By Alex Golden, MD; Joan Tamburro, DO; and Allison Vidimos, MD
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Since the utility of propranolol for treatment of infantile hemangiomas was serendipitously identified in 2008, the nonselective beta-adrenergic blocker has gained increasing acceptance as a first-line treatment for this indication. Use of propranolol in children is associated in the literature with rare adverse effects, most notably hypotension, bradycardia and hypoglycemia. Nonetheless, this beta-blocker has been used in pediatric cardiology for over 40 years with a favorable safety profile, even in high-risk populations such as preterm neonates and patients with complex congenital heart disease.
Optimal propranolol use takes a team
Since 2009, Cleveland Clinic Children’s Vascular Anomalies Program has used propranolol to treat more than 150 children with infantile hemangiomas, with 100 percent success and no major side effects requiring therapy discontinuation.
We believe treatment of infantile hemangiomas with propranolol is most safely and effectively accomplished by a multidisciplinary team, with input from pediatric dermatologists, plastic surgeons, radiologists, ophthalmologists, otolaryngologists and cardiologists. Appropriate coordination of care among these subspecialties is indispensable for successful treatment.
The diversity of presentation of infantile hemangiomas, the range of subspecialties involved in patient care and the challenge of assessing for cardiac risk were important considerations when we began to use propranolol as a treatment at Cleveland Clinic. Given the importance of systematizing the approach in order to allow an organized assessment of outcomes and any adverse events, we adopted the standardized clinical assessment and management plan (SCAMP) paradigm.
Standardizing the team approach with a SCAMP
SCAMPs (introduced by Rathod and colleagues) have been used successfully in multiple medical specialties, including pediatric cardiology, to reduce variation in clinical practice and resource utilization while optimizing patient care.
Intrinsic to the SCAMP approach is the ability to continuously revise the standardized treatment plan as new data emerge. This allows protocols to benefit from continuous improvement while preserving the ability to carefully measure and assess outcomes. The SCAMP method is an important tool in efforts to drive therapeutic innovations from theory to practice in a timely manner without comprising patient safety.
Drawing on the SCAMP methodology, Cleveland Clinic Children’s Vascular Anomalies Committee developed a standardized protocol for initiating treatment with propranolol in the outpatient setting. The protocol was established with three initial goals:
- Patient safety, with careful pretreatment cardiovascular evaluation and initiation of treatment under supervision of an experienced pediatric cardiologist
- Facilitation of multidisciplinary involvement in patient care
- Careful documentation of methods and results to foster continuous quality improvement
As our experience with propranolol use for this indication increased, we improved dosing protocols, expanded and updated parent education materials, incorporated professional medical photography to monitor and document treatment response, and improved surveillance for comorbidities such as PHACES syndrome, among other updates.
Outcomes speak for themselves
What resulted from application of the SCAMP, in its multiple and continuously improving iterations, was a tremendously successful experience in treating our pediatric patients with infantile hemangioma. A full 100 percent of patients had arrest of hemangioma growth from the very first dose, and all cases saw significant shrinkage of the lesions over time, usually in the first few weeks of therapy. The figure below presents photos from a few representative cases.
Figure. Photos from representative cases of infantile hemangioma managed under the SCAMP paradigm for propranolol treatment in Cleveland Clinic Children’s Vascular Anomalies Program. Left: Forehead hemangioma with deep and superficial components at presentation at 6 months of age (note brow distortion) and after seven months of treatment. Middle: Facial lesion at presentation at 1 month of age andafter 16 months of treatment. Right: Ulcerated hemangioma at presentation at 2 months of age (note distortion of the right cheek and jawline) and after 14 months of treatment.
Treatment of the vast majority of patients was started in the outpatient setting, with monitoring of vital signs two hours after the first dose. The only patients who began treatment as inpatients were premature infants with very low birth weight already being cared for in the neonatal ICU and patients already admitted for another indication, such as one child with stridor due to an infantile hemangioma of the airway.
No patient had any side effect requiring therapy discontinuation. One patient with a severe retro-ocular infantile hemangioma causing compression of the optic nerve and vein had a prior history of reactive airway disease and developed chronic cough. Adjustment of his pulmonary medication regimen allowed successful continuation of propranolol therapy.
An unprecedented SCAMP application
To our knowledge, this is the first-ever application of the SCAMP paradigm in a pediatric dermatology setting.
The SCAMP has helped our Vascular Anomalies Program bridge the central multidisciplinary aspects of effective care and communication. The SCAMP has been modified many times to date, including such changes as converting from three-times-daily to twice-daily dosing schedules after the age of 6 months, eliminating standard pretreatment echocardiography, and continuously improving the patient instructions given to families.
Dr. Golden is a pediatric cardiologist in Cleveland Clinic Children’s Center for Pediatric and Congenital Heart Disease and a member of the Vascular Anomalies Committee.
Dr. Tamburro is a pediatric dermatologist in Cleveland Clinic’s Department of Dermatology.
Dr. Vidimos is Chair of Cleveland Clinic’s Department of Dermatology. She treats children and adolescents as well as adults.