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Diagnosis and Management of Infantile Hemangioma

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• In two RCTs reporting level <strong>of</strong> clearance, at least 40 percent <strong>of</strong> children in laser or<br />

observation arms had complete or near complete clearance <strong>of</strong> IH (low SOE for lack <strong>of</strong><br />

difference between PDL <strong>and</strong> observation).<br />

• Cohort studies assessed outcomes after CO2 <strong>and</strong> Nd:YAG (neodymium yttrium<br />

aluminum garnet) lasers <strong>and</strong> typically reported some resolution <strong>of</strong> lesion size, but<br />

heterogeneity among studies limits our abilities to draw conclusions (insufficient SOE).<br />

• Harms associated with laser treatment included skin atrophy, bleeding, scarring,<br />

ulceration, purpura, <strong>and</strong> pigmentation changes. Bleeding <strong>and</strong> ulceration were observed in<br />

the immediate postoperative period, distinguishing these complications from the possible<br />

natural complications <strong>of</strong> IH themselves (moderate SOE for association <strong>of</strong> PDL with<br />

pigmentation changes; low for association with bleeding; <strong>and</strong> insufficient for scarring.<br />

Low SOE for association <strong>of</strong> Nd:YAG laser with scarring <strong>and</strong> insufficient for association<br />

with bleeding <strong>and</strong> pigmentation changes).<br />

Overview <strong>of</strong> the Literature<br />

Eleven comparative studies (three RCTs, 210-212 seven retrospective cohort studies, 213-219 <strong>and</strong><br />

one prospective comparative study that used treated <strong>and</strong> untreated lesions <strong>and</strong> intervention <strong>and</strong><br />

control groups 220 ) <strong>and</strong> 30 case series addressed surgical approaches. The RCTs were conducted<br />

in the Netherl<strong>and</strong>s, 210 Japan, 211 <strong>and</strong> the UK. 212 Cohort studies were performed in the United<br />

States, 216,217 Greece, 218 Singapore, 213 Russia, 219 <strong>and</strong> Germany. 214,215 Two RCTs 210,212 compared<br />

PDL to observation; one used traditional PDL in infants aged 1 to 14 weeks, 212 <strong>and</strong> the second<br />

used PDL with epidermal cooling in infants aged 0 to 6 months. 210 The third RCT 211 compared<br />

the use <strong>of</strong> non-cooled traditional PDL to longer pulse PDL with epidermal cooling in infants<br />

between 1 <strong>and</strong> 3 months old. We considered RCTs to be <strong>of</strong> good 210 <strong>and</strong> fair quality. 211,212<br />

Cohort studies examined various comparisons between different laser types including PDL<br />

versus Nd:YAG, 215 Argon versus Nd:YAG, 217 short pulse PDL versus longer pulse PDL. 213 One<br />

compared Nd:YAG <strong>and</strong> CO2 lasers <strong>and</strong> also included a non-surgical comparison group for<br />

airway IH. 214 Two studies compared different skin cooling protocols with the same laser types,<br />

including Nd:YAG 218 <strong>and</strong> PDL. 216 One cohort study compared cryosurgery, photothermolysis<br />

with intense pulsed light, <strong>and</strong> photothermolysis plus sclerosis with alcohol <strong>and</strong> lidocaine. 219 We<br />

considered two cohort studies as fair quality, 213,218 <strong>and</strong> the rest as poor. 214-217,219 We considered<br />

the self-controlled comparative study (rated using the Newcastle Ottawa tool) as poor quality. 220<br />

Overall, longer pulse PDL with epidermal cooling was the most commonly used laser for<br />

cutaneous lesions <strong>and</strong> Nd:YAG was the most commonly used intralesionally. Most studies<br />

reported a higher success rate with longer pulse PDL compared to observation in managing the<br />

size <strong>of</strong> IH, although the magnitude <strong>of</strong> effect differed substantially. CO2 laser was used for<br />

subglottic IH in a single study, <strong>and</strong> was noted to have a higher success rate <strong>and</strong> lower<br />

complication rate than both Nd:YAG <strong>and</strong> observation. Studies addressing other surgical<br />

approaches (cryosurgery, intense pulsed light thermolysis) reported some improvements in IH<br />

but included few participants in each arm (total n = 263).<br />

SOE for outcomes after laser <strong>and</strong> surgical treatments ranged from insufficient to low for<br />

effectiveness outcomes. The evidence was limited by low sample size, <strong>and</strong> variations in the laser<br />

settings used including wavelength <strong>and</strong> cooling protocols. For Nd:YAG <strong>and</strong> CO2 lasers, all<br />

studies were limited by sample size, <strong>and</strong> SOE was insufficient for all outcome parameters.<br />

Thirty case series reported on harms <strong>of</strong> surgical approaches for IH (3831 children).<br />

Seventeen case series reported on harms from laser treatments, including 10 studies <strong>of</strong> PDL, 221-<br />

66

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