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Diagnosis and Management of Infantile Hemangioma

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229,230<br />

four studies <strong>of</strong> Nd:YAG lasers, 231-234 one <strong>of</strong> combined PDL <strong>and</strong> Nd:YAG, 235 one <strong>of</strong> longpulse<br />

Alex<strong>and</strong>rite laser, 236 <strong>and</strong> one report <strong>of</strong> carbon dioxide laser. 237 Most studies included<br />

children with IH in multiple locations; one included children with only airway IH. 237 Ages <strong>of</strong><br />

children in these series, where clearly reported, ranged from less than 1 month to 11 years. We<br />

considered one study to be <strong>of</strong> good quality for harms reporting, 223 two <strong>of</strong> fair quality, 227,230 <strong>and</strong><br />

14 <strong>of</strong> poor quality. 221,222,224-226,228,229,231-237 We rated one cohort study that compared propranolol<br />

with concurrent PDL or followed by PDL <strong>and</strong> two comparing laser <strong>and</strong> topical timolol as poor<br />

quality for harms reporting <strong>and</strong> discuss harms <strong>of</strong> PDL here <strong>and</strong> harms <strong>of</strong> propranolol in the betablocker<br />

section <strong>of</strong> KQ2 above. 14,106,150<br />

Thirteen case series (840 children) reported harms from surgical procedures, typically<br />

excision or resection, to treat IH. 238-249 Ages ranged from 1 month to 19 years. The majority <strong>of</strong><br />

studies focused on treatment <strong>of</strong> facial IH, including three studies <strong>of</strong> lip IH, 240,244,248 two series <strong>of</strong><br />

periocular/periorbital IH, 242,245 two reports <strong>of</strong> various facial locations, 241,247 <strong>and</strong> one study <strong>of</strong><br />

nasal tip IH. 243 All <strong>of</strong> the studies were rated as poor quality for assessment <strong>of</strong> harms as data<br />

collection was not predefined.<br />

Detailed Analysis<br />

Effectiveness <strong>of</strong> Laser Treatment<br />

PDL Compared With Observation<br />

Two RCTs compared PDL to observation. One good quality RCT 210 r<strong>and</strong>omized 22 children<br />

with IH between 0 <strong>and</strong> 6 months <strong>of</strong> age into equal groups <strong>of</strong> observation or PDL with epidermal<br />

cooling. Twelve-month size change scores were used for analysis. Further, parents were asked to<br />

answer quality <strong>of</strong> life questionnaires at enrollment <strong>and</strong> at age 12 months. There was no statistical<br />

difference seen in echo depth or total surface area between the two groups; however color was<br />

significantly improved in the PDL group compared with control (p=0.03). Photographs reviewed<br />

for overall improvement also showed a “significant improvement” for the PDL group (46%) over<br />

the observation group (18%), but this “significant improvement” was not quantitatively defined.<br />

Parent-reported quality <strong>of</strong> life scales showed no difference in the severity <strong>of</strong> skin problems<br />

between groups. Sixty-three percent <strong>of</strong> parents in the PDL group reported improvement in the IH<br />

at 12 months compared with 33 percent in the observation group (p=NR). Thirteen percent <strong>of</strong><br />

parents perceived the treatments to be very painful.<br />

The second, fair-quality RCT r<strong>and</strong>omized 121 children to PDL (n=60) <strong>and</strong> observation<br />

(n=61) groups. 212,250 The investigators attempted to reduce bias by including a blinded panel <strong>of</strong><br />

parents <strong>of</strong> non-study children to describe whether they perceived the hemangioma to be a<br />

problem at 1 year <strong>of</strong> age. The investigators reported no differences in the number <strong>of</strong> children<br />

experiencing near complete resolution (42%-44% in each group) but more children in the PDL<br />

group (30%) than in the control arm (5%) experienced complete resolution (p=0.001). Outcomes<br />

between groups were similar at the 5-year followup <strong>of</strong> 117 children (32 <strong>of</strong> 57 in the PDL arm<br />

had complete clearance vs. 27 <strong>of</strong> 60 in the observation arm, p=0.31 <strong>and</strong> 41 <strong>of</strong> 57 <strong>and</strong> 48 <strong>of</strong> 60<br />

had minimal residual signs, p=0.39). Table 25 outlines key outcomes.<br />

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