Is Routine Electrocardiography Necessary Before Initiation of Propranolol for Treatment of Infantile Hemangiomas?

Yarbrough, Kevin B.; Tollefson, Megha M.; Krol, Alfons; Leitenberger, Sabra; Mann, Julianne A.; MacArthur, Carol J.

doi:10.1111/pde.12972

Cited by 12 publications

(8 citation statements)

References 19 publications

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“…Based on our cohort, children with IH requiring cardiological assessment are those with clinical symptoms (cardiac murmur), abnormal blood pressure or heart rate, syndromic forms (PHACES), high risk of heart failure (hepatic, military haemangiomas), or off-label use (preterm birth, neonate period). These results are consistent with previous studies reporting that systematic echocardiography 44,45 or ECG 40,46 before propranolol initiation are not relevant in terms of contraindication assessment and correlation with SAE occurrence 47 .…”

Section: Discussionsupporting

confidence: 92%

Hemangiol® in infantile haemangioma: A paediatric post-marketing surveillance drug study

et al.

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Aim: Infantile haemangioma (IH) is the most common benign tumour in children. Since 2014, propranolol has become the first-choice therapy and currently Hemangiol® is the only approved drug for complicated haemangioma. This post-marketing study reported the use of Hemangiol® for IH in paediatric practice. Method and Results: From January 2014 to November 2018, 94 children (median age 4 [0;21] months; 75% female) treated with Hemangiol® for proliferative IH were enrolled in the study. The systematic paediatric cardiology consultation never contraindicated beta-blockers. Two Hemangiol® initiation protocols were used: a conventional ambulatory 3-week titration phase protocol (N=76, 80.9%), and a rapid initiation protocol with a 48-hour dose escalation in conventional hospitalization for severe proliferative IH (N=18, 19.1%). In both protocols, the haemodynamic tolerance was good. The mean maintenance dose of Hemangiol® was 2.7±0.8 mg/kg/day, with a median treatment duration of 7 [1.5;19] months. Adverse events (AEs) have been found in 25 (26,6%) patients including 8 (8.5%) patients with serious AEs (uncontrolled bronchial hyperreactivity, N=5; serious hypoglycaemia, N=3). Some patients had one or more AEs, a total of 24 non-serious AEs was reported in 19 patients (sleep disturbances, N=9; respiratory disorders, N=5; digestive disorders, N=6). No cardiac adverse event was reported. Conclusion: This post-marketing surveillance drug study supports the good tolerance of Hemangiol® in children with IH. A rapid initiation protocol is of interest when treatment is urgent. The pre-therapeutic paediatric cardiology consultation should not be systematic but only indicated on specific patients.

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Section: Discussionsupporting

confidence: 92%

Hemangiol® in infantile haemangioma: A paediatric post-marketing surveillance drug study

et al.

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“…Based on our cohort, children with IH requiring cardiological assessment are those with clinical symptoms (cardiac murmur), abnormal blood pressure or heart rate, syndromic forms (PHACES), high risk of heart failure (hepatic, miliary haemangiomas or very large superficial IH) or off-label use (preterm birth, neonate period). These results are consistent with previous studies reporting that systematic echocardiography 46,47 or ECG 42,48 before propranolol initiation are not relevant in terms of contraindication assessment and correlation with SAE occurrence. 49 Most patients (81%) underwent a conventional initiation protocol with a 3-week titration phase in daycare hospital.…”

Section: T a B L E 3 Serious Adverse Eventssupporting

confidence: 92%

Hemangiol in infantile haemangioma: A paediatric post‐marketing surveillance drug study

Socchi

Bigorre

Normandin

et al. 2020

Brit J Clinical Pharma

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HAL is a multidisciplinary open access archive for the deposit and dissemination of scientific research documents, whether they are published or not. The documents may come from teaching and research institutions in France or abroad, or from public or private research centers. L'archive ouverte pluridisciplinaire HAL, est destinée au dépôt et à la diffusion de documents scientifiques de niveau recherche, publiés ou non, émanant des établissements d'enseignement et de recherche français ou étrangers, des laboratoires publics ou privés.

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“…Our findings support previously published findings, providing further confirmation that pretreatment ECG is not necessary in most infants with IH starting propranolol and validating the limited screening approach proposed in the consensus guidelines . Future revision of these guidelines should emphasize that ECG abnormalities lack significant positive predictive value for treatment‐related side effects.…”

supporting

confidence: 89%

“…Consensus guidelines for propranolol treatment of infantile hemangiomas (IH) published in 2013 included a recommendation for electrocardiography (ECG) screening for infants in high‐risk groups: below‐normal heart rate for age, presence of an arrhythmia, or family history of arrhythmia or congenital heart disease . This approach has been validated in three studies, but many clinicians routinely check baseline ECG before initiation of propranolol treatment. The objective of this retrospective cohort study was to confirm that there is limited value in universal ECG before initiation of propranolol for IH.…”

mentioning

confidence: 99%

Utility of routine electrocardiographic screening before initiation of propranolol for infantile hemangiomas

Lund

Chamlin

Mancini

2018

Pediatric Dermatology

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Screening electrocardiography (ECG) before initiation of propranolol for treatment of infantile hemangiomas (IH) is controversial. A retrospective chart review was conducted to assess the utility of pretreatment ECG in infants with IH starting propranolol. Although nearly half of the ECGs were abnormal, no contraindications to treatment were identified from screening ECG, and no association was found between any of the reported side effects and abnormal ECG. These results support previously published data, and in a larger cohort, providing further confirmation that pretreatment ECG is not necessary in most infants with IH.

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Is Routine Electrocardiography Necessary Before Initiation of Propranolol for Treatment of Infantile Hemangiomas?

Abstract: Our findings suggest that routine ECG may not be necessary or helpful in the vast majority of patients treated with propranolol for IHs.

Cited by 12 publications

References 19 publications

Hemangiol® in infantile haemangioma: A paediatric post-marketing surveillance drug study

Hemangiol® in infantile haemangioma: A paediatric post-marketing surveillance drug study

Hemangiol in infantile haemangioma: A paediatric post‐marketing surveillance drug study

Utility of routine electrocardiographic screening before initiation of propranolol for infantile hemangiomas

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