including bleeding, atrophic scars<br />

<strong>and</strong> hypertrophic scars) 218<br />

Argon laser Delayed healing 217 1 (2/31) 13%<br />

Postoperative bleeding 217 1 (1/31) 3.2%<br />

Reaction to local anesthesia 1 (1/31) 3.2%<br />

(seizure <strong>and</strong> hospitalization) 217<br />

Observation Hypopigmentation 212 1 (9/61) 15%<br />

Skin atrophy 212 1 (5/61) 8%<br />

Ulceration 212 1 (4/61) 7%<br />

Painful ulceration 212 1 (2/61) 3%<br />

Bleeding 212 1 (2/61) 3%<br />

Infection 212 1 (4/61) 7%<br />

IH = infantile hemangioma; n = number; Nd:YAG = neodymium yttrium aluminum garnet; PDL = pulsed dye laser<br />

* One study <strong>of</strong> cryosurgery reported harms by number <strong>of</strong> IH. Scarring occurred in 4/17 treated IH <strong>and</strong> on 1 untreated IH. 220<br />

**<br />

One study reported atrophic scarring <strong>and</strong> ulceration in 1/17 children receiving PDL <strong>and</strong> concurrent propranolol. 150 One study<br />

(not represented in table) reported that 12.4% <strong>of</strong> the parents <strong>of</strong> 11 children receiving PDL judged that the treatment was painful.<br />

Another study included followup at 5 years post-PDL or observation <strong>and</strong> noted more scarring in the PDL group (49% vs 28% in<br />

controls, p=0.02 <strong>and</strong> more hypopigmentation (44% vs 23% in observation group, p=0.03). The number with skin atrophy was<br />

similar between groups. 212,250<br />

r*** One cohort study comparing topical timolol with PDL plus Nd:YAG laser reported crusting <strong>and</strong> hyperpigmentation in 4/30<br />

children. 14 Another study comparing topical timolol plus PDL to timolol alone reported that no children experienced any adverse<br />

effects. 106<br />

Ten case series reported on 1785 children who were treated with PDL (Table 32). One<br />

Korean study (good quality for harms reporting) treated 47 superficial or mixed IH in 40 patients<br />

monitored for hyper- <strong>and</strong> hypo- pigmentation, skin atrophy, hypertrophic scarring, <strong>and</strong> ulceration<br />

during treatment. 223 The only adverse event noted in this study was hyperpigmentation in two<br />

patients with superficial IH. The final assessment in this study was at the end <strong>of</strong> treatment so no<br />

75

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