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BACKGROUND: Despite widespread use, there is a lack of data regarding treatment for infantile hemangioma (IH) with propranolol. The aim of this study is to report treatment criteria and protocol, complications and early outcomes in a cohort of infants diagnosed with infantile hemangiomas (IH) and treated with propranolol using.
METHODS: A retrospective review of one institution’s experience treating IH with propranolol was conducted. All patients with IH presenting to the Children’s Hospital Vascular Anomalies Center between May 2009-November 2011 were evaluated by a pediatric plastic surgeon and a pediatrician for potential treatment with propranolol. Exclusion criteria included history of hypoglycemia, respiratory disorders, hypotension, and arrhythmia. Propranolol, 2 mg/kg/day, was initiated during a 48 hour inpatient observation. Patients were followed serially, including weights, and laryngoscopy for airway lesions and serial photography for all others. Complications were recorded and parental feedback was assessed. Cosmetic outcomes were determined by Visual Analog Cosmetic Scale (VACS) scores, assigned by two independent reviewers (one surgeon, and one non-surgeon): “Abhorrent”, 0-24; “Poor”, 25-49; “Moderate”, 50-74; and “Excellent”, 75-100. Scores were separately assigned for color, size and overall appearance. Statistical analysis was performed using Wilcoxon Paired Signed Rank and ANOVA, p<0.05.
RESULTS: Twenty-three patients were treated with propranolol (8 male, 15 female). Therapy was initiated at 6 months of age or younger with the exception of one patient (average age 14.9 weeks, range 3-40). Twenty-two lesions were on the head and neck, and one lesion was on the trunk. Four patients received additional treatment, including timolol (two patients), and laser treatment (three patients).
At time of final data assessment, treatment was ongoing in 10 patients (43.5%). Wean had been initiated in 9 patients (39.1%), after an average treatment duration of 36.8 weeks (range 24-60). Of these, four patients were currently undergoing wean, three had completed wean, and two patients experienced rebound growth and treatment was re-initiated. Four patients were lost to follow-up.
Weight gain was assessed relative to age. There was no significant difference between first (average 39.8th percentile, 12.3 weeks after initiation of propranolol) compared to most recent weight (average 33.1th percentile, 38.0 weeks after initiation of propranolol), p=0.521.
Parenteral feedback was obtained for all patients. Twenty-two responded to treatment, with reduction in both size and hyperemia (95.65% response). Preoperative and postoperative VACS scores were determined for fifteen patients (65.2%): color, 50.9 versus 80.5 (p<0.000); size, 44.8 versus 80.6 (p<0.000), and overall 45.4 versus 83.7 (p<0.000). There was no inter-rater difference between scores (preoperative p=0.845, postoperative p=0.188).
Two patients experienced complications (8.7%): One patient with hypoglycemia during a diarrheal illness, and one patient with hypoglycemia during inpatient initiation of therapy. There were no cases of hypotension, gastroesophageal reflux, somnolence, wheezing, agitation, rash, or cold hands/night sweats.
CONCLUSIONS: We present a series of patients safely treated with 2mg/kg/day propranolol. Using a strict protocol for assessment and treatment, very few complications were observed. Patients achieved significant reduction in size and improvement of the overall appearance of IH as determined by parenteral measurement (95.7% response rate) and VACS score.